[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).

           *       *       *       *       *       *       *

                              ----------                              


                       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.

           *       *       *       *       *       *       *


                                  
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