Food and Drug Administration Amendments Act of 2007
PL 110-85 (H.R.3580), enacted 09/27/2007

121 STAT. 823 
PUBLIC LAW 110–85—SEPT. 27, 2007 
Public Law 110–85 
110th Congress 
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. 
Be it enacted by the Senate and House of Representatives of 
the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Food and Drug Administration 
Amendments Act of 2007’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents for this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 
Sec. 101. Short title; references in title; finding. 
Sec. 102. Definitions. 
Sec. 103. Authority to assess and use drug fees. 
Sec. 104. Fees relating to advisory review of prescription-drug television adver-
tising. 
Sec. 105. Reauthorization; reporting requirements. 
Sec. 106. Sunset dates. 
Sec. 107. Effective date. 
Sec. 108. Savings clause. 
Sec. 109. Technical amendment; conforming amendment. 
TITLE II—MEDICAL DEVICE USER FEE AMENDMENTS OF 2007 
Sec. 201. Short title; references in title; finding. 
Subtitle A—Fees Related to Medical Devices 
Sec. 211. Definitions. 
Sec. 212. Authority to assess and use device fees. 
Sec. 213. Reauthorization; reporting requirements. 
Sec. 214. Savings clause. 
Sec. 215. Additional authorization of appropriations for postmarket safety informa-
tion. 
Sec. 216. Effective date. 
Sec. 217. Sunset clause. 
Subtitle B—Amendments Regarding Regulation of Medical Devices 
Sec. 221. Extension of authority for third party review of premarket notification. 
Sec. 222. Registration. 
Sec. 223. Filing of lists of drugs and devices manufactured, prepared, propagated, 
and compounded by registrants; statements; accompanying disclosures. 
Sec. 224. Electronic registration and listing. 
Sec. 225. Report by Government Accountability Office. 
Sec. 226. Unique device identification system. 
Sec. 227. Frequency of reporting for certain devices. 
21 USC 301 note. 
Food and Drug 
Administration 
Amendments Act 
of 2007. 
Sept. 27, 2007 
[H.R. 3580] 
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121 STAT. 824 
PUBLIC LAW 110–85—SEPT. 27, 2007 
Sec. 228. Inspections by accredited persons. 
Sec. 229. Study of nosocomial infections relating to medical devices. 
Sec. 230. Report by the Food and Drug Administration regarding labeling informa-
tion on the relationship between the use of indoor tanning devices and 
development of skin cancer or other skin damage. 
TITLE III—PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT 
OF 2007 
Sec. 301. Short title. 
Sec. 302. Tracking pediatric device approvals. 
Sec. 303. Modification to humanitarian device exemption. 
Sec. 304. Encouraging pediatric medical device research. 
Sec. 305. Demonstration grants for improving pediatric device availability. 
Sec. 306. Amendments to office of pediatric therapeutics and pediatric advisory 
committee. 
Sec. 307. Postmarket surveillance. 
TITLE IV—PEDIATRIC RESEARCH EQUITY ACT OF 2007 
Sec. 401. Short title. 
Sec. 402. Reauthorization of Pediatric Research Equity Act. 
Sec. 403. Establishment of internal committee. 
Sec. 404. Government Accountability Office report. 
TITLE V—BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007 
Sec. 501. Short title. 
Sec. 502. Reauthorization of Best Pharmaceuticals for Children Act. 
Sec. 503. Training of pediatric pharmacologists. 
TITLE VI—REAGAN-UDALL FOUNDATION 
Sec. 601. The Reagan-Udall Foundation for the Food and Drug Administration. 
Sec. 602. Office of the Chief Scientist. 
Sec. 603. Critical path public-private partnerships. 
TITLE VII—CONFLICTS OF INTEREST 
Sec. 701. Conflicts of interest. 
TITLE VIII—CLINICAL TRIAL DATABASES 
Sec. 801. Expanded clinical trial registry data bank. 
TITLE IX—ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY 
OF DRUGS 
Subtitle A—Postmarket Studies and Surveillance 
Sec. 901. Postmarket studies and clinical trials regarding human drugs; risk eval-
uation and mitigation strategies. 
Sec. 902. Enforcement. 
Sec. 903. No effect on withdrawal or suspension of approval. 
Sec. 904. Benefit-risk assessments. 
Sec. 905. Active postmarket risk identification and analysis. 
Sec. 906. Statement for inclusion in direct-to-consumer advertisements of drugs. 
Sec. 907. No effect on veterinary medicine. 
Sec. 908. Authorization of appropriations. 
Sec. 909. Effective date and applicability. 
Subtitle B—Other Provisions to Ensure Drug Safety and Surveillance 
Sec. 911. Clinical trial guidance for antibiotic drugs. 
Sec. 912. Prohibition against food to which drugs or biological products have been 
added. 
Sec. 913. Assuring pharmaceutical safety. 
Sec. 914. Citizen petitions and petitions for stay of agency action. 
Sec. 915. Postmarket drug safety information for patients and providers. 
Sec. 916. Action package for approval. 
Sec. 917. Risk communication. 
Sec. 918. Referral to advisory committee. 
Sec. 919. Response to the institute of medicine. 
Sec. 920. Database for authorized generic drugs. 
Sec. 921. Adverse drug reaction reports and postmarket safety. 
TITLE X—FOOD SAFETY 
Sec. 1001. Findings. 
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121 STAT. 825 
PUBLIC LAW 110–85—SEPT. 27, 2007 
Sec. 1002. Ensuring the safety of pet food. 
Sec. 1003. Ensuring efficient and effective communications during a recall. 
Sec. 1004. State and Federal Cooperation. 
Sec. 1005. Reportable Food Registry. 
Sec. 1006. Enhanced aquaculture and seafood inspection. 
Sec. 1007. Consultation regarding genetically engineered seafood products. 
Sec. 1008. Sense of Congress. 
Sec. 1009. Annual report to Congress. 
Sec. 1010. Publication of annual reports. 
Sec. 1011. Rule of construction. 
TITLE XI—OTHER PROVISIONS 
Subtitle A—In General 
Sec. 1101. Policy on the review and clearance of scientific articles published by 
FDA employees. 
Sec. 1102. Priority review to encourage treatments for tropical diseases. 
Sec. 1103. Improving genetic test safety and quality. 
Sec. 1104. NIH Technical amendments. 
Sec. 1105. Severability clause. 
Subtitle B—Antibiotic Access and Innovation 
Sec. 1111. Identification of clinically susceptible concentrations of antimicrobials. 
Sec. 1112. Orphan antibiotic drugs. 
Sec. 1113. Exclusivity of certain drugs containing single enantiomers. 
Sec. 1114. Report. 
TITLE I—PRESCRIPTION DRUG USER 
FEE AMENDMENTS OF 2007 
SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the ‘‘Prescription 
Drug User Fee Amendments of 2007’’. 
(b) REFERENCES
IN
TITLE.—Except as otherwise specified, 
amendments made by this title to a section or other provision 
of law are amendments to such section or other provision of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 
(c) FINDING.—The Congress finds that the fees authorized by 
the amendments made in this title will be dedicated toward expe-
diting the drug development process and the process for the review 
of human drug applications, including postmarket drug safety 
activities, as set forth in the goals identified for purposes of part 
2 of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act, in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Chairman 
of the Committee on Energy and Commerce of the House of Rep-
resentatives, as set forth in the Congressional Record. 
SEC. 102. DEFINITIONS. 
Section 735 (21 U.S.C. 379g) is amended— 
(1) in the matter before paragraph (1), by striking ‘‘For 
purposes of this subchapter’’ and inserting ‘‘For purposes of 
this part’’; 
(2) in paragraph (1)— 
(A) in subparagraph (A), by striking ‘‘505(b)(1),’’ and 
inserting ‘‘505(b), or’’; 
(B) by striking subparagraph (B); 
(C) by redesignating subparagraph (C) as subpara-
graph (B); and 
21 USC 379g 
note. 
21 USC 301 note. 
Prescription 
Drug User Fee 
Amendments of 
2007. 
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121 STAT. 826 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(D) in the matter following subparagraph (B), as so 
redesignated, by striking ‘‘subparagraph (C)’’ and inserting 
‘‘subparagraph (B)’’; 
(3) in paragraph (3)(C)— 
(A) by striking ‘‘505(j)(7)(A)’’ and inserting ‘‘505(j)(7)(A) 
(not including the discontinued section of such list)’’; and 
(B) by inserting before the period ‘‘(not including the 
discontinued section of such list)’’; 
(4) in paragraph (4), by inserting before the period at 
the end the following: ‘‘(such as capsules, tablets, or lyophilized 
products before reconstitution)’’; 
(5) by amending paragraph (6)(F) to read as follows: 
‘‘(F) Postmarket safety activities with respect to drugs 
approved under human drug applications or supplements, 
including the following activities: 
‘‘(i) Collecting, developing, and reviewing safety 
information on approved drugs, including adverse 
event reports. 
‘‘(ii) Developing and using improved adverse-event 
data-collection systems, including information tech-
nology systems. 
‘‘(iii) Developing and using improved analytical 
tools to assess potential safety problems, including 
access to external data bases. 
‘‘(iv) Implementing and enforcing section 505(o) 
(relating to postapproval studies and clinical trials and 
labeling changes) and section 505(p) (relating to risk 
evaluation and mitigation strategies). 
‘‘(v) Carrying out section 505(k)(5) (relating to 
adverse event reports and postmarket safety activi-
ties).’’; 
(6) in paragraph (8)— 
(A) by striking ‘‘April of the preceding fiscal year’’ 
and inserting ‘‘October of the preceding fiscal year’’; and 
(B) by striking ‘‘April 1997’’ and inserting ‘‘October 
1996’’; 
(7) by redesignating paragraph (9) as paragraph (11); and 
(8) by inserting after paragraph (8) the following para-
graphs: 
‘‘(9) The term ‘person’ includes an affiliate thereof. 
‘‘(10) The term ‘active’, with respect to a commercial inves-
tigational new drug application, means such an application 
to which information was submitted during the relevant 
period.’’. 
SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES. 
(a) TYPES
OF FEES.—Section 736(a) (21 U.S.C. 379h(a)) is 
amended— 
(1) in the matter preceding paragraph (1), by striking 
‘‘2003’’ and inserting ‘‘2008’’; 
(2) in paragraph (1)— 
(A) in subparagraph (D)— 
(i) in the heading, by inserting ‘‘OR WITHDRAWN 
BEFORE FILING’’ after ‘‘REFUSED FOR FILING’’; and 
(ii) by inserting before the period at the end the 
following: ‘‘or withdrawn without a waiver before 
filing’’; 
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121 STAT. 827 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(B) by redesignating subparagraphs (E) and (F) as 
subparagraphs (F) and (G), respectively; and 
(C) by inserting after subparagraph (D) the following: 
‘‘(E) FEES FOR APPLICATIONS PREVIOUSLY REFUSED FOR 
FILING
OR
WITHDRAWN
BEFORE
FILING.—A human drug 
application or supplement that was submitted but was 
refused for filing, or was withdrawn before being accepted 
or refused for filing, shall be subject to the full fee under 
subparagraph (A) upon being resubmitted or filed over 
protest, unless the fee is waived or reduced under sub-
section (d).’’; and 
(3) in paragraph (2)— 
(A) in subparagraph (A), by striking ‘‘subparagraph 
(B)’’ and inserting ‘‘subparagraphs (B) and (C)’’; and 
(B) by adding at the end the following: 
‘‘(C) SPECIAL RULES FOR POSITRON EMISSION TOMOG-
RAPHY DRUGS.— 
‘‘(i) IN
GENERAL.—Except as provided in clause 
(ii), each person who is named as the applicant in 
an approved human drug application for a positron 
emission tomography drug shall be subject under 
subparagraph (A) to one-sixth of an annual establish-
ment fee with respect to each such establishment 
identified in the application as producing positron 
emission tomography drugs under the approved 
application. 
‘‘(ii) EXCEPTION
FROM
ANNUAL
ESTABLISHMENT 
FEE.—Each person who is named as the applicant in 
an application described in clause (i) shall not be 
assessed an annual establishment fee for a fiscal year 
if the person certifies to the Secretary, at a time speci-
fied by the Secretary and using procedures specified 
by the Secretary, that— 
‘‘(I) the person is a not-for-profit medical center 
that has only 1 establishment for the production 
of positron emission tomography drugs; and 
‘‘(II) at least 95 percent of the total number 
of doses of each positron emission tomography drug 
produced by such establishment during such fiscal 
year will be used within the medical center. 
‘‘(iii) DEFINITION.—For purposes of this subpara-
graph, the term ‘positron emission tomography drug’ 
has the meaning given to the term ‘compounded 
positron emission tomography drug’ in section 201(ii), 
except that paragraph (1)(B) of such section shall not 
apply.’’. 
(b) FEE REVENUE AMOUNTS.—Section 736(b) (21 U.S.C. 379h(b)) 
is amended to read as follows: 
‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) IN GENERAL.—For each of the fiscal years 2008 through 
2012, fees under subsection (a) shall, except as provided in 
subsections (c), (d), (f), and (g), be established to generate 
a total revenue amount under such subsection that is equal 
to the sum of— 
‘‘(A) $392,783,000; and 
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121 STAT. 828 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(B) an amount equal to the modified workload adjust-
ment factor for fiscal year 2007 (as determined under para-
graph (3)). 
‘‘(2) TYPES OF FEES.—Of the total revenue amount deter-
mined for a fiscal year under paragraph (1)— 
‘‘(A) one-third shall be derived from fees under sub-
section (a)(1) (relating to human drug applications and 
supplements); 
‘‘(B) one-third shall be derived from fees under sub-
section (a)(2) (relating to prescription drug establishments); 
and 
‘‘(C) one-third shall be derived from fees under sub-
section (a)(3) (relating to prescription drug products). 
‘‘(3) MODIFIED WORKLOAD ADJUSTMENT FACTOR FOR FISCAL 
YEAR 2007.—For purposes of paragraph (1)(B), the Secretary 
shall determine the modified workload adjustment factor by 
determining the dollar amount that results from applying the 
methodology that was in effect under subsection (c)(2) for fiscal 
year 2007 to the amount $354,893,000, except that, with respect 
to the portion of such determination that is based on the 
change in the total number of commercial investigational new 
drug applications, the Secretary shall count the number of 
such applications that were active during the most recent 12- 
month period for which data on such submissions is available. 
‘‘(4) ADDITIONAL FEE REVENUES FOR DRUG SAFETY.— 
‘‘(A) IN GENERAL.—For each of the fiscal years 2008 
through 2012, paragraph (1)(A) shall be applied by sub-
stituting the amount determined under subparagraph (B) 
for ‘$392,783,000’. 
‘‘(B) AMOUNT DETERMINED.—For each of the fiscal years 
2008 through 2012, the amount determined under this 
subparagraph is the sum of— 
‘‘(i) $392,783,000; plus 
‘‘(ii)(I) for fiscal year 2008, $25,000,000; 
‘‘(II) for fiscal year 2009, $35,000,000; 
‘‘(III) for fiscal year 2010, $45,000,000; 
‘‘(IV) for fiscal year 2011, $55,000,000; and 
‘‘(V) for fiscal year 2012, $65,000,000.’’. 
(c) ADJUSTMENTS TO FEES.— 
(1) INFLATION ADJUSTMENT.—Section 736(c)(1) (21 U.S.C. 
379h(c)(1)) is amended— 
(A) in the matter preceding subparagraph (A), by 
striking ‘‘The revenues established in subsection (b)’’ and 
inserting ‘‘For fiscal year 2009 and subsequent fiscal years, 
the revenues established in subsection (b)’’; 
(B) in subparagraph (A), by striking ‘‘or’’ at the end; 
(C) in subparagraph (B), by striking the period at 
the end and inserting ‘‘, or’’; 
(D) by inserting after subparagraph (B) the following: 
‘‘(C) the average annual change in the cost, per full- 
time equivalent position of the Food and Drug Administra-
tion, of all personnel compensation and benefits paid with 
respect to such positions for the first 5 years of the pre-
ceding 6 fiscal years.’’; and 
(E) in the matter following subparagraph (C) (as added 
by subparagraph (D)), by striking ‘‘fiscal year 2003’’ and 
inserting ‘‘fiscal year 2008’’. 
Applicability. 
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121 STAT. 829 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(2) WORKLOAD ADJUSTMENT.—Section 736(c)(2) (21 U.S.C. 
379h(c)(2)) is amended— 
(A) in the matter preceding subparagraph (A), by 
striking ‘‘Beginning with fiscal year 2004,’’ and inserting 
‘‘For fiscal year 2009 and subsequent fiscal years,’’; 
(B) in subparagraph (A), in the first sentence— 
(i) by striking ‘‘human drug applications,’’ and 
inserting ‘‘human drug applications (adjusted for 
changes in review activities, as described in the notice 
that the Secretary is required to publish in the Federal 
Register under this subparagraph),’’; 
(ii) by striking ‘‘commercial investigational new 
drug applications,’’; and 
(iii) by inserting before the period the following: 
‘‘, and the change in the total number of active commer-
cial investigational new drug applications (adjusted 
for changes in review activities, as so described) during 
the most recent 12-month period for which data on 
such submissions is available’’; 
(C) in subparagraph (B), by adding at the end the 
following: ‘‘Any adjustment for changes in review activities 
made in setting fees and revenue amounts for fiscal year 
2009 may not result in the total workload adjustment 
being more than 2 percentage points higher than it would 
have been in the absence of the adjustment for changes 
in review activities.’’; and 
(D) by adding at the end the following: 
‘‘(C) The Secretary shall contract with an independent 
accounting firm to study the adjustment for changes in 
review activities applied in setting fees and revenue 
amounts for fiscal year 2009 and to make recommendations, 
if warranted, for future changes in the methodology for 
calculating the adjustment. After review of the rec-
ommendations, the Secretary shall, if warranted, make 
appropriate changes to the methodology, and the changes 
shall be effective for each of the fiscal years 2010 through 
2012. The Secretary shall not make any adjustment for 
changes in review activities for any fiscal year after 2009 
unless such study has been completed.’’. 
(3) RENT AND RENT-RELATED COST ADJUSTMENT.—Section 
736(c) (21 U.S.C. 379h(c)) is amended— 
(A) by redesignating paragraphs (3), (4), and (5) as 
paragraphs (4), (5), and (6), respectively; and 
(B) by inserting after paragraph (2) the following: 
‘‘(3) RENT AND RENT-RELATED COST ADJUSTMENT.—For fiscal 
year 2010 and each subsequent fiscal year, the Secretary shall, 
before making adjustments under paragraphs (1) and (2), 
decrease the fee revenue amount established in subsection (b) 
if actual costs paid for rent and rent-related expenses for the 
preceding fiscal year are less than estimates made for such 
year in fiscal year 2006. Any reduction made under this para-
graph shall not exceed the amount by which such costs fall 
below the estimates made in fiscal year 2006 for such fiscal 
year, and shall not exceed $11,721,000 for any fiscal year.’’. 
(4) FINAL
YEAR
ADJUSTMENT.—Paragraph (4) of section 
736(c) (21 U.S.C. 379h(c)), as redesignated by paragraph (3)(A), 
is amended to read as follows: 
Effective date. 
Contracts. 
Study. 
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121 STAT. 830 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(4) FINAL YEAR ADJUSTMENT.— 
‘‘(A) INCREASE IN FEES.—For fiscal year 2012, the Sec-
retary may, in addition to adjustments under this para-
graph and paragraphs (1), (2), and (3), further increase 
the fee revenues and fees established in subsection (b) 
if such an adjustment is necessary to provide for not more 
than 3 months of operating reserves of carryover user 
fees for the process for the review of human drug applica-
tions for the first 3 months of fiscal year 2013. If such 
an adjustment is necessary, the rationale for the amount 
of the increase shall be contained in the annual notice 
establishing fee revenues and fees for fiscal year 2012. 
If the Secretary has carryover balances for such process 
in excess of 3 months of such operating reserves, the adjust-
ment under this subparagraph shall not be made. 
‘‘(B) DECREASE IN FEES.— 
‘‘(i) IN GENERAL.—For fiscal year 2012, the Sec-
retary may, in addition to adjustments under this para-
graph and paragraphs (1), (2), and (3), decrease the 
fee revenues and fees established in subsection (b) 
by the amount determined in clause (ii), if, for fiscal 
year 2009 or 2010— 
‘‘(I) the amount of the total appropriations for 
the Food and Drug Administration for such fiscal 
year (excluding the amount of fees appropriated 
for such fiscal year) exceeds the amount of the 
total appropriations for the Food and Drug 
Administration for fiscal year 2008 (excluding the 
amount of fees appropriated for such fiscal year), 
adjusted as provided under paragraph (1); and 
‘‘(II) the amount of the total appropriations 
expended for the process for the review of human 
drug applications at the Food and Drug Adminis-
tration for such fiscal year (excluding the amount 
of fees appropriated for such fiscal year) exceeds 
the amount of appropriations expended for the 
process for the review of human drug applications 
at the Food and Drug Administration for fiscal 
year 2008 (excluding the amount of fees appro-
priated for such fiscal year), adjusted as provided 
under paragraph (1). 
‘‘(ii) AMOUNT OF DECREASE.—The amount deter-
mined in this clause is the lesser of— 
‘‘(I) the amount equal to the sum of the 
amounts that, for each of fiscal years 2009 and 
2010, is the lesser of— 
‘‘(aa) the excess amount described in 
clause (i)(II) for such fiscal year; or 
‘‘(bb) the amount specified in subsection 
(b)(4)(B)(ii) for such fiscal year; or 
‘‘(II) $65,000,000. 
‘‘(iii) LIMITATIONS.— 
‘‘(I) FISCAL YEAR CONDITION.—In making the 
determination under clause (ii), an amount 
described in subclause (I) of such clause for fiscal 
year 2009 or 2010 shall be taken into account 
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121 STAT. 831 
PUBLIC LAW 110–85—SEPT. 27, 2007 
only if subclauses (I) and (II) of clause (i) apply 
to such fiscal year. 
‘‘(II) RELATION
TO
SUBPARAGRAPH
(A).—The 
Secretary shall limit any decrease under this para-
graph if such a limitation is necessary to provide 
for the 3 months of operating reserves described 
in subparagraph (A).’’. 
(5) LIMIT.—Paragraph (5) of section 736(c) (21 U.S.C. 
379h(c)), as redesignated by paragraph (3)(A), is amended by 
striking ‘‘2002’’ and inserting ‘‘2007’’. 
(d) FEE WAIVER
OR REDUCTION.—Section 736(d) (21 U.S.C. 
379h(d)) is amended— 
(1) in paragraph (1), in the matter preceding subparagraph 
(A)— 
(A) by inserting after ‘‘The Secretary shall grant’’ the 
following: ‘‘to a person who is named as the applicant 
in a human drug application’’; and 
(B) by inserting ‘‘to that person’’ after ‘‘one or more 
fees assessed’’; 
(2) by redesignating paragraphs (2) and (3) as paragraphs 
(3) and (4), respectively; 
(3) by inserting after paragraph (1) the following: 
‘‘(2) CONSIDERATIONS.—In determining whether to grant 
a waiver or reduction of a fee under paragraph (1), the Secretary 
shall consider only the circumstances and assets of the 
applicant involved and any affiliate of the applicant.’’; and 
(4) in paragraph (4) (as redesignated by paragraph (2)), 
in subparagraph (A), by inserting before the period the fol-
lowing: ‘‘, and that does not have a drug product that has 
been approved under a human drug application and introduced 
or delivered for introduction into interstate commerce’’. 
(e) CREDITING AND AVAILABILITY OF FEES.— 
(1) AUTHORIZATION OF APPROPRIATIONS.—Section 736(g)(3) 
(21 U.S.C. 379h(g)(3)) is amended to read as follows: 
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the 
fiscal years 2008 through 2012, there is authorized to be appro-
priated for fees under this section an amount equal to the 
total revenue amount determined under subsection (b) for the 
fiscal year, as adjusted or otherwise affected under subsection 
(c) and paragraph (4) of this subsection.’’. 
(2) OFFSET.—Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is 
amended to read as follows: 
‘‘(4) OFFSET.—If the sum of the cumulative amount of fees 
collected under this section for the fiscal years 2008 through 
2010 and the amount of fees estimated to be collected under 
this section for fiscal year 2011 exceeds the cumulative amount 
appropriated under paragraph (3) for the fiscal years 2008 
through 2011, the excess shall be credited to the appropriation 
account of the Food and Drug Administration as provided in 
paragraph (1), and shall be subtracted from the amount of 
fees that would otherwise be authorized to be collected under 
this section pursuant to appropriation Acts for fiscal year 
2012.’’. 
(f) EXEMPTION FOR ORPHAN DRUGS.—Section 736 (21 U.S.C. 
379h) is further amended by adding at the end the following: 
‘‘(k) ORPHAN DRUGS.— 
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121 STAT. 832 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(1) EXEMPTION.—A drug designated under section 526 for 
a rare disease or condition and approved under section 505 
or under section 351 of the Public Health Service Act shall 
be exempt from product and establishment fees under this 
section, if the drug meets all of the following conditions: 
‘‘(A) The drug meets the public health requirements 
contained in this Act as such requirements are applied 
to requests for waivers for product and establishment fees. 
‘‘(B) The drug is owned or licensed and is marketed 
by a company that had less than $50,000,000 in gross 
worldwide revenue during the previous year. 
‘‘(2) EVIDENCE
OF
QUALIFICATION.—An exemption under 
paragraph (1) applies with respect to a drug only if the 
applicant involved submits a certification that its gross annual 
revenues did not exceed $50,000,000 for the preceding 12 
months before the exemption was requested.’’. 
(g) CONFORMING
AMENDMENT.—Section 736(a) (21 U.S.C. 
379h(a)) is amended in paragraphs (1)(A)(i), (1)(A)(ii), (2)(A), and 
(3)(A) by striking ‘‘(c)(4)’’ each place such term appears and inserting 
‘‘(c)(5)’’. 
(h) TECHNICAL AMENDMENT.— 
(1) AMENDMENT.—Section 736(g)(1) (21 U.S.C. 379h(g)(1)) 
is amended by striking the first sentence and inserting the 
following: ‘‘Fees authorized under subsection (a) shall be col-
lected and available for obligation only to the extent and in 
the amount provided in advance in appropriations Acts. Such 
fees are authorized to remain available until expended.’’. 
(2) EFFECTIVE DATE.—Paragraph (1) shall take effect as 
if included in section 504 of the Prescription Drug User Fee 
Amendments of 2002 (Public Law 107–188; 116 Stat. 687). 
SEC. 104. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION- 
DRUG TELEVISION ADVERTISING. 
Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et 
seq.) is amended by adding after section 736 the following: 
‘‘SEC. 736A. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION- 
DRUG TELEVISION ADVERTISING. 
‘‘(a) TYPES
OF DIRECT-TO-CONSUMER TELEVISION ADVERTISE-
MENT REVIEW FEES.—Beginning in fiscal year 2008, the Secretary 
shall assess and collect fees in accordance with this section as 
follows: 
‘‘(1) ADVISORY REVIEW FEE.— 
‘‘(A) IN GENERAL.—With respect to a proposed direct- 
to-consumer television advertisement (referred to in this 
section as a ‘DTC advertisement’), each person that on 
or after October 1, 2007, submits such an advertisement 
for advisory review by the Secretary prior to its initial 
public dissemination shall, except as provided in subpara-
graph (B), be subject to a fee established under subsection 
(c)(3). 
‘‘(B) EXCEPTION FOR REQUIRED SUBMISSIONS.—A DTC 
advertisement that is required to be submitted to the Sec-
retary prior to initial public dissemination is not subject 
to a fee under subparagraph (A) unless the sponsor des-
ignates the submission as a submission for advisory review. 
‘‘(C) 
NOTICE
TO
SECRETARY
OF
NUMBER
OF 
ADVERTISEMENTS.—Not later than June 1 of each fiscal 
Deadlines. 
Federal Register, 
publication. 
Effective date. 
21 USC 379h–1. 
21 USC 379h 
note. 
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121 STAT. 833 
PUBLIC LAW 110–85—SEPT. 27, 2007 
year, the Secretary shall publish a notice in the Federal 
Register requesting any person to notify the Secretary 
within 30 days of the number of DTC advertisements the 
person intends to submit for advisory review in the next 
fiscal year. Notwithstanding the preceding sentence, for 
fiscal year 2008, the Secretary shall publish such a notice 
in the Federal Register not later than 30 days after the 
date of the enactment of the Food and Drug Administration 
Amendments Act of 2007. 
‘‘(D) PAYMENT.— 
‘‘(i) IN GENERAL.—The fee required by subpara-
graph (A) (referred to in this section as ‘an advisory 
review fee’) shall be due not later than October 1 
of the fiscal year in which the DTC advertisement 
involved is intended to be submitted for advisory 
review, subject to subparagraph (F)(i). Notwithstanding 
the preceding sentence, the advisory review fee for 
any DTC advertisement that is intended to be sub-
mitted for advisory review during fiscal year 2008 shall 
be due not later than 120 days after the date of the 
enactment of the Food and Drug Administration 
Amendments of 2007 or an earlier date as specified 
by the Secretary. 
‘‘(ii) EFFECT OF SUBMISSION.—Notification of the 
Secretary under subparagraph (C) of the number of 
DTC advertisements a person intends to submit for 
advisory review is a legally binding commitment by 
that person to pay the annual advisory review fee 
for that number of submissions on or before October 
1 of the fiscal year in which the advertisement is 
intended to be submitted. Notwithstanding the pre-
ceding sentence, the commitment shall be a legally 
binding commitment by that person to pay the annual 
advisory review fee for that number of submissions 
for fiscal year 2008 by the date specified in clause 
(i). 
‘‘(iii) NOTICE
REGARDING
CARRYOVER
SUBMIS-
SIONS.—In making a notification under subparagraph 
(C), the person involved shall in addition notify the 
Secretary if under subparagraph (F)(i) the person 
intends to submit a DTC advertisement for which the 
advisory review fee has already been paid. If the person 
does not so notify the Secretary, each DTC advertise-
ment submitted by the person for advisory review in 
the fiscal year involved shall be subject to the advisory 
review fee. 
‘‘(E) MODIFICATION OF ADVISORY REVIEW FEE.— 
‘‘(i) LATE
PAYMENT.—If a person has submitted 
a notification under subparagraph (C) with respect 
to a fiscal year and has not paid all advisory review 
fees due under subparagraph (D) not later than 
November 1 of such fiscal year (or, in the case of 
such a notification submitted with respect to fiscal 
year 2008, not later than 150 days after the date 
of the enactment of the Food and Drug Administration 
Amendments Act of 2007 or an earlier date specified 
by the Secretary), the fees shall be regarded as late 
Applicability. 
Deadlines. 
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121 STAT. 834 
PUBLIC LAW 110–85—SEPT. 27, 2007 
and an increase in the amount of fees applies in accord-
ance with this clause, notwithstanding any other provi-
sion of this section. For such person, all advisory review 
fees for such fiscal year shall be due and payable 
20 days before any direct-to-consumer advertisement 
is submitted to the Secretary for advisory review, and 
each such fee shall be equal to 150 percent of the 
fee that otherwise would have applied pursuant to 
subsection (c)(3). 
‘‘(ii) EXCEEDING
IDENTIFIED
NUMBER
OF
SUBMIS-
SIONS.—If a person submits a number of DTC 
advertisements for advisory review in a fiscal year 
that exceeds the number identified by the person under 
subparagraph (C), an increase in the amount of fees 
applies under this clause for each submission in excess 
of such number, notwithstanding any other provision 
of this section. For each such DTC advertisement, the 
advisory review fee shall be due and payable 20 days 
before the advertisement is submitted to the Secretary, 
and the fee shall be equal to 150 percent of the fee 
that otherwise would have applied pursuant to sub-
section (c)(3). 
‘‘(F) LIMITS.— 
‘‘(i) SUBMISSIONS.—For each advisory review fee 
paid by a person for a fiscal year, the person is entitled 
to acceptance for advisory review by the Secretary 
of one DTC advertisement and acceptance of one 
resubmission for advisory review of the same advertise-
ment. The advertisement shall be submitted for review 
in the fiscal year for which the fee was assessed, except 
that a person may carry over not more than one paid 
advisory review submission to the next fiscal year. 
Resubmissions may be submitted without regard to 
the fiscal year of the initial advisory review submission. 
‘‘(ii) NO
REFUNDS.—Except as provided by sub-
sections (d)(4) and (f), fees paid under this section 
shall not be refunded. 
‘‘(iii) NO WAIVERS, EXEMPTIONS, OR REDUCTIONS.— 
The Secretary shall not grant a waiver, exemption, 
or reduction of any fees due or payable under this 
section. 
‘‘(iv) RIGHT TO ADVISORY REVIEW NOT TRANSFER-
ABLE.—The right to an advisory review under this 
paragraph is not transferable, except to a successor 
in interest. 
‘‘(2) OPERATING RESERVE FEE.— 
‘‘(A) IN GENERAL.—Each person that on or after October 
1, 2007, is assessed an advisory review fee under paragraph 
(1) shall be subject to fee established under subsection 
(d)(2) (referred to in this section as an ‘operating reserve 
fee’) for the first fiscal year in which an advisory review 
fee is assessed to such person. The person is not subject 
to an operating reserve fee for any other fiscal year. 
‘‘(B) PAYMENT.—Except as provided in subparagraph 
(C), the operating reserve fee shall be due no later than— 
Deadlines. 
Deadline. 
Deadline. 
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121 STAT. 835 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(i) October 1 of the first fiscal year in which 
the person is required to pay an advisory review fee 
under paragraph (1); or 
‘‘(ii) for fiscal year 2008, 120 days after the date 
of the enactment of the Food and Drug Administration 
Amendments Act of 2007 or an earlier date specified 
by the Secretary. 
