396 
HR 3580 RDS
(1)(B) or (7)(B) of subsection (d), as applicable and 
when known. 
‘‘(6) The disposition of the article of food, when 
known. 
‘‘(7) Product information typically found on 
packaging including product codes, use-by dates, and 
names of manufacturers, packers, or distributors 
sufficient to identify the article of food. 
‘‘(8) Contact information for the responsible 
party. 
‘‘(9) The contact information for parties di-
rectly linked in the supply chain and notified under 
paragraph (6)(B) or (7)(C) of subsection (d), as ap-
plicable. 
‘‘(10) The information required by the Sec-
retary to be included in a notification provided by 
the responsible party involved under paragraph 
(6)(B) or (7)(C) of subsection (d) or required in a 
report under subsection (d)(7)(A). 
‘‘(11) The unique number described in sub-
section (d)(4). 
‘‘(f) COORDINATION
OF
FEDERAL, STATE, AND 
LOCAL EFFORTS.— 
‘‘(1) DEPARTMENT OF AGRICULTURE.—In im-
plementing this section, the Secretary shall— 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00396
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
397 
HR 3580 RDS
‘‘(A) share information and coordinate reg-
ulatory efforts with the Department of Agri-
culture; and 
‘‘(B) if the Secretary receives a report sub-
mitted about a food within the jurisdiction of 
the Department of Agriculture, promptly pro-
vide such report to the Department of Agri-
culture. 
‘‘(2) STATES
AND
LOCALITIES.—In imple-
menting this section, the Secretary shall work with 
the State and local public health officials to share 
information and coordinate regulatory efforts, in 
order to— 
‘‘(A) help to ensure coverage of the safety 
of the food supply chain, including those food 
establishments regulated by the States and lo-
calities that are not required to register under 
section 415; and 
‘‘(B) reduce duplicative regulatory efforts. 
‘‘(g) 
MAINTENANCE
AND
INSPECTION
OF 
RECORDS.—The responsible party shall maintain records 
related to each report received, notification made, and re-
port submitted to the Food and Drug Administration 
under this section for 2 years. A responsible party shall, 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00397
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
398 
HR 3580 RDS
at the request of the Secretary, permit inspection of such 
records as provided for section 414. 
‘‘(h) REQUEST FOR INFORMATION.—Except as pro-
vided by section 415(a)(4), section 552 of title 5, United 
States Code, shall apply to any request for information 
regarding a record in the Reportable Food Registry. 
‘‘(i) SAFETY REPORT.—A report or notification 
under subsection (d) shall be considered to be a safety re-
port under section 756 and may be accompanied by a 
statement, which shall be part of any report released for 
public disclosure, that denies that the report or the notifi-
cation constitutes an admission that the product involved 
caused or contributed to a death, serious injury, or serious 
illness. 
‘‘(j) ADMISSION.—A report or notification under this 
section shall not be considered an admission that the arti-
cle of food involved is adulterated or caused or contributed 
to a death, serious injury, or serious illness. 
‘‘(k) HOMELAND
SECURITY
NOTIFICATION.—If, 
after receiving a report under subsection (d), the Sec-
retary believes such food may have been deliberately adul-
terated, the Secretary shall immediately notify the Sec-
retary of Homeland Security. The Secretary shall make 
relevant information from the Reportable Food Registry 
available to the Secretary of Homeland Security.’’. 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00398
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
399 
HR 3580 RDS
(c) DEFINITION.—Section 201(ff) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)) is 
amended by striking ‘‘section 201(g)’’ and inserting ‘‘sec-
tions 201(g) and 417’’. 
(d) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331), as 
amended by section 912, is further amended— 
(1) in subsection (e), by— 
(A) striking ‘‘414,’’ and inserting ‘‘414, 
417(g),’’; and 
(B) 
striking 
‘‘414(b)’’ 
and 
inserting 
‘‘414(b), 417’’; and 
(2) by adding at the end the following: 
‘‘(mm) The failure to submit a report or provide a 
notification required under section 417(d). 
‘‘(nn) The falsification of a report or notification re-
quired under section 417(d).’’. 
