[House Report 113-188]
[From the U.S. Government Publishing Office]
113th Congress Report
HOUSE OF REPRESENTATIVES
1st Session 113-188
======================================================================
AMENDING THE FEDERAL FOOD, DRUG, AND COSMETIC ACT TO REAUTHORIZE USER
FEE PROGRAMS RELATING TO NEW ANIMAL DRUGS
_______
August 2, 2013.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Upton, from the Committee on Energy and Commerce,
submitted the following
R E P O R T
[To accompany H.R. 1407]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 1407) to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize user fee programs relating to new
animal drugs, having considered the same, report favorably
thereon with amendments and recommend that the bill as amended
do pass.
CONTENTS
Page
Purpose and Summary.............................................. 17
Background and Need for Legislation.............................. 17
Hearings......................................................... 18
Committee Consideration.......................................... 18
Committee Votes.................................................. 19
Committee Oversight Findings..................................... 19
Statement of General Performance Goals and Objectives............ 19
New Budget Authority, Entitlement Authority, and Tax Expenditures 19
Earmarks, Limited Tax Benefits, and Limited Tariff Benefits...... 19
Committee Cost Estimate.......................................... 19
Congressional Budget Office Estimate............................. 19
Federal Mandates Statement....................................... 24
Duplication of Federal Programs.................................. 24
Disclosure of Directed Rule Makings.............................. 24
Advisory Committee Statement..................................... 24
Applicability to Legislative Branch.............................. 24
Section-by-Section Analysis of the Legislation................... 24
Changes in Existing Law Made by the Bill, as Reported............ 25
The amendments are as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. TABLE OF CONTENTS.
Sec. 1. Table of Contents.
TITLE I--ANIMAL DRUG USER FEE AMENDMENTS
Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use animal drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Savings clause.
Sec. 106. Effective date.
Sec. 107. Sunset dates.
TITLE II--ANIMAL GENERIC DRUG USER FEE AMENDMENTS
Sec. 201. Short title; finding.
Sec. 202. Authority to assess and use generic new animal drug fees.
Sec. 203. Reauthorization; reporting requirements.
Sec. 204. Savings clause.
Sec. 205. Effective date.
Sec. 206. Sunset dates.
TITLE I--ANIMAL DRUG USER FEE AMENDMENTS
SEC. 101. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Animal Drug User
Fee Amendments of 2013''.
(b) Finding.--Congress finds that the fees authorized by the
amendments made in this title will be dedicated toward expediting the
animal drug development process and the review of new and supplemental
animal drug applications and investigational animal drug submissions as
set forth in the goals identified, for purposes of part 4 of subchapter
C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the
letters from the Secretary of Health and Human Services to the Chairman
of the Committee on Energy and Commerce of the House of Representatives
and the Chairman of the Committee on Health, Education, Labor, and
Pensions of the Senate as set forth in the Congressional Record.
SEC. 102. DEFINITIONS.
Section 739 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-11) is amended to read as follows:
``SEC. 739. DEFINITIONS.
``For purposes of this part:
``(1) The term `animal drug application' means an application
for approval of any new animal drug submitted under section
512(b)(1). Such term does not include either a new animal drug
application submitted under section 512(b)(2) or a supplemental
animal drug application.
``(2) The term `supplemental animal drug application' means--
``(A) a request to the Secretary to approve a change
in an animal drug application which has been approved;
or
``(B) a request to the Secretary to approve a change
to an application approved under section 512(c)(2) for
which data with respect to safety or effectiveness are
required.
``(3) The term `animal drug product' means each specific
strength or potency of a particular active ingredient or
ingredients in final dosage form marketed by a particular
manufacturer or distributor, which is uniquely identified by
the labeler code and product code portions of the national drug
code, and for which an animal drug application or a
supplemental animal drug application has been approved.
``(4) The term `animal drug establishment' means a foreign or
domestic place of business which is at one general physical
location consisting of one or more buildings all of which are
within 5 miles of each other, at which one or more animal drug
products are manufactured in final dosage form.
``(5) The term `investigational animal drug submission'
means--
``(A) the filing of a claim for an investigational
exemption under section 512(j) for a new animal drug
intended to be the subject of an animal drug
application or a supplemental animal drug application;
or
``(B) the submission of information for the purpose
of enabling the Secretary to evaluate the safety or
effectiveness of an animal drug application or
supplemental animal drug application in the event of
their filing.
``(6) The term `animal drug sponsor' means either an
applicant named in an animal drug application that has not been
withdrawn by the applicant and for which approval has not been
withdrawn by the Secretary, or a person who has submitted an
investigational animal drug submission that has not been
terminated or otherwise rendered inactive by the Secretary.
``(7) The term `final dosage form' means, with respect to an
animal drug product, a finished dosage form which is approved
for administration to an animal without substantial further
manufacturing. Such term includes animal drug products intended
for mixing in animal feeds.
``(8) The term `process for the review of animal drug
applications' means the following activities of the Secretary
with respect to the review of animal drug applications,
supplemental animal drug applications, and investigational
animal drug submissions:
``(A) The activities necessary for the review of
animal drug applications, supplemental animal drug
applications, and investigational animal drug
submissions.
``(B) The issuance of action letters which approve
animal drug applications or supplemental animal drug
applications or which set forth in detail the specific
deficiencies in animal drug applications, supplemental
animal drug applications, or investigational animal
drug submissions and, where appropriate, the actions
necessary to place such applications, supplements, or
submissions in condition for approval.
``(C) The inspection of animal drug establishments
and other facilities undertaken as part of the
Secretary's review of pending animal drug applications,
supplemental animal drug applications, and
investigational animal drug submissions.
``(D) Monitoring of research conducted in connection
with the review of animal drug applications,
supplemental animal drug applications, and
investigational animal drug submissions.
``(E) The development of regulations and policy
related to the review of animal drug applications,
supplemental animal drug applications, and
investigational animal drug submissions.
``(F) Development of standards for products subject
to review.
``(G) Meetings between the agency and the animal drug
sponsor.
``(H) Review of advertising and labeling prior to
approval of an animal drug application or supplemental
animal drug application, but not after such application
has been approved.
``(9) The term `costs of resources allocated for the process
for the review of animal drug applications' means the expenses
in connection with the process for the review of animal drug
applications for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees consulted with
respect to the review of specific animal drug
applications, supplemental animal drug applications, or
investigational animal drug submissions, and costs
related to such officers, employees, committees, and
contractors, including costs for travel, education, and
recruitment and other personnel activities;
``(B) management of information and the acquisition,
maintenance, and repair of computer resources;
``(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(D) collecting fees under section 740 and
accounting for resources allocated for the review of
animal drug applications, supplemental animal drug
applications, and investigational animal drug
submissions.
``(10) The term `adjustment factor' applicable to a fiscal
year refers to the formula set forth in section 735(8) with the
base or comparator month being October 2002.
``(11) The term `person' includes an affiliate thereof.
``(12) The term `affiliate' refers to the definition set
forth in section 735(11).''.
SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
Section 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-12) is amended to read as follows:
``SEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
``(a) Types of Fees.--Beginning in fiscal year 2004, the Secretary
shall assess and collect fees in accordance with this section as
follows:
``(1) Animal drug application and supplement fee.--
``(A) In general.--Each person that submits, on or
after September 1, 2003, an animal drug application or
a supplemental animal drug application shall be subject
to a fee as follows:
``(i) A fee established in subsection (c) for
an animal drug application, except an animal
drug application described in section
512(d)(4).
``(ii) A fee established in subsection (c),
in an amount that is equal to 50 percent of the
amount of the fee under clause (i), for--
``(I) a supplemental animal drug
application for which safety or
effectiveness data are required; and
``(II) an animal drug application
described in section 512(d)(4).
``(B) Payment.--The fee required by subparagraph (A)
shall be due upon submission of the animal drug
application or supplemental animal drug application.
``(C) Exception for previously filed application or
supplement.--If an animal drug application or a
supplemental animal drug application was submitted by a
person that paid the fee for such application or
supplement, was accepted for filing, and was not
approved or was withdrawn (without a waiver or refund),
the submission of an animal drug application or a
supplemental animal drug application for the same
product by the same person (or the person's licensee,
assignee, or successor) shall not be subject to a fee
under subparagraph (A).
``(D) Refund of fee if application refused for
filing.--The Secretary shall refund 75 percent of the
fee paid under subparagraph (B) for any animal drug
application or supplemental animal drug application
which is refused for filing.
``(E) Refund of fee if application withdrawn.--If an
animal drug application or a supplemental animal drug
application is withdrawn after the application or
supplement was filed, the Secretary may refund the fee
or portion of the fee paid under subparagraph (B) if no
substantial work was performed on the application or
supplement after the application or supplement was
filed. The Secretary shall have the sole discretion to
refund the fee under this paragraph. A determination by
the Secretary concerning a refund under this paragraph
shall not be reviewable.
``(2) Animal drug product fee.--
``(A) In general.--Each person--
``(i) who is named as the applicant in an
animal drug application or supplemental animal
drug application for an animal drug product
which has been submitted for listing under
section 510; and
``(ii) who, after September 1, 2003, had
pending before the Secretary an animal drug
application or supplemental animal drug
application,
shall pay for each such animal drug product the annual
fee established in subsection (c).
``(B) Payment; fee due date.--Such fee shall be
payable for the fiscal year in which the animal drug
product is first submitted for listing under section
510, or is submitted for relisting under section 510 if
the animal drug product has been withdrawn from listing
and relisted. After such fee is paid for that fiscal
year, such fee shall be due each subsequent fiscal year
that the product remains listed, upon the later of--
``(i) the first business day after the date
of enactment of an appropriations Act providing
for the collection and obligation of fees for
such fiscal year under this section; or
``(ii) January 31 of each year.
``(C) Limitation.--Such fee shall be paid only once
for each animal drug product for a fiscal year in which
the fee is payable.
``(3) Animal drug establishment fee.--
``(A) In general.--Each person--
``(i) who owns or operates, directly or
through an affiliate, an animal drug
establishment;
``(ii) who is named as the applicant in an
animal drug application or supplemental animal
drug application for an animal drug product
which has been submitted for listing under
section 510; and
``(iii) who, after September 1, 2003, had
pending before the Secretary an animal drug
application or supplemental animal drug
application,
shall be assessed an annual establishment fee as
established in subsection (c) for each animal drug
establishment listed in its approved animal drug
application as an establishment that manufactures the
animal drug product named in the application.
``(B) Payment; fee due date.--The annual
establishment fee shall be assessed in each fiscal year
in which the animal drug product named in the
application is assessed a fee under paragraph (2)
unless the animal drug establishment listed in the
application does not engage in the manufacture of the
animal drug product during the fiscal year. The fee
under this paragraph for a fiscal year shall be due
upon the later of--
``(i) the first business day after the date
of enactment of an appropriations Act providing
for the collection and obligation of fees for
such fiscal year under this section; or
``(ii) January 31 of each year.
``(C) Limitation.--
``(i) In general.--An establishment shall be
assessed only one fee per fiscal year under
this section, subject to clause (ii).
``(ii) Certain manufacturers.--If a single
establishment manufactures both animal drug
products and prescription drug products, as
defined in section 735(3), such establishment
shall be assessed both the animal drug
establishment fee and the prescription drug
establishment fee, as set forth in section
736(a)(2), within a single fiscal year.
``(4) Animal drug sponsor fee.--
``(A) In general.--Each person--
``(i) who meets the definition of an animal
drug sponsor within a fiscal year; and
``(ii) who, after September 1, 2003, had
pending before the Secretary an animal drug
application, a supplemental animal drug
application, or an investigational animal drug
submission,
shall be assessed an annual sponsor fee as established
under subsection (c).
``(B) Payment; fee due date.--The fee under this
paragraph for a fiscal year shall be due upon the later
of--
``(i) the first business day after the date
of enactment of an appropriations Act providing
for the collection and obligation of fees for
such fiscal year under this section; or
``(ii) January 31 of each year.
``(C) Limitation.--Each animal drug sponsor shall pay
only one such fee each fiscal year.
``(b) Fee Revenue Amounts.--
``(1) In general.--Subject to subsections (c), (d), (f), and
(g)--
``(A) for fiscal year 2014, the fees required under
subsection (a) shall be established to generate a total
revenue amount of $23,600,000; and
``(B) for each of fiscal years 2015 through 2018, the
fees required under subsection (a) shall be established
to generate a total revenue amount of $21,600,000.
``(2) Types of fees.--Of the total revenue amount determined
for a fiscal year under paragraph (1)--
``(A) 20 percent shall be derived from fees under
subsection (a)(1) (relating to animal drug applications
and supplements);
``(B) 27 percent shall be derived from fees under
subsection (a)(2) (relating to animal drug products);
``(C) 26 percent shall be derived from fees under
subsection (a)(3) (relating to animal drug
establishments); and
``(D) 27 percent shall be derived from fees under
subsection (a)(4) (relating to animal drug sponsors).
``(c) Annual Fee Setting; Adjustments.--
``(1) Annual fee setting.--The Secretary shall establish, 60
days before the start of each fiscal year beginning after
September 30, 2003, for that fiscal year, animal drug
application fees, supplemental animal drug application fees,
animal drug sponsor fees, animal drug establishment fees, and
animal drug product fees based on the revenue amounts
established under subsection (b) and the adjustments provided
under this subsection.
``(2) Inflation adjustment.--For fiscal year 2015 and
subsequent fiscal years, the revenue amounts established in
subsection (b) shall be adjusted by the Secretary by notice,
published in the Federal Register, for a fiscal year, by an
amount equal to the sum of--
``(A) one;
``(B) the average annual percent change in the cost,
per full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and
benefits paid with respect to such positions for the
first 3 of the preceding 4 fiscal years for which data
are available, multiplied by the average proportion of
personnel compensation and benefits costs to total Food
and Drug Administration costs for the first 3 years of
the preceding 4 fiscal years for which data are
available; and
``(C) the average annual percent change that occurred
in the Consumer Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally
adjusted; all items less food and energy; annual index)
for the first 3 years of the preceding 4 years for
which data are available multiplied by the average
proportion of all costs other than personnel
compensation and benefits costs to total Food and Drug
Administration costs for the first 3 years of the
preceding 4 fiscal years for which data are available.
The adjustment made each fiscal year under this paragraph shall
be added on a compounded basis to the sum of all adjustments
made each fiscal year after fiscal year 2014 under this
paragraph.
``(3) Workload adjustment.--For fiscal year 2015 and
subsequent fiscal years, after the revenue amounts established
in subsection (b) are adjusted for inflation in accordance with
paragraph (2), the revenue amounts shall be further adjusted
for such fiscal year to reflect changes in the workload of the
Secretary for the process for the review of animal drug
applications. With respect to such adjustment--
``(A) such adjustment shall be determined by the
Secretary based on a weighted average of the change in
the total number of animal drug applications,
supplemental animal drug applications for which data
with respect to safety or effectiveness are required,
manufacturing supplemental animal drug applications,
investigational animal drug study submissions, and
investigational animal drug protocol submissions
submitted to the Secretary;
``(B) the Secretary shall publish in the Federal
Register the fees resulting from such adjustment and
the supporting methodologies; and
``(C) under no circumstances shall such adjustment
result in fee revenues for a fiscal year that are less
than the fee revenues for that fiscal year established
in subsection (b), as adjusted for inflation under
paragraph (2).
``(4) Final year adjustment.--For fiscal year 2018, the
Secretary may, in addition to other adjustments under this
subsection, further increase the fees under this section, if
such an adjustment is necessary to provide for up to 3 months
of operating reserves of carryover user fees for the process
for the review of animal drug applications for the first 3
months of fiscal year 2019. If the Food and Drug Administration
has carryover balances for the process for the review of animal
drug applications in excess of 3 months of such operating
reserves, then this adjustment will not be made. If this
adjustment is necessary, then the rationale for the amount of
the increase shall be contained in the annual notice setting
fees for fiscal year 2018.
``(5) Limit.--The total amount of fees charged, as adjusted
under this subsection, for a fiscal year may not exceed the
total costs for such fiscal year for the resources allocated
for the process for the review of animal drug applications.
``(d) Fee Waiver or Reduction.--
``(1) In general.--The Secretary shall grant a waiver from or
a reduction of one or more fees assessed under subsection (a)
where the Secretary finds that--
``(A) the assessment of the fee would present a
significant barrier to innovation because of limited
resources available to such person or other
circumstances;
``(B) the fees to be paid by such person will exceed
the anticipated present and future costs incurred by
the Secretary in conducting the process for the review
of animal drug applications for such person;
``(C) the animal drug application or supplemental
animal drug application is intended solely to provide
for use of the animal drug in--
``(i) a Type B medicated feed (as defined in
section 558.3(b)(3) of title 21, Code of
Federal Regulations (or any successor
regulation)) intended for use in the
manufacture of Type C free-choice medicated
feeds; or
``(ii) a Type C free-choice medicated feed
(as defined in section 558.3(b)(4) of title 21,
Code of Federal Regulations (or any successor
regulation));
``(D) the animal drug application or supplemental
animal drug application is intended solely to provide
for a minor use or minor species indication; or
``(E) the sponsor involved is a small business
submitting its first animal drug application to the
Secretary for review.
``(2) Use of standard costs.--In making the finding in
paragraph (1)(B), the Secretary may use standard costs.
``(3) Rules for small businesses.--
``(A) Definition.--In paragraph (1)(E), the term
`small business' means an entity that has fewer than
500 employees, including employees of affiliates.
``(B) Waiver of application fee.--The Secretary shall
waive under paragraph (1)(E) the application fee for
the first animal drug application that a small business
or its affiliate submits to the Secretary for review.
After a small business or its affiliate is granted such
a waiver, the small business or its affiliate shall pay
application fees for all subsequent animal drug
applications and supplemental animal drug applications
for which safety or effectiveness data are required in
the same manner as an entity that does not qualify as a
small business.
``(C) Certification.--The Secretary shall require any
person who applies for a waiver under paragraph (1)(E)
to certify their qualification for the waiver. The
Secretary shall periodically publish in the Federal
Register a list of persons making such certifications.
``(e) Effect of Failure To Pay Fees.--An animal drug application or
supplemental animal drug application submitted by a person subject to
fees under subsection (a) shall be considered incomplete and shall not
be accepted for filing by the Secretary until all fees owed by such
person have been paid. An investigational animal drug submission under
section 739(5)(B) that is submitted by a person subject to fees under
subsection (a) shall be considered incomplete and shall not be accepted
for review by the Secretary until all fees owed by such person have
been paid. The Secretary may discontinue review of any animal drug
application, supplemental animal drug application, or investigational
animal drug submission from a person if such person has not submitted
for payment all fees owed under this section by 30 days after the date
upon which they are due.
``(f) Assessment of Fees.--
``(1) Limitation.--Fees may not be assessed under subsection
(a) for a fiscal year beginning after fiscal year 2003 unless
appropriations for salaries and expenses of the Food and Drug
Administration for such fiscal year (excluding the amount of
fees appropriated for such fiscal year) are equal to or greater
than the amount of appropriations for the salaries and expenses
of the Food and Drug Administration for the fiscal year 2003
(excluding the amount of fees appropriated for such fiscal
year) multiplied by the adjustment factor applicable to the
fiscal year involved.
``(2) Authority.--If the Secretary does not assess fees under
subsection (a) during any portion of a fiscal year because of
paragraph (1) and if at a later date in such fiscal year the
Secretary may assess such fees, the Secretary may assess and
collect such fees, without any modification in the rate, for
animal drug applications, supplemental animal drug
applications, investigational animal drug submissions, animal
drug sponsors, animal drug establishments, and animal drug
products at any time in such fiscal year notwithstanding the
provisions of subsection (a) relating to the date fees are to
be paid.
``(g) Crediting and Availability of Fees.--
``(1) In general.--Subject to paragraph (2)(C), fees
authorized under subsection (a) shall be collected and
available for obligation only to the extent and in the amount
provided in advance in appropriations Acts. Such fees are
authorized to be appropriated to remain available until
expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salary and expenses with such fiscal
year limitation. The sums transferred shall be available solely
for the process for the review of animal drug applications.
