347 
379h), there are authorized to be appropriated to carry 
out the amendment made by this section, in addition to 
such funds, $25,000,000 for each of fiscal years 2008 
through 2012. 
(e) GAO REPORT.—Not later than 18 months after 
the date of the enactment of this Act, the Comptroller 
General of the United States shall evaluate data privacy, 
confidentiality, and security issues relating to accessing, 
transmitting, and maintaining data for the active 
postmarket risk identification and analysis system de-
scribed in paragraphs (3) and (4) of section 505(k) of the 
Federal Food, Drug, and Cosmetic Act, as added by sub-
section (a), and make recommendations to the Committee 
on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor and Pen-
sions of the Senate, and any other congressional commit-
tees of relevant jurisdiction, regarding the need for any 
additional legislative or regulatory actions to ensure pri-
vacy, confidentiality, and security of this data or otherwise 
address privacy, confidentiality, and security issues to en-
sure the effective operation of such active postmarket 
identification and analysis system.
348 
SEC. 906. STATEMENT FOR INCLUSION IN DIRECT-TO-CON-
SUMER ADVERTISEMENTS OF DRUGS. 
(a) PUBLISHED DIRECT-TO-CONSUMER ADVERTISE-
MENTS.—Section 502(n) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352), as amended by section 
901(d)(6), is further amended by inserting ‘‘and in the 
case of published direct-to-consumer advertisements the 
following statement printed in conspicuous text: ‘You are 
encouraged to report negative side effects of prescription 
drugs to the FDA. Visit www.fda.gov/medwatch, or call 
1–800-FDA-1088.’,’’ after ‘‘section 701(a),’’. 
(b) STUDY.— 
(1) IN GENERAL.—In the case of direct-to-con-
sumer television advertisements, the Secretary of 
Health and Human Services, in consultation with 
the Advisory Committee on Risk Communication 
under section 567 of the Federal Food, Drug, and 
Cosmetic Act (as added by section 917), shall, not 
later than 6 months after the date of the enactment 
of this Act, conduct a study to determine if the 
statement in section 502(n) of such Act (as added 
by subsection (a)) required with respect to published 
direct-to-consumer advertisements is appropriate for 
inclusion in such television advertisements. 
(2) CONTENT.—As part of the study under 
paragraph (1), such Secretary shall consider whether
349 
the information in the statement described in para-
graph (1) would detract from the presentation of 
risk information in a direct-to-consumer television 
advertisement. If such Secretary determines the in-
clusion of such statement is appropriate in direct-to- 
consumer television advertisements, such Secretary 
shall issue regulations requiring the implementation 
of such statement in direct-to-consumer television 
advertisements, including determining a reasonable 
length of time for displaying the statement in such 
advertisements. The Secretary shall report to the ap-
propriate committees of Congress the findings of 
such study and any plans to issue regulations under 
this paragraph. 
SEC. 907. NO EFFECT ON VETERINARY MEDICINE. 
This subtitle, and the amendments made by this sub-
title, shall have no effect on the use of drugs approved 
under section 505 of the Federal Food, Drug, and Cos-
metic Act by, or on the lawful written or oral order of, 
a licensed veterinarian within the context of a veteri-
narian-client-patient relationship, as provided for under 
section 512(a)(5) of such Act. 
SEC. 908. AUTHORIZATION OF APPROPRIATIONS. 
(a) IN GENERAL.—For carrying out this subtitle and 
the amendments made by this subtitle, there is authorized
350 
to be appropriated $25,000,000 for each of fiscal years 
2008 through 2012. 
(b) RELATION TO OTHER FUNDING.—The authoriza-
tion of appropriations under subsection (a) is in addition 
to any other funds available for carrying out this subtitle 
and the amendments made by this subtitle. 
SEC. 909. EFFECTIVE DATE AND APPLICABILITY. 
(a) EFFECTIVE DATE.—This subtitle takes effect 
180 days after the date of the enactment of this Act. 
