[House Report 110-874]
[From the U.S. Government Publishing Office]
110th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 110-874
======================================================================
HEART DISEASE EDUCATION, ANALYSIS RESEARCH, AND TREATMENT FOR WOMEN ACT
(HEART FOR WOMEN ACT)
_______
September 23, 2008.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Dingell, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 1014]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 1014) to amend the Federal Food, Drug, and
Cosmetic Act and the Public Health Service Act to improve the
prevention, diagnosis, and treatment of heart disease, stroke,
and other cardiovascular diseases in women, having considered
the same, report favorably thereon with an amendment and
recommend that the bill as amended do pass.
CONTENTS
Page
Amendment........................................................ 2
Purpose and Summary.............................................. 4
Background and Need for Legislation.............................. 4
Hearings......................................................... 6
Committee Consideration.......................................... 6
Committee Votes.................................................. 6
Committee Oversight Findings..................................... 6
Statement of General Performance Goals and Objectives............ 6
New Budget Authority, Entitlement Authority, and Tax Expenditures 6
Earmarks and Tax and Tariff Benefits............................. 7
Committee Cost Estimate.......................................... 7
Congressional Budget Office Estimate............................. 7
Federal Mandates Statement....................................... 7
Advisory Committee Statement..................................... 7
Constitutional Authority Statement............................... 7
Applicability to Legislative Branch.............................. 7
Section-by-Section Analysis of the Legislation................... 7
Changes in Existing Law Made by the Bill, as Reported............ 9
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Heart Disease Education, Analysis
Research, and Treatment for Women Act'' or the ``HEART for Women Act''.
SEC. 2. REPORTING OF DATA IN APPLICATIONS FOR DRUGS, BIOLOGICS, AND
DEVICES.
(a) Drugs.--
(1) New drug applications.--Section 505(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended--
(A) in paragraph (1), in the second sentence--
(i) by striking ``drug, and (G)'' and
inserting ``drug; (G)''; and
(ii) by inserting before the period the
following: ``; and (H) the information required
under paragraph (7)''; and
(B) by adding at the end the following:
``(7)(A) With respect to clinical data in an application under this
subsection, the Secretary may deny such an application if the
application fails to meet the requirements of sections 314.50(d)(5)(v)
and 314.50(d)(5)(vi)(a) of title 21, Code of Federal Regulations.
``(B) The Secretary shall modify the sections referred to in
subparagraph (A) to require that an application under this subsection
include any clinical data possessed by the applicant that relates to
the safety or effectiveness of the drug involved by gender, age, and
racial subgroup.
``(C) Promptly after approving an application under this subsection,
the Secretary shall, through an Internet site of the Department of
Health and Human Services, make available to the public the information
submitted to the Secretary pursuant to subparagraphs (A) and (B),
subject to sections 301(j) and 520(h)(4) of this Act, subsection (b)(4)
of section 552 of title 5, United States Code (commonly referred to as
the `Freedom of Information Act'), and other provisions of law that
relate to trade secrets or confidential commercial information.
``(D) The Secretary shall develop guidance for staff of the Food and
Drug Administration to ensure that applications under this subsection
are adequately reviewed to determine whether the applications include
the information required pursuant to subparagraphs (A) and (B).''.
(2) Investigational new drug applications.--Section 505(i) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is
amended--
(A) in paragraph (2), by striking ``Subject to
paragraph (3),'' and inserting ``Subject to paragraphs
(3) and (5),'' ; and
(B) by adding at the end the following:
``(5)(A) The Secretary may place a clinical hold (as described in
paragraph (3)) on an investigation if the sponsor of the investigation
fails to meet the requirements of section 312.33(a) of title 21, Code
of Federal Regulations.
``(B) The Secretary shall modify the section referred to in
subparagraph (A) to require that reports under such section include any
clinical data possessed by the sponsor of the investigation that
relates to the safety or effectiveness of the drug involved by gender,
age, and racial subgroup.''.
(b) Biologics License Applications.--Section 351 of the Public Health
Service Act (42 U.S.C. 262) is amended by adding at the end the
following:
``(k) The provisions of section 505(b)(7) of the Federal Food, Drug,
and Cosmetic Act (relating to clinical data submission) apply with
respect to an application under subsection (a) of this section to the
same extent and in the same manner as such provisions apply with
respect to an application under section 505(b) of such Act.''.