‘‘(C) LATE NOTICE OF SUBMISSION.—If, in the first fiscal 
year of a person’s participation in the program under this 
section, that person submits any DTC advertisements for 
advisory review that are in excess of the number identified 
by that person in response to the Federal Register notice 
described in subsection (a)(1)(C), that person shall pay 
an operating reserve fee for each of those advisory reviews 
equal to the advisory review fee for each submission estab-
lished under paragraph (1)(E)(ii). Fees required by this 
subparagraph shall be in addition to any fees required 
by subparagraph (A). Fees under this subparagraph shall 
be due 20 days before any DTC advertisement is submitted 
by such person to the Secretary for advisory review. 
‘‘(D) LATE PAYMENT.— 
‘‘(i) IN GENERAL.—Notwithstanding subparagraph 
(B), and subject to clause (ii), an operating reserve 
fee shall be regarded as late if the person required 
to pay the fee has not paid the complete operating 
reserve fee by— 
‘‘(I) for fiscal year 2008, 150 days after the 
date of the enactment of the Food and Drug 
Administration Amendments Act of 2007 or an 
earlier date specified by the Secretary; or 
‘‘(II) in any subsequent year, November 1. 
‘‘(ii) COMPLETE PAYMENT.—The complete operating 
reserve fee shall be due and payable 20 days before 
any DTC advertisement is submitted by such person 
to the Secretary for advisory review. 
‘‘(iii) AMOUNT.—Notwithstanding any other provi-
sion of this section, an operating reserve fee that is 
regarded as late under this subparagraph shall be 
equal to 150 percent of the operating reserve fee that 
otherwise would have applied pursuant to subsection 
(d). 
‘‘(b) ADVISORY REVIEW FEE REVENUE AMOUNTS.—Fees under 
subsection (a)(1) shall be established to generate revenue amounts 
of $6,250,000 for each of fiscal years 2008 through 2012, as adjusted 
pursuant to subsections (c) and (g)(4). 
‘‘(c) ADJUSTMENTS.— 
‘‘(1) INFLATION ADJUSTMENT.—Beginning with fiscal year 
2009, the revenues established in subsection (b) shall be 
adjusted by the Secretary by notice, published in the Federal 
Register, for a fiscal year to reflect the greater of— 
‘‘(A) the total percentage change that occurred in the 
Consumer Price Index for all urban consumers (all items; 
U.S. city average), for the 12-month period ending June 
30 preceding the fiscal year for which fees are being estab-
lished; 
‘‘(B) the total percentage change for the previous fiscal 
year in basic pay under the General Schedule in accordance 
Effective date. 
Notice. 
Federal Register, 
publication. 
Deadlines. 
Deadline. 
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121 STAT. 836 
PUBLIC LAW 110–85—SEPT. 27, 2007 
with section 5332 of title 5, United States Code, as adjusted 
by any locality-based comparability payment pursuant to 
section 5304 of such title for Federal employees stationed 
in the District of Columbia; or 
‘‘(C) the average annual change in the cost, per full- 
time equivalent position of the Food and Drug Administra-
tion, of all personnel compensation and benefits paid with 
respect to such positions for the first 5 fiscal years of 
the previous 6 fiscal years. 
The adjustment made each fiscal year by this subsection shall 
be added on a compounded basis to the sum of all adjustments 
made each fiscal year after fiscal year 2008 under this sub-
section. 
‘‘(2) WORKLOAD ADJUSTMENT.—Beginning with fiscal year 
2009, after the fee revenues established in subsection (b) are 
adjusted for a fiscal year for inflation in accordance with para-
graph (1), the fee revenues shall be adjusted further for such 
fiscal year to reflect changes in the workload of the Secretary 
with respect to the submission of DTC advertisements for 
advisory review prior to initial dissemination. With respect 
to such adjustment: 
‘‘(A) The adjustment shall be determined by the Sec-
retary based upon the number of DTC advertisements 
identified pursuant to subsection (a)(1)(C) for the upcoming 
fiscal year, excluding allowable previously paid carry over 
submissions. The adjustment shall be determined by multi-
plying the number of such advertisements projected for 
that fiscal year that exceeds 150 by $27,600 (adjusted 
each year beginning with fiscal year 2009 for inflation 
in accordance with paragraph (1)). The Secretary shall 
publish in the Federal Register the fee revenues and fees 
resulting from the adjustment and the supporting meth-
odologies. 
‘‘(B) Under no circumstances shall the adjustment 
result in fee revenues for a fiscal year that are less than 
the fee revenues established for the prior fiscal year. 
‘‘(3) ANNUAL FEE SETTING FOR ADVISORY REVIEW.— 
‘‘(A) IN GENERAL.—Not later than August 1 of each 
fiscal year (or, with respect to fiscal year 2008, not later 
than 90 days after the date of the enactment of the Food 
and Drug Administration Amendments Act of 2007), the 
Secretary shall establish for the next fiscal year the DTC 
advertisement advisory review fee under subsection (a)(1), 
based on the revenue amounts established under subsection 
(b), the adjustments provided under paragraphs (1) and 
(2), and the number of DTC advertisements identified 
pursuant to subsection (a)(1)(C), excluding allowable pre-
viously-paid carry over submissions. The annual advisory 
review fee shall be established by dividing the fee revenue 
for a fiscal year (as adjusted pursuant to this subsection) 
by the number of DTC advertisements so identified, 
excluding allowable previously-paid carry over submissions 
under subsection (a)(1)(F)(i). 
‘‘(B) FISCAL
YEAR
2008
FEE
LIMIT.—Notwithstanding 
subsection (b) and the adjustments pursuant to this sub-
section, the fee established under subparagraph (A) for 
Deadlines. 
Federal Register, 
publication. 
Effective date. 
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121 STAT. 837 
PUBLIC LAW 110–85—SEPT. 27, 2007 
fiscal year 2008 may not be more than $83,000 per submis-
sion for advisory review. 
‘‘(C) ANNUAL FEE LIMIT.—Notwithstanding subsection 
(b) and the adjustments pursuant to this subsection, the 
fee established under subparagraph (A) for a fiscal year 
after fiscal year 2008 may not be more than 50 percent 
more than the fee established for the prior fiscal year. 
‘‘(D) LIMIT.—The total amount of fees obligated for 
a fiscal year may not exceed the total costs for such fiscal 
year for the resources allocated for the process for the 
advisory review of prescription drug advertising. 
‘‘(d) OPERATING RESERVES.— 
‘‘(1) IN GENERAL.—The Secretary shall establish in the Food 
and Drug Administration salaries and expenses appropriation 
account without fiscal year limitation a Direct-to-Consumer 
Advisory Review Operating Reserve, of at least $6,250,000 in 
fiscal year 2008, to continue the program under this section 
in the event the fees collected in any subsequent fiscal year 
pursuant to subsection (a)(1) do not generate the fee revenue 
amount established for that fiscal year. 
‘‘(2) FEE SETTING.—The Secretary shall establish the oper-
ating reserve fee under subsection (a)(2)(A) for each person 
required to pay the fee by multiplying the number of DTC 
advertisements identified by that person pursuant to subsection 
(a)(1)(C) by the advisory review fee established pursuant to 
subsection (c)(3) for that fiscal year, except that in no case 
shall the operating reserve fee assessed be less than the oper-
ating reserve fee assessed if the person had first participated 
in the program under this section in fiscal year 2008. 
‘‘(3) USE OF OPERATING RESERVE.—The Secretary may use 
funds from the reserves only to the extent necessary in any 
fiscal year to make up the difference between the fee revenue 
amount established for that fiscal year under subsections (b) 
and (c) and the amount of fees actually collected for that fiscal 
year pursuant to subsection (a)(1), or to pay costs of ending 
the program under this section if it is terminated pursuant 
to subsection (f) or not reauthorized beyond fiscal year 2012. 
‘‘(4) REFUND OF OPERATING RESERVES.—Within 120 days 
after the end of fiscal year 2012, or if the program under 
this section ends early pursuant to subsection (f), the Secretary, 
after setting aside sufficient operating reserve amounts to 
terminate the program under this section, shall refund all 
amounts remaining in the operating reserve on a pro rata 
basis to each person that paid an operating reserve fee assess-
ment. In no event shall the refund to any person exceed the 
total amount of operating reserve fees paid by such person 
pursuant to subsection (a)(2). 
‘‘(e) EFFECT OF FAILURE TO PAY FEES.—Notwithstanding any 
other requirement, a submission for advisory review of a DTC 
advertisement submitted by a person subject to fees under sub-
section (a) shall be considered incomplete and shall not be accepted 
for review by the Secretary until all fees owed by such person 
under this section have been paid. 
‘‘(f) EFFECT OF INADEQUATE FUNDING OF PROGRAM.— 
‘‘(1) INITIAL FUNDING.—If on November 1, 2007, or 120 
days after the date of the enactment of the Food and Drug 
Administration Amendments Act of 2007, whichever is later, 
Effective date. 
Deadline. 
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121 STAT. 838 
PUBLIC LAW 110–85—SEPT. 27, 2007 
the Secretary has not received at least $11,250,000 in advisory 
review fees and operating reserve fees combined, the program 
under this section shall not commence and all collected fees 
shall be refunded. 
‘‘(2) LATER FISCAL YEARS.—Beginning in fiscal year 2009, 
if, on November 1 of the fiscal year, the combination of the 
operating reserves, annual fee revenues from that fiscal year, 
and unobligated fee revenues from prior fiscal years falls below 
$9,000,000, adjusted for inflation (as described in subsection 
(c)(1)), the program under this section shall terminate, and 
the Secretary shall notify all participants, retain any money 
from the unused advisory review fees and the operating 
reserves needed to terminate the program, and refund the 
remainder of the unused fees and operating reserves. To the 
extent required to terminate the program, the Secretary shall 
first use unobligated advisory review fee revenues from prior 
fiscal years, then the operating reserves, and finally, unused 
advisory review fees from the relevant fiscal year. 
‘‘(g) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN
GENERAL.—Fees authorized under subsection (a) 
shall be collected and available for obligation only to the extent 
and in the amount provided in advance in appropriations Acts. 
Such fees are authorized to remain available until expended. 
Such sums as may be necessary may be transferred from the 
Food and Drug Administration salaries and expenses appropria-
tion account without fiscal year limitation to such appropriation 
account for salaries and expenses with such fiscal year limita-
tion. The sums transferred shall be available solely for the 
process for the advisory review of prescription drug advertising. 
‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.— 
‘‘(A) IN
GENERAL.—The fees authorized by this sec-
tion— 
‘‘(i) shall be retained in each fiscal year in an 
amount not to exceed the amount specified in appro-
priation Acts, or otherwise made available for obliga-
tion for such fiscal year; and 
‘‘(ii) shall be available for obligation only if the 
amounts appropriated as budget authority for such 
fiscal year are sufficient to support a number of full- 
time equivalent review employees that is not fewer 
than the number of such employees supported in fiscal 
year 2007. 
‘‘(B) REVIEW
EMPLOYEES.—For purposes of subpara-
graph (A)(ii), the term ‘full-time equivalent review 
employees’ means the total combined number of full-time 
equivalent employees in— 
‘‘(i) the Center for Drug Evaluation and Research, 
Division of Drug Marketing, Advertising, and Commu-
nications, Food and Drug Administration; and 
‘‘(ii) the Center for Biologics Evaluation and 
Research, 
Advertising 
and 
Promotional 
Labeling 
Branch, Food and Drug Administration. 
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the 
fiscal years 2008 through 2012, there is authorized to be appro-
priated for fees under this section an amount equal to the 
total revenue amount determined under subsection (b) for the 
Effective date. 
Notification. 
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121 STAT. 839 
PUBLIC LAW 110–85—SEPT. 27, 2007 
fiscal year, as adjusted pursuant to subsection (c) and para-
graph (4) of this subsection, plus amounts collected for the 
reserve fund under subsection (d). 
‘‘(4) OFFSET.—Any amount of fees collected for a fiscal 
year under this section that exceeds the amount of fees specified 
in appropriation Acts for such fiscal year shall be credited 
to the appropriation account of the Food and Drug Administra-
tion as provided in paragraph (1), and shall be subtracted 
from the amount of fees that would otherwise be collected 
under this section pursuant to appropriation Acts for a subse-
quent fiscal year. 
‘‘(h) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘advisory review’ means reviewing and pro-
viding advisory comments on DTC advertisements regarding 
compliance of a proposed advertisement with the requirements 
of this Act prior to its initial public dissemination. 
‘‘(2) The term ‘advisory review fee’ has the meaning 
indicated for such term in subsection (a)(1)(D). 
‘‘(3) The term ‘carry over submission’ means a submission 
for an advisory review for which a fee was paid in one fiscal 
year that is submitted for review in the following fiscal year. 
‘‘(4) The term ‘direct-to-consumer television advertisement’ 
means an advertisement for a prescription drug product (as 
defined in section 735(3)) intended to be displayed on any 
television channel for less than 3 minutes. 
‘‘(5) The term ‘DTC advertisement’ has the meaning 
indicated for such term in subsection (a)(1)(A). 
‘‘(6) The term ‘operating reserve fee’ has the meaning 
indicated for such term in subsection (a)(2)(A). 
‘‘(7) The term ‘person’ includes an individual, partnership, 
corporation, and association, and any affiliate thereof or suc-
cessor in interest. 
‘‘(8) The term ‘process for the advisory review of prescrip-
tion drug advertising’ means the activities necessary to review 
and provide advisory comments on DTC advertisements prior 
to public dissemination and, to the extent the Secretary has 
additional staff resources available under the program under 
this section that are not necessary for the advisory review 
of DTC advertisements, the activities necessary to review and 
provide advisory comments on other proposed advertisements 
and promotional material prior to public dissemination. 
‘‘(9) The term ‘resources allocated for the process for the 
advisory review of prescription drug advertising’ means the 
expenses incurred in connection with the process for the 
advisory review of prescription drug advertising for— 
‘‘(A) officers and employees of the Food and Drug 
Administration, contractors of the Food and Drug Adminis-
tration, advisory committees, and costs related to such 
officers, employees, and committees, and to contracts with 
such contractors; 
‘‘(B) management of information, and the acquisition, 
maintenance, and repair of computer resources; 
‘‘(C) leasing, maintenance, renovation, and repair of 
facilities and acquisition, maintenance, and repair of fix-
tures, furniture, scientific equipment, and other necessary 
materials and supplies; 
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121 STAT. 840 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(D) collection of fees under this section and accounting 
for resources allocated for the advisory review of prescrip-
tion drug advertising; and 
‘‘(E) terminating the program under this section pursu-
ant to subsection (f)(2) if that becomes necessary. 
‘‘(10) The term ‘resubmission’ means a subsequent submis-
sion for advisory review of a direct-to-consumer television 
advertisement that has been revised in response to the Sec-
retary’s comments on an original submission. A resubmission 
may not introduce significant new concepts or creative themes 
into the television advertisement. 
‘‘(11) The term ‘submission for advisory review’ means an 
original submission of a direct-to-consumer television advertise-
ment for which the sponsor voluntarily requests advisory com-
ments before the advertisement is publicly disseminated.’’. 
SEC. 105. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et 
seq.), as amended by section 104, is further amended by inserting 
after section 736A the following: 
‘‘SEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS. 
‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal year 2008, 
not later than 120 days after the end of each fiscal year for which 
fees are collected under this part, the Secretary shall prepare and 
submit to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Education, Labor, 
and Pensions of the Senate a report concerning the progress of 
the Food and Drug Administration in achieving the goals identified 
in the letters described in section 101(c) of the Food and Drug 
Administration Amendments Act of 2007 during such fiscal year 
and the future plans of the Food and Drug Administration for 
meeting the goals. The report for a fiscal year shall include informa-
tion on all previous cohorts for which the Secretary has not given 
a complete response on all human drug applications and supple-
ments in the cohort. 
‘‘(b) FISCAL REPORT.—Beginning with fiscal year 2008, not later 
than 120 days after the end of each fiscal year for which fees 
are collected under this part, the Secretary shall prepare and submit 
to the Committee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report on the implementation of the 
authority for such fees during such fiscal year and the use, by 
the Food and Drug Administration, of the fees collected for such 
fiscal year. 
‘‘(c) PUBLIC
AVAILABILITY.—The Secretary shall make the 
reports required under subsections (a) and (b) available to the 
public on the Internet Web site of the Food and Drug Administra-
tion. 
‘‘(d) REAUTHORIZATION.— 
‘‘(1) CONSULTATION.—In developing recommendations to 
present to the Congress with respect to the goals, and plans 
for meeting the goals, for the process for the review of human 
drug applications for the first 5 fiscal years after fiscal year 
2012, and for the reauthorization of this part for such fiscal 
years, the Secretary shall consult with— 
‘‘(A) the Committee on Energy and Commerce of the 
House of Representatives; 
Web site. 
21 USC 379h–2. 
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121 STAT. 841 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(B) the Committee on Health, Education, Labor, and 
Pensions of the Senate; 
‘‘(C) scientific and academic experts; 
‘‘(D) health care professionals; 
‘‘(E) representatives of patient and consumer advocacy 
groups; and 
‘‘(F) the regulated industry. 
‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations 
with the regulated industry on the reauthorization of this part, 
the Secretary shall— 
‘‘(A) publish a notice in the Federal Register requesting 
public input on the reauthorization; 
‘‘(B) hold a public meeting at which the public may 
present its views on the reauthorization, including specific 
suggestions for changes to the goals referred to in sub-
section (a); 
‘‘(C) provide a period of 30 days after the public meeting 
to obtain written comments from the public suggesting 
changes to this part; and 
‘‘(D) publish the comments on the Food and Drug 
Administration’s Internet Web site. 
‘‘(3) PERIODIC
CONSULTATION.—Not less frequently than 
once every month during negotiations with the regulated 
industry, the Secretary shall hold discussions with representa-
tives of patient and consumer advocacy groups to continue 
discussions of their views on the reauthorization and their 
suggestions for changes to this part as expressed under para-
graph (2). 
‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotia-
tions with the regulated industry, the Secretary shall— 
‘‘(A) present the recommendations developed under 
paragraph (1) to the Congressional committees specified 
in such paragraph; 
‘‘(B) publish such recommendations in the Federal Reg-
ister; 
‘‘(C) provide for a period of 30 days for the public 
to provide written comments on such recommendations; 
‘‘(D) hold a meeting at which the public may present 
its views on such recommendations; and 
‘‘(E) after consideration of such public views and com-
ments, revise such recommendations as necessary. 
‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 
January 15, 2012, the Secretary shall transmit to the Congress 
the revised recommendations under paragraph (4), a summary 
of the views and comments received under such paragraph, 
and any changes made to the recommendations in response 
to such views and comments. 
‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 
‘‘(A) PUBLIC AVAILABILITY.—Before presenting the rec-
ommendations developed under paragraphs (1) through (5) 
to the Congress, the Secretary shall make publicly avail-
able, on the public Web site of the Food and Drug Adminis-
tration, minutes of all negotiation meetings conducted 
under this subsection between the Food and Drug Adminis-
tration and the regulated industry. 
‘‘(B) CONTENT.—The minutes described under subpara-
graph (A) shall summarize any substantive proposal made 
Web site. 
Deadline. 
Federal Register, 
publication. 
Web site. 
Federal Register, 
publication. 
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121 STAT. 842 
PUBLIC LAW 110–85—SEPT. 27, 2007 
by any party to the negotiations as well as significant 
controversies or differences of opinion during the negotia-
tions and their resolution.’’. 
SEC. 106. SUNSET DATES. 
(a) AUTHORIZATION.—The amendments made by sections 102, 
103, and 104 cease to be effective October 1, 2012. 
(b) REPORTING REQUIREMENTS.—The amendment made by sec-
tion 105 ceases to be effective January 31, 2013. 
SEC. 107. EFFECTIVE DATE. 
The amendments made by this title shall take effect on October 
1, 2007, or the date of the enactment of this Act, whichever is 
later, except that fees under part 2 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 
for all human drug applications received on or after October 1, 
2007, regardless of the date of the enactment of this Act. 
SEC. 108. SAVINGS CLAUSE. 
Notwithstanding section 509 of the Prescription Drug User 
Fee Amendments of 2002 (21 U.S.C. 379g note), and notwith-
standing the amendments made by this title, part 2 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic Act, 
as in effect on the day before the date of the enactment of this 
title, shall continue to be in effect with respect to human drug 
applications and supplements (as defined in such part as of such 
day) that on or after October 1, 2002, but before October 1, 2007, 
were accepted by the Food and Drug Administration for filing 
with respect to assessing and collecting any fee required by such 
part for a fiscal year prior to fiscal year 2008. 
SEC. 109. TECHNICAL AMENDMENT; CONFORMING AMENDMENT. 
(a) Section 739 (21 U.S.C. 379j–11) is amended in the matter 
preceding paragraph (1) by striking ‘‘subchapter’’ and inserting 
‘‘part’’. 
(b) Paragraph (11) of section 739 (21 U.S.C. 379j–11) is amended 
by striking ‘‘735(9)’’ and inserting ‘‘735(11)’’. 
TITLE II—MEDICAL DEVICE USER FEE 
AMENDMENTS OF 2007 
SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the ‘‘Medical 
Device User Fee Amendments of 2007’’. 
(b) REFERENCES
IN
TITLE.—Except as otherwise specified, 
amendments made by this title to a section or other provision 
of law are amendments to such section or other provision of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 
(c) FINDING.—The Congress finds that the fees authorized under 
the amendments made by this title will be dedicated toward expe-
diting the process for the review of device applications and for 
assuring the safety and effectiveness of devices, as set forth in 
the goals identified for purposes of part 3 of subchapter C of 
chapter VII of the Federal Food, Drug, and Cosmetic Act in the 
letters from the Secretary of Health and Human Services to the 
Chairman of the Committee on Health, Education, Labor, and Pen-
sions of the Senate and the Chairman of the Committee on Energy 
21 USC 379i 
note. 
21 USC 301 note. 
Medical Device 
User Fee 
Amendments of 
2007. 
21 USC 379g 
note. 
21 USC 379g 
note. 
21 USC 379h–2. 
21 USC 379g 
note. 
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121 STAT. 843 
PUBLIC LAW 110–85—SEPT. 27, 2007 
and Commerce of the House of Representatives, as set forth in 
the Congressional Record. 
Subtitle A—Fees Related to Medical 
Devices 
SEC. 211. DEFINITIONS. 
Section 737 is amended— 
(1) in the matter preceding paragraph (1), by striking ‘‘For 
purposes of this subchapter’’ and inserting ‘‘For purposes of 
this part’’; 
(2) by redesignating paragraphs (5), (6), (7), and (8) as 
paragraphs (8), (9), (10), and (12), respectively; 
(3) by inserting after paragraph (4) the following: 
‘‘(5) The term ‘30-day notice’ means a notice under section 
515(d)(6) that is limited to a request to make modifications 
to manufacturing procedures or methods of manufacture 
affecting the safety and effectiveness of the device. 
‘‘(6) The term ‘request for classification information’ means 
a request made under section 513(g) for information respecting 
the class in which a device has been classified or the require-
ments applicable to a device. 
‘‘(7) The term ‘annual fee’, for periodic reporting concerning 
a class III device, means the annual fee associated with periodic 
reports required by a premarket application approval order.’’; 
(4) in paragraph (10), as so redesignated— 
(A) by striking ‘‘April of the preceding fiscal year’’ 
and inserting ‘‘October of the preceding fiscal year’’; and 
(B) by striking ‘‘April 2002’’ and inserting ‘‘October 
2001’’; 
(5) by inserting after paragraph (10), as so amended, the 
following: 
‘‘(11) The term ‘person’ includes an affiliate thereof.’’; and 
(6) by inserting after paragraph (12), as so redesignated, 
the following: 
‘‘(13) The term ‘establishment subject to a registration fee’ 
means an establishment that is required to register with the 
Secretary under section 510 and is one of the following types 
of establishments: 
‘‘(A) MANUFACTURER.—An establishment that makes 
by any means any article that is a device, including an 
establishment that sterilizes or otherwise makes such 
article for or on behalf of a specification developer or any 
other person. 
‘‘(B) SINGLE-USE DEVICE REPROCESSOR.—An establish-
ment that, within the meaning of section 201(ll)(2)(A), per-
forms additional processing and manufacturing operations 
on a single-use device that has previously been used on 
a patient. 
‘‘(C) SPECIFICATION
DEVELOPER.—An establishment 
that develops specifications for a device that is distributed 
under the establishment’s name but which performs no 
manufacturing, including an establishment that, in addi-
tion to developing specifications, also arranges for the 
manufacturing of devices labeled with another establish-
ment’s name by a contract manufacturer.’’. 
21 USC 379i. 
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121 STAT. 844 
PUBLIC LAW 110–85—SEPT. 27, 2007 
SEC. 212. AUTHORITY TO ASSESS AND USE DEVICE FEES. 
(a) TYPES OF FEES.— 
(1) IN
GENERAL.—Section 738(a) (21 U.S.C. 379j(a)) is 
amended— 
(A) in paragraph (1), by striking ‘‘Beginning on the 
date of the enactment of the Medical Device User Fee 
and Modernization Act of 2002’’ and inserting ‘‘Beginning 
in fiscal year 2008’’; and 
(B) by amending the designation and heading of para-
graph (2) to read as follows: 
‘‘(2) PREMARKET APPLICATION, PREMARKET REPORT, SUPPLE-
MENT, AND SUBMISSION FEE, AND ANNUAL FEE FOR PERIODIC 
REPORTING CONCERNING A CLASS III DEVICE.—’’. 
(2) 
FEE
AMOUNTS.—Section 
738(a)(2)(A) 
(21 
U.S.C. 
379j(a)(2)(A)) is amended— 
(A) in clause (iii), by striking ‘‘a fee equal to the fee 
that applies’’ and inserting ‘‘a fee equal to 75 percent 
of the fee that applies’’; 
(B) in clause (iv), by striking ‘‘21.5 percent’’ and 
inserting ‘‘15 percent’’; 
(C) in clause (v), by striking ‘‘7.2 percent’’ and inserting 
‘‘7 percent’’; 
(D) by redesignating clauses (vi) and (vii) as clauses 
(vii) and (viii), respectively; 
(E) by inserting after clause (v) the following: 
‘‘(vi) For a 30-day notice, a fee equal to 1.6 percent 
of the fee that applies under clause (i).’’; 
(F) in clause (viii), as so redesignated— 
(i) by striking ‘‘1.42 percent’’ and inserting ‘‘1.84 
percent’’; and 
(ii) by striking ‘‘, subject to any adjustment under 
subsection (e)(2)(C)(ii)’’; and 
(G) by inserting after such clause (viii) the following: 
‘‘(ix) For a request for classification information, 
a fee equal to 1.35 percent of the fee that applies 
under clause (i). 
‘‘(x) For periodic reporting concerning a class III 
device, an annual fee equal to 3.5 percent of the fee 
that applies under clause (i).’’. 
(3) PAYMENT.—Section 738(a)(2)(C) (21 U.S.C. 379j(a)(2)(C)) 
is amended to read as follows: 
‘‘(C) PAYMENT.—The fee required by subparagraph (A) 
shall be due upon submission of the premarket application, 
premarket report, supplement, premarket notification 
submission, 
30-day 
notice, 
request 
for 
classification 
information, or periodic reporting concerning a class III 
device. Applicants submitting portions of applications 
pursuant to section 515(c)(4) shall pay such fees upon 
submission of the first portion of such applications.’’. 
(4) REFUNDS.—Section 738(a)(2)(D) (21 U.S.C. 379j(a)(2)(D)) 
is amended— 
(A) in clause (iii), by striking the last two sentences; 
and 
(B) by adding after clause (iii) the following: 
‘‘(iv) MODULAR APPLICATIONS WITHDRAWN BEFORE 
FIRST ACTION.—The Secretary shall refund 75 percent 
of the application fee paid for an application submitted 
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121 STAT. 845 
PUBLIC LAW 110–85—SEPT. 27, 2007 
under section 515(c)(4) that is withdrawn before a 
second portion is submitted and before a first action 
on the first portion. 
‘‘(v) LATER WITHDRAWN MODULAR APPLICATIONS.— 
If an application submitted under section 515(c)(4) is 
withdrawn after a second or subsequent portion is 
submitted but before any first action, the Secretary 
may return a portion of the fee. The amount of refund, 
if any, shall be based on the level of effort already 
expended on the review of the portions submitted. 
‘‘(vi) SOLE DISCRETION TO REFUND.—The Secretary 
shall have sole discretion to refund a fee or portion 
of the fee under clause (iii) or (v). A determination 
by the Secretary concerning a refund under clause 
(iii) or (v) shall not be reviewable.’’. 
(5) ANNUAL
ESTABLISHMENT
REGISTRATION
FEE.—Section 
738(a) (21 U.S.C. 379j(a)) is amended by adding after paragraph 
(2) the following: 
‘‘(3) ANNUAL ESTABLISHMENT REGISTRATION FEE.— 
‘‘(A) IN GENERAL.—Except as provided in subparagraph 
(B), each establishment subject to a registration fee shall 
be subject to a fee for each initial or annual registration 
under section 510 beginning with its registration for fiscal 
year 2008. 
‘‘(B) EXCEPTION.—No fee shall be required under 
subparagraph (A) for an establishment operated by a State 
or Federal governmental entity or an Indian tribe (as 
defined in the Indian Self Determination and Educational 
Assistance Act), unless a device manufactured by the 
establishment is to be distributed commercially. 
‘‘(C) PAYMENT.—The fee required under subparagraph 
(A) shall be due once each fiscal year, upon the initial 
registration of the establishment or upon the annual reg-
istration under section 510.’’. 
(b) FEE
AMOUNTS.—Section 738(b) (21 U.S.C. 379j(b)) is 
amended to read as follows: 
‘‘(b) FEE AMOUNTS.—Except as provided in subsections (c), (d), 
(e), and (h) the fees under subsection (a) shall be based on the 
following fee amounts: 
Fee Type 
Fiscal 
Year 
2008 
Fiscal 
Year 
2009 
Fiscal 
Year 
2010 
Fiscal 
Year 
2011 
Fiscal 
Year 
2012 
Premarket Application ....
$185,000 
$200,725 
$217,787 
$236,298 
$256,384
................
Establishment Registra-
tion ................................
$1,706 
$1,851 
$2,008 
$2,179 
$2,364.’’. 
(c) ANNUAL FEE SETTING.— 
(1) IN GENERAL.—Section 738(c) (21 U.S.C. 379j(c)(1)) is 
amended— 
(A) in the subsection heading, by striking ‘‘Annual 
Fee Setting’’ and inserting ‘‘ANNUAL FEE SETTING’’; and 
(B) in paragraph (1), by striking the last sentence. 
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121 STAT. 846 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(2) ADJUSTMENT OF ANNUAL ESTABLISHMENT FEE.—Section 
738(c) (21 U.S.C. 379j(c)), as amended by paragraph (1), is 
further amended— 
(A) by redesignating paragraphs (2) and (3) as para-
graphs (3) and (4), respectively; 
(B) by inserting after paragraph (1) the following: 
‘‘(2) ADJUSTMENT.— 
‘‘(A) IN GENERAL.—When setting fees for fiscal year 
2010, the Secretary may increase the fee under subsection 
(a)(3)(A) (applicable to establishments subject to registra-
tion) only if the Secretary estimates that the number of 
establishments submitting fees for fiscal year 2009 is fewer 
than 12,250. The percentage increase shall be the percent-
age by which the estimate of establishments submitting 
fees in fiscal year 2009 is fewer than 12,750, but in no 
case may the percentage increase be more than 8.5 percent 
over that specified in subsection (b) for fiscal year 2010. 
If the Secretary makes any adjustment to the fee under 
subsection (a)(3)(A) for fiscal year 2010, then such fee for 
fiscal years 2011 and 2012 shall be adjusted so that such 
fee for fiscal year 2011 is equal to the adjusted fee for 
fiscal year 2010 increased by 8.5 percent, and such fee 
for fiscal year 2012 is equal to the adjusted fee for fiscal 
year 2011 increased by 8.5 percent. 
‘‘(B) PUBLICATION.—For any adjustment made under 
subparagraph (A), the Secretary shall publish in the Fed-
eral Register the Secretary’s determination to make the 
adjustment and the rationale for the determination.’’; and 
(C) in paragraph (4), as redesignated by this para-
graph, in subparagraph (A)— 
(i) by striking ‘‘For fiscal years 2006 and 2007, 
the Secretary’’ and inserting ‘‘The Secretary’’; and 
(ii) by striking ‘‘for the first month of fiscal year 
2008’’ and inserting ‘‘for the first month of the next 
fiscal year’’. 
(d) SMALL BUSINESSES; FEE WAIVER
AND FEE REDUCTION 
REGARDING PREMARKET APPROVAL.— 
(1) IN GENERAL.—Section 738(d)(1) (21 U.S.C. 379j(d)(1)) 
is amended— 
(A) by striking ‘‘, partners, and parent firms’’; and 
(B) by striking ‘‘clauses (i) through (vi) of subsection 
(a)(2)(A)’’ and inserting ‘‘clauses (i) through (v) and clauses 
(vii), (ix), and (x) of subsection (a)(2)(A)’’. 
(2) RULES RELATING TO PREMARKET APPROVAL FEES.— 
(A) 
DEFINITION.—Section 
738(d)(2)(A) 
(21 
U.S.C. 
379j(d)(2)(A)) is amended by striking ‘‘, partners, and 
parent firms’’. 
(B) EVIDENCE OF QUALIFICATION.—Section 738(d)(2)(B) 
(21 U.S.C. 379j(d)(2)(B)) is amended— 
(i) by striking ‘‘(B) EVIDENCE OF QUALIFICATION.— 
An applicant’’ and inserting the following: 
‘‘(B) EVIDENCE OF QUALIFICATION.— 
‘‘(i) IN GENERAL.—An applicant’’; 
(ii) by striking ‘‘The applicant shall support its 
claim’’ and inserting the following: 
Federal Register, 
publication. 