(b) DRUGS DEEMED TO HAVE RISK EVALUATION 
AND MITIGATION STRATEGIES.— 
(1) IN GENERAL.—A drug that was approved 
before the effective date of this Act is, in accordance 
with paragraph (2), deemed to have in effect an ap-
proved risk evaluation and mitigation strategy under 
section 505–1 of the Federal Food, Drug, and Cos-
metic Act (as added by section 901) (referred to in 
this section as the ‘‘Act’’) if there are in effect on 
the effective date of this Act elements to assure safe 
use— 
(A) required under section 314.520 or sec-
tion 601.42 of title 21, Code of Federal Regula-
tions; or 
(B) otherwise agreed to by the applicant 
and the Secretary for such drug.
351 
(2) 
ELEMENTS
OF
STRATEGY; 
ENFORCE-
MENT.—The approved risk evaluation and mitigation 
strategy in effect for a drug under paragraph (1)— 
(A) is deemed to consist of the timetable 
required under section 505–1(d) and any addi-
tional elements under subsections (e) and (f) of 
such section in effect for such drug on the ef-
fective date of this Act; and 
(B) is subject to enforcement by the Sec-
retary to the same extent as any other risk 
evaluation and mitigation strategy under sec-
tion 505–1 of the Act, except that sections 
303(f)(4) and 502(y) and (z) of the Act (as 
added by section 902) shall not apply to such 
strategy before the Secretary has completed re-
view of, and acted on, the first assessment of 
such strategy under such section 505–1. 
(3) SUBMISSION.—Not later than 180 days 
after the effective date of this Act, the holder of an 
approved application for which a risk evaluation and 
mitigation strategy is deemed to be in effect under 
paragraph (1) shall submit to the Secretary a pro-
posed risk evaluation and mitigation strategy. Such 
proposed strategy is subject to section 505–1 of the
352 
Act as if included in such application at the time of 
submission of the application to the Secretary. 
Subtitle B—Other Provisions to En-
sure Drug Safety and Surveil-
lance 
SEC. 911. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC 
DRUGS. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 510 the following: 
‘‘SEC. 511. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC 
DRUGS. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of the enactment of this section, the Secretary shall 
issue guidance for the conduct of clinical trials with re-
spect to antibiotic drugs, including antimicrobials to treat 
acute bacterial sinusitis, acute bacterial otitis media, and 
acute bacterial exacerbation of chronic bronchitis. Such 
guidance shall indicate the appropriate models and valid 
surrogate markers. 
‘‘(b) REVIEW.—Not later than 5 years after the date 
of the enactment of this section, the Secretary shall review 
and update the guidance described under subsection (a) 
to reflect developments in scientific and medical informa-
tion and technology.’’.
366 
under subparagraph (2)(A), and regardless 
of whether the Secretary responded to the 
petition at or before the approval of the 
application at issue in the petition. 
‘‘(3) ANNUAL REPORT ON DELAYS IN APPROV-
ALS PER PETITIONS.—The Secretary shall annually 
submit to the Congress a report that specifies— 
‘‘(A) the number of applications that were 
approved during the preceding 12-month pe-
riod; 
‘‘(B) the number of such applications 
whose effective dates were delayed by petitions 
referred to in paragraph (1) during such period; 
‘‘(C) the number of days by which such ap-
plications were so delayed; and 
‘‘(D) the number of such petitions that 
were submitted during such period. 
‘‘(4) EXCEPTIONS.—This subsection does not 
apply to— 
‘‘(A) a petition that relates solely to the 
timing of the approval of an application pursu-
ant to subsection (j)(5)(B)(iv); or 
‘‘(B) a petition that is made by the spon-
sor of an application and that seeks only to 
have the Secretary take or refrain from taking
367 
any form of action with respect to that applica-
tion. 
‘‘(5) DEFINITIONS.— 
‘‘(A) APPLICATION.—For purposes of this 
subsection, the term ‘application’ means an ap-
plication submitted under subsection (b)(2) or 
(j). 
‘‘(B) PETITION.—For purposes of this 
subsection, other than paragraph (1)(A)(i), the 
term ‘petition’ means a request described in 
paragraph (1)(A)(i).’’. 
(b) REPORT.—Not later than 1 year after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall submit a report to the Congress on 
ways to encourage the early submission of petitions under 
section 505(q), as added by subsection (a). 