(c) Devices.--
(1) Premarket approval.--Section 515 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360e) is amended--
(A) in subsection (c)(1)--
(i) in subparagraph (G)--
(I) by moving the margin 2 ems to the
left; and
(II) by striking ``and'' after the
semicolon at the end;
(ii) by redesignating subparagraph (H) as
subparagraph (I); and
(iii) by inserting after subparagraph (G) the
following subparagraph:
``(H) the information required under subsection (d)(7);
and''; and
(B) in subsection (d), by adding at the end the
following paragraph:
``(7) To the extent consistent with the regulation of devices, the
provisions of section 505(b)(7) (relating to clinical data submission)
apply with respect to an application for premarket approval of a device
under subsection (c) of this section to the same extent and in the same
manner as such provisions apply with respect to an application for
premarket approval of a drug under section 505(b).''.
(2) Investigational devices.--Section 520(g)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)(2)) is
amended by adding at the end the following subparagraph:
``(D) To the extent consistent with the regulation of devices, the
provisions of section 505(i)(5) (relating to individual study
information) apply with respect to an application for an exemption
pursuant to subparagraph (A) of this paragraph to the same extent and
in the same manner as such provisions apply with respect to an
application for an exemption under section 505(i).''.
(d) Rules of Construction.--This Act and the amendments made by this
Act may not be construed--
(1) as establishing new requirements under the Federal Food,
Drug, and Cosmetic Act relating to the design of clinical
investigations that were not otherwise in effect on the day
before the date of the enactment of this Act; or
(2) as having any effect on the authority of the Secretary of
Health and Human Services to enforce regulations under the
Federal Food, Drug, and Cosmetic Act that are not expressly
referenced in this Act or the amendments made by this Act.
(e) Application.--This section and the amendments made by this
section apply only with respect to applications received under section
505 or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355,
360e) or section 351 of the Public Health Service Act (42 U.S.C. 262)
on or after the date of the enactment of this Act.
SEC. 3. REPORTING AND ANALYSIS OF PATIENT SAFETY DATA.
(a) Data Standards.--Section 923(b) of the Public Health Service Act
(42 U.S.C. 299b-23(b)) is amended by adding at the end the following:
``The Secretary shall provide that all nonidentifiable patient safety
work product reported to and among the network of patient safety
databases be stratified by sex.''.
(b) Use of Information.--Section 923(c) of the Public Health Service
Act (42 U.S.C. 299b-23(c)) is amended by adding at the end the
following: ``Such analyses take into account data that specifically
relates to women and any disparities between treatment and the quality
of care between males and females.''.
SEC. 4. QUALITY OF CARE REPORTS BY THE AGENCY FOR HEALTHCARE RESEARCH
AND QUALITY.
Section 903 of the Public Health Service Act (42 U.S.C. 299a-1) is
amended--
(1) in subsection (b)(1)(B), by inserting before the
semicolon the following: ``, including quality of and access to
care for women with heart disease, stroke, and other
cardiovascular diseases''; and
(2) in subsection (c), by adding at the end the following:
``(4) Annual report on women and heart disease.--Not later
than September 30, 2009, and annually thereafter, the
Secretary, acting through the Director, shall prepare and
submit to Congress a report concerning the findings related to
the quality of and access to care for women with heart disease,
stroke, and other cardiovascular diseases. The report shall
contain recommendations for eliminating disparities in, and
improving the treatment of, heart disease, stroke, and other
cardiovascular diseases in women.''.
SEC. 5. EDUCATIONAL CAMPAIGNS.
(a) Distribution of Educational Material.--The Secretary of Health
and Human Services (referred to in this section as the ``Secretary'')
shall develop and distribute to females who are age 65 or older,
physicians, and other appropriate healthcare professionals, educational
materials relating to the prevention, diagnosis, and treatment of heart
disease, stroke, and cardiovascular diseases in women. The Secretary
may carry out this subsection through contracts with public and private
nonprofit entities.
(b) Healthcare Professional Educational Campaign.--The Secretary,
acting through the Bureau of Health Professions of the Health Resources
and Services Administration, shall conduct an education and awareness
campaign for physicians and other healthcare professionals relating to
the prevention, diagnosis, and treatment of heart disease, stroke, and
other cardiovascular diseases in women. The Bureau of Health
Professions may carry out this subsection through contracts with public
and private nonprofit entities.