``(2) Collections and appropriation acts.--
``(A) In general.--The fees authorized by this
section--
``(i) subject to subparagraph (C), shall be
collected and available in each fiscal year in
an amount not to exceed the amount specified in
appropriation Acts, or otherwise made available
for obligation for such fiscal year; and
``(ii) shall be available to defray increases
in the costs of the resources allocated for the
process for the review of animal drug
applications (including increases in such costs
for an additional number of full-time
equivalent positions in the Department of
Health and Human Services to be engaged in such
process) over such costs, excluding costs paid
from fees collected under this section, for
fiscal year 2003 multiplied by the adjustment
factor.
``(B) Compliance.--The Secretary shall be considered
to have met the requirements of subparagraph (A)(ii) in
any fiscal year if the costs funded by appropriations
and allocated for the process for the review of animal
drug applications--
``(i) are not more than 3 percent below the
level specified in subparagraph (A)(ii); or
``(ii)(I) are more than 3 percent below the
level specified in subparagraph (A)(ii), and
fees assessed for the fiscal year following the
subsequent fiscal year are decreased by the
amount in excess of 3 percent by which such
costs fell below the level specified in
subparagraph (A)(ii); and
``(II) such costs are not more than 5 percent
below the level specified in subparagraph
(A)(ii).
``(C) Provision for early payments.--Payment of fees
authorized under this section for a fiscal year, prior
to the due date for such fees, may be accepted by the
Secretary in accordance with authority provided in
advance in a prior year appropriations Act.
``(3) Authorization of appropriations.--For each of the
fiscal years 2014 through 2018, there is authorized to be
appropriated for fees under this section an amount equal to the
total revenue amount determined under subsection (b) for the
fiscal year, as adjusted or otherwise affected under subsection
(c) and paragraph (4).
``(4) Offset of overcollections; recovery of collection
shortfalls.--
``(A) Offset of overcollections.--If the sum of the
cumulative amount of fees collected under this section
for fiscal years 2014 through 2016 and the amount of
fees estimated to be collected under this section for
fiscal year 2017 (including any increased fee
collections attributable to subparagraph (B)), exceeds
the cumulative amount appropriated pursuant to
paragraph (3) for the fiscal years 2014 through 2017,
the excess amount shall be credited to the
appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall
be subtracted from the amount of fees that would
otherwise be authorized to be collected under this
section pursuant to appropriation Acts for fiscal year
2018.
``(B) Recovery of collection shortfalls.--
``(i) Fiscal year 2016.--For fiscal year
2016, the amount of fees otherwise authorized
to be collected under this section shall be
increased by the amount, if any, by which the
amount collected under this section and
appropriated for fiscal year 2014 falls below
the amount of fees authorized for fiscal year
2014 under paragraph (3).
``(ii) Fiscal year 2017.--For fiscal year
2017, the amount of fees otherwise authorized
to be collected under this section shall be
increased by the amount, if any, by which the
amount collected under this section and
appropriated for fiscal year 2015 falls below
the amount of fees authorized for fiscal year
2015 under paragraph (3).
``(iii) Fiscal year 2018.--For fiscal year
2018, the amount of fees otherwise authorized
to be collected under this section (including
any reduction in the authorized amount under
subparagraph (A)), shall be increased by the
cumulative amount, if any, by which the amount
collected under this section and appropriated
for fiscal years 2016 and 2017 (including
estimated collections for fiscal year 2017)
falls below the cumulative amount of fees
authorized under paragraph (3) for fiscal years
2016 and 2017.
``(h) Collection of Unpaid Fees.--In any case where the Secretary
does not receive payment of a fee assessed under subsection (a) within
30 days after it is due, such fee shall be treated as a claim of the
United States Government subject to subchapter II of chapter 37 of
title 31, United States Code.
``(i) Written Requests for Waivers, Reductions, and Refunds.--To
qualify for consideration for a waiver or reduction under subsection
(d), or for a refund of any fee collected in accordance with subsection
(a), a person shall submit to the Secretary a written request for such
waiver, reduction, or refund not later than 180 days after such fee is
due.
``(j) Construction.--This section may not be construed to require
that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employees, and advisory
committees not engaged in the process of the review of animal drug
applications, be reduced to offset the number of officers, employees,
and advisory committees so engaged.
``(k) Abbreviated New Animal Drug Applications.--The Secretary
shall--
``(1) to the extent practicable, segregate the review of
abbreviated new animal drug applications from the process for
the review of animal drug applications; and
``(2) adopt other administrative procedures to ensure that
review times of abbreviated new animal drug applications do not
increase from their current level due to activities under the
user fee program.''.
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-13) is amended to read as follows:
``SEC. 740A. REAUTHORIZATION; REPORTING REQUIREMENTS.
``(a) Performance Report.--Beginning with fiscal year 2014, not later
than 120 days after the end of each fiscal year during which fees are
collected under this part, the Secretary shall prepare and submit to
the Committee on Energy and Commerce of the House of Representatives
and the Committee on Health, Education, Labor, and Pensions of the
Senate a report concerning the progress of the Food and Drug
Administration in achieving the goals identified in the letters
described in section 101(b) of the Animal Drug User Fee Amendments of
2013 toward expediting the animal drug development process and the
review of the new and supplemental animal drug applications and
investigational animal drug submissions during such fiscal year, the
future plans of the Food and Drug Administration for meeting the goals,
the review times for abbreviated new animal drug applications, and the
administrative procedures adopted by the Food and Drug Administration
to ensure that review times for abbreviated new animal drug
applications are not increased from their current level due to
activities under the user fee program.
``(b) Fiscal Report.--Beginning with fiscal year 2014, not later than
120 days after the end of each fiscal year during which fees are
collected under this part, the Secretary shall prepare and submit to
the Committee on Energy and Commerce of the House of Representatives
and the Committee on Health, Education, Labor, and Pensions of the
Senate a report on the implementation of the authority for such fees
during such fiscal year and the use, by the Food and Drug
Administration, of the fees collected during such fiscal year for which
the report is made.
``(c) Public Availability.--The Secretary shall make the reports
required under subsections (a) and (b) available to the public on the
Internet Web site of the Food and Drug Administration.
``(d) Reauthorization.--
``(1) Consultation.--In developing recommendations to present
to the Congress with respect to the goals, and plans for
meeting the goals, for the process for the review of animal
drug applications for the first 5 fiscal years after fiscal
year 2018, and for the reauthorization of this part for such
fiscal years, the Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the
House of Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) veterinary professionals;
``(E) representatives of patient and consumer
advocacy groups; and
``(F) the regulated industry.
``(2) Prior public input.--Prior to beginning negotiations
with the regulated industry on the reauthorization of this
part, the Secretary shall--
``(A) publish a notice in the Federal Register
requesting public input on the reauthorization;
``(B) hold a public meeting at which the public may
present its views on the reauthorization, including
specific suggestions for changes to the goals referred
to in subsection (a);
``(C) provide a period of 30 days after the public
meeting to obtain written comments from the public
suggesting changes to this part; and
``(D) publish the comments on the Food and Drug
Administration's Internet Web site.
``(3) Periodic consultation.--Not less frequently than once
every 4 months during negotiations with the regulated industry,
the Secretary shall hold discussions with representatives of
veterinary, patient, and consumer advocacy groups to continue
discussions of their views on the reauthorization and their
suggestions for changes to this part as expressed under
paragraph (2).
``(4) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under
paragraph (1) to the congressional committees specified
in such paragraph;
``(B) publish such recommendations in the Federal
Register;
``(C) provide for a period of 30 days for the public
to provide written comments on such recommendations;
``(D) hold a meeting at which the public may present
its views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(5) Transmittal of recommendations.--Not later than January
15, 2018, the Secretary shall transmit to Congress the revised
recommendations under paragraph (4), a summary of the views and
comments received under such paragraph, and any changes made to
the recommendations in response to such views and comments.
``(6) Minutes of negotiation meetings.--
``(A) Public availability.--Before presenting the
recommendations developed under paragraphs (1) through
(5) to Congress, the Secretary shall make publicly
available, on the Internet Web site of the Food and
Drug Administration, minutes of all negotiation
meetings conducted under this subsection between the
Food and Drug Administration and the regulated
industry.
``(B) Content.--The minutes described under
subparagraph (A) shall summarize any substantive
proposal made by any party to the negotiations as well
as significant controversies or differences of opinion
during the negotiations and their resolution.''.
SEC. 105. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 4 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-11 et seq.), as in effect on the day before the date of
the enactment of this title, shall continue to be in effect with
respect to animal drug applications and supplemental animal drug
applications (as defined in such part as of such day) that on or after
October 1, 2008, but before October 1, 2013, were accepted by the Food
and Drug Administration for filing with respect to assessing and
collecting any fee required by such part for a fiscal year prior to
fiscal year 2014.
SEC. 106. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2013, or the date of enactment of this title, whichever is later,
except that fees under part 4 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, as amended by this title, shall
be assessed for all animal drug applications and supplemental animal
drug applications received on or after October 1, 2013, regardless of
the date of the enactment of this title.
SEC. 107. SUNSET DATES.
(a) Authorization.--Section 740 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-12) shall cease to be effective October 1,
2018.
(b) Reporting Requirements.--Section 740A of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-13) shall cease to be effective
January 31, 2019.
(c) Previous Sunset Provision.--
(1) In general.--Section 108 of the Animal Drug User Fee
Amendments of 2008 (Public Law 110-316) is repealed.
(2) Conforming amendment.--Public Law 110-316 (122 Stat.
2509) is amended in the table of contents in section 1, by
striking the item relating to section 108.
(d) Technical Clarification.--Effective November 18, 2003, section 5
of the Animal Drug User Fee Act of 2003 (Public Law 108-130) is
repealed.
TITLE II--ANIMAL GENERIC DRUG USER FEE AMENDMENTS
SECTION 201. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Animal Generic
Drug User Fee Amendments of 2013''.
(b) Finding.--The fees authorized by this title will be dedicated
toward expediting the generic new animal drug development process and
the review of abbreviated applications for generic new animal drugs,
supplemental abbreviated applications for generic new animal drugs, and
investigational submissions for generic new animal drugs as set forth
in the goals identified in the letters from the Secretary of Health and
Human Services to the Chairman of the Committee on Energy and Commerce
of the House of Representatives and the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate as set forth in
the Congressional Record.
SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES.
Section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-21) is amended to read as follows:
``SEC. 741. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES.
``(a) Types of Fees.--Beginning with respect to fiscal year 2009, the
Secretary shall assess and collect fees in accordance with this section
as follows:
``(1) Abbreviated application fee.--
``(A) In general.--Each person that submits, on or
after July 1, 2008, an abbreviated application for a
generic new animal drug shall be subject to a fee as
established in subsection (c) for such an application.
``(B) Payment.--The fee required by subparagraph (A)
shall be due upon submission of the abbreviated
application.
``(C) Exceptions.--
``(i) Previously filed application.--If an
abbreviated application was submitted by a
person that paid the fee for such application,
was accepted for filing, and was not approved
or was withdrawn (without a waiver or refund),
the submission of an abbreviated application
for the same product by the same person (or the
person's licensee, assignee, or successor)
shall not be subject to a fee under
subparagraph (A).
``(ii) Certain abbreviated applications
involving combination animal drugs.--An
abbreviated application for an animal drug
described in section 512(d)(4) and submitted on
or after October 1, 2013, shall be subject to a
fee equal to 50 percent of the amount of the
abbreviated application fee established in
subsection (c).
``(D) Refund of fee if application refused for
filing.--The Secretary shall refund 75 percent of the
fee paid under subparagraph (B) for any abbreviated
application which is refused for filing.
``(E) Refund of fee if application withdrawn.--If an
abbreviated application is withdrawn after the
application was filed, the Secretary may refund the fee
or portion of the fee paid under subparagraph (B) if no
substantial work was performed on the application after
the application was filed. The Secretary shall have the
sole discretion to refund the fee under this
subparagraph. A determination by the Secretary
concerning a refund under this subparagraph shall not
be reviewable.
``(2) Generic new animal drug product fee.--
``(A) In general.--Each person--
``(i) who is named as the applicant in an
abbreviated application or supplemental
abbreviated application for a generic new
animal drug product which has been submitted
for listing under section 510; and
``(ii) who, after September 1, 2008, had
pending before the Secretary an abbreviated
application or supplemental abbreviated
application,
shall pay for each such generic new animal drug product
the annual fee established in subsection (c).
``(B) Payment; fee due date.--Such fee shall be
payable for the fiscal year in which the generic new
animal drug product is first submitted for listing
under section 510, or is submitted for relisting under
section 510 if the generic new animal drug product has
been withdrawn from listing and relisted. After such
fee is paid for that fiscal year, such fee shall be due
each subsequent fiscal year that the product remains
listed, upon the later of--
``(i) the first business day after the date
of enactment of an appropriations Act providing
for the collection and obligation of fees for
such fiscal year under this section; or
``(ii) January 31 of each year.
``(C) Limitation.--Such fee shall be paid only once
for each generic new animal drug product for a fiscal
year in which the fee is payable.
``(3) Generic new animal drug sponsor fee.--
``(A) In general.--Each person--
``(i) who meets the definition of a generic
new animal drug sponsor within a fiscal year;
and
``(ii) who, after September 1, 2008, had
pending before the Secretary an abbreviated
application, a supplemental abbreviated
application, or an investigational submission,
shall be assessed an annual generic new animal drug
sponsor fee as established under subsection (c).
``(B) Payment; fee due date.--Such fee shall be due
each fiscal year upon the later of--
``(i) the first business day after the date
of enactment of an appropriations Act providing
for the collection and obligation of fees for
such fiscal year under this section; or
``(ii) January 31 of each year.
``(C) Amount of fee.--Each generic new animal drug
sponsor shall pay only 1 such fee each fiscal year, as
follows:
``(i) 100 percent of the amount of the
generic new animal drug sponsor fee published
for that fiscal year under subsection (c) for
an applicant with more than 6 approved
abbreviated applications.
``(ii) 75 percent of the amount of the
generic new animal drug sponsor fee published
for that fiscal year under subsection (c) for
an applicant with more than 1 and fewer than 7
approved abbreviated applications.
``(iii) 50 percent of the amount of the
generic new animal drug sponsor fee published
for that fiscal year under subsection (c) for
an applicant with 1 or fewer approved
abbreviated applications.
``(b) Fee Amounts.--Subject to subsections (c), (d), (f), and (g),
the fees required under subsection (a) shall be established to generate
fee revenue amounts as follows:
``(1) Total fee revenues for application fees.--The total fee
revenues to be collected in abbreviated application fees under
subsection (a)(1) shall be $1,832,000 for fiscal year 2014,
$1,736,000 for fiscal year 2015, $1,857,000 for fiscal year
2016, $1,984,000 for fiscal year 2017, and $2,117,000 for
fiscal year 2018.
``(2) Total fee revenues for product fees.--The total fee
revenues to be collected in generic new animal drug product
fees under subsection (a)(2) shall be $2,748,000 for fiscal
year 2014, $2,604,000 for fiscal year 2015, $2,786,000 for
fiscal year 2016, $2,976,000 for fiscal year 2017, and
$3,175,000 for fiscal year 2018.
``(3) Total fee revenues for sponsor fees.--The total fee
revenues to be collected in generic new animal drug sponsor
fees under subsection (a)(3) shall be $2,748,000 for fiscal
year 2014, $2,604,000 for fiscal year 2015, $2,786,000 for
fiscal year 2016, $2,976,000 for fiscal year 2017, and
$3,175,000 for fiscal year 2018.
``(c) Annual Fee Setting; Adjustments.--
``(1) Annual fee setting.--The Secretary shall establish, 60
days before the start of each fiscal year beginning after
September 30, 2008, for that fiscal year, abbreviated
application fees, generic new animal drug sponsor fees, and
generic new animal drug product fees, based on the revenue
amounts established under subsection (b) and the adjustments
provided under this subsection.
``(2) Workload adjustment.--The fee revenues shall be
adjusted each fiscal year after fiscal year 2014 to reflect
changes in review workload. With respect to such adjustment:
``(A) This adjustment shall be determined by the
Secretary based on a weighted average of the change in
the total number of abbreviated applications for
generic new animal drugs, manufacturing supplemental
abbreviated applications for generic new animal drugs,
investigational generic new animal drug study
submissions, and investigational generic new animal
drug protocol submissions submitted to the Secretary.
The Secretary shall publish in the Federal Register the
fees resulting from this adjustment and the supporting
methodologies.
``(B) Under no circumstances shall this workload
adjustment result in fee revenues for a fiscal year
that are less than the fee revenues for that fiscal
year established in subsection (b).
``(3) Final year adjustment.--For fiscal year 2018, the
Secretary may, in addition to other adjustments under this
subsection, further increase the fees under this section, if
such an adjustment is necessary, to provide for up to 3 months
of operating reserves of carryover user fees for the process
for the review of abbreviated applications for generic new
animal drugs for the first 3 months of fiscal year 2019. If the
Food and Drug Administration has carryover balances for the
process for the review of abbreviated applications for generic
new animal drugs in excess of 3 months of such operating
reserves, then this adjustment shall not be made. If this
adjustment is necessary, then the rationale for the amount of
the increase shall be contained in the annual notice setting
fees for fiscal year 2018.
``(4) Limit.--The total amount of fees charged, as adjusted
under this subsection, for a fiscal year may not exceed the
total costs for such fiscal year for the resources allocated
for the process for the review of abbreviated applications for
generic new animal drugs.
``(d) Fee Waiver or Reduction.--The Secretary shall grant a waiver
from or a reduction of 1 or more fees assessed under subsection (a)
where the Secretary finds that the generic new animal drug is intended
solely to provide for a minor use or minor species indication.
``(e) Effect of Failure To Pay Fees.--An abbreviated application for
a generic new animal drug submitted by a person subject to fees under
subsection (a) shall be considered incomplete and shall not be accepted
for filing by the Secretary until all fees owed by such person have
been paid. An investigational submission for a generic new animal drug
that is submitted by a person subject to fees under subsection (a)
shall be considered incomplete and shall not be accepted for review by
the Secretary until all fees owed by such person have been paid. The
Secretary may discontinue review of any abbreviated application for a
generic new animal drug, supplemental abbreviated application for a
generic new animal drug, or investigational submission for a generic
new animal drug from a person if such person has not submitted for
payment all fees owed under this section by 30 days after the date upon
which they are due.
``(f) Assessment of Fees.--
``(1) Limitation.--Fees may not be assessed under subsection
(a) for a fiscal year beginning after fiscal year 2008 unless
appropriations for salaries and expenses of the Food and Drug
Administration for such fiscal year (excluding the amount of
fees appropriated for such fiscal year) are equal to or greater
than the amount of appropriations for the salaries and expenses
of the Food and Drug Administration for the fiscal year 2003
(excluding the amount of fees appropriated for such fiscal
year) multiplied by the adjustment factor applicable to the
fiscal year involved.
``(2) Authority.--If the Secretary does not assess fees under
subsection (a) during any portion of a fiscal year because of
paragraph (1) and if at a later date in such fiscal year the
Secretary may assess such fees, the Secretary may assess and
collect such fees, without any modification in the rate, for
abbreviated applications, generic new animal drug sponsors, and
generic new animal drug products at any time in such fiscal
year notwithstanding the provisions of subsection (a) relating
to the date fees are to be paid.
``(g) Crediting and Availability of Fees.--
``(1) In general.--Subject to paragraph (2)(C), fees
authorized under subsection (a) shall be collected and
available for obligation only to the extent and in the amount
provided in advance in appropriations Acts. Such fees are
authorized to be appropriated to remain available until
expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salary and expenses with such fiscal
year limitation. The sums transferred shall be available solely
for the process for the review of abbreviated applications for
generic new animal drugs.
``(2) Collections and appropriation acts.--
``(A) In general.--The fees authorized by this
section--
``(i) subject to subparagraph (C), shall be
collected and available in each fiscal year in
an amount not to exceed the amount specified in
appropriation Acts, or otherwise made available
for obligation for such fiscal year; and
``(ii) shall be available to defray increases
in the costs of the resources allocated for the
process for the review of abbreviated
applications for generic new animal drugs
(including increases in such costs for an
additional number of full-time equivalent
positions in the Department of Health and Human
Services to be engaged in such process) over
such costs, excluding costs paid from fees
collected under this section, for fiscal year
2008 multiplied by the adjustment factor.
