H. R. 3580—129 
(B) otherwise agreed to by the applicant and the Sec-
retary for such drug. 
(2) ELEMENTS OF STRATEGY; ENFORCEMENT.—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 additional elements under sub-
sections (e) and (f) of such section in effect for such drug 
on the effective date of this Act; and 
(B) is subject to enforcement by the Secretary to the 
same extent as any other risk evaluation and mitigation 
strategy under section 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 review 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 proposed risk evaluation and mitigation strategy. Such pro-
posed strategy is subject to section 505–1 of the Act as if 
included in such application at the time of submission of the 
application to the Secretary. 
Subtitle B—Other Provisions to Ensure 
Drug Safety and Surveillance 
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 respect 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 information and technology.’’. 
SEC. 912. PROHIBITION AGAINST FOOD TO WHICH DRUGS OR 
BIOLOGICAL PRODUCTS HAVE BEEN ADDED. 
(a) PROHIBITION.—Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331), as amended by section 901(d), is 
amended by adding at the end the following: 
‘‘(ll) The introduction or delivery for introduction into interstate 
commerce of any food to which has been added a drug approved 
under section 505, a biological product licensed under section 351 
of the Public Health Service Act, or a drug or a biological product 
for which substantial clinical investigations have been instituted
H. R. 3580—130 
and for which the existence of such investigations has been made 
public, unless— 
‘‘(1) such drug or such biological product was marketed 
in food before any approval of the drug under section 505, 
before licensure of the biological product under such section 
351, and before any substantial clinical investigations involving 
the drug or the biological product have been instituted; 
‘‘(2) the Secretary, in the Secretary’s discretion, has issued 
a regulation, after notice and comment, approving the use 
of such drug or such biological product in the food; 
‘‘(3) the use of the drug or the biological product in the 
food is to enhance the safety of the food to which the drug 
or the biological product is added or applied and not to have 
independent biological or therapeutic effects on humans, and 
the use is in conformity with— 
‘‘(A) a regulation issued under section 409 prescribing 
conditions of safe use in food; 
‘‘(B) a regulation listing or affirming conditions under 
which the use of the drug or the biological product in 
food is generally recognized as safe; 
‘‘(C) the conditions of use identified in a notification 
to the Secretary of a claim of exemption from the premarket 
approval requirements for food additives based on the noti-
fier’s determination that the use of the drug or the 
biological product in food is generally recognized as safe, 
provided that the Secretary has not questioned the general 
recognition of safety determination in a letter to the noti-
fier; 
‘‘(D) a food contact substance notification that is effec-
tive under section 409(h); or 
‘‘(E) such drug or biological product had been marketed 
for smoking cessation prior to the date of the enactment 
of the Food and Drug Administration Amendments Act 
of 2007; or 
‘‘(4) the drug is a new animal drug whose use is not 
unsafe under section 512.’’. 
(b) CONFORMING CHANGES.—The Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.) is amended— 
(1) in section 304(a)(1), by striking ‘‘section 404 or 505’’ 
and inserting ‘‘section 301(ll), 404, or 505’’; and 
(2) in section 801(a), by striking ‘‘is adulterated, mis-
branded, or in violation of section 505,’’ and inserting ‘‘is 
adulterated, misbranded, or in violation of section 505, or 
prohibited from introduction or delivery for introduction into 
interstate commerce under section 301(ll),’’. 
SEC. 913. ASSURING PHARMACEUTICAL SAFETY. 
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 351 et seq.), as amended in section 403, is amended by 
inserting after section 505C the following: 
‘‘SEC. 505D. PHARMACEUTICAL SECURITY. 
‘‘(a) IN GENERAL.—The Secretary shall develop standards and 
identify and validate effective technologies for the purpose of 
securing the drug supply chain against counterfeit, diverted, sub-
potent, substandard, adulterated, misbranded, or expired drugs. 
‘‘(b) STANDARDS DEVELOPMENT.—
H. R. 3580—131 
‘‘(1) IN GENERAL.—The Secretary shall, in consultation with 
the agencies specified in paragraph (4), manufacturers, distribu-
tors, pharmacies, and other supply chain stakeholders, 
prioritize and develop standards for the identification, valida-
tion, authentication, and tracking and tracing of prescription 
drugs. 