SEC. 915. POSTMARKET DRUG SAFETY INFORMATION FOR 
PATIENTS AND PROVIDERS. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355), as amended by section 914(a), is 
amended by adding at the end the following: 
‘‘(r) POSTMARKET DRUG SAFETY INFORMATION FOR 
PATIENTS AND PROVIDERS.— 
‘‘(1) ESTABLISHMENT.—Not later than 1 year 
after the date of the enactment of the Food and
368 
Drug Administration Amendments Act of 2007, the 
Secretary shall improve the transparency of informa-
tion about drugs and allow patients and health care 
providers better access to information about drugs 
by developing and maintaining an Internet Web site 
that— 
‘‘(A) provides links to drug safety informa-
tion listed in paragraph (2) for prescription 
drugs that are approved under this section or li-
censed under section 351 of the Public Health 
Service Act; and 
‘‘(B) improves communication of drug 
safety information to patients and providers. 
‘‘(2) INTERNET
WEB
SITE.—The Secretary 
shall carry out paragraph (1) by— 
‘‘(A) developing and maintaining an acces-
sible, consolidated Internet Web site with easily 
searchable drug safety information, including 
the information found on United States Govern-
ment Internet Web sites, such as the United 
States National Library of Medicine’s Daily 
Med and Medline Plus Web sites, in addition to 
other such Web sites maintained by the Sec-
retary;
369 
‘‘(B) ensuring that the information pro-
vided on the Internet Web site is comprehensive 
and includes, when available and appropriate— 
‘‘(i) patient labeling and patient pack-
aging inserts; 
‘‘(ii) a link to a list of each drug, 
whether approved under this section or li-
censed under such section 351, for which 
a Medication Guide, as provided for under 
part 208 of title 21, Code of Federal Regu-
lations (or any successor regulations), is 
required; 
‘‘(iii) a link to the registry and results 
data bank provided for under subsections 
(i) and (j) of section 402 of the Public 
Health Service Act; 
‘‘(iv) the most recent safety informa-
tion and alerts issued by the Food and 
Drug Administration for drugs approved 
by the Secretary under this section, such 
as product recalls, warning letters, and im-
port alerts; 
‘‘(v) publicly available information 
about implemented RiskMAPs and risk
370 
evaluation and mitigation strategies under 
subsection (o); 
‘‘(vi) guidance documents and regula-
tions related to drug safety; and 
‘‘(vii) other material determined ap-
propriate by the Secretary; 
‘‘(C) providing access to summaries of the 
assessed and aggregated data collected from the 
active surveillance infrastructure under sub-
section (k)(3) to provide information of known 
and serious side-effects for drugs approved 
under this section or licensed under such sec-
tion 351; 
‘‘(D) preparing, by 18 months after ap-
proval of a drug or after use of the drug by 
10,000 individuals, whichever is later, a sum-
mary analysis of the adverse drug reaction re-
ports received for the drug, including identifica-
tion of any new risks not previously identified, 
potential new risks, or known risks reported in 
unusual number; 
‘‘(E) enabling patients, providers, and 
drug sponsors to submit adverse event reports 
through the Internet Web site;
371 
‘‘(F) providing educational materials for 
patients and providers about the appropriate 
means of disposing of expired, damaged, or un-
usable medications; and 
‘‘(G) supporting initiatives that the Sec-
retary determines to be useful to fulfill the pur-
poses of the Internet Web site. 
‘‘(3) POSTING OF DRUG LABELING.—The Sec-
retary shall post on the Internet Web site estab-
lished under paragraph (1) the approved profes-
sional labeling and any required patient labeling of 
a drug approved under this section or licensed under 
such section 351 not later than 21 days after the 
date the drug is approved or licensed, including in 
a supplemental application with respect to a labeling 
change. 
‘‘(4) PRIVATE SECTOR RESOURCES.—To ensure 
development of the Internet Web site by the date de-
scribed in paragraph (1), the Secretary may, on a 
temporary or permanent basis, implement systems 
or products developed by private entities. 
‘‘(5) AUTHORITY FOR CONTRACTS.—The Sec-
retary may enter into contracts with public and pri-
vate entities to fulfill the requirements of this sub-
section.