``(B) Compliance.--The Secretary shall be considered
to have met the requirements of subparagraph (A)(ii) in
any fiscal year if the costs funded by appropriations
and allocated for the process for the review of
abbreviated applications for generic new animal drugs--
``(i) are not more than 3 percent below the
level specified in subparagraph (A)(ii); or
``(ii)(I) are more than 3 percent below the
level specified in subparagraph (A)(ii), and
fees assessed for the fiscal year following the
subsequent fiscal year are decreased by the
amount in excess of 3 percent by which such
costs fell below the level specified in
subparagraph (A)(ii); and
``(II) such costs are not more than 5 percent
below the level specified in subparagraph
(A)(ii).
``(C) Provision for early payments.--Payment of fees
authorized under this section for a fiscal year, prior
to the due date for such fees, may be accepted by the
Secretary in accordance with authority provided in
advance in a prior year appropriations Act.
``(3) Authorization of appropriations.--There are authorized
to be appropriated for fees under this section--
``(A) $7,328,000 for fiscal year 2014;
``(B) $6,944,000 for fiscal year 2015;
``(C) $7,429,000 for fiscal year 2016;
``(D) $7,936,000 for fiscal year 2017; and
``(E) $8,467,000 for fiscal year 2018;
as adjusted to reflect adjustments in the total fee revenues
made under this section and changes in the total amounts
collected by abbreviated application fees, generic new animal
drug sponsor fees, and generic new animal drug product fees.
``(4) Offset.--If the sum of the cumulative amount of fees
collected under this section for the fiscal years 2014 through
2016 and the amount of fees estimated to be collected under
this section for fiscal year 2017 exceeds the cumulative amount
appropriated under paragraph (3) for the fiscal years 2014
through 2017, the excess amount shall be credited to the
appropriation account of the Food and Drug Administration as
provided in paragraph (1), and shall be subtracted from the
amount of fees that would otherwise be authorized to be
collected under this section pursuant to appropriation Acts for
fiscal year 2018.
``(h) Collection of Unpaid Fees.--In any case where the Secretary
does not receive payment of a fee assessed under subsection (a) within
30 days after it is due, such fee shall be treated as a claim of the
United States Government subject to subchapter II of chapter 37 of
title 31, United States Code.
``(i) Written Requests for Waivers, Reductions, and Refunds.--To
qualify for consideration for a waiver or reduction under subsection
(d), or for a refund of any fee collected in accordance with subsection
(a), a person shall submit to the Secretary a written request for such
waiver, reduction, or refund not later than 180 days after such fee is
due.
``(j) Construction.--This section may not be construed to require
that the number of full-time equivalent positions in the Department of
Health and Human Services, for officers, employees, and advisory
committees not engaged in the process of the review of abbreviated
applications for generic new animal drugs, be reduced to offset the
number of officers, employees, and advisory committees so engaged.
``(k) Definitions.--In this section and section 742:
``(1) Abbreviated application for a generic new animal
drug.--The terms `abbreviated application for a generic new
animal drug' and `abbreviated application' mean an abbreviated
application for the approval of any generic new animal drug
submitted under section 512(b)(2). Such term does not include a
supplemental abbreviated application for a generic new animal
drug.
``(2) Adjustment factor.--The term `adjustment factor'
applicable to a fiscal year is the Consumer Price Index for all
urban consumers (all items; United States city average) for
October of the preceding fiscal year divided by--
``(A) for purposes of subsection (f)(1), such Index
for October 2002; and
``(B) for purposes of subsection (g)(2)(A)(ii), such
Index for October 2007.
``(3) Costs of resources allocated for the process for the
review of abbreviated applications for generic new animal
drugs.--The term `costs of resources allocated for the process
for the review of abbreviated applications for generic new
animal drugs' means the expenses in connection with the process
for the review of abbreviated applications for generic new
animal drugs for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees consulted with
respect to the review of specific abbreviated
applications, supplemental abbreviated applications, or
investigational submissions, and costs related to such
officers, employees, committees, and contractors,
including costs for travel, education, and recruitment
and other personnel activities;
``(B) management of information, and the acquisition,
maintenance, and repair of computer resources;
``(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(D) collecting fees under this section and
accounting for resources allocated for the review of
abbreviated applications, supplemental abbreviated
applications, and investigational submissions.
``(4) Final dosage form.--The term `final dosage form' means,
with respect to a generic new animal drug product, a finished
dosage form which is approved for administration to an animal
without substantial further manufacturing. Such term includes
generic new animal drug products intended for mixing in animal
feeds.
``(5) Generic new animal drug.--The term `generic new animal
drug' means a new animal drug that is the subject of an
abbreviated application.
``(6) Generic new animal drug product.--The term `generic new
animal drug product' means each specific strength or potency of
a particular active ingredient or ingredients in final dosage
form marketed by a particular manufacturer or distributor,
which is uniquely identified by the labeler code and product
code portions of the national drug code, and for which an
abbreviated application for a generic new animal drug or a
supplemental abbreviated application has been approved.
``(7) Generic new animal drug sponsor.--The term `generic new
animal drug sponsor' means either an applicant named in an
abbreviated application for a generic new animal drug that has
not been withdrawn by the applicant and for which approval has
not been withdrawn by the Secretary, or a person who has
submitted an investigational submission for a generic new
animal drug that has not been terminated or otherwise rendered
inactive by the Secretary.
``(8) Investigational submission for a generic new animal
drug.--The terms `investigational submission for a generic new
animal drug' and `investigational submission' mean--
``(A) the filing of a claim for an investigational
exemption under section 512(j) for a generic new animal
drug intended to be the subject of an abbreviated
application or a supplemental abbreviated application;
or
``(B) the submission of information for the purpose
of enabling the Secretary to evaluate the safety or
effectiveness of a generic new animal drug in the event
of the filing of an abbreviated application or
supplemental abbreviated application for such drug.
``(9) Person.--The term `person' includes an affiliate
thereof (as such term is defined in section 735(11)).
``(10) Process for the review of abbreviated applications for
generic new animal drugs.--The term `process for the review of
abbreviated applications for generic new animal drugs' means
the following activities of the Secretary with respect to the
review of abbreviated applications, supplemental abbreviated
applications, and investigational submissions:
``(A) The activities necessary for the review of
abbreviated applications, supplemental abbreviated
applications, and investigational submissions.
``(B) The issuance of action letters which approve
abbreviated applications or supplemental abbreviated
applications or which set forth in detail the specific
deficiencies in abbreviated applications, supplemental
abbreviated applications, or investigational
submissions and, where appropriate, the actions
necessary to place such applications, supplemental
applications, or submissions in condition for approval.
``(C) The inspection of generic new animal drug
establishments and other facilities undertaken as part
of the Secretary's review of pending abbreviated
applications, supplemental abbreviated applications,
and investigational submissions.
``(D) Monitoring of research conducted in connection
with the review of abbreviated applications,
supplemental abbreviated applications, and
investigational submissions.
``(E) The development of regulations and policy
related to the review of abbreviated applications,
supplemental abbreviated applications, and
investigational submissions.
``(F) Development of standards for products subject
to review.
``(G) Meetings between the agency and the generic new
animal drug sponsor.
``(H) Review of advertising and labeling prior to
approval of an abbreviated application or supplemental
abbreviated application, but not after such application
has been approved.
``(11) Supplemental abbreviated application for generic new
animal drug.--The terms `supplemental abbreviated application
for a generic new animal drug' and `supplemental abbreviated
application' mean a request to the Secretary to approve a
change in an approved abbreviated application.''.
SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-22) is amended to read as follows:
``SEC. 742. REAUTHORIZATION; REPORTING REQUIREMENTS.
``(a) Performance Reports.--Beginning with fiscal year 2014, not
later than 120 days after the end of each fiscal year during which fees
are collected under this part, the Secretary shall prepare and submit
to the Committee on Health, Education, Labor, and Pensions of the
Senate, and the Committee on Energy and Commerce of the House of
Representatives a report concerning the progress of the Food and Drug
Administration in achieving the goals identified in the letters
described in section 201(b) of the Animal Generic Drug User Fee
Amendments of 2013 toward expediting the generic new animal drug
development process and the review of abbreviated applications for
generic new animal drugs, supplemental abbreviated applications for
generic new animal drugs, and investigational submissions for generic
new animal drugs during such fiscal year.
``(b) Fiscal Report.--Beginning with fiscal year 2014, not later than
120 days after the end of each fiscal year during which fees are
collected under this part, the Secretary shall prepare and submit to
the Committee on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House of
Representatives a report on the implementation of the authority for
such fees during such fiscal year and the use, by the Food and Drug
Administration, of the fees collected during such fiscal year for which
the report is made.
``(c) Public Availability.--The Secretary shall make the reports
required under subsections (a) and (b) available to the public on the
Internet Web site of the Food and Drug Administration.
``(d) Reauthorization.--
``(1) Consultation.--In developing recommendations to present
to Congress with respect to the goals, and plans for meeting
the goals, for the process for the review of abbreviated
applications for generic new animal drugs for the first 5
fiscal years after fiscal year 2018, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the
House of Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) veterinary professionals;
``(E) representatives of patient and consumer
advocacy groups; and
``(F) the regulated industry.
``(2) Prior public input.--Prior to beginning negotiations
with the regulated industry on the reauthorization of this
part, the Secretary shall--
``(A) publish a notice in the Federal Register
requesting public input on the reauthorization;
``(B) hold a public meeting at which the public may
present its views on the reauthorization, including
specific suggestions for changes to the goals referred
to in subsection (a);
``(C) provide a period of 30 days after the public
meeting to obtain written comments from the public
suggesting changes to this part; and
``(D) publish the comments on the Food and Drug
Administration's Internet Web site.
``(3) Periodic consultation.--Not less frequently than once
every 4 months during negotiations with the regulated industry,
the Secretary shall hold discussions with representatives of
veterinary, patient, and consumer advocacy groups to continue
discussions of their views on the reauthorization and their
suggestions for changes to this part as expressed under
paragraph (2).
``(4) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under
paragraph (1) to the congressional committees specified
in such paragraph;
``(B) publish such recommendations in the Federal
Register;
``(C) provide for a period of 30 days for the public
to provide written comments on such recommendations;
``(D) hold a meeting at which the public may present
its views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(5) Transmittal of recommendations.--Not later than January
15, 2018, the Secretary shall transmit to Congress the revised
recommendations under paragraph (4), a summary of the views and
comments received under such paragraph, and any changes made to
the recommendations in response to such views and comments.
``(6) Minutes of negotiation meetings.--
``(A) Public availability.--Before presenting the
recommendations developed under paragraphs (1) through
(5) to Congress, the Secretary shall make publicly
available, on the Internet Web site of the Food and
Drug Administration, minutes of all negotiation
meetings conducted under this subsection between the
Food and Drug Administration and the regulated
industry.
``(B) Content.--The minutes described under
subparagraph (A) shall summarize any substantive
proposal made by any party to the negotiations as well
as significant controversies or differences of opinion
during the negotiations and their resolution.''.
SEC. 204. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 5 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
Act, as in effect on the day before the date of enactment of this
title, shall continue to be in effect with respect to abbreviated
applications for a generic new animal drug and supplemental abbreviated
applications for a generic new animal drug (as defined in such part as
of such day) that on or after October 1, 2008, but before October 1,
2013, were accepted by the Food and Drug Administration for filing with
respect to assessing and collecting any fee required by such part for a
fiscal year prior to fiscal year 2014.
SEC. 205. EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2013, or the date of enactment of this title, whichever is later,
except that fees under part 5 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, as amended by this title, shall
be assessed for all abbreviated applications for a generic new animal
drug and supplemental abbreviated applications for a generic new animal
drug received on or after October 1, 2013, regardless of the date of
enactment of this title.
SEC. 206. SUNSET DATES.
(a) Authorization.--Section 741 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-21) shall cease to be effective October 1,
2018.
(b) Reporting Requirements.--Section 742 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-22) shall cease to be effective
January 31, 2019.
(c) Previous Sunset Provision.--
(1) In general.--Section 204 of the Animal Generic Drug User
Fee Act of 2008 (Public Law 110-316) is repealed.
(2) Conforming amendment.--Public Law 110-316 (122 Stat.
3509) is amended in the table of contents in section 1, by
striking the item relating to section 204.
Amend the title to read:
A bill to amend the Federal Food, Drug, and Cosmetic Act to
reauthorize user fee programs relating to new animal drugs and generic
new animal drugs.
Purpose and Summary
H.R. 1407, the ``Animal Drug User Fee Amendments of 2013,''
was introduced on April 9, 2013, by Rep. John Shimkus (R-IL)
and subsequently referred to the Committee on Energy and
Commerce Subcommittee on Health.
This legislation would amend the Federal Food, Drug, and
Cosmetic Act to reauthorize user fee programs relating to new
and generic animal drugs.
Background and Need for Legislation
Title I of H.R. 1407 would reauthorize the Animal Drug User
Fee Act. In 2003, Congress first enacted the Animal Drug User
Fee Act (ADUFA) to help improve the Food and Drug
Administration's (FDA) review of new animal drugs. The program
was modeled after the Prescription Drug User Fee Program for
human drugs and authorized for five years (ADUFA I).\1\ Under
the user fee authority of ADUFA I, FDA collected funds to help
expedite the new animal drug approval process, reduce the
application backlog, and improve communications with drug
sponsors. In 2008, because of the success of the program,
Congress reauthorized ADUFA for an additional five years (ADUFA
II). Unless Congress reauthorizes these user fees, FDA cannot
collect them after September 30, 2013.
---------------------------------------------------------------------------
\1\Department of Health and Human Services, Food and Drug
Administration, Fiscal Year 2005. http://www.fda.gov/aboutfda/
reportsmanualsforms/reports/budgetreports/2005fda budgetsummary/
ucm112985.htm
---------------------------------------------------------------------------
Following the process prescribed by statute, FDA and
industry negotiated a proposed agreement (agreement) regarding
the size and scope of the user fees for Fiscal Years (FY) 2014
to 2018. In February 2013, FDA sent its final legislative
recommendations on the agreement to the Committee on Energy and
Commerce. Under the agreement, industry would pay approximately
$23,600,000 in FY 2014 ($21,600,000 plus $2,000,000 for one-
time information technology funding), and similar amounts in
the remaining four years based on inflation adjusters. The fee
would be paid through application fees (20 percent), product
fees (27 percent), sponsor fees (27 percent), and establishment
fees (26 percent).\2\
---------------------------------------------------------------------------
\2\Proposed ADUFA III Provisions of the Federal Food, Drug, and
Cosmetic Act. Page 6-7.
---------------------------------------------------------------------------
Title II of H.R. 1407 would reauthorize the Animal Generic
Drug User Fee Act (AGDUFA). The language of this title is
identical to H.R. 1408, which was introduced by Rep. Gardner
(R-CO) on April 9, 2013. H.R 1408 was also the subject of the
legislative hearing on April 9.
In 2008, Congress authorized the AGDUFA program for five
years in order to improve the review of abbreviated new animal
drug applications (AGDUFA I). AGDUFA I enabled the agency to
eliminate its application backlog and reduce review times. FDA
cannot collect these user fees after September 30, 2013, unless
they are reauthorized by Congress.
Similar to ADUFA, FDA and industry negotiated an agreement
regarding the size and scope of AGDUFA for FY 2014 to 2018, and
FDA sent its final legislative recommendations on the AGDUFA
agreement to the Committee in February 2013. Under the proposed
AGDUFA agreement, the industry would pay $7,328,00 in FY 2014
($6,478,000 plus $850,000 for one-time information technology
funding), $6,944,00 in FY 2015, $7,429,000 in FY 2016,
$7,936,000 in FY 2017, and $8,467,000 in FY 2018. These fees
would be paid through application fees (25 percent), product
fees (37.5 percent), and sponsor fees (37.5 percent).\3\
---------------------------------------------------------------------------
\3\Proposed ADUFA III Provisions of the Federal Food, Drug, and
Cosmetic Act. Page 6-7.
---------------------------------------------------------------------------
Hearings
The Subcommittee on Health held a hearing on the
reauthorization of Animal Drug User Fee Program and the Animal
Generic Drug User Fee Program on April 9, 2013. The
Subcommittee received testimony from: Dr. Bernadette Dunham,
Director, Center for Veterinary Medicine, Food and Drug
Administration; Dr. Richard A. Carnevale, Vice President,
Regulatory, Scientific and International Affairs, Animal Health
Institute; Dr. Mike Apley, Professor and Section Head,
Production Medicine and Clinical Pharmacology, College of
Veterinary Medicine, Kansas State University; and Dr. Lance B.
Price, Professor, Department of Occupational and Environmental
Health, George Washington University.
Committee Consideration
On May 8, 2013, the Subcommittee on Health met in open
markup session and approved H.R. 1407, Animal Drug User Fee
Amendments Act of 2013, for full Committee consideration, as
amended, by a voice vote.
On May 15, 2013, the full Committee met in open markup
session and approved H.R. 1407 by voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken in connection with ordering
H.R. 1407 reported. A motion by Mr. Upton to order H.R. 1407
reported to the House, as amended, was agreed to by a voice
vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee made findings that are
reflected in this report.
Statement of General Performance Goals and Objectives
H.R. 1407, Animal Drug User Fee Amendments Act of 2013,
would reauthorize the Animal Drug User Fee Act and the Animal
Drug User Fee Act through September 30, 2018.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
1407, Animal Drug User Fee Amendments Act of 2013, would result
in no new or increased budget authority, entitlement authority,
or tax expenditures or revenues.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
In compliance with clause 9(e), 9(f), and 9(g) of rule XXI
of the Rules of the House of Representatives, the Committee
finds that H.R. 1407, Animal Drug User Fee Amendments Act of
2013, contains no earmarks, limited tax benefits, or limited
tariff benefits.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, May 24, 2013.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 1407, the Animal
Drug User Fee Amendments of 2013.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Julia
Christensen.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
H.R. 1407--Animal Drug User Fee Amendments of 2013
Summary: H.R. 1407 would authorize the collection and
spending of fees by the Food and Drug Administration (FDA) for
certain activities to expedite the development and marketing
approval of drugs for use in animals. Fees would supplement
appropriated funds to cover FDA's costs associated with
reviewing certain applications and investigational submissions
for brand and generic animal drugs. Such fees could be
collected and made available for obligation only to the extent
and in the amounts provided in advance in appropriation acts.
The legislation would extend through fiscal year 2018, and make
several technical changes to, FDA's existing fee programs for
brand and generic animal drugs, which expire at the end of
fiscal year 2013.
CBO estimates that implementing H.R. 1407 would reduce
discretionary outlays, on net, by $7 million over the 2014-2018
period, assuming appropriation actions consistent with the
bill.
Pay-as-you-go procedures do not apply to this legislation
because it would not affect direct spending or revenues.
H.R. 1407 contains no intergovernmental mandates as defined
in the Unfunded Mandates Reform Act (UMRA). The bill would
impose private-sector mandates, as defined in UMRA, because it
would require manufacturers of drugs for use in animals to pay
specified fees to FDA. CBO estimates that the direct cost of
complying with these requirements would not exceed the annual
threshold established by UMRA for private-sector mandates ($150
million in 2013, adjusted annually for inflation).
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 1407 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------
2014 2015 2016 2017 2018 2014-2018
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Title I: Fees Relating to Animal Drugs:
Collections from Fees:
Estimated Authorization Level................... -24 -22 -22 -23 -23 -114
Estimated Outlays............................... -24 -22 -22 -23 -23 -114
Spending of Fees:
Estimated Authorization Level................... 24 22 22 23 23 114
Estimated Outlays............................... 19 21 22 23 23 109
Subtotal, Estimated Authorization Level..... 0 0 0 0 0 0
Subtotal, Estimated Outlays................. -5 -1 * * * -6
Title II: Fees Relating to Generic Animal Drugs:
Collections from Fees
Estimated Authorization Level................... -7 -7 -7 -8 -8 -38
Estimated Outlays............................... -7 -7 -7 -8 -8 -38
Spending of Fees
Estimated Authorization Level................... 7 7 7 8 8 38
Estimated Outlays............................... 6 7 7 8 8 36
Subtotal, Estimated Authorization Level..... 0 0 0 0 0 0
Subtotal, Estimated Outlays................. -1 * * * * -2
Administrative Expenses:
Estimated Authorization Level....................... * * * * * 1
Estimated Outlays................................... * * * * * 1
Net Effect on Spending by the Food and Drug
Administration:
Estimated Authorization Level....................... * * * * * 1
Estimated Outlays................................... -6 -1 * * * -7
----------------------------------------------------------------------------------------------------------------
Note: Components may not sum to totals because of rounding; * = between -$500,000 and $500,000.