SEC. 6. EXTENSION OF WISEWOMAN PROGRAM.
Section 1509 of the Public Health Service Act (42 U.S.C. 300n-4a) is
amended--
(1) in subsection (a)--
(A) by striking the heading and inserting ``In
General.--''; and
(B) in the matter preceding paragraph (1), by
striking ``may make grants'' and all that follows
through ``purpose'' and inserting the following: ``may
make grants to such States for the purpose''; and
(2) in subsection (d)(1), by striking ``there are
authorized'' and all that follows through the period and
inserting ``there are authorized to be appropriated $37,000,000
for fiscal year 2009, $38,850,000 for fiscal year 2010,
$40,792,500 for fiscal year 2011, $42,832,000 for fiscal year
2012, and $44,974,000 for fiscal year 2013.''.
Purpose and Summary
The purpose of H.R. 1014, the Heart Disease Education,
Analysis, Research, and Treatment for Women Act (or the HEART
for Women Act), is to amend the Federal Food, Drug, and
Cosmetic Act (FFDCA) and the Public Health Service Act to
improve the prevention, diagnosis, and treatment of heart
disease, stroke, and other cardiovascular diseases in women.
H.R. 1014 authorizes the Department of Health and Human
Services (HHS) to educate health care professionals and older
women about unique aspects of care in the prevention,
diagnosis, and treatment of women with heart disease and
stroke.
H.R. 1014 authorizes the Secretary to deny an application
for approval or place a clinical hold on an investigation, as
appropriate, of a new drug, investigational new drug, biologic,
device, or investigational device, if the application fails to
meet current reporting requirements concerning the
stratification of data by gender, age, and race. The Secretary
is then required to make this information publicly available.
H.R. 1014 requires the Secretary, acting through the
Director of the Agency for Healthcare Research and Quality
(AHRQ), to prepare and submit annual recommendations to
Congress for eliminating disparities in, and improving the
treatment of, heart disease in women.
H.R. 1014 authorizes the expansion of the program of the
Centers for Disease Control and Prevention (CDC) known as the
Well-Integrated Screening and Evaluation for Women Across the
Nation (WISEWOMAN) program. This program, currently available
in only 20 States, provides free cardiovascular disease
screenings to low-income uninsured women.
Background and Need for Legislation
Heart disease and other forms of cardiovascular disease are
the leading cause of death in the United States and a major
cause of disability. More than 850,000 people die of
cardiovascular disease in the United States annually,
representing nearly 36 percent of all U.S. deaths.
Cardiovascular disease is a broad term that includes several
more specific groups of diseases of the heart, the blood vessel
system within the heart, and stroke. Heart disease alone is the
number one cause of death in the United States, and stroke
alone is the third leading cause of death. The most common
heart disease in the United States is coronary heart disease,
which often appears as a heart attack.
Although heart disease is sometimes thought of as a ``man's
disease,'' one in three American women die of heart disease and
other cardiovascular diseases, making it the leading cause of
death for both women and men in the United States. Heart
disease is the leading cause of death among women aged 65 years
and older and is the second and third leading cause of death
among women aged 45 to 64 years and women aged 25 to 44 years,
respectively.
Recent studies attribute these statistics in part to
disparities in preventive care and treatment for cardiovascular
disease between women and men. In particular, there is a
pervasive lack of awareness among women about cardiovascular
health and the risks of heart disease. Many minority women,
including African American, Hispanic, Native American, and some
sub-groups of Asian American women, have a greater prevalence
of risk factors or are at a higher risk of death from heart
disease, stroke, and other cardiovascular diseases, but they
are less likely to be aware of this risk.
There is also a pervasive lack of awareness among health
care providers that cardiovascular disease is the leading cause
of death for women. For instance, a recent survey found that
only about 8 percent of primary care physicians know that more
women than men die each year from cardiovascular disease. Women
are less likely than men to receive certain treatments for
cardiovascular disease, perhaps due to lack of awareness and
the differences in symptoms between women and men. For example,
only about 33 percent of percutaneous coronary interventions,
such as angioplasties and stent placements, are performed in
women.
