‘‘(7) To the extent consistent with the regulation of de-
vices, 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 pre-
market 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 indi-
vidual study information) apply with respect to an appli-
cation 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 other-
wise in effect on the day before the date of the enact-
ment of this Act; or 
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(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 Cos-
metic 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 pro-
vide that all nonidentifiable patient safety work product re-
ported to and among the network of patient safety databases 
be stratified by sex.’’. 
(b) USE OF INFORMATION.—Section 923(c) of the Pub-
lic 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.’’. 
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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 re-
port 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 dis-
parities 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 
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