Basis of estimate: For this estimate, CBO assumes that H.R.
1407 will be enacted near the start of fiscal year 2014, that
the full amounts authorized will be collected and appropriated
for each year, and that outlays will follow historical patterns
for the fee programs. Assuming appropriation actions that
trigger the collection of fees and are consistent with other
provisions of the bill, CBO estimates that implementing H.R.
1407 would reduce discretionary outlays, on net, by $7 million
over the 2014-2018 period, mostly because the spending of
authorized fees lags slightly behind their collection.
Conditions for assessment and use of fees
H.R. 1407 would authorize the collection and spending of
fees by FDA for certain activities to expedite the development
and marketing approval of drugs for use in animals for fiscal
years 2014 through 2018. Under current law, FDA administers two
separate fee programs involving animal drugs: One program
covers brand-name animal drugs and the other program covers
generic drugs for use in animals. Both fee programs will expire
at the end of fiscal year 2013.
Fees authorized by the bill could be collected and made
available for obligation by FDA only to the extent and in the
amounts provided in advance in appropriation acts. The
legislation would also retain the existing statutory
limitations that fees cannot be assessed in a given year unless
appropriations for salaries and expenses of FDA (excluding the
amount of user fees appropriated for such fiscal year) satisfy
a maintenance-of-effort requirement. Fees could be assessed
only if the amount appropriated in that year equals or exceeds
the amount appropriated for 2003 increased by an adjustment
factor that reflects the percentage increase in the consumer
price index for all urban consumers.
In addition, for each of the programs, fees could be
collected and spent in a given year only if the cost of
resources allocated to reviewing brand and generic animal drug
applications (excluding fees) exceeds the amount that is 3
percent below the level allocated for such activities in a base
year inflated by an adjustment factor. This estimate assumes
that such conditions would be met.
Title I: Fees relating to animal drugs
H.R. 1407 would authorize FDA to assess and spend certain
fees from manufacturers of brand-name drugs for use in animals
to help defray FDA's costs of expediting the regulatory review
process for such drugs through fiscal year 2018. For fiscal
year 2012, FDA collected about $21 million in fees associated
with brand-name animal drugs.
Similar to the existing fee structure, four categories of
fees would be authorized by title I of the bill: (1) animal
drug application and supplement fees, (2) animal drug product
fees, (3) animal drug establishment fees, and (4) animal drug
sponsor fees. H.R. 1407 would authorize the appropriation of
specific aggregate amounts of collections for each fiscal year
2014 through 2018, subject to further adjustments defined by
the legislation. Collections would be adjusted each year by an
inflation factor to reflect changes in FDA's operating costs.
Collections could also be modified based on certain workload
estimates, when applicable. (No such adjustments for workload
have occurred over the last four years of the existing program,
and we expect that they would not occur in the future.) For
fiscal year 2018, the bill would authorize the collection of
operating reserves for the beginning of fiscal year 2019,
unless carryover balances for the fee program exceed three
months of such reserves. CBO expects that the final-year
adjustment for operating reserves would not be made. We
estimate aggregate collections from fees for the brand animal
drug program authorized by H.R. 1407 would total $114 million
over the 2014-2018 period.
CBO estimates that authorizing the fee program for brand
animal drugs through 2018 would reduce discretionary outlays,
on net, by $6 million over the 2014-2018 period, assuming
appropriation actions consistent with the bill. The estimated
authorization levels for collections and spending offset each
other exactly from 2014 through 2018. However, spending of
authorized fees lags somewhat behind their collection, thereby
generating savings over the period.
Title II: Fees relating to generic animal drugs
H.R. 1407 would extend FDA's authority to assess and spend
fees from manufacturers of certain generic new drugs for use in
animals that would help cover the costs of regulatory
activities to expedite the development and approval for
marketing such drugs through fiscal year 2018. (The term
``generic new drug'' refers to drugs that must gain marketing
approval by FDA because they are not generally recognized as
safe and effective for use in animals and are approved under an
abbreviated review process.) Collections associated with FDA's
fee program for generic animal drugs totaled about $7 million
for fiscal year 2012.
Three categories of fees would be authorized by title II of
the bill: (1) fees for abbreviated applications, (2) fees on
generic new drug products for animals, and (3) fees on sponsors
of generic new drugs for animals. The bill would authorize the
appropriation of specific aggregate amounts of collections for
each fiscal year 2014 through 2018. Collections could be
further adjusted each year based on certain workload estimates,
when applicable. (No such adjustments for workload have
occurred over the last four years of the existing program, and
we expect that they would not occur in the future.) For fiscal
year 2018, the bill would authorize additional adjustments to
collections under specific circumstances, including the
assessment of up to three months of operating reserves for the
beginning of fiscal year 2019, unless carryover balances for
the fee program exceed three months of such reserves. CBO
expects that the final-year adjustment for operating reserves
would not be made. We estimate aggregate collections from fees
for generic new animal drugs authorized by the bill would total
$38 million over the 2014-2018 period.
CBO estimates that authorizing the fee program for generic
new animal drugs over the 2014-2018 period would reduce
discretionary outlays, on net, by $2 million over that period,
assuming appropriation actions consistent with the bill.
Because FDA would have the authority to spend collections, the
estimated negative budget authority resulting from collections
would exactly offset the budget authority for spending in each
fiscal year. However, spending of fees would lag behind the
collections and thus generate net discretionary savings over
the 2014-2018 period.
Other administrative expenses
Funding for certain administrative activities associated
with the fee programs authorized by H.R. 1407 would not be
fully covered by fees. The bill would require that FDA report
annually to the Congress on its performance under the fee
programs and on the fiscal status of the programs. The
legislation would also require that FDA consult with the
Congressional committees of jurisdiction and outside experts,
including industry and consumer groups, and publish its
recommendations concerning reauthorization of the fee programs.
CBO estimates that such administrative activities associated
with implementing H.R. 1407 that are not covered by fees would
cost less than $500,000 annually.
Pay-as-You-Go considerations: None.
Estimated impact on state, local, and tribal governments:
H.R. 1407 contains no intergovernmental mandates as defined in
UMRA and would impose no costs on state, local, or tribal
governments.
Estimated impact on the private sector: The imposition of
application, product, establishment, and sponsor fees that
private entities would pay to FDA would be considered a
private-sector mandate as defined in UMRA. CBO estimates that
the fees collected over the 2014-2018 period would total $153
million. Those amounts would not exceed the annual threshold
specified in UMRA ($150 million in 2013, adjusted annually for
inflation) in any of the five years that the mandate would be
effective.
Previous CBO estimate: On March 20, 2013, CBO transmitted a
cost estimate for S. 622, the Animal Drug and Animal Generic
Drug User Fee Reauthorization Act of 2013, as reported by the
Senate Committee on Health, Education, Labor, and Pensions on
March 20, 2013. The text of the two pieces of legislation is
nearly identical, and the CBO cost estimates are the same.
Estimate prepared by: Federal Costs: Julia Christensen;
Impact on State, Local, and Tribal Governments: Lisa Ramirez-
Branum; Impact on the Private Sector: Alexia Diorio.
Estimate approved by: Holly Harvey, Deputy Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Duplication of Federal Programs
No provision of H.R. 1407 establishes or reauthorizes a
program of the Federal Government known to be duplicative of
another Federal program, a program that was included in any
report from the Government Accountability Office to Congress
pursuant to section 21 of Public Law 111-139, or a program
related to a program identified in the most recent Catalog of
Federal Domestic Assistance.
Disclosure of Directed Rule Makings
The Committee estimates that enacting H.R. 1407
specifically directs to be completed zero specific rule makings
within the meaning of 5 U.S.C. 551.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
TITLE I--ANIMAL DRUG USER FEE AMENDMENTS
Section 101. Short Title; Finding: This section provides
the short title and finding.
Section 102. Definitions: This section defines the terms
``animal drug application,'' ``supplemental animal drug
application,'' ``animal drug product,'' ``animal drug
establishment,'' ``investigational animal drug submission,''
``animal drug sponsor,'' ``final dosage form,'' ``process for
the review of animal drug applications,'' ``costs of resources
allocated for the process for the review of animal drug
applications,'' ``adjustment factor,'' ``person,'' and
``affiliate.''
Section 103. Authority to Assess and Use Animal Drug Fees:
This section establishes the fees due under this title of the
bill.
Section 104. Reauthorization; Reporting Requirements: This
section requires FDA to submit a performance report and
financial report within 120 days after the end of each FY. Both
of these reports will be available on the FDA website. The
section also establishes the process for the reauthorization of
the user fee.
Section 105. Savings Clause: Animal drug applications and
supplemental animal drug applications submitted and accepted
for filing by the FDA on or after October 1, 2008, but before
October 1, 2013, and which are still pending as of the AGDUFA
II enactment are subject to AGDUFA I fees.
Section 106. Effective Date: This section establishes the
effective date as the later of October 1, 2013, or the date of
enactment.
Section 107. Sunset Dates: This section provides that the
title will cease to be effective on October 1, 2018.
TITLE II--ANIMAL GENERIC DRUG USER FEE
Section 201. Short Title; Finding: This section provides
the short title and finding.
Section 202. Authority to Assess and Use Generic New Animal
Drug Fees: This section establishes the animal generic drug
fees under the bill.
Section 203. Reauthorization; Reporting Requirements: This
section requires the Secretary to submit a financial report and
performance report within 120 days after the end of each fiscal
year. Both of these reports will be available on the FDA's
website. The section also establishes the process for the
reauthorization of the fee.
Section 204. Savings Clause: Applications submitted and
accepted for filing on or after October 1, 2008, but before
October 1, 2013, and which are still pending as of the AGDUFA
II enactment, are subject to AGDUFA I fees.
Section 205. Effective Date: This section establishes the
effective date as the later of October 1, 2013, or the date of
enactment.
Section 206. Sunset Dates: This section provides that the
title will cease to be effective on October 1, 2018.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER VII--GENERAL AUTHORITY
* * * * * * *
Subchapter C--Fees
* * * * * * *
PART 4--FEES RELATING TO ANIMAL DRUGS
[SEC. 739. DEFINITIONS.
[For purposes of this part:
[(1) The term ``animal drug application'' means an
application for approval of any new animal drug
submitted under section 512(b)(1). Such term does not
include either a new animal drug application submitted
under section 512(b)(2) or a supplemental animal drug
application.
[(2) The term ``supplemental animal drug
application'' means--
[(A) a request to the Secretary to approve a
change in an animal drug application which has
been approved; or
[(B) a request to the Secretary to approve a
change to an application approved under section
512(c)(2) for which data with respect to safety
or effectiveness are required.
[(3) The term ``animal drug product'' means each
specific strength or potency of a particular active
ingredient or ingredients in final dosage form marketed
by a particular manufacturer or distributor, which is
uniquely identified by the labeler code and product
code portions of the national drug code, and for which
an animal drug application or a supplemental animal
drug application has been approved.
[(4) The term ``animal drug establishment'' means a
foreign or domestic place of business which is at one
general physical location consisting of one or more
buildings all of which are within 5 miles of each
other, at which one or more animal drug products are
manufactured in final dosage form.
[(5) The term ``investigational animal drug
submission'' means--
[(A) the filing of a claim for an
investigational exemption under section 512(j)
for a new animal drug intended to be the
subject of an animal drug application or a
supplemental animal drug application, or
[(B) the submission of information for the
purpose of enabling the Secretary to evaluate
the safety or effectiveness of an animal drug
application or supplemental animal drug
application in the event of their filing.
[(6) The term ``animal drug sponsor'' means either an
applicant named in an animal drug application that has
not been withdrawn by the applicant and for which
approval has not been withdrawn by the Secretary, or a
person who has submitted an investigational animal drug
submission that has not been terminated or otherwise
rendered inactive by the Secretary.
[(7) The term ``final dosage form'' means, with
respect to an animal drug product, a finished dosage
form which is approved for administration to an animal
without substantial further manufacturing. Such term
includes animal drug products intended for mixing in
animal feeds.
[(8) The term ``process for the review of animal drug
applications'' means the following activities of the
Secretary with respect to the review of animal drug
applications, supplemental animal drug applications,
and investigational animal drug submissions:
[(A) The activities necessary for the review
of animal drug applications, supplemental
animal drug applications, and investigational
animal drug submissions.
[(B) The issuance of action letters which
approve animal drug applications or
supplemental animal drug applications or which
set forth in detail the specific deficiencies
in animal drug applications, supplemental
animal drug applications, or investigational
animal drug submissions and, where appropriate,
the actions necessary to place such
applications, supplements or submissions in
condition for approval.
[(C) The inspection of animal drug
establishments and other facilities undertaken
as part of the Secretary's review of pending
animal drug applications, supplemental animal
drug applications, and investigational animal
drug submissions.
[(D) Monitoring of research conducted in
connection with the review of animal drug
applications, supplemental animal drug
applications, and investigational animal drug
submissions.
[(E) The development of regulations and
policy related to the review of animal drug
applications, supplemental animal drug
applications, and investigational animal drug
submissions.
[(F) Development of standards for products
subject to review.
[(G) Meetings between the agency and the
animal drug sponsor.
[(H) Review of advertising and labeling prior
to approval of an animal drug application or
supplemental animal drug application, but not
after such application has been approved.
[(9) The term ``costs of resources allocated for the
process for the review of animal drug applications''
means the expenses incurred in connection with the
process for the review of animal drug applications
for--
[(A) officers and employees of the Food and
Drug Administration, contractors of the Food
and Drug Administration, advisory committees
consulted with respect to the review of
specific animal drug applications, supplemental
animal drug applications, or investigational
animal drug submissions, and costs related to
such officers, employees, committees, and
contractors, including costs for travel,
education, and recruitment and other personnel
activities,
[(B) management of information, and the
acquisition, maintenance, and repair of
computer resources,
[(C) leasing, maintenance, renovation, and
repair of facilities and acquisition,
maintenance, and repair of fixtures, furniture,
scientific equipment, and other necessary
materials and supplies, and
[(D) collecting fees under section 740 and
accounting for resources allocated for the
review of animal drug applications,
supplemental animal drug applications, and
investigational animal drug submissions.
[(10) The term ``adjustment factor'' applicable to a
fiscal year refers to the formula set forth in section
735(8) with the base or comparator month being October
2002.
[(11) The term ``person'' includes an affiliate
thereof.
[(12) The term ``affiliate'' refers to the definition
set forth in section 735(11).
[SEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
[(a) Types of Fees.--Beginning in fiscal year 2004, the
Secretary shall assess and collect fees in accordance with this
section as follows:
[(1) Animal drug application and supplement fee.--
[(A) In general.--Each person that submits,
on or after September 1, 2003, an animal drug
application or a supplemental animal drug
application shall be subject to a fee as
follows:
[(i) A fee established in subsection
(b) for an animal drug application,
except an animal drug application
subject to the criteria set forth in
section 512(d)(4); and
[(ii) A fee established in subsection
(b), in an amount that is equal to 50
percent of the amount of the fee under
clause (i), for--
[(I) a supplemental animal
drug application for which
safety or effectiveness data
are required; and
[(II) an animal drug
application subject to the
criteria set forth in section
512(d)(4).
[(B) Payment.--The fee required by
subparagraph (A) shall be due upon submission
of the animal drug application or supplemental
animal drug application.
[(C) Exception for previously filed
application or supplement.--If an animal drug
application or a supplemental animal drug
application was submitted by a person that paid
the fee for such application or supplement, was
accepted for filing, and was not approved or
was withdrawn (without a waiver or refund), the
submission of an animal drug application or a
supplemental animal drug application for the
same product by the same person (or the
person's licensee, assignee, or successor)
shall not be subject to a fee under
subparagraph (A).
[(D) Refund of fee if application refused for
filing.--The Secretary shall refund 75 percent
of the fee paid under subparagraph (B) for any
animal drug application or supplemental animal
drug application which is refused for filing.
[(E) Refund of fee if application
withdrawn.--If an animal drug application or a
supplemental animal drug application is
withdrawn after the application or supplement
was filed, the Secretary may refund the fee or
portion of the fee paid under subparagraph (B)
if no substantial work was performed on the
application or supplement after the application
or supplement was filed. The Secretary shall
have the sole discretion to refund the fee
under this paragraph. A determination by the
Secretary concerning a refund under this
paragraph shall not be reviewable.
[(2) Animal drug product fee.--Each person--
[(A) who is named as the applicant in an
animal drug application or supplemental animal
drug application for an animal drug product
which has been submitted for listing under
section 510, and
[(B) who, after September 1, 2003, had
pending before the Secretary an animal drug
application or supplemental animal drug
application;
shall pay for each such animal drug product the annual
fee established in subsection (b). Such fee shall be
payable for the fiscal year in which the animal drug
product is first submitted for listing under section
510, or is submitted for relisting under section 510 if
the animal drug product has been withdrawn from listing
and relisted. After such fee is paid for that fiscal
year, such fee shall be payable on or before January 31
of each year. Such fee shall be paid only once for each
animal drug product for a fiscal year in which the fee
is payable.
[(3) Animal drug establishment fee.--Each person--
[(A) who owns or operates, directly or
through an affiliate, an animal drug
establishment, and
[(B) who is named as the applicant in an
animal drug application or supplemental animal
drug application for an animal drug product
which has been submitted for listing under
section 510, and
[(C) who, after September 1, 2003, had
pending before the Secretary an animal drug
application or supplemental animal drug
application,
shall be assessed an annual fee established in
subsection (b) for each animal drug establishment
listed in its approved animal drug application as an
establishment that manufactures the animal drug product
named in the application. The annual establishment fee
shall be assessed in each fiscal year in which the
animal drug product named in the application is
assessed a fee under paragraph (2) unless the animal
drug establishment listed in the application does not
engage in the manufacture of the animal drug product
during the fiscal year. The fee shall be paid on or
before January 31 of each year. The establishment shall
be assessed only one fee per fiscal year under this
section: Provided, however, That where a single
establishment manufactures both animal drug products
and prescription drug products, as defined in section
735(3), such establishment shall be assessed both the
animal drug establishment fee and the prescription drug
establishment fee, as set forth in section 736(a)(2),
within a single fiscal year.
[(4) Animal drug sponsor fee.--Each person--
[(A) who meets the definition of an animal
drug sponsor within a fiscal year; and
[(B) who, after September 1, 2003, had
pending before the Secretary an animal drug
application, a supplemental animal drug
application, or an investigational animal drug
submission,
shall be assessed an annual fee established under
subsection (b). The fee shall be paid on or before
January 31 of each year. Each animal drug sponsor shall
pay only one such fee each fiscal year.
[(b) Fee Amounts.--Except as provided in subsection (a)(1)
and subsections (c), (d), (f), and (g), the fees required under
subsection (a) shall be established to generate fee revenue
amounts as follows:
[(1) Total fee revenues for application and
supplement fees.--The total fee revenues to be
collected in animal drug application fees under
subsection (a)(1)(A)(i) and supplemental and other
animal drug application fees under subsection
(a)(1)(A)(ii) shall be $3,815,000 for fiscal year 2009,
$4,320,000 for fiscal year 2010, $4,862,000 for fiscal
year 2011, $5,442,000 for fiscal year 2012, and
$6,061,000 for fiscal year 2013.
[(2) Total fee revenues for product fees.--The total
fee revenues to be collected in product fees under
subsection (a)(2) shall be $3,815,000 for fiscal year
2009, $4,320,000 for fiscal year 2010, $4,862,000 for
fiscal year 2011, $5,442,000 for fiscal year 2012, and
$6,061,000 for fiscal year 2013.