(e) EFFECTIVE DATE.—The requirements of section 
417(d) of the Federal Food, Drug, and Cosmetic Act, as 
added by subsection (a), shall become effective 1 year after 
the date of the enactment of this Act. 
(f) GUIDANCE.—Not later than 9 months after the 
date of the enactment of this Act, the Secretary shall issue 
a guidance to industry about submitting reports to the 
electronic portal established under section 417 of the Fed-
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00399
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
400 
HR 3580 RDS
eral Food, Drug, and Cosmetic Act (as added by this sec-
tion) and providing notifications to other persons in the 
supply chain of an article of food under such section 417. 
(g) EFFECT.—Nothing in this title, or an amendment 
made by this title, shall be construed to alter the jurisdic-
tion between the Secretaries of Agriculture and of Health 
and Human Services, under applicable statutes and regu-
lations. 
SEC. 1006. ENHANCED AQUACULTURE AND SEAFOOD IN-
SPECTION. 
(a) FINDINGS.—Congress finds the following: 
(1) In 2007, there has been an overwhelming 
increase in the volume of aquaculture and seafood 
that has been found to contain substances that are 
not approved for use in food in the United States. 
(2) As of May 2007, inspection programs are 
not able to satisfactorily accomplish the goals of en-
suring the food safety of the United States. 
(3) To protect the health and safety of con-
sumers in the United States, the ability of the Sec-
retary to perform inspection functions must be en-
hanced. 
(b) HEIGHTENED INSPECTIONS.—The Secretary is 
authorized to enhance, as necessary, the inspection regime 
of the Food and Drug Administration for aquaculture and 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00400
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
401 
HR 3580 RDS
seafood, consistent with obligations of the United States 
under international agreements and United States law. 
(c) REPORT TO CONGRESS.—Not later than 180 days 
after the date of the enactment of this Act, the Secretary 
shall submit to Congress a report that— 
(1) describes the specifics of the aquaculture 
and seafood inspection program; 
(2) describes the feasibility of developing a 
traceability system for all catfish and seafood prod-
ucts, both domestic and imported, for the purpose of 
identifying the processing plant of origin of such 
products; and 
(3) provides for an assessment of the risks as-
sociated with particular contaminants and banned 
substances. 
(d) PARTNERSHIPS WITH STATES.—Upon the re-
quest by any State, the Secretary may enter into partner-
ship agreements, as soon as practicable after the request 
is made, to implement inspection programs to Federal 
standards regarding the importation of aquaculture and 
seafood. 
SEC. 1007. CONSULTATION REGARDING GENETICALLY EN-
GINEERED SEAFOOD PRODUCTS. 
The Commissioner of Food and Drugs shall consult 
with the Assistant Administrator of the National Marine 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00401
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
402 
HR 3580 RDS
Fisheries Service of the National Oceanic and Atmos-
pheric Administration to produce a report on any environ-
mental risks associated with genetically engineered sea-
food products, including the impact on wild fish stocks. 
SEC. 1008. SENSE OF CONGRESS. 
It is the sense of Congress that— 
(1) it is vital for Congress to provide the Food 
and Drug Administration with additional resources, 
authorities, and direction with respect to ensuring 
the safety of the food supply of the United States; 
(2) additional inspectors are required to im-
prove the Food and Drug Administration’s ability to 
safeguard the food supply of the United States; 
(3) because of the increasing volume of inter-
national trade in food products the Secretary should 
make it a priority to enter into agreements with the 
trading partners of the United States with respect to 
food safety; and 
(4) Congress should work to develop a com-
prehensive response to the issue of food safety. 
SEC. 1009. ANNUAL REPORT TO CONGRESS. 
The Secretary shall, on an annual basis, submit to 
the Committee on Health, Education, Labor, and Pen-
sions and the Committee on Appropriations of the Senate 
and the Committee on Energy and Commerce and the 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00402
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
403 
HR 3580 RDS
Committee on Appropriations of the House of Representa-
tives a report that includes, with respect to the preceding 
1-year period— 
(1) the number and amount of food products 
regulated by the Food and Drug Administration im-
ported into the United States, aggregated by country 
and type of food; 
(2) a listing of the number of Food and Drug 
Administration inspectors of imported food products 
referenced in paragraph (1) and the number of Food 
and Drug Administration inspections performed on 
such products; and 
(3) aggregated data on the findings of such in-
spections, including data related to violations of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
201 et seq.), and enforcement actions used to follow- 
up on such findings and violations. 
