[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1032 Reported in House (RH)]

                                                 Union Calendar No. 379
111th CONGRESS
  2d Session
                                H. R. 1032

                          [Report No. 111-639]

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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 12, 2009

Mrs. Capps (for herself, Mrs. Bono Mack, Mr. Abercrombie, Mr. Baca, Ms. 
Baldwin, Ms. Bean, Ms. Berkley, Mr. Berman, Mrs. Biggert, Mr. Bishop of 
New York, Ms. Bordallo, Mr. Boucher, Ms. Corrine Brown of Florida, Ms. 
 Ginny Brown-Waite of Florida, Mr. Burton of Indiana, Mrs. Capito, Mr. 
    Carson of Indiana, Ms. Castor of Florida, Mrs. Christensen, Mr. 
   Cummings, Mrs. Davis of California, Ms. DeGette, Ms. DeLauro, Mr. 
Lincoln Diaz-Balart of Florida, Ms. Edwards of Maryland, Mrs. Emerson, 
Mr. Engel, Ms. Eshoo, Mr. Fortenberry, Mr. Frank of Massachusetts, Mr. 
   Gerlach, Ms. Giffords, Mr. Gonzalez, Mr. Gordon of Tennessee, Ms. 
 Granger, Mr. Graves, Mr. Al Green of Texas, Mr. Gene Green of Texas, 
   Mr. Grijalva, Ms. Harman, Mr. Hinchey, Ms. Hirono, Mr. Holt, Mr. 
Israel, Mr. Issa, Ms. Jackson-Lee of Texas, Ms. Kaptur, Mr. Kildee, Ms. 
Kilpatrick of Michigan, Ms. Lee of California, Mr. Levin, Mr. Lipinski, 
Mr. LoBiondo, Ms. Zoe Lofgren of California, Mrs. Lowey, Mrs. Maloney, 
 Mr. Markey of Massachusetts, Mr. Marshall, Ms. Matsui, Ms. McCollum, 
Mr. McDermott, Mr. McGovern, Mr. McHugh, Mr. Moore of Kansas, Ms. Moore 
of Wisconsin, Mr. Nadler of New York, Mrs. Napolitano, Ms. Norton, Mr. 
 Oberstar, Mr. Olver, Mr. Pascrell, Ms. Pingree of Maine, Mr. Platts, 
Mr. Radanovich, Mr. Reyes, Mr. Rogers of Alabama, Ms. Ros-Lehtinen, Ms. 
Roybal-Allard, Ms. Schakowsky, Mrs. Schmidt, Ms. Schwartz, Mr. Serrano, 
Mr. Sestak, Ms. Shea-Porter, Mr. Sires, Ms. Slaughter, Mr. Smith of New 
Jersey, Mr. Stark, Ms. Sutton, Mrs. Tauscher, Mr. Taylor, Mr. Tierney, 
   Ms. Tsongas, Mr. Van Hollen, Mr. Walz, Ms. Wasserman Schultz, Mr. 
    Whitfield, Ms. Woolsey, Mr. Wu, Mr. Michaud, Mr. Price of North 
Carolina, and Mrs. Blackburn) introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

                           September 28, 2010

 Additional sponsors: Mr. Scalise, Mr. Pastor of Arizona, Ms. Loretta 
Sanchez of California, Mrs. Myrick, Mrs. McMorris Rodgers, Mr. Kennedy, 
   Mr. Weiner, Mr. Alexander, Mr. Filner, Mr. Bishop of Georgia, Mr. 
 Johnson of Georgia, Mr. Murtha, Mr. Rothman of New Jersey, Mr. Space, 
  Mrs. McCarthy of New York, Mr. Hall of New York, Mr. Gutierrez, Ms. 
Kilroy, Ms. Kosmas, Mr. Kirk, Mr. Arcuri, Mr. Jackson of Illinois, Ms. 
 Titus, Mr. Lynch, Mr. Kanjorski, Mr. Stupak, Ms. Waters, Mr. Snyder, 
  Mr. Calvert, Ms. Linda T. Sanchez of California, Mr. Courtney, Mr. 
McCotter, Mr. Jones, Ms. Fallin, Ms. Richardson, Mr. Frelinghuysen, Mr. 
   Carter, Mr. Peterson, Mr. Lance, Mrs. Kirkpatrick of Arizona, Mr. 
Bartlett, Mr. Patrick J. Murphy of Pennsylvania, Ms. Jenkins, Mr. Cao, 
    Mr. Moran of Virginia, Mr. Boswell, Mr. Paulsen, Mr. Petri, Mr. 
 Kissell, Mr. Young of Alaska, Mr. Ellison, Mr. Harper, Mr. Ellsworth, 
 Mr. Butterfield, Mr. McCarthy of California, Ms. Herseth Sandlin, Mr. 
  Miller of North Carolina, Mr. Ross, Ms. Speier, Mr. Rodriguez, Mr. 
 Lewis of Georgia, Mr. Rahall, Mr. Tiahrt, Mr. Wittman, Mr. Melancon, 
                             and Mr. Cohen