[(3) Total fee revenues for establishment fees.--The
total fee revenues to be collected in establishment
fees under subsection (a)(3) shall be $3,815,000 for
fiscal year 2009, $4,320,000 for fiscal year 2010,
$4,862,000 for fiscal year 2011, $5,442,000 for fiscal
year 2012, and $6,061,000 for fiscal year 2013.
[(4) Total fee revenues for sponsor fees.--The total
fee revenues to be collected in sponsor fees under
subsection (a)(4) shall be $3,815,000 for fiscal year
2009, $4,320,000 for fiscal year 2010, $4,862,000 for
fiscal year 2011, $5,442,000 for fiscal year 2012, and
$6,061,000 for fiscal year 2013.
[(c) Adjustments.--
[(1) Workload adjustment.--The fee revenues shall be
adjusted each fiscal year after fiscal year 2009 to
reflect changes in review workload. With respect to
such adjustment:
[(A) This adjustment shall be determined by
the Secretary based on a weighted average of
the change in the total number of animal drug
applications, supplemental animal drug
applications for which data with respect to
safety or effectiveness are required,
manufacturing supplemental animal drug
applications, investigational animal drug study
submissions, and investigational animal drug
protocol submissions submitted to the
Secretary. The Secretary shall publish in the
Federal Register the fees resulting from this
adjustment and the supporting methodologies.
[(B) Under no circumstances shall this
workload adjustment result in fee revenues for
a fiscal year that are less than the fee
revenues for that fiscal year established in
subsection (b).
[(2) Final year adjustment.--For fiscal year 2013,
the Secretary may further increase the fees to provide
for up to 3 months of operating reserves of carryover
user fees for the process for the review of animal drug
applications for the first 3 months of fiscal year
2014. If the Food and Drug Administration has carryover
balances for the process for the review of animal drug
applications in excess of 3 months of such operating
reserves, then this adjustment will not be made. If
this adjustment is necessary, then the rationale for
the amount of the increase shall be contained in the
annual notice setting fees for fiscal year 2013.
[(3) Annual fee setting.--The Secretary shall
establish, 60 days before the start of each fiscal year
beginning after September 30, 2003, for that fiscal
year, animal drug application fees, supplemental animal
drug application fees, animal drug sponsor fees, animal
drug establishment fees, and animal drug product fees
based on the revenue amounts established under
subsection (b) and the adjustments provided under this
subsection.
[(4) Limit.--The total amount of fees charged, as
adjusted under this subsection, for a fiscal year may
not exceed the total costs for such fiscal year for the
resources allocated for the process for the review of
animal drug applications.
[(d) Fee Waiver or Reduction.--
[(1) In general.--The Secretary shall grant a waiver
from or a reduction of 1 or more fees assessed under
subsection (a) where the Secretary finds that--
[(A) the assessment of the fee would present
a significant barrier to innovation because of
limited resources available to such person or
other circumstances,
[(B) the fees to be paid by such person will
exceed the anticipated present and future costs
incurred by the Secretary in conducting the
process for the review of animal drug
applications for such person,
[(C) the animal drug application or
supplemental animal drug application is
intended solely to provide for use of the
animal drug in--
[(i) a Type B medicated feed (as
defined in section 558.3(b)(3) of title
21, Code of Federal Regulations (or any
successor regulation)) intended for use
in the manufacture of Type C free-
choice medicated feeds, or
[(ii) a Type C free-choice medicated
feed (as defined in section 558.3(b)(4)
of title 21, Code of Federal
Regulations (or any successor
regulation)),
[(D) the animal drug application or
supplemental animal drug application is
intended solely to provide for a minor use or
minor species indication, or
[(E) the sponsor involved is a small business
submitting its first animal drug application to
the Secretary for review.
[(2) Use of standard costs.--In making the finding in
paragraph (1)(B), the Secretary may use standard costs.
[(3) Rules for small businesses.--
[(A) Definition.--In paragraph (1)(E), the
term ``small business'' means an entity that
has fewer than 500 employees, including
employees of affiliates.
[(B) Waiver of application fee.--The
Secretary shall waive under paragraph (1)(E)
the application fee for the first animal drug
application that a small business or its
affiliate submits to the Secretary for review.
After a small business or its affiliate is
granted such a waiver, the small business or
its affiliate shall pay application fees for
all subsequent animal drug applications and
supplemental animal drug applications for which
safety or effectiveness data are required in
the same manner as an entity that does not
qualify as a small business.
[(C) Certification.--The Secretary shall
require any person who applies for a waiver
under paragraph (1)(E) to certify their
qualification for the waiver. The Secretary
shall periodically publish in the Federal
Register a list of persons making such
certifications.
[(e) Effect of Failure To Pay Fees.--An animal drug
application or supplemental animal drug application submitted
by a person subject to fees under subsection (a) shall be
considered incomplete and shall not be accepted for filing by
the Secretary until all fees owed by such person have been
paid. An investigational animal drug submission under section
739(5)(B) that is submitted by a person subject to fees under
subsection (a) shall be considered incomplete and shall not be
accepted for review by the Secretary until all fees owed by
such person have been paid. The Secretary may discontinue
review of any animal drug application, supplemental animal drug
application or investigational animal drug submission from a
person if such person has not submitted for payment all fees
owed under this section by 30 days after the date upon which
they are due.
[(f) Assessment of Fees.--
[(1) Limitation.--Fees may not be assessed under
subsection (a) for a fiscal year beginning after fiscal
year 2003 unless appropriations for salaries and
expenses of the Food and Drug Administration for such
fiscal year (excluding the amount of fees appropriated
for such fiscal year) are equal to or greater than the
amount of appropriations for the salaries and expenses
of the Food and Drug Administration for the fiscal year
2003 (excluding the amount of fees appropriated for
such fiscal year) multiplied by the adjustment factor
applicable to the fiscal year involved.
[(2) Authority.--If the Secretary does not assess
fees under subsection (a) during any portion of a
fiscal year because of paragraph (1) and if at a later
date in such fiscal year the Secretary may assess such
fees, the Secretary may assess and collect such fees,
without any modification in the rate, for animal drug
applications, supplemental animal drug applications,
investigational animal drug submissions, animal drug
sponsors, animal drug establishments and animal drug
products at any time in such fiscal year
notwithstanding the provisions of subsection (a)
relating to the date fees are to be paid.
[(g) Crediting and Availability of Fees.--
[(1) In general.--Fees authorized under subsection
(a) shall be collected and available for obligation
only to the extent and in the amount provided in
advance in appropriations Acts. Such fees are
authorized to be appropriated to remain available until
expended. Such sums as may be necessary may be
transferred from the Food and Drug Administration
salaries and expenses appropriation account without
fiscal year limitation to such appropriation account
for salary and expenses with such fiscal year
limitation. The sums transferred shall be available
solely for the process for the review of animal drug
applications.
[(2) Collections and appropriation acts.--
[(A) In general.--The fees authorized by this
section--
[(i) shall be retained in each fiscal
year in an amount not to exceed the
amount specified in appropriation Acts,
or otherwise made available for
obligation for such fiscal year, and
[(ii) shall only be collected and
available to defray increases in the
costs of the resources allocated for
the process for the review of animal
drug applications (including increases
in such costs for an additional number
of full-time equivalent positions in
the Department of Health and Human
Services to be engaged in such process)
over such costs, excluding costs paid
from fees collected under this section,
for fiscal year 2003 multiplied by the
adjustment factor.
[(B) Compliance.--The Secretary shall be
considered to have met the requirements of
subparagraph (A)(ii) in any fiscal year if the
costs funded by appropriations and allocated
for the process for the review of animal drug
applications--
[(i) are not more than 3 percent
below the level specified in
subparagraph (A)(ii); or
[(ii)(I) are more than 3 percent
below the level specified in
subparagraph (A)(ii), and fees assessed
for the fiscal year following the
subsequent fiscal year are decreased by
the amount in excess of 3 percent by
which such costs fell below the level
specified in subparagraph (A)(ii); and
[(II) such costs are not more than 5
percent below the level specified in
subparagraph (A)(ii).
[(3) Authorization of appropriations.--There are
authorized to be appropriated for fees under this
section--
[(A) $15,260,000 for fiscal year 2009;
[(B) $17,280,000 for fiscal year 2010;
[(C) $19,448,000 for fiscal year 2011;
[(D) $21,768,000 for fiscal year 2012; and
[(E) $24,244,000 for fiscal year 2013;
as adjusted to reflect adjustments in the total fee
revenues made under this section and changes in the
total amounts collected by animal drug application
fees, supplemental animal drug application fees, animal
drug sponsor fees, animal drug establishment fees, and
animal drug product fees.
[(4) Offset.--If the sum of the cumulative amount of
fees collected under this section for fiscal years 2009
through 2011 and the amount of fees estimated to be
collected under this section for fiscal year 2012
exceeds the cumulative amount appropriated under
paragraph (3) for the fiscal years 2009 through 2012,
the excess amount shall be credited to the
appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall
be subtracted from the amount of fees that would
otherwise be authorized to be collected under this
section pursuant to appropriation Acts for fiscal year
2013.
[(h) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States Code.
[(i) Written Requests for Waivers, Reductions, and Refunds.--
To qualify for consideration for a waiver or reduction under
subsection (d), or for a refund of any fee collected in
accordance with subsection (a), a person shall submit to the
Secretary a written request for such waiver, reduction, or
refund not later than 180 days after such fee is due.
[(j) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in the process
of the review of animal drug applications, be reduced to offset
the number of officers, employees, and advisory committees so
engaged.
[(k) Abbreviated New Animal Drug Applications.--The Secretary
shall--
[(1) to the extent practicable, segregate the review
of abbreviated new animal drug applications from the
process for the review of animal drug applications, and
[(2) adopt other administrative procedures to ensure
that review times of abbreviated new animal drug
applications do not increase from their current level
due to activities under the user fee program.
[SEC. 740A. REAUTHORIZATION; REPORTING REQUIREMENTS.
[(a) Performance Report.--Beginning with fiscal year 2009,
not later than 60 days after the end of each fiscal year during
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in
section 101(b) of the Animal Drug User Fee Amendments of 2008
toward expediting the animal drug development process and the
review of the new and supplemental animal drug applications and
investigational animal drug submissions during such fiscal
year, the future plans of the Food and Drug Administration for
meeting the goals, the review times for abbreviated new animal
drug applications, and the administrative procedures adopted by
the Food and Drug Administration to ensure that review times
for abbreviated new animal drug applications are not increased
from their current level due to activities under the user fee
program.
[(b) Fiscal Report.--Beginning with fiscal year 2009, not
later than 120 days after the end of each fiscal year during
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected during such fiscal year for which the
report is made.
[(c) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to the
public on the Internet Web site of the Food and Drug
Administration.
[(d) Reauthorization.--
[(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals, and
plans for meeting the goals, for the process for the
review of animal drug applications for the first 5
fiscal years after fiscal year 2013, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
[(A) the Committee on Energy and Commerce of
the House of Representatives;
[(B) the Committee on Health, Education,
Labor, and Pensions of the Senate;
[(C) scientific and academic experts;
[(D) veterinary professionals;
[(E) representatives of patient and consumer
advocacy groups; and
[(F) the regulated industry.
[(2) Prior public input.--Prior to beginning
negotiations with the regulated industry on the
reauthorization of this part, the Secretary shall--
[(A) publish a notice in the Federal Register
requesting public input on the reauthorization;
[(B) hold a public meeting at which the
public may present its views on the
reauthorization, including specific suggestions
for changes to the goals referred to in
subsection (a);
[(C) provide a period of 30 days after the
public meeting to obtain written comments from
the public suggesting changes to this part; and
[(D) publish the comments on the Food and
Drug Administration's Internet Web site.
[(3) Periodic consultation.--Not less frequently than
once every 4 months during negotiations with the
regulated industry, the Secretary shall hold
discussions with representatives of veterinary,
patient, and consumer advocacy groups to continue
discussions of their views on the reauthorization and
their suggestions for changes to this part as expressed
under paragraph (2).
[(4) Public review of recommendations.--After
negotiations with the regulated industry, the Secretary
shall--
[(A) present the recommendations developed
under paragraph (1) to the Congressional
committees specified in such paragraph;
[(B) publish such recommendations in the
Federal Register;
[(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
[(D) hold a meeting at which the public may
present its views on such recommendations; and
[(E) after consideration of such public views
and comments, revise such recommendations as
necessary.
[(5) Transmittal of recommendations.--Not later than
January 15, 2013, the Secretary shall transmit to the
Congress the revised recommendations under paragraph
(4), a summary of the views and comments received under
such paragraph, and any changes made to the
recommendations in response to such views and comments.
[(6) Minutes of negotiation meetings.--
[(A) Public availability.--Before presenting
the recommendations developed under paragraphs
(1) through (5) to the Congress, the Secretary
shall make publicly available, on the Internet
Web site of the Food and Drug Administration,
minutes of all negotiation meetings conducted
under this subsection between the Food and Drug
Administration and the regulated industry.
[(B) Content.--The minutes described under
subparagraph (A) shall summarize any
substantive proposal made by any party to the
negotiations as well as significant
controversies or differences of opinion during
the negotiations and their resolution.]
SEC. 739. DEFINITIONS.
For purposes of this part:
(1) The term ``animal drug application'' means an
application for approval of any new animal drug
submitted under section 512(b)(1). Such term does not
include either a new animal drug application submitted
under section 512(b)(2) or a supplemental animal drug
application.
(2) The term ``supplemental animal drug application''
means--
(A) a request to the Secretary to approve a
change in an animal drug application which has
been approved; or
(B) a request to the Secretary to approve a
change to an application approved under section
512(c)(2) for which data with respect to safety
or effectiveness are required.
(3) The term ``animal drug product'' means each
specific strength or potency of a particular active
ingredient or ingredients in final dosage form marketed
by a particular manufacturer or distributor, which is
uniquely identified by the labeler code and product
code portions of the national drug code, and for which
an animal drug application or a supplemental animal
drug application has been approved.
(4) The term ``animal drug establishment'' means a
foreign or domestic place of business which is at one
general physical location consisting of one or more
buildings all of which are within 5 miles of each
other, at which one or more animal drug products are
manufactured in final dosage form.
(5) The term ``investigational animal drug
submission'' means--
(A) the filing of a claim for an
investigational exemption under section 512(j)
for a new animal drug intended to be the
subject of an animal drug application or a
supplemental animal drug application; or
(B) the submission of information for the
purpose of enabling the Secretary to evaluate
the safety or effectiveness of an animal drug
application or supplemental animal drug
application in the event of their filing.
(6) The term ``animal drug sponsor'' means either an
applicant named in an animal drug application that has
not been withdrawn by the applicant and for which
approval has not been withdrawn by the Secretary, or a
person who has submitted an investigational animal drug
submission that has not been terminated or otherwise
rendered inactive by the Secretary.
(7) The term ``final dosage form'' means, with
respect to an animal drug product, a finished dosage
form which is approved for administration to an animal
without substantial further manufacturing. Such term
includes animal drug products intended for mixing in
animal feeds.
(8) The term ``process for the review of animal drug
applications'' means the following activities of the
Secretary with respect to the review of animal drug
applications, supplemental animal drug applications,
and investigational animal drug submissions:
(A) The activities necessary for the review
of animal drug applications, supplemental
animal drug applications, and investigational
animal drug submissions.
(B) The issuance of action letters which
approve animal drug applications or
supplemental animal drug applications or which
set forth in detail the specific deficiencies
in animal drug applications, supplemental
animal drug applications, or investigational
animal drug submissions and, where appropriate,
the actions necessary to place such
applications, supplements, or submissions in
condition for approval.
(C) The inspection of animal drug
establishments and other facilities undertaken
as part of the Secretary's review of pending
animal drug applications, supplemental animal
drug applications, and investigational animal
drug submissions.
(D) Monitoring of research conducted in
connection with the review of animal drug
applications, supplemental animal drug
applications, and investigational animal drug
submissions.
(E) The development of regulations and policy
related to the review of animal drug
applications, supplemental animal drug
applications, and investigational animal drug
submissions.
(F) Development of standards for products
subject to review.
(G) Meetings between the agency and the
animal drug sponsor.
(H) Review of advertising and labeling prior
to approval of an animal drug application or
supplemental animal drug application, but not
after such application has been approved.
(9) The term ``costs of resources allocated for the
process for the review of animal drug applications''
means the expenses in connection with the process for
the review of animal drug applications for--
(A) officers and employees of the Food and
Drug Administration, contractors of the Food
and Drug Administration, advisory committees
consulted with respect to the review of
specific animal drug applications, supplemental
animal drug applications, or investigational
animal drug submissions, and costs related to
such officers, employees, committees, and
contractors, including costs for travel,
education, and recruitment and other personnel
activities;
(B) management of information and the
acquisition, maintenance, and repair of
computer resources;
(C) leasing, maintenance, renovation, and
repair of facilities and acquisition,
maintenance, and repair of fixtures, furniture,
scientific equipment, and other necessary
materials and supplies; and
(D) collecting fees under section 740 and
accounting for resources allocated for the
review of animal drug applications,
supplemental animal drug applications, and
investigational animal drug submissions.
(10) The term ``adjustment factor'' applicable to a
fiscal year refers to the formula set forth in section
735(8) with the base or comparator month being October
2002.
(11) The term ``person'' includes an affiliate
thereof.
(12) The term ``affiliate'' refers to the definition
set forth in section 735(11).
SEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
(a) Types of Fees.--Beginning in fiscal year 2004, the
Secretary shall assess and collect fees in accordance with this
section as follows:
(1) Animal drug application and supplement fee.--
(A) In general.--Each person that submits, on
or after September 1, 2003, an animal drug
application or a supplemental animal drug
application shall be subject to a fee as
follows:
(i) A fee established in subsection
(c) for an animal drug application,
except an animal drug application
described in section 512(d)(4).
(ii) A fee established in subsection
(c), in an amount that is equal to 50
percent of the amount of the fee under
clause (i), for--
(I) a supplemental animal
drug application for which
safety or effectiveness data
are required; and
(II) an animal drug
application described in
section 512(d)(4).
(B) Payment.--The fee required by
subparagraph (A) shall be due upon submission
of the animal drug application or supplemental
animal drug application.
(C) Exception for previously filed
application or supplement.--If an animal drug
application or a supplemental animal drug
application was submitted by a person that paid
the fee for such application or supplement, was
accepted for filing, and was not approved or
was withdrawn (without a waiver or refund), the
submission of an animal drug application or a
supplemental animal drug application for the
same product by the same person (or the
person's licensee, assignee, or successor)
shall not be subject to a fee under
subparagraph (A).
(D) Refund of fee if application refused for
filing.--The Secretary shall refund 75 percent
of the fee paid under subparagraph (B) for any
animal drug application or supplemental animal
drug application which is refused for filing.
(E) Refund of fee if application withdrawn.--
If an animal drug application or a supplemental
animal drug application is withdrawn after the
application or supplement was filed, the
Secretary may refund the fee or portion of the
fee paid under subparagraph (B) if no
substantial work was performed on the
application or supplement after the application
or supplement was filed. The Secretary shall
have the sole discretion to refund the fee
under this paragraph. A determination by the
Secretary concerning a refund under this
paragraph shall not be reviewable.
(2) Animal drug product fee.--
(A) In general.--Each person--
(i) who is named as the applicant in
an animal drug application or
supplemental animal drug application
for an animal drug product which has
been submitted for listing under
section 510; and
(ii) who, after September 1, 2003,
had pending before the Secretary an
animal drug application or supplemental
animal drug application,
shall pay for each such animal drug product the
annual fee established in subsection (c).
(B) Payment; fee due date.--Such fee shall be
payable for the fiscal year in which the animal
drug product is first submitted for listing
under section 510, or is submitted for
relisting under section 510 if the animal drug
product has been withdrawn from listing and
relisted. After such fee is paid for that
fiscal year, such fee shall be due each
subsequent fiscal year that the product remains
listed, upon the later of--
(i) the first business day after the
date of enactment of an appropriations
Act providing for the collection and
obligation of fees for such fiscal year
under this section; or
(ii) January 31 of each year.
(C) Limitation.--Such fee shall be paid only
once for each animal drug product for a fiscal
year in which the fee is payable.