Additionally, women tend to present with cardiovascular
disease at an older age than men, and therefore often suffer
from multiple conditions that may mask the symptoms of heart
attacks and complicate treatment. Certain diagnostic tests may
be less accurate in women, such as electrocardiogram exercise
stress tests. Additionally, drug effectiveness and metabolism
differ between women and men, which affect the success of
treatment.
Stroke kills 2.3 times as many women as breast cancer.
Nearly 61 percent of stroke-related deaths occur in women.
Although the evidence of disparities in stroke presentation and
treatment is unclear, there are important sex differences in
patients experiencing stroke. For instance, stroke severity is
greater in women than in men. Women often receive fewer
diagnostic tests and interventional procedures than men.
Additionally, although 46,000 more women than men have a stroke
each year, women receive only 39 percent of carotid
endarterectomy procedures to prevent stroke; however, this may
be due to higher perioperative risks for women.
There is no statutory requirement that women must be
included in clinical trials, but the Food and Drug
Administration (FDA) requires new drug applicants to submit
data, stratified by sex, age group, and race, to the agency
during the Investigational New Drug stage and as part of the
New Drug Application. According to a 2001 Government
Accountability Office report, however, new drug applicants
routinely fail to comply with these mandatory reporting
requirements and FDA frequently fails to enforce them.
Consequently, treating physicians are often missing specific
information about how drugs and medical devices perform in
women or whether or not tests have been conducted for these
products in women.
The CDC administers the WISEWOMAN program. WISEWOMAN began
as a demonstration program authorized in 1993 by Congress. The
program is available to low-income women aged 40 to 64 who are
enrolled in the National Breast and Cervical Cancer Early
Detection Program. WISEWOMAN successfully screens low-income
and uninsured women for heart disease, stroke, and other forms
of cardiovascular disease through blood pressure and blood
cholesterol testing. Up to this point, however, the available
funding has limited the program to 21 projects in only 20
States.
Hearings
The Subcommittee on Health held a legislative hearing on
H.R. 1014 on May 1, 2007. The Subcommittee heard from two
witnesses: Susan K. Bennett, M.D., Clinical Director, Women's
Heart Program, George Washington University Hospital, a
national spokesperson for the American Heart Association; and,
Ms. Janet Wolf, Supervisor, County of Santa Barbara, heart
disease survivor.
Committee Consideration
On Wednesday, September 17, 2008, the full Committee met in
open markup session and ordered H.R. 1014 favorably reported to
the House, amended, by a 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. No
record votes were taken on amendments or in connection with
ordering H.R. 1014 reported to the House. A motion by Mr.
Dingell to order H.R. 1014 favorably reported to the House,
amended, was agreed to by a voice vote.
Committee Oversight Findings
Regarding clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Subcommittee on Health held a
legislative hearing on H.R. 1014, and the oversight findings of
the Committee regarding the bill are reflected in this report.
Statement of General Performance Goals and Objectives
The objectives of H.R. 1014 are to improve the prevention,
diagnosis, and treatment of women with cardiovascular disease
through a multi-pronged strategy, including requiring the Food
and Drug Administration to enforce reporting requirements
regarding gender-specific data about new and investigational
medicines and devices; raising awareness among older women and
their health care providers; and improving cardiovascular
disease screening for women.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Regarding compliance with clause 3(c)(2) of rule XIII of
the Rules of the House of Representatives, the Committee will
adopt as its own the estimate of budget authority and revenues
regarding H.R. 1014 prepared by the Director of the
Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
Earmarks and Tax and Tariff Benefits
Regarding compliance with clause 9 of rule XXI of the Rules
of the House of Representatives, H.R. 1014 does not contain any
congressional earmarks, limited tax benefits, or limited tariff
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.
Committee Cost Estimate
The Committee adopts as its own the cost estimate on H.R.
1014 prepared by the Director of the Congressional Budget
Office pursuant to section 402 of the Congressional Budget Act
of 1974.
Congressional Budget Office Estimate
Regarding clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, a cost estimate on H.R. 1014 by the
Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974 was not available at the time
of the filing of this report.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates regarding H.R. 1014 prepared by the Director of the
Congressional Budget Office pursuant to section 423 of the
Unfunded Mandates Reform Act.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act would be created by H.R.
