H. R. 3580—142 
(1) work with companies, relevant professional associations, 
and other organizations to collect and aggregate information 
pertaining to the recall; 
(2) use existing networks of communication, including elec-
tronic forms of information dissemination, to enhance the 
quality and speed of communication with the public; and 
(3) post information regarding recalled human and pet 
foods on the Internet Web site of the Food and Drug Adminis-
tration in a single location, which shall include a searchable 
database of recalled human foods and a searchable database 
of recalled pet foods, that is easily accessed and understood 
by the public. 
SEC. 1004. STATE AND FEDERAL COOPERATION. 
(a) IN GENERAL.—The Secretary shall work with the States 
in undertaking activities and programs that assist in improving 
the safety of food, including fresh and processed produce, so that 
State food safety programs and activities conducted by the Secretary 
function in a coordinated and cost-effective manner. With the assist-
ance provided under subsection (b), the Secretary shall encourage 
States to— 
(1) establish, continue, or strengthen State food safety pro-
grams, especially with respect to the regulation of retail 
commercial food establishments; and 
(2) establish procedures and requirements for ensuring that 
processed produce under the jurisdiction of State food safety 
programs is not unsafe for human consumption. 
(b) ASSISTANCE.—The Secretary may provide to a State, for 
planning, developing, and implementing such a food safety pro-
gram— 
(1) advisory assistance; 
(2) technical assistance, training, and laboratory assistance 
(including necessary materials and equipment); and 
(3) financial and other assistance. 
(c) SERVICE AGREEMENTS.—The Secretary may, under an agree-
ment entered into with a Federal, State, or local agency, use, 
on a reimbursable basis or otherwise, the personnel, services, and 
facilities of the agency to carry out the responsibilities of the agency 
under this section. An agreement entered into with a State agency 
under this subsection may provide for training of State employees. 
SEC. 1005. REPORTABLE FOOD REGISTRY. 
(a) FINDINGS.—Congress makes the following findings: 
(1) In 1994, Congress passed the Dietary Supplement 
Health and Education Act of 1994 (Public Law 103–417) to 
provide the Food and Drug Administration the legal framework 
which is intended to ensure that dietary supplements are safe 
and properly labeled foods. 
(2) In 2006, Congress passed the Dietary Supplement and 
Nonprescription Drug Consumer Protection Act (Public Law 
109–462) to establish a mandatory reporting system of serious 
adverse events for nonprescription drugs and dietary supple-
ments sold and consumed in the United States. 
(3) The adverse event reporting system created under the 
Dietary Supplement and Nonprescription Drug Consumer 
Protection Act is intended to serve as an early warning system 
for potential public health issues associated with the use of 
these products.
H. R. 3580—143 
(4) A reliable mechanism to track patterns of adulteration 
in food would support efforts by the Food and Drug Administra-
tion to target limited inspection resources to protect the public 
health. 
(b) IN GENERAL.—Chapter IV of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at 
the end the following: 
‘‘SEC. 417. REPORTABLE FOOD REGISTRY. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) RESPONSIBLE
PARTY.—The term ‘responsible party’, 
with respect to an article of food, means a person that submits 
the registration under section 415(a) for a food facility that 
is required to register under section 415(a), at which such 
article of food is manufactured, processed, packed, or held. 
‘‘(2) REPORTABLE FOOD.—The term ‘reportable food’ means 
an article of food (other than infant formula) for which there 
is a reasonable probability that the use of, or exposure to, 
such article of food will cause serious adverse health con-
sequences or death to humans or animals. 
‘‘(b) ESTABLISHMENT.— 
‘‘(1) IN GENERAL.—Not later than 1 year after the date 
of the enactment of this section, the Secretary shall establish 
within the Food and Drug Administration a Reportable Food 
Registry to which instances of reportable food may be submitted 
by the Food and Drug Administration after receipt of reports 
under subsection (d), via an electronic portal, from— 
‘‘(A) Federal, State, and local public health officials; 
or 
‘‘(B) responsible parties. 
