(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 sex, race, and eth-
nicity.’’. 
(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 sex, race, and ethnicity, in-
cluding differences in safety and effectiveness.’’; and 
(2) by adding at the end the following: 
VerDate Aug 31 2005 
02:30 Feb 17, 2007
Jkt 059200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H1014.IH
H1014
hmoore on PROD1PC68 with HMBILLS
‘‘(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 
subparagraph (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 sex, 
race, and ethnicity, including differences in safety and ef-
fectiveness. 
‘‘(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 clause 
(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 
sex, race, and ethnicity.’’. 
VerDate Aug 31 2005 
02:30 Feb 17, 2007
Jkt 059200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H1014.IH
H1014
hmoore on PROD1PC68 with HMBILLS
(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. 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. 5. 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— 
VerDate Aug 31 2005 
02:30 Feb 17, 2007
Jkt 059200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H1014.IH
H1014
hmoore on PROD1PC68 with HMBILLS