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121 STAT. 847 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(ii) FIRMS
SUBMITTING
TAX
RETURNS
TO
THE 
UNITED
STATES
INTERNAL
REVENUE
SERVICE.—The 
applicant shall support its claim’’; 
(iii) by striking ‘‘, partners, and parent firms’’ each 
place it appears; 
(iv) by striking the last sentence and inserting 
‘‘If no tax forms are submitted for any affiliate, the 
applicant shall certify that the applicant has no affili-
ates.’’; and 
(v) by adding at the end the following: 
‘‘(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE 
UNITED STATES INTERNAL REVENUE SERVICE.—In the 
case of an applicant that has not previously submitted 
a Federal income tax return, the applicant and each 
of its affiliates shall demonstrate that it meets the 
definition under subparagraph (A) by submission of 
a signed certification, in such form as the Secretary 
may direct through a notice published in the Federal 
Register, that the applicant or affiliate meets the cri-
teria for a small business and a certification, in 
English, from the national taxing authority of the 
country in which the applicant or, if applicable, affiliate 
is headquartered. The certification from such taxing 
authority shall bear the official seal of such taxing 
authority and shall provide the applicant’s or affiliate’s 
gross receipts or sales for the most recent year in 
both the local currency of such country and in United 
States dollars, the exchange rate used in converting 
such local currency to dollars, and the dates during 
which these receipts or sales were collected. The 
applicant shall also submit a statement signed by the 
head of the applicant’s firm or by its chief financial 
officer that the applicant has submitted certifications 
for all of its affiliates, or that the applicant has no 
affiliates.’’. 
(3) 
REDUCED
FEES.—Section 
738(d)(2)(C) 
(21 
U.S.C. 
379j(d)(2)(C)) is amended to read as follows: 
‘‘(C) REDUCED FEES.—Where the Secretary finds that 
the applicant involved meets the definition under subpara-
graph (A), the fees established under subsection (c)(1) may 
be paid at a reduced rate of— 
‘‘(i) 25 percent of the fee established under such 
subsection for a premarket application, a premarket 
report, a supplement, or periodic reporting concerning 
a class III device; and 
‘‘(ii) 50 percent of the fee established under such 
subsection for a 30-day notice or a request for classifica-
tion information.’’. 
(e) SMALL BUSINESSES; FEE REDUCTION REGARDING PREMARKET 
NOTIFICATION SUBMISSIONS.— 
(1) IN GENERAL.—Section 738(e)(1) (21 U.S.C. 379j(e)(1)) 
is amended— 
(A) by striking ‘‘2004’’ and inserting ‘‘2008’’; and 
(B) 
by 
striking 
‘‘(a)(2)(A)(vii)’’ 
and 
inserting 
‘‘(a)(2)(A)(viii)’’. 
(2) RULES RELATING TO PREMARKET NOTIFICATION SUBMIS-
SIONS.— 
Certification. 
Federal Register, 
publication. 
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121 STAT. 848 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(A) 
DEFINITION.—Section 
738(e)(2)(A) 
(21 
U.S.C. 
379j(e)(2)(A)) is amended by striking ‘‘, partners, and parent 
firms’’. 
(B) EVIDENCE OF QUALIFICATION.—Section 738(e)(2)(B) 
(21 U.S.C. 379j(e)(2)(B)) is amended— 
(i) by striking ‘‘(B) EVIDENCE OF QUALIFICATION.— 
An applicant’’ and inserting the following: 
‘‘(B) EVIDENCE OF QUALIFICATION.— 
‘‘(i) IN GENERAL.—An applicant’’; 
(ii) by striking ‘‘The applicant shall support its 
claim’’ and inserting the following: 
‘‘(ii) FIRMS
SUBMITTING
TAX
RETURNS
TO
THE 
UNITED
STATES
INTERNAL
REVENUE
SERVICE.—The 
applicant shall support its claim’’; 
(iii) by striking ‘‘, partners, and parent firms’’ each 
place it appears; 
(iv) by striking the last sentence and inserting 
‘‘If no tax forms are submitted for any affiliate, the 
applicant shall certify that the applicant has no affili-
ates.’’; and 
(v) by adding at the end the following: 
‘‘(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE 
UNITED STATES INTERNAL REVENUE SERVICE.—In the 
case of an applicant that has not previously submitted 
a Federal income tax return, the applicant and each 
of its affiliates shall demonstrate that it meets the 
definition under subparagraph (A) by submission of 
a signed certification, in such form as the Secretary 
may direct through a notice published in the Federal 
Register, that the applicant or affiliate meets the cri-
teria for a small business and a certification, in 
English, from the national taxing authority of the 
country in which the applicant or, if applicable, affiliate 
is headquartered. The certification from such taxing 
authority shall bear the official seal of such taxing 
authority and shall provide the applicant’s or affiliate’s 
gross receipts or sales for the most recent year in 
both the local currency of such country and in United 
States dollars, the exchange rate used in converting 
such local currency to dollars, and the dates during 
which these receipts or sales were collected. The 
applicant shall also submit a statement signed by the 
head of the applicant’s firm or by its chief financial 
officer that the applicant has submitted certifications 
for all of its affiliates, or that the applicant has no 
affiliates.’’. 
(3) 
REDUCED
FEES.—Section 
738(e)(2)(C) 
(21 
U.S.C. 
379j(e)(2)(C)) is amended to read as follows: 
‘‘(C) REDUCED FEES.—For fiscal year 2008 and each 
subsequent fiscal year, where the Secretary finds that the 
applicant involved meets the definition under subparagraph 
(A), the fee for a premarket notification submission may 
be paid at 50 percent of the fee that applies under sub-
section (a)(2)(A)(viii), and as established under subsection 
(c)(1).’’. 
(f) EFFECT OF FAILURE TO PAY FEES.—Section 738(f) (21 U.S.C. 
379j(f)) is amended to read as follows: 
Certification. 
Federal Register, 
publication. 
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121 STAT. 849 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(f) EFFECT OF FAILURE TO PAY FEES.— 
‘‘(1) NO
ACCEPTANCE
OF
SUBMISSIONS.—A premarket 
application, premarket report, supplement, premarket notifica-
tion submission, 30-day notice, request for classification 
information, or periodic reporting concerning a class III device 
submitted by a person subject to fees under subsections (a)(2) 
and (a)(3) shall be considered incomplete and shall not be 
accepted by the Secretary until all fees owed by such person 
have been paid. 
‘‘(2) NO REGISTRATION.—Registration information submitted 
under section 510 by an establishment subject to a registration 
fee shall be considered incomplete and shall not be accepted 
by the Secretary until the registration fee under subsection 
(a)(3) owed for the establishment has been paid. Until the 
fee is paid and the registration is complete, the establishment 
is deemed to have failed to register in accordance with section 
510.’’. 
(g) 
CONDITIONS.—Section 
738(g) 
(21 
U.S.C. 
379j(g)) 
is 
amended— 
(1) by striking paragraph (1) and inserting the following: 
‘‘(1) PERFORMANCE
GOALS; TERMINATION
OF
PROGRAM.— 
With respect to the amount that, under the salaries and 
expenses account of the Food and Drug Administration, is 
appropriated for a fiscal year for devices and radiological prod-
ucts, fees may not be assessed under subsection (a) for the 
fiscal year, and the Secretary is not expected to meet any 
performance goals identified for the fiscal year, if— 
‘‘(A) the amount so appropriated for the fiscal year, 
excluding the amount of fees appropriated for the fiscal 
year, is more than 1 percent less than $205,720,000 multi-
plied by the adjustment factor applicable to such fiscal 
year; or 
‘‘(B) fees were not assessed under subsection (a) for 
the previous fiscal year.’’; and 
(2) by amending paragraph (2) to read as follows: 
‘‘(2) AUTHORITY.—If the Secretary does not assess fees 
under subsection (a) during any portion of a fiscal year because 
of paragraph (1) and if at a later date in such fiscal year 
the Secretary may assess such fees, the Secretary may assess 
and collect such fees, without any modification in the rate 
for premarket applications, supplements, premarket reports, 
premarket notification submissions, 30-day notices, requests 
for classification information, periodic reporting concerning a 
class III device, and establishment registrations at any time 
in such fiscal year, notwithstanding the provisions of subsection 
(a) relating to the date fees are to be paid.’’. 
(h) CREDITING AND AVAILABILITY OF FEES.— 
(1) AUTHORIZATION OF APPROPRIATIONS.—Section 738(h)(3) 
(21 U.S.C. 379j(h)(3)) is amended to read as follows: 
‘‘(3) AUTHORIZATIONS
OF
APPROPRIATIONS.—There are 
authorized to be appropriated for fees under this section— 
‘‘(A) $48,431,000 for fiscal year 2008; 
‘‘(B) $52,547,000 for fiscal year 2009; 
‘‘(C) $57,014,000 for fiscal year 2010; 
‘‘(D) $61,860,000 for fiscal year 2011; and 
‘‘(E) $67,118,000 for fiscal year 2012.’’. 
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121 STAT. 850 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(2) OFFSET.—Section 738(h)(4) (21 U.S.C. 379j(h)(3)) is 
amended to read as follows: 
‘‘(4) OFFSET.—If the cumulative amount of fees collected 
during fiscal years 2008, 2009, and 2010, added to the amount 
estimated to be collected for fiscal year 2011, which estimate 
shall be based upon the amount of fees received by the Sec-
retary through June 30, 2011, exceeds the amount of fees 
specified in aggregate in paragraph (3) for these four fiscal 
years, the aggregate amount in excess shall be credited to 
the appropriation account of the Food and Drug Administration 
as provided in paragraph (1), and shall be subtracted from 
the amount of fees that would otherwise be authorized to be 
collected under this section pursuant to appropriation Acts 
for fiscal year 2012.’’. 
SEC. 213. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Part 3 of subchapter C of chapter VII is amended by inserting 
after section 738 the following: 
‘‘SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS. 
‘‘(a) REPORTS.— 
‘‘(1) PERFORMANCE REPORT.—For fiscal years 2008 through 
2012, not later than 120 days after the end of each fiscal 
year during which fees are collected under this part, the Sec-
retary shall prepare and submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Representa-
tives, a report concerning the progress of the Food and Drug 
Administration in achieving the goals identified in the letters 
described in section 201(c) of the Food and Drug Administration 
Amendments Act of 2007 during such fiscal year and the future 
plans of the Food and Drug Administration for meeting the 
goals. The report for a fiscal year shall include information 
on all previous cohorts for which the Secretary has not given 
a complete response on all device premarket applications and 
reports, supplements, and premarket notifications in the cohort. 
‘‘(2) FISCAL REPORT.—For fiscal years 2008 through 2012, 
not later than 120 days after the end of each fiscal year during 
which fees are collected under this part, the Secretary shall 
prepare and submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives, a report 
on the implementation of the authority for such fees during 
such fiscal year and the use, by the Food and Drug Administra-
tion, of the fees collected during such fiscal year for which 
the report is made. 
‘‘(3) PUBLIC AVAILABILITY.—The Secretary shall make the 
reports required under paragraphs (1) and (2) available to 
the public on the Internet Web site of the Food and Drug 
Administration. 
‘‘(b) REAUTHORIZATION.— 
‘‘(1) CONSULTATION.—In developing recommendations to 
present to Congress with respect to the goals, and plans for 
meeting the goals, for the process for the review of device 
applications for the first 5 fiscal years after fiscal year 2012, 
and for the reauthorization of this part for such fiscal years, 
the Secretary shall consult with— 
Web site. 
21 USC 379j–1. 
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121 STAT. 851 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(A) the Committee on Energy and Commerce of the 
House of Representatives; 
‘‘(B) the Committee on Health, Education, Labor, and 
Pensions of the Senate; 
‘‘(C) scientific and academic experts; 
‘‘(D) health care professionals; 
‘‘(E) representatives of patient and consumer advocacy 
groups; and 
‘‘(F) the regulated industry. 
‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations 
with the regulated industry on the reauthorization of this part, 
the Secretary shall— 
‘‘(A) publish a notice in the Federal Register requesting 
public input on the reauthorization; 
‘‘(B) hold a public meeting at which the public may 
present its views on the reauthorization, including specific 
suggestions for changes to the goals referred to in sub-
section (a)(1); 
‘‘(C) provide a period of 30 days after the public meeting 
to obtain written comments from the public suggesting 
changes to this part; and 
‘‘(D) publish the comments on the Food and Drug 
Administration’s Internet Web site. 
‘‘(3) PERIODIC
CONSULTATION.—Not less frequently than 
once every month during negotiations with the regulated 
industry, the Secretary shall hold discussions with representa-
tives of patient and consumer advocacy groups to continue 
discussions of their views on the reauthorization and their 
suggestions for changes to this part as expressed under para-
graph (2). 
‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotia-
tions with the regulated industry, the Secretary shall— 
‘‘(A) present the recommendations developed under 
paragraph (1) to the Congressional committees specified 
in such paragraph; 
‘‘(B) publish such recommendations in the Federal Reg-
ister; 
‘‘(C) provide for a period of 30 days for the public 
to provide written comments on such recommendations; 
‘‘(D) hold a meeting at which the public may present 
its views on such recommendations; and 
‘‘(E) after consideration of such public views and com-
ments, revise such recommendations as necessary. 
‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 
January 15, 2012, the Secretary shall transmit to Congress 
the revised recommendations under paragraph (4), a summary 
of the views and comments received under such paragraph, 
and any changes made to the recommendations in response 
to such views and comments. 
‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 
‘‘(A) PUBLIC AVAILABILITY.—Before presenting the rec-
ommendations developed under paragraphs (1) through (5) 
to the Congress, the Secretary shall make publicly avail-
able, on the public Web site of the Food and Drug Adminis-
tration, minutes of all negotiation meetings conducted 
under this subsection between the Food and Drug Adminis-
tration and the regulated industry. 
Web site. 
Deadline. 
Federal Register, 
publication. 
Web site. 
Federal Register, 
publication. 
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121 STAT. 852 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(B) CONTENT.—The minutes described under subpara-
graph (A) shall summarize any substantive proposal made 
by any party to the negotiations as well as significant 
controversies or differences of opinion during the negotia-
tions and their resolution.’’. 
SEC. 214. SAVINGS CLAUSE. 
Notwithstanding section 107 of the Medical Device User Fee 
and Modernization Act of 2002 (Public Law 107–250), and notwith-
standing the amendments made by this subtitle, part 3 of sub-
chapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379i et seq.), as in effect on the day before the 
date of the enactment of this subtitle, shall continue to be in 
effect with respect to premarket applications, premarket reports, 
premarket notification submissions, and supplements (as defined 
in such part as of such day) that on or after October 1, 2002, 
but before October 1, 2007, were accepted by the Food and Drug 
Administration for filing with respect to assessing and collecting 
any fee required by such part for a fiscal year prior to fiscal 
year 2008. 
SEC. 215. ADDITIONAL AUTHORIZATION OF APPROPRIATIONS FOR 
POSTMARKET SAFETY INFORMATION. 
For the purpose of collecting, developing, reviewing, and evalu-
ating postmarket safety information on medical devices, there are 
authorized to be appropriated to the Food and Drug Administration, 
in addition to the amounts authorized by other provisions of law 
for such purpose— 
(1) $7,100,000 for fiscal year 2008; 
(2) $7,455,000 for fiscal year 2009; 
(3) $7,827,750 for fiscal year 2010; 
(4) $8,219,138 for fiscal year 2011; and 
(5) $8,630,094 for fiscal year 2012. 
SEC. 216. EFFECTIVE DATE. 
The amendments made by this subtitle shall take effect on 
October 1, 2007, or the date of the enactment of this Act, whichever 
is later, except that fees under part 3 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 
for all premarket applications, premarket reports, supplements, 
30-day notices, and premarket notification submissions received 
on or after October 1, 2007, regardless of the date of the enactment 
of this Act. 
SEC. 217. SUNSET CLAUSE. 
The amendments made by this subtitle cease to be effective 
October 1, 2012, except that section 738A of the Federal Food, 
Drug, and Cosmetic Act (regarding annual performance and finan-
cial reports) ceases to be effective January 31, 2013. 
Subtitle B—Amendments Regarding 
Regulation of Medical Devices 
SEC. 221. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF 
PREMARKET NOTIFICATION. 
Section 523(c) (21 U.S.C. 360m(c)) is amended by striking 
‘‘2007’’ and inserting ‘‘2012’’. 
21 USC 379i 
note. 
21 USC 379i 
note. 
21 USC 379i 
note. 
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121 STAT. 853 
PUBLIC LAW 110–85—SEPT. 27, 2007 
SEC. 222. REGISTRATION. 
(a) ANNUAL REGISTRATION
OF PRODUCERS
OF DRUGS
AND 
DEVICES.—Section 510(b) (21 U.S.C. 360(b)) is amended— 
(1) by striking ‘‘(b) On or before’’ and inserting ‘‘(b)(1) 
On or before’’; 
(2) by striking ‘‘or a device or devices’’; and 
(3) by adding at the end the following: 
‘‘(2) During the period beginning on October 1 and ending 
on December 31 of each year, every person who owns or operates 
any establishment in any State engaged in the manufacture, 
preparation, propagation, compounding, or processing of a device 
or devices shall register with the Secretary his name, places of 
business, and all such establishments.’’. 
(b) REGISTRATION
OF
FOREIGN
ESTABLISHMENTS.—Section 
510(i)(1) (21 U.S.C. 360(i)(1)) is amended by striking ‘‘On or before 
December 31’’ and all that follows and inserting the following: 
‘‘Any establishment within any foreign country engaged in the 
manufacture, preparation, propagation, compounding, or processing 
of a drug or device that is imported or offered for import into 
the United States shall, through electronic means in accordance 
with the criteria of the Secretary— 
‘‘(A) upon first engaging in any such activity, immediately 
register with the Secretary the name and place of business 
of the establishment, the name of the United States agent 
for the establishment, the name of each importer of such drug 
or device in the United States that is known to the establish-
ment, and the name of each person who imports or offers 
for import such drug or device to the United States for purposes 
of importation; and 
‘‘(B) each establishment subject to the requirements of 
subparagraph (A) shall thereafter— 
‘‘(i) with respect to drugs, register with the Secretary 
on or before December 31 of each year; and 
‘‘(ii) with respect to devices, register with the Secretary 
during the period beginning on October 1 and ending on 
December 31 of each year.’’. 
SEC. 223. FILING OF LISTS OF DRUGS AND DEVICES MANUFACTURED, 
PREPARED, PROPAGATED, AND COMPOUNDED BY REG-
ISTRANTS; STATEMENTS; ACCOMPANYING DISCLOSURES. 
Section 510(j)(2) (21 U.S.C. 360(j)(2)) is amended, in the matter 
preceding subparagraph (A), by striking ‘‘Each person’’ and all 
that follows through ‘‘the following information:’’ and inserting 
‘‘Each person who registers with the Secretary under this section 
shall report to the Secretary, with regard to drugs once during 
the month of June of each year and once during the month of 
December of each year, and with regard to devices once each year 
during the period beginning on October 1 and ending on December 
31, the following information:’’. 
SEC. 224. ELECTRONIC REGISTRATION AND LISTING. 
Section 510(p) (21 U.S.C. 360(p)) is amended to read as follows: 
‘‘(p) Registrations and listings under this section (including 
the submission of updated information) shall be submitted to the 
Secretary by electronic means unless the Secretary grants a request 
for waiver of such requirement because use of electronic means 
is not reasonable for the person requesting such waiver.’’. 
Reports. 
Deadlines. 
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121 STAT. 854 
PUBLIC LAW 110–85—SEPT. 27, 2007 
SEC. 225. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE. 
(a) IN GENERAL.—The Comptroller General of the United States 
shall conduct a study on the appropriate use of the process under 
section 510(k) of the Federal Food, Drug, and Cosmetic Act as 
part of the device classification process to determine whether a 
new device is as safe and effective as a classified device. 
(b) CONSIDERATION.—In determining the effectiveness of the 
premarket notification and classification authority under section 
510(k) and subsections (f) and (i) of section 513 of the Federal 
Food, Drug, and Cosmetic Act, the study under subsection (a) shall 
consider the Secretary of Health and Human Services’s evaluation 
of the respective intended uses and technologies of such devices, 
including the effectiveness of such Secretary’s comparative assess-
ment of technological characteristics such as device materials, prin-
ciples of operations, and power sources. 
(c) REPORT.—Not later than 1 year after the date of the enact-
ment of this Act, the Comptroller General shall complete the study 
under subsection (a) and submit to the Congress a report on the 
results of such study. 
SEC. 226. UNIQUE DEVICE IDENTIFICATION SYSTEM. 
(a) IN GENERAL.—Section 519 (21 U.S.C. 360i) is amended— 
(1) by redesignating subsection (f) as subsection (g); and 
(2) by inserting after subsection (e) the following: 
‘‘Unique Device Identification System 
‘‘(f) The Secretary shall promulgate regulations establishing 
a unique device identification system for medical devices requiring 
the label of devices to bear a unique identifier, unless the Secretary 
requires an alternative placement or provides an exception for 
a particular device or type of device. The unique identifier shall 
adequately identify the device through distribution and use, and 
may include information on the lot or serial number.’’. 
(b) CONFORMING AMENDMENT.—Section 303 (21 U.S.C. 333) 
is amended— 
(1) by redesignating the subsection that follows subsection 
(e) as subsection (f); and 
(2) in paragraph (1)(B)(ii) of subsection (f), as so redesig-
nated, by striking ‘‘519(f)’’ and inserting ‘‘519(g)’’. 
SEC. 227. FREQUENCY OF REPORTING FOR CERTAIN DEVICES. 
Subparagraph (B) of section 519(a)(1) (21 U.S.C. 360i(a)(1)) 
is amended by striking ‘‘were to recur;’’ and inserting the following: 
‘‘were to recur, which report under this subparagraph— 
‘‘(i) shall be submitted in accordance with part 
803 of title 21, Code of Federal Regulations (or suc-
cessor regulations), unless the Secretary grants an 
exemption or variance from, or an alternative to, a 
requirement under such regulations pursuant to sec-
tion 803.19 of such part, if the device involved is— 
‘‘(I) a class III device; 
‘‘(II) a class II device that is permanently 
implantable, is life supporting, or is life sustaining; 
or 
‘‘(III) a type of device which the Secretary 
has, by notice published in the Federal Register 
or letter to the person who is the manufacturer 
Federal Register, 
publication. 
Regulations. 
Study. 
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121 STAT. 855 
PUBLIC LAW 110–85—SEPT. 27, 2007 
or importer of the device, indicated should be sub-
ject to such part 803 in order to protect the public 
health; 
‘‘(ii) shall, if the device is not subject to clause 
(i), be submitted in accordance with criteria established 
by the Secretary for reports made pursuant to this 
clause, which criteria shall require the reports to be 
in summary form and made on a quarterly basis; or 
‘‘(iii) shall, if the device is imported into the United 
States and for which part 803 of title 21, Code of 
Federal Regulations (or successor regulations) requires 
an importer to submit a report to the manufacturer, 
be submitted by the importer to the manufacturer in 
accordance with part 803 of title 21, Code of Federal 
Regulations (or successor regulations)’’. 
SEC. 228. INSPECTIONS BY ACCREDITED PERSONS. 
Section 704(g) (21 U.S.C. 374(g)) is amended— 
(1) in paragraph (1), by striking ‘‘Not later than one year 
after the date of the enactment of this subsection, the Secretary’’ 
and inserting ‘‘The Secretary’’; 
(2) in paragraph (2), by— 
(A) striking ‘‘Not later than 180 days after the date 
of enactment of this subsection, the Secretary’’ and 
inserting ‘‘The Secretary’’; and 
(B) striking the fifth sentence; 
(3) in paragraph (3), by adding at the end the following: 
‘‘(F) Such person shall notify the Secretary of any with-
drawal, suspension, restriction, or expiration of certificate of 
conformance with the quality systems standard referred to 
in paragraph (7) for any device establishment that such person 
inspects under this subsection not later than 30 days after 
such withdrawal, suspension, restriction, or expiration. 
‘‘(G) Such person may conduct audits to establish conform-
ance with the quality systems standard referred to in paragraph 
(7).’’; 
(4) by amending paragraph (6) to read as follows: 
‘‘(6)(A) Subject to subparagraphs (B) and (C), a device establish-
ment is eligible for inspection by persons accredited under para-
graph (2) if the following conditions are met: 
‘‘(i) The Secretary classified the results of the most recent 
inspection of the establishment as ‘no action indicated’ or ‘vol-
untary action indicated’. 
‘‘(ii) With respect to inspections of the establishment to 
be conducted by an accredited person, the owner or operator 
of the establishment submits to the Secretary a notice that— 
‘‘(I) provides the date of the last inspection of the 
establishment by the Secretary and the classification of 
that inspection; 
‘‘(II) states the intention of the owner or operator to 
use an accredited person to conduct inspections of the 
establishment; 
‘‘(III) identifies the particular accredited person the 
owner or operator intends to select to conduct such inspec-
tions; and 
Notification. 
Deadline. 
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121 STAT. 856 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(IV) includes a certification that, with respect to the 
devices that are manufactured, prepared, propagated, com-
pounded, or processed in the establishment— 
‘‘(aa) at least 1 of such devices is marketed in 
the United States; and 
‘‘(bb) at least 1 of such devices is marketed, or 
is intended to be marketed, in 1 or more foreign coun-
tries, 1 of which countries certifies, accredits, or other-
wise recognizes the person accredited under paragraph 
(2) and identified under subclause (III) as a person 
authorized to conduct inspections of device establish-
ments. 
‘‘(B)(i) Except with respect to the requirement of subparagraph 
(A)(i), a device establishment is deemed to have clearance to partici-
pate in the program and to use the accredited person identified 
in the notice under subparagraph (A)(ii) for inspections of the 
establishment unless the Secretary, not later than 30 days after 
receiving such notice, issues a response that— 
‘‘(I) denies clearance to participate as provided under 
subparagraph (C); or 
‘‘(II) makes a request under clause (ii). 
‘‘(ii) The Secretary may request from the owner or operator 
of a device establishment in response to the notice under subpara-
graph (A)(ii) with respect to the establishment, or from the par-
ticular accredited person identified in such notice— 
‘‘(I) compliance data for the establishment in accordance 
with clause (iii)(I); or 
‘‘(II) information concerning the relationship between the 
owner or operator of the establishment and the accredited 
person identified in such notice in accordance with clause 
(iii)(II). 
The owner or operator of the establishment, or such accredited 
person, as the case may be, shall respond to such a request not 
later than 60 days after receiving such request. 
‘‘(iii)(I) The compliance data to be submitted by the owner 
or operator of a device establishment in response to a request 
under clause (ii)(I) are data describing whether the quality controls 
of the establishment have been sufficient for ensuring consistent 
compliance with current good manufacturing practice within the 
meaning of section 501(h) and with other applicable provisions 
of this Act. Such data shall include complete reports of inspectional 
findings regarding good manufacturing practice or other quality 
control audits that, during the preceding 2-year period, were con-
ducted at the establishment by persons other than the owner or 
operator of the establishment, together with all other compliance 
data the Secretary deems necessary. Data under the preceding 
sentence shall demonstrate to the Secretary whether the establish-
ment has facilitated consistent compliance by promptly correcting 
any compliance problems identified in such inspections. 
‘‘(II) A request to an accredited person under clause (ii)(II) 
may not seek any information that is not required to be maintained 
by such person in records under subsection (f)(1). 
‘‘(iv) A device establishment is deemed to have clearance to 
participate in the program and to use the accredited person identi-
fied in the notice under subparagraph (A)(ii) for inspections of 
the establishment unless the Secretary, not later than 60 days 
after receiving the information requested under clause (ii), issues 
Deadline. 
Deadline. 
Deadline. 
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121 STAT. 857 
PUBLIC LAW 110–85—SEPT. 27, 2007 
a response that denies clearance to participate as provided under 
subparagraph (C). 
‘‘(C)(i) The Secretary may deny clearance to a device establish-
ment if the Secretary has evidence that the certification under 
subparagraph (A)(ii)(IV) is untrue and the Secretary provides to 
the owner or operator of the establishment a statement summa-
rizing such evidence. 
‘‘(ii) The Secretary may deny clearance to a device establish-
ment if the Secretary determines that the establishment has failed 
to demonstrate consistent compliance for purposes of subparagraph 
(B)(iii)(I) and the Secretary provides to the owner or operator of 
the establishment a statement of the reasons for such determina-
tion. 
‘‘(iii)(I) The Secretary may reject the selection of the accredited 
person identified in the notice under subparagraph (A)(ii) if the 
Secretary provides to the owner or operator of the establishment 
a statement of the reasons for such rejection. Reasons for the 
rejection may include that the establishment or the accredited 
person, as the case may be, has failed to fully respond to the 
request, or that the Secretary has concerns regarding the relation-
ship between the establishment and such accredited person. 
‘‘(II) If the Secretary rejects the selection of an accredited 
person by the owner or operator of a device establishment, the 
owner or operator may make an additional selection of an accredited 
person by submitting to the Secretary a notice that identifies the 
additional selection. Clauses (i) and (ii) of subparagraph (B), and 
subclause (I) of this clause, apply to the selection of an accredited 
person through a notice under the preceding sentence in the same 
manner and to the same extent as such provisions apply to a 
selection of an accredited person through a notice under subpara-
graph (A)(ii). 
‘‘(iv) In the case of a device establishment that is denied clear-
ance under clause (i) or (ii) or with respect to which the selection 
of the accredited person is rejected under clause (iii), the Secretary 
shall designate a person to review the statement of reasons, or 
statement summarizing such evidence, as the case may be, of the 
Secretary under such clause if, during the 30-day period beginning 
on the date on which the owner or operator of the establishment 
receives such statement, the owner or operator requests the review. 
The review shall commence not later than 30 days after the owner 
or operator requests the review, unless the Secretary and the owner 
or operator otherwise agree.’’; 
(5) in paragraph (7)— 
(A) in subparagraph (A), by striking ‘‘(A) Persons’’ and 
all that follows through the end and inserting the following: 
‘‘(A) Persons accredited under paragraph (2) to conduct 
inspections shall record in writing their inspection observa-
tions and shall present the observations to the device 
establishment’s designated representative and describe 
each observation. Additionally, such accredited person shall 
prepare an inspection report in a form and manner des-
ignated by the Secretary to conduct inspections, taking 
into consideration the goals of international harmonization 
of quality systems standards. Any official classification of 
the inspection shall be determined by the Secretary.’’; and 
(B) by adding at the end the following: 
Reports. 
Records. 
Deadline. 
Applicability. 
Notification. 
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121 STAT. 858 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(F) For the purpose of setting risk-based inspectional priorities, 
the Secretary shall accept voluntary submissions of reports of audits 
assessing conformance with appropriate quality systems standards 
set by the International Organization for Standardization (ISO) 
and identified by the Secretary in public notice. If the owner or 
operator of an establishment elects to submit audit reports under 
this subparagraph, the owner or operator shall submit all such 
audit reports with respect to the establishment during the preceding 
2-year periods.’’; and 
(6) in paragraph (10)(C)(iii), by striking ‘‘based’’ and 
inserting ‘‘base’’. 
SEC. 229. STUDY OF NOSOCOMIAL INFECTIONS RELATING TO MEDICAL 
DEVICES. 
(a) IN GENERAL.—The Comptroller General of the United States 
shall conduct a study on— 
(1) the number of nosocomial infections attributable to 
new and reused medical devices; and 
(2) the causes of such nosocomial infections, including the 
following: 
(A) Reprocessed single-use devices. 
(B) Handling of sterilized medical devices. 
(C) In-hospital sterilization of medical devices. 
(D) Health care professionals’ practices for patient 
examination and treatment. 
(E) Hospital-based policies and procedures for infection 
control and prevention. 
(F) Hospital-based practices for handling of medical 
waste. 
(G) Other causes. 
(b) REPORT.—Not later than 1 year after the date of the enact-
ment of this Act, the Comptroller General shall complete the study 
under subsection (a) and submit to the Congress a report on the 
results of such study. 
(c) DEFINITION.—In this section, the term ‘‘nosocomial infection’’ 
means an infection that is acquired while an individual is a patient 
at a hospital and was neither present nor incubating in the patient 
prior to receiving services in the hospital. 
SEC. 230. REPORT BY THE FOOD AND DRUG ADMINISTRATION 
REGARDING LABELING INFORMATION ON THE RELATION-
SHIP BETWEEN THE USE OF INDOOR TANNING DEVICES 
AND DEVELOPMENT OF SKIN CANCER OR OTHER SKIN 
DAMAGE. 
(a) IN GENERAL.—The Secretary of Health and Human Services 
(referred to in this section as the ‘‘Secretary’’), acting through the 
Commissioner of Food and Drugs, shall determine— 
(1) whether the labeling requirements for indoor tanning 
devices, including the positioning requirements, provide suffi-
cient information to consumers regarding the risks that the 
use of such devices pose for the development of irreversible 
damage to the eyes and skin, including skin cancer; and 
(2)(A) whether modifying the warning label required on 
tanning beds to read, ‘‘Ultraviolet radiation can cause skin 
cancer’’, or any other additional warning, would communicate 
the risks of indoor tanning more effectively; or 
(B) whether there is no warning that would be capable 
of adequately communicating such risks. 
Audits. 
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121 STAT. 859 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(b) CONSUMER TESTING.—In making the determinations under 
subsection (a), the Secretary shall conduct appropriate consumer 
testing to determine consumer understanding of label warnings. 
(c) REPORT.—Not later than 1 year after the date of the enact-
ment of this Act, the Secretary shall submit to the Congress a 
report that provides the determinations under subsection (a). In 
addition, the Secretary shall include in the report the measures 
being implemented by the Secretary to significantly reduce the 
risks associated with indoor tanning devices. 
TITLE III—PEDIATRIC MEDICAL DEVICE 
SAFETY AND IMPROVEMENT ACT OF 
2007 
SEC. 301. SHORT TITLE. 
This title may be cited as the ‘‘Pediatric Medical Device Safety 
and Improvement Act of 2007’’. 
SEC. 302. TRACKING PEDIATRIC DEVICE APPROVALS. 
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 351 et seq.) is amended by inserting after section 515 the 
following: 
‘‘SEC. 515A. PEDIATRIC USES OF DEVICES. 
‘‘(a) NEW DEVICES.— 
‘‘(1) IN GENERAL.—A person that submits to the Secretary 
an application under section 520(m), or an application (or 
supplement to an application) or a product development protocol 
under section 515, shall include in the application or protocol 
the information described in paragraph (2). 