‘‘(2) REVIEW BY SECRETARY.—The Secretary shall promptly 
review and assess the information submitted under paragraph 
(1) for the purposes of identifying reportable food, submitting 
entries to the Reportable Food Registry, acting under subsection 
(c), and exercising other existing food safety authorities under 
this Act to protect the public health. 
‘‘(c) ISSUANCE OF AN ALERT BY THE SECRETARY.— 
‘‘(1) IN GENERAL.—The Secretary shall issue, or cause to 
be issued, an alert or a notification with respect to a reportable 
food using information from the Reportable Food Registry as 
the Secretary deems necessary to protect the public health. 
‘‘(2) EFFECT.—Paragraph (1) shall not affect the authority 
of the Secretary to issue an alert or a notification under any 
other provision of this Act. 
‘‘(d) REPORTING AND NOTIFICATION.— 
‘‘(1) IN GENERAL.—Except as provided in paragraph (2), 
as soon as practicable, but in no case later than 24 hours 
after a responsible party determines that an article of food 
is a reportable food, the responsible party shall— 
‘‘(A) submit a report to the Food and Drug Administra-
tion through the electronic portal established under sub-
section (b) that includes the data elements described in 
subsection (e) (except the elements described in paragraphs 
(8), (9), and (10) of such subsection); and 
‘‘(B) investigate the cause of the adulteration if the 
adulteration of the article of food may have originated 
with the responsible party.
H. R. 3580—144 
‘‘(2) NO
REPORT
REQUIRED.—A responsible party is not 
required to submit a report under paragraph (1) if— 
‘‘(A) the adulteration originated with the responsible 
party; 
‘‘(B) the responsible party detected the adulteration 
prior to any transfer to another person of such article 
of food; and 
‘‘(C) the responsible party— 
‘‘(i) corrected such adulteration; or 
‘‘(ii) destroyed or caused the destruction of such 
article of food. 
‘‘(3) REPORTS
BY
PUBLIC
HEALTH
OFFICIALS.—A Federal, 
State, or local public health official may submit a report about 
a reportable food to the Food and Drug Administration through 
the electronic portal established under subsection (b) that 
includes the data elements described in subsection (e) that 
the official is able to provide. 
‘‘(4) REPORT NUMBER.—The Secretary shall ensure that, 
upon submission of a report under paragraph (1) or (3), a 
unique number is issued through the electronic portal estab-
lished under subsection (b) to the person submitting such 
report, by which the Secretary is able to link reports about 
the reportable food submitted and amended under this sub-
section and identify the supply chain for such reportable food. 
‘‘(5) REVIEW.—The Secretary shall promptly review a report 
submitted under paragraph (1) or (3). 
‘‘(6) RESPONSE TO REPORT SUBMITTED BY A RESPONSIBLE 
PARTY.—After consultation with the responsible party that sub-
mitted a report under paragraph (1), the Secretary may require 
such responsible party to perform, as soon as practicable, but 
in no case later than a time specified by the Secretary, 1 
or more of the following: 
‘‘(A) Amend the report submitted by the responsible 
party under paragraph (1) to include the data element 
described in subsection (e)(9). 
‘‘(B) Provide a notification— 
‘‘(i) to the immediate previous source of the article 
of food, if the Secretary deems necessary; 
‘‘(ii) to the immediate subsequent recipient of the 
article of food, if the Secretary deems necessary; and 
‘‘(iii) that includes— 
‘‘(I) the data elements described in subsection 
(e) that the Secretary deems necessary; 
‘‘(II) the actions described under paragraph 
(7) that the recipient of the notification shall per-
form, as required by the Secretary; and 
‘‘(III) any other information that the Secretary 
may require. 
‘‘(7) SUBSEQUENT REPORTS AND NOTIFICATIONS.—Except as 
provided in paragraph (8), the Secretary may require a respon-
sible party to perform, as soon as practicable, but in no case 
later than a time specified by the Secretary, after the respon-
sible party receives a notification under subparagraph (C) or 
paragraph (6)(B), 1 or more of the following: 
‘‘(A) Submit a report to the Food and Drug Administra-
tion through the electronic portal established under sub-
section (b) that includes those data elements described
H. R. 3580—145 
in subsection (e) and other information that the Secretary 
deems necessary. 
