414 
with the Secretary’s procedures for paying such 
fees. 
‘‘(C) NO WAIVERS, EXEMPTIONS, REDUC-
TIONS, OR REFUNDS.—The Secretary may not 
grant a waiver, exemption, reduction, or refund 
of any fees due and payable under this section. 
‘‘(5) OFFSETTING
COLLECTIONS.—Fees col-
lected pursuant to this subsection for any fiscal 
year— 
‘‘(A) shall be deposited and credited as off-
setting collections to the account providing ap-
propriations to the Food and Drug Administra-
tion; and 
‘‘(B) shall not be collected for any fiscal 
year except to the extent provided in advance in 
appropriation Acts.’’. 
SEC. 1103. IMPROVING GENETIC TEST SAFETY AND QUAL-
ITY. 
(a) REPORT.—If the Secretary’s Advisory Committee 
on Genetics, Health, and Society does not complete and 
submit the Regulatory Oversight of Genetic/Genomic Test-
ing Report & Action Recommendations to the Secretary 
of Health and Human Services (referred to in this section 
as the ‘‘Secretary’’) by July of 2008, the Secretary shall 
enter into a contract with the Institute of Medicine to con-
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duct a study to assess the overall safety and quality of 
genetic tests and prepare a report that includes rec-
ommendations to improve Federal oversight and regula-
tion of genetic tests. Such study shall take into consider-
ation relevant reports by the Secretary’s Advisory Com-
mittee on Genetics, Health, and Society and other groups 
and shall be completed not later than 1 year after the date 
on which the Secretary entered into such contract. 
(b) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as requiring Federal efforts with 
respect to regulatory oversight of genetic tests to cease 
or be limited or delayed pending completion of the report 
by the Secretary’s Advisory Committee on Genetics, 
Health, and Society or the Institute of Medicine. 
SEC. 1104. NIH TECHNICAL AMENDMENTS. 
The Public Health Service Act (42 U.S.C. 201 et 
seq.) is amended— 
(1) in section 319C–2(j)(3)(B), by striking 
‘‘section 319C–1(h)’’ and inserting ‘‘section 319C– 
1(i)’’; 
(2) in section 402(b)(4), by inserting ‘‘minority 
and other’’ after ‘‘reducing’’; 
(3) in section 403(a)(4)(C)(iv)(III), by inserting 
‘‘and postdoctoral training funded through research 
grants’’ before the semicolon; 
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(4) by designating the second section 403C (re-
lating to the drug diethylstilbestrol) as section 
403D; and 
(5) in section 403C(a)— 
(A) in the matter preceding paragraph 
(1)— 
(i) by inserting ‘‘graduate students 
supported by the National Institutes of 
Health’’ after ‘‘with respect to’’; and 
(ii) by deleting ‘‘each degree-granting 
program’’; 
(B) in paragraph (1), by inserting ‘‘such’’ 
after ‘‘percentage of’’; and 
(C) in paragraph (2), by inserting ‘‘(not 
including any leaves of absence)’’ after ‘‘average 
time’’. 
SEC. 1105. SEVERABILITY CLAUSE. 
If any provision of this Act, an amendment made this 
Act, or the application of such provision or amendment 
to any person or circumstance is held to be unconstitu-
tional, the remainder of this Act, the amendments made 
by this Act, and the application of the provisions of such 
to any person or circumstances shall not be affected there-
by. 
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417 
Subtitle B—Antibiotic Access and 
Innovation 
SEC. 1111. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE 
CONCENTRATIONS OF ANTIMICROBIALS. 
(a) DEFINITION.—In this section, the term ‘‘clinically 
susceptible concentrations’’ means specific values which 
characterize bacteria as clinically susceptible, inter-
mediate, or resistant to the drug (or drugs) tested. 
(b) IDENTIFICATION.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’), through the Commissioner of Food and Drugs, 
shall identify (where such information is reasonably avail-
able) and periodically update clinically susceptible con-
centrations. 