‘‘(2) REQUIRED INFORMATION.—The application or protocol 
described in paragraph (1) shall include, with respect to the 
device for which approval is sought and if readily available— 
‘‘(A) a description of any pediatric subpopulations that 
suffer from the disease or condition that the device is 
intended to treat, diagnose, or cure; and 
‘‘(B) the number of affected pediatric patients. 
‘‘(3) ANNUAL REPORT.—Not later than 18 months after the 
date of the enactment of this section, and annually thereafter, 
the Secretary shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives 
a report that includes— 
‘‘(A) the number of devices approved in the year pre-
ceding the year in which the report is submitted, for which 
there is a pediatric subpopulation that suffers from the 
disease or condition that the device is intended to treat, 
diagnose, or cure; 
‘‘(B) the number of devices approved in the year pre-
ceding the year in which the report is submitted, labeled 
for use in pediatric patients; 
‘‘(C) the number of pediatric devices approved in the 
year preceding the year in which the report is submitted, 
exempted from a fee pursuant to section 738(a)(2)(B)(v); 
and 
21 USC 360e–1. 
21 USC 301 note. 
Pediatric Medical 
Device Safety 
and 
Improvement Act 
of 2007. 
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121 STAT. 860 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(D) the review time for each device described in sub-
paragraphs (A), (B), and (C). 
‘‘(b) DETERMINATION OF PEDIATRIC EFFECTIVENESS BASED ON 
SIMILAR COURSE OF DISEASE OR CONDITION OR SIMILAR EFFECT 
OF DEVICE ON ADULTS.— 
‘‘(1) IN GENERAL.—If the course of the disease or condition 
and the effects of the device are sufficiently similar in adults 
and pediatric patients, the Secretary may conclude that adult 
data may be used to support a determination of a reasonable 
assurance of effectiveness in pediatric populations, as appro-
priate. 
‘‘(2) EXTRAPOLATION BETWEEN SUBPOPULATIONS.—A study 
may not be needed in each pediatric subpopulation if data 
from one subpopulation can be extrapolated to another sub-
population. 
‘‘(c) PEDIATRIC SUBPOPULATION.—For purposes of this section, 
the term ‘pediatric subpopulation’ has the meaning given the term 
in section 520(m)(6)(E)(ii).’’. 
SEC. 303. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION. 
(a) IN GENERAL.—Section 520(m) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360j(m)) is amended— 
(1) in paragraph (3), by striking ‘‘No’’ and inserting ‘‘Except 
as provided in paragraph (6), no’’; 
(2) in paragraph (5)— 
(A) by inserting ‘‘, if the Secretary has reason to believe 
that the requirements of paragraph (6) are no longer met,’’ 
after ‘‘public health’’; and 
(B) by adding at the end the following: ‘‘If the person 
granted an exemption under paragraph (2) fails to dem-
onstrate continued compliance with the requirements of 
this subsection, the Secretary may suspend or withdraw 
the exemption from the effectiveness requirements of sec-
tions 514 and 515 for a humanitarian device only after 
providing notice and an opportunity for an informal 
hearing.’’; and 
(3) by striking paragraph (6) and inserting after paragraph 
(5) the following new paragraphs: 
‘‘(6)(A) Except as provided in subparagraph (D), the prohibition 
in paragraph (3) shall not apply with respect to a person granted 
an exemption under paragraph (2) if each of the following conditions 
apply: 
‘‘(i)(I) The device with respect to which the exemption is 
granted is intended for the treatment or diagnosis of a disease 
or condition that occurs in pediatric patients or in a pediatric 
subpopulation, and such device is labeled for use in pediatric 
patients or in a pediatric subpopulation in which the disease 
or condition occurs. 
‘‘(II) The device was not previously approved under this 
subsection for the pediatric patients or the pediatric subpopula-
tion described in subclause (I) prior to the date of the enactment 
of the Pediatric Medical Device Safety and Improvement Act 
of 2007. 
‘‘(ii) During any calendar year, the number of such devices 
distributed during that year does not exceed the annual dis-
tribution number specified by the Secretary when the Secretary 
grants such exemption. The annual distribution number shall 
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121 STAT. 861 
PUBLIC LAW 110–85—SEPT. 27, 2007 
be based on the number of individuals affected by the disease 
or condition that such device is intended to treat, diagnose, 
or cure, and of that number, the number of individuals likely 
to use the device, and the number of devices reasonably nec-
essary to treat such individuals. In no case shall the annual 
distribution number exceed the number identified in paragraph 
(2)(A). 
‘‘(iii) Such person immediately notifies the Secretary if 
the number of such devices distributed during any calendar 
year exceeds the annual distribution number referred to in 
clause (ii). 
‘‘(iv) The request for such exemption is submitted on or 
before October 1, 2012. 
‘‘(B) The Secretary may inspect the records relating to the 
number of devices distributed during any calendar year of a person 
granted an exemption under paragraph (2) for which the prohibition 
in paragraph (3) does not apply. 
‘‘(C) A person may petition the Secretary to modify the annual 
distribution number specified by the Secretary under subparagraph 
(A)(ii) with respect to a device if additional information on the 
number of individuals affected by the disease or condition arises, 
and the Secretary may modify such number but in no case shall 
the annual distribution number exceed the number identified in 
paragraph (2)(A). 
‘‘(D) If a person notifies the Secretary, or the Secretary deter-
mines through an inspection under subparagraph (B), that the 
number of devices distributed during any calendar year exceeds 
the annual distribution number, as required under subparagraph 
(A)(iii), and modified under subparagraph (C), if applicable, then 
the prohibition in paragraph (3) shall apply with respect to such 
person for such device for any sales of such device after such 
notification. 
‘‘(E)(i) In this subsection, the term ‘pediatric patients’ means 
patients who are 21 years of age or younger at the time of the 
diagnosis or treatment. 
‘‘(ii) In this subsection, the term ‘pediatric subpopulation’ means 
1 of the following populations: 
‘‘(I) Neonates. 
‘‘(II) Infants. 
‘‘(III) Children. 
‘‘(IV) Adolescents. 
‘‘(7) The Secretary shall refer any report of an adverse event 
regarding a device for which the prohibition under paragraph (3) 
does not apply pursuant to paragraph (6)(A) that the Secretary 
receives to the Office of Pediatric Therapeutics, established under 
section 6 of the Best Pharmaceuticals for Children Act (Public 
Law 107–109). In considering the report, the Director of the Office 
of Pediatric Therapeutics, in consultation with experts in the Center 
for Devices and Radiological Health, shall provide for periodic 
review of the report by the Pediatric Advisory Committee, including 
obtaining any recommendations of such committee regarding 
whether the Secretary should take action under this Act in response 
to the report. 
‘‘(8) The Secretary, acting through the Office of Pediatric Thera-
peutics and the Center for Devices and Radiological Health, shall 
provide for an annual review by the Pediatric Advisory Committee 
Annual review. 
Applicability. 
Deadline. 
Notification. 
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121 STAT. 862 
PUBLIC LAW 110–85—SEPT. 27, 2007 
of all devices described in paragraph (6) to ensure that the exemp-
tion under paragraph (2) remains appropriate for the pediatric 
populations for which it is granted.’’. 
(b) REPORT.—Not later than January 1, 2012, the Comptroller 
General of the United States shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of Representa-
tives a report on the impact of allowing persons granted an exemp-
tion under section 520(m)(2) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j(m)(2)) with respect to a device to profit 
from such device pursuant to section 520(m)(6) of such Act (21 
U.S.C. 360j(m)(6)) (as amended by subsection (a)), including— 
(1) an assessment of whether such section 520(m)(6) (as 
amended by subsection (a)) has increased the availability of 
pediatric devices for conditions that occur in small numbers 
of children, including any increase or decrease in the number 
of— 
(A) exemptions granted under such section 520(m)(2) 
for pediatric devices; and 
(B) applications approved under section 515 of such 
Act (21 U.S.C. 360e) for devices intended to treat, diagnose, 
or cure conditions that occur in pediatric patients or for 
devices labeled for use in a pediatric population; 
(2) the conditions or diseases the pediatric devices were 
intended to treat or diagnose and the estimated size of the 
pediatric patient population for each condition or disease; 
(3) the costs of purchasing pediatric devices, based on a 
representative sampling of children’s hospitals; 
(4) the extent to which the costs of such devices are covered 
by health insurance; 
(5) the impact, if any, of allowing profit on access to such 
devices for patients; 
(6) the profits made by manufacturers for each device that 
receives an exemption; 
(7) an estimate of the extent of the use of the pediatric 
devices by both adults and pediatric populations for a condition 
or disease other than the condition or disease on the label 
of such devices; 
(8) recommendations of the Comptroller General of the 
United States regarding the effectiveness of such section 
520(m)(6) (as amended by subsection (a)) and whether any 
modifications to such section 520(m)(6) (as amended by sub-
section (a)) should be made; 
(9) existing obstacles to pediatric device development; and 
(10) an evaluation of the demonstration grants described 
in section 305, which shall include an evaluation of the number 
of pediatric medical devices— 
(A) that have been or are being studied in children; 
and 
(B) that have been submitted to the Food and Drug 
Administration for approval, clearance, or review under 
such section 520(m) (as amended by this Act) and any 
regulatory actions taken. 
(c) GUIDANCE.—Not later than 180 days after the date of the 
enactment of this Act, the Commissioner of Food and Drugs shall 
issue guidance for institutional review committees on how to 
evaluate requests for approval for devices for which a humanitarian 
Deadline. 
21 USC 360j 
note. 
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121 STAT. 863 
PUBLIC LAW 110–85—SEPT. 27, 2007 
device exemption under section 520(m)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted. 
SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH. 
(a) CONTACT POINT FOR AVAILABLE FUNDING.—Section 402(b) 
of the Public Health Service Act (42 U.S.C. 282(b)) is amended— 
(1) in paragraph (21), by striking ‘‘and’’ after the semicolon 
at the end; 
(2) in paragraph (22), by striking the period at the end 
and inserting ‘‘; and’’; and 
(3) by inserting after paragraph (22) the following: 
‘‘(23) shall designate a contact point or office to help 
innovators and physicians identify sources of funding available 
for pediatric medical device development.’’. 
(b) PLAN FOR PEDIATRIC MEDICAL DEVICE RESEARCH.— 
(1) IN GENERAL.—Not later than 180 days after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services, acting through the Commissioner of Food 
and Drugs, the Director of the National Institutes of Health, 
and the Director of the Agency for Healthcare Research and 
Quality, shall submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives a plan 
for expanding pediatric medical device research and develop-
ment. In developing such plan, the Secretary of Health and 
Human Services shall consult with individuals and organiza-
tions with appropriate expertise in pediatric medical devices. 
(2) CONTENTS.—The plan under paragraph (1) shall 
include— 
(A) the current status of federally funded pediatric 
medical device research; 
(B) any gaps in such research, which may include 
a survey of pediatric medical providers regarding unmet 
pediatric medical device needs, as needed; and 
(C) a research agenda for improving pediatric medical 
device development and Food and Drug Administration 
clearance or approval of pediatric medical devices, and 
for evaluating the short- and long-term safety and effective-
ness of pediatric medical devices. 
SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC 
DEVICE AVAILABILITY. 
(a) IN GENERAL.— 
(1) REQUEST FOR PROPOSALS.—Not later than 90 days after 
the date of the enactment of this Act, the Secretary of Health 
and Human Services shall issue a request for proposals for 
1 or more grants or contracts to nonprofit consortia for dem-
onstration projects to promote pediatric device development. 
(2) DETERMINATION ON GRANTS OR CONTRACTS.—Not later 
than 180 days after the date the Secretary of Health and 
Human Services issues a request for proposals under paragraph 
(1), the Secretary shall make a determination on the grants 
or contracts under this section. 
(b) APPLICATION.—A nonprofit consortium that desires to 
receive a grant or contract under this section shall submit an 
application to the Secretary of Health and Human Services at 
such time, in such manner, and containing such information as 
the Secretary may require. 
Deadline. 
42 USC 282 note. 
Deadline. 
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121 STAT. 864 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(c) USE OF FUNDS.—A nonprofit consortium that receives a 
grant or contract under this section shall facilitate the development, 
production, and distribution of pediatric medical devices by— 
(1) encouraging innovation and connecting qualified 
individuals with pediatric device ideas with potential manufac-
turers; 
(2) mentoring and managing pediatric device projects 
through the development process, including product identifica-
tion, prototype design, device development, and marketing; 
(3) connecting innovators and physicians to existing Federal 
and non-Federal resources, including resources from the Food 
and Drug Administration, the National Institutes of Health, 
the Small Business Administration, the Department of Energy, 
the Department of Education, the National Science Foundation, 
the Department of Veterans Affairs, the Agency for Healthcare 
Research and Quality, and the National Institute of Standards 
and Technology; 
(4) assessing the scientific and medical merit of proposed 
pediatric device projects; and 
(5) providing assistance and advice as needed on business 
development, 
personnel 
training, 
prototype 
development, 
postmarket needs, and other activities consistent with the pur-
poses of this section. 
(d) COORDINATION.— 
(1) NATIONAL
INSTITUTES
OF
HEALTH.—Each consortium 
that receives a grant or contract under this section shall— 
(A) coordinate with the National Institutes of Health’s 
pediatric device contact point or office, designated under 
section 402(b)(23) of the Public Health Service Act, as 
added by section 304(a) of this Act; and 
(B) provide to the National Institutes of Health any 
identified pediatric device needs that the consortium lacks 
sufficient capacity to address or those needs in which the 
consortium has been unable to stimulate manufacturer 
interest. 
(2) FOOD
AND
DRUG
ADMINISTRATION.—Each consortium 
that receives a grant or contract under this section shall coordi-
nate with the Commissioner of Food and Drugs and device 
companies to facilitate the application for approval or clearance 
of devices labeled for pediatric use. 
(3) EFFECTIVENESS AND OUTCOMES.—Each consortium that 
receives a grant or contract under this section shall annually 
report to the Secretary of Health and Human Services on 
the status of pediatric device development, production, and 
distribution that has been facilitated by the consortium. 
(e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 
to be appropriated to carry out this section $6,000,000 for each 
of fiscal years 2008 through 2012. 
SEC. 306. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS 
AND PEDIATRIC ADVISORY COMMITTEE. 
(a) OFFICE OF PEDIATRIC THERAPEUTICS.—Section 6(b) of the 
Best Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is 
amended by inserting ‘‘, including increasing pediatric access to 
medical devices’’ after ‘‘pediatric issues’’. 
Reports. 
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121 STAT. 865 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(b) PEDIATRIC ADVISORY COMMITTEE.—Section 14 of the Best 
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is 
amended— 
(1) in subsection (a), by inserting ‘‘(including drugs and 
biological products) and medical devices’’ after ‘‘therapeutics’’; 
and 
(2) in subsection (b)— 
(A) in paragraph (1), by inserting ‘‘(including drugs 
and biological products) and medical devices’’ after ‘‘thera-
peutics’’; and 
(B) in paragraph (2)— 
(i) in subparagraph (A), by striking ‘‘and 505B’’ 
and inserting ‘‘505B, 510(k), 515, and 520(m)’’; 
(ii) by striking subparagraph (B) and inserting 
the following: 
‘‘(B) identification of research priorities related to 
therapeutics (including drugs and biological products) and 
medical devices for pediatric populations and the need for 
additional diagnostics and treatments for specific pediatric 
diseases or conditions;’’; and 
(iii) in subparagraph (C), by inserting ‘‘(including 
drugs and biological products) and medical devices’’ 
after ‘‘therapeutics’’. 
SEC. 307. POSTMARKET SURVEILLANCE. 
Section 522 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360l) is amended— 
(1) by amending the section heading and designation to 
read as follows: 
‘‘SEC. 522. POSTMARKET SURVEILLANCE.’’; 
(2) by striking subsection (a) and inserting the following: 
‘‘(a) POSTMARKET SURVEILLANCE.— 
‘‘(1) IN GENERAL.— 
‘‘(A) CONDUCT.—The Secretary may by order require 
a manufacturer to conduct postmarket surveillance for any 
device of the manufacturer that is a class II or class III 
device— 
‘‘(i) the failure of which would be reasonably likely 
to have serious adverse health consequences; 
‘‘(ii) that is expected to have significant use in 
pediatric populations; or 
‘‘(iii) that is intended to be— 
‘‘(I) implanted in the human body for more 
than 1 year; or 
‘‘(II) a life-sustaining or life-supporting device 
used outside a device user facility. 
‘‘(B) 
CONDITION.—The 
Secretary 
may 
order 
a 
postmarket surveillance under subparagraph (A) as a condi-
tion to approval or clearance of a device described in 
subparagraph (A)(ii). 
‘‘(2) RULE OF CONSTRUCTION.—The provisions of paragraph 
(1) shall have no effect on authorities otherwise provided under 
the Act or regulations issued under this Act.’’; and 
(3) in subsection (b)— 
(A) by striking ‘‘(b) SURVEILLANCE APPROVAL.—Each’’ 
and inserting the following: 
‘‘(b) SURVEILLANCE APPROVAL.— 
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121 STAT. 866 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(1) IN GENERAL.—Each’’; 
(B) by striking ‘‘The Secretary, in consultation’’ and 
inserting ‘‘Except as provided in paragraph (2), the Sec-
retary, in consultation’’; 
(C) by striking ‘‘Any determination’’ and inserting 
‘‘Except as provided in paragraph (2), any determination’’; 
and 
(D) by adding at the end the following: 
‘‘(2) LONGER SURVEILLANCE FOR PEDIATRIC DEVICES.—The 
Secretary may by order require a prospective surveillance 
period of more than 36 months with respect to a device that 
is expected to have significant use in pediatric populations 
if such period of more than 36 months is necessary in order 
to assess the impact of the device on growth and development, 
or the effects of growth, development, activity level, or other 
factors on the safety or efficacy of the device. 
‘‘(c) DISPUTE RESOLUTION.—A manufacturer may request review 
under section 562 of any order or condition requiring postmarket 
surveillance under this section. During the pendency of such review, 
the device subject to such a postmarket surveillance order or condi-
tion shall not, because of noncompliance with such order or condi-
tion, be deemed in violation of section 301(q)(1)(C), adulterated 
under section 501(f)(1), misbranded under section 502(t)(3), or in 
violation of, as applicable, section 510(k) or section 515, unless 
deemed necessary to protect the public health.’’. 
TITLE IV—PEDIATRIC RESEARCH 
EQUITY ACT OF 2007 
SEC. 401. SHORT TITLE. 
This title may be cited as the ‘‘Pediatric Research Equity Act 
of 2007’’. 
SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQUITY ACT. 
(a) IN GENERAL.—Section 505B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355c) is amended to read as follows: 
‘‘SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND 
BIOLOGICAL PRODUCTS. 
‘‘(a) NEW DRUGS AND BIOLOGICAL PRODUCTS.— 
‘‘(1) IN GENERAL.—A person that submits, on or after the 
date of the enactment of the Pediatric Research Equity Act 
of 2007, an application (or supplement to an application)— 
‘‘(A) under section 505 for a new active ingredient, 
new indication, new dosage form, new dosing regimen, 
or new route of administration, or 
‘‘(B) under section 351 of the Public Health Service 
Act (42 U.S.C. 262) for a new active ingredient, new indica-
tion, new dosage form, new dosing regimen, or new route 
of administration, 
shall submit with the application the assessments described 
in paragraph (2). 
‘‘(2) ASSESSMENTS.— 
‘‘(A) IN GENERAL.—The assessments referred to in para-
graph (1) shall contain data, gathered using appropriate 
21 USC 301 note. 
Pediatric 
Research Equity 
Act of 2007. 
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121 STAT. 867 
PUBLIC LAW 110–85—SEPT. 27, 2007 
formulations for each age group for which the assessment 
is required, that are adequate— 
‘‘(i) to assess the safety and effectiveness of the 
drug or the biological product for the claimed indica-
tions in all relevant pediatric subpopulations; and 
‘‘(ii) to support dosing and administration for each 
pediatric subpopulation for which the drug or the 
biological product is safe and effective. 
‘‘(B) SIMILAR COURSE OF DISEASE OR SIMILAR EFFECT 
OF DRUG OR BIOLOGICAL PRODUCT.— 
‘‘(i) IN GENERAL.—If the course of the disease and 
the effects of the drug are sufficiently similar in adults 
and pediatric patients, the Secretary may conclude 
that pediatric effectiveness can be extrapolated from 
adequate and well-controlled studies in adults, usually 
supplemented with other information obtained in pedi-
atric patients, such as pharmacokinetic studies. 
‘‘(ii) EXTRAPOLATION
BETWEEN
AGE
GROUPS.—A 
study may not be needed in each pediatric age group 
if data from one age group can be extrapolated to 
another age group. 
‘‘(iii) INFORMATION
ON
EXTRAPOLATION.—A brief 
documentation of the scientific data supporting the 
conclusion under clauses (i) and (ii) shall be included 
in any pertinent reviews for the application under sec-
tion 505 of this Act or section 351 of the Public Health 
Service Act (42 U.S.C. 262). 
‘‘(3) DEFERRAL.— 
‘‘(A) IN GENERAL.—On the initiative of the Secretary 
or at the request of the applicant, the Secretary may defer 
submission of some or all assessments required under para-
graph (1) until a specified date after approval of the drug 
or issuance of the license for a biological product if— 
‘‘(i) the Secretary finds that— 
‘‘(I) the drug or biological product is ready 
for approval for use in adults before pediatric 
studies are complete; 
‘‘(II) pediatric studies should be delayed until 
additional safety or effectiveness data have been 
collected; or 
‘‘(III) there is another appropriate reason for 
deferral; and 
‘‘(ii) the applicant submits to the Secretary— 
‘‘(I) certification of the grounds for deferring 
the assessments; 
‘‘(II) a description of the planned or ongoing 
studies; 
‘‘(III) evidence that the studies are being con-
ducted or will be conducted with due diligence 
and at the earliest possible time; and 
‘‘(IV) a timeline for the completion of such 
studies. 
‘‘(B) ANNUAL REVIEW.— 
‘‘(i) IN GENERAL.—On an annual basis following 
the approval of a deferral under subparagraph (A), 
the applicant shall submit to the Secretary the fol-
lowing information: 
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121 STAT. 868 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(I) Information detailing the progress made 
in conducting pediatric studies. 
‘‘(II) If no progress has been made in con-
ducting such studies, evidence and documentation 
that such studies will be conducted with due dili-
gence and at the earliest possible time. 
‘‘(ii) PUBLIC AVAILABILITY.—The information sub-
mitted through the annual review under clause (i) 
shall promptly be made available to the public in an 
easily accessible manner, including through the Web 
site of the Food and Drug Administration. 
‘‘(4) WAIVERS.— 
‘‘(A) FULL WAIVER.—On the initiative of the Secretary 
or at the request of an applicant, the Secretary shall grant 
a full waiver, as appropriate, of the requirement to submit 
assessments for a drug or biological product under this 
subsection if the applicant certifies and the Secretary finds 
that— 
‘‘(i) necessary studies are impossible or highly 
impracticable (because, for example, the number of 
patients is so small or the patients are geographically 
dispersed); 
‘‘(ii) there is evidence strongly suggesting that the 
drug or biological product would be ineffective or 
unsafe in all pediatric age groups; or 
‘‘(iii) the drug or biological product— 
‘‘(I) does not represent a meaningful thera-
peutic benefit over existing therapies for pediatric 
patients; and 
‘‘(II) is not likely to be used in a substantial 
number of pediatric patients. 
‘‘(B) PARTIAL WAIVER.—On the initiative of the Sec-
retary or at the request of an applicant, the Secretary 
shall grant a partial waiver, as appropriate, of the require-
ment to submit assessments for a drug or biological product 
under this subsection with respect to a specific pediatric 
age group if the applicant certifies and the Secretary finds 
that— 
‘‘(i) necessary studies are impossible or highly 
impracticable (because, for example, the number of 
patients in that age group is so small or patients 
in that age group are geographically dispersed); 
‘‘(ii) there is evidence strongly suggesting that the 
drug or biological product would be ineffective or 
unsafe in that age group; 
‘‘(iii) the drug or biological product— 
‘‘(I) does not represent a meaningful thera-
peutic benefit over existing therapies for pediatric 
patients in that age group; and 
‘‘(II) is not likely to be used by a substantial 
number of pediatric patients in that age group; 
or 
‘‘(iv) the applicant can demonstrate that reasonable 
attempts to produce a pediatric formulation necessary 
for that age group have failed. 
‘‘(C) PEDIATRIC
FORMULATION
NOT
POSSIBLE.—If a 
waiver is granted on the ground that it is not possible 
Web site. 
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121 STAT. 869 
PUBLIC LAW 110–85—SEPT. 27, 2007 
to develop a pediatric formulation, the waiver shall cover 
only the pediatric groups requiring that formulation. An 
applicant seeking either a full or partial waiver shall 
submit to the Secretary documentation detailing why a 
pediatric formulation cannot be developed and, if the waiver 
is granted, the applicant’s submission shall promptly be 
made available to the public in an easily accessible manner, 
including through posting on the Web site of the Food 
and Drug Administration. 
‘‘(D) LABELING REQUIREMENT.—If the Secretary grants 
a full or partial waiver because there is evidence that 
a drug or biological product would be ineffective or unsafe 
in pediatric populations, the information shall be included 
in the labeling for the drug or biological product. 
‘‘(b) MARKETED DRUGS AND BIOLOGICAL PRODUCTS.— 
‘‘(1) IN GENERAL.—After providing notice in the form of 
a letter (that, for a drug approved under section 505, references 
a declined written request under section 505A for a labeled 
indication which written request is not referred under section 
505A(n)(1)(A) to the Foundation of the National Institutes of 
Health for the pediatric studies), the Secretary may (by order 
in the form of a letter) require the sponsor or holder of an 
approved application for a drug under section 505 or the holder 
of a license for a biological product under section 351 of the 
Public Health Service Act to submit by a specified date the 
assessments described in subsection (a)(2), if the Secretary 
finds that— 
‘‘(A)(i) the drug or biological product is used for a 
substantial number of pediatric patients for the labeled 
indications; and 
‘‘(ii) adequate pediatric labeling could confer a benefit 
on pediatric patients; 
‘‘(B) there is reason to believe that the drug or 
biological product would represent a meaningful thera-
peutic benefit over existing therapies for pediatric patients 
for 1 or more of the claimed indications; or 
‘‘(C) the absence of adequate pediatric labeling could 
pose a risk to pediatric patients. 
‘‘(2) WAIVERS.— 
‘‘(A) FULL WAIVER.—At the request of an applicant, 
the Secretary shall grant a full waiver, as appropriate, 
of the requirement to submit assessments under this sub-
section if the applicant certifies and the Secretary finds 
that— 
‘‘(i) necessary studies are impossible or highly 
impracticable (because, for example, the number of 
patients in that age group is so small or patients 
in that age group are geographically dispersed); or 
‘‘(ii) there is evidence strongly suggesting that the 
drug or biological product would be ineffective or 
unsafe in all pediatric age groups. 
‘‘(B) PARTIAL WAIVER.—At the request of an applicant, 
the Secretary shall grant a partial waiver, as appropriate, 
of the requirement to submit assessments under this sub-
section with respect to a specific pediatric age group if 
the applicant certifies and the Secretary finds that— 
Public 
information. 
Web site. 
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121 STAT. 870 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(i) necessary studies are impossible or highly 
impracticable (because, for example, the number of 
patients in that age group is so small or patients 
in that age group are geographically dispersed); 
‘‘(ii) there is evidence strongly suggesting that the 
drug or biological product would be ineffective or 
unsafe in that age group; 
‘‘(iii)(I) the drug or biological product— 
‘‘(aa) does not represent a meaningful thera-
peutic benefit over existing therapies for pediatric 
patients in that age group; and 
‘‘(bb) is not likely to be used in a substantial 
number of pediatric patients in that age group; 
and 
‘‘(II) the absence of adequate labeling could not 
pose significant risks to pediatric patients; or 
‘‘(iv) the applicant can demonstrate that reasonable 
attempts to produce a pediatric formulation necessary 
for that age group have failed. 
‘‘(C) PEDIATRIC
FORMULATION
NOT
POSSIBLE.—If a 
waiver is granted on the ground that it is not possible 
to develop a pediatric formulation, the waiver shall cover 
only the pediatric groups requiring that formulation. An 
applicant seeking either a full or partial waiver shall 
submit to the Secretary documentation detailing why a 
pediatric formulation cannot be developed and, if the waiver 
is granted, the applicant’s submission shall promptly be 
made available to the public in an easily accessible manner, 
including through posting on the Web site of the Food 
and Drug Administration. 
‘‘(D) LABELING REQUIREMENT.—If the Secretary grants 
a full or partial waiver because there is evidence that 
a drug or biological product would be ineffective or unsafe 
in pediatric populations, the information shall be included 
in the labeling for the drug or biological product. 
‘‘(3) EFFECT OF SUBSECTION.—Nothing in this subsection 
alters or amends section 301(j) of this Act or section 552 of 
title 5 or section 1905 of title 18, United States Code. 
‘‘(c) MEANINGFUL THERAPEUTIC BENEFIT.—For the purposes of 
paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a) and para-
graphs (1)(B) and (2)(B)(iii)(I)(aa) of subsection (b), a drug or 
biological product shall be considered to represent a meaningful 
therapeutic benefit over existing therapies if the Secretary deter-
mines that— 
‘‘(1) if approved, the drug or biological product could rep-
resent an improvement in the treatment, diagnosis, or preven-
tion of a disease, compared with marketed products adequately 
labeled for that use in the relevant pediatric population; or 
‘‘(2) the drug or biological product is in a class of products 
or for an indication for which there is a need for additional 
options. 
‘‘(d) SUBMISSION OF ASSESSMENTS.—If a person fails to submit 
an assessment described in subsection (a)(2), or a request for 
approval of a pediatric formulation described in subsection (a) or 
(b), in accordance with applicable provisions of subsections (a) and 
(b)— 
Public 
information. 
Web site. 
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121 STAT. 871 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(1) the drug or biological product that is the subject of 
the assessment or request may be considered misbranded solely 
because of that failure and subject to relevant enforcement 
action (except that the drug or biological product shall not 
be subject to action under section 303); but 
‘‘(2) the failure to submit the assessment or request shall 
not be the basis for a proceeding— 
‘‘(A) to withdraw approval for a drug under section 
505(e); or 
‘‘(B) to revoke the license for a biological product under 
section 351 of the Public Health Service Act. 
‘‘(e) MEETINGS.—Before and during the investigational process 
for a new drug or biological product, the Secretary shall meet 
at appropriate times with the sponsor of the new drug or biological 
product to discuss— 
‘‘(1) information that the sponsor submits on plans and 
timelines for pediatric studies; or 
‘‘(2) any planned request by the sponsor for waiver or 
deferral of pediatric studies. 
‘‘(f) REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, 
AND WAIVERS.— 
‘‘(1) REVIEW.—Beginning not later than 30 days after the 
date of the enactment of the Pediatric Research Equity Act 
of 2007, the Secretary shall utilize the internal committee estab-
lished under section 505C to provide consultation to reviewing 
divisions on all pediatric plans and assessments prior to 
approval of an application or supplement for which a pediatric 
assessment is required under this section and all deferral and 
waiver requests granted pursuant to this section. 
‘‘(2) ACTIVITY BY COMMITTEE.—The committee referred to 
in paragraph (1) may operate using appropriate members of 
such committee and need not convene all members of the com-
mittee. 
‘‘(3) DOCUMENTATION
OF
COMMITTEE
ACTION.—For each 
drug or biological product, the committee referred to in para-
graph (1) shall document, for each activity described in para-
graph (4) or (5), which members of the committee participated 
in such activity. 
‘‘(4) REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, 
AND
WAIVERS.—Consultation on pediatric plans and assess-
ments by the committee referred to in paragraph (1) pursuant 
to this section shall occur prior to approval of an application 
or supplement for which a pediatric assessment is required 
under this section. The committee shall review all requests 
for deferrals and waivers from the requirement to submit a 
pediatric assessment granted under this section and shall pro-
vide recommendations as needed to reviewing divisions, 
including with respect to whether such a supplement, when 
submitted, shall be considered for priority review. 
‘‘(5) RETROSPECTIVE
REVIEW
OF
PEDIATRIC
ASSESSMENTS, 
DEFERRALS, AND WAIVERS.—Not later than 1 year after the 
date of the enactment of the Pediatric Research Equity Act 
of 2007, the committee referred to in paragraph (1) shall con-
duct a retrospective review and analysis of a representative 
sample of assessments submitted and deferrals and waivers 
approved under this section since the enactment of the Pediatric 
Research Equity Act of 2003. Such review shall include an 
Deadline. 
Deadline. 
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121 STAT. 872 
PUBLIC LAW 110–85—SEPT. 27, 2007 
analysis of the quality and consistency of pediatric information 
in pediatric assessments and the appropriateness of waivers 
and deferrals granted. Based on such review, the Secretary 
shall issue recommendations to the review divisions for 
improvements and initiate guidance to industry related to the 
scope of pediatric studies required under this section. 
‘‘(6) TRACKING OF ASSESSMENTS AND LABELING CHANGES.— 
The Secretary, in consultation with the committee referred 
to in paragraph (1), shall track and make available to the 
public in an easily accessible manner, including through posting 
on the Web site of the Food and Drug Administration— 
‘‘(A) the number of assessments conducted under this 
section; 
‘‘(B) the specific drugs and biological products and their 
uses assessed under this section; 
‘‘(C) the types of assessments conducted under this 
section, including trial design, the number of pediatric 
patients studied, and the number of centers and countries 
involved; 
‘‘(D) the total number of deferrals requested and 
granted under this section and, if granted, the reasons 
for such deferrals, the timeline for completion, and the 
number completed and pending by the specified date, as 
outlined in subsection (a)(3); 
‘‘(E) the number of waivers requested and granted 
under this section and, if granted, the reasons for the 
waivers; 
‘‘(F) the number of pediatric formulations developed 
and the number of pediatric formulations not developed 
and the reasons any such formulation was not developed; 
‘‘(G) the labeling changes made as a result of assess-
ments conducted under this section; 
‘‘(H) an annual summary of labeling changes made 
as a result of assessments conducted under this section 
for distribution pursuant to subsection (h)(2); 
‘‘(I) an annual summary of information submitted 
pursuant to subsection (a)(3)(B); and 
‘‘(J) the number of times the committee referred to 
in paragraph (1) made a recommendation to the Secretary 
under paragraph (4) regarding priority review, the number 
of times the Secretary followed or did not follow such 
a recommendation, and, if not followed, the reasons why 
such a recommendation was not followed. 