‘‘(2) STANDARDIZED NUMERAL IDENTIFIER.—Not later than 
30 months after the date of the enactment of the Food and 
Drug Administration Amendments Act of 2007, the Secretary 
shall develop a standardized numerical identifier (which, to 
the extent practicable, shall be harmonized with international 
consensus standards for such an identifier) to be applied to 
a prescription drug at the point of manufacturing and repack-
aging (in which case the numerical identifier shall be linked 
to the numerical identifier applied at the point of manufac-
turing) at the package or pallet level, sufficient to facilitate 
the identification, validation, authentication, and tracking and 
tracing of the prescription drug. 
‘‘(3) PROMISING TECHNOLOGIES.—The standards developed 
under this subsection shall address promising technologies, 
which may include— 
‘‘(A) radio frequency identification technology; 
‘‘(B) nanotechnology; 
‘‘(C) encryption technologies; and 
‘‘(D) other track-and-trace or authentication tech-
nologies. 
‘‘(4) INTERAGENCY COLLABORATION.—In carrying out this 
subsection, the Secretary shall consult with Federal health 
and security agencies, including— 
‘‘(A) the Department of Justice; 
‘‘(B) the Department of Homeland Security; 
‘‘(C) the Department of Commerce; and 
‘‘(D) other appropriate Federal and State agencies. 
‘‘(c) INSPECTION AND ENFORCEMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall expand and enhance 
the resources and facilities of agency components of the Food 
and Drug Administration involved with regulatory and criminal 
enforcement of this Act to secure the drug supply chain against 
counterfeit, diverted, subpotent, substandard, adulterated, mis-
branded, or expired drugs including biological products and 
active pharmaceutical ingredients from domestic and foreign 
sources. 
‘‘(2) ACTIVITIES.—The Secretary shall undertake enhanced 
and joint enforcement activities with other Federal and State 
agencies, and establish regional capacities for the validation 
of prescription drugs and the inspection of the prescription 
drug supply chain. 
‘‘(d) DEFINITION.—In this section, the term ‘prescription drug’ 
means a drug subject to section 503(b)(1).’’. 
SEC. 914. CITIZEN PETITIONS AND PETITIONS FOR STAY OF AGENCY 
ACTION. 
(a) IN GENERAL.—Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355), as amended by section 901(a), is 
amended by adding at the end the following: 
‘‘(q) PETITIONS AND CIVIL ACTIONS REGARDING APPROVAL OF 
CERTAIN APPLICATIONS.—
H. R. 3580—132 
‘‘(1) IN GENERAL.— 
‘‘(A) DETERMINATION.—The Secretary shall not delay 
approval of a pending application submitted under sub-
section (b)(2) or (j) because of any request to take any 
form of action relating to the application, either before 
or during consideration of the request, unless— 
‘‘(i) the request is in writing and is a petition 
submitted to the Secretary pursuant to section 10.30 
or 10.35 of title 21, Code of Federal Regulations (or 
any successor regulations); and 
‘‘(ii) the Secretary determines, upon reviewing the 
petition, that a delay is necessary to protect the public 
health. 
‘‘(B) NOTIFICATION.—If the Secretary determines under 
subparagraph (A) that a delay is necessary with respect 
to an application, the Secretary shall provide to the 
applicant, not later than 30 days after making such deter-
mination, the following information: 
‘‘(i) Notification of the fact that a determination 
under subparagraph (A) has been made. 
‘‘(ii) If applicable, any clarification or additional 
data that the applicant should submit to the docket 
on the petition to allow the Secretary to review the 
petition promptly. 
‘‘(iii) A brief summary of the specific substantive 
issues raised in the petition which form the basis of 
the determination. 
‘‘(C) FORMAT.—The information described in subpara-
graph (B) shall be conveyed via either, at the discretion 
of the Secretary— 
‘‘(i) a document; or 
‘‘(ii) a meeting with the applicant involved. 
‘‘(D) PUBLIC DISCLOSURE.—Any information conveyed 
by the Secretary under subparagraph (C) shall be consid-
ered part of the application and shall be subject to the 
disclosure requirements applicable to information in such 
application. 
‘‘(E) DENIAL BASED ON INTENT TO DELAY.—If the Sec-
retary determines that a petition or a supplement to the 
petition was submitted with the primary purpose of 
delaying the approval of an application and the petition 
does not on its face raise valid scientific or regulatory 
issues, the Secretary may deny the petition at any point 
based on such determination. The Secretary may issue 
guidance to describe the factors that will be used to deter-
mine under this subparagraph whether a petition is sub-
mitted with the primary purpose of delaying the approval 
of an application. 