(3) Animal drug establishment fee.--
(A) In general.--Each person--
(i) who owns or operates, directly or
through an affiliate, an animal drug
establishment;
(ii) who is named as the applicant in
an animal drug application or
supplemental animal drug application
for an animal drug product which has
been submitted for listing under
section 510; and
(iii) who, after September 1, 2003,
had pending before the Secretary an
animal drug application or supplemental
animal drug application,
shall be assessed an annual establishment fee
as established in subsection (c) for each
animal drug establishment listed in its
approved animal drug application as an
establishment that manufactures the animal drug
product named in the application.
(B) Payment; fee due date.--The annual
establishment fee shall be assessed in each
fiscal year in which the animal drug product
named in the application is assessed a fee
under paragraph (2) unless the animal drug
establishment listed in the application does
not engage in the manufacture of the animal
drug product during the fiscal year. The fee
under this paragraph for a fiscal year shall be
due upon the later of--
(i) the first business day after the
date of enactment of an appropriations
Act providing for the collection and
obligation of fees for such fiscal year
under this section; or
(ii) January 31 of each year.
(C) Limitation.--
(i) In general.--An establishment
shall be assessed only one fee per
fiscal year under this section, subject
to clause (ii).
(ii) Certain manufacturers.--If a
single establishment manufactures both
animal drug products and prescription
drug products, as defined in section
735(3), such establishment shall be
assessed both the animal drug
establishment fee and the prescription
drug establishment fee, as set forth in
section 736(a)(2), within a single
fiscal year.
(4) Animal drug sponsor fee.--
(A) In general.--Each person--
(i) who meets the definition of an
animal drug sponsor within a fiscal
year; and
(ii) who, after September 1, 2003,
had pending before the Secretary an
animal drug application, a supplemental
animal drug application, or an
investigational animal drug submission,
shall be assessed an annual sponsor fee as
established under subsection (c).
(B) Payment; fee due date.--The fee under
this paragraph for a fiscal year shall be due
upon the later of--
(i) the first business day after the
date of enactment of an appropriations
Act providing for the collection and
obligation of fees for such fiscal year
under this section; or
(ii) January 31 of each year.
(C) Limitation.--Each animal drug sponsor
shall pay only one such fee each fiscal year.
(b) Fee Revenue Amounts.--
(1) In general.--Subject to subsections (c), (d),
(f), and (g)--
(A) for fiscal year 2014, the fees required
under subsection (a) shall be established to
generate a total revenue amount of $23,600,000;
and
(B) for each of fiscal years 2015 through
2018, the fees required under subsection (a)
shall be established to generate a total
revenue amount of $21,600,000.
(2) Types of fees.--Of the total revenue amount
determined for a fiscal year under paragraph (1)--
(A) 20 percent shall be derived from fees
under subsection (a)(1) (relating to animal
drug applications and supplements);
(B) 27 percent shall be derived from fees
under subsection (a)(2) (relating to animal
drug products);
(C) 26 percent shall be derived from fees
under subsection (a)(3) (relating to animal
drug establishments); and
(D) 27 percent shall be derived from fees
under subsection (a)(4) (relating to animal
drug sponsors).
(c) Annual Fee Setting; Adjustments.--
(1) Annual fee setting.--The Secretary shall
establish, 60 days before the start of each fiscal year
beginning after September 30, 2003, for that fiscal
year, animal drug application fees, supplemental animal
drug application fees, animal drug sponsor fees, animal
drug establishment fees, and animal drug product fees
based on the revenue amounts established under
subsection (b) and the adjustments provided under this
subsection.
(2) Inflation adjustment.--For fiscal year 2015 and
subsequent fiscal years, the revenue amounts
established in subsection (b) shall be adjusted by the
Secretary by notice, published in the Federal Register,
for a fiscal year, by an amount equal to the sum of--
(A) one;
(B) the average annual percent change in the
cost, per full-time equivalent position of the
Food and Drug Administration, of all personnel
compensation and benefits paid with respect to
such positions for the first 3 of the preceding
4 fiscal years for which data are available,
multiplied by the average proportion of
personnel compensation and benefits costs to
total Food and Drug Administration costs for
the first 3 years of the preceding 4 fiscal
years for which data are available; and
(C) the average annual percent change that
occurred in the Consumer Price Index for urban
consumers (Washington-Baltimore, DC-MD-VA-WV;
not seasonally adjusted; all items less food
and energy; annual index) for the first 3 years
of the preceding 4 years for which data are
available multiplied by the average proportion
of all costs other than personnel compensation
and benefits costs to total Food and Drug
Administration costs for the first 3 years of
the preceding 4 fiscal years for which data are
available.
The adjustment made each fiscal year under this
paragraph shall be added on a compounded basis to the
sum of all adjustments made each fiscal year after
fiscal year 2014 under this paragraph.
(3) Workload adjustment.--For fiscal year 2015 and
subsequent fiscal years, after the revenue amounts
established in subsection (b) are adjusted for
inflation in accordance with paragraph (2), the revenue
amounts shall be further adjusted for such fiscal year
to reflect changes in the workload of the Secretary for
the process for the review of animal drug applications.
With respect to such adjustment--
(A) such adjustment shall be determined by
the Secretary based on a weighted average of
the change in the total number of animal drug
applications, supplemental animal drug
applications for which data with respect to
safety or effectiveness are required,
manufacturing supplemental animal drug
applications, investigational animal drug study
submissions, and investigational animal drug
protocol submissions submitted to the
Secretary;
(B) the Secretary shall publish in the
Federal Register the fees resulting from such
adjustment and the supporting methodologies;
and
(C) under no circumstances shall such
adjustment result in fee revenues for a fiscal
year that are less than the fee revenues for
that fiscal year established in subsection (b),
as adjusted for inflation under paragraph (2).
(4) Final year adjustment.--For fiscal year 2018, the
Secretary may, in addition to other adjustments under
this subsection, further increase the fees under this
section, if such an adjustment is necessary to provide
for up to 3 months of operating reserves of carryover
user fees for the process for the review of animal drug
applications for the first 3 months of fiscal year
2019. If the Food and Drug Administration has carryover
balances for the process for the review of animal drug
applications in excess of 3 months of such operating
reserves, then this adjustment will not be made. If
this adjustment is necessary, then the rationale for
the amount of the increase shall be contained in the
annual notice setting fees for fiscal year 2018.
(5) Limit.--The total amount of fees charged, as
adjusted under this subsection, for a fiscal year may
not exceed the total costs for such fiscal year for the
resources allocated for the process for the review of
animal drug applications.
(d) Fee Waiver or Reduction.--
(1) In general.--The Secretary shall grant a waiver
from or a reduction of one or more fees assessed under
subsection (a) where the Secretary finds that--
(A) the assessment of the fee would present a
significant barrier to innovation because of
limited resources available to such person or
other circumstances;
(B) the fees to be paid by such person will
exceed the anticipated present and future costs
incurred by the Secretary in conducting the
process for the review of animal drug
applications for such person;
(C) the animal drug application or
supplemental animal drug application is
intended solely to provide for use of the
animal drug in--
(i) a Type B medicated feed (as
defined in section 558.3(b)(3) of title
21, Code of Federal Regulations (or any
successor regulation)) intended for use
in the manufacture of Type C free-
choice medicated feeds; or
(ii) a Type C free-choice medicated
feed (as defined in section 558.3(b)(4)
of title 21, Code of Federal
Regulations (or any successor
regulation));
(D) the animal drug application or
supplemental animal drug application is
intended solely to provide for a minor use or
minor species indication; or
(E) the sponsor involved is a small business
submitting its first animal drug application to
the Secretary for review.
(2) Use of standard costs.--In making the finding in
paragraph (1)(B), the Secretary may use standard costs.
(3) Rules for small businesses.--
(A) Definition.--In paragraph (1)(E), the
term ``small business'' means an entity that
has fewer than 500 employees, including
employees of affiliates.
(B) Waiver of application fee.--The Secretary
shall waive under paragraph (1)(E) the
application fee for the first animal drug
application that a small business or its
affiliate submits to the Secretary for review.
After a small business or its affiliate is
granted such a waiver, the small business or
its affiliate shall pay application fees for
all subsequent animal drug applications and
supplemental animal drug applications for which
safety or effectiveness data are required in
the same manner as an entity that does not
qualify as a small business.
(C) Certification.--The Secretary shall
require any person who applies for a waiver
under paragraph (1)(E) to certify their
qualification for the waiver. The Secretary
shall periodically publish in the Federal
Register a list of persons making such
certifications.
(e) Effect of Failure To Pay Fees.--An animal drug
application or supplemental animal drug application submitted
by a person subject to fees under subsection (a) shall be
considered incomplete and shall not be accepted for filing by
the Secretary until all fees owed by such person have been
paid. An investigational animal drug submission under section
739(5)(B) that is submitted by a person subject to fees under
subsection (a) shall be considered incomplete and shall not be
accepted for review by the Secretary until all fees owed by
such person have been paid. The Secretary may discontinue
review of any animal drug application, supplemental animal drug
application, or investigational animal drug submission from a
person if such person has not submitted for payment all fees
owed under this section by 30 days after the date upon which
they are due.
(f) Assessment of Fees.--
(1) Limitation.--Fees may not be assessed under
subsection (a) for a fiscal year beginning after fiscal
year 2003 unless appropriations for salaries and
expenses of the Food and Drug Administration for such
fiscal year (excluding the amount of fees appropriated
for such fiscal year) are equal to or greater than the
amount of appropriations for the salaries and expenses
of the Food and Drug Administration for the fiscal year
2003 (excluding the amount of fees appropriated for
such fiscal year) multiplied by the adjustment factor
applicable to the fiscal year involved.
(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal
year because of paragraph (1) and if at a later date in
such fiscal year the Secretary may assess such fees,
the Secretary may assess and collect such fees, without
any modification in the rate, for animal drug
applications, supplemental animal drug applications,
investigational animal drug submissions, animal drug
sponsors, animal drug establishments, and animal drug
products at any time in such fiscal year
notwithstanding the provisions of subsection (a)
relating to the date fees are to be paid.
(g) Crediting and Availability of Fees.--
(1) In general.--Subject to paragraph (2)(C), fees
authorized under subsection (a) shall be collected and
available for obligation only to the extent and in the
amount provided in advance in appropriations Acts. Such
fees are authorized to be appropriated to remain
available until expended. Such sums as may be necessary
may be transferred from the Food and Drug
Administration salaries and expenses appropriation
account without fiscal year limitation to such
appropriation account for salary and expenses with such
fiscal year limitation. The sums transferred shall be
available solely for the process for the review of
animal drug applications.
(2) Collections and appropriation acts.--
(A) In general.--The fees authorized by this
section--
(i) subject to subparagraph (C),
shall be collected and available in
each fiscal year in an amount not to
exceed the amount specified in
appropriation Acts, or otherwise made
available for obligation for such
fiscal year; and
(ii) shall be available to defray
increases in the costs of the resources
allocated for the process for the
review of animal drug applications
(including increases in such costs for
an additional number of full-time
equivalent positions in the Department
of Health and Human Services to be
engaged in such process) over such
costs, excluding costs paid from fees
collected under this section, for
fiscal year 2003 multiplied by the
adjustment factor.
(B) Compliance.--The Secretary shall be
considered to have met the requirements of
subparagraph (A)(ii) in any fiscal year if the
costs funded by appropriations and allocated
for the process for the review of animal drug
applications--
(i) are not more than 3 percent below
the level specified in subparagraph
(A)(ii); or
(ii)(I) are more than 3 percent below
the level specified in subparagraph
(A)(ii), and fees assessed for the
fiscal year following the subsequent
fiscal year are decreased by the amount
in excess of 3 percent by which such
costs fell below the level specified in
subparagraph (A)(ii); and
(II) such costs are not more than 5
percent below the level specified in
subparagraph (A)(ii).
(C) Provision for early payments.--Payment of
fees authorized under this section for a fiscal
year, prior to the due date for such fees, may
be accepted by the Secretary in accordance with
authority provided in advance in a prior year
appropriations Act.
(3) Authorization of appropriations.--For each of the
fiscal years 2014 through 2018, there is authorized to
be appropriated for fees under this section an amount
equal to the total revenue amount determined under
subsection (b) for the fiscal year, as adjusted or
otherwise affected under subsection (c) and paragraph
(4).
(4) Offset of overcollections; recovery of collection
shortfalls.--
(A) Offset of overcollections.--If the sum of
the cumulative amount of fees collected under
this section for fiscal years 2014 through 2016
and the amount of fees estimated to be
collected under this section for fiscal year
2017 (including any increased fee collections
attributable to subparagraph (B)), exceeds the
cumulative amount appropriated pursuant to
paragraph (3) for the fiscal years 2014 through
2017, the excess amount shall be credited to
the appropriation account of the Food and Drug
Administration as provided in paragraph (1),
and shall be subtracted from the amount of fees
that would otherwise be authorized to be
collected under this section pursuant to
appropriation Acts for fiscal year 2018.
(B) Recovery of collection shortfalls.--
(i) Fiscal year 2016.--For fiscal
year 2016, the amount of fees otherwise
authorized to be collected under this
section shall be increased by the
amount, if any, by which the amount
collected under this section and
appropriated for fiscal year 2014 falls
below the amount of fees authorized for
fiscal year 2014 under paragraph (3).
(ii) Fiscal year 2017.--For fiscal
year 2017, the amount of fees otherwise
authorized to be collected under this
section shall be increased by the
amount, if any, by which the amount
collected under this section and
appropriated for fiscal year 2015 falls
below the amount of fees authorized for
fiscal year 2015 under paragraph (3).
(iii) Fiscal year 2018.--For fiscal
year 2018, the amount of fees otherwise
authorized to be collected under this
section (including any reduction in the
authorized amount under subparagraph
(A)), shall be increased by the
cumulative amount, if any, by which the
amount collected under this section and
appropriated for fiscal years 2016 and
2017 (including estimated collections
for fiscal year 2017) falls below the
cumulative amount of fees authorized
under paragraph (3) for fiscal years
2016 and 2017.
(h) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States Code.
(i) Written Requests for Waivers, Reductions, and Refunds.--
To qualify for consideration for a waiver or reduction under
subsection (d), or for a refund of any fee collected in
accordance with subsection (a), a person shall submit to the
Secretary a written request for such waiver, reduction, or
refund not later than 180 days after such fee is due.
(j) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in the process
of the review of animal drug applications, be reduced to offset
the number of officers, employees, and advisory committees so
engaged.
(k) Abbreviated New Animal Drug Applications.--The Secretary
shall--
(1) to the extent practicable, segregate the review
of abbreviated new animal drug applications from the
process for the review of animal drug applications; and
(2) adopt other administrative procedures to ensure
that review times of abbreviated new animal drug
applications do not increase from their current level
due to activities under the user fee program.
SEC. 740A. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Report.--Beginning with fiscal year 2014, not
later than 120 days after the end of each fiscal year during
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in
section 101(b) of the Animal Drug User Fee Amendments of 2013
toward expediting the animal drug development process and the
review of the new and supplemental animal drug applications and
investigational animal drug submissions during such fiscal
year, the future plans of the Food and Drug Administration for
meeting the goals, the review times for abbreviated new animal
drug applications, and the administrative procedures adopted by
the Food and Drug Administration to ensure that review times
for abbreviated new animal drug applications are not increased
from their current level due to activities under the user fee
program.
(b) Fiscal Report.--Beginning with fiscal year 2014, not
later than 120 days after the end of each fiscal year during
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected during such fiscal year for which the
report is made.
(c) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to the
public on the Internet Web site of the Food and Drug
Administration.
(d) Reauthorization.--
(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals, and
plans for meeting the goals, for the process for the
review of animal drug applications for the first 5
fiscal years after fiscal year 2018, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
(A) the Committee on Energy and Commerce of
the House of Representatives;
(B) the Committee on Health, Education,
Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) veterinary professionals;
(E) representatives of patient and consumer
advocacy groups; and
(F) the regulated industry.
(2) Prior public input.--Prior to beginning
negotiations with the regulated industry on the
reauthorization of this part, the Secretary shall--
(A) publish a notice in the Federal Register
requesting public input on the reauthorization;
(B) hold a public meeting at which the public
may present its views on the reauthorization,
including specific suggestions for changes to
the goals referred to in subsection (a);
(C) provide a period of 30 days after the
public meeting to obtain written comments from
the public suggesting changes to this part; and
(D) publish the comments on the Food and Drug
Administration's Internet Web site.
(3) Periodic consultation.--Not less frequently than
once every 4 months during negotiations with the
regulated industry, the Secretary shall hold
discussions with representatives of veterinary,
patient, and consumer advocacy groups to continue
discussions of their views on the reauthorization and
their suggestions for changes to this part as expressed
under paragraph (2).
(4) Public review of recommendations.--After
negotiations with the regulated industry, the Secretary
shall--
(A) present the recommendations developed
under paragraph (1) to the congressional
committees specified in such paragraph;
(B) publish such recommendations in the
Federal Register;
(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
(D) hold a meeting at which the public may
present its views on such recommendations; and
(E) after consideration of such public views
and comments, revise such recommendations as
necessary.
(5) Transmittal of recommendations.--Not later than
January 15, 2018, the Secretary shall transmit to
Congress the revised recommendations under paragraph
(4), a summary of the views and comments received under
such paragraph, and any changes made to the
recommendations in response to such views and comments.
(6) Minutes of negotiation meetings.--
(A) Public availability.--Before presenting
the recommendations developed under paragraphs
(1) through (5) to Congress, the Secretary
shall make publicly available, on the Internet
Web site of the Food and Drug Administration,
minutes of all negotiation meetings conducted
under this subsection between the Food and Drug
Administration and the regulated industry.
(B) Content.--The minutes described under
subparagraph (A) shall summarize any
substantive proposal made by any party to the
negotiations as well as significant
controversies or differences of opinion during
the negotiations and their resolution.
PART 5--FEES RELATING TO GENERIC NEW ANIMAL DRUGS
[SEC. 741. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES.
[(a) Types of Fees.--Beginning with respect to fiscal year
2009, the Secretary shall assess and collect fees in accordance
with this section as follows:
[(1) Abbreviated application fee.--
[(A) In general.--Each person that submits,
on or after July 1, 2008, an abbreviated
application for a generic new animal drug shall
be subject to a fee as established in
subsection (b) for such an application.
[(B) Payment.--The fee required by
subparagraph (A) shall be due upon submission
of the abbreviated application.
[(C) Exception for previously filed
application.--If an abbreviated application was
submitted by a person that paid the fee for
such application, was accepted for filing, and
was not approved or was withdrawn (without a
waiver or refund), the submission of an
abbreviated application for the same product by
the same person (or the person's licensee,
assignee, or successor) shall not be subject to
a fee under subparagraph (A).
[(D) Refund of fee if application refused for
filing.--The Secretary shall refund 75 percent
of the fee paid under subparagraph (B) for any
abbreviated application which is refused for
filing.
[(E) Refund of fee if application
withdrawn.--If an abbreviated application is
withdrawn after the application was filed, the
Secretary may refund the fee or portion of the
fee paid under subparagraph (B) if no
substantial work was performed on the
application after the application was filed.
The Secretary shall have the sole discretion to
refund the fee under this subparagraph. A
determination by the Secretary concerning a
refund under this subparagraph shall not be
reviewable.
[(2) Generic new animal drug product fee.--Each
person--
[(A) who is named as the applicant in an
abbreviated application or supplemental
abbreviated application for a generic new
animal drug product which has been submitted
for listing under section 510, and
[(B) who, after September 1, 2008, had
pending before the Secretary an abbreviated
application or supplemental abbreviated
application,
shall pay for each such generic new animal drug product
the annual fee established in subsection (b). Such fee
shall be payable for the fiscal year in which the
generic new animal drug product is first submitted for
listing under section 510, or is submitted for
relisting under section 510 if the generic new animal
drug product has been withdrawn from listing and
relisted. After such fee is paid for that fiscal year,
such fee shall be payable on or before January 31 of
each year. Such fee shall be paid only once for each
generic new animal drug product for a fiscal year in
which the fee is payable.