‘‘(B) Investigate the cause of the adulteration if the 
adulteration of the article of food may have originated 
with the responsible party. 
‘‘(C) Provide a notification— 
‘‘(i) to the immediate previous source of the article 
of food, if the Secretary deems necessary; 
‘‘(ii) to the immediate subsequent recipient of the 
article of food, if the Secretary deems necessary; and 
‘‘(iii) that includes— 
‘‘(I) the data elements described in subsection 
(e) that the Secretary deems necessary; 
‘‘(II) the actions described under this para-
graph that the recipient of the notification shall 
perform, as required by the Secretary; and 
‘‘(III) any other information that the Secretary 
may require. 
‘‘(8) AMENDED REPORT.—If a responsible party receives a 
notification under paragraph (6)(B) or paragraph (7)(C) with 
respect to an article of food after the responsible party has 
submitted a report to the Food and Drug Administration under 
paragraph (1) with respect to such article of food— 
‘‘(A) the responsible party is not required to submit 
an additional report or make a notification under para-
graph (7); and 
‘‘(B) the responsible party shall amend the report sub-
mitted by the responsible party under paragraph (1) to 
include the data elements described in paragraph (9), and, 
with respect to both such notification and such report, 
paragraph (11) of subsection (e). 
‘‘(e) DATA ELEMENTS.—The data elements described in this 
subsection are the following: 
‘‘(1) The registration numbers of the responsible party 
under section 415(a)(3). 
‘‘(2) The date on which an article of food was determined 
to be a reportable food. 
‘‘(3) A description of the article of food including the 
quantity or amount. 
‘‘(4) The extent and nature of the adulteration. 
‘‘(5) If the adulteration of the article of food may have 
originated with the responsible party, the results of the inves-
tigation required under paragraph (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 manufac-
turers, packers, or distributors sufficient to identify the article 
of food. 
‘‘(8) Contact information for the responsible party. 
‘‘(9) The contact information for parties directly linked in 
the supply chain and notified under paragraph (6)(B) or (7)(C) 
of subsection (d), as applicable. 
‘‘(10) The information required by the Secretary 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).
H. R. 3580—146 
‘‘(11) The unique number described in subsection (d)(4). 
‘‘(f) COORDINATION OF FEDERAL, STATE, AND LOCAL EFFORTS.— 
‘‘(1) DEPARTMENT OF AGRICULTURE.—In implementing this 
section, the Secretary shall— 
‘‘(A) share information and coordinate regulatory 
efforts with the Department of Agriculture; and 
‘‘(B) if the Secretary receives a report submitted about 
a food within the jurisdiction of the Department of Agri-
culture, promptly provide such report to the Department 
of Agriculture. 
‘‘(2) STATES AND LOCALITIES.—In implementing 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 localities that are not required to register 
under section 415; and 
‘‘(B) reduce duplicative regulatory efforts. 
‘‘(g) MAINTENANCE AND INSPECTION OF RECORDS.—The respon-
sible party shall maintain records related to each report received, 
notification made, and report submitted to the Food and Drug 
Administration under this section for 2 years. A responsible party 
shall, at the request of the Secretary, permit inspection of such 
records as provided for section 414. 
‘‘(h) REQUEST FOR INFORMATION.—Except as provided 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 report 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 notification 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 article 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 Secretary believes such food may 
have been deliberately adulterated, the Secretary shall immediately 
notify the Secretary of Homeland Security. The Secretary shall 
make relevant information from the Reportable Food Registry avail-
able to the Secretary of Homeland Security.’’. 
(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 ‘‘sections 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:
H. R. 3580—147 
‘‘(mm) The failure to submit a report or provide a notification 
required under section 417(d). 
‘‘(nn) The falsification of a report or notification required 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 estab-
lished under section 417 of the Federal Food, Drug, and Cosmetic 
Act (as added by this section) 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 jurisdiction between 
the Secretaries of Agriculture and of Health and Human Services, 
under applicable statutes and regulations. 
