(d) PREMARKET APPROVALS.—Section 515 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) 
is amended— 
(1) in subsection (c)— 
(A) in paragraph (1)— 
(i) in subparagraph (F), by striking 
‘‘and’’ at the end; 
(ii) in subparagraph (G), by striking 
the period and inserting ‘‘; and’’; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(H) information regarding the device, to the 
extent appropriate, stratified by gender, race and 
ethnicity, including differences in safety and effec-
tiveness.’’; and 
(B) by adding at the end the following: 
‘‘(5) The Secretary shall develop standards that en-
sure that submissions to the Secretary pursuant to this 
subsection are adequately reviewed to determine whether 
such submissions include the information required under 
paragraph (1)(H).’’; and 
(2) in subsection (d)— 
(A) in paragraph (1)— 
(i) in subparagraph (D), by striking 
‘‘or’’ at the end;
(ii) in subparagraph (E), by striking 
the period and inserting ‘‘; or’’; and 
(iii) by inserting after subparagraph 
(E), the following: 
‘‘(F) the application does not contain, as appro-
priate, the information required in subsection 
(c)(1)(H).’’; and 
(B) by adding at the end the following: 
‘‘(7) Upon the approval of an application under this 
section, the Secretary shall report to the scientific commu-
nity and make available to the public, in a timely manner, 
data regarding such device stratified by gender, race, and 
ethnicity.’’. 
(e) INVESTIGATIONAL DEVICE EXEMPTIONS.—Sec-
tion 520(g)(2) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360j(g)) is amended— 
(1) in subparagraph (B), by adding at the end 
the following: 
‘‘(iv) A requirement that any application in-
clude information regarding the device, to the extent 
appropriate, stratified by gender, race, and ethnicity, 
including differences in safety and effectiveness.’’; 
and 
(2) by adding at the end the following:
‘‘(d) The Secretary shall develop standards that en-
sure that submissions to the Secretary pursuant to this 
subsection are adequately reviewed to determine whether 
such submissions include the information required under 
paragraph (B)(iv).’’. 
(f) 
BIOLOGICAL
PRODUCT
LICENSES.—Section 
351(a)(2) of the Public Health Service Act (42 U.S.C. 
262) is amended by adding at the end the following: 
‘‘(D)(i) Notwithstanding any other provision of this 
Act, the applicant shall include in any application to the 
Secretary pursuant to this section appropriate information 
regarding the subject biological product stratified by gen-
der, race, and ethnicity, including differences in safety and 
effectiveness. 
‘‘(ii) The Secretary shall develop standards that en-
sure that submissions to the Secretary pursuant to this 
section are adequately reviewed to determine whether such 
submissions include the information required under para-
graph (D)(i). 
‘‘(iii) Upon the approval of an application under this 
subsection, the Secretary shall report to the scientific com-
munity and make available to the public, in a timely man-
ner, data regarding such biological product stratified by 
gender, race, and ethnicity.’’.
(g) GAO STUDY.—Not later than 2 years after the 
date of enactment of this section, the Comptroller General 
of the United States shall study the drug approval proc-
esses of the Food and Drug Administration to ensure that 
the Food and Drug Administration is complying with the 
amendments made by this section. 
SEC. 4. GENDER-BASED REPORTING AND ANALYSIS OF PA-
TIENT SAFETY DATA. 
(a) DATA STANDARDS.—Section 923(b) of the Public 
Health Service Act (as amended by the Patient Safety and 
Quality Improvement Act of 2005 (Public Law 109–41)) 
is amended by adding at the end the following: ‘‘The Sec-
retary shall provide that all nonidentifiable patient safety 
work product reported to and among the network of pa-
tient safety databases be stratified by gender.’’. 
(b) USE OF INFORMATION.—Section 923(c) of the 
Public Health Service Act (as amended by the Patient 
Safety and Quality Improvement Act of 2005 (Public law 
109–41)) is amended by adding at the end the following: 
‘‘Such analyses take into account data that specifically re-
lates to women and any disparities between treatment and 
the quality of care between males and females.’’.