[(3) Generic new animal drug sponsor fee.--
[(A) In general.--Each person--
[(i) who meets the definition of a
generic new animal drug sponsor within
a fiscal year, and
[(ii) who, after September 1, 2008,
had pending before the Secretary an
abbreviated application, a supplemental
abbreviated application, or an
investigational submission,
shall be assessed an annual fee established
under subsection (b). The fee shall be paid on
or before January 31 of each year.
[(B) Amount of fee.--Each generic new animal
drug sponsor shall pay only 1 such fee each
fiscal year, as follows:
[(i) 100 percent of the amount of the
generic new animal drug sponsor fee
published for that fiscal year under
subsection (c)(3) for an applicant with
more than 6 approved abbreviated
applications.
[(ii) 75 percent of the amount of the
generic new animal drug sponsor fee
published for that fiscal year under
subsection (c)(3) for an applicant with
more than 1 and fewer than 7 approved
abbreviated applications.
[(iii) 50 percent of the amount of
the generic new animal drug sponsor fee
published for that fiscal year under
subsection (c)(3) for an applicant with
1 or fewer approved abbreviated
applications.
[(b) Fee Amounts.--Except as provided in subsection (a)(1)
and subsections (c), (d), (f), and (g), the fees required under
subsection (a) shall be established to generate fee revenue
amounts as follows:
[(1) Total fee revenues for application fees.--The
total fee revenues to be collected in abbreviated
application fees under subsection (a)(1) shall be
$1,449,000 for fiscal year 2009, $1,532,000 for fiscal
year 2010, $1,619,000 for fiscal year 2011, $1,712,000
for fiscal year 2012, and $1,809,000 for fiscal year
2013.
[(2) Total fee revenues for product fees.--The total
fee revenues to be collected in generic new animal drug
product fees under subsection (a)(2) shall be
$1,691,000 for fiscal year 2009, $1,787,000 for fiscal
year 2010, $1,889,000 for fiscal year 2011, $1,997,000
for fiscal year 2012, and $2,111,000 for fiscal year
2013.
[(3) Total fee revenues for sponsor fees.--The total
fee revenues to be collected in generic new animal drug
sponsor fees under subsection (a)(3) shall be
$1,691,000 for fiscal year 2009, $1,787,000 for fiscal
year 2010, $1,889,000 for fiscal year 2011, $1,997,000
for fiscal year 2012, and $2,111,000 for fiscal year
2013.
[(c) Adjustments.--
[(1) Workload adjustment.--The fee revenues shall be
adjusted each fiscal year after fiscal year 2009 to
reflect changes in review workload. With respect to
such adjustment:
[(A) This adjustment shall be determined by
the Secretary based on a weighted average of
the change in the total number of abbreviated
applications for generic new animal drugs,
manufacturing supplemental abbreviated
applications for generic new animal drugs,
investigational generic new animal drug study
submissions, and investigational generic new
animal drug protocol submissions submitted to
the Secretary. The Secretary shall publish in
the Federal Register the fees resulting from
this adjustment and the supporting
methodologies.
[(B) Under no circumstances shall this
workload adjustment result in fee revenues for
a fiscal year that are less than the fee
revenues for that fiscal year established in
subsection (b).
[(2) Final year adjustment.--For fiscal year 2013,
the Secretary may further increase the fees to provide
for up to 3 months of operating reserves of carryover
user fees for the process for the review of abbreviated
applications for generic new animal drugs for the first
3 months of fiscal year 2014. If the Food and Drug
Administration has carryover balances for the process
for the review of abbreviated applications for generic
new animal drugs in excess of 3 months of such
operating reserves, then this adjustment shall not be
made. If this adjustment is necessary, then the
rationale for the amount of the increase shall be
contained in the annual notice setting fees for fiscal
year 2013.
[(3) Annual fee setting.--The Secretary shall
establish, 60 days before the start of each fiscal year
beginning after September 30, 2008, for that fiscal
year, abbreviated application fees, generic new animal
drug sponsor fees, and generic new animal drug product
fees based on the revenue amounts established under
subsection (b) and the adjustments provided under this
subsection.
[(4) Limit.--The total amount of fees charged, as
adjusted under this subsection, for a fiscal year may
not exceed the total costs for such fiscal year for the
resources allocated for the process for the review of
abbreviated applications for generic new animal drugs.
[(d) Fee Waiver or Reduction.--The Secretary shall grant a
waiver from or a reduction of 1 or more fees assessed under
subsection (a) where the Secretary finds that the generic new
animal drug is intended solely to provide for a minor use or
minor species indication.
[(e) Effect of Failure To Pay Fees.--An abbreviated
application for a generic new animal drug submitted by a person
subject to fees under subsection (a) shall be considered
incomplete and shall not be accepted for filing by the
Secretary until all fees owed by such person have been paid. An
investigational submission for a generic new animal drug that
is submitted by a person subject to fees under subsection (a)
shall be considered incomplete and shall not be accepted for
review by the Secretary until all fees owed by such person have
been paid. The Secretary may discontinue review of any
abbreviated application for a generic new animal drug,
supplemental abbreviated application for a generic new animal
drug, or investigational submission for a generic new animal
drug from a person if such person has not submitted for payment
all fees owed under this section by 30 days after the date upon
which they are due.
[(f) Assessment of Fees.--
[(1) Limitation.--Fees may not be assessed under
subsection (a) for a fiscal year beginning after fiscal
year 2008 unless appropriations for salaries and
expenses of the Food and Drug Administration for such
fiscal year (excluding the amount of fees appropriated
for such fiscal year) are equal to or greater than the
amount of appropriations for the salaries and expenses
of the Food and Drug Administration for the fiscal year
2003 (excluding the amount of fees appropriated for
such fiscal year) multiplied by the adjustment factor
applicable to the fiscal year involved.
[(2) Authority.--If the Secretary does not assess
fees under subsection (a) during any portion of a
fiscal year because of paragraph (1) and if at a later
date in such fiscal year the Secretary may assess such
fees, the Secretary may assess and collect such fees,
without any modification in the rate, for abbreviated
applications, generic new animal drug sponsors, and
generic new animal drug products at any time in such
fiscal year notwithstanding the provisions of
subsection (a) relating to the date fees are to be
paid.
[(g) Crediting and Availability of Fees.--
[(1) In general.--Fees authorized under subsection
(a) shall be collected and available for obligation
only to the extent and in the amount provided in
advance in appropriations Acts. Such fees are
authorized to be appropriated to remain available until
expended. Such sums as may be necessary may be
transferred from the Food and Drug Administration
salaries and expenses appropriation account without
fiscal year limitation to such appropriation account
for salary and expenses with such fiscal year
limitation. The sums transferred shall be available
solely for the process for the review of abbreviated
applications for generic new animal drugs.
[(2) Collections and appropriation acts.--
[(A) In general.--The fees authorized by this
section--
[(i) shall be retained in each fiscal
year in an amount not to exceed the
amount specified in appropriation Acts,
or otherwise made available for
obligation for such fiscal year; and
[(ii) shall only be collected and
available to defray increases in the
costs of the resources allocated for
the process for the review of
abbreviated applications for generic
new animal drugs (including increases
in such costs for an additional number
of full-time equivalent positions in
the Department of Health and Human
Services to be engaged in such process)
over such costs, excluding costs paid
from fees collected under this section,
for fiscal year 2008 multiplied by the
adjustment factor.
[(B) Compliance.--The Secretary shall be
considered to have met the requirements of
subparagraph (A)(ii) in any fiscal year if the
costs funded by appropriations and allocated
for the process for the review of abbreviated
applications for generic new animal drugs--
[(i) are not more than 3 percent
below the level specified in
subparagraph (A)(ii); or
[(ii)(I) are more than 3 percent
below the level specified in
subparagraph (A)(ii), and fees assessed
for the fiscal year following the
subsequent fiscal year are decreased by
the amount in excess of 3 percent by
which such costs fell below the level
specified in subparagraph (A)(ii); and
[(II) such costs are not more than 5
percent below the level specified in
subparagraph (A)(ii).
[(3) Authorization of appropriations.--There are
authorized to be appropriated for fees under this
section--
[(A) $4,831,000 for fiscal year 2009;
[(B) $5,106,000 for fiscal year 2010;
[(C) $5,397,000 for fiscal year 2011;
[(D) $5,706,000 for fiscal year 2012; and
[(E) $6,031,000 for fiscal year 2013;
as adjusted to reflect adjustments in the total fee
revenues made under this section and changes in the
total amounts collected by abbreviated application
fees, generic new animal drug sponsor fees, and generic
new animal drug product fees.
[(4) Offset.--If the sum of the cumulative amount of
fees collected under this section for the fiscal years
2009 through 2011 and the amount of fees estimated to
be collected under this section for fiscal year 2012
exceeds the cumulative amount appropriated under
paragraph (3) for the fiscal years 2009 through 2012,
the excess amount shall be credited to the
appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall
be subtracted from the amount of fees that would
otherwise be authorized to be collected under this
section pursuant to appropriation Acts for fiscal year
2013.
[(h) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States Code.
[(i) Written Requests for Waivers, Reductions, and Refunds.--
To qualify for consideration for a waiver or reduction under
subsection (d), or for a refund of any fee collected in
accordance with subsection (a), a person shall submit to the
Secretary a written request for such waiver, reduction, or
refund not later than 180 days after such fee is due.
[(j) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in the process
of the review of abbreviated applications for generic new
animal drugs, be reduced to offset the number of officers,
employees, and advisory committees so engaged.
[(k) Definitions.--In this section and section 742:
[(1) Abbreviated application for a generic new animal
drug.--The terms ``abbreviated application for a
generic new animal drug'' and ``abbreviated
application'' mean an abbreviated application for the
approval of any generic new animal drug submitted under
section 512(b)(2). Such term does not include a
supplemental abbreviated application for a generic new
animal drug.
[(2) Adjustment factor.--The term ``adjustment
factor'' applicable to a fiscal year is the Consumer
Price Index for all urban consumers (all items; United
States city average) for October of the preceding
fiscal year divided by--
[(A) for purposes of subsection (f)(1), such
Index for October 2002; and
[(B) for purposes of subsection
(g)(2)(A)(ii), such Index for October 2007.
[(3) Costs of resources allocated for the process for
the review of abbreviated applications for generic new
animal drugs.--The term ``costs of resources allocated
for the process for the review of abbreviated
applications for generic new animal drugs'' means the
expenses incurred in connection with the process for
the review of abbreviated applications for generic new
animal drugs for--
[(A) officers and employees of the Food and
Drug Administration, contractors of the Food
and Drug Administration, advisory committees
consulted with respect to the review of
specific abbreviated applications, supplemental
abbreviated applications, or investigational
submissions, and costs related to such
officers, employees, committees, and
contractors, including costs for travel,
education, and recruitment and other personnel
activities;
[(B) management of information, and the
acquisition, maintenance, and repair of
computer resources;
[(C) leasing, maintenance, renovation, and
repair of facilities and acquisition,
maintenance, and repair of fixtures, furniture,
scientific equipment, and other necessary
materials and supplies; and
[(D) collecting fees under this section and
accounting for resources allocated for the
review of abbreviated applications,
supplemental abbreviated applications, and
investigational submissions.
[(4) Final dosage form.--The term ``final dosage
form'' means, with respect to a generic new animal drug
product, a finished dosage form which is approved for
administration to an animal without substantial further
manufacturing. Such term includes generic new animal
drug products intended for mixing in animal feeds.
[(5) Generic new animal drug.--The term ``generic new
animal drug'' means a new animal drug that is the
subject of an abbreviated application.
[(6) Generic new animal drug product.--The term
``generic new animal drug product'' means each specific
strength or potency of a particular active ingredient
or ingredients in final dosage form marketed by a
particular manufacturer or distributor, which is
uniquely identified by the labeler code and product
code portions of the national drug code, and for which
an abbreviated application for a generic new animal
drug or a supplemental abbreviated application has been
approved.
[(7) Generic new animal drug sponsor.--The term
``generic new animal drug sponsor'' means either an
applicant named in an abbreviated application for a
generic new animal drug that has not been withdrawn by
the applicant and for which approval has not been
withdrawn by the Secretary, or a person who has
submitted an investigational submission for a generic
new animal drug that has not been terminated or
otherwise rendered inactive by the Secretary.
[(8) Investigational submission for a generic new
animal drug.--The terms ``investigational submission
for a generic new animal drug'' and ``investigational
submission'' mean--
[(A) the filing of a claim for an
investigational exemption under section 512(j)
for a generic new animal drug intended to be
the subject of an abbreviated application or a
supplemental abbreviated application; or
[(B) the submission of information for the
purpose of enabling the Secretary to evaluate
the safety or effectiveness of a generic new
animal drug in the event of the filing of an
abbreviated application or supplemental
abbreviated application for such drug.
[(9) Person.--The term ``person'' includes an
affiliate thereof (as such term is defined in section
735(11)).
[(10) Process for the review of abbreviated
applications for generic new animal drugs.--The term
``process for the review of abbreviated applications
for generic new animal drugs'' means the following
activities of the Secretary with respect to the review
of abbreviated applications, supplemental abbreviated
applications, and investigational submissions:
[(A) The activities necessary for the review
of abbreviated applications, supplemental
abbreviated applications, and investigational
submissions.
[(B) The issuance of action letters which
approve abbreviated applications or
supplemental abbreviated applications or which
set forth in detail the specific deficiencies
in abbreviated applications, supplemental
abbreviated applications, or investigational
submissions and, where appropriate, the actions
necessary to place such applications,
supplemental applications, or submissions in
condition for approval.
[(C) The inspection of generic new animal
drug establishments and other facilities
undertaken as part of the Secretary's review of
pending abbreviated applications, supplemental
abbreviated applications, and investigational
submissions.
[(D) Monitoring of research conducted in
connection with the review of abbreviated
applications, supplemental abbreviated
applications, and investigational submissions.
[(E) The development of regulations and
policy related to the review of abbreviated
applications, supplemental abbreviated
applications, and investigational submissions.
[(F) Development of standards for products
subject to review.
[(G) Meetings between the agency and the
generic new animal drug sponsor.
[(H) Review of advertising and labeling prior
to approval of an abbreviated application or
supplemental abbreviated application, but not
after such application has been approved.
[(11) Supplemental abbreviated application for
generic new animal drug.--The terms ``supplemental
abbreviated application for a generic new animal drug''
and ``supplemental abbreviated application'' mean a
request to the Secretary to approve a change in an
approved abbreviated application.
[SEC. 742. REAUTHORIZATION; REPORTING REQUIREMENTS.
[(a) Performance Reports.--Beginning with fiscal year 2009,
not later than 60 days after the end of each fiscal year during
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Health, Education,
Labor, and Pensions of the Senate, and the Committee on Energy
and Commerce of the House of Representatives a report
concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in
section 201(3) of the Animal Generic Drug User Fee Act of 2008
toward expediting the generic new animal drug development
process and the review of abbreviated applications for generic
new animal drugs, supplemental abbreviated applications for
generic new animal drugs, and investigational submissions for
generic new animal drugs during such fiscal year.
[(b) Fiscal Report.--Beginning with fiscal year 2009, not
later than 120 days after the end of each fiscal year during
which fees are collected under this part, the Secretary shall
prepare and submit to Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected during such fiscal year for which the
report is made.
[(c) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to the
public on the Internet Web site of the Food and Drug
Administration.
[(d) Reauthorization.--
[(1) Consultation.--In developing recommendations to
present to Congress with respect to the goals, and
plans for meeting the goals, for the process for the
review of abbreviated applications for generic new
animal drugs for the first 5 fiscal years after fiscal
year 2013, and for the reauthorization of this part for
such fiscal years, the Secretary shall consult with--
[(A) the Committee on Energy and Commerce of
the House of Representatives;
[(B) the Committee on Health, Education,
Labor, and Pensions of the Senate;
[(C) scientific and academic experts;
[(D) veterinary professionals;
[(E) representatives of patient and consumer
advocacy groups; and
[(F) the regulated industry.
[(2) Prior public input.--Prior to beginning
negotiations with the regulated industry on the
reauthorization of this part, the Secretary shall--
[(A) publish a notice in the Federal Register
requesting public input on the reauthorization;
[(B) hold a public meeting at which the
public may present its views on the
reauthorization, including specific suggestions
for changes to the goals referred to in
subsection (a);
[(C) provide a period of 30 days after the
public meeting to obtain written comments from
the public suggesting changes to this part; and
[(D) publish the comments on the Food and
Drug Administration's Internet Web site.
[(3) Periodic consultation.--Not less frequently than
once every 4 months during negotiations with the
regulated industry, the Secretary shall hold
discussions with representatives of veterinary,
patient, and consumer advocacy groups to continue
discussions of their views on the reauthorization and
their suggestions for changes to this part as expressed
under paragraph (2).
[(4) Public review of recommendations.--After
negotiations with the regulated industry, the Secretary
shall--
[(A) present the recommendations developed
under paragraph (1) to the congressional
committees specified in such paragraph;
[(B) publish such recommendations in the
Federal Register;
[(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
[(D) hold a meeting at which the public may
present its views on such recommendations; and
[(E) after consideration of such public views
and comments, revise such recommendations as
necessary.
[(5) Transmittal of recommendations.--Not later than
January 15, 2013, the Secretary shall transmit to
Congress the revised recommendations under paragraph
(4), a summary of the views and comments received under
such paragraph, and any changes made to the
recommendations in response to such views and comments.
[(6) Minutes of negotiation meetings.--
[(A) Public availability.--Before presenting
the recommendations developed under paragraphs
(1) through (5) to Congress, the Secretary
shall make publicly available, on the Internet
Web site of the Food and Drug Administration,
minutes of all negotiation meetings conducted
under this subsection between the Food and Drug
Administration and the regulated industry.
[(B) Content.--The minutes described under
subparagraph (A) shall summarize any
substantive proposal made by any party to the
negotiations as well as significant
controversies or differences of opinion during
the negotiations and their resolution.]
SEC. 741. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES.
(a) Types of Fees.--Beginning with respect to fiscal year
2009, the Secretary shall assess and collect fees in accordance
with this section as follows:
(1) Abbreviated application fee.--
(A) In general.--Each person that submits, on
or after July 1, 2008, an abbreviated
application for a generic new animal drug shall
be subject to a fee as established in
subsection (c) for such an application.
(B) Payment.--The fee required by
subparagraph (A) shall be due upon submission
of the abbreviated application.
(C) Exceptions.--
(i) Previously filed application.--If
an abbreviated application was
submitted by a person that paid the fee
for such application, was accepted for
filing, and was not approved or was
withdrawn (without a waiver or refund),
the submission of an abbreviated
application for the same product by the
same person (or the person's licensee,
assignee, or successor) shall not be
subject to a fee under subparagraph
(A).
(ii) Certain abbreviated applications
involving combination animal drugs.--An
abbreviated application for an animal
drug described in section 512(d)(4) and
submitted on or after October 1, 2013,
shall be subject to a fee equal to 50
percent of the amount of the
abbreviated application fee established
in subsection (c).
(D) Refund of fee if application refused for
filing.--The Secretary shall refund 75 percent
of the fee paid under subparagraph (B) for any
abbreviated application which is refused for
filing.
(E) Refund of fee if application withdrawn.--
If an abbreviated application is withdrawn
after the application was filed, the Secretary
may refund the fee or portion of the fee paid
under subparagraph (B) if no substantial work
was performed on the application after the
application was filed. The Secretary shall have
the sole discretion to refund the fee under
this subparagraph. A determination by the
Secretary concerning a refund under this
subparagraph shall not be reviewable.
(2) Generic new animal drug product fee.--
(A) In general.--Each person--
(i) who is named as the applicant in
an abbreviated application or
supplemental abbreviated application
for a generic new animal drug product
which has been submitted for listing
under section 510; and
(ii) who, after September 1, 2008,
had pending before the Secretary an
abbreviated application or supplemental
abbreviated application,
shall pay for each such generic new animal drug
product the annual fee established in
subsection (c).
(B) Payment; fee due date.--Such fee shall be
payable for the fiscal year in which the
generic new animal drug product is first
submitted for listing under section 510, or is
submitted for relisting under section 510 if
the generic new animal drug product has been
withdrawn from listing and relisted. After such
fee is paid for that fiscal year, such fee
shall be due each subsequent fiscal year that
the product remains listed, upon the later of--
(i) the first business day after the
date of enactment of an appropriations
Act providing for the collection and
obligation of fees for such fiscal year
under this section; or
(ii) January 31 of each year.
