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Union Calendar No. 570 

110TH CONGRESS 

2D SESSION H. R. 1014 

[Report No. 110–874] 

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 13, 2007 

Mrs. CAPPS (for herself and Mrs. CUBIN) introduced the following bill; which 

was referred to the Committee on Energy and Commerce 

SEPTEMBER 23, 2008 

Additional sponsors: Mr. GORDON of Tennessee, Mr. ROSS, Mr. OLVER, Mr. 

MCNULTY, Mr. BISHOP of New York, Mr. BUTTERFIELD, Mrs. MCCARTHY of New York, Mr. DELAHUNT, Ms. SLAUGHTER, Ms. LORETTA

SANCHEZ of California, Mrs. DAVIS of California, Ms. MCCOLLUM of 

Minnesota, Mr. TERRY, Ms. HIRONO, Ms. HOOLEY, Ms. KILPATRICK, Mr. 

MEEHAN, Ms. SCHAKOWSKY, Mr. GRIJALVA, Ms. HERSETH SANDLIN, 

Mrs. CAPITO, Mr. CLAY, Mr. REYES, Mr. SHAYS, Mr. MCDERMOTT, Ms. 

NORTON, Ms. ESHOO, Mr. CUMMINGS, Mr. BOSWELL, Mr. AL GREEN of 

Texas, Mrs. TAUSCHER, Mr. PRICE of North Carolina, Mrs. LOWEY, Ms. 

BORDALLO, Mr. LYNCH, Mr. MCCOTTER, Mr. WU, Mr. VAN HOLLEN, 

Mr. LANTOS, Ms. ZOE LOFGREN of California, Mr. STARK, Mr. 

HINOJOSA, Mr. HASTINGS of Florida, Mr. GENE GREEN of Texas, Mr. 

GERLACH, Mr. ELLISON, Mr. BERMAN, Ms. MILLENDER-MCDONALD, 

Ms. LINDA T. SA ́NCHEZ of California, Ms. SOLIS, Mr. MELANCON, Mr. 

PLATTS, Mr. BRADY of Pennsylvania, Mr. RUSH, Ms. BERKLEY, Mr. 

COHEN, Mr. RODRIGUEZ, Mr. FILNER, Mr. KENNEDY, Ms. SUTTON, Mr. 

BOUCHER, Mrs. BOYDA of Kansas, Mr. RANGEL, Mr. MARSHALL, Mr. 

MCHUGH, Mr. JINDAL, Ms. FALLIN, Mr. GONZALEZ, Mr. ISSA, Mr. 

WAXMAN, Mr. HINCHEY, Mr. LAMPSON, Mr. ALLEN, Mrs. NAPOLITANO, 

Mr. WEXLER, Mr. MARKEY, Mr. SULLIVAN, Ms. MOORE of Wisconsin, 

Mr. MOORE of Kansas, Mr. ARCURI, Mr. STUPAK, Mr. SAXTON, Mrs. 

JONES of Ohio, Mr. HONDA, Ms. DELAURO, Mr. ETHERIDGE, Mrs. 

MALONEY of New York, Ms. JACKSON-LEE of Texas, Mr. ROTHMAN, Mr. 


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WYNN, Ms. WOOLSEY, Mr. OBERSTAR, Ms. CORRINE BROWN of Florida, 

Mrs. BONO MACK, Mr. REHBERG, Mr. ORTIZ, Mr. CARSON, Mr. GOODE, 

Ms. MATSUI, Ms. DEGETTE, Mr. FARR, Mr. ABERCROMBIE, Mr. FERGUSON, Mrs. SCHMIDT, Ms. CASTOR, Ms. GRANGER, Ms. SCHWARTZ, Ms. 

HARMAN, Mrs. GILLIBRAND, Ms. EDDIE BERNICE JOHNSON of Texas, 

Ms. KAPTUR, Ms. CLARKE, Mr. LOEBSACK, Mr. PERLMUTTER, Mr. MURTHA, Ms. ROS-LEHTINEN, Mrs. CHRISTENSEN, Mr. THOMPSON of Mississippi, Mr. PASTOR, Ms. BALDWIN, Mr. ALTMIRE, Mr. BONNER, Mr. 

MCGOVERN, Ms. WATSON, Mr. WAMP, Ms. SHEA-PORTER, Mr. SESSIONS, Mr. BISHOP of Utah, Mr. SOUDER, Ms. LEE, Ms. WASSERMAN

SCHULTZ, Mr. ENGEL, Mrs. MYRICK, Mr. TOWNS, Mrs. BLACKBURN, Ms. 