1014.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for H.R. 1014 is provided in Article
I, section 8, clause 3, which grants Congress the power to
regulate commerce with foreign nations, among the several
States, and with the Indian Tribes, and in the provisions of
Article I, section 8, clause 1, that relate to expending funds
to provide for the general welfare of the United States.
Applicability to Legislative Branch
The Committee finds that H.R. 1014 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 of 1995.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 establishes the short title as the Heart Disease
Education, Analysis, Research, and Treatment for Women Act or
the HEART for Women Act.
Section 2. Reporting of data in applications for drugs, biologics, and
devices
Section 2 grants the HHS Secretary the authority to deny
New Drug Applications, Biologics Licensing Applications, and
Premarket Approval applications for devices or to place a
clinical hold on Investigational New Drugs or Investigational
Device Exemptions that do not include safety or efficacy data
reported by gender, age, and racial subgroup. FDA currently
requires this information, and this provision reasserts the
importance of collecting clinical trial information stratified
by gender, age, and race.
Section 2 requires the HHS Secretary to make information
about the safety and effectiveness of newly approved drugs,
biologics, or devices available to the public through its
Internet site, consistent with laws protecting trade secrets or
commercially confidential information. The Secretary is also
required to develop guidance for FDA staff to ensure that
applications are adequately reviewed for safety and efficacy
data reported by gender, age, and racial subgroup.
Section 2 clarifies that this Act neither establishes new
requirements under the FFDCA relating to the design of clinical
trials nor affects the authority of the HHS Secretary to
enforce regulations under the FFDCA not expressly referenced in
this Act. The requirements of this section apply only to
applications received by the FDA on or after the date of
enactment of this Act.
Section 3. Reporting and analysis of patient safety data
Section 3 requires that non-identifiable patient safety
data reported by Patient Safety Organizations (PSOs) be
stratified by sex and requires that PSOs analyze such data to
identify any disparities in treatment and quality of care
between males and females in issuing their findings.
Section 4. Quality of care reports by the Agency for Healthcare
Research and Quality
Section 4 requires the Agency for Healthcare Research and
Quality to submit an annual report to Congress no later than
September 30, 2009, and annually thereafter on the quality of,
and access to, care for women with heart disease, stroke, and
other cardiovascular diseases. This annual report will make
recommendations for eliminating disparities in, and improving
the treatment of, heart disease, stroke, and other forms of
cardiovascular disease in women.
Section 5. Educational campaigns
Section 5 requires the Secretary to develop and distribute
to women who are 65 years or older, physicians, and other
appropriate health care professionals educational materials
related to the prevention, diagnosis, and treatment of
cardiovascular diseases in women.
Section 5 also requires the Secretary, acting through the
Bureau of Health Professions of the Health Resources and
Services Administration, to conduct an education and awareness
campaign for physicians and other health care professionals
related to the prevention, diagnosis, and treatment of heart
disease, stroke, and other forms of cardiovascular disease in
women.
Section 6. Extension of WISEWOMAN Program
Section 6 makes all States, U.S. territories, and Indian
Tribes eligible to receive grants from the CDC under the
WISEWOMAN program. Section 6 authorizes $37,000,000 for fiscal
year (FY) 2009, $38,850,000 for FY 2010, $40,792,500 for FY
2011, $42,832,000 for FY 2012, and $44,974,000 for FY 2013 to
carry out this section.
The Committee has authorized increased funding for
WISEWOMAN to allow the program to screen more low-income
uninsured and underinsured women across the Nation. Heart
disease, stroke, and other cardiovascular diseases are the
leading killer of women in all 50 States. The Committee intends
that the CDC use the increased resources authorized under this
Act to fund WISEWOMAN programs in as many additional States as
possible, subject to appropriations being made available. The
Committee believes it is important to continue to monitor the
effectiveness of this program.