(C) Limitation.--Such fee shall be paid only
once for each generic new animal drug product
for a fiscal year in which the fee is payable.
(3) Generic new animal drug sponsor fee.--
(A) In general.--Each person--
(i) who meets the definition of a
generic new animal drug sponsor within
a fiscal year; and
(ii) who, after September 1, 2008,
had pending before the Secretary an
abbreviated application, a supplemental
abbreviated application, or an
investigational submission,
shall be assessed an annual generic new animal
drug sponsor fee as established under
subsection (c).
(B) Payment; fee due date.--Such fee shall be
due each fiscal year upon the later of--
(i) the first business day after the
date of enactment of an appropriations
Act providing for the collection and
obligation of fees for such fiscal year
under this section; or
(ii) January 31 of each year.
(C) Amount of fee.--Each generic new animal
drug sponsor shall pay only 1 such fee each
fiscal year, as follows:
(i) 100 percent of the amount of the
generic new animal drug sponsor fee
published for that fiscal year under
subsection (c) for an applicant with
more than 6 approved abbreviated
applications.
(ii) 75 percent of the amount of the
generic new animal drug sponsor fee
published for that fiscal year under
subsection (c) for an applicant with
more than 1 and fewer than 7 approved
abbreviated applications.
(iii) 50 percent of the amount of the
generic new animal drug sponsor fee
published for that fiscal year under
subsection (c) for an applicant with 1
or fewer approved abbreviated
applications.
(b) Fee Amounts.--Subject to subsections (c), (d), (f), and
(g), the fees required under subsection (a) shall be
established to generate fee revenue amounts as follows:
(1) Total fee revenues for application fees.--The
total fee revenues to be collected in abbreviated
application fees under subsection (a)(1) shall be
$1,832,000 for fiscal year 2014, $1,736,000 for fiscal
year 2015, $1,857,000 for fiscal year 2016, $1,984,000
for fiscal year 2017, and $2,117,000 for fiscal year
2018.
(2) Total fee revenues for product fees.--The total
fee revenues to be collected in generic new animal drug
product fees under subsection (a)(2) shall be
$2,748,000 for fiscal year 2014, $2,604,000 for fiscal
year 2015, $2,786,000 for fiscal year 2016, $2,976,000
for fiscal year 2017, and $3,175,000 for fiscal year
2018.
(3) Total fee revenues for sponsor fees.--The total
fee revenues to be collected in generic new animal drug
sponsor fees under subsection (a)(3) shall be
$2,748,000 for fiscal year 2014, $2,604,000 for fiscal
year 2015, $2,786,000 for fiscal year 2016, $2,976,000
for fiscal year 2017, and $3,175,000 for fiscal year
2018.
(c) Annual Fee Setting; Adjustments.--
(1) Annual fee setting.--The Secretary shall
establish, 60 days before the start of each fiscal year
beginning after September 30, 2008, for that fiscal
year, abbreviated application fees, generic new animal
drug sponsor fees, and generic new animal drug product
fees, based on the revenue amounts established under
subsection (b) and the adjustments provided under this
subsection.
(2) Workload adjustment.--The fee revenues shall be
adjusted each fiscal year after fiscal year 2014 to
reflect changes in review workload. With respect to
such adjustment:
(A) This adjustment shall be determined by
the Secretary based on a weighted average of
the change in the total number of abbreviated
applications for generic new animal drugs,
manufacturing supplemental abbreviated
applications for generic new animal drugs,
investigational generic new animal drug study
submissions, and investigational generic new
animal drug protocol submissions submitted to
the Secretary. The Secretary shall publish in
the Federal Register the fees resulting from
this adjustment and the supporting
methodologies.
(B) Under no circumstances shall this
workload adjustment result in fee revenues for
a fiscal year that are less than the fee
revenues for that fiscal year established in
subsection (b).
(3) Final year adjustment.--For fiscal year 2018, the
Secretary may, in addition to other adjustments under
this subsection, further increase the fees under this
section, if such an adjustment is necessary, to provide
for up to 3 months of operating reserves of carryover
user fees for the process for the review of abbreviated
applications for generic new animal drugs for the first
3 months of fiscal year 2019. If the Food and Drug
Administration has carryover balances for the process
for the review of abbreviated applications for generic
new animal drugs in excess of 3 months of such
operating reserves, then this adjustment shall not be
made. If this adjustment is necessary, then the
rationale for the amount of the increase shall be
contained in the annual notice setting fees for fiscal
year 2018.
(4) Limit.--The total amount of fees charged, as
adjusted under this subsection, for a fiscal year may
not exceed the total costs for such fiscal year for the
resources allocated for the process for the review of
abbreviated applications for generic new animal drugs.
(d) Fee Waiver or Reduction.--The Secretary shall grant a
waiver from or a reduction of 1 or more fees assessed under
subsection (a) where the Secretary finds that the generic new
animal drug is intended solely to provide for a minor use or
minor species indication.
(e) Effect of Failure To Pay Fees.--An abbreviated
application for a generic new animal drug submitted by a person
subject to fees under subsection (a) shall be considered
incomplete and shall not be accepted for filing by the
Secretary until all fees owed by such person have been paid. An
investigational submission for a generic new animal drug that
is submitted by a person subject to fees under subsection (a)
shall be considered incomplete and shall not be accepted for
review by the Secretary until all fees owed by such person have
been paid. The Secretary may discontinue review of any
abbreviated application for a generic new animal drug,
supplemental abbreviated application for a generic new animal
drug, or investigational submission for a generic new animal
drug from a person if such person has not submitted for payment
all fees owed under this section by 30 days after the date upon
which they are due.
(f) Assessment of Fees.--
(1) Limitation.--Fees may not be assessed under
subsection (a) for a fiscal year beginning after fiscal
year 2008 unless appropriations for salaries and
expenses of the Food and Drug Administration for such
fiscal year (excluding the amount of fees appropriated
for such fiscal year) are equal to or greater than the
amount of appropriations for the salaries and expenses
of the Food and Drug Administration for the fiscal year
2003 (excluding the amount of fees appropriated for
such fiscal year) multiplied by the adjustment factor
applicable to the fiscal year involved.
(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal
year because of paragraph (1) and if at a later date in
such fiscal year the Secretary may assess such fees,
the Secretary may assess and collect such fees, without
any modification in the rate, for abbreviated
applications, generic new animal drug sponsors, and
generic new animal drug products at any time in such
fiscal year notwithstanding the provisions of
subsection (a) relating to the date fees are to be
paid.
(g) Crediting and Availability of Fees.--
(1) In general.--Subject to paragraph (2)(C), fees
authorized under subsection (a) shall be collected and
available for obligation only to the extent and in the
amount provided in advance in appropriations Acts. Such
fees are authorized to be appropriated to remain
available until expended. Such sums as may be necessary
may be transferred from the Food and Drug
Administration salaries and expenses appropriation
account without fiscal year limitation to such
appropriation account for salary and expenses with such
fiscal year limitation. The sums transferred shall be
available solely for the process for the review of
abbreviated applications for generic new animal drugs.
(2) Collections and appropriation acts.--
(A) In general.--The fees authorized by this
section--
(i) subject to subparagraph (C),
shall be collected and available in
each fiscal year in an amount not to
exceed the amount specified in
appropriation Acts, or otherwise made
available for obligation for such
fiscal year; and
(ii) shall be available to defray
increases in the costs of the resources
allocated for the process for the
review of abbreviated applications for
generic new animal drugs (including
increases in such costs for an
additional number of full-time
equivalent positions in the Department
of Health and Human Services to be
engaged in such process) over such
costs, excluding costs paid from fees
collected under this section, for
fiscal year 2008 multiplied by the
adjustment factor.
(B) Compliance.--The Secretary shall be
considered to have met the requirements of
subparagraph (A)(ii) in any fiscal year if the
costs funded by appropriations and allocated
for the process for the review of abbreviated
applications for generic new animal drugs--
(i) are not more than 3 percent below
the level specified in subparagraph
(A)(ii); or
(ii)(I) are more than 3 percent below
the level specified in subparagraph
(A)(ii), and fees assessed for the
fiscal year following the subsequent
fiscal year are decreased by the amount
in excess of 3 percent by which such
costs fell below the level specified in
subparagraph (A)(ii); and
(II) such costs are not more than 5
percent below the level specified in
subparagraph (A)(ii).
(C) Provision for early payments.--Payment of
fees authorized under this section for a fiscal
year, prior to the due date for such fees, may
be accepted by the Secretary in accordance with
authority provided in advance in a prior year
appropriations Act.
(3) Authorization of appropriations.--There are
authorized to be appropriated for fees under this
section--
(A) $7,328,000 for fiscal year 2014;
(B) $6,944,000 for fiscal year 2015;
(C) $7,429,000 for fiscal year 2016;
(D) $7,936,000 for fiscal year 2017; and
(E) $8,467,000 for fiscal year 2018;
as adjusted to reflect adjustments in the total fee
revenues made under this section and changes in the
total amounts collected by abbreviated application
fees, generic new animal drug sponsor fees, and generic
new animal drug product fees.
(4) Offset.--If the sum of the cumulative amount of
fees collected under this section for the fiscal years
2014 through 2016 and the amount of fees estimated to
be collected under this section for fiscal year 2017
exceeds the cumulative amount appropriated under
paragraph (3) for the fiscal years 2014 through 2017,
the excess amount shall be credited to the
appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall
be subtracted from the amount of fees that would
otherwise be authorized to be collected under this
section pursuant to appropriation Acts for fiscal year
2018.
(h) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States Code.
(i) Written Requests for Waivers, Reductions, and Refunds.--
To qualify for consideration for a waiver or reduction under
subsection (d), or for a refund of any fee collected in
accordance with subsection (a), a person shall submit to the
Secretary a written request for such waiver, reduction, or
refund not later than 180 days after such fee is due.
(j) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in the process
of the review of abbreviated applications for generic new
animal drugs, be reduced to offset the number of officers,
employees, and advisory committees so engaged.
(k) Definitions.--In this section and section 742:
(1) Abbreviated application for a generic new animal
drug.--The terms ``abbreviated application for a
generic new animal drug'' and ``abbreviated
application'' mean an abbreviated application for the
approval of any generic new animal drug submitted under
section 512(b)(2). Such term does not include a
supplemental abbreviated application for a generic new
animal drug.
(2) Adjustment factor.--The term ``adjustment
factor'' applicable to a fiscal year is the Consumer
Price Index for all urban consumers (all items; United
States city average) for October of the preceding
fiscal year divided by--
(A) for purposes of subsection (f)(1), such
Index for October 2002; and
(B) for purposes of subsection (g)(2)(A)(ii),
such Index for October 2007.
(3) Costs of resources allocated for the process for
the review of abbreviated applications for generic new
animal drugs.--The term ``costs of resources allocated
for the process for the review of abbreviated
applications for generic new animal drugs'' means the
expenses in connection with the process for the review
of abbreviated applications for generic new animal
drugs for--
(A) officers and employees of the Food and
Drug Administration, contractors of the Food
and Drug Administration, advisory committees
consulted with respect to the review of
specific abbreviated applications, supplemental
abbreviated applications, or investigational
submissions, and costs related to such
officers, employees, committees, and
contractors, including costs for travel,
education, and recruitment and other personnel
activities;
(B) management of information, and the
acquisition, maintenance, and repair of
computer resources;
(C) leasing, maintenance, renovation, and
repair of facilities and acquisition,
maintenance, and repair of fixtures, furniture,
scientific equipment, and other necessary
materials and supplies; and
(D) collecting fees under this section and
accounting for resources allocated for the
review of abbreviated applications,
supplemental abbreviated applications, and
investigational submissions.
(4) Final dosage form.--The term ``final dosage
form'' means, with respect to a generic new animal drug
product, a finished dosage form which is approved for
administration to an animal without substantial further
manufacturing. Such term includes generic new animal
drug products intended for mixing in animal feeds.
(5) Generic new animal drug.--The term ``generic new
animal drug'' means a new animal drug that is the
subject of an abbreviated application.
(6) Generic new animal drug product.--The term
``generic new animal drug product'' means each specific
strength or potency of a particular active ingredient
or ingredients in final dosage form marketed by a
particular manufacturer or distributor, which is
uniquely identified by the labeler code and product
code portions of the national drug code, and for which
an abbreviated application for a generic new animal
drug or a supplemental abbreviated application has been
approved.
(7) Generic new animal drug sponsor.--The term
``generic new animal drug sponsor'' means either an
applicant named in an abbreviated application for a
generic new animal drug that has not been withdrawn by
the applicant and for which approval has not been
withdrawn by the Secretary, or a person who has
submitted an investigational submission for a generic
new animal drug that has not been terminated or
otherwise rendered inactive by the Secretary.
(8) Investigational submission for a generic new
animal drug.--The terms ``investigational submission
for a generic new animal drug'' and ``investigational
submission'' mean--
(A) the filing of a claim for an
investigational exemption under section 512(j)
for a generic new animal drug intended to be
the subject of an abbreviated application or a
supplemental abbreviated application; or
(B) the submission of information for the
purpose of enabling the Secretary to evaluate
the safety or effectiveness of a generic new
animal drug in the event of the filing of an
abbreviated application or supplemental
abbreviated application for such drug.
(9) Person.--The term ``person'' includes an
affiliate thereof (as such term is defined in section
735(11)).
(10) Process for the review of abbreviated
applications for generic new animal drugs.--The term
``process for the review of abbreviated applications
for generic new animal drugs'' means the following
activities of the Secretary with respect to the review
of abbreviated applications, supplemental abbreviated
applications, and investigational submissions:
(A) The activities necessary for the review
of abbreviated applications, supplemental
abbreviated applications, and investigational
submissions.
(B) The issuance of action letters which
approve abbreviated applications or
supplemental abbreviated applications or which
set forth in detail the specific deficiencies
in abbreviated applications, supplemental
abbreviated applications, or investigational
submissions and, where appropriate, the actions
necessary to place such applications,
supplemental applications, or submissions in
condition for approval.
(C) The inspection of generic new animal drug
establishments and other facilities undertaken
as part of the Secretary's review of pending
abbreviated applications, supplemental
abbreviated applications, and investigational
submissions.
(D) Monitoring of research conducted in
connection with the review of abbreviated
applications, supplemental abbreviated
applications, and investigational submissions.
(E) The development of regulations and policy
related to the review of abbreviated
applications, supplemental abbreviated
applications, and investigational submissions.
(F) Development of standards for products
subject to review.
(G) Meetings between the agency and the
generic new animal drug sponsor.
(H) Review of advertising and labeling prior
to approval of an abbreviated application or
supplemental abbreviated application, but not
after such application has been approved.
(11) Supplemental abbreviated application for generic
new animal drug.--The terms ``supplemental abbreviated
application for a generic new animal drug'' and
``supplemental abbreviated application'' mean a request
to the Secretary to approve a change in an approved
abbreviated application.
SEC. 742. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Reports.--Beginning with fiscal year 2014,
not later than 120 days after the end of each fiscal year
during which fees are collected under this part, the Secretary
shall prepare and submit to the Committee on Health, Education,
Labor, and Pensions of the Senate, and the Committee on Energy
and Commerce of the House of Representatives a report
concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in
section 201(b) of the Animal Generic Drug User Fee Amendments
of 2013 toward expediting the generic new animal drug
development process and the review of abbreviated applications
for generic new animal drugs, supplemental abbreviated
applications for generic new animal drugs, and investigational
submissions for generic new animal drugs during such fiscal
year.
(b) Fiscal Report.--Beginning with fiscal year 2014, not
later than 120 days after the end of each fiscal year during
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected during such fiscal year for which the
report is made.
(c) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to the
public on the Internet Web site of the Food and Drug
Administration.
(d) Reauthorization.--
(1) Consultation.--In developing recommendations to
present to Congress with respect to the goals, and
plans for meeting the goals, for the process for the
review of abbreviated applications for generic new
animal drugs for the first 5 fiscal years after fiscal
year 2018, and for the reauthorization of this part for
such fiscal years, the Secretary shall consult with--
(A) the Committee on Energy and Commerce of
the House of Representatives;
(B) the Committee on Health, Education,
Labor, and Pensions of the Senate;
(C) scientific and academic experts;
(D) veterinary professionals;
(E) representatives of patient and consumer
advocacy groups; and
(F) the regulated industry.
(2) Prior public input.--Prior to beginning
negotiations with the regulated industry on the
reauthorization of this part, the Secretary shall--
(A) publish a notice in the Federal Register
requesting public input on the reauthorization;
(B) hold a public meeting at which the public
may present its views on the reauthorization,
including specific suggestions for changes to
the goals referred to in subsection (a);
(C) provide a period of 30 days after the
public meeting to obtain written comments from
the public suggesting changes to this part; and
(D) publish the comments on the Food and Drug
Administration's Internet Web site.
(3) Periodic consultation.--Not less frequently than
once every 4 months during negotiations with the
regulated industry, the Secretary shall hold
discussions with representatives of veterinary,
patient, and consumer advocacy groups to continue
discussions of their views on the reauthorization and
their suggestions for changes to this part as expressed
under paragraph (2).
(4) Public review of recommendations.--After
negotiations with the regulated industry, the Secretary
shall--
(A) present the recommendations developed
under paragraph (1) to the congressional
committees specified in such paragraph;
(B) publish such recommendations in the
Federal Register;
(C) provide for a period of 30 days for the
public to provide written comments on such
recommendations;
(D) hold a meeting at which the public may
present its views on such recommendations; and
(E) after consideration of such public views
and comments, revise such recommendations as
necessary.
(5) Transmittal of recommendations.--Not later than
January 15, 2018, the Secretary shall transmit to
Congress the revised recommendations under paragraph
(4), a summary of the views and comments received under
such paragraph, and any changes made to the
recommendations in response to such views and comments.
(6) Minutes of negotiation meetings.--
(A) Public availability.--Before presenting
the recommendations developed under paragraphs
(1) through (5) to Congress, the Secretary
shall make publicly available, on the Internet
Web site of the Food and Drug Administration,
minutes of all negotiation meetings conducted
under this subsection between the Food and Drug
Administration and the regulated industry.
(B) Content.--The minutes described under
subparagraph (A) shall summarize any
substantive proposal made by any party to the
negotiations as well as significant
controversies or differences of opinion during
the negotiations and their resolution.
* * * * * * *
PUBLIC LAW 110-316
* * * * * * *
SECTION 1. TABLE OF CONTENTS
The table of contents of this Act is as follows:
Sec. 1. Table of contents.
Sec. 2. References in Act.
TITLE I--ANIMAL DRUG USER FEE AMENDMENTS
Sec. 101. Short title; finding.
* * * * * * *
[Sec. 108. Sunset dates.]
* * * * * * *
[Sec. 204. Sunset dates.]
* * * * * * *
TITLE I--ANIMAL DRUG USER FEE AMENDMENTS
SEC. 101. SHORT TITLE; FINDING
(a) Short Title.--This title may be cited as the ``Animal
Drug User Fee Amendments of 2008''.
* * * * * * *
[SEC. 108. SUNSET DATES.
[(a) Authorization.--The amendments made by sections 102 and
103 cease to be effective October 1, 2013.
[(b) Reporting Requirements.--The amendment made by section
104 ceases to be effective January 31, 2014.]
* * * * * * *
TITLE II--ANIMAL GENERIC DRUG USER FEE
SEC. 201. SHORT TITLE; FINDINGS
(a) Short Title.--This title may be cited as the ``Animal
Generic Drug User Fee Act of 2008''.
* * * * * * *
[SEC. 204. SUNSET DATES
[(a) Authorization.--The amendments made by section 202 shall
cease to be effective October 1, 2013.
[(b) Reporting Requirements.--The amendment made by section
203 shall cease to be effective January 31, 2014.]
* * * * * * *
SECTION 5 OF THE ANIMAL DRUG USER FEE ACT OF 2003
* * * * * * *
[SEC. 5. SUNSET.
[The amendments made by section 3 shall not be in effect
after October 1, 2008, and section 4 shall not be in effect
after 120 days after such date.]