SEC. 1006. ENHANCED AQUACULTURE AND SEAFOOD INSPECTION. 
(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 ensuring the food safety 
of the United States. 
(3) To protect the health and safety of consumers in the 
United States, the ability of the Secretary to perform inspection 
functions must be enhanced. 
(b) HEIGHTENED INSPECTIONS.—The Secretary is authorized to 
enhance, as necessary, the inspection regime of the Food and Drug 
Administration for aquaculture and seafood, consistent with obliga-
tions 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 products, 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 associated with 
particular contaminants and banned substances. 
(d) PARTNERSHIPS WITH STATES.—Upon the request by any 
State, the Secretary may enter into partnership agreements, as 
soon as practicable after the request is made, to implement inspec-
tion programs to Federal standards regarding the importation of 
aquaculture and seafood. 
SEC. 1007. CONSULTATION REGARDING GENETICALLY ENGINEERED 
SEAFOOD PRODUCTS. 
The Commissioner of Food and Drugs shall consult with the 
Assistant Administrator of the National Marine Fisheries Service
H. R. 3580—148 
of the National Oceanic and Atmospheric Administration to produce 
a report on any environmental risks associated with genetically 
engineered seafood 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 improve the Food 
and Drug Administration’s ability to safeguard the food supply 
of the United States; 
(3) because of the increasing volume of international 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 comprehensive 
response to the issue of food safety. 
SEC. 1009. ANNUAL REPORT TO CONGRESS. 
The Secretary shall, on an annual basis, submit to the Com-
mittee on Health, Education, Labor, and Pensions and the Com-
mittee on Appropriations of the Senate and the Committee on 
Energy and Commerce and the Committee on Appropriations of 
the House of Representatives 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 imported 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 inspec-
tions performed on such products; and 
(3) aggregated data on the findings of such inspections, 
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 Administration, a report concerning 
the results of the Administration’s pesticide residue monitoring 
program, that includes— 
(1) information and analysis similar to that contained in 
the report entitled ‘‘Food and Drug Administration Pesticide 
Program Residue Monitoring 2003’’ as released in June of 2005; 
(2) based on an analysis of previous samples, an identifica-
tion of products or countries (for imports) that require special 
attention and additional study based on a comparison with 
equivalent products manufactured, distributed, or sold in the 
United States (including details on the plans for such additional 
studies), including in the initial report (and subsequent reports 
as determined necessary) the results and analysis of the Gin-
seng Dietary Supplements Special Survey as described on page
H. R. 3580—149 
13 of the report entitled ‘‘Food and Drug Administration Pes-
ticide Program Residue Monitoring 2003’’; 
(3) information on the relative number of interstate and 
imported shipments of each tested commodity that were sam-
pled, including recommendations on whether sampling is statis-
tically significant, provides confidence intervals or other related 
statistical information, and whether the number of samples 
should be increased and the details of any plans to provide 
for such increase; and 
(4) a description of whether certain commodities are being 
improperly imported as another commodity, including a descrip-
tion of additional steps that are being planned to prevent 
such smuggling. 
(b) INITIAL REPORTS.—Annual reports under subsection (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 Commissioner of 
Food and Drugs, the Administrator of the Food Safety and Inspec-
tion 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 products, respec-
tively. 
SEC. 1011. RULE OF CONSTRUCTION. 
Nothing in this title (or an amendment made by this title) 
shall be construed to affect— 
(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 dietary supple-
ments created under the Dietary Supplement and Nonprescrip-
tion Drug Consumer Protection 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 Commissioner of 
Food and Drugs, shall establish and make publicly available clear
H. R. 3580—150 
written policies to implement this section and govern the timely 
submission, review, clearance, and disclaimer requirements for arti-
cles. 
‘‘(c) TIMING
OF SUBMISSION
FOR REVIEW.—If an officer or 
employee, including a Staff Fellow and a contractor who performs 
staff work, of the Food and Drug Administration is directed by 
the policies established under subsection (b) to submit an article 
to the supervisor of such officer or employee, or to some other 
official of the Food and Drug Administration, for review and clear-
ance before such officer or employee may seek to publish or present 
such an article at a conference, such officer or employee shall 
submit such article for such review and clearance not less than 
30 days before submitting the article for publication or presentation. 
