II 

110TH CONGRESS 

2D SESSION H. R. 1014 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 26 (legislative day, SEPTEMBER 17), 2008 

Received 

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. 

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


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Heart Disease Edu3 cation, Analysis Research, and Treatment for Women 

4 Act’’ or the ‘‘HEART for Women Act’’. 

5 SEC. 2. REPORTING OF DATA IN APPLICATIONS FOR 

6 DRUGS, BIOLOGICS, AND DEVICES. 

7 (a) DRUGS.— 

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

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

10 U.S.C. 355(b)) is amended— 

11 (A) in paragraph (1), in the second sen12 tence— 

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

14 inserting ‘‘drug; (G)’’; and 

15 (ii) by inserting before the period the 

16 following: ‘‘; and (H) the information re17 quired under paragraph (7)’’; and 

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

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

20 under this subsection, the Secretary may deny such an ap21 plication if the application fails to meet the requirements 

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

23 21, Code of Federal Regulations. 

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

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

26 under this subsection include any clinical data possessed 


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1 by the applicant that relates to the safety or effectiveness 

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

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

4 this subsection, the Secretary shall, through an Internet 

5 site of the Department of Health and Human Services, 

6 make available to the public the information submitted to 

7 the Secretary pursuant to subparagraphs (A) and (B), 

8 subject to sections 301(j) and 520(h)(4) of this Act, sub9 section (b)(4) of section 552 of title 5, United States Code 

10 (commonly referred to as the ‘Freedom of Information 

11 Act’), and other provisions of law that relate to trade se12 crets or confidential commercial information. 

13 ‘‘(D) The Secretary shall develop guidance for staff 

14 of the Food and Drug Administration to ensure that appli15 cations under this subsection are adequately reviewed to 

16 determine whether the applications include the informa17 tion required pursuant to subparagraphs (A) and (B).’’. 

18 (2) INVESTIGATIONAL NEW DRUG APPLICA19 TIONS.—Section 505(i) of the Federal Food, Drug, 

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

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

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

23 paragraphs (3) and (5),’’ ; and 

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


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

2 described in paragraph (3)) on an investigation if the 

3 sponsor of the investigation fails to meet the requirements 

4 of section 312.33(a) of title 21, Code of Federal Regula5 tions. 

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

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

8 section include any clinical data possessed by the sponsor 

9 of the investigation that relates to the safety or effective10 ness of the drug involved by gender, age, and racial sub11 group.’’. 

12 (b) BIOLOGICS LICENSE APPLICATIONS.—Section 

13 351 of the Public Health Service Act (42 U.S.C. 262) is 

14 amended by adding at the end the following: 

15 ‘‘(k) The provisions of section 505(b)(7) of the Fed16 eral Food, Drug, and Cosmetic Act (relating to clinical 

17 data submission) apply with respect to an application 

18 under subsection (a) of this section to the same extent 

19 and in the same manner as such provisions apply with re20 spect to an application under section 505(b) of such Act.’’. 

21 (c) DEVICES.— 

22 (1) PREMARKET APPROVAL.—Section 515 of 

23 the Federal Food, Drug, and Cosmetic Act (21 

24 U.S.C. 360e) is amended— 

25 (A) in subsection (c)(1)— 


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1 (i) in subparagraph (G)— 

2 (I) by moving the margin 2 ems 

3 to the left; and 

4 (II) by striking ‘‘and’’ after the 

5 semicolon at the end; 

6 (ii) by redesignating subparagraph 

7 (H) as subparagraph (I); and 

8 (iii) by inserting after subparagraph 

9 (G) the following subparagraph: 

10 ‘‘(H) the information required under subsection 

11 (d)(7); and’’; and 

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

13 the following paragraph: 

14 ‘‘(7) To the extent consistent with the regulation of 

15 devices, the provisions of section 505(b)(7) (relating to 

16 clinical data submission) apply with respect to an applica17 tion for premarket approval of a device under subsection 

18 (c) of this section to the same extent and in the same man19 ner as such provisions apply with respect to an application 

20 for premarket approval of a drug under section 505(b).’’. 