SEC. 1010. PUBLICATION OF ANNUAL REPORTS. 
(a) IN GENERAL.—The Commissioner of Food and 
Drugs shall annually submit to Congress and publish on 
the Internet Web site of the Food and Drug Administra-
tion, a report concerning the results of the Administra-
tion’s pesticide residue monitoring program, that in-
cludes— 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00403
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
404 
HR 3580 RDS
(1) information and analysis similar to that 
contained in the report entitled ‘‘Food and Drug Ad-
ministration Pesticide Program Residue Monitoring 
2003’’ as released in June of 2005; 
(2) based on an analysis of previous samples, 
an identification of products or countries (for im-
ports) that require special attention and additional 
study based on a comparison with equivalent prod-
ucts manufactured, distributed, or sold in the United 
States (including details on the plans for such addi-
tional studies), including in the initial report (and 
subsequent reports as determined necessary) the re-
sults and analysis of the Ginseng Dietary Supple-
ments Special Survey as described on page 13 of the 
report entitled ‘‘Food and Drug Administration Pes-
ticide Program Residue Monitoring 2003’’; 
(3) information on the relative number of inter-
state and imported shipments of each tested com-
modity that were sampled, including recommenda-
tions on whether sampling is statistically significant, 
provides confidence intervals or other related statis-
tical information, and whether the number of sam-
ples should be increased and the details of any plans 
to provide for such increase; and 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00404
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
405 
HR 3580 RDS
(4) a description of whether certain commod-
ities are being improperly imported as another com-
modity, including a description of additional steps 
that are being planned to prevent such smuggling. 
(b) INITIAL REPORTS.—Annual reports under sub-
section (a) for fiscal years 2004 through 2006 may be 
combined into a single report, by not later than June 1, 
2008, for purposes of publication under subsection (a). 
Thereafter such reports shall be completed by June 1 of 
each year for the data collected for the year that was 2- 
years prior to the year in which the report is published. 
(c) MEMORANDUM OF UNDERSTANDING.—The Com-
missioner of Food and Drugs, the Administrator of the 
Food Safety and Inspection Service, the Department of 
Commerce, and the head of the Agricultural Marketing 
Service shall enter into a memorandum of understanding 
to permit inclusion of data in the reports under subsection 
(a) relating to testing carried out by the Food Safety and 
Inspection Service and the Agricultural Marketing Service 
on meat, poultry, eggs, and certain raw agricultural prod-
ucts, respectively. 
SEC. 1011. RULE OF CONSTRUCTION. 
Nothing in this title (or an amendment made by this 
title) shall be construed to affect— 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00405
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
406 
HR 3580 RDS
(1) the regulation of dietary supplements under 
the Dietary Supplement Health and Education Act 
of 1994 (Public Law 103–417); or 
(2) the adverse event reporting system for die-
tary supplements created under the Dietary Supple-
ment and Nonprescription Drug Consumer Protec-
tion Act (Public Law 109–462). 
TITLE XI—OTHER PROVISIONS 
Subtitle A—In General 
SEC. 1101. POLICY ON THE REVIEW AND CLEARANCE OF 
SCIENTIFIC ARTICLES PUBLISHED BY FDA 
EMPLOYEES. 
Subchapter A of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 371 et seq.), as 
amended by section 701, is further amended by adding 
at the end the following: 
‘‘SEC. 713. POLICY ON THE REVIEW AND CLEARANCE OF 
SCIENTIFIC ARTICLES PUBLISHED BY FDA 
EMPLOYEES. 
‘‘(a) DEFINITION.—In this section, the term ‘article’ 
means a paper, poster, abstract, book, book chapter, or 
other published writing. 
