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‘‘(E) CONFIDENTIAL INFORMATION.—This paragraph does not 
authorize the disclosure of any trade secret, confidential 
commercial or financial information, 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 COMMUNICATION.— 
‘‘(1) IN GENERAL.—The Secretary shall establish an advisory 
committee to be known as the ‘Advisory 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 effectively communicate risks 
associated with the products regulated by the Food and Drug 
Administration. 
‘‘(3) MEMBERS.—The Secretary shall ensure that the Com-
mittee is composed of experts on risk communication, experts 
on the risks described in subsection (b), and representatives 
of patient, consumer, and health professional organizations. 
‘‘(4) PERMANENCE OF COMMITTEE.—Section 14 of the Fed-
eral Advisory Committee Act shall not apply to the Committee 
established under this subsection. 
‘‘(b) PARTNERSHIPS FOR RISK COMMUNICATION.— 
‘‘(1) IN GENERAL.—The Secretary shall partner with profes-
sional medical societies, medical schools, academic medical cen-
ters, and other stakeholders to develop robust and multi-faceted 
systems for communication to health care providers about 
emerging postmarket drug risks. 
‘‘(2) PARTNERSHIPS.—The systems developed under para-
graph (1) shall— 
‘‘(A) account for the diversity among physicians in 
terms of practice, willingness to adopt technology, and med-
ical specialty; and 
‘‘(B) include the use of existing communication chan-
nels, including electronic communications, in place at the 
Food and Drug Administration.’’. 
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 applica-
tion under this section or section 351 of the Public Health Service 
Act, the Secretary shall— 
‘‘(1) refer such drug to a Food and Drug Administration 
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 committee prior to the 
approval of the drug, provide in the action letter on the applica-
tion for the drug a summary of the reasons why the Secretary
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did not refer the drug to an advisory committee prior to 
approval.’’. 
SEC. 919. RESPONSE TO THE INSTITUTE OF MEDICINE. 
(a) IN GENERAL.—Not later than 1 year after the date of the 
enactment of this title, the Secretary shall issue a report responding 
to the 2006 report of the Institute of Medicine entitled ‘‘The Future 
of Drug Safety—Promoting and Protecting the Health of the Public’’. 
(b) CONTENT OF REPORT.—The report issued by the Secretary 
under subsection (a) shall include— 
(1) an update on the implementation by the Food and 
Drug Administration of its plan to respond to the Institute 
of Medicine report described under such subsection; and 
(2) an assessment of how the Food and Drug Administra-
tion has implemented— 
(A) the recommendations described in such Institute 
of Medicine report; and 
(B) the requirement under section 505–1(c)(2) of the 
Federal Food, Drug, and Cosmetic Act (as added by this 
title), that the appropriate office responsible for reviewing 
a drug and the office responsible for postapproval safety 
with respect to the drug work together to assess, imple-
ment, and ensure compliance with the requirements of 
such section 505–1. 
SEC. 920. DATABASE FOR AUTHORIZED GENERIC DRUGS. 
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355), as amended by section 918, is further amended by 
adding at the end the following: 
‘‘(t) DATABASE FOR AUTHORIZED GENERIC DRUGS.— 
‘‘(1) IN GENERAL.— 
‘‘(A) PUBLICATION.—The Commissioner shall— 
‘‘(i) not later than 9 months after the date of the 
enactment of the Food and Drug Administration 
Amendments Act of 2007, publish a complete list on 
the Internet Web site of the Food and Drug Adminis-
tration of all authorized generic drugs (including drug 
trade name, brand company manufacturer, and the 
date the authorized generic drug entered the market); 
and 
‘‘(ii) update the list quarterly to include each 
authorized generic drug included in an annual report 
submitted to the Secretary by the sponsor of a listed 
drug during the preceding 3-month period. 
‘‘(B) NOTIFICATION.—The Commissioner shall notify 
relevant Federal agencies, including the Centers for Medi-
care & Medicaid Services and the Federal Trade Commis-
sion, when the Commissioner first publishes the informa-
tion described in subparagraph (A) that the information 
has been published and that the information will be 
updated quarterly. 