‘‘(g) LABELING CHANGES.— 
‘‘(1) DISPUTE RESOLUTION.— 
‘‘(A) REQUEST FOR LABELING CHANGE AND FAILURE TO 
AGREE.—If, on or after the date of the enactment of the 
Pediatric Research Equity Act of 2007, the Commissioner 
determines that a sponsor and the Commissioner have 
been unable to reach agreement on appropriate changes 
to the labeling for the drug that is the subject of the 
application or supplement, not later than 180 days after 
the date of the submission of the application or supple-
ment— 
‘‘(i) the Commissioner shall request that the 
sponsor of the application make any labeling change 
Deadline. 
Public 
information. 
Web site. 
Recommenda- 
tions. 
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121 STAT. 873 
PUBLIC LAW 110–85—SEPT. 27, 2007 
that the Commissioner determines to be appropriate; 
and 
‘‘(ii) if the sponsor does not agree within 30 days 
after the Commissioner’s request to make a labeling 
change requested by the Commissioner, the Commis-
sioner shall refer the matter to the Pediatric Advisory 
Committee. 
‘‘(B) ACTION BY THE PEDIATRIC ADVISORY COMMITTEE.— 
Not later than 90 days after receiving a referral under 
subparagraph (A)(ii), the Pediatric Advisory Committee 
shall— 
‘‘(i) review the pediatric study reports; and 
‘‘(ii) make a recommendation to the Commissioner 
concerning appropriate labeling changes, if any. 
‘‘(C) 
CONSIDERATION
OF
RECOMMENDATIONS.—The 
Commissioner shall consider the recommendations of the 
Pediatric Advisory Committee and, if appropriate, not later 
than 30 days after receiving the recommendation, make 
a request to the sponsor of the application or supplement 
to make any labeling changes that the Commissioner deter-
mines to be appropriate. 
‘‘(D) MISBRANDING.—If the sponsor of the application 
or supplement, within 30 days after receiving a request 
under subparagraph (C), does not agree to make a labeling 
change requested by the Commissioner, the Commissioner 
may deem the drug that is the subject of the application 
or supplement to be misbranded. 
‘‘(E) NO EFFECT ON AUTHORITY.—Nothing in this sub-
section limits the authority of the United States to bring 
an enforcement action under this Act when a drug lacks 
appropriate pediatric labeling. Neither course of action (the 
Pediatric Advisory Committee process or an enforcement 
action referred to in the preceding sentence) shall preclude, 
delay, or serve as the basis to stay the other course of 
action. 
‘‘(2) OTHER LABELING CHANGES.—If, on or after the date 
of the enactment of the Pediatric Research Equity Act of 2007, 
the Secretary makes a determination that a pediatric assess-
ment conducted under this section does or does not demonstrate 
that the drug that is the subject of such assessment is safe 
and effective in pediatric populations or subpopulations, 
including whether such assessment results are inconclusive, 
the Secretary shall order the label of such product to include 
information about the results of the assessment and a state-
ment of the Secretary’s determination. 
‘‘(h) DISSEMINATION OF PEDIATRIC INFORMATION.— 
‘‘(1) IN GENERAL.—Not later than 210 days after the date 
of submission of a pediatric assessment under this section, 
the Secretary shall make available to the public in an easily 
accessible manner the medical, statistical, and clinical pharma-
cology reviews of such pediatric assessments, and shall post 
such assessments on the Web site of the Food and Drug 
Administration. 
‘‘(2) DISSEMINATION OF INFORMATION REGARDING LABELING 
CHANGES.—Beginning on the date of the enactment of the Pedi-
atric Research Equity Act of 2007, the Secretary shall require 
that the sponsors of the assessments that result in labeling 
Effective date. 
Deadline. 
Public 
information. 
Web site. 
Deadline. 
Deadline. 
Deadline. 
Deadline. 
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121 STAT. 874 
PUBLIC LAW 110–85—SEPT. 27, 2007 
changes that are reflected in the annual summary developed 
pursuant to subsection (f)(6)(H) distribute such information 
to physicians and other health care providers. 
‘‘(3) EFFECT OF SUBSECTION.—Nothing in this subsection 
shall alter or amend section 301(j) of this Act or section 552 
of title 5 or section 1905 of title 18, United States Code. 
‘‘(i) ADVERSE EVENT REPORTING.— 
‘‘(1) REPORTING IN YEAR ONE.—Beginning on the date of 
the enactment of the Pediatric Research Equity Act of 2007, 
during the one-year period beginning on the date a labeling 
change is made pursuant to subsection (g), the Secretary shall 
ensure that all adverse event reports that have been received 
for such drug (regardless of when such report was received) 
are referred to the Office of Pediatric Therapeutics. In consid-
ering such reports, the Director of such Office shall provide 
for the review of such reports by the Pediatric Advisory Com-
mittee, including obtaining any recommendations of such com-
mittee regarding whether the Secretary should take action 
under this Act in response to such reports. 
‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Following the one- 
year period described in paragraph (1), the Secretary shall, 
as appropriate, refer to the Office of Pediatric Therapeutics 
all pediatric adverse event reports for a drug for which a 
pediatric study was conducted under this section. In considering 
such reports, the Director of such Office may provide for the 
review of such reports by the Pediatric Advisory Committee, 
including obtaining any recommendation of such Committee 
regarding whether the Secretary should take action in response 
to such reports. 
‘‘(3) EFFECT.—The requirements of this subsection shall 
supplement, not supplant, other review of such adverse event 
reports by the Secretary. 
‘‘(j) SCOPE OF AUTHORITY.—Nothing in this section provides 
to the Secretary any authority to require a pediatric assessment 
of any drug or biological product, or any assessment regarding 
other populations or uses of a drug or biological product, other 
than the pediatric assessments described in this section. 
‘‘(k) ORPHAN DRUGS.—Unless the Secretary requires otherwise 
by regulation, this section does not apply to any drug for an indica-
tion for which orphan designation has been granted under section 
526. 
‘‘(l) INSTITUTE OF MEDICINE STUDY.— 
‘‘(1) IN GENERAL.—Not later than three years after the 
date of the enactment of the Pediatric Research Equity Act 
of 2007, the Secretary shall contract with the Institute of Medi-
cine to conduct a study and report to Congress regarding the 
pediatric studies conducted pursuant to this section or precursor 
regulations since 1997 and labeling changes made as a result 
of such studies. 
‘‘(2) CONTENT OF STUDY.—The study under paragraph (1) 
shall review and assess the use of extrapolation for pediatric 
subpopulations, the use of alternative endpoints for pediatric 
populations, neonatal assessment tools, the number and type 
of pediatric adverse events, and ethical issues in pediatric clin-
ical trials. 
Deadline. 
Contracts. 
Reports. 
Effective date. 
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121 STAT. 875 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(3) REPRESENTATIVE SAMPLE.—The Institute of Medicine 
may devise an appropriate mechanism to review a representa-
tive sample of studies conducted pursuant to this section from 
each review division within the Center for Drug Evaluation 
and Research in order to make the requested assessment. 
‘‘(m) INTEGRATION
WITH
OTHER
PEDIATRIC
STUDIES.—The 
authority under this section shall remain in effect so long as an 
application subject to this section may be accepted for filing by 
the Secretary on or before the date specified in section 505A(q).’’. 
(b) APPLICABILITY.— 
(1) IN GENERAL.—Notwithstanding subsection (h) of section 
505B of the Federal Food, Drug and Cosmetic Act, as in effect 
on the day before the date of the enactment of this Act, a 
pending assessment, including a deferred assessment, required 
under such section 505B shall be deemed to have been required 
under section 505B of the Federal Food, Drug and Cosmetic 
Act as in effect on or after the date of the enactment of this 
Act. 
(2) CERTAIN
ASSESSMENTS
AND
WAIVER
REQUESTS.—An 
assessment pending on or after the date that is 1 year prior 
to the date of the enactment of this Act shall be subject to 
the tracking and disclosure requirements established under 
such section 505B, as in effect on or after such date of enact-
ment, except that any such assessments submitted or waivers 
of such assessments requested before such date of enactment 
shall not be subject to subsections (a)(4)(C), (b)(2)(C), (f)(6)(F), 
and (h) of such section 505B. 
SEC. 403. ESTABLISHMENT OF INTERNAL COMMITTEE. 
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 351 et seq.) is amended by inserting after section 505B 
the following: 
‘‘SEC. 505C. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC PLANS, 
ASSESSMENTS, DEFERRALS, AND WAIVERS. 
‘‘The Secretary shall establish an internal committee within 
the Food and Drug Administration to carry out the activities as 
described in sections 505A(f) and 505B(f). Such internal committee 
shall include employees of the Food and Drug Administration, with 
expertise in pediatrics (including representation from the Office 
of Pediatric Therapeutics), biopharmacology, statistics, chemistry, 
legal issues, pediatric ethics, and the appropriate expertise per-
taining to the pediatric product under review, such as expertise 
in child and adolescent psychiatry, and other individuals designated 
by the Secretary.’’. 
SEC. 404. GOVERNMENT ACCOUNTABILITY OFFICE REPORT. 
Not later than January 1, 2011, the Comptroller General of 
the United States, in consultation with the Secretary of Health 
and Human Services, shall submit to the Congress a report that 
addresses the effectiveness of sections 505A and 505B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and section 
409I of the Public Health Service Act (42 U.S.C. 284m) in ensuring 
that medicines used by children are tested and properly labeled. 
Such report shall include— 
(1) the number and importance of drugs and biological 
products for children that are being tested as a result of the 
amendments made by this title and title V and the importance 
Establishment. 
21 USC 355d. 
21 USC 355c 
note. 
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121 STAT. 876 
PUBLIC LAW 110–85—SEPT. 27, 2007 
for children, health care providers, parents, and others of 
labeling changes made as a result of such testing; 
(2) the number and importance of drugs and biological 
products for children that are not being tested for their use 
notwithstanding the provisions of this title and title V and 
possible reasons for the lack of testing; 
(3) the number of drugs and biological products for which 
testing is being done and labeling changes required, including 
the date labeling changes are made and which labeling changes 
required the use of the dispute resolution process established 
pursuant to the amendments made by this title, together with 
a description of the outcomes of such process, including a 
description of the disputes and the recommendations of the 
Pediatric Advisory Committee; 
(4) any recommendations for modifications to the programs 
established under sections 505A and 505B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355a) and section 409I 
of the Public Health Service Act (42 U.S.C. 284m) that the 
Secretary determines to be appropriate, including a detailed 
rationale for each recommendation; and 
(5)(A) the efforts made by the Secretary to increase the 
number of studies conducted in the neonate population; and 
(B) the results of those efforts, including efforts made to 
encourage the conduct of appropriate studies in neonates by 
companies with products that have sufficient safety and other 
information to make the conduct of the studies ethical and 
safe. 
TITLE V—BEST PHARMACEUTICALS 
FOR CHILDREN ACT OF 2007 
SEC. 501. SHORT TITLE. 
This title may be cited as the ‘‘Best Pharmaceuticals for Chil-
dren Act of 2007’’. 
SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHIL-
DREN ACT. 
(a) PEDIATRIC STUDIES OF DRUGS.— 
(1) IN GENERAL.—Section 505A of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a) is amended to read as 
follows: 
‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS. 
‘‘(a) DEFINITIONS.—As used in this section, the term ‘pediatric 
studies’ or ‘studies’ means at least one clinical investigation (that, 
at the Secretary’s discretion, may include pharmacokinetic studies) 
in pediatric age groups (including neonates in appropriate cases) 
in which a drug is anticipated to be used, and, at the discretion 
of the Secretary, may include preclinical studies. 
‘‘(b) MARKET EXCLUSIVITY FOR NEW DRUGS.— 
‘‘(1) IN GENERAL.—Except as provided in paragraph (2), 
if, prior to approval of an application that is submitted under 
section 505(b)(1), the Secretary determines that information 
relating to the use of a new drug in the pediatric population 
may produce health benefits in that population, the Secretary 
makes a written request for pediatric studies (which shall 
21 USC 301 note. 
Best 
Pharmaceuticals 
for Children Act 
of 2007. 
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121 STAT. 877 
PUBLIC LAW 110–85—SEPT. 27, 2007 
include a timeframe for completing such studies), the applicant 
agrees to the request, such studies are completed using appro-
priate formulations for each age group for which the study 
is requested within any such timeframe, and the reports thereof 
are submitted and accepted in accordance with subsection 
(d)(3)— 
‘‘(A)(i)(I) the period referred to in subsection (c)(3)(E)(ii) 
of section 505, and in subsection (j)(5)(F)(ii) of such section, 
is deemed to be five years and six months rather than 
five years, and the references in subsections (c)(3)(E)(ii) 
and (j)(5)(F)(ii) of such section to four years, to forty-eight 
months, and to seven and one-half years are deemed to 
be four and one-half years, fifty-four months, and eight 
years, respectively; or 
‘‘(II) the period referred to in clauses (iii) and (iv) 
of subsection (c)(3)(E) of such section, and in clauses (iii) 
and (iv) of subsection (j)(5)(F) of such section, is deemed 
to be three years and six months rather than three years; 
and 
‘‘(ii) if the drug is designated under section 526 for 
a rare disease or condition, the period referred to in section 
527(a) is deemed to be seven years and six months rather 
than seven years; and 
‘‘(B)(i) if the drug is the subject of— 
‘‘(I) a listed patent for which a certification has 
been submitted under subsection (b)(2)(A)(ii) or 
(j)(2)(A)(vii)(II) of section 505 and for which pediatric 
studies were submitted prior to the expiration of the 
patent (including any patent extensions); or 
‘‘(II) a listed patent for which a certification has 
been submitted under subsections (b)(2)(A)(iii) or 
(j)(2)(A)(vii)(III) of section 505, 
the period during which an application may not be 
approved under section 505(c)(3) or section 505(j)(5)(B) 
shall be extended by a period of six months after the 
date the patent expires (including any patent extensions); 
or 
‘‘(ii) if the drug is the subject of a listed patent for 
which a certification has been submitted under subsection 
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the 
patent infringement litigation resulting from the certifi-
cation the court determines that the patent is valid and 
would be infringed, the period during which an application 
may not be approved under section 505(c)(3) or section 
505(j)(5)(B) shall be extended by a period of six months 
after the date the patent expires (including any patent 
extensions). 
‘‘(2) EXCEPTION.—The Secretary shall not extend the period 
referred to in paragraph (1)(A) or (1)(B) if the determination 
made under subsection (d)(3) is made later than 9 months 
prior to the expiration of such period. 
‘‘(c) MARKET EXCLUSIVITY FOR ALREADY-MARKETED DRUGS.— 
‘‘(1) IN GENERAL.—Except as provided in paragraph (2), 
if the Secretary determines that information relating to the 
use of an approved drug in the pediatric population may 
produce health benefits in that population and makes a written 
request to the holder of an approved application under section 
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121 STAT. 878 
PUBLIC LAW 110–85—SEPT. 27, 2007 
505(b)(1) for pediatric studies (which shall include a timeframe 
for completing such studies), the holder agrees to the request, 
such studies are completed using appropriate formulations for 
each age group for which the study is requested within any 
such timeframe, and the reports thereof are submitted and 
accepted in accordance with subsection (d)(3)— 
‘‘(A)(i)(I) the period referred to in subsection (c)(3)(E)(ii) 
of section 505, and in subsection (j)(5)(F)(ii) of such section, 
is deemed to be five years and six months rather than 
five years, and the references in subsections (c)(3)(E)(ii) 
and (j)(5)(F)(ii) of such section to four years, to forty-eight 
months, and to seven and one-half years are deemed to 
be four and one-half years, fifty-four months, and eight 
years, respectively; or 
‘‘(II) the period referred to in clauses (iii) and (iv) 
of subsection (c)(3)(D) of such section, and in clauses (iii) 
and (iv) of subsection (j)(5)(F) of such section, is deemed 
to be three years and six months rather than three years; 
and 
‘‘(ii) if the drug is designated under section 526 for 
a rare disease or condition, the period referred to in section 
527(a) is deemed to be seven years and six months rather 
than seven years; and 
‘‘(B)(i) if the drug is the subject of— 
‘‘(I) a listed patent for which a certification has 
been submitted under subsection (b)(2)(A)(ii) or 
(j)(2)(A)(vii)(II) of section 505 and for which pediatric 
studies were submitted prior to the expiration of the 
patent (including any patent extensions); or 
‘‘(II) a listed patent for which a certification has 
been submitted under subsection (b)(2)(A)(iii) or 
(j)(2)(A)(vii)(III) of section 505, 
the period during which an application may not be 
approved under section 505(c)(3) or section 505(j)(5)(B)(ii) 
shall be extended by a period of six months after the 
date the patent expires (including any patent extensions); 
or 
‘‘(ii) if the drug is the subject of a listed patent for 
which a certification has been submitted under subsection 
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the 
patent infringement litigation resulting from the certifi-
cation the court determines that the patent is valid and 
would be infringed, the period during which an application 
may not be approved under section 505(c)(3) or section 
505(j)(5)(B) shall be extended by a period of six months 
after the date the patent expires (including any patent 
extensions). 
‘‘(2) EXCEPTION.—The Secretary shall not extend the period 
referred to in paragraph (1)(A) or (1)(B) if the determination 
made under subsection (d)(3) is made later than 9 months 
prior to the expiration of such period. 
‘‘(d) CONDUCT OF PEDIATRIC STUDIES.— 
‘‘(1) REQUEST FOR STUDIES.— 
‘‘(A) IN GENERAL.—The Secretary may, after consulta-
tion with the sponsor of an application for an investiga-
tional new drug under section 505(i), the sponsor of an 
application for a new drug under section 505(b)(1), or the 
Deadline. 
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121 STAT. 879 
PUBLIC LAW 110–85—SEPT. 27, 2007 
holder of an approved application for a drug under section 
505(b)(1), issue to the sponsor or holder a written request 
for the conduct of pediatric studies for such drug. In issuing 
such request, the Secretary shall take into account ade-
quate representation of children of ethnic and racial minori-
ties. Such request to conduct pediatric studies shall be 
in writing and shall include a timeframe for such studies 
and a request to the sponsor or holder to propose pediatric 
labeling resulting from such studies. 
‘‘(B) SINGLE
WRITTEN
REQUEST.—A single written 
request— 
‘‘(i) may relate to more than one use of a drug; 
and 
‘‘(ii) may include uses that are both approved and 
unapproved. 
‘‘(2) WRITTEN REQUEST FOR PEDIATRIC STUDIES.— 
‘‘(A) REQUEST AND RESPONSE.— 
‘‘(i) IN GENERAL.—If the Secretary makes a written 
request for pediatric studies (including neonates, as 
appropriate) under subsection (b) or (c), the applicant 
or holder, not later than 180 days after receiving the 
written request, shall respond to the Secretary as to 
the intention of the applicant or holder to act on the 
request by— 
‘‘(I) indicating when the pediatric studies will 
be initiated, if the applicant or holder agrees to 
the request; or 
‘‘(II) indicating that the applicant or holder 
does not agree to the request and stating the rea-
sons for declining the request. 
‘‘(ii) DISAGREE WITH REQUEST.—If, on or after the 
date of the enactment of the Best Pharmaceuticals 
for Children Act of 2007, the applicant or holder does 
not agree to the request on the grounds that it is 
not possible to develop the appropriate pediatric formu-
lation, the applicant or holder shall submit to the 
Secretary the reasons such pediatric formulation 
cannot be developed. 
‘‘(B) ADVERSE EVENT REPORTS.—An applicant or holder 
that, on or after the date of the enactment of the Best 
Pharmaceuticals for Children Act of 2007, agrees to the 
request for such studies shall provide the Secretary, at 
the same time as the submission of the reports of such 
studies, with all postmarket adverse event reports 
regarding the drug that is the subject of such studies 
and are available prior to submission of such reports. 
‘‘(3) MEETING THE STUDIES REQUIREMENT.—Not later than 
180 days after the submission of the reports of the studies, 
the Secretary shall accept or reject such reports and so notify 
the sponsor or holder. The Secretary’s only responsibility in 
accepting or rejecting the reports shall be to determine, within 
the 180-day period, whether the studies fairly respond to the 
written request, have been conducted in accordance with com-
monly accepted scientific principles and protocols, and have 
been reported in accordance with the requirements of the Sec-
retary for filing. 
Deadline. 
Notification. 
Timeframe. 
Minorities. 
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121 STAT. 880 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(4) EFFECT OF SUBSECTION.—Nothing in this subsection 
alters or amends section 301(j) of this Act or section 552 of 
title 5 or section 1905 of title 18, United States Code. 
‘‘(e) NOTICE OF DETERMINATIONS ON STUDIES REQUIREMENT.— 
‘‘(1) IN
GENERAL.—The Secretary shall publish a notice 
of any determination, made on or after the date of the enact-
ment of the Best Pharmaceuticals for Children Act of 2007, 
that the requirements of subsection (d) have been met and 
that submissions and approvals under subsection (b)(2) or (j) 
of section 505 for a drug will be subject to the provisions 
of this section. Such notice shall be published not later than 
30 days after the date of the Secretary’s determination 
regarding market exclusivity and shall include a copy of the 
written request made under subsection (b) or (c). 
‘‘(2) IDENTIFICATION
OF
CERTAIN
DRUGS.—The Secretary 
shall publish a notice identifying any drug for which, on or 
after the date of the enactment of the Best Pharmaceuticals 
for Children Act of 2007, a pediatric formulation was developed, 
studied, and found to be safe and effective in the pediatric 
population (or specified subpopulation) if the pediatric formula-
tion for such drug is not introduced onto the market within 
one year after the date that the Secretary publishes the notice 
described in paragraph (1). Such notice identifying such drug 
shall be published not later than 30 days after the date of 
the expiration of such one year period. 
‘‘(f) INTERNAL REVIEW OF WRITTEN REQUESTS AND PEDIATRIC 
STUDIES.— 
‘‘(1) INTERNAL
REVIEW.—The Secretary shall utilize the 
internal review committee established under section 505C to 
review all written requests issued on or after the date of the 
enactment of the Best Pharmaceuticals for Children Act of 
2007, in accordance with paragraph (2). 
‘‘(2) REVIEW
OF
WRITTEN
REQUESTS.—The committee 
referred to in paragraph (1) shall review all written requests 
issued pursuant to this section prior to being issued. 
‘‘(3) REVIEW
OF
PEDIATRIC
STUDIES.—The committee 
referred to in paragraph (1) may review studies conducted 
pursuant to this section to make a recommendation to the 
Secretary whether to accept or reject such reports under sub-
section (d)(3). 
‘‘(4) ACTIVITY BY COMMITTEE.—The committee referred to 
in paragraph (1) may operate using appropriate members of 
such committee and need not convene all members of the com-
mittee. 
‘‘(5) DOCUMENTATION
OF
COMMITTEE
ACTION.—For each 
drug, the committee referred to in paragraph (1) shall docu-
ment, for each activity described in paragraph (2) or (3), which 
members of the committee participated in such activity. 
‘‘(6) 
TRACKING
PEDIATRIC
STUDIES
AND
LABELING 
CHANGES.—The Secretary, in consultation with the committee 
referred to in paragraph (1), shall track and make available 
to the public, in an easily accessible manner, including through 
posting on the Web site of the Food and Drug Administration— 
‘‘(A) the number of studies conducted under this section 
and under section 409I of the Public Health Service Act; 
‘‘(B) the specific drugs and drug uses, including labeled 
and off-labeled indications, studied under such sections; 
Public 
information. 
Web site. 
Deadline. 
Publication. 
Deadline. 
Records. 
Publication. 
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121 STAT. 881 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(C) the types of studies conducted under such sections, 
including trial design, the number of pediatric patients 
studied, and the number of centers and countries involved; 
‘‘(D) the number of pediatric formulations developed 
and the number of pediatric formulations not developed 
and the reasons such formulations were not developed; 
‘‘(E) the labeling changes made as a result of studies 
conducted under such sections; 
‘‘(F) an annual summary of labeling changes made 
as a result of studies conducted under such sections for 
distribution pursuant to subsection (k)(2); and 
‘‘(G) information regarding reports submitted on or 
after the date of the enactment of the Best Pharmaceuticals 
for Children Act of 2007. 
‘‘(g) LIMITATIONS.—Notwithstanding subsection (c)(2), a drug 
to which the six-month period under subsection (b) or (c) has already 
been applied— 
‘‘(1) may receive an additional six-month period under sub-
section (c)(1)(A)(i)(II) for a supplemental application if all other 
requirements under this section are satisfied, except that such 
drug may not receive any additional such period under sub-
section (c)(1)(B); and 
‘‘(2) may not receive any additional such period under 
subsection (c)(1)(A)(ii). 
‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH REQUIREMENTS.— 
Notwithstanding any other provision of law, if any pediatric study 
is required by a provision of law (including a regulation) other 
than this section and such study meets the completeness, timeliness, 
and other requirements of this section, such study shall be deemed 
to satisfy the requirement for market exclusivity pursuant to this 
section. 
‘‘(i) LABELING CHANGES.— 
‘‘(1) PRIORITY
STATUS
FOR
PEDIATRIC
APPLICATIONS
AND 
SUPPLEMENTS.—Any application or supplement to an applica-
tion under section 505 proposing a labeling change as a result 
of any pediatric study conducted pursuant to this section— 
‘‘(A) shall be considered to be a priority application 
or supplement; and 
‘‘(B) shall be subject to the performance goals estab-
lished by the Commissioner for priority drugs. 
‘‘(2) DISPUTE RESOLUTION.— 
‘‘(A) REQUEST FOR LABELING CHANGE AND FAILURE TO 
AGREE.—If, on or after the date of the enactment of the 
Best Pharmaceuticals for Children Act of 2007, the 
Commissioner determines that the sponsor and the 
Commissioner have been unable to reach agreement on 
appropriate changes to the labeling for the drug that is 
the subject of the application, not later than 180 days 
after the date of submission of the application— 
‘‘(i) the Commissioner shall request that the 
sponsor of the application make any labeling change 
that the Commissioner determines to be appropriate; 
and 
‘‘(ii) if the sponsor of the application does not agree 
within 30 days after the Commissioner’s request to 
Deadline. 
Deadline. 
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121 STAT. 882 
PUBLIC LAW 110–85—SEPT. 27, 2007 
make a labeling change requested by the Commis-
sioner, the Commissioner shall refer the matter to 
the Pediatric Advisory Committee. 
‘‘(B) ACTION BY THE PEDIATRIC ADVISORY COMMITTEE.— 
Not later than 90 days after receiving a referral under 
subparagraph (A)(ii), the Pediatric Advisory Committee 
shall— 
‘‘(i) review the pediatric study reports; and 
‘‘(ii) make a recommendation to the Commissioner 
concerning appropriate labeling changes, if any. 
‘‘(C) 
CONSIDERATION
OF
RECOMMENDATIONS.—The 
Commissioner shall consider the recommendations of the 
Pediatric Advisory Committee and, if appropriate, not later 
than 30 days after receiving the recommendation, make 
a request to the sponsor of the application to make any 
labeling change that the Commissioner determines to be 
appropriate. 
‘‘(D) MISBRANDING.—If the sponsor of the application, 
within 30 days after receiving a request under subpara-
graph (C), does not agree to make a labeling change 
requested by the Commissioner, the Commissioner may 
deem the drug that is the subject of the application to 
be misbranded. 
‘‘(E) NO EFFECT ON AUTHORITY.—Nothing in this sub-
section limits the authority of the United States to bring 
an enforcement action under this Act when a drug lacks 
appropriate pediatric labeling. Neither course of action (the 
Pediatric Advisory Committee process or an enforcement 
action referred to in the preceding sentence) shall preclude, 
delay, or serve as the basis to stay the other course of 
action. 
‘‘(j) OTHER LABELING CHANGES.—If, on or after the date of 
the enactment of the Best Pharmaceuticals for Children Act of 
2007, the Secretary determines that a pediatric study conducted 
under this section does or does not demonstrate that the drug 
that is the subject of the study is safe and effective, including 
whether such study results are inconclusive, in pediatric populations 
or subpopulations, the Secretary shall order the labeling of such 
product to include information about the results of the study and 
a statement of the Secretary’s determination. 
‘‘(k) DISSEMINATION OF PEDIATRIC INFORMATION.— 
‘‘(1) IN GENERAL.—Not later than 210 days after the date 
of submission of a report on a pediatric study under this section, 
the Secretary shall make available to the public the medical, 
statistical, and clinical pharmacology reviews of pediatric 
studies conducted under subsection (b) or (c). 
‘‘(2) DISSEMINATION OF INFORMATION REGARDING LABELING 
CHANGES.—Beginning on the date of the enactment of the Best 
Pharmaceuticals for Children Act of 2007, the Secretary shall 
include as a requirement of a written request that the sponsors 
of the studies that result in labeling changes that are reflected 
in the annual summary developed pursuant to subsection 
(f)(3)(F) distribute, at least annually (or more frequently if 
the Secretary determines that it would be beneficial to the 
public health), such information to physicians and other health 
care providers. 
Deadline. 
Public 
information. 
Deadline. 
Deadline. 
Deadline. 
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121 STAT. 883 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(3) EFFECT OF SUBSECTION.—Nothing in this subsection 
alters or amends section 301(j) of this Act or section 552 of 
title 5 or section 1905 of title 18, United States Code. 
‘‘(l) ADVERSE EVENT REPORTING.— 
‘‘(1) REPORTING IN YEAR ONE.—Beginning on the date of 
the enactment of the Best Pharmaceuticals for Children Act 
of 2007, during the one-year period beginning on the date 
a labeling change is approved pursuant to subsection (i), the 
Secretary shall ensure that all adverse event reports that have 
been received for such drug (regardless of when such report 
was received) are referred to the Office of Pediatric Thera-
peutics established under section 6 of the Best Pharmaceuticals 
for Children Act (Public Law 107–109). In considering the 
reports, the Director of such Office shall provide for the review 
of the reports by the Pediatric Advisory Committee, including 
obtaining any recommendations of such Committee regarding 
whether the Secretary should take action under this Act in 
response to such reports. 
‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Following the one- 
year period described in paragraph (1), the Secretary shall, 
as appropriate, refer to the Office of Pediatric Therapeutics 
all pediatric adverse event reports for a drug for which a 
pediatric study was conducted under this section. In considering 
such reports, the Director of such Office may provide for the 
review of such reports by the Pediatric Advisory Committee, 
including obtaining any recommendation of such Committee 
regarding whether the Secretary should take action in response 
to such reports. 
‘‘(3) EFFECT.—The requirements of this subsection shall 
supplement, not supplant, other review of such adverse event 
reports by the Secretary. 
‘‘(m) CLARIFICATION OF INTERACTION OF MARKET EXCLUSIVITY 
UNDER THIS SECTION AND MARKET EXCLUSIVITY AWARDED TO AN 
APPLICANT FOR APPROVAL OF A DRUG UNDER SECTION 505(j).— 
If a 180-day period under section 505(j)(5)(B)(iv) overlaps with 
a 6-month exclusivity period under this section, so that the 
applicant for approval of a drug under section 505(j) entitled to 
the 180-day period under that section loses a portion of the 180- 
day period to which the applicant is entitled for the drug, the 
180-day period shall be extended from— 
‘‘(1) the date on which the 180-day period would have 
expired by the number of days of the overlap, if the 180- 
day period would, but for the application of this subsection, 
expire after the 6-month exclusivity period; or 
‘‘(2) the date on which the 6-month exclusivity period 
expires, by the number of days of the overlap if the 180- 
day period would, but for the application of this subsection, 
expire during the six-month exclusivity period. 
‘‘(n) REFERRAL IF PEDIATRIC STUDIES NOT COMPLETED.— 
‘‘(1) IN GENERAL.—Beginning on the date of the enactment 
of the Best Pharmaceuticals for Children Act of 2007, if pedi-
atric studies of a drug have not been completed under sub-
section (d) and if the Secretary, through the committee estab-
lished under section 505C, determines that there is a continuing 
need for information relating to the use of the drug in the 
pediatric population (including neonates, as appropriate), the 
Secretary shall carry out the following: 
Effective date. 
Effective date. 
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121 STAT. 884 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(A) For a drug for which a listed patent has not 
expired, make a determination regarding whether an 
assessment shall be required to be submitted under section 
505B(b). Prior to making such a determination, the Sec-
retary may not take more than 30 days to certify whether 
the Foundation for the National Institutes of Health has 
sufficient funding at the time of such certification to initiate 
and fund all of the studies in the written request in their 
entirety within the timeframes specified within the written 
request. Only if the Secretary makes such certification 
in the affirmative, the Secretary shall refer all pediatric 
studies in the written request to the Foundation for the 
National Institutes of Health for the conduct of such 
studies, and such Foundation shall fund such studies. If 
no certification has been made at the end of the 30-day 
period, or if the Secretary certifies that funds are not 
sufficient to initiate and fund all the studies in their 
entirety, the Secretary shall consider whether assessments 
shall be required under section 505B(b) for such drug. 
‘‘(B) For a drug that has no listed patents or has 
1 or more listed patents that have expired, the Secretary 
shall refer the drug for inclusion on the list established 
under section 409I of the Public Health Service Act for 
the conduct of studies. 
‘‘(2) PUBLIC NOTICE.—The Secretary shall give the public 
notice of a decision under paragraph (1)(A) not to require an 
assessment under section 505B and the basis for such decision. 
‘‘(3) EFFECT OF SUBSECTION.—Nothing in this subsection 
alters or amends section 301(j) of this Act or section 552 of 
title 5 or section 1905 of title 18, United States Code. 