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 V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
* * * * * * *
NEW DRUGS
Sec. 505. (a) * * *
(b)(1) Any person may file with the Secretary an application
with respect to any drug subject to the provisions of
subsection (a). Such persons shall submit to the Secretary as a
part of the application (A) full reports of investigations
which have been made to show whether or not such drug is safe
for use and whether such drug is effective in use; (B) a full
list of the articles used as components of such drug; (C) a
full statement of the composition of such drug; (D) a full
description of the methods used in, and the facilities and
controls used for, the manufacture, processing, and packing of
such drug; (E) such samples of such drug and of the articles
used as components thereof as the Secretary may require; (F)
specimens of the labeling proposed to be used for such [drug,
and (G)] drug; (G) any assessments required under section 505B;
and (H) the information required under paragraph (7). The
applicant shall file with the application the patent number and
the expiration date of any patent which claims the drug for
which the applicant submitted the application or which claims a
method of using such drug and with respect to which a claim of
patent infringement could reasonably be asserted if a person
not licensed by the owner engaged in the manufacture, use, or
sale of the drug. If a application is filed under this
subsection for a drug and a patent which claims such drug or a
method of using such drug is issued after the filing date but
before approval of the application, the applicant shall amend
the application to include the information required by the
preceding sentence. Upon approval of the application, the
Secretary shall publish information submitted under the two
preceding sentences. The Secretary shall, in consultation with
the Director of the National Institutes of Health and with
representatives of the drug manufacturing industry, review and
develop guidance, as appropriate, on the inclusion of women and
minorities in clinical trials required by clause (A).
* * * * * * *
(7)(A) With respect to clinical data in an application under
this subsection, the Secretary may deny such an application if
the application fails to meet the requirements of sections
314.50(d)(5)(v) and 314.50(d)(5)(vi)(a) of title 21, Code of
Federal Regulations.
(B) The Secretary shall modify the sections referred to in
subparagraph (A) to require that an application under this
subsection include any clinical data possessed by the applicant
that relates to the safety or effectiveness of the drug
involved by gender, age, and racial subgroup.
(C) Promptly after approving an application under this
subsection, the Secretary shall, through an Internet site of
the Department of Health and Human Services, make available to
the public the information submitted to the Secretary pursuant
to subparagraphs (A) and (B), subject to sections 301(j) and
520(h)(4) of this Act, subsection (b)(4) of section 552 of
title 5, United States Code (commonly referred to as the
``Freedom of Information Act''), and other provisions of law
that relate to trade secrets or confidential commercial
information.
(D) The Secretary shall develop guidance for staff of the
Food and Drug Administration to ensure that applications under
this subsection are adequately reviewed to determine whether
the applications include the information required pursuant to
subparagraphs (A) and (B).
* * * * * * *
(i)(1) * * *
(2) [Subject to paragraph (3),] Subject to paragraphs (3) and
(5), a clinical investigation of a new drug may begin 30 days
after the Secretary has received from the manufacturer or
sponsor of the investigation a submission containing such
information about the drug and the clinical investigation,
including--
(A) * * *
* * * * * * *
(5)(A) The Secretary may place a clinical hold (as described
in paragraph (3)) on an investigation if the sponsor of the
investigation fails to meet the requirements of section
312.33(a) of title 21, Code of Federal Regulations.
(B) The Secretary shall modify the section referred to in
subparagraph (A) to require that reports under such section
include any clinical data possessed by the sponsor of the
investigation that relates to the safety or effectiveness of
the drug involved by gender, age, and racial subgroup.
* * * * * * *
PREMARKET APPROVAL
Sec. 515. (a) * * *
* * * * * * *
(c) Application for Premarket Approval.--(1) Any person may
file with the Secretary an application for premarket approval
for a class III device. Such an application for a device shall
contain--
(A) * * *
* * * * * * *
(G) the certification required under section
402(j)(5)(B) of the Public Health Service Act (which
shall not be considered an element of such
application); [and]
(H) the information required under subsection (d)(7);
and
[(H)] (I) such other information relevant to the
subject matter of the application as the Secretary,
with the concurrence of the appropriate panel under
section 513, may require.
* * * * * * *
(d) Action on an Application for Premarket Approval.--(1) * *
*
* * * * * * *
(7) To the extent consistent with the regulation of devices,
the provisions of section 505(b)(7) (relating to clinical data
submission) apply with respect to an application for premarket
approval of a device under subsection (c) of this section to
the same extent and in the same manner as such provisions apply
with respect to an application for premarket approval of a drug
under section 505(b).