‘‘(d) TIMING FOR REVIEW AND CLEARANCE.—The supervisor or 
other reviewing official shall review such article and provide written 
clearance, or written clearance on the condition of specified changes 
being made, to such officer or employee not later than 30 days 
after such officer or employee submitted such article for review. 
‘‘(e) NON-TIMELY REVIEW.—If, 31 days after such submission 
under subsection (c), the supervisor or other reviewing official has 
not cleared or has not reviewed such article and provided written 
clearance, such officer or employee may consider such article not 
to have been cleared 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 construed as 
affecting any restrictions on such publication or presentation pro-
vided by other provisions of law.’’. 
SEC. 1102. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROP-
ICAL DISEASES. 
Subchapter A of chapter V of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at 
the end the following: 
‘‘SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROP-
ICAL DISEASES. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) PRIORITY
REVIEW.—The term ‘priority review’, 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 Sec-
retary of such application, as described in the Manual of Policies 
and Procedures of the Food and Drug Administration and goals 
identified in the letters described in section 101(c) of the Food 
and Drug Administration Amendments Act of 2007. 
‘‘(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.
H. R. 3580—151 
‘‘(D) Buruli Ulcer. 
‘‘(E) Cholera. 
‘‘(F) Dengue/dengue haemorrhagic fever. 
‘‘(G) Dracunculiasis (guinea-worm disease). 
‘‘(H) Fascioliasis. 
‘‘(I) Human African trypanosomiasis. 
‘‘(J) Leishmaniasis. 
‘‘(K) Leprosy. 
‘‘(L) Lymphatic filariasis. 
‘‘(M) Onchocerciasis. 
‘‘(N) Schistosomiasis. 
‘‘(O) Soil transmitted helmithiasis. 
‘‘(P) Yaws. 
‘‘(Q) Any other infectious disease for which there is 
no significant market in developed nations and that dis-
proportionately affects poor and marginalized populations, 
designated by regulation by the Secretary. 
‘‘(4) TROPICAL DISEASE PRODUCT APPLICATION.—The term 
‘tropical disease product application’ means an application 
that— 
‘‘(A) is a human drug application as defined in section 
735(1)— 
‘‘(i) for prevention or treatment of a tropical dis-
ease; and 
‘‘(ii) the Secretary deems eligible for priority 
review; 
‘‘(B) is approved after the date of the enactment 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 ingredient 
(including any ester or salt of the active ingredient) of 
which has been approved in any 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 application. 
‘‘(2) TRANSFERABILITY.—The sponsor of a tropical disease 
product that receives a priority review voucher under this sec-
tion may transfer (including 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 application. 
‘‘(3) LIMITATION.— 
‘‘(A) NO AWARD FOR PRIOR APPROVED APPLICATION.— 
A sponsor of a tropical disease product may not receive 
a priority review voucher under this section if the tropical 
disease product application was submitted to the Secretary 
prior to the date of the enactment of this section. 
‘‘(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
H. R. 3580—152 
after the date of the enactment of the Food and Drug 
Administration Amendments Act of 2007. 
‘‘(4) NOTIFICATION.—The sponsor of a human drug applica-
tion shall notify the Secretary not later than 365 days prior 
to submission of the human drug application that is the subject 
of a priority review 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 section. 
‘‘(c) PRIORITY REVIEW USER FEE.— 
‘‘(1) IN
GENERAL.—The Secretary shall establish a user 
fee program under which a sponsor of a human drug application 
that is the subject of a priority 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. 
‘‘(2) FEE AMOUNT.—The amount of the priority 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 Sep-
tember 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 submis-
sion of a human drug application 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 application 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 with 
the Secretary’s procedures for paying such fees. 