372 
‘‘(6) REVIEW.—The Advisory Committee on 
Risk Communication under section 567 shall, on a 
regular basis, perform a comprehensive review and 
evaluation of the types of risk communication infor-
mation provided on the Internet Web site established 
under paragraph (1) and, through other means, 
shall identify, clarify, and define the purposes and 
types of information available to facilitate the effi-
cient flow of information to patients and providers, 
and shall recommend ways for the Food and Drug 
Administration to work with outside entities to help 
facilitate the dispensing of risk communication infor-
mation to patients and providers.’’. 
SEC. 916. ACTION PACKAGE FOR APPROVAL. 
Section 505(l) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(l)) is amended by— 
(1) redesignating paragraphs (1), (2), (3), (4), 
and (5) as subparagraphs (A), (B), (C), (D), and 
(E), respectively; 
(2) striking ‘‘(l) Safety and’’ and inserting 
‘‘(l)(1) Safety and’’; and 
(3) adding at the end the following: 
‘‘(2) ACTION PACKAGE FOR APPROVAL.— 
‘‘(A) ACTION
PACKAGE.—The Secretary shall 
publish the action package for approval of an appli-
373 
cation under subsection (b) or section 351 of the 
Public Health Service Act on the Internet Web site 
of the Food and Drug Administration— 
‘‘(i) not later than 30 days after the date 
of approval of such application for a drug no 
active ingredient (including any ester or salt of 
the active ingredient) of which has been ap-
proved in any other application under this sec-
tion or section 351 of the Public Health Service 
Act; and 
‘‘(ii) not later than 30 days after the third 
request for such action package for approval re-
ceived under section 552 of title 5, United 
States Code, for any other drug. 
‘‘(B) IMMEDIATE
PUBLICATION
OF
SUMMARY 
REVIEW.—Notwithstanding subparagraph (A), the 
Secretary shall publish, on the Internet Web site of 
the Food and Drug Administration, the materials 
described in subparagraph (C)(iv) not later than 48 
hours after the date of approval of the drug, except 
where such materials require redaction by the Sec-
retary. 
‘‘(C) CONTENTS.—An action package for ap-
proval of an application under subparagraph (A) 
shall be dated and shall include the following:
374 
‘‘(i) Documents generated by the Food and 
Drug Administration related to review of the 
application. 
‘‘(ii) Documents pertaining to the format 
and content of the application generated during 
drug development. 
‘‘(iii) Labeling submitted by the applicant. 
‘‘(iv) A summary review that documents 
conclusions from all reviewing disciplines about 
the drug, noting any critical issues and dis-
agreements with the applicant and within the 
review team and how they were resolved, rec-
ommendations for action, and an explanation of 
any nonconcurrence with review conclusions. 
‘‘(v) The Division Director and Office Di-
rector’s decision document which includes— 
‘‘(I) a brief statement of concurrence 
with the summary review; 
‘‘(II) a separate review or addendum 
to the review if disagreeing with the sum-
mary review; and 
‘‘(III) a separate review or addendum 
to the review to add further analysis.
375 
‘‘(vi) Identification by name of each officer 
or employee of the Food and Drug Administra-
tion who— 
‘‘(I) participated in the decision to ap-
prove the application; and 
‘‘(II) consents to have his or her name 
included in the package. 
‘‘(D) REVIEW.—A scientific review of an appli-
cation is considered the work of the reviewer and 
shall not be altered by management or the reviewer 
once final. 
‘‘(E) 
CONFIDENTIAL
INFORMATION.—This 
paragraph does not authorize the disclosure of any 
trade secret, confidential commercial or financial in-
formation, or other matter listed in section 552(b) 
of title 5, United States Code.’’. 
SEC. 917. RISK COMMUNICATION. 
Subchapter E of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.), as 
amended by section 603, is amended by adding at the end 
the following: 
‘‘SEC. 567. RISK COMMUNICATION. 
‘‘(a) ADVISORY COMMITTEE ON RISK COMMUNICA-
TION.—
376 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish an advisory committee to be known as the ‘Advi-
sory Committee on Risk Communication’ (referred 
to in this section as the ‘Committee’). 
‘‘(2) DUTIES OF COMMITTEE.—The Committee 
shall advise the Commissioner on methods to effec-
tively communicate risks associated with the prod-
ucts regulated by the Food and Drug Administra-
tion. 
‘‘(3) MEMBERS.—The Secretary shall ensure 
that the Committee is composed of experts on risk 
communication, experts on the risks described in 
subsection (b), and representatives of patient, con-
sumer, and health professional organizations. 