PRYCE of Ohio, Mr. NEAL of Massachusetts, Mr. MICHAUD, Mr. WELLER

of Illinois, Mr. ISRAEL, Mr. KIND, Mr. LANGEVIN, Mr. HARE, Mr. BURGESS, Mr. TIERNEY, Ms. WATERS, Mr. WELCH of Vermont, Mr. PAYNE, 

Mr. FRANK of Massachusetts, Mr. JOHNSON of Georgia, Mr. WALSH of 

New York, Mr. KUHL of New York, Mr. KANJORSKI, Mr. LIPINSKI, Mr. 

MILLER of North Carolina, Mr. FORTENBERRY, Mr. GRAVES, Mr. BURTON of Indiana, Mr. CARTER, Ms. BEAN, Mr. UDALL of Colorado, Mr. 

JACKSON of Illinois, Mr. BOREN, Ms. ROYBAL-ALLARD, Ms. VELA ́ZQUEZ, 

Mr. YARMUTH, Mr. WEINER, Mrs. MILLER of Michigan, Ms. GIFFORDS, 

Mrs. DRAKE, Mr. DOYLE, Mr. ALEXANDER, Mr. JONES of North Carolina, Mr. PETERSON of Minnesota, Mr. ENGLISH of Pennsylvania, Mrs. 

BIGGERT, Mr. BARROW, Mr. EMANUEL, Mr. WELDON of Florida, Mr. 

HOLDEN, Mr. RUPPERSBERGER, Mr. MORAN of Virginia, Mr. GEORGE

MILLER of California, Mr. KILDEE, Mr. JEFFERSON, Mr. EDWARDS, Mr. 

MATHESON, Mr. ROGERS of Alabama, Mrs. EMERSON, Mrs. BACHMANN, 

Mrs. MCMORRIS RODGERS, Mrs. JO ANN DAVIS of Virginia, Mrs. WILSON of New Mexico, Mr. RADANOVICH, Ms. GINNY BROWN-WAITE of 

Florida, Mr. NADLER, Mr. SIRES, Mr. HODES, Mr. SMITH of New Jersey, Mr. BISHOP of Georgia, Mr. FORTUN ̃O, Mr. SERRANO, Mr. PICKERING, Mr. ELLSWORTH, Mr. LOBIONDO, Mr. LINCOLN DAVIS of Tennessee, Mr. WOLF, Mr. COURTNEY, Mr. HOLT, Ms. TSONGAS, Mr. CALVERT, Mr. SPACE, Mr. PASCRELL, Mr. CUELLAR, Mr. MCINTYRE, Mr. 

HALL of Texas, Mr. SMITH of Washington, Mr. CARSON, Mr. LEWIS of 

Georgia, Mr. RAHALL, Ms. RICHARDSON, Mr. GUTIERREZ, Mr. RAMSTAD, 

Mr. LINCOLN DIAZ-BALART of Florida, Mr. MARCHANT, Mr. TAYLOR, 

Mr. KAGEN, Mr. FOSTER, Mr. KIRK, Mr. WALZ of Minnesota, Mr. 

UPTON, Mr. BLUMENAUER, Mr. TIM MURPHY of Pennsylvania, Mr. 

WITTMAN of Virginia, Mr. SCALISE, Mr. LAHOOD, and Mr. FATTAH

SEPTEMBER 23, 2008 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 


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[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 13, 2007] 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Heart Disease Edu5 cation, Analysis Research, and Treatment for Women Act’’ 

6 or the ‘‘HEART for Women Act’’. 

7 SEC. 2. REPORTING OF DATA IN APPLICATIONS FOR DRUGS, 

8 BIOLOGICS, AND DEVICES. 

9 (a) DRUGS.— 

10 (1) NEW DRUG APPLICATIONS.—Section 505(b) 

11 of the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 355(b)) is amended— 

13 (A) in paragraph (1), in the second sen14 tence— 

15 (i) by striking ‘‘drug, and (G)’’ and 

16 inserting ‘‘drug; (G)’’; and 


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1 (ii) by inserting before the period the 

2 following: ‘‘; and (H) the information re3 quired under paragraph (7)’’; and 

4 (B) by adding at the end the following: 

5 ‘‘(7)(A) With respect to clinical data in an application 

6 under this subsection, the Secretary may deny such an ap7 plication if the application fails to meet the requirements 

8 of sections 314.50(d)(5)(v) and 314.50(d)(5)(vi)(a) of title 

9 21, Code of Federal Regulations. 

10 ‘‘(B) The Secretary shall modify the sections referred 

11 to in subparagraph (A) to require that an application 

12 under this subsection include any clinical data possessed 

13 by the applicant that relates to the safety or effectiveness 

14 of the drug involved by gender, age, and racial subgroup. 