* * * * * * *
GENERAL PROVISIONS RESPECTING CONTROL OF DEVICES INTENDED FOR HUMAN USE
Sec. 520. (a) * * *
* * * * * * *
(g) Exemption for Devices for Investigational Use.--(1) * * *
(2)(A) * * *
* * * * * * *
(D) To the extent consistent with the regulation of devices,
the provisions of section 505(i)(5) (relating to individual
study information) apply with respect to an application for an
exemption pursuant to subparagraph (A) of this paragraph to the
same extent and in the same manner as such provisions apply
with respect to an application for an exemption under section
505(i).
* * * * * * *
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PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
Part F--Licensing--Biological Products and Clinical Laboratories
Subpart 1--Biological Products
REGULATION OF BIOLOGICAL PRODUCTS
Sec. 351. (a) * * *
* * * * * * *
(k) The provisions of section 505(b)(7) of the Federal Food,
Drug, and Cosmetic Act (relating to clinical data submission)
apply with respect to an application under subsection (a) of
this section to the same extent and in the same manner as such
provisions apply with respect to an application under section
505(b) of such Act.
* * * * * * *
TITLE IX--AGENCY FOR HEALTHCARE RESEARCH AND QUALITY
PART A--ESTABLISHMENT AND GENERAL DUTIES
* * * * * * *
SEC. 903. RESEARCH ON HEALTH DISPARITIES.
(a) * * *
(b) Research and Demonstration Projects.--
(1) In general.--In carrying out subsection (a), the
Director shall conduct and support research and support
demonstrations to--
(A) * * *
(B) identify and evaluate clinical and
organizational strategies to improve the
quality, outcomes, and access to care for
health disparity populations, including
minority health disparity populations,
including quality of and access to care for
women with heart disease, stroke, and other
cardiovascular diseases;
* * * * * * *
(c) Quality Measurement Development.--
(1) * * *
* * * * * * *
(4) Annual report on women and heart disease.--Not
later than September 30, 2009, and annually thereafter,
the Secretary, acting through the Director, shall
prepare and submit to Congress a report concerning the
findings related to the quality of and access to care
for women with heart disease, stroke, and other
cardiovascular diseases. The report shall contain
recommendations for eliminating disparities in, and
improving the treatment of, heart disease, stroke, and
other cardiovascular diseases in women.
* * * * * * *
PART C--PATIENT SAFETY IMPROVEMENT
* * * * * * *
SEC. 923. NETWORK OF PATIENT SAFETY DATABASES.
(a) * * *
(b) Data Standards.--The Secretary may determine common
formats for the reporting to and among the network of patient
safety databases maintained under subsection (a) of
nonidentifiable patient safety work product, including
necessary work product elements, common and consistent
definitions, and a standardized computer interface for the
processing of such work product. To the extent practicable,
such standards shall be consistent with the administrative
simplification provisions of part C of title XI of the Social
Security Act. The Secretary shall provide that all
nonidentifiable patient safety work product reported to and
among the network of patient safety databases be stratified by
sex.
(c) Use of Information.--Information reported to and among
the network of patient safety databases under subsection (a)
shall be used to analyze national and regional statistics,
including trends and patterns of health care errors. The
information resulting from such analyses shall be made
available to the public and included in the annual quality
reports prepared under section 913(b)(2). Such analyses take
into account data that specifically relates to women and any
disparities between treatment and the quality of care between
males and females.
* * * * * * *
TITLE XV--PREVENTIVE HEALTH MEASURES WITH RESPECT TO BREAST AND
CERVICAL CANCERS
* * * * * * *
SEC. 1509. SUPPLEMENTAL GRANTS FOR ADDITIONAL PREVENTIVE HEALTH
SERVICES.
(a) [Demonstration Projects.--] In General.--In the case of
States receiving grants under section 1501, the Secretary,
acting through the Director of the Centers for Disease Control
and Prevention, [may make grants to not more than 3 such States
to carry out demonstration projects for the purpose] may make
grants to such States for the purpose of--
(1) * * *
* * * * * * *
(d) Funding.--
(1) In general.--Subject to paragraph (2), for the
purpose of carrying out this section, [there are
authorized to be appropriated $3,000,000 for fiscal
year 1994, and such sums as may be necessary for each
of the fiscal years 1995 through 2003.] there are
authorized to be appropriated $37,000,000 for fiscal
year 2009, $38,850,000 for fiscal year 2010,
$40,792,500 for fiscal year 2011, $42,832,000 for
fiscal year 2012, and $44,974,000 for fiscal year 2013.
* * * * * * *