‘‘(b) POLICIES.—The Secretary, through the Com-
missioner of Food and Drugs, shall establish and make 
publicly available clear written policies to implement this 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00406
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
408 
HR 3580 RDS
and may submit the article for publication or presentation 
with an appropriate disclaimer as specified in the policies 
established under subsection (b). 
‘‘(f) EFFECT.—Nothing in this section shall be con-
strued as affecting any restrictions on such publication or 
presentation provided by other provisions of law.’’. 
SEC. 1102. PRIORITY REVIEW TO ENCOURAGE TREATMENTS 
FOR TROPICAL DISEASES. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS 
FOR TROPICAL DISEASES. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) PRIORITY REVIEW.—The term ‘priority re-
view’, with respect to a human drug application as 
defined in section 735(1), means review and action 
by the Secretary on such application not later than 
6 months after receipt by the Secretary of such ap-
plication, as described in the Manual of Policies and 
Procedures of the Food and Drug Administration 
and goals identified in the letters described in sec-
tion 101(c) of the Food and Drug Administration 
Amendments Act of 2007. 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00408
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
409 
HR 3580 RDS
‘‘(2) PRIORITY REVIEW VOUCHER.—The term 
‘priority review voucher’ means a voucher issued by 
the Secretary to the sponsor of a tropical disease 
product application that entitles the holder of such 
voucher to priority review of a single human drug 
application submitted under section 505(b)(1) or 
section 351 of the Public Health Service Act after 
the date of approval of the tropical disease product 
application. 
‘‘(3) TROPICAL DISEASE.—The term ‘tropical 
disease’ means any of the following: 
‘‘(A) Tuberculosis. 
‘‘(B) Malaria. 
‘‘(C) Blinding trachoma. 
‘‘(D) Buruli Ulcer. 
‘‘(E) Cholera. 
‘‘(F) Dengue/dengue haemorrhagic fever. 
‘‘(G) Dracunculiasis (guinea-worm dis-
ease). 
‘‘(H) Fascioliasis. 
‘‘(I) Human African trypanosomiasis. 
‘‘(J) Leishmaniasis. 
‘‘(K) Leprosy. 
‘‘(L) Lymphatic filariasis. 
‘‘(M) Onchocerciasis. 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00409
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
410 
HR 3580 RDS
‘‘(N) Schistosomiasis. 
‘‘(O) Soil transmitted helmithiasis. 
‘‘(P) Yaws. 
‘‘(Q) Any other infectious disease for 
which there is no significant market in devel-
oped nations and that disproportionately affects 
poor and marginalized populations, designated 
by regulation by the Secretary. 
‘‘(4) TROPICAL
DISEASE
PRODUCT
APPLICA-
TION.—The term ‘tropical disease product applica-
tion’ means an application that— 
‘‘(A) is a human drug application as de-
fined in section 735(1)— 
‘‘(i) for prevention or treatment of a 
tropical disease; and 
‘‘(ii) the Secretary deems eligible for 
priority review; 
‘‘(B) is approved after the date of the en-
actment of the Food and Drug Administration 
Amendments Act of 2007, by the Secretary for 
use in the prevention, detection, or treatment of 
a tropical disease; and 
‘‘(C) is for a human drug, no active ingre-
dient (including any ester or salt of the active 
ingredient) of which has been approved in any 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00410
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
411 
HR 3580 RDS
other application under section 505(b)(1) or 
section 351 of the Public Health Service Act. 
‘‘(b) PRIORITY REVIEW VOUCHER.— 
‘‘(1) IN GENERAL.—The Secretary shall award 
a priority review voucher to the sponsor of a tropical 
disease product application upon approval by the 
Secretary of such tropical disease product applica-
tion. 
‘‘(2) TRANSFERABILITY.—The sponsor of a 
tropical disease product that receives a priority re-
view voucher under this section may transfer (in-
cluding by sale) the entitlement to such voucher to 
a sponsor of a human drug for which an application 
under section 505(b)(1) or section 351 of the Public 
Health Service Act will be submitted after the date 
of the approval of the tropical disease product appli-
cation. 
