[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1014 Engrossed in House (EH)]

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
110th CONGRESS
  2d Session
                                H. R. 1014

_______________________________________________________________________

                                 AN ACT


 
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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

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.''.

            Passed the House of Representatives September 25, 2008.

            Attest:

                                                                 Clerk.
110th CONGRESS

  2d Session

                               H. R. 1014

_______________________________________________________________________

                                 AN ACT

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.