‘‘(o) PROMPT APPROVAL OF DRUGS UNDER SECTION 505(j) WHEN 
PEDIATRIC INFORMATION IS ADDED TO LABELING.— 
‘‘(1) GENERAL RULE.—A drug for which an application has 
been submitted or approved under section 505(j) shall not be 
considered ineligible for approval under that section or mis-
branded under section 502 on the basis that the labeling of 
the drug omits a pediatric indication or any other aspect of 
labeling pertaining to pediatric use when the omitted indication 
or other aspect is protected by patent or by exclusivity under 
clause (iii) or (iv) of section 505(j)(5)(F). 
‘‘(2) LABELING.—Notwithstanding clauses (iii) and (iv) of 
section 505(j)(5)(F), the Secretary may require that the labeling 
of a drug approved under section 505(j) that omits a pediatric 
indication or other aspect of labeling as described in paragraph 
(1) include— 
‘‘(A) a statement that, because of marketing exclusivity 
for a manufacturer— 
‘‘(i) the drug is not labeled for pediatric use; or 
‘‘(ii) in the case of a drug for which there is an 
additional pediatric use not referred to in paragraph 
(1), the drug is not labeled for the pediatric use under 
paragraph (1); and 
‘‘(B) a statement of any appropriate pediatric contra-
indications, warnings, or precautions that the Secretary 
considers necessary. 
‘‘(3) PRESERVATION OF PEDIATRIC EXCLUSIVITY AND OTHER 
PROVISIONS.—This subsection does not affect— 
Deadline. 
Certification. 
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121 STAT. 885 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(A) the availability or scope of exclusivity under this 
section; 
‘‘(B) the availability or scope of exclusivity under sec-
tion 505 for pediatric formulations; 
‘‘(C) the question of the eligibility for approval of any 
application under section 505(j) that omits any other condi-
tions of approval entitled to exclusivity under clause (iii) 
or (iv) of section 505(j)(5)(F); or 
‘‘(D) except as expressly provided in paragraphs (1) 
and (2), the operation of section 505. 
‘‘(p) INSTITUTE OF MEDICINE STUDY.—Not later than 3 years 
after the date of the enactment of the Best Pharmaceuticals for 
Children Act of 2007, the Secretary shall enter into a contract 
with the Institute of Medicine to conduct a study and report to 
Congress regarding the written requests made and the studies 
conducted pursuant to this section. The Institute of Medicine may 
devise an appropriate mechanism to review a representative sample 
of requests made and studies conducted pursuant to this section 
in order to conduct such study. Such study shall— 
‘‘(1) review such representative written requests issued by 
the Secretary since 1997 under subsections (b) and (c); 
‘‘(2) review and assess such representative pediatric studies 
conducted under subsections (b) and (c) since 1997 and labeling 
changes made as a result of such studies; 
‘‘(3) review the use of extrapolation for pediatric subpopula-
tions, the use of alternative endpoints for pediatric populations, 
neonatal assessment tools, and ethical issues in pediatric clin-
ical trials; 
‘‘(4) review and assess the pediatric studies of biological 
products as required under subsections (a) and (b) of section 
505B; and 
‘‘(5) make recommendations regarding appropriate incen-
tives for encouraging pediatric studies of biologics. 
‘‘(q) SUNSET.—A drug may not receive any 6-month period 
under subsection (b) or (c) unless— 
‘‘(1) on or before October 1, 2012, the Secretary makes 
a written request for pediatric studies of the drug; 
‘‘(2) on or before October 1, 2012, an application for the 
drug is accepted for filing under section 505(b); and 
‘‘(3) all requirements of this section are met.’’. 
(2) APPLICABILITY.— 
(A) IN GENERAL.—The amendment made by this sub-
section shall apply to written requests under section 505A 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a) issued on or after the date of the enactment of 
this Act. 
(B) CERTAIN WRITTEN REQUESTS.—A written request 
issued under section 505A of the Federal Food, Drug, and 
Cosmetic Act, as in effect on the day before the date of 
the enactment of this Act, which has been accepted and 
for which no determination under subsection (d)(2) of such 
section has been made before such date of enactment, shall 
be subject to such section 505A, except that such written 
requests shall be subject to subsections (d)(2)(A)(ii), (e)(1) 
and (2), (f), (i)(2)(A), (j), (k)(1), (l)(1), and (n) of section 
505A of the Federal Food, Drug, and Cosmetic Act, as 
21 USC 355a 
note. 
Deadline. 
Deadline. 
Deadline. 
Contracts. 
Reports. 
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121 STAT. 886 
PUBLIC LAW 110–85—SEPT. 27, 2007 
in effect on or after the date of the enactment of this 
Act. 
(b) PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.—Section 409I 
of the Public Health Service Act (42 U.S.C. 284m) is amended 
to read as follows: 
‘‘SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 
‘‘(a) LIST OF PRIORITY ISSUES IN PEDIATRIC THERAPEUTICS.— 
‘‘(1) IN GENERAL.—Not later than one year after the date 
of the enactment of the Best Pharmaceuticals for Children 
Act of 2007, the Secretary, acting through the Director of the 
National Institutes of Health and in consultation with the 
Commissioner of Food and Drugs and experts in pediatric 
research, shall develop and publish a priority list of needs 
in pediatric therapeutics, including drugs or indications that 
require study. The list shall be revised every three years. 
‘‘(2) CONSIDERATION OF AVAILABLE INFORMATION.—In devel-
oping and prioritizing the list under paragraph (1), the Sec-
retary shall consider— 
‘‘(A) therapeutic gaps in pediatrics that may include 
developmental 
pharmacology, 
pharmacogenetic 
deter-
minants of drug response, metabolism of drugs and bio-
logics in children, and pediatric clinical trials; 
‘‘(B) particular pediatric diseases, disorders or condi-
tions where more complete knowledge and testing of thera-
peutics, including drugs and biologics, may be beneficial 
in pediatric populations; and 
‘‘(C) the adequacy of necessary infrastructure to con-
duct pediatric pharmacological research, including research 
networks and trained pediatric investigators. 
‘‘(b) PEDIATRIC STUDIES AND RESEARCH.—The Secretary, acting 
through the National Institutes of Health, shall award funds to 
entities that have the expertise to conduct pediatric clinical trials 
or other research (including qualified universities, hospitals, labora-
tories, contract research organizations, practice groups, federally 
funded programs such as pediatric pharmacology research units, 
other public or private institutions, or individuals) to enable the 
entities to conduct the drug studies or other research on the issues 
described in subsection (a). The Secretary may use contracts, grants, 
or other appropriate funding mechanisms to award funds under 
this subsection. 
‘‘(c) PROCESS FOR PROPOSED PEDIATRIC STUDY REQUESTS AND 
LABELING CHANGES.— 
‘‘(1) SUBMISSION OF PROPOSED PEDIATRIC STUDY REQUEST.— 
The Director of the National Institutes of Health shall, as 
appropriate, submit proposed pediatric study requests for 
consideration by the Commissioner of Food and Drugs for pedi-
atric studies of a specific pediatric indication identified under 
subsection (a). Such a proposed pediatric study request shall 
be made in a manner equivalent to a written request made 
under subsection (b) or (c) of section 505A of the Federal 
Food, Drug, and Cosmetic Act, including with respect to the 
information provided on the pediatric studies to be conducted 
pursuant to the request. The Director of the National Institutes 
of Health may submit a proposed pediatric study request for 
a drug for which— 
Deadline. 
Publication. 
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121 STAT. 887 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(A)(i) there is an approved application under section 
505(j) of the Federal Food, Drug, and Cosmetic Act; or 
‘‘(ii) there is a submitted application that could be 
approved under the criteria of such section; and 
‘‘(B) there is no patent protection or market exclusivity 
protection for at least one form of the drug under the 
Federal Food, Drug, and Cosmetic Act; and 
‘‘(C) additional studies are needed to assess the safety 
and effectiveness of the use of the drug in the pediatric 
population. 
‘‘(2) WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICA-
TIONS
FOR
DRUGS
LACKING
EXCLUSIVITY.—The Commissioner 
of Food and Drugs, in consultation with the Director of the 
National Institutes of Health, may issue a written request 
based on the proposed pediatric study request for the indication 
or indications submitted pursuant to paragraph (1) (which shall 
include a timeframe for negotiations for an agreement) for 
pediatric studies concerning a drug identified under subsection 
(a) to all holders of an approved application for the drug under 
section 505 of the Federal Food, Drug, and Cosmetic Act. Such 
a written request shall be made in a manner equivalent to 
the manner in which a written request is made under sub-
section (b) or (c) of section 505A of such Act, including with 
respect to information provided on the pediatric studies to 
be conducted pursuant to the request and using appropriate 
formulations for each age group for which the study is 
requested. 
‘‘(3) REQUESTS
FOR
PROPOSALS.—If the Commissioner of 
Food and Drugs does not receive a response to a written request 
issued under paragraph (2) not later than 30 days after the 
date on which a request was issued, the Secretary, acting 
through the Director of the National Institutes of Health and 
in consultation with the Commissioner of Food and Drugs, 
shall publish a request for proposals to conduct the pediatric 
studies described in the written request in accordance with 
subsection (b). 
‘‘(4) DISQUALIFICATION.—A holder that receives a first right 
of refusal shall not be entitled to respond to a request for 
proposals under paragraph (3). 
‘‘(5) CONTRACTS, GRANTS, OR
OTHER
FUNDING
MECHA-
NISMS.—A contract, grant, or other funding may be awarded 
under this section only if a proposal is submitted to the Sec-
retary in such form and manner, and containing such agree-
ments, assurances, and information as the Secretary determines 
to be necessary to carry out this section. 
‘‘(6) REPORTING OF STUDIES.— 
‘‘(A) IN GENERAL.—On completion of a pediatric study 
in accordance with an award under this section, a report 
concerning the study shall be submitted to the Director 
of the National Institutes of Health and the Commissioner 
of Food and Drugs. The report shall include all data gen-
erated in connection with the study, including a written 
request if issued. 
‘‘(B) AVAILABILITY OF REPORTS.—Each report submitted 
under subparagraph (A) shall be considered to be in the 
public domain (subject to section 505A(d)(4) of the Federal 
Food, Drug, and Cosmetic Act) and shall be assigned a 
Deadline. 
Publication. 
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121 STAT. 888 
PUBLIC LAW 110–85—SEPT. 27, 2007 
docket number by the Commissioner of Food and Drugs. 
An interested person may submit written comments con-
cerning such pediatric studies to the Commissioner of Food 
and Drugs, and the written comments shall become part 
of the docket file with respect to each of the drugs. 
‘‘(C) ACTION BY COMMISSIONER.—The Commissioner of 
Food and Drugs shall take appropriate action in response 
to the reports submitted under subparagraph (A) in accord-
ance with paragraph (7). 
‘‘(7) REQUESTS FOR LABELING CHANGE.—During the 180- 
day period after the date on which a report is submitted under 
paragraph (6)(A), the Commissioner of Food and Drugs shall— 
‘‘(A) review the report and such other data as are 
available concerning the safe and effective use in the pedi-
atric population of the drug studied; 
‘‘(B) negotiate with the holders of approved applications 
for the drug studied for any labeling changes that the 
Commissioner of Food and Drugs determines to be appro-
priate and requests the holders to make; and 
‘‘(C)(i) place in the public docket file a copy of the 
report and of any requested labeling changes; and 
‘‘(ii) publish in the Federal Register and through a 
posting on the Web site of the Food and Drug Administra-
tion a summary of the report and a copy of any requested 
labeling changes. 
‘‘(8) DISPUTE RESOLUTION.— 
‘‘(A) REFERRAL TO PEDIATRIC ADVISORY COMMITTEE.— 
If, not later than the end of the 180-day period specified 
in paragraph (7), the holder of an approved application 
for the drug involved does not agree to any labeling change 
requested by the Commissioner of Food and Drugs under 
that paragraph, the Commissioner of Food and Drugs shall 
refer the request to the Pediatric Advisory Committee. 
‘‘(B) ACTION BY THE PEDIATRIC ADVISORY COMMITTEE.— 
Not later than 90 days after receiving a referral under 
subparagraph (A), the Pediatric Advisory Committee 
shall— 
‘‘(i) review the available information on the safe 
and effective use of the drug in the pediatric popu-
lation, including study reports submitted under this 
section; and 
‘‘(ii) make a recommendation to the Commissioner 
of Food and Drugs as to appropriate labeling changes, 
if any. 
‘‘(9) FDA DETERMINATION.—Not later than 30 days after 
receiving a recommendation from the Pediatric Advisory Com-
mittee under paragraph (8)(B)(ii) with respect to a drug, the 
Commissioner of Food and Drugs shall consider the rec-
ommendation and, if appropriate, make a request to the holders 
of approved applications for the drug to make any labeling 
change that the Commissioner of Food and Drugs determines 
to be appropriate. 
‘‘(10) FAILURE
TO
AGREE.—If a holder of an approved 
application for a drug, within 30 days after receiving a request 
to make a labeling change under paragraph (9), does not agree 
to make a requested labeling change, the Commissioner of 
Deadline. 
Deadline. 
Recommenda- 
tions. 
Deadline. 
Deadline. 
Federal Register, 
publication. 
Web site. 
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121 STAT. 889 
PUBLIC LAW 110–85—SEPT. 27, 2007 
Food and Drugs may deem the drug to be misbranded under 
the Federal Food, Drug, and Cosmetic Act. 
‘‘(11) NO
EFFECT
ON
AUTHORITY.—Nothing in this sub-
section limits the authority of the United States to bring an 
enforcement action under the Federal Food, Drug, and Cosmetic 
Act when a drug lacks appropriate pediatric labeling. Neither 
course of action (the Pediatric Advisory Committee process 
or an enforcement action referred to in the preceding sentence) 
shall preclude, delay, or serve as the basis to stay the other 
course of action. 
‘‘(d) DISSEMINATION
OF PEDIATRIC INFORMATION.—Not later 
than one year after the date of the enactment of the Best Pharma-
ceuticals for Children Act of 2007, the Secretary, acting through 
the Director of the National Institutes of Health, shall study the 
feasibility of establishing a compilation of information on pediatric 
drug use and report the findings to Congress. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(1) IN GENERAL.—There are authorized to be appropriated 
to carry out this section— 
‘‘(A) $200,000,000 for fiscal year 2008; and 
‘‘(B) such sums as are necessary for each of the four 
succeeding fiscal years. 
‘‘(2) AVAILABILITY.—Any amount appropriated under para-
graph (1) shall remain available to carry out this section until 
expended.’’. 
(c) FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.— 
Section 499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 
290b(c)(1)(C)) is amended by striking ‘‘and studies listed by the 
Secretary pursuant to section 409I(a)(1)(A) of this Act and referred 
under section 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic 
Act (21 U.S.C. 355(a)(d)(4)(C)’ ’’ and inserting ‘‘and studies for which 
the Secretary issues a certification in the affirmative under section 
505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic Act’’. 
(d) CONTINUATION OF OPERATION OF COMMITTEE.—Section 14 
of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m 
note) is amended by adding at the end the following new subsection: 
‘‘(d) CONTINUATION OF OPERATION OF COMMITTEE.—Notwith-
standing section 14 of the Federal Advisory Committee Act, the 
advisory committee shall continue to operate during the five-year 
period beginning on the date of the enactment of the Best Pharma-
ceuticals for Children Act of 2007.’’. 
(e) PEDIATRIC
SUBCOMMITTEE
OF
THE
ONCOLOGIC
DRUGS 
ADVISORY COMMITTEE.—Section 15 of the Best Pharmaceuticals 
for Children Act (42 U.S.C. 284m note) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1)— 
(i) in subparagraph (B), by striking ‘‘and’’ after 
the semicolon; 
(ii) in subparagraph (C), by striking the period 
at the end and inserting ‘‘; and’’; and 
(iii) by adding at the end the following new 
subparagraph: 
‘‘(D) provide recommendations to the internal review 
committee created under section 505B(f) of the Federal 
Food, Drug, and Cosmetic Act regarding the implementa-
tion of amendments to sections 505A and 505B of the 
Deadline. 
Reports. 
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121 STAT. 890 
PUBLIC LAW 110–85—SEPT. 27, 2007 
Federal Food, Drug, and Cosmetic Act with respect to 
the treatment of pediatric cancers.’’; and 
(B) by adding at the end the following new paragraph: 
‘‘(3) CONTINUATION OF OPERATION OF SUBCOMMITTEE.—Not-
withstanding section 14 of the Federal Advisory Committee 
Act, the Subcommittee shall continue to operate during the 
five-year period beginning on the date of the enactment of 
the Best Pharmaceuticals for Children Act of 2007.’’; and 
(2) in subsection (d), by striking ‘‘2003’’ and inserting 
‘‘2009’’. 
(f) EFFECTIVE DATE AND LIMITATION FOR RULE RELATING TO 
TOLL-FREE NUMBER FOR ADVERSE EVENTS ON LABELING FOR HUMAN 
DRUG PRODUCTS.— 
(1) IN GENERAL.—Notwithstanding subchapter II of chapter 
5, and chapter 7, of title 5, United States Code (commonly 
known as the ‘‘Administrative Procedure Act’’) and any other 
provision of law, the proposed rule issued by the Commissioner 
of Food and Drugs entitled ‘‘Toll-Free Number for Reporting 
Adverse Events on Labeling for Human Drug Products,’’ 69 
Fed. Reg. 21778, (April 22, 2004) shall take effect on January 
1, 2008, unless such Commissioner issues the final rule before 
such date. 
(2) LIMITATION.—The proposed rule that takes effect under 
subsection (a), or the final rule described under subsection 
(a), shall, notwithstanding section 17(a) of the Best Pharma-
ceuticals for Children Act (21 U.S.C. 355b(a)), not apply to 
a drug— 
(A) for which an application is approved under section 
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355); 
(B) that is not described under section 503(b)(1) of 
such Act (21 U.S.C. 353(b)(1)); and 
(C) the packaging of which includes a toll-free number 
through which consumers can report complaints to the 
manufacturer or distributor of the drug. 
SEC. 503. TRAINING OF PEDIATRIC PHARMACOLOGISTS. 
(a) INVESTMENT IN TOMORROW’S PEDIATRIC RESEARCHERS.—Sec-
tion 452G(2) of the Public Health Service Act (42 U.S.C. 285g– 
10(2)) is amended by adding before the period at the end the 
following: ‘‘, including pediatric pharmacological research’’. 
(b) PEDIATRIC RESEARCH LOAN REPAYMENT PROGRAM.—Section 
487F(a)(1) of the Public Health Service Act (42 U.S.C. 288–6(a)(1)) 
is amended by inserting ‘‘including pediatric pharmacological 
research,’’ after ‘‘pediatric research,’’. 
TITLE VI—REAGAN-UDALL 
FOUNDATION 
SEC. 601. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG 
ADMINISTRATION. 
(a) IN GENERAL.—Chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at 
the end the following: 
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121 STAT. 891 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘Subchapter I—Reagan-Udall Foundation for the Food and 
Drug Administration 
‘‘SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUNDATION. 
‘‘(a) IN GENERAL.—A nonprofit corporation to be known as 
the Reagan-Udall Foundation for the Food and Drug Administration 
(referred to in this subchapter as the ‘Foundation’) shall be estab-
lished in accordance with this section. The Foundation shall be 
headed by an Executive Director, appointed by the members of 
the Board of Directors under subsection (e). The Foundation shall 
not be an agency or instrumentality of the United States Govern-
ment. 
‘‘(b) PURPOSE OF FOUNDATION.—The purpose of the Foundation 
is to advance the mission of the Food and Drug Administration 
to modernize medical, veterinary, food, food ingredient, and cosmetic 
product development, accelerate innovation, and enhance product 
safety. 
‘‘(c) DUTIES OF THE FOUNDATION.—The Foundation shall— 
‘‘(1) taking into consideration the Critical Path reports 
and priorities published by the Food and Drug Administration, 
identify unmet needs in the development, manufacture, and 
evaluation of the safety and effectiveness, including post-
approval, of devices, including diagnostics, biologics, and drugs, 
and the safety of food, food ingredients, and cosmetics, and 
including the incorporation of more sensitive and predictive 
tools and devices to measure safety; 
‘‘(2) establish goals and priorities in order to meet the 
unmet needs identified in paragraph (1); 
‘‘(3) in consultation with the Secretary, identify existing 
and proposed Federal intramural and extramural research and 
development programs relating to the goals and priorities estab-
lished under paragraph (2), coordinate Foundation activities 
with such programs, and minimize Foundation duplication of 
existing efforts; 
‘‘(4) award grants to, or enter into contracts, memoranda 
of understanding, or cooperative agreements with, scientists 
and entities, which may include the Food and Drug Administra-
tion, university consortia, public-private partnerships, institu-
tions of higher education, entities described in section 501(c)(3) 
of the Internal Revenue Code (and exempt from tax under 
section 501(a) of such Code), and industry, to efficiently and 
effectively advance the goals and priorities established under 
paragraph (2); 
‘‘(5) recruit meeting participants and hold or sponsor (in 
whole or in part) meetings as appropriate to further the goals 
and priorities established under paragraph (2); 
‘‘(6) release and publish information and data and, to the 
extent practicable, license, distribute, and release material, re-
agents, and techniques to maximize, promote, and coordinate 
the availability of such material, reagents, and techniques for 
use by the Food and Drug Administration, nonprofit organiza-
tions, and academic and industrial researchers to further the 
goals and priorities established under paragraph (2); 
‘‘(7) ensure that— 
‘‘(A) action is taken as necessary to obtain patents 
for inventions developed by the Foundation or with funds 
from the Foundation; 
Publication. 
Grants. 
Contracts. 
Memorandums. 
21 USC 379dd. 
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121 STAT. 892 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(B) action is taken as necessary to enable the licensing 
of inventions developed by the Foundation or with funds 
from the Foundation; and 
‘‘(C) executed licenses, memoranda of understanding, 
material transfer agreements, contracts, and other such 
instruments, promote, to the maximum extent practicable, 
the broadest conversion to commercial and noncommercial 
applications of licensed and patented inventions of the 
Foundation to further the goals and priorities established 
under paragraph (2); 
‘‘(8) provide objective clinical and scientific information to 
the Food and Drug Administration and, upon request, to other 
Federal agencies to assist in agency determinations of how 
to ensure that regulatory policy accommodates scientific 
advances and meets the agency’s public health mission; 
‘‘(9) conduct annual assessments of the unmet needs identi-
fied in paragraph (1); and 
‘‘(10) carry out such other activities consistent with the 
purposes of the Foundation as the Board determines appro-
priate. 
‘‘(d) BOARD OF DIRECTORS.— 
‘‘(1) ESTABLISHMENT.— 
‘‘(A) IN GENERAL.—The Foundation shall have a Board 
of Directors (referred to in this subchapter as the ‘Board’), 
which shall be composed of ex officio and appointed mem-
bers in accordance with this subsection. All appointed mem-
bers of the Board shall be voting members. 
‘‘(B) EX
OFFICIO
MEMBERS.—The ex officio members 
of the Board shall be the following individuals or their 
designees: 
‘‘(i) The Commissioner. 
‘‘(ii) The Director of the National Institutes of 
Health. 
‘‘(iii) The Director of the Centers for Disease Con-
trol and Prevention. 
‘‘(iv) The Director of the Agency for Healthcare 
Research and Quality. 
‘‘(C) APPOINTED MEMBERS.— 
‘‘(i) IN GENERAL.—The ex officio members of the 
Board under subparagraph (B) shall, by majority vote, 
appoint to the Board 14 individuals, of which 9 shall 
be from a list of candidates to be provided by the 
National Academy of Sciences and 5 shall be from 
lists of candidates provided by patient and consumer 
advocacy groups, professional scientific and medical 
societies, and industry trade organizations. Of such 
appointed members— 
‘‘(I) 4 shall be representatives of the general 
pharmaceutical, device, food, cosmetic, and bio-
technology industries; 
‘‘(II) 3 shall be representatives of academic 
research organizations; 
‘‘(III) 2 shall be representatives of patient or 
consumer advocacy organizations; 
‘‘(IV) 1 shall be a representative of health care 
providers; and 
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121 STAT. 893 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(V) 4 shall be at-large members with expertise 
or experience relevant to the purpose of the 
Foundation. 
‘‘(ii) REQUIREMENTS.— 
‘‘(I) EXPERTISE.—The ex officio members shall 
ensure the Board membership includes individuals 
with expertise in areas including the sciences of 
developing, manufacturing, and evaluating the 
safety and effectiveness of devices, including 
diagnostics, biologics, and drugs, and the safety 
of food, food ingredients, and cosmetics. 
‘‘(II) FEDERAL
EMPLOYEES.—No employee of 
the Federal Government shall be appointed as a 
member of the Board under this subparagraph 
or under paragraph (3)(B). 
‘‘(D) INITIAL MEETING.— 
‘‘(i) IN
GENERAL.—Not later than 30 days after 
the date of the enactment of this subchapter, the Sec-
retary shall convene a meeting of the ex officio mem-
bers of the Board to— 
‘‘(I) incorporate the Foundation; and 
‘‘(II) appoint the members of the Board in 
accordance with subparagraph (C). 
‘‘(ii) SERVICE OF EX OFFICIO MEMBERS.—Upon the 
appointment of the members of the Board under clause 
(i)(II)— 
‘‘(I) the terms of service of the Director of 
the Centers for Disease Control and Prevention 
and of the Director of the Agency for Healthcare 
Research and Quality as ex officio members of 
the Board shall terminate; and 
‘‘(II) the Commissioner and the Director of 
the National Institutes of Health shall continue 
to serve as ex officio members of the Board, but 
shall be nonvoting members. 
‘‘(iii) CHAIR.—The ex officio members of the Board 
under subparagraph (B) shall designate an appointed 
member of the Board to serve as the Chair of the 
Board. 
‘‘(2) DUTIES OF BOARD.—The Board shall— 
‘‘(A) establish bylaws for the Foundation that— 
‘‘(i) are published in the Federal Register and 
available for public comment; 
‘‘(ii) establish policies for the selection of the offi-
cers, employees, agents, and contractors of the Founda-
tion; 
‘‘(iii) establish policies, including ethical standards, 
for the acceptance, solicitation, and disposition of dona-
tions and grants to the Foundation and for the disposi-
tion of the assets of the Foundation, including appro-
priate limits on the ability of donors to designate, 
by stipulation or restriction, the use or recipient of 
donated funds; 
‘‘(iv) establish policies that would subject all 
employees, fellows, and trainees of the Foundation to 
the conflict of interest standards under section 208 
of title 18, United States Code; 
Federal Register, 
publication. 
Deadline. 
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121 STAT. 894 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(v) establish licensing, distribution, and publica-
tion policies that support the widest and least restric-
tive use by the public of information and inventions 
developed by the Foundation or with Foundation funds 
to carry out the duties described in paragraphs (6) 
and (7) of subsection (c), and may include charging 
cost-based fees for published material produced by the 
Foundation; 
‘‘(vi) specify principles for the review of proposals 
and awarding of grants and contracts that include 
peer review and that are consistent with those of the 
Foundation for the National Institutes of Health, to 
the extent determined practicable and appropriate by 
the Board; 
‘‘(vii) specify a cap on administrative expenses for 
recipients of a grant, contract, or cooperative agree-
ment from the Foundation; 
‘‘(viii) establish policies for the execution of memo-
randa of understanding and cooperative agreements 
between the Foundation and other entities, including 
the Food and Drug Administration; 
‘‘(ix) establish policies for funding training fellow-
ships, whether at the Foundation, academic or sci-
entific institutions, or the Food and Drug Administra-
tion, for scientists, doctors, and other professionals who 
are not employees of regulated industry, to foster 
greater understanding of and expertise in new sci-
entific tools, diagnostics, manufacturing techniques, 
and potential barriers to translating basic research 
into clinical and regulatory practice; 
‘‘(x) specify a process for annual Board review of 
the operations of the Foundation; and 
‘‘(xi) establish specific duties of the Executive 
Director; 
‘‘(B) prioritize and provide overall direction to the 
activities of the Foundation; 
‘‘(C) evaluate the performance of the Executive 
Director; and 
‘‘(D) carry out any other necessary activities regarding 
the functioning of the Foundation. 
‘‘(3) TERMS AND VACANCIES.— 
‘‘(A) TERM.—The term of office of each member of the 
Board appointed under paragraph (1)(C) shall be 4 years, 
except that the terms of offices for the initial appointed 
members of the Board shall expire on a staggered basis 
as determined by the ex officio members. 
‘‘(B) VACANCY.—Any vacancy in the membership of 
the Board— 
‘‘(i) shall not affect the power of the remaining 
members to execute the duties of the Board; and 
‘‘(ii) shall be filled by appointment by the appointed 
members described in paragraph (1)(C) by majority 
vote. 
‘‘(C) PARTIAL TERM.—If a member of the Board does 
not serve the full term applicable under subparagraph (A), 
the individual appointed under subparagraph (B) to fill 
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121 STAT. 895 
PUBLIC LAW 110–85—SEPT. 27, 2007 
the resulting vacancy shall be appointed for the remainder 
of the term of the predecessor of the individual. 
‘‘(D) SERVING
PAST
TERM.—A member of the Board 
may continue to serve after the expiration of the term 
of the member until a successor is appointed. 
‘‘(4) COMPENSATION.—Members of the Board may not 
receive compensation for service on the Board. Such members 
may be reimbursed for travel, subsistence, and other necessary 
expenses incurred in carrying out the duties of the Board, 
as set forth in the bylaws issued by the Board. 
‘‘(e) INCORPORATION.—The ex officio members of the Board shall 
serve as incorporators and shall take whatever actions necessary 
to incorporate the Foundation. 
‘‘(f) NONPROFIT STATUS.—In carrying out subsection (b), the 
Board shall establish such policies and bylaws under subsection 
(d), and the Executive Director shall carry out such activities under 
subsection (g), as may be necessary to ensure that the Foundation 
maintains status as an organization that— 
‘‘(1) is described in subsection (c)(3) of section 501 of the 
Internal Revenue Code of 1986; and 
‘‘(2) is, under subsection (a) of such section, exempt from 
taxation. 
‘‘(g) EXECUTIVE DIRECTOR.— 
‘‘(1) IN GENERAL.—The Board shall appoint an Executive 
Director who shall serve at the pleasure of the Board. The 
Executive Director shall be responsible for the day-to-day oper-
ations of the Foundation and shall have such specific duties 
and responsibilities as the Board shall prescribe. 
‘‘(2) COMPENSATION.—The compensation of the Executive 
Director shall be fixed by the Board but shall not be greater 
than the compensation of the Commissioner. 
‘‘(h) ADMINISTRATIVE POWERS.—In carrying out this subchapter, 
the Board, acting through the Executive Director, may— 
‘‘(1) adopt, alter, and use a corporate seal, which shall 
be judicially noticed; 
‘‘(2) hire, promote, compensate, and discharge 1 or more 
officers, employees, and agents, as may be necessary, and define 
their duties; 
‘‘(3) prescribe the manner in which— 
‘‘(A) real or personal property of the Foundation is 
acquired, held, and transferred; 
‘‘(B) general operations of the Foundation are to be 
conducted; and 
‘‘(C) the privileges granted to the Board by law are 
exercised and enjoyed; 
‘‘(4) with the consent of the applicable executive department 
or independent agency, use the information, services, and facili-
ties of such department or agencies in carrying out this section; 
‘‘(5) enter into contracts with public and private organiza-
tions for the writing, editing, printing, and publishing of books 
and other material; 
‘‘(6) hold, administer, invest, and spend any gift, devise, 
or bequest of real or personal property made to the Foundation 
under subsection (i); 
‘‘(7) enter into such other contracts, leases, cooperative 
agreements, and other transactions as the Board considers 
appropriate to conduct the activities of the Foundation; 
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121 STAT. 896 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(8) modify or consent to the modification of any contract 
or agreement to which it is a party or in which it has an 
interest under this subchapter; 
‘‘(9) take such action as may be necessary to obtain patents 
and licenses for devices and procedures developed by the 
Foundation and its employees; 
‘‘(10) sue and be sued in its corporate name, and complain 
and defend in courts of competent jurisdiction; 
‘‘(11) appoint other groups of advisors as may be determined 
necessary to carry out the functions of the Foundation; and 
‘‘(12) exercise other powers as set forth in this section, 
and such other incidental powers as are necessary to carry 
out its powers, duties, and functions in accordance with this 
subchapter. 
‘‘(i) ACCEPTANCE OF FUNDS FROM OTHER SOURCES.—The Execu-
tive Director may solicit and accept on behalf of the Foundation, 
any funds, gifts, grants, devises, or bequests of real or personal 
property made to the Foundation, including from private entities, 
for the purposes of carrying out the duties of the Foundation. 
‘‘(j) SERVICE
OF FEDERAL EMPLOYEES.—Federal Government 
employees may serve on committees advisory to the Foundation 
and otherwise cooperate with and assist the Foundation in carrying 
out its functions, so long as such employees do not direct or control 
Foundation activities. 
‘‘(k) DETAIL OF GOVERNMENT EMPLOYEES; FELLOWSHIPS.— 
‘‘(1) DETAIL
FROM
FEDERAL
AGENCIES.—Federal Govern-
ment employees may be detailed from Federal agencies with 
or without reimbursement to those agencies to the Foundation 
at any time, and such detail shall be without interruption 
or loss of civil service status or privilege. Each such employee 
shall abide by the statutory, regulatory, ethical, and procedural 
standards applicable to the employees of the agency from which 
such employee is detailed and those of the Foundation. 
‘‘(2) 
VOLUNTARY
SERVICE; 
ACCEPTANCE
OF
FEDERAL 
EMPLOYEES.— 
‘‘(A) FOUNDATION.—The Executive Director of the 
Foundation may accept the services of employees detailed 
from Federal agencies with or without reimbursement to 
those agencies. 
‘‘(B) FOOD AND DRUG ADMINISTRATION.—The Commis-
sioner may accept the uncompensated services of Founda-
tion fellows or trainees. Such services shall be considered 
to be undertaking an activity under contract with the Sec-
retary as described in section 708. 