‘‘(F) FINAL AGENCY ACTION.—The Secretary shall take 
final agency action on a petition not later than 180 days 
after the date on which the petition is submitted. The 
Secretary shall not extend such period for any reason, 
including— 
‘‘(i) any determination made under subparagraph 
(A);
H. R. 3580—133 
‘‘(ii) the submission of comments relating to the 
petition or supplemental information supplied by the 
petitioner; or 
‘‘(iii) the consent of the petitioner. 
‘‘(G) EXTENSION OF 30-MONTH PERIOD.—If the filing of 
an application resulted in first-applicant status under sub-
section (j)(5)(D)(i)(IV) and approval of the application was 
delayed because of a petition, the 30-month period under 
such subsection is deemed to be extended by a period 
of time equal to the period beginning on the date on which 
the Secretary received the petition and ending on the date 
of final agency action on the petition (inclusive of such 
beginning and ending dates), without regard to whether 
the Secretary grants, in whole or in part, or denies, in 
whole or in part, the petition. 
‘‘(H) CERTIFICATION.—The Secretary shall not consider 
a petition for review unless the party submitting such 
petition does so in written form and the subject document 
is signed and contains the following certification: ‘I certify 
that, to my best knowledge and belief: (a) this petition 
includes all information and views upon which the petition 
relies; (b) this petition includes representative data and/ 
or information known to the petitioner which are unfavor-
able to the petition; and (c) I have taken reasonable steps 
to ensure that any representative data and/or information 
which are unfavorable to the petition were disclosed to 
me. I further certify that the information upon which I 
have based the action requested herein first became known 
to the party on whose behalf this petition is submitted 
on or about the following date: llllllllll. If 
I received or expect to receive payments, including cash 
and other forms of consideration, to file this information 
or its contents, I received or expect to receive those pay-
ments from the following persons or organizations: 
lllllllllllll. I verify under penalty of per-
jury that the foregoing is true and correct as of the date 
of the submission of this petition.’, with the date on which 
such information first became known to such party and 
the names of such persons or organizations inserted in 
the first and second blank space, respectively. 
‘‘(I) VERIFICATION.—The Secretary shall not accept for 
review any supplemental information or comments on a 
petition unless the party submitting such information or 
comments does so in written form and the subject document 
is signed and contains the following verification: ‘I certify 
that, to my best knowledge and belief: (a) I have not 
intentionally delayed submission of this document or its 
contents; and (b) the information upon which I have based 
the action requested herein first became known to me 
on or about llllllllll. If I received or expect 
to receive payments, including cash and other forms of 
consideration, to file this information or its contents, I 
received or expect to receive those payments from the fol-
lowing persons or organizations: lllll. I verify under 
penalty of perjury that the foregoing is true and correct 
as of the date of the submission of this petition.’, with 
the date on which such information first became known
H. R. 3580—134 
to the party and the names of such persons or organizations 
inserted in the first and second blank space, respectively. 
‘‘(2) EXHAUSTION OF ADMINISTRATIVE REMEDIES.— 
‘‘(A) FINAL AGENCY ACTION WITHIN 180 DAYS.—The Sec-
retary shall be considered to have taken final agency action 
on a petition if— 
‘‘(i) during the 180-day period referred to in para-
graph (1)(F), the Secretary makes a final decision 
within the meaning of section 10.45(d) of title 21, Code 
of Federal Regulations (or any successor regulation); 
or 
‘‘(ii) such period expires without the Secretary 
having made such a final decision. 
‘‘(B) DISMISSAL OF CERTAIN CIVIL ACTIONS.—If a civil 
action is filed against the Secretary with respect to any 
issue raised in the petition before the Secretary has taken 
final agency action on the petition within the meaning 
of subparagraph (A), the court shall dismiss without preju-
dice the action for failure to exhaust administrative rem-
edies. 
‘‘(C) ADMINISTRATIVE RECORD.—For purposes of judicial 
review related to the approval of an application for which 
a petition under paragraph (1) was submitted, the adminis-
trative record regarding any issue raised by the petition 
shall include— 
‘‘(i) the petition filed under paragraph (1) and any 
supplements and comments thereto; 
‘‘(ii) the Secretary’s response to such petition, if 
issued; and 
‘‘(iii) other information, as designated by the Sec-
retary, related to the Secretary’s determinations 
regarding the issues raised in such petition, as long 
as the information was considered by the agency no 
later than the date of final agency action as defined 
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 APPROVALS PER PETI-
TIONS.—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 period; 
‘‘(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 applications 
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 pursuant to subsection 
(j)(5)(B)(iv); or 
‘‘(B) a petition that is made by the sponsor of an 
application and that seeks only to have the Secretary take 
or refrain from taking any form of action with respect 
to that application.