‘‘(C) NO
WAIVERS, 
EXEMPTIONS, 
REDUCTIONS, 
OR 
REFUNDS.—The Secretary may not grant a waiver, exemp-
tion, reduction, or refund of any fees due and payable 
under this section. 
‘‘(5) OFFSETTING COLLECTIONS.—Fees collected pursuant to 
this subsection for any fiscal year— 
‘‘(A) shall be deposited and credited as offsetting collec-
tions to the account providing appropriations to the Food 
and Drug Administration; 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 QUALITY. 
(a) REPORT.—If the Secretary’s Advisory Committee on 
Genetics, Health, and Society does not complete and submit the 
Regulatory Oversight of Genetic/Genomic Testing 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
H. R. 3580—153 
Medicine to conduct a study to assess the overall safety and quality 
of genetic tests and prepare a report that includes recommendations 
to improve Federal oversight and regulation of genetic tests. Such 
study shall take into consideration relevant reports by the Sec-
retary’s Advisory Committee 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 section 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; 
(4) by designating the second section 403C (relating 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 ‘‘percent-
age 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 unconstitutional, 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 thereby. 
Subtitle B—Antibiotic Access and 
Innovation 
SEC. 1111. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE CON-
CENTRATIONS OF ANTIMICROBIALS. 
(a) DEFINITION.—In this section, the term ‘‘clinically susceptible 
concentrations’’ means specific values which characterize bacteria 
as clinically susceptible, intermediate, or resistant to the drug (or 
drugs) tested. 
(b) IDENTIFICATION.—The Secretary of Health and Human Serv-
ices (referred to in this section as the ‘‘Secretary’’), through the 
Commissioner of Food and Drugs, shall identify (where such
H. R. 3580—154 
information is reasonably available) and periodically update clini-
cally susceptible concentrations. 
(c) PUBLIC AVAILABILITY.—The Secretary, through the Commis-
sioner 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 construed to 
restrict, in any manner, the prescribing of antibiotics by physicians, 
or to limit the practice of medicine, including for diseases such 
as Lyme and tick-borne diseases. 
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-nega-
tive 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 DEVELOPMENT OF ORPHAN 
DRUGS.—Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) 
is amended to read as follows: 
‘‘(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 further amended by 
adding at the end the following: 
‘‘(u) CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.— 
‘‘(1) IN GENERAL.—For purposes of subsections (c)(3)(E)(ii) 
and (j)(5)(F)(ii), if an application is submitted under subsection 
(b) for a non-racemic drug containing as an active ingredient 
(including any ester or salt of the active ingredient) a single 
enantiomer that is contained in a racemic drug approved in 
another application under subsection (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 racemic drug; and 
‘‘(ii) the application submitted under subsection (b) 
for such non-racemic drug— 
‘‘(I) includes full reports of new clinical investiga-
tions (other than bioavailability studies)— 
‘‘(aa) necessary for the approval of the applica-
tion under subsections (c) and (d); and 
‘‘(bb) conducted or sponsored by the applicant; 
and 
‘‘(II) does not rely on any investigations that are 
part of an application submitted under subsection (b) 
for approval of the approved racemic drug; and 
‘‘(B) the application submitted under subsection (b) 
for such non-racemic drug is not submitted for approval 
of a condition of use—
H. R. 3580—155 
‘‘(i) in a therapeutic category in which the approved 
racemic drug has been approved; or 
‘‘(ii) for which any other enantiomer of the racemic 
drug has been approved. 
‘‘(2) LIMITATION.— 
‘‘(A) NO
APPROVAL
IN
CERTAIN
THERAPEUTIC
CAT-
EGORIES.—Until the date that is 10 years after the date 
of approval of a non-racemic 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 labeling of a non- 
racemic drug described in paragraph (1) and with respect 
to which the applicant has made the election provided 
for by such 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 
Pharmacopeia 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 subparagraph (A) and may 
amend such list by regulation. 
‘‘(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 sub-
section 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 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 antibiotics and 
other drugs; and
H. R. 3580—156 
(2) prevented or delayed timely generic drug entry into 
the market. 
Speaker of the House of Representatives. 
Vice President of the United States and
President of the Senate.