21 (2) INVESTIGATIONAL DEVICES.—Section 

22 520(g)(2) of the Federal Food, Drug, and Cosmetic 

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

24 the end the following subparagraph: 


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

2 devices, the provisions of section 505(i)(5) (relating to in3 dividual study information) apply with respect to an appli4 cation for an exemption pursuant to subparagraph (A) of 

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

6 as such provisions apply with respect to an application for 

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

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

9 amendments made by this Act may not be construed— 

10 (1) as establishing new requirements under the 

11 Federal Food, Drug, and Cosmetic Act relating to 

12 the design of clinical investigations that were not 

13 otherwise in effect on the day before the date of the 

14 enactment of this Act; or 

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

16 Secretary of Health and Human Services to enforce 

17 regulations under the Federal Food, Drug, and Cos18 metic Act that are not expressly referenced in this 

19 Act or the amendments made by this Act. 

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

21 made by this section apply only with respect to applica22 tions received under section 505 or 515 of the Federal 

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

24 section 351 of the Public Health Service Act (42 U.S.C. 

25 262) on or after the date of the enactment of this Act. 


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1 SEC. 3. REPORTING AND ANALYSIS OF PATIENT SAFETY 

2 DATA. 

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

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

5 by adding at the end the following: ‘‘The Secretary shall 

6 provide that all nonidentifiable patient safety work prod7 uct reported to and among the network of patient safety 

8 databases be stratified by sex.’’. 

9 (b) USE OF INFORMATION.—Section 923(c) of the 

10 Public Health Service Act (42 U.S.C. 299b–23(c)) is 

11 amended by adding at the end the following: ‘‘Such anal12 yses take into account data that specifically relates to 

13 women and any disparities between treatment and the 

14 quality of care between males and females.’’. 

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

16 HEALTHCARE RESEARCH AND QUALITY. 

17 Section 903 of the Public Health Service Act (42 

18 U.S.C. 299a–1) is amended— 

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

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

21 and access to care for women with heart disease, 

22 stroke, and other cardiovascular diseases’’; and 

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

24 following: 

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

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


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1 annually thereafter, the Secretary, acting through 

2 the Director, shall prepare and submit to Congress 

3 a report concerning the findings related to the qual4 ity of and access to care for women with heart dis5 ease, stroke, and other cardiovascular diseases. The 

6 report shall contain recommendations for eliminating 

7 disparities in, and improving the treatment of, heart 

8 disease, stroke, and other cardiovascular diseases in 

9 women.’’. 

10 SEC. 5. EDUCATIONAL CAMPAIGNS. 

11 (a) DISTRIBUTION OF EDUCATIONAL MATERIAL.— 

12 The Secretary of Health and Human Services (referred 

13 to in this section as the ‘‘Secretary’’) shall develop and 

14 distribute to females who are age 65 or older, physicians, 

15 and other appropriate healthcare professionals, edu16 cational materials relating to the prevention, diagnosis, 

17 and treatment of heart disease, stroke, and cardiovascular 

18 diseases in women. The Secretary may carry out this sub19 section through contracts with public and private non20 profit entities. 

21 (b) HEALTHCARE PROFESSIONAL EDUCATIONAL

22 CAMPAIGN.—The Secretary, acting through the Bureau of 

23 Health Professions of the Health Resources and Services 

24 Administration, shall conduct an education and awareness 

25 campaign for physicians and other healthcare profesVerDate Aug 31 2005 22:22 Dec 30, 2008 Jkt 079200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H1014.RDS H1014

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1 sionals relating to the prevention, diagnosis, and treat2 ment of heart disease, stroke, and other cardiovascular 

3 diseases in women. The Bureau of Health Professions may 

4 carry out this subsection through contracts with public 

5 and private nonprofit entities. 

6 SEC. 6. EXTENSION OF WISEWOMAN PROGRAM. 

7 Section 1509 of the Public Health Service Act (42 

8 U.S.C. 300n–4a) is amended— 

9 (1) in subsection (a)— 

10 (A) by striking the heading and inserting 

11 ‘‘IN GENERAL.—’’; and 

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

13 by striking ‘‘may make grants’’ and all that fol14 lows through ‘‘purpose’’ and inserting the fol15 lowing: ‘‘may make grants to such States for 

16 the purpose’’; and 

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

18 authorized’’ and all that follows through the period 

19 and inserting ‘‘there are authorized to be appro20 priated $37,000,000 for fiscal year 2009, 

21 $38,850,000 for fiscal year 2010, $40,792,500 for 


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1 fiscal year 2011, $42,832,000 for fiscal year 2012, 

2 and $44,974,000 for fiscal year 2013.’’. 

Passed the House of Representatives September 25, 

2008. 

Attest: LORRAINE C. MILLER, 

Clerk. 


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