H. R. 3580—135 
‘‘(5) DEFINITIONS.— 
‘‘(A) APPLICATION.—For purposes of this subsection, the 
term ‘application’ means an application 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 enact-
ment 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 Drug Administration Amend-
ments Act of 2007, the Secretary shall improve the transparency 
of information about drugs and allow patients and health care 
providers better access to information about drugs by devel-
oping and maintaining an Internet Web site that— 
‘‘(A) provides links to drug safety information listed 
in paragraph (2) for prescription drugs that are approved 
under this section or licensed under section 351 of the 
Public Health Service Act; and 
‘‘(B) improves communication of drug safety informa-
tion to patients and providers. 
‘‘(2) INTERNET WEB SITE.—The Secretary shall carry out 
paragraph (1) by— 
‘‘(A) developing and maintaining an accessible, consoli-
dated Internet Web site with easily searchable drug safety 
information, including the information found on United 
States Government 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 Secretary; 
‘‘(B) ensuring that the information provided on the 
Internet Web site is comprehensive and includes, when 
available and appropriate— 
‘‘(i) patient labeling and patient packaging inserts; 
‘‘(ii) a link to a list of each drug, whether approved 
under this section or licensed under such section 351, 
for which a Medication Guide, as provided for under 
part 208 of title 21, Code of Federal Regulations (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 information 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 import alerts;
H. R. 3580—136 
‘‘(v) publicly available information about imple-
mented RiskMAPs and risk evaluation and mitigation 
strategies under subsection (o); 
‘‘(vi) guidance documents and regulations related 
to drug safety; and 
‘‘(vii) other material determined appropriate by the 
Secretary; 
‘‘(C) providing access to summaries of the assessed 
and aggregated data collected from the active surveillance 
infrastructure under subsection (k)(3) to provide informa-
tion of known and serious side-effects for drugs approved 
under this section or licensed under such section 351; 
‘‘(D) preparing, by 18 months after approval of a drug 
or after use of the drug by 10,000 individuals, whichever 
is later, a summary analysis of the adverse drug reaction 
reports received for the drug, including identification 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; 
‘‘(F) providing educational materials for patients and 
providers about the appropriate means of disposing of 
expired, damaged, or unusable medications; and 
‘‘(G) supporting initiatives that the Secretary deter-
mines to be useful to fulfill the purposes of the Internet 
Web site. 
‘‘(3) POSTING OF DRUG LABELING.—The Secretary shall post 
on the Internet Web site established under paragraph (1) the 
approved professional 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 described 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 Secretary may enter 
into contracts with public and private entities to fulfill the 
requirements of this subsection. 
‘‘(6) REVIEW.—The Advisory Committee on Risk Commu-
nication under section 567 shall, on a regular basis, perform 
a comprehensive review and evaluation of the types of risk 
communication information 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 efficient flow of informa-
tion 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 
information to patients and providers.’’. 
SEC. 916. ACTION PACKAGE FOR APPROVAL. 
Section 505(l) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(l)) is amended by—
H. R. 3580—137 
(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 application 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 approved in any other application under 
this section 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 received under section 
552 of title 5, United States Code, for any other drug. 
‘‘(B) IMMEDIATE PUBLICATION OF SUMMARY REVIEW.—Not-
withstanding 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 Secretary. 
‘‘(C) CONTENTS.—An action package for approval of an 
application under subparagraph (A) shall be dated and shall 
include the following: 
‘‘(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 disagreements with the applicant and 
within the review team and how they were resolved, rec-
ommendations for action, and an explanation of any non-
concurrence with review conclusions. 
‘‘(v) The Division Director and Office Director’s decision 
document which includes— 
‘‘(I) a brief statement of concurrence with the sum-
mary review; 
‘‘(II) a separate review or addendum to the review 
if disagreeing with the summary review; and 
‘‘(III) a separate review or addendum to the review 
to add further analysis. 
‘‘(vi) Identification by name of each officer or employee 
of the Food and Drug Administration who— 
‘‘(I) participated in the decision to approve the 
application; and 
‘‘(II) consents to have his or her name included 
in the package. 
‘‘(D) REVIEW.—A scientific review of an application is 
considered the work of the reviewer and shall not be altered 
by management or the reviewer once final.