15 ‘‘(C) Promptly after approving an application under 

16 this subsection, the Secretary shall, through an Internet site 

17 of the Department of Health and Human Services, make 

18 available to the public the information submitted to the Sec19 retary pursuant to subparagraphs (A) and (B), subject to 

20 sections 301(j) and 520(h)(4) of this Act, subsection (b)(4) 

21 of section 552 of title 5, United States Code (commonly re22 ferred to as the ‘Freedom of Information Act’), and other 

23 provisions of law that relate to trade secrets or confidential 

24 commercial information. 


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1 ‘‘(D) The Secretary shall develop guidance for staff of 

2 the Food and Drug Administration to ensure that applica3 tions under this subsection are adequately reviewed to deter4 mine whether the applications include the information re5 quired pursuant to subparagraphs (A) and (B).’’. 

6 (2) INVESTIGATIONAL NEW DRUG APPLICA7 TIONS.—Section 505(i) of the Federal Food, Drug, 

8 and Cosmetic Act (21 U.S.C. 355(i)) is amended— 

9 (A) in paragraph (2), by striking ‘‘Subject 

10 to paragraph (3),’’ and inserting ‘‘Subject to 

11 paragraphs (3) and (5),’’ ; and 

12 (B) by adding at the end the following: 

13 ‘‘(5)(A) The Secretary may place a clinical hold (as 

14 described in paragraph (3)) on an investigation if the spon15 sor of the investigation fails to meet the requirements of 

16 section 312.33(a) of title 21, Code of Federal Regulations. 

17 ‘‘(B) The Secretary shall modify the section referred 

18 to in subparagraph (A) to require that reports under such 

19 section include any clinical data possessed by the sponsor 

20 of the investigation that relates to the safety or effectiveness 

21 of the drug involved by gender, age, and racial subgroup.’’. 

22 (b) BIOLOGICS LICENSE APPLICATIONS.—Section 351 

23 of the Public Health Service Act (42 U.S.C. 262) is amend24 ed by adding at the end the following: 


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1 ‘‘(k) The provisions of section 505(b)(7) of the Federal 

2 Food, Drug, and Cosmetic Act (relating to clinical data 

3 submission) apply with respect to an application under 

4 subsection (a) of this section to the same extent and in the 

5 same manner as such provisions apply with respect to an 

6 application under section 505(b) of such Act.’’. 

7 (c) DEVICES.— 

8 (1) PREMARKET APPROVAL.—Section 515 of the 

9 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

10 360e) is amended— 

11 (A) in subsection (c)(1)— 

12 (i) in subparagraph (G)— 

13 (I) by moving the margin 2 ems 

14 to the left; and 

15 (II) by striking ‘‘and’’ after the 

16 semicolon at the end; 

17 (ii) by redesignating subparagraph 

18 (H) as subparagraph (I); and 

19 (iii) by inserting after subparagraph 

20 (G) the following subparagraph: 

21 ‘‘(H) the information required under subsection 

22 (d)(7); and’’; and 

23 (B) in subsection (d), by adding at the end 

24 the following paragraph: 


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1 ‘‘(7) To the extent consistent with the regulation of de2 vices, the provisions of section 505(b)(7) (relating to clinical 

3 data submission) apply with respect to an application for 

4 premarket approval of a device under subsection (c) of this 

5 section to the same extent and in the same manner as such 

6 provisions apply with respect to an application for pre7 market approval of a drug under section 505(b).’’. 

8 (2) INVESTIGATIONAL DEVICES.—Section 

9 520(g)(2) of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 360j(g)(2)) is amended by adding at 

11 the end the following subparagraph: 

12 ‘‘(D) To the extent consistent with the regulation of 

13 devices, the provisions of section 505(i)(5) (relating to indi14 vidual study information) apply with respect to an appli15 cation for an exemption pursuant to subparagraph (A) of 

16 this paragraph to the same extent and in the same manner 

17 as such provisions apply with respect to an application for 

18 an exemption under section 505(i).’’. 

19 (d) RULES OF CONSTRUCTION.—This Act and the 

20 amendments made by this Act may not be construed— 

21 (1) as establishing new requirements under the 

22 Federal Food, Drug, and Cosmetic Act relating to the 

23 design of clinical investigations that were not other24 wise in effect on the day before the date of the enact25 ment of this Act; or 


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1 (2) as having any effect on the authority of the 

2 Secretary of Health and Human Services to enforce 

3 regulations under the Federal Food, Drug, and Cos4 metic Act that are not expressly referenced in this Act 

5 or the amendments made by this Act. 