‘‘(l) ANNUAL REPORTS.— 
‘‘(1) REPORTS TO FOUNDATION.—Any recipient of a grant, 
contract, 
fellowship, 
memorandum 
of 
understanding, 
or 
cooperative agreement from the Foundation under this section 
shall submit to the Foundation a report on an annual basis 
for the duration of such grant, contract, fellowship, memo-
randum of understanding, or cooperative agreement, that 
describes the activities carried out under such grant, contract, 
fellowship, memorandum of understanding, or cooperative 
agreement. 
‘‘(2) REPORT TO CONGRESS AND THE FDA.—Beginning with 
fiscal year 2009, the Executive Director shall submit to Con-
gress and the Commissioner an annual report that— 
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121 STAT. 897 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(A) describes the activities of the Foundation and 
the progress of the Foundation in furthering the goals 
and priorities established under subsection (c)(2), including 
the practical impact of the Foundation on regulated product 
development; 
‘‘(B) provides a specific accounting of the source and 
use of all funds used by the Foundation to carry out such 
activities; and 
‘‘(C) provides information on how the results of Founda-
tion activities could be incorporated into the regulatory 
and product review activities of the Food and Drug 
Administration. 
‘‘(m) SEPARATION
OF FUNDS.—The Executive Director shall 
ensure that the funds received from the Treasury are held in 
separate accounts from funds received from entities under sub-
section (i). 
‘‘(n) FUNDING.—From amounts appropriated to the Food and 
Drug Administration for each fiscal year, the Commissioner shall 
transfer not less than $500,000 and not more than $1,250,000, 
to the Foundation to carry out subsections (a), (b), and (d) through 
(m).’’. 
(b) OTHER FOUNDATION PROVISIONS.—Chapter VII of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) (as 
amended by subsection (a)) is amended by adding at the end the 
following: 
‘‘SEC. 771. LOCATION OF FOUNDATION. 
‘‘The Foundation shall, if practicable, be located not more than 
20 miles from the District of Columbia. 
‘‘SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION. 
‘‘(a) IN GENERAL.—The Commissioner shall receive and assess 
the report submitted to the Commissioner by the Executive Director 
of the Foundation under section 770(l)(2). 
‘‘(b) REPORT TO CONGRESS.—Beginning with fiscal year 2009, 
the Commissioner shall submit to Congress an annual report 
summarizing the incorporation of the information provided by the 
Foundation in the report described under section 770(l)(2) and 
by other recipients of grants, contracts, memoranda of under-
standing, or cooperative agreements into regulatory and product 
review activities of the Food and Drug Administration. 
‘‘(c) EXTRAMURAL GRANTS.—The provisions of this subchapter 
and section 566 shall have no effect on any grant, contract, memo-
randum of understanding, or cooperative agreement between the 
Food and Drug Administration and any other entity entered into 
before, on, or after the date of the enactment of this subchapter.’’. 
(c) CONFORMING AMENDMENT.—Section 742(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379l(b)) is amended by 
adding at the end the following: ‘‘Any such fellowships and training 
programs under this section or under section 770(d)(2)(A)(ix) may 
include provision by such scientists and physicians of services on 
a voluntary and uncompensated basis, as the Secretary determines 
appropriate. Such scientists and physicians shall be subject to all 
legal and ethical requirements otherwise applicable to officers or 
employees of the Department of Health and Human Services.’’. 
21 USC 379dd–2. 
21 USC 379dd–1. 
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121 STAT. 898 
PUBLIC LAW 110–85—SEPT. 27, 2007 
SEC. 602. OFFICE OF THE CHIEF SCIENTIST. 
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 391 et seq.) is amended by adding at the end the following: 
‘‘SEC. 910. OFFICE OF THE CHIEF SCIENTIST. 
‘‘(a) ESTABLISHMENT; APPOINTMENT.—The Secretary shall estab-
lish within the Office of the Commissioner an office to be known 
as the Office of the Chief Scientist. The Secretary shall appoint 
a Chief Scientist to lead such Office. 
‘‘(b) DUTIES OF THE OFFICE.—The Office of the Chief Scientist 
shall— 
‘‘(1) oversee, coordinate, and ensure quality and regulatory 
focus of the intramural research programs of the Food and 
Drug Administration; 
‘‘(2) track and, to the extent necessary, coordinate intra-
mural research awards made by each center of the Administra-
tion or science-based office within the Office of the Commis-
sioner, and ensure that there is no duplication of research 
efforts supported by the Reagan-Udall Foundation for the Food 
and Drug Administration; 
‘‘(3) develop and advocate for a budget to support intra-
mural research; 
‘‘(4) develop a peer review process by which intramural 
research can be evaluated; 
‘‘(5) identify and solicit intramural research proposals from 
across the Food and Drug Administration through an advisory 
board composed of employees of the Administration that shall 
include— 
‘‘(A) representatives of each of the centers and the 
science-based offices within the Office of the Commissioner; 
and 
‘‘(B) experts on trial design, epidemiology, demo-
graphics, pharmacovigilance, basic science, and public 
health; and 
‘‘(6) develop postmarket safety performance measures that 
are as measurable and rigorous as the ones already developed 
for premarket review.’’. 
SEC. 603. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS. 
Subchapter E of chapter V of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding 
at the end the following: 
‘‘SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS. 
‘‘(a) ESTABLISHMENT.—The Secretary, acting through the 
Commissioner of Food and Drugs, may enter into collaborative 
agreements, to be known as Critical Path Public-Private Partner-
ships, with one or more eligible entities to implement the Critical 
Path Initiative of the Food and Drug Administration by developing 
innovative, collaborative projects in research, education, and out-
reach for the purpose of fostering medical product innovation, 
enabling the acceleration of medical product development, manufac-
turing, and translational therapeutics, and enhancing medical 
product safety. 
‘‘(b) ELIGIBLE ENTITY.—In this section, the term ‘eligible entity’ 
means an entity that meets each of the following: 
‘‘(1) The entity is— 
21 USC 
360bbb–5. 
21 USC 399a. 
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121 STAT. 899 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(A) an institution of higher education (as such term 
is defined in section 101 of the Higher Education Act of 
1965) or a consortium of such institutions; or 
‘‘(B) an organization described in section 501(c)(3) of 
the Internal Revenue Code of 1986 and exempt from tax 
under section 501(a) of such Code. 
‘‘(2) The entity has experienced personnel and clinical and 
other technical expertise in the biomedical sciences, which may 
include graduate training programs in areas relevant to prior-
ities of the Critical Path Initiative. 
‘‘(3) The entity demonstrates to the Secretary’s satisfaction 
that the entity is capable of— 
‘‘(A) developing and critically evaluating tools, methods, 
and processes— 
‘‘(i) to increase efficiency, predictability, and 
productivity of medical product development; and 
‘‘(ii) to more accurately identify the benefits and 
risks of new and existing medical products; 
‘‘(B) establishing partnerships, consortia, and collabora-
tions with health care practitioners and other providers 
of health care goods or services; pharmacists; pharmacy 
benefit managers and purchasers; health maintenance 
organizations and other managed health care organiza-
tions; health care insurers; government agencies; patients 
and consumers; manufacturers of prescription drugs, 
biological products, diagnostic technologies, and devices; 
and academic scientists; and 
‘‘(C) securing funding for the projects of a Critical 
Path Public-Private Partnership from Federal and non-
federal governmental sources, foundations, and private 
individuals. 
‘‘(c) FUNDING.—The Secretary may not enter into a collaborative 
agreement under subsection (a) unless the eligible entity involved 
provides an assurance that the entity will not accept funding for 
a Critical Path Public-Private Partnership project from any 
organization that manufactures or distributes products regulated 
by the Food and Drug Administration unless the entity provides 
assurances in its agreement with the Food and Drug Administration 
that the results of the Critical Path Public-Private Partnership 
project will not be influenced by any source of funding. 
‘‘(d) ANNUAL REPORT.—Not later than 18 months after the 
date of the enactment of this section, and annually thereafter, 
the Secretary, in collaboration with the parties to each Critical 
Path Public-Private Partnership, shall submit a report to the Com-
mittee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives— 
‘‘(1) reviewing the operations and activities of the Partner-
ships in the previous year; and 
‘‘(2) addressing such other issues relating to this section 
as the Secretary determines to be appropriate. 
‘‘(e) DEFINITION.—In this section, the term ‘medical product’ 
includes a drug, a biological product as defined in section 351 
of the Public Health Service Act, a device, and any combination 
of such products. 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec-
tion, there are authorized to be appropriated $5,000,000 for fiscal 
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121 STAT. 900 
PUBLIC LAW 110–85—SEPT. 27, 2007 
year 2008 and such sums as may be necessary for each of fiscal 
years 2009 through 2012.’’. 
TITLE VII—CONFLICTS OF INTEREST 
SEC. 701. CONFLICTS OF INTEREST. 
(a) IN GENERAL.—Subchapter A of chapter VII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended 
by inserting at the end the following: 
‘‘SEC. 712. CONFLICTS OF INTEREST. 
‘‘(a) DEFINITIONS.—For purposes of this section: 
‘‘(1) ADVISORY COMMITTEE.—The term ‘advisory committee’ 
means an advisory committee under the Federal Advisory Com-
mittee Act that provides advice or recommendations to the 
Secretary regarding activities of the Food and Drug Administra-
tion. 
‘‘(2) FINANCIAL
INTEREST.—The term ‘financial interest’ 
means a financial interest under section 208(a) of title 18, 
United States Code. 
‘‘(b) APPOINTMENTS TO ADVISORY COMMITTEES.— 
‘‘(1) RECRUITMENT.— 
‘‘(A) IN GENERAL.—The Secretary shall— 
‘‘(i) develop and implement strategies on effective 
outreach to potential members of advisory committees 
at universities, colleges, other academic research cen-
ters, professional and medical societies, and patient 
and consumer groups; 
‘‘(ii) seek input from professional medical and sci-
entific societies to determine the most effective 
informational and recruitment activities; and 
‘‘(iii) take into account the advisory committees 
with the greatest number of vacancies. 
‘‘(B) RECRUITMENT ACTIVITIES.—The recruitment activi-
ties under subparagraph (A) may include— 
‘‘(i) advertising the process for becoming an 
advisory committee member at medical and scientific 
society conferences; 
‘‘(ii) making widely available, including by using 
existing electronic communications channels, the con-
tact information for the Food and Drug Administration 
point of contact regarding advisory committee nomina-
tions; and 
‘‘(iii) developing a method through which an entity 
receiving funding from the National Institutes of 
Health, the Agency for Healthcare Research and 
Quality, the Centers for Disease Control and Preven-
tion, or the Veterans Health Administration can iden-
tify a person who the Food and Drug Administration 
can contact regarding the nomination of individuals 
to serve on advisory committees. 
‘‘(2) EVALUATION AND CRITERIA.—When considering a term 
appointment to an advisory committee, the Secretary shall 
review the expertise of the individual and the financial disclo-
sure report filed by the individual pursuant to the Ethics in 
Government Act of 1978 for each individual under consideration 
21 USC 379d–1. 
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121 STAT. 901 
PUBLIC LAW 110–85—SEPT. 27, 2007 
for the appointment, so as to reduce the likelihood that an 
appointed individual will later require a written determination 
as referred to in section 208(b)(1) of title 18, United States 
Code, a written certification as referred to in section 208(b)(3) 
of title 18, United States Code, or a waiver as referred to 
in subsection (c)(2) of this section for service on the committee 
at a meeting of the committee. 
‘‘(c) DISCLOSURES; PROHIBITIONS ON PARTICIPATION; WAIVERS.— 
‘‘(1) DISCLOSURE
OF
FINANCIAL
INTEREST.—Prior to a 
meeting of an advisory committee regarding a ‘particular 
matter’ (as that term is used in section 208 of title 18, United 
States Code), each member of the committee who is a full- 
time Government employee or special Government employee 
shall disclose to the Secretary financial interests in accordance 
with subsection (b) of such section 208. 
‘‘(2) PROHIBITIONS AND WAIVERS ON PARTICIPATION.— 
‘‘(A) IN GENERAL.—Except as provided under subpara-
graph (B), a member of an advisory committee may not 
participate with respect to a particular matter considered 
in an advisory committee meeting if such member (or an 
immediate family member of such member) has a financial 
interest that could be affected by the advice given to the 
Secretary with respect to such matter, excluding interests 
exempted in regulations issued by the Director of the Office 
of Government Ethics as too remote or inconsequential 
to affect the integrity of the services of the Government 
officers or employees to which such regulations apply. 
‘‘(B) WAIVER.—If the Secretary determines it necessary 
to afford the advisory committee essential expertise, the 
Secretary may grant a waiver of the prohibition in subpara-
graph (A) to permit a member described in such subpara-
graph to— 
‘‘(i) participate as a non-voting member with 
respect to a particular matter considered in a com-
mittee meeting; or 
‘‘(ii) participate as a voting member with respect 
to a particular matter considered in a committee 
meeting. 
‘‘(C) LIMITATION ON WAIVERS AND OTHER EXCEPTIONS.— 
‘‘(i) DEFINITION.—For purposes of this subpara-
graph, the term ‘exception’ means each of the following 
with respect to members of advisory committees: 
‘‘(I) A waiver under section 505(n)(4) (as in 
effect on the day before the date of the enactment 
of the Food and Drug Administration Amendments 
Act of 2007). 
‘‘(II) A written determination under section 
208(b) of title 18, United States Code. 
‘‘(III) A written certification under section 
208(b)(3) of such title. 
‘‘(ii) DETERMINATION OF TOTAL NUMBER OF MEM-
BERS SLOTS AND MEMBER EXCEPTIONS DURING FISCAL 
YEAR 2007.—The Secretary shall determine— 
‘‘(I)(aa) for each meeting held by any advisory 
committee during fiscal year 2007, the number 
of members who participated in the meeting; and 
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121 STAT. 902 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(bb) the sum of the respective numbers deter-
mined under item (aa) (referred to in this subpara-
graph as the ‘‘total number of 2007 meeting slots’’); 
and 
‘‘(II)(aa) for each meeting held by any advisory 
committee during fiscal year 2007, the number 
of members who received an exception for the 
meeting; and 
‘‘(bb) the sum of the respective numbers deter-
mined under item (aa) (referred to in this subpara-
graph as the ‘‘total number of 2007 meeting excep-
tions’’). 
‘‘(iii) DETERMINATION OF PERCENTAGE REGARDING 
EXCEPTIONS DURING FISCAL YEAR 2007.—The Secretary 
shall determine the percentage constituted by— 
‘‘(I) the total number of 2007 meeting excep-
tions; divided by 
‘‘(II) the total number of 2007 meeting slots. 
‘‘(iv) LIMITATION FOR FISCAL YEARS 2008 THROUGH 
2012.—The number of exceptions at the Food and Drug 
Administration for members of advisory committees 
for a fiscal year may not exceed the following: 
‘‘(I) For fiscal year 2008, 95 percent of the 
percentage determined under clause (iii) (referred 
to in this clause as the ‘‘base percentage’’). 
‘‘(II) For fiscal year 2009, 90 percent of the 
base percentage. 
‘‘(III) For fiscal year 2010, 85 percent of the 
base percentage. 
‘‘(IV) For fiscal year 2011, 80 percent of the 
base percentage. 
‘‘(V) For fiscal year 2012, 75 percent of the 
base percentage. 
‘‘(v) ALLOCATION OF EXCEPTIONS.—The exceptions 
authorized under clause (iv) for a fiscal year may be 
allocated within the centers or other organizational 
units of the Food and Drug Administration as deter-
mined appropriate by the Secretary. 
‘‘(3) DISCLOSURE
OF
WAIVER.—Notwithstanding section 
107(a)(2) of the Ethics in Government Act (5 U.S.C. App.), 
the following shall apply: 
‘‘(A) 15 OR MORE DAYS IN ADVANCE.—As soon as prac-
ticable, but (except as provided in subparagraph (B)) not 
later than 15 days prior to a meeting of an advisory com-
mittee to which a written determination as referred to 
in section 208(b)(1) of title 18, United States Code, a writ-
ten certification as referred to in section 208(b)(3) of title 
18, United States Code, or a waiver as referred to in 
paragraph (2)(B) applies, the Secretary shall disclose (other 
than information exempted from disclosure under section 
552 of title 5, United States Code, and section 552a of 
title 5, United States Code (popularly known as the 
Freedom of Information Act and the Privacy Act of 1974, 
respectively)) on the Internet Web site of the Food and 
Drug Administration— 
‘‘(i) the type, nature, and magnitude of the finan-
cial interests of the advisory committee member to 
Applicability. 
Web site. 
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121 STAT. 903 
PUBLIC LAW 110–85—SEPT. 27, 2007 
which such determination, certification, or waiver 
applies; and 
‘‘(ii) the reasons of the Secretary for such deter-
mination, certification, or waiver. 
‘‘(B) LESS
THAN
30
DAYS
IN
ADVANCE.—In the case 
of a financial interest that becomes known to the Secretary 
less than 30 days prior to a meeting of an advisory com-
mittee to which a written determination as referred to 
in section 208(b)(1) of title 18, United States Code, a writ-
ten certification as referred to in section 208(b)(3) of title 
18, United States Code, or a waiver as referred to in 
paragraph (2)(B) applies, the Secretary shall disclose (other 
than information exempted from disclosure under section 
552 of title 5, United States Code, and section 552a of 
title 5, United States Code) on the Internet Web site of 
the Food and Drug Administration, the information 
described in clauses (i) and (ii) of subparagraph (A) as 
soon as practicable after the Secretary makes such deter-
mination, certification, or waiver, but in no case later than 
the date of such meeting. 
‘‘(d) PUBLIC RECORD.—The Secretary shall ensure that the 
public record and transcript of each meeting of an advisory com-
mittee includes the disclosure required under subsection (c)(3) (other 
than information exempted from disclosure under section 552 of 
title 5, United States Code, and section 552a of title 5, United 
States Code). 
‘‘(e) ANNUAL REPORT.—Not later than February 1 of each year, 
the Secretary shall submit to the Committee on Appropriations 
and the Committee on Health, Education, Labor, and Pensions 
of the Senate, and the Committee on Appropriations and the Com-
mittee on Energy and Commerce of the House of Representatives 
a report that describes— 
‘‘(1) with respect to the fiscal year that ended on September 
30 of the previous year, the number of vacancies on each 
advisory committee, the number of nominees received for each 
committee, and the number of such nominees willing to serve; 
‘‘(2) with respect to such year, the aggregate number of 
disclosures required under subsection (c)(3) for each meeting 
of each advisory committee and the percentage of individuals 
to whom such disclosures did not apply who served on such 
committee for each such meeting; 
‘‘(3) with respect to such year, the number of times the 
disclosures required under subsection (c)(3) occurred under 
subparagraph (B) of such subsection; and 
‘‘(4) how the Secretary plans to reduce the number of 
vacancies reported under paragraph (1) during the fiscal year 
following such year, and mechanisms to encourage the nomina-
tion of individuals for service on an advisory committee, 
including those who are classified by the Food and Drug 
Administration as academicians or practitioners. 
‘‘(f) PERIODIC REVIEW OF GUIDANCE.—Not less than once every 
5 years, the Secretary shall review guidance of the Food and Drug 
Administration regarding conflict of interest waiver determinations 
with respect to advisory committees and update such guidance 
as necessary.’’. 
(b) CONFORMING AMENDMENTS.—Section 505(n) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended by— 
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121 STAT. 904 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(1) striking paragraph (4); and 
(2) redesignating paragraphs (5), (6), (7), and (8) as para-
graphs (4), (5), (6), and (7), respectively. 
(c) EFFECTIVE DATE.—The amendments made by this section 
shall take effect on October 1, 2007. 
TITLE VIII—CLINICAL TRIAL 
DATABASES 
SEC. 801. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK. 
(a) IN GENERAL.—Section 402 of the Public Health Service 
Act (42 U.S.C. 282) is amended by— 
(1) redesignating subsections (j) and (k) as subsections 
(k) and (l), respectively; and 
(2) inserting after subsection (i) the following: 
‘‘(j) EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.— 
‘‘(1) DEFINITIONS; REQUIREMENT.— 
‘‘(A) DEFINITIONS.—In this subsection: 
‘‘(i) 
APPLICABLE
CLINICAL
TRIAL.—The 
term 
‘applicable clinical trial’ means an applicable device 
clinical trial or an applicable drug clinical trial. 
‘‘(ii) APPLICABLE DEVICE CLINICAL TRIAL.—The term 
‘applicable device clinical trial’ means— 
‘‘(I) a prospective clinical study of health out-
comes comparing an intervention with a device 
subject to section 510(k), 515, or 520(m) of the 
Federal Food, Drug, and Cosmetic Act against a 
control in human subjects (other than a small clin-
ical trial to determine the feasibility of a device, 
or a clinical trial to test prototype devices where 
the primary outcome measure relates to feasibility 
and not to health outcomes); and 
‘‘(II) a pediatric postmarket surveillance as 
required under section 522 of the Federal Food, 
Drug, and Cosmetic Act. 
‘‘(iii) APPLICABLE DRUG CLINICAL TRIAL.— 
‘‘(I) IN GENERAL.—The term ‘applicable drug 
clinical trial’ means a controlled clinical investiga-
tion, other than a phase I clinical investigation, 
of a drug subject to section 505 of the Federal 
Food, Drug, and Cosmetic Act or to section 351 
of this Act. 
‘‘(II) CLINICAL INVESTIGATION.—For purposes 
of subclause (I), the term ‘clinical investigation’ 
has the meaning given that term in section 312.3 
of title 21, Code of Federal Regulations (or any 
successor regulation). 
‘‘(III) PHASE I.—For purposes of subclause (I), 
the term ‘phase I’ has the meaning given that 
term in section 312.21 of title 21, Code of Federal 
Regulations (or any successor regulation). 
‘‘(iv) CLINICAL TRIAL INFORMATION.—The term ‘clin-
ical trial information’ means, with respect to an 
applicable clinical trial, those data elements that the 
responsible party is required to submit under para-
graph (2) or under paragraph (3). 
21 USC 355 note. 
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121 STAT. 905 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(v) COMPLETION
DATE.—The term ‘completion 
date’ means, with respect to an applicable clinical trial, 
the date that the final subject was examined or 
received an intervention for the purposes of final collec-
tion of data for the primary outcome, whether the 
clinical trial concluded according to the prespecified 
protocol or was terminated. 
‘‘(vi) DEVICE.—The term ‘device’ means a device 
as defined in section 201(h) of the Federal Food, Drug, 
and Cosmetic Act. 
‘‘(vii) DRUG.—The term ‘drug’ means a drug as 
defined in section 201(g) of the Federal Food, Drug, 
and Cosmetic Act or a biological product as defined 
in section 351 of this Act. 
‘‘(viii) ONGOING.—The term ‘ongoing’ means, with 
respect to a clinical trial of a drug or a device and 
to a date, that— 
‘‘(I) 1 or more patients is enrolled in the clin-
ical trial; and 
‘‘(II) the date is before the completion date 
of the clinical trial. 
‘‘(ix) RESPONSIBLE PARTY.—The term ‘responsible 
party’, with respect to a clinical trial of a drug or 
device, means— 
‘‘(I) the sponsor of the clinical trial (as defined 
in section 50.3 of title 21, Code of Federal Regula-
tions (or any successor regulation)); or 
‘‘(II) the principal investigator of such clinical 
trial if so designated by a sponsor, grantee, con-
tractor, or awardee, so long as the principal inves-
tigator is responsible for conducting the trial, has 
access to and control over the data from the clinical 
trial, has the right to publish the results of the 
trial, and has the ability to meet all of the require-
ments under this subsection for the submission 
of clinical trial information. 
‘‘(B) REQUIREMENT.—The Secretary shall develop a 
mechanism by which the responsible party for each 
applicable clinical trial shall submit the identity and con-
tact information of such responsible party to the Secretary 
at the time of submission of clinical trial information under 
paragraph (2). 
‘‘(2) EXPANSION OF CLINICAL TRIAL REGISTRY DATA BANK 
WITH RESPECT TO CLINICAL TRIAL INFORMATION.— 
‘‘(A) IN GENERAL.— 
‘‘(i) EXPANSION OF DATA BANK.—To enhance patient 
enrollment and provide a mechanism to track subse-
quent progress of clinical trials, the Secretary, acting 
through the Director of NIH, shall expand, in accord-
ance with this subsection, the clinical trials registry 
of the data bank described under subsection (i)(1) 
(referred to in this subsection as the ‘registry data 
bank’). The Director of NIH shall ensure that the reg-
istry data bank is made publicly available through 
the Internet. 
Public 
information. 
Internet. 
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121 STAT. 906 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(ii) CONTENT.—The clinical trial information 
required to be submitted under this paragraph for 
an applicable clinical trial shall include— 
‘‘(I) descriptive information, including— 
‘‘(aa) a brief title, intended for the lay 
public; 
‘‘(bb) a brief summary, intended for the 
lay public; 
‘‘(cc) the primary purpose; 
‘‘(dd) the study design; 
‘‘(ee) for an applicable drug clinical trial, 
the study phase; 
‘‘(ff) study type; 
‘‘(gg) the primary disease or condition 
being studied, or the focus of the study; 
‘‘(hh) the intervention name and interven-
tion type; 
‘‘(ii) the study start date; 
‘‘(jj) the expected completion date; 
‘‘(kk) the target number of subjects; and 
‘‘(ll) outcomes, including primary and sec-
ondary outcome measures; 
‘‘(II) recruitment information, including— 
‘‘(aa) eligibility criteria; 
‘‘(bb) gender; 
‘‘(cc) age limits; 
‘‘(dd) whether the trial accepts healthy vol-
unteers; 
‘‘(ee) overall recruitment status; 
‘‘(ff) individual site status; and 
‘‘(gg) in the case of an applicable drug 
clinical trial, if the drug is not approved under 
section 505 of the Federal Food, Drug, and 
Cosmetic Act or licensed under section 351 
of this Act, specify whether or not there is 
expanded access to the drug under section 561 
of the Federal Food, Drug, and Cosmetic Act 
for those who do not qualify for enrollment 
in the clinical trial and how to obtain informa-
tion about such access; 
‘‘(III) 
location 
and 
contact 
information, 
including— 
‘‘(aa) the name of the sponsor; 
‘‘(bb) the responsible party, by official title; 
and 
‘‘(cc) the facility name and facility contact 
information (including the city, State, and zip 
code for each clinical trial location, or a toll- 
free number through which such location 
information may be accessed); and 
‘‘(IV) administrative data (which the Secretary 
may make publicly available as necessary), 
including— 
‘‘(aa) the unique protocol identification 
number; 
‘‘(bb) other protocol identification num-
bers, if any; and 
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121 STAT. 907 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(cc) the Food and Drug Administration 
IND/IDE protocol number and the record 
verification date. 
‘‘(iii) MODIFICATIONS.—The Secretary may by regu-
lation modify the requirements for clinical trial 
information under this paragraph, if the Secretary pro-
vides a rationale for why such a modification improves 
and does not reduce such clinical trial information. 
‘‘(B) FORMAT AND STRUCTURE.— 
‘‘(i) SEARCHABLE
CATEGORIES.—The Director of 
NIH shall ensure that the public may, in addition 
to keyword searching, search the entries in the registry 
data bank by 1 or more of the following criteria: 
‘‘(I) The disease or condition being studied in 
the clinical trial, using Medical Subject Headers 
(MeSH) descriptors. 
‘‘(II) The name of the intervention, including 
any drug or device being studied in the clinical 
trial. 
‘‘(III) The location of the clinical trial. 
‘‘(IV) The age group studied in the clinical 
trial, including pediatric subpopulations. 
‘‘(V) The study phase of the clinical trial. 
‘‘(VI) The sponsor of the clinical trial, which 
may be the National Institutes of Health or 
another Federal agency, a private industry source, 
or a university or other organization. 
‘‘(VII) The recruitment status of the clinical 
trial. 
‘‘(VIII) The National Clinical Trial number or 
other study identification for the clinical trial. 
‘‘(ii) ADDITIONAL
SEARCHABLE
CATEGORY.—Not 
later than 18 months after the date of the enactment 
of the Food and Drug Administration Amendments 
Act of 2007, the Director of NIH shall ensure that 
the public may search the entries of the registry data 
bank by the safety issue, if any, being studied in the 
clinical trial as a primary or secondary outcome. 
‘‘(iii) OTHER ELEMENTS.—The Director of NIH shall 
also ensure that the public may search the entries 
of the registry data bank by such other elements as 
the Director deems necessary on an ongoing basis. 
‘‘(iv) FORMAT.—The Director of the NIH shall 
ensure that the registry data bank is easily used by 
the public, and that entries are easily compared. 
‘‘(C) DATA SUBMISSION.—The responsible party for an 
applicable clinical trial, including an applicable drug clin-
ical trial for a serious or life-threatening disease or condi-
tion, that is initiated after, or is ongoing on the date 
that is 90 days after, the date of the enactment of the 
Food and Drug Administration Amendments Act of 2007, 
shall submit to the Director of NIH for inclusion in the 
registry data bank the clinical trial information described 
in of subparagraph (A)(ii) not later than the later of— 
‘‘(i) 90 days after such date of enactment; 
‘‘(ii) 21 days after the first patient is enrolled in 
such clinical trial; or 
Deadlines. 
Deadline. 
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121 STAT. 908 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(iii) in the case of a clinical trial that is not 
for a serious or life-threatening disease or condition 
and that is ongoing on such date of enactment, 1 
year after such date of enactment. 
‘‘(D) POSTING OF DATA.— 
‘‘(i) 
APPLICABLE
DRUG
CLINICAL
TRIAL.—The 
Director of NIH shall ensure that clinical trial informa-
tion for an applicable drug clinical trial submitted in 
accordance with this paragraph is posted in the reg-
istry data bank not later than 30 days after such 
submission. 
‘‘(ii) APPLICABLE
DEVICE
CLINICAL
TRIAL.—The 
Director of NIH shall ensure that clinical trial informa-
tion for an applicable device clinical trial submitted 
in accordance with this paragraph is posted publicly 
in the registry data bank— 
‘‘(I) not earlier than the date of clearance 
under section 510(k) of the Federal Food, Drug, 
and Cosmetic Act, or approval under section 515 
or 520(m) of such Act, as applicable, for a device 
that was not previously cleared or approved, and 
not later than 30 days after such date; or 
‘‘(II) for a device that was previously cleared 
or approved, not later than 30 days after the clin-
ical trial information under paragraph (3)(C) is 
required to be posted by the Secretary. 
‘‘(3) EXPANSION
OF
REGISTRY
DATA
BANK
TO
INCLUDE 
RESULTS OF CLINICAL TRIALS.— 
‘‘(A) LINKING
REGISTRY
DATA
BANK
TO
EXISTING 
RESULTS.— 
‘‘(i) IN GENERAL.—Beginning not later than 90 days 
after the date of the enactment of the Food and Drug 
Administration Amendments Act of 2007, for those 
clinical trials that form the primary basis of an efficacy 
claim or are conducted after the drug involved is 
approved or after the device involved is cleared or 
approved, the Secretary shall ensure that the registry 
data bank includes links to results information as 
described in clause (ii) for such clinical trial— 
‘‘(I) not earlier than 30 days after the date 
of the approval of the drug involved or clearance 
or approval of the device involved; or 
‘‘(II) not later than 30 days after the results 
information described in clause (ii) becomes pub-
licly available. 
‘‘(ii) REQUIRED INFORMATION.— 
‘‘(I) FDA INFORMATION.—The Secretary shall 
ensure that the registry data bank includes links 
to the following information: 
‘‘(aa) If an advisory committee considered 
at a meeting an applicable clinical trial, any 
posted Food and Drug Administration sum-
mary document regarding such applicable clin-
ical trial. 
‘‘(bb) If an applicable drug clinical trial 
was conducted under section 505A or 505B 
of the Federal Food, Drug, and Cosmetic Act, 
Deadlines. 
Deadlines. 
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121 STAT. 909 
PUBLIC LAW 110–85—SEPT. 27, 2007 
a link to the posted Food and Drug Adminis-
tration assessment of the results of such trial. 
‘‘(cc) Food and Drug Administration public 
health advisories regarding the drug or device 
that is the subject of the applicable clinical 
trial, if any. 
‘‘(dd) For an applicable drug clinical trial, 
the Food and Drug Administration action 
package for approval document required under 
section 505(l)(2) of the Federal Food, Drug, 
and Cosmetic Act. 
‘‘(ee) For an applicable device clinical trial, 
in the case of a premarket application under 
section 515 of the Federal Food, Drug, and 
Cosmetic Act, the detailed summary of 
information 
respecting 
the 
safety 
and 
effectiveness of the device required under sec-
tion 520(h)(1) of such Act, or, in the case of 
a report under section 510(k) of such Act, the 
section 510(k) summary of the safety and 
effectiveness data required under section 
807.95(d) of title 21, Code of Federal Regula-
tions (or any successor regulation). 
‘‘(II) NIH INFORMATION.—The Secretary shall 
ensure that the registry data bank includes links 
to the following information: 
‘‘(aa) Medline citations to any publications 
focused on the results of an applicable clinical 
trial. 
‘‘(bb) The entry for the drug that is the 
subject of an applicable drug clinical trial in 
the National Library of Medicine database of 
structured product labels, if available. 
‘‘(iii) RESULTS FOR EXISTING DATA BANK ENTRIES.— 
The Secretary may include the links described in clause 
(ii) for data bank entries for clinical trials submitted 
to the data bank prior to enactment of the Food and 
Drug Administration Amendments Act of 2007, as 
available. 
‘‘(B) INCLUSION
OF
RESULTS.—The Secretary, acting 
through the Director of NIH, shall— 
‘‘(i) expand the registry data bank to include the 
results of applicable clinical trials (referred to in this 
subsection as the ‘registry and results data bank’); 
‘‘(ii) ensure that such results are made publicly 
available through the Internet; 
‘‘(iii) post publicly a glossary for the lay public 
explaining technical terms related to the results of 
clinical trials; and 
‘‘(iv) in consultation with experts on risk commu-
nication, provide information with the information 
included under subparagraph (C) in the registry and 
results data bank to help ensure that such information 
does not mislead the patients or the public. 