‘‘(4) PERMANENCE
OF
COMMITTEE.—Section 
14 of the Federal Advisory Committee Act shall not 
apply to the Committee established under this sub-
section. 
‘‘(b) PARTNERSHIPS FOR RISK COMMUNICATION.— 
‘‘(1) IN GENERAL.—The Secretary shall partner 
with professional medical societies, medical schools, 
academic medical centers, and other stakeholders to 
develop robust and multi-faceted systems for com-
munication to health care providers about emerging 
postmarket drug risks.
377 
‘‘(2) PARTNERSHIPS.—The systems developed 
under paragraph (1) shall— 
‘‘(A) account for the diversity among phy-
sicians in terms of practice, willingness to adopt 
technology, and medical specialty; and 
‘‘(B) include the use of existing commu-
nication channels, including electronic commu-
nications, in place at the Food and Drug Ad-
ministration.’’. 
SEC. 918. REFERRAL TO ADVISORY COMMITTEE. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act, as amended by section 915, is further amended by 
adding at the end the following: 
‘‘(s) REFERRAL TO ADVISORY COMMITTEE.—Prior to 
the approval of a drug no active ingredient (including any 
ester or salt of the active ingredient) of which has been 
approved in any other application under this section or 
section 351 of the Public Health Service Act, the Sec-
retary shall— 
‘‘(1) refer such drug to a Food and Drug Ad-
ministration advisory committee for review at a 
meeting of such advisory committee; or 
‘‘(2) if the Secretary does not refer such a drug 
to a Food and Drug Administration advisory com-
mittee prior to the approval of the drug, provide in
384 
SEC. 1002. ENSURING THE SAFETY OF PET FOOD. 
(a) PROCESSING AND INGREDIENT STANDARDS.— 
Not later than 2 years after the date of the enactment 
of this Act, the Secretary of Health and Human Services 
(referred to in this title as the ‘‘Secretary’’), in consulta-
tion with the Association of American Feed Control Offi-
cials and other relevant stakeholder groups, including vet-
erinary medical associations, animal health organizations, 
and pet food manufacturers, shall by regulation estab-
lish— 
(1) ingredient standards and definitions with 
respect to pet food; 
(2) processing standards for pet food; and 
(3) updated standards for the labeling of pet 
food that include nutritional and ingredient informa-
tion. 
(b) EARLY WARNING SURVEILLANCE SYSTEMS AND 
NOTIFICATION DURING PET FOOD RECALLS.—Not later 
than 1 year after the date of the enactment of this Act, 
the Secretary shall establish an early warning and surveil-
lance system to identify adulteration of the pet food supply 
and outbreaks of illness associated with pet food. In estab-
lishing such system, the Secretary shall— 
(1) consider using surveillance and monitoring 
mechanisms similar to, or in coordination with, those 
used to monitor human or animal health, such as
385 
the Foodborne Diseases Active Surveillance Network 
(FoodNet) and PulseNet of the Centers for Disease 
Control and Prevention, the Food Emergency Re-
sponse Network of the Food and Drug Administra-
tion and the Department of Agriculture, and the 
National Animal Health Laboratory Network of the 
Department of Agriculture; 
(2) consult with relevant professional associa-
tions and private sector veterinary hospitals; 
(3) work with the National Companion Animal 
Surveillance Program, the Health Alert Network, or 
other notification networks as appropriate to inform 
veterinarians and relevant stakeholders during any 
recall of pet food; and 
(4) use such information and conduct such 
other activities as the Secretary deems appropriate. 
SEC. 1003. ENSURING EFFICIENT AND EFFECTIVE COMMU-
NICATIONS DURING A RECALL. 
The Secretary shall, during an ongoing recall of 
human or pet food regulated by the Secretary— 
(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, in-
cluding electronic forms of information dissemina-
386 
tion, to enhance the quality and speed of commu-
nication with the public; and 
(3) post information regarding recalled human 
and pet foods on the Internet Web site of the Food 
and Drug Administration 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 proc-
essed produce, so that State food safety programs and ac-
tivities conducted by the Secretary function in a coordi-
nated and cost-effective manner. With the assistance pro-
vided under subsection (b), the Secretary shall encourage 
States to— 
(1) establish, continue, or strengthen State food 
safety programs, especially with respect to the regu-
lation of retail commercial food establishments; and 
(2) establish procedures and requirements for 
ensuring that processed produce under the jurisdic-
tion of State food safety programs is not unsafe for 
human consumption.