‘‘(2) INCLUSION.—The Commissioner shall include in the 
list described in paragraph (1) each authorized generic drug 
included in an annual report submitted to the Secretary by 
the sponsor of a listed drug after January 1, 1999. 
‘‘(3) AUTHORIZED GENERIC DRUG.—In this section, the term 
‘authorized generic drug’ means a listed drug (as that term 
is used in subsection (j)) that—
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‘‘(A) has been approved under subsection (c); and 
‘‘(B) is marketed, sold, or distributed directly or 
indirectly to retail class of trade under a different labeling, 
packaging (other than repackaging as the listed drug in 
blister packs, unit doses, or similar packaging for use in 
institutions), product code, labeler code, trade name, or 
trade mark than the listed drug.’’. 
SEC. 921. ADVERSE DRUG REACTION REPORTS AND POSTMARKET 
SAFETY. 
Subsection (k) of section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355), as amended by section 905, is 
amended by adding at the end the following: 
‘‘(5) The Secretary shall— 
‘‘(A) conduct regular, bi-weekly screening of the 
Adverse Event Reporting System database and post a quar-
terly report on the Adverse Event Reporting System Web 
site of any new safety information or potential signal of 
a serious risk identified by Adverse Event Reporting 
System within the last quarter; 
‘‘(B) report to Congress not later than 2 year after 
the date of the enactment of the Food and Drug Administra-
tion Amendments Act of 2007 on procedures and processes 
of the Food and Drug Administration for addressing 
ongoing post market safety issues identified by the Office 
of Surveillance and Epidemiology and how recommenda-
tions of the Office of Surveillance and Epidemiology are 
handled within the agency; and 
‘‘(C) on an annual basis, review the entire backlog 
of postmarket safety commitments to determine which 
commitments require revision or should be eliminated, 
report to the Congress on these determinations, and assign 
start dates and estimated completion dates for such 
commitments.’’. 
TITLE X—FOOD SAFETY 
SEC. 1001. FINDINGS. 
Congress finds that— 
(1) the safety and integrity of the United States food supply 
are vital to public health, to public confidence in the food 
supply, and to the success of the food sector of the Nation’s 
economy; 
(2) illnesses and deaths of individuals and companion ani-
mals caused by contaminated food— 
(A) have contributed to a loss of public confidence 
in food safety; and 
(B) have caused significant economic losses to manufac-
turers and producers not responsible for contaminated food 
items; 
(3) the task of preserving the safety of the food supply 
of the United States faces tremendous pressures with regard 
to— 
(A) emerging pathogens and other contaminants and 
the ability to detect all forms of contamination;
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(B) an increasing volume of imported food from a wide 
variety of countries; and 
(C) a shortage of adequate resources for monitoring 
and inspection; 
(4) according to the Economic Research Service of the 
Department of Agriculture, the United States is increasing 
the amount of food that it imports such that— 
(A) from 2003 to 2007, the value of food imports has 
increased from $45,600,000,000 to $64,000,000,000; and 
(B) imported food accounts for 13 percent of the average 
American diet including 31 percent of fruits, juices, and 
nuts, 9.5 percent of red meat, and 78.6 percent of fish 
and shellfish; and 
(5) the number of full-time equivalent Food and Drug 
Administration employees conducting inspections has decreased 
from 2003 to 2007. 
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 consultation with the Association of American Feed 
Control Officials and other relevant stakeholder groups, including 
veterinary medical associations, animal health organizations, and 
pet food manufacturers, shall by regulation establish— 
(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 information. 
(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 surveillance system to identify adulteration of 
the pet food supply and outbreaks of illness associated with pet 
food. In establishing 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 the Foodborne Diseases Active 
Surveillance Network (FoodNet) and PulseNet of the Centers 
for Disease Control and Prevention, the Food Emergency 
Response Network of the Food and Drug Administration and 
the Department of Agriculture, and the National Animal Health 
Laboratory Network of the Department of Agriculture; 
(2) consult with relevant professional associations and pri-
vate sector veterinary hospitals; 
(3) work with the National Companion Animal Surveillance 
Program, the Health Alert Network, or other notification net-
works 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 COMMUNICATIONS 
DURING A RECALL. 
The Secretary shall, during an ongoing recall of human or 
pet food regulated by the Secretary—