‘‘(3) LIMITATION.— 
‘‘(A) NO AWARD FOR PRIOR APPROVED AP-
PLICATION.—A sponsor of a tropical disease 
product may not receive a priority review 
voucher under this section if the tropical dis-
ease product application was submitted to the 
Secretary prior to the date of the enactment of 
this section. 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00411
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
412 
HR 3580 RDS
‘‘(B) ONE-YEAR
WAITING
PERIOD.—The 
Secretary shall issue a priority review voucher 
to the sponsor of a tropical disease product no 
earlier than the date that is 1 year after the 
date of the enactment of the Food and Drug 
Administration Amendments Act of 2007. 
‘‘(4) NOTIFICATION.—The sponsor of a human 
drug application shall notify the Secretary not later 
than 365 days prior to submission of the human 
drug application that is the subject of a priority re-
view voucher of an intent to submit the human drug 
application, including the date on which the sponsor 
intends to submit the application. Such notification 
shall be a legally binding commitment to pay for the 
user fee to be assessed in accordance with this sec-
tion. 
‘‘(c) PRIORITY REVIEW USER FEE.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish a user fee program under which a sponsor of a 
human drug application that is the subject of a pri-
ority review voucher shall pay to the Secretary a fee 
determined under paragraph (2). Such fee shall be 
in addition to any fee required to be submitted by 
the sponsor under chapter VII. 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00412
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
413 
HR 3580 RDS
‘‘(2) FEE AMOUNT.—The amount of the pri-
ority review user fee shall be determined each fiscal 
year by the Secretary and based on the average cost 
incurred by the agency in the review of a human 
drug application subject to priority review in the 
previous fiscal year. 
‘‘(3) ANNUAL
FEE
SETTING.—The Secretary 
shall establish, before the beginning of each fiscal 
year beginning after September 30, 2007, for that 
fiscal year, the amount of the priority review user 
fee. 
‘‘(4) PAYMENT.— 
‘‘(A) IN
GENERAL.—The priority review 
user fee required by this subsection shall be due 
upon the submission of a human drug applica-
tion under section 505(b)(1) or section 351 of 
the Public Health Services Act for which the 
priority review voucher is used. 
‘‘(B) COMPLETE APPLICATION.—An appli-
cation described under subparagraph (A) for 
which the sponsor requests the use of a priority 
review voucher shall be considered incomplete if 
the fee required by this subsection and all other 
applicable user fees are not paid in accordance 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00413
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
414 
HR 3580 RDS
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-
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00414
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
415 
HR 3580 RDS
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; 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00415
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
416 
HR 3580 RDS
(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. 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00416
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
417 
HR 3580 RDS
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. 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00417
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
418 
HR 3580 RDS
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-
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00418
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
420 
HR 3580 RDS
mitted under subsection (b) for approval of 
the approved racemic drug; and 
‘‘(B) the application submitted under sub-
section (b) for such non-racemic drug is not 
submitted for approval of a condition of use— 
‘‘(i) in a therapeutic category in which 
the approved racemic drug has been ap-
proved; or 
‘‘(ii) for which any other enantiomer 
of the racemic drug has been approved. 
‘‘(2) LIMITATION.— 
‘‘(A) NO APPROVAL IN CERTAIN THERA-
PEUTIC CATEGORIES.—Until the date that is 10 
years after the date of approval of a non-race-
mic drug described in paragraph (1) and with 
respect to which the applicant has made the 
election provided for by such paragraph, the 
Secretary shall not approve such non-racemic 
drug for any condition of use in the therapeutic 
category in which the racemic drug has been 
approved. 
‘‘(B) LABELING.—If applicable, the label-
ing of a non-racemic drug described in para-
graph (1) and with respect to which the appli-
cant has made the election provided for by such 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00420
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
421 
HR 3580 RDS
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 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00421
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS
422 
HR 3580 RDS
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. 
Passed the House of Representatives September 19, 
2007. 
Attest: 
LORRAINE C. MILLER, 
Clerk. 
VerDate Aug 31 2005 
04:59 Sep 21, 2007
Jkt 059200
PO 00000
Frm 00422
Fmt 6652
Sfmt 6201
E:\BILLS\H3580.RDS
H3580
ccoleman on PROD1PC77 with BILLS