SEC. 5. REPORTING OF HOSPITAL QUALITY DATA BY GEN-
DER. 
Section 1886(b)(3)(B)(iv)(II) of the Social Security 
Act (42 U.S.C. 1395ww(b)(3)(B)(vii)(II)), as amended by 
section 501 of the Medicare Prescription Drug, Improve-
ment, and modernization Act of 2003 (Public law 108– 
173), is amended by adding at the end the following: ‘‘The 
Secretary shall make such data available to the public, in 
a form and manner that stratifies the data by gender.’’. 
SEC. 6. 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 disease’’; 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, 2006, and 
annually thereafter, the Secretary, acting through 
the Director, shall prepare and submit to Congress 
a report concerning the findings related to the qual-
ity of and access to care for women with heart dis-
ease, 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. 7. ANALYSIS OF DATA BY QUALITY IMPROVEMENT OR-
GANIZATIONS. 
Section 1154(a) of the Social Security Act (42 U.S.C. 
1320c–3(a)) is amended by adding at the end the fol-
lowing: 
‘‘(18) The organization shall execute its respon-
sibilities under subparagraphs (A) and (B) of para-
graph (1) by offering to providers, practitioners, 
Medicare Advantage organizations under part C, 
and prescription drug sponsors offering prescription 
drug plans under part D quality improvement assist-
ance aimed at eliminating gender disparities in the 
quality of care for women, particularly minority 
women, who suffer from heart disease, stroke, and 
other cardiovascular diseases. For purposes of this 
part and title XVIII, the functions described in this 
paragraph shall be treated as a review function.’’. 
SEC. 8. REPORTS BY ACCREDITING ORGANIZATIONS. 
The Social Security Act is amended by inserting after 
section 1808 (42 U.S.C. 1395b-9) the following:
‘‘SEC. 1809. STRATIFICATION OF DATA BY GENDER IN AP-
PLYING CONDITIONS OF PARTICIPATION AND 
CONDITIONS OF COVERAGE. 
‘‘ The Secretary shall ensure that data are stratified 
by gender when collected and used in surveys evaluating 
whether providers meet the applicable conditions of par-
ticipation or conditions of coverage under parts A, B, C 
and D of this title. When determined feasible by the Sec-
retary, such data shall be stratified by gender when re-
ported to the public or otherwise made available to the 
public.’’. 
SEC. 9. EDUCATIONAL CAMPAIGNS. 
(a) DISTRIBUTION
OF
EDUCATIONAL
MATERIAL 
THROUGH THE CENTER FOR BENEFICIARY CHOICES.— 
The Secretary of Health and Human Services, acting 
through the Center for Beneficiary Choices of the Centers 
for Medicare & Medicaid Services, shall develop and dis-
tribute to female medicare beneficiaries, physicians, and 
other appropriate healthcare professionals educational ma-
terials relating to the prevention, diagnosis, and treatment 
of heart disease, stroke, and cardiovascular diseases in 
women. The Center for Beneficiary Choices may carry out 
this subsection through contracts with public and private 
nonprofit entities. 
(b) HEALTHCARE
PROFESSIONAL
EDUCATIONAL 
CAMPAIGN.—The Secretary of Health and Human Serv-
ices, acting through the Bureau of Health Professions of 
the Health Resources and Services Administration, shall 
conduct an education and awareness campaign for physi-
cians 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 sub-
section through contracts with public and private non-
profit entities. 
SEC. 10. EXTENSION OF WISEWOMAN. 
There are authorized to be appropriated such sums 
as may be necessary for each fiscal year to enable the Di-
rector of the Centers for Disease Control and Prevention 
to implement Well-Integrated Screening and Evaluation 
for Women Across the Nation (WISEWOMAN) program 
projects in all State and territories, which may include 
projects among Indian tribes. 
Æ