                           September 28, 2010

Reported with amendments, committed to the Committee of the Whole House 
          on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
    [For text of introduced bill, see copy of bill as introduced on 
                           February 12, 2009]


_______________________________________________________________________

                                 A BILL


 
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. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE.

    (a) In General.--The Comptroller General of the United States shall 
conduct a study investigating the extent to which sponsors of clinical 
studies of investigational drugs, biologics, and devices and sponsors 
of applications for approval or licensure of new drugs, biologics, and 
devices comply with Food and Drug Administration requirements and 
follow guidance for presentation of clinical study safety and 
effectiveness data by sex, age, and racial subgroups.
    (b) Report by GAO.--
            (1) Submission.--Not later than 12 months after the date of 
        the enactment of this Act, the Comptroller General shall 
        complete the study under subsection (a) 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 results of such 
        study.
            (2) Contents.--The report required by paragraph (1) shall 
        include each of the following:
                    (A) A description of the extent to which the Food 
                and Drug Administration assists sponsors in complying 
                with the requirements and following the guidance 
                referred to in subsection (a).
                    (B) A description of the effectiveness of the Food 
                and Drug Administration's enforcement of compliance 
                with such requirements.
                    (C) An analysis of the extent to which females, 
                racial and ethnic minorities, and adults of all ages 
                are adequately represented in Food and Drug 
                Administration-approved clinical studies (at all 
                phases) so that product safety and effectiveness data 
                can be evaluated by gender, age, and racial subgroup.
                    (D) An analysis of the extent to which a summary of 
                product safety and effectiveness data disaggregated by 
                sex, age, and racial subgroup is readily available to 
                the public in a timely manner by means of the product 
                label or the Food and Drug Administration's Website.
                    (E) Appropriate recommendations for--
                            (i) modifications to the requirements and 
                        guidance referred to in subsection (a); or
                            (ii) oversight by the Food and Drug 
                        Administration of such requirements.
    (c) Report by HHS.--Not later than 6 months after the submission by 
the Comptroller General of the report required under subsection (b), 
the Secretary of Health and Human Services shall 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 
response to that report, including a corrective action plan as needed 
to respond to the recommendations in that report.
    (d) Definitions.--In this section:
            (1) The term ``biologic'' has the meaning given to the term 
        ``biological product'' in section 351(i) of the Public Health 
        Service Act (42 U.S.C. 262(i)).
            (2) The term ``device'' has the meaning given to such term 
        in section 201(h) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 321(h)).
            (3) The term ``drug'' has the meaning given to such term in 
        section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321(g)).

SEC. 3. REPORTING ON QUALITY OF AND ACCESS TO CARE FOR WOMEN WITH 
              CARDIOVASCULAR DISEASES.

    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended by adding at the end the following:

``SEC. 399V-5. REPORTING ON QUALITY OF AND ACCESS TO CARE FOR WOMEN 
              WITH CARDIOVASCULAR DISEASES.

    ``Not later than September 30, 2013, and annually thereafter, the 
Secretary of Health and Human Services shall prepare and submit to the 
Congress a report on 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. 4. 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 $23,000,000 
        for fiscal year 2012, $25,300,000 for fiscal year 2013, 
        $27,800,000 for fiscal year 2014, $30,800,000 for fiscal year 
        2015, and $34,000,000 for fiscal year 2016.''.
            Amend the title so as to read: ``A bill to amend the Public 
        Health Service Act to improve the prevention, diagnosis, and 
        treatment of heart disease, stroke, and other cardiovascular 
        diseases in women.''.
                                                 Union Calendar No. 379

111th CONGRESS

  2d Session

                               H. R. 1032

                          [Report No. 111-639]

_______________________________________________________________________

                                 A BILL

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.

_______________________________________________________________________

                           September 28, 2010

Reported with amendments, committed to the Committee of the Whole House 
          on the State of the Union, and ordered to be printed