‘‘(5)(A) The Secretary may place a clinical hold (as 
described in paragraph (3)) on an investigation if the 
sponsor of the investigation fails to meet the requirements 
of section 312.33(a) of title 21, Code of Federal Regula-
tions. 
‘‘(B) The Secretary shall modify the section referred 
to in subparagraph (A) to require that reports under such 
section include any clinical data possessed by the sponsor 
of the investigation that relates to the safety or effective-
ness of the drug involved by gender, age, and racial sub-
group.’’. 
(b) BIOLOGICS LICENSE APPLICATIONS.—Section 
351 of the Public Health Service Act (42 U.S.C. 262) is 
amended by adding at the end the following: 
‘‘(k) The provisions of section 505(b)(7) of the Fed-
eral Food, Drug, and Cosmetic Act (relating to clinical 
data submission) apply with respect to an application 
under subsection (a) of this section to the same extent 
and in the same manner as such provisions apply with re-
spect to an application under section 505(b) of such Act.’’. 
(c) DEVICES.— 
(1) PREMARKET
APPROVAL.—Section 515 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360e) is amended— 
(A) in subsection (c)(1)—
(i) in subparagraph (G)— 
(I) by moving the margin 2 ems 
to the left; and 
(II) by striking ‘‘and’’ after the 
semicolon at the end; 
(ii) by redesignating subparagraph 
(H) as subparagraph (I); and 
(iii) by inserting after subparagraph 
(G) the following subparagraph: 
‘‘(H) the information required under subsection 
(d)(7); and’’; and 
(B) in subsection (d), by adding at the end 
the following paragraph: 
‘‘(7) To the extent consistent with the regulation of 
devices, the provisions of section 505(b)(7) (relating to 
clinical data submission) apply with respect to an applica-
tion for premarket approval of a device under subsection 
(c) of this section to the same extent and in the same man-
ner as such provisions apply with respect to an application 
for premarket 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 in-
dividual 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 
otherwise in effect on the day before the date of the 
enactment of this Act; or 
(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 applica-
tions 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 
provide that all nonidentifiable patient safety work prod-
uct reported to and among the network of patient safety 
databases be stratified by sex.’’. 
(b) USE OF INFORMATION.—Section 923(c) of the 
Public Health Service Act (42 U.S.C. 299b–23(c)) is 
amended by adding at the end the following: ‘‘Such anal-
yses take into account data that specifically relates to 
women and any disparities between treatment and the 
quality of care between males and females.’’. 
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 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. 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 appropriate healthcare professionals, edu-
cational materials relating to the prevention, diagnosis, 
and treatment of heart disease, stroke, and cardiovascular 
diseases in women. The Secretary may carry out this sub-
section through contracts with public and private non-
profit entities. 
(b) HEALTHCARE
PROFESSIONAL
EDUCATIONAL 
CAMPAIGN.—The Secretary, acting through the Bureau of 
Health Professions of the Health Resources and Services 
Administration, shall conduct an education and awareness 
campaign for physicians and other healthcare profes-