6 (e) APPLICATION.—This section and the amendments 

7 made by this section apply only with respect to applications 

8 received under section 505 or 515 of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 355, 360e) or section 

10 351 of the Public Health Service Act (42 U.S.C. 262) on 

11 or after the date of the enactment of this Act. 

12 SEC. 3. REPORTING AND ANALYSIS OF PATIENT SAFETY 

13 DATA. 

14 (a) DATA STANDARDS.—Section 923(b) of the Public 

15 Health Service Act (42 U.S.C. 299b–23(b)) is amended by 

16 adding at the end the following: ‘‘The Secretary shall pro17 vide that all nonidentifiable patient safety work product re18 ported to and among the network of patient safety databases 

19 be stratified by sex.’’. 

20 (b) USE OF INFORMATION.—Section 923(c) of the Pub21 lic Health Service Act (42 U.S.C. 299b–23(c)) is amended 

22 by adding at the end the following: ‘‘Such analyses take 

23 into account data that specifically relates to women and 

24 any disparities between treatment and the quality of care 

25 between males and females.’’. 


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1 SEC. 4. QUALITY OF CARE REPORTS BY THE AGENCY FOR 

2 HEALTHCARE RESEARCH AND QUALITY. 

3 Section 903 of the Public Health Service Act (42 

4 U.S.C. 299a–1) is amended— 

5 (1) in subsection (b)(1)(B), by inserting before 

6 the semicolon the following: ‘‘, including quality of 

7 and access to care for women with heart disease, 

8 stroke, and other cardiovascular diseases’’; and 

9 (2) in subsection (c), by adding at the end the 

10 following: 

11 ‘‘(4) ANNUAL REPORT ON WOMEN AND HEART

12 DISEASE.—Not later than September 30, 2009, and 

13 annually thereafter, the Secretary, acting through the 

14 Director, shall prepare and submit to Congress a re15 port concerning the findings related to the quality of 

16 and access to care for women with heart disease, 

17 stroke, and other cardiovascular diseases. The report 

18 shall contain recommendations for eliminating dis19 parities in, and improving the treatment of, heart 

20 disease, stroke, and other cardiovascular diseases in 

21 women.’’. 

22 SEC. 5. EDUCATIONAL CAMPAIGNS. 

23 (a) DISTRIBUTION OF EDUCATIONAL MATERIAL.—The 

24 Secretary of Health and Human Services (referred to in 

25 this section as the ‘‘Secretary’’) shall develop and distribute 

26 to females who are age 65 or older, physicians, and other 


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1 appropriate healthcare professionals, educational materials 

2 relating to the prevention, diagnosis, and treatment of heart 

3 disease, stroke, and cardiovascular diseases in women. The 

4 Secretary may carry out this subsection through contracts 

5 with public and private nonprofit entities. 

6 (b) HEALTHCARE PROFESSIONAL EDUCATIONAL CAM7 PAIGN.—The Secretary, acting through the Bureau of 

8 Health Professions of the Health Resources and Services Ad9 ministration, shall conduct an education and awareness 

10 campaign for physicians and other healthcare professionals 

11 relating to the prevention, diagnosis, and treatment of heart 

12 disease, stroke, and other cardiovascular diseases in women. 

13 The Bureau of Health Professions may carry out this sub14 section through contracts with public and private nonprofit 

15 entities. 

16 SEC. 6. EXTENSION OF WISEWOMAN PROGRAM. 

17 Section 1509 of the Public Health Service Act (42 

18 U.S.C. 300n–4a) is amended— 

19 (1) in subsection (a)— 

20 (A) by striking the heading and inserting 

21 ‘‘IN GENERAL.—’’; and 

22 (B) in the matter preceding paragraph (1), 

23 by striking ‘‘may make grants’’ and all that fol24 lows through ‘‘purpose’’ and inserting the folVerDate Aug 31 2005 04:16 Sep 24, 2008 Jkt 069200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6203 E:\BILLS\H1014.RH H1014

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1 lowing: ‘‘may make grants to such States for the 

2 purpose’’; and 

3 (2) in subsection (d)(1), by striking ‘‘there are 

4 authorized’’ and all that follows through the period 

5 and inserting ‘‘there are authorized to be appro6 priated $37,000,000 for fiscal year 2009, $38,850,000 

7 for fiscal year 2010, $40,792,500 for fiscal year 2011, 

8 $42,832,000 for fiscal year 2012, and $44,974,000 for 

9 fiscal year 2013.’’. 


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Union Calendar No. 570 

110TH CONGRESS 

2D SESSION H. R. 1014 

[Report No. 110–874] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

in women. disease, stroke, and other cardiovascular diseases the prevention, diagnosis, and treatment of heart Act and the Public Health Service Act to improve 

SEPTEMBER 23, 2008 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


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