(c) PUBLIC AVAILABILITY.—The Secretary, through 
the Commissioner of Food and Drugs, shall make such 
clinically susceptible concentrations publicly available, 
such as by posting on the Internet, not later than 30 days 
after the date of identification and any update under this 
section. 
(d) EFFECT.—Nothing in this section shall be con-
strued to restrict, in any manner, the prescribing of anti-
biotics by physicians, or to limit the practice of medicine, 
including for diseases such as Lyme and tick-borne dis-
eases. 
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SEC. 1112. ORPHAN ANTIBIOTIC DRUGS. 
(a) PUBLIC MEETING.—The Commissioner of Food 
and Drugs shall convene a public meeting regarding which 
serious and life threatening infectious diseases, such as 
diseases due to gram-negative bacteria and other diseases 
due to antibiotic-resistant bacteria, potentially qualify for 
available grants and contracts under section 5(a) of the 
Orphan Drug Act (21 U.S.C. 360ee(a)) or other incentives 
for development. 
(b) GRANTS AND CONTRACTS FOR THE DEVELOP-
MENT OF ORPHAN DRUGS.—Section 5(c) of the Orphan 
Drug Act (21 U.S.C. 360ee(c)) is amended to read as fol-
lows: 
‘‘(c) For grants and contracts under subsection (a), 
there is authorized to be appropriated $30,000,000 for 
each of fiscal years 2008 through 2012.’’. 
SEC. 1113. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING 
SINGLE ENANTIOMERS. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355), as amended by section 920, is fur-
ther amended by adding at the end the following: 
‘‘(u) 
CERTAIN
DRUGS
CONTAINING
SINGLE 
ENANTIOMERS.— 
‘‘(1) IN
GENERAL.—For purposes of sub-
sections (c)(3)(E)(ii) and (j)(5)(F)(ii), if an applica-
tion is submitted under subsection (b) for a non-ra-
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cemic drug containing as an active ingredient (in-
cluding any ester or salt of the active ingredient) a 
single enantiomer that is contained in a racemic 
drug approved in another application under sub-
section (b), the applicant may, in the application for 
such non-racemic drug, elect to have the single 
enantiomer not be considered the same active ingre-
dient as that contained in the approved racemic 
drug, if— 
‘‘(A)(i) the single enantiomer has not been 
previously approved except in the approved ra-
cemic drug; and 
‘‘(ii) the application submitted under sub-
section (b) for such non-racemic drug— 
‘‘(I) includes full reports of new clin-
ical 
investigations 
(other 
than 
bio-
availability studies)— 
‘‘(aa) necessary for the approval 
of the application under subsections 
(c) and (d); and 
‘‘(bb) conducted or sponsored by 
the applicant; and 
‘‘(II) does not rely on any investiga-
tions that are part of an application sub-
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paragraph shall include a statement that the 
non-racemic drug is not approved, and has not 
been shown to be safe and effective, for any 
condition of use of the racemic drug. 
‘‘(3) DEFINITION.— 
‘‘(A) IN GENERAL.—For purposes of this 
subsection, the term ‘therapeutic category’ 
means a therapeutic category identified in the 
list developed by the United States Pharma-
copeia 
pursuant 
to 
section 
1860D– 
4(b)(3)(C)(ii) of the Social Security Act and as 
in effect on the date of the enactment of this 
subsection. 
‘‘(B) PUBLICATION BY SECRETARY.—The 
Secretary shall publish the list described in sub-
paragraph (A) and may amend such list by reg-
ulation. 
‘‘(4) AVAILABILITY.—The election referred to 
in paragraph (1) may be made only in an application 
that is submitted to the Secretary after the date of 
the enactment of this subsection and before October 
1, 2012.’’. 
SEC. 1114. REPORT. 
Not later than January 1, 2012, the Comptroller 
General of the United States shall submit a report to the 
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Committee on Health, Education, Labor, and Pensions of 
the Senate and the Committee on Energy and Commerce 
of the House of Representatives that examines whether 
and how this subtitle has— 
(1) encouraged the development of new anti-
biotics and other drugs; and 
(2) prevented or delayed timely generic drug 
entry into the market. 
Æ 
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