387 
(b) ASSISTANCE.—The Secretary may provide to a 
State, for planning, developing, and implementing such a 
food safety program— 
(1) advisory assistance; 
(2) technical assistance, training, and labora-
tory assistance (including necessary materials and 
equipment); and 
(3) financial and other assistance. 
(c) SERVICE AGREEMENTS.—The Secretary may, 
under an agreement 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 find-
ings: 
(1) In 1994, Congress passed the Dietary Sup-
plement Health and Education Act of 1994 (Public 
Law 103–417) to provide the Food and Drug Ad-
ministration the legal framework which is intended 
to ensure that dietary supplements are safe and 
properly labeled foods.
388 
(2) In 2006, Congress passed the Dietary Sup-
plement and Nonprescription Drug Consumer Pro-
tection 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 prod-
ucts. 
(4) A reliable mechanism to track patterns of 
adulteration in food would support efforts by the 
Food and Drug Administration to target limited in-
spection 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 amend-
ed by adding at the end the following: 
‘‘SEC. 417. REPORTABLE FOOD REGISTRY. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) RESPONSIBLE PARTY.—The term ‘respon-
sible 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
389 
under section 415(a), at which such article of food 
is manufactured, processed, packed, or held. 
‘‘(2) REPORTABLE
FOOD.—The term ‘report-
able food’ means an article of food (other than in-
fant formula) for which there is a reasonable prob-
ability 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 Sec-
retary shall establish within the Food and Drug Ad-
ministration a Reportable Food Registry to which 
instances of reportable food may be submitted by the 
Food and Drug Administration after receipt of re-
ports 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
393 
‘‘(ii) to the immediate subsequent re-
cipient of the article of food, if the Sec-
retary 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 perform, as re-
quired by the Secretary; and 
‘‘(III) any other information that 
the Secretary may require. 
‘‘(7) SUBSEQUENT
REPORTS
AND
NOTIFICA-
TIONS.—Except as provided in paragraph (8), the 
Secretary may require a responsible party to per-
form, as soon as practicable, but in no case later 
than a time specified by the Secretary, after the re-
sponsible party receives a notification under sub-
paragraph (C) or paragraph (6)(B), 1 or more of 
the following: 
‘‘(A) Submit a report to the Food and 
Drug Administration through the electronic 
portal established under subsection (b) that in-
cludes those data elements described in sub-
394 
section (e) and other information that the Sec-
retary deems necessary. 
‘‘(B) Investigate the cause of the adultera-
tion 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 re-
cipient of the article of food, if the Sec-
retary 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 paragraph that the recipient of 
the notification shall perform, as re-
quired 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
395 
food after the responsible party has submitted a re-
port 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 notifi-
cation under paragraph (7); and 
‘‘(B) the responsible party shall amend the 
report submitted by the responsible party under 
paragraph (1) to include the data elements de-
scribed in paragraph (9), and, with respect to 
both such notification and such report, para-
graph (11) of subsection (e). 
‘‘(e) DATA ELEMENTS.—The data elements described 
in this subsection are the following: 
‘‘(1) The registration numbers of the respon-
sible 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 includ-
ing 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 investigation required under paragraph
396 
(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—
397 
‘‘(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,
400 
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
401 
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
402 
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
403 
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—
404 
(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
405 
(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—
408 
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.
409 
‘‘(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.
410 
‘‘(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
411 
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.
412 
‘‘(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.
413 
‘‘(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
415 
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;
416 
(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.
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.
418 
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-
419 
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-
420 
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
421 
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
422 
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: 
Clerk.
110TH CONGRESS 
1ST SESSION 
H. R. 3580 
AN ACT 
To amend the Federal Food, Drug, and Cosmetic 
Act to revise and extend the user-fee programs 
for prescription drugs and for medical devices, to 
enhance the postmarket authorities of the Food 
and Drug Administration with respect to the 
safety of drugs, and for other purposes.