‘‘(C) BASIC RESULTS.—Not later than 1 year after the 
date of the enactment of the Food and Drug Administration 
Amendments Act of 2007, the Secretary shall include in 
Deadline. 
Public 
information. 
Internet. 
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121 STAT. 910 
PUBLIC LAW 110–85—SEPT. 27, 2007 
the registry and results data bank the following elements 
for drugs that are approved under section 505 of the Fed-
eral Food, Drug, and Cosmetic Act or licensed under section 
351 of this Act and devices that are cleared under section 
510(k) of the Federal Food, Drug, and Cosmetic Act or 
approved under section 515 or 520(m) of such Act: 
‘‘(i) DEMOGRAPHIC AND BASELINE CHARACTERISTICS 
OF PATIENT SAMPLE.—A table of the demographic and 
baseline data collected overall and for each arm of 
the clinical trial to describe the patients who partici-
pated in the clinical trial, including the number of 
patients who dropped out of the clinical trial and the 
number of patients excluded from the analysis, if any. 
‘‘(ii) PRIMARY
AND
SECONDARY
OUTCOMES.—The 
primary and secondary outcome measures as submitted 
under paragraph (2)(A)(ii)(I)(ll), and a table of values 
for each of the primary and secondary outcome meas-
ures for each arm of the clinical trial, including the 
results of scientifically appropriate tests of the statis-
tical significance of such outcome measures. 
‘‘(iii) POINT OF CONTACT.—A point of contact for 
scientific information about the clinical trial results. 
‘‘(iv) CERTAIN AGREEMENTS.—Whether there exists 
an agreement (other than an agreement solely to 
comply with applicable provisions of law protecting 
the privacy of participants) between the sponsor or 
its agent and the principal investigator (unless the 
sponsor is an employer of the principal investigator) 
that restricts in any manner the ability of the principal 
investigator, after the completion date of the trial, 
to discuss the results of the trial at a scientific meeting 
or any other public or private forum, or to publish 
in a scientific or academic journal information con-
cerning the results of the trial. 
‘‘(D) EXPANDED REGISTRY AND RESULTS DATA BANK.— 
‘‘(i) EXPANSION BY RULEMAKING.—To provide more 
complete results information and to enhance patient 
access to and understanding of the results of clinical 
trials, not later than 3 years after the date of the 
enactment of the Food and Drug Administration 
Amendments Act of 2007, the Secretary shall by regu-
lation expand the registry and results data bank as 
provided under this subparagraph. 
‘‘(ii) CLINICAL TRIALS.— 
‘‘(I) APPROVED
PRODUCTS.—The regulations 
under this subparagraph shall require the inclu-
sion of the results information described in clause 
(iii) for— 
‘‘(aa) each applicable drug clinical trial for 
a drug that is approved under section 505 
of the Federal Food, Drug, and Cosmetic Act 
or licensed under section 351 of this Act; and 
‘‘(bb) each applicable device clinical trial 
for a device that is cleared under section 
510(k) of the Federal Food, Drug, and Cos-
metic Act or approved under section 515 or 
520(m) of such Act. 
Deadline. 
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121 STAT. 911 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(II) UNAPPROVED PRODUCTS.—The regulations 
under this subparagraph shall establish whether 
or not the results information described in clause 
(iii) shall be required for— 
‘‘(aa) an applicable drug clinical trial for 
a drug that is not approved under section 505 
of the Federal Food, Drug, and Cosmetic Act 
and not licensed under section 351 of this 
Act (whether approval or licensure was sought 
or not); and 
‘‘(bb) an applicable device clinical trial for 
a device that is not cleared under section 
510(k) of the Federal Food, Drug, and Cos-
metic Act and not approved under section 515 
or section 520(m) of such Act (whether clear-
ance or approval was sought or not). 
‘‘(iii) REQUIRED ELEMENTS.—The regulations under 
this subparagraph shall require, in addition to the 
elements described in subparagraph (C), information 
within each of the following categories: 
‘‘(I) A summary of the clinical trial and its 
results that is written in non-technical, under-
standable language for patients, if the Secretary 
determines that such types of summary can be 
included without being misleading or promotional. 
‘‘(II) A summary of the clinical trial and its 
results that is technical in nature, if the Secretary 
determines that such types of summary can be 
included without being misleading or promotional. 
‘‘(III) The full protocol or such information 
on the protocol for the trial as may be necessary 
to help to evaluate the results of the trial. 
‘‘(IV) Such other categories as the Secretary 
determines appropriate. 
‘‘(iv) RESULTS SUBMISSION.—The results informa-
tion described in clause (iii) shall be submitted to the 
Director of NIH for inclusion in the registry and results 
data bank as provided by subparagraph (E), except 
that the Secretary shall by regulation determine— 
‘‘(I) whether the 1-year period for submission 
of clinical trial information described in subpara-
graph (E)(i) should be increased from 1 year to 
a period not to exceed 18 months; 
‘‘(II) whether the clinical trial information 
described in clause (iii) should be required to be 
submitted for an applicable clinical trial for which 
the clinical trial information described in subpara-
graph (C) is submitted to the registry and results 
data bank before the effective date of the regula-
tions issued under this subparagraph; and 
‘‘(III) in the case when the clinical trial 
information described in clause (iii) is required 
to be submitted for the applicable clinical trials 
described in clause (ii)(II), the date by which such 
clinical trial information shall be required to be 
submitted, taking into account— 
Regulations. 
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121 STAT. 912 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(aa) 
the 
certification 
process 
under 
subparagraph (E)(iii) when approval, licen-
sure, or clearance is sought; and 
‘‘(bb) whether there should be a delay of 
submission when approval, licensure, or clear-
ance will not be sought. 
‘‘(v) ADDITIONAL
PROVISIONS.—The regulations 
under this subparagraph shall also establish— 
‘‘(I) a standard format for the submission of 
clinical trial information under this paragraph to 
the registry and results data bank; 
‘‘(II) additional information on clinical trials 
and results that is written in nontechnical, under-
standable language for patients; 
‘‘(III) considering the experience under the 
pilot quality control project described in paragraph 
(5)(C), procedures for quality control, including 
using representative samples, with respect to 
completeness and content of clinical trial informa-
tion under this subsection, to help ensure that 
data elements are not false or misleading and are 
non-promotional; 
‘‘(IV) the appropriate timing and requirements 
for updates of clinical trial information, and 
whether and, if so, how such updates should be 
tracked; 
‘‘(V) a statement to accompany the entry for 
an applicable clinical trial when the primary and 
secondary outcome measures for such clinical trial 
are submitted under paragraph (4)(A) after the 
date specified for the submission of such informa-
tion in paragraph (2)(C); and 
‘‘(VI) additions or modifications to the manner 
of reporting of the data elements established under 
subparagraph (C). 
‘‘(vi) CONSIDERATION OF WORLD HEALTH ORGANIZA-
TION
DATA
SET.—The Secretary shall consider the 
status of the consensus data elements set for reporting 
clinical trial results of the World Health Organization 
when issuing the regulations under this subparagraph. 
‘‘(vii) PUBLIC MEETING.—The Secretary shall hold 
a public meeting no later than 18 months after the 
date of the enactment of the Food and Drug Adminis-
tration Amendments Act of 2007 to provide an oppor-
tunity for input from interested parties with regard 
to the regulations to be issued under this subpara-
graph. 
‘‘(E) SUBMISSION OF RESULTS INFORMATION.— 
‘‘(i) IN GENERAL.—Except as provided in clauses 
(iii), (iv), (v), and (vi) the responsible party for an 
applicable clinical trial that is described in clause (ii) 
shall submit to the Director of NIH for inclusion in 
the registry and results data bank the clinical trial 
information described in subparagraph (C) not later 
than 1 year, or such other period as may be provided 
by regulation under subparagraph (D), after the earlier 
of— 
Deadline. 
Deadline. 
Procedures. 
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121 STAT. 913 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(I) the estimated completion date of the trial 
as described in paragraph (2)(A)(ii)(I)(jj)); or 
‘‘(II) the actual date of completion. 
‘‘(ii) CLINICAL
TRIALS
DESCRIBED.—An applicable 
clinical trial described in this clause is an applicable 
clinical trial subject to— 
‘‘(I) paragraph (2)(C); and 
‘‘(II)(aa) subparagraph (C); or 
‘‘(bb) the regulations issued under subpara-
graph (D). 
‘‘(iii) DELAYED SUBMISSION OF RESULTS WITH CER-
TIFICATION.—If the responsible party for an applicable 
clinical trial submits a certification that clause (iv) 
or (v) applies to such clinical trial, the responsible 
party shall submit to the Director of NIH for inclusion 
in the registry and results data bank the clinical trial 
information described in subparagraphs (C) and (D) 
as required under the applicable clause. 
‘‘(iv) SEEKING
INITIAL
APPROVAL
OF
A
DRUG
OR 
DEVICE.—With respect to an applicable clinical trial 
that is completed before the drug is initially approved 
under section 505 of the Federal Food, Drug, and Cos-
metic Act or initially licensed under section 351 of 
this Act, or the device is initially cleared under section 
510(k) or initially approved under section 515 or 520(m) 
of the Federal Food, Drug, and Cosmetic Act, the 
responsible party shall submit to the Director of NIH 
for inclusion in the registry and results data bank 
the clinical trial information described in subpara-
graphs (C) and (D) not later than 30 days after the 
drug or device is approved under such section 505, 
licensed under such section 351, cleared under such 
section 510(k), or approved under such section 515 
or 520(m), as applicable. 
‘‘(v) SEEKING APPROVAL OF A NEW USE FOR THE 
DRUG OR DEVICE.— 
‘‘(I) 
IN
GENERAL.—With 
respect 
to 
an 
applicable clinical trial where the manufacturer 
of the drug or device is the sponsor of an applicable 
clinical trial, and such manufacturer has filed, or 
will file within 1 year, an application seeking 
approval under section 505 of the Federal Food, 
Drug, and Cosmetic Act, licensing under section 
351 of this Act, or clearance under section 510(k), 
or approval under section 515 or 520(m), of the 
Federal Food, Drug, and Cosmetic Act for the use 
studied in such clinical trial (which use is not 
included in the labeling of the approved drug or 
device), then the responsible party shall submit 
to the Director of NIH for inclusion in the registry 
and results data bank the clinical trial information 
described in subparagraphs (C) and (D) on the 
earlier of the date that is 30 days after the date— 
‘‘(aa) the new use of the drug or device 
is approved under such section 505, licensed 
under such section 351, cleared under such 
Deadlines. 
Deadline. 
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121 STAT. 914 
PUBLIC LAW 110–85—SEPT. 27, 2007 
section 510(k), or approved under such section 
515 or 520(m); 
‘‘(bb) the Secretary issues a letter, such 
as a complete response letter, not approving 
the submission or not clearing the submission, 
a not approvable letter, or a not substantially 
equivalent letter for the new use of the drug 
or device under such section 505, 351, 510(k), 
515, or 520(m); or 
‘‘(cc) except as provided in subclause (III), 
the application or premarket notification 
under such section 505, 351, 510(k), 515, or 
520(m) is withdrawn without resubmission for 
no less than 210 days. 
‘‘(II) REQUIREMENT THAT EACH CLINICAL TRIAL 
IN APPLICATION BE TREATED THE SAME.—If a manu-
facturer makes a certification under clause (iii) 
that this clause applies with respect to a clinical 
trial, the manufacturer shall make such a certifi-
cation with respect to each applicable clinical trial 
that is required to be submitted in an application 
or report for licensure, approval, or clearance 
(under section 351 of this Act or section 505, 
510(k), 515, or 520(m) of the Federal Food, Drug, 
and Cosmetic Act, as applicable) of the use studied 
in the clinical trial. 
‘‘(III) TWO-YEAR LIMITATION.—The responsible 
party shall submit to the Director of NIH for inclu-
sion in the registry and results data bank the 
clinical trial information subject to subclause (I) 
on the date that is 2 years after the date a certifi-
cation under clause (iii) was made to the Director 
of NIH, if an action referred to in item (aa), (bb), 
or (cc) of subclause (I) has not occurred by such 
date. 
‘‘(vi) EXTENSIONS.—The Director of NIH may pro-
vide an extension of the deadline for submission of 
clinical trial information under clause (i) if the respon-
sible party for the trial submits to the Director a 
written request that demonstrates good cause for the 
extension and provides an estimate of the date on 
which the information will be submitted. The Director 
of NIH may grant more than one such extension for 
a clinical trial. 
‘‘(F) NOTICE TO DIRECTOR OF NIH.—The Commissioner 
of Food and Drugs shall notify the Director of NIH when 
there is an action described in subparagraph (E)(iv) or 
item (aa), (bb), or (cc) of subparagraph (E)(v)(I) with respect 
to an application or a report that includes a certification 
required under paragraph (5)(B) of such action not later 
than 30 days after such action. 
‘‘(G) POSTING
OF
DATA.—The Director of NIH shall 
ensure that the clinical trial information described in sub-
paragraphs (C) and (D) for an applicable clinical trial sub-
mitted in accordance with this paragraph is posted publicly 
in the registry and results database not later than 30 
days after such submission. 
Public 
information. 
Deadline. 
Deadline. 
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121 STAT. 915 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(H) WAIVERS
REGARDING
CERTAIN
CLINICAL
TRIAL 
RESULTS.—The Secretary may waive any applicable 
requirements of this paragraph for an applicable clinical 
trial, upon a written request from the responsible party, 
if the Secretary determines that extraordinary cir-
cumstances justify the waiver and that providing the 
waiver is consistent with the protection of public health, 
or in the interest of national security. Not later than 30 
days after any part of a waiver is granted, the Secretary 
shall notify, in writing, the appropriate committees of Con-
gress of the waiver and provide an explanation for why 
the waiver was granted. 
‘‘(I) ADVERSE EVENTS.— 
‘‘(i) REGULATIONS.—Not later than 18 months after 
the date of the enactment of the Food and Drug 
Administration Amendments Act of 2007, the Secretary 
shall by regulation determine the best method for 
including in the registry and results data bank appro-
priate results information on serious adverse and fre-
quent adverse events for drugs described in subpara-
graph (C) in a manner and form that is useful and 
not misleading to patients, physicians, and scientists. 
‘‘(ii) DEFAULT.—If the Secretary fails to issue the 
regulation required by clause (i) by the date that is 
24 months after the date of the enactment of the 
Food and Drug Administration Amendments Act of 
2007, clause (iii) shall take effect. 
‘‘(iii) ADDITIONAL ELEMENTS.—Upon the application 
of clause (ii), the Secretary shall include in the registry 
and results data bank for drugs described in subpara-
graph (C), in addition to the clinical trial information 
described in subparagraph (C), the following elements: 
‘‘(I) SERIOUS
ADVERSE
EVENTS.—A table of 
anticipated and unanticipated serious adverse 
events grouped by organ system, with number and 
frequency of such event in each arm of the clinical 
trial. 
‘‘(II) FREQUENT ADVERSE EVENTS.—A table of 
anticipated and unanticipated adverse events that 
are not included in the table described in subclause 
(I) that exceed a frequency of 5 percent within 
any arm of the clinical trial, grouped by organ 
system, with number and frequency of such event 
in each arm of the clinical trial. 
‘‘(iv) POSTING OF OTHER INFORMATION.—In carrying 
out clause (iii), the Secretary shall, in consultation 
with experts in risk communication, post with the 
tables information to enhance patient understanding 
and to ensure such tables do not mislead patients 
or the lay public. 
‘‘(v) RELATION TO SUBPARAGRAPH (C).—Clinical trial 
information included in the registry and results data 
bank pursuant to this subparagraph is deemed to be 
clinical trial information included in such data bank 
pursuant to subparagraph (C). 
‘‘(4) ADDITIONAL SUBMISSIONS OF CLINICAL TRIAL INFORMA-
TION.— 
Effective date. 
Deadline. 
Deadline. 
Notification. 
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121 STAT. 916 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(A) VOLUNTARY SUBMISSIONS.—A responsible party for 
a clinical trial that is not an applicable clinical trial, or 
that is an applicable clinical trial that is not subject to 
paragraph (2)(C), may submit complete clinical trial 
information described in paragraph (2) or paragraph (3) 
provided the responsible party submits clinical trial 
information for each applicable clinical trial that is required 
to be submitted under section 351 or under section 505, 
510(k), 515, or 520(m) of the Federal Food, Drug, and 
Cosmetic Act in an application or report for licensure, 
approval, or clearance of the drug or device for the use 
studied in the clinical trial. 
‘‘(B) REQUIRED SUBMISSIONS.— 
‘‘(i) IN GENERAL.—Notwithstanding paragraphs (2) 
and (3) and subparagraph (A), in any case in which 
the Secretary determines for a specific clinical trial 
described in clause (ii) that posting in the registry 
and results data bank of clinical trial information for 
such clinical trial is necessary to protect the public 
health— 
‘‘(I) the Secretary may require by notification 
that such information be submitted to the Sec-
retary in accordance with paragraphs (2) and (3) 
except with regard to timing of submission; 
‘‘(II) unless the responsible party submits a 
certification under paragraph (3)(E)(iii), such 
information shall be submitted not later than 30 
days after the date specified by the Secretary in 
the notification; and 
‘‘(III) failure to comply with the requirements 
under subclauses (I) and (II) shall be treated as 
a violation of the corresponding requirement of 
such paragraphs. 
‘‘(ii) CLINICAL TRIALS DESCRIBED.—A clinical trial 
described in this clause is— 
‘‘(I) an applicable clinical trial for a drug that 
is approved under section 505 of the Federal Food, 
Drug, and Cosmetic Act or licensed under section 
351 of this Act or for a device that is cleared 
under section 510(k) of the Federal Food, Drug, 
and Cosmetic Act or approved under section 515 
or section 520(m) of such Act, whose completion 
date is on or after the date 10 years before the 
date of the enactment of the Food and Drug 
Administration Amendments Act of 2007; or 
‘‘(II) an applicable clinical trial that is 
described by both by paragraph (2)(C) and para-
graph (3)(D)(ii)(II)). 
‘‘(C) UPDATES TO CLINICAL TRIAL DATA BANK.— 
‘‘(i) SUBMISSION
OF
UPDATES.—The responsible 
party for an applicable clinical trial shall submit to 
the Director of NIH for inclusion in the registry and 
results data bank updates to reflect changes to the 
clinical trial information submitted under paragraph 
(2). Such updates— 
‘‘(I) shall be provided not less than once every 
12 months, unless there were no changes to the 
Deadlines. 
Deadline. 
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121 STAT. 917 
PUBLIC LAW 110–85—SEPT. 27, 2007 
clinical trial information during the preceding 12- 
month period; 
‘‘(II) shall include identification of the dates 
of any such changes; 
‘‘(III) not later than 30 days after the recruit-
ment status of such clinical trial changes, shall 
include an update of the recruitment status; and 
‘‘(IV) not later than 30 days after the comple-
tion date of the clinical trial, shall include notifica-
tion to the Director that such clinical trial is com-
plete. 
‘‘(ii) 
PUBLIC
AVAILABILITY
OF
UPDATES.—The 
Director of NIH shall make updates submitted under 
clause (i) publicly available in the registry data bank. 
Except with regard to overall recruitment status, indi-
vidual site status, location, and contact information, 
the Director of NIH shall ensure that updates to ele-
ments required under subclauses (I) to (V) of paragraph 
(2)(A)(ii) do not result in the removal of any informa-
tion from the original submissions or any preceding 
updates, and information in such databases is pre-
sented in a manner that enables users to readily access 
each original element submission and to track the 
changes made by the updates. The Director of NIH 
shall provide a link from the table of primary and 
secondary outcomes required under paragraph (3)(C)(ii) 
to the tracked history required under this clause of 
the primary and secondary outcome measures sub-
mitted under paragraph (2)(A)(ii)(I)(ll). 
‘‘(5) COORDINATION AND COMPLIANCE.— 
‘‘(A) CLINICAL TRIALS SUPPORTED BY GRANTS FROM FED-
ERAL AGENCIES.— 
‘‘(i) GRANTS FROM CERTAIN FEDERAL AGENCIES.— 
If an applicable clinical trial is funded in whole or 
in part by a grant from any agency of the Department 
of Health and Human Services, including the Food 
and Drug Administration, the National Institutes of 
Health, or the Agency for Healthcare Research and 
Quality, any grant or progress report forms required 
under such grant shall include a certification that the 
responsible party has made all required submissions 
to the Director of NIH under paragraphs (2) and (3). 
‘‘(ii) VERIFICATION
BY
FEDERAL
AGENCIES.—The 
heads of the agencies referred to in clause (i), as 
applicable, shall verify that the clinical trial informa-
tion for each applicable clinical trial for which a 
grantee is the responsible party has been submitted 
under paragraphs (2) and (3) before releasing any 
remaining funding for a grant or funding for a future 
grant to such grantee. 
‘‘(iii) NOTICE AND OPPORTUNITY TO REMEDY.—If the 
head of an agency referred to in clause (i), as 
applicable, verifies that a grantee has not submitted 
clinical trial information as described in clause (ii), 
such agency head shall provide notice to such grantee 
of such non-compliance and allow such grantee 30 days 
Deadline. 
Certification. 
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121 STAT. 918 
PUBLIC LAW 110–85—SEPT. 27, 2007 
to correct such non-compliance and submit the required 
clinical trial information. 
‘‘(iv) CONSULTATION WITH OTHER FEDERAL AGEN-
CIES.—The Secretary shall— 
‘‘(I) consult with other agencies that conduct 
research involving human subjects in accordance 
with any section of part 46 of title 45, Code of 
Federal Regulations (or any successor regulations), 
to determine if any such research is an applicable 
clinical trial; and 
‘‘(II) develop with such agencies procedures 
comparable to those described in clauses (i), (ii), 
and (iii) to ensure that clinical trial information 
for such applicable clinical trial is submitted under 
paragraphs (2) and (3). 
‘‘(B) CERTIFICATION TO ACCOMPANY DRUG, BIOLOGICAL 
PRODUCT, AND DEVICE SUBMISSIONS.—At the time of submis-
sion of an application under section 505 of the Federal 
Food, Drug, and Cosmetic Act, section 515 of such Act, 
section 520(m) of such Act, or section 351 of this Act, 
or submission of a report under section 510(k) of such 
Act, such application or submission shall be accompanied 
by a certification that all applicable requirements of this 
subsection have been met. Where available, such certifi-
cation shall include the appropriate National Clinical Trial 
control numbers. 
‘‘(C) QUALITY CONTROL.— 
‘‘(i) PILOT QUALITY CONTROL PROJECT.—Until the 
effective date of the regulations issued under para-
graph (3)(D), the Secretary, acting through the Director 
of NIH and the Commissioner of Food and Drugs, 
shall conduct a pilot project to determine the optimal 
method of verification to help to ensure that the clinical 
trial information submitted under paragraph (3)(C) is 
non-promotional and is not false or misleading in any 
particular under subparagraph (D). The Secretary shall 
use the publicly available information described in 
paragraph (3)(A) and any other information available 
to the Secretary about applicable clinical trials to verify 
the accuracy of the clinical trial information submitted 
under paragraph (3)(C). 
‘‘(ii) NOTICE
OF
COMPLIANCE.—If the Secretary 
determines that any clinical trial information was not 
submitted as required under this subsection, or was 
submitted but is false or misleading in any particular, 
the Secretary shall notify the responsible party and 
give such party an opportunity to remedy such non-
compliance by submitting the required revised clinical 
trial information not later than 30 days after such 
notification. 
‘‘(D) TRUTHFUL CLINICAL TRIAL INFORMATION.— 
‘‘(i) IN
GENERAL.—The clinical trial information 
submitted by a responsible party under this subsection 
shall not be false or misleading in any particular. 
‘‘(ii) EFFECT.—Clause (i) shall not have the effect 
of— 
Deadline. 
Procedures. 
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121 STAT. 919 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(I) requiring clinical trial information with 
respect to an applicable clinical trial to include 
information from any source other than such clin-
ical trial involved; or 
‘‘(II) 
requiring 
clinical 
trial 
information 
described in paragraph (3)(D) to be submitted for 
purposes of paragraph (3)(C). 
‘‘(E) PUBLIC NOTICES.— 
‘‘(i) NOTICE
OF
VIOLATIONS.—If the responsible 
party for an applicable clinical trial fails to submit 
clinical trial information for such clinical trial as 
required under paragraphs (2) or (3), the Director of 
NIH shall include in the registry and results data 
bank entry for such clinical trial a notice— 
‘‘(I) that the responsible party is not in compli-
ance with this Act by— 
‘‘(aa) failing to submit required clinical 
trial information; or 
‘‘(bb) submitting false or misleading clin-
ical trial information; 
‘‘(II) of the penalties imposed for the violation, 
if any; and 
‘‘(III) whether the responsible party has cor-
rected the clinical trial information in the registry 
and results data bank. 
‘‘(ii) NOTICE OF FAILURE TO SUBMIT PRIMARY AND 
SECONDARY
OUTCOMES.—If the responsible party for 
an applicable clinical trial fails to submit the primary 
and secondary outcomes as required under section 
2(A)(ii)(I)(ll), the Director of NIH shall include in the 
registry and results data bank entry for such clinical 
trial a notice that the responsible party is not in 
compliance by failing to register the primary and sec-
ondary outcomes in accordance with this act, and that 
the primary and secondary outcomes were not publicly 
disclosed in the database before conducting the clinical 
trial. 
‘‘(iii) FAILURE TO SUBMIT STATEMENT.—The notice 
under clause (i) for a violation described in clause 
(i)(I)(aa) shall include the following statement: ‘The 
entry for this clinical trial was not complete at the 
time of submission, as required by law. This may or 
may not have any bearing on the accuracy of the 
information in the entry.’. 
‘‘(iv) SUBMISSION
OF
FALSE
INFORMATION
STATE-
MENT.—The notice under clause (i) for a violation 
described in clause (i)(I)(bb) shall include the following 
statement: ‘The entry for this clinical trial was found 
to be false or misleading and therefore not in compli-
ance with the law.’. 
‘‘(v) NON-SUBMISSION OF STATEMENT.—The notice 
under clause (ii) for a violation described in clause 
(ii) shall include the following statement: ‘The entry 
for this clinical trial did not contain information on 
the primary and secondary outcomes at the time of 
submission, as required by law. This may or may not 
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121 STAT. 920 
PUBLIC LAW 110–85—SEPT. 27, 2007 
have any bearing on the accuracy of the information 
in the entry.’. 
‘‘(vi) COMPLIANCE SEARCHES.—The Director of NIH 
shall provide that the public may easily search the 
registry and results data bank for entries that include 
notices required under this subparagraph. 
‘‘(6) LIMITATION
ON
DISCLOSURE
OF
CLINICAL
TRIAL 
INFORMATION.— 
‘‘(A) IN GENERAL.—Nothing in this subsection (or under 
section 552 of title 5, United States Code) shall require 
the Secretary to publicly disclose, by any means other 
than the registry and results data bank, information 
described in subparagraph (B). 
‘‘(B) INFORMATION DESCRIBED.—Information described 
in this subparagraph is— 
‘‘(i) information submitted to the Director of NIH 
under this subsection, or information of the same gen-
eral nature as (or integrally associated with) the 
information so submitted; and 
‘‘(ii) information not otherwise publicly available, 
including because it is protected from disclosure under 
section 552 of title 5, United States Code. 
‘‘(7) 
AUTHORIZATION
OF
APPROPRIATIONS.—There 
are 
authorized to be appropriated to carry out this subsection 
$10,000,000 for each fiscal year.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) PROHIBITED ACTS.—Section 301 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding 
at the end the following: 
‘‘(jj)(1) The failure to submit the certification required by section 
402(j)(5)(B) of the Public Health Service Act, or knowingly submit-
ting a false certification under such section. 
‘‘(2) The failure to submit clinical trial information required 
under subsection (j) of section 402 of the Public Health Service 
Act. 
‘‘(3) The submission of clinical trial information under sub-
section (j) of section 402 of the Public Health Service Act that 
is false or misleading in any particular under paragraph (5)(D) 
of such subsection (j).’’. 
(2) CIVIL MONEY PENALTIES.—Subsection (f) of section 303 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), 
as redesignated by section 226, is amended— 
(A) by redesignating paragraphs (3), (4), and (5) as 
paragraphs (5), (6), and (7), respectively; 
(B) by inserting after paragraph (2) the following: 
‘‘(3)(A) Any person who violates section 301(jj) shall be subject 
to a civil monetary penalty of not more than $10,000 for all viola-
tions adjudicated in a single proceeding. 
‘‘(B) If a violation of section 301(jj) is not corrected within 
the 30-day period following notification under section 402(j)(5)(C)(ii), 
the person shall, in addition to any penalty under subparagraph 
(A), be subject to a civil monetary penalty of not more than $10,000 
for each day of the violation after such period until the violation 
is corrected.’’; 
(C) in paragraph (2)(C), by striking ‘‘paragraph (3)(A)’’ 
and inserting ‘‘paragraph (5)(A)’’; 
Deadline. 
Penalties. 
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121 STAT. 921 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(D) in paragraph (5), as so redesignated, by striking 
‘‘paragraph (1) or (2)’’ each place it appears and inserting 
‘‘paragraph (1), (2), or (3)’’; 
(E) in paragraph (6), as so redesignated, by striking 
‘‘paragraph (3)(A)’’ and inserting ‘‘paragraph (5)(A)’’; and 
(F) in paragraph (7), as so redesignated, by striking 
‘‘paragraph (4)’’ each place it appears and inserting ‘‘para-
graph (6)’’. 
(3) NEW DRUGS AND DEVICES.— 
(A) INVESTIGATIONAL
NEW
DRUGS.—Section 505(i) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) 
is amended in paragraph (4), by adding at the end the 
following: ‘‘The Secretary shall update such regulations 
to require inclusion in the informed consent documents 
and process a statement that clinical trial information for 
such clinical investigation has been or will be submitted 
for inclusion in the registry data bank pursuant to sub-
section (j) of section 402 of the Public Health Service Act.’’. 
(B) NEW DRUG APPLICATIONS.—Section 505(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) 
is amended by adding at the end the following: 
‘‘(6) An application submitted under this subsection shall 
be accompanied by the certification required under section 
402(j)(5)(B) of the Public Health Service Act. Such certification 
shall not be considered an element of such application.’’. 
(C) DEVICE REPORTS UNDER SECTION 510(k).—Section 
510(k) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(k)) is amended by adding at the end the fol-
lowing: 
‘‘A notification submitted under this subsection that contains clin-
ical trial data for an applicable device clinical trial (as defined 
in section 402(j)(1) of the Public Health Service Act) shall be accom-
panied by the certification required under section 402(j)(5)(B) of 
such Act. Such certification shall not be considered an element 
of such notification.’’. 
(D) DEVICE PREMARKET APPROVAL APPLICATION.—Sec-
tion 515(c)(1) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360e(c)(1)) is amended— 
(i) in subparagraph (F), by striking ‘‘; and’’ and 
inserting a semicolon; 
(ii) by redesignating subparagraph (G) as subpara-
graph (H); and 
(iii) by inserting after subparagraph (F) the fol-
lowing: 
‘‘(G) the certification required under section 402(j)(5)(B) 
of the Public Health Service Act (which shall not be consid-
ered an element of such application); and’’. 
(E) 
HUMANITARIAN
DEVICE
EXEMPTION.—Section 
520(m)(2) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360e(c)) is amended in the first sentence in 
the matter following subparagraph (C), by inserting at 
the end before the period ‘‘and such application shall 
include the certification required under section 402(j)(5)(B) 
of the Public Health Service Act (which shall not be consid-
ered an element of such application)’’. 
(c) SURVEILLANCES.—Not later than 12 months after the date 
of the enactment of this Act, the Secretary of Health and Human 
Deadline. 
Guidance. 
42 USC 282 note. 
21 USC 360j. 
Regulations. 
Certification. 
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121 STAT. 922 
PUBLIC LAW 110–85—SEPT. 27, 2007 
Services shall issue guidance on how the requirements of section 
402(j) of the Public Health Service Act, as added by this section, 
apply to a pediatric postmarket surveillance described in paragraph 
(1)(A)(ii)(II) of such section 402(j) that is not a clinical trial. 
(d) PREEMPTION.— 
(1) IN GENERAL.—Upon the expansion of the registry and 
results data bank under section 402(j)(3)(D) of the Public Health 
Service Act, as added by this section, no State or political 
subdivision of a State may establish or continue in effect any 
requirement for the registration of clinical trials or for the 
inclusion of information relating to the results of clinical trials 
in a database. 
(2) RULE
OF
CONSTRUCTION.—The fact of submission of 
clinical trial information, if submitted in compliance with sub-
section (j) of section 402 of the Public Health Service Act 
(as amended by this section), that relates to a use of a drug 
or device not included in the official labeling of the approved 
drug or device shall not be construed by the Secretary of 
Health and Human Services or in any administrative or judicial 
proceeding, as evidence of a new intended use of the drug 
or device that is different from the intended use of the drug 
or device set forth in the official labeling of the drug or device. 
The availability of clinical trial information through the registry 
and results data bank under such subsection (j), if submitted 
in compliance with such subsection, shall not be considered 
as labeling, adulteration, or misbranding of the drug or device 
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.). 
TITLE 
IX—ENHANCED 
AUTHORITIES 
REGARDING POSTMARKET SAFETY OF 
DRUGS 
Subtitle A—Postmarket Studies and 
Surveillance 
SEC. 901. POSTMARKET STUDIES AND CLINICAL TRIALS REGARDING 
HUMAN DRUGS; RISK EVALUATION AND MITIGATION 
STRATEGIES. 
(a) IN GENERAL.—Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) is amended by adding at the end 
the following subsections: 
‘‘(o) POSTMARKET STUDIES AND CLINICAL TRIALS; LABELING.— 
‘‘(1) IN GENERAL.—A responsible person may not introduce 
or deliver for introduction into interstate commerce the new 
drug involved if the person is in violation of a requirement 
established under paragraph (3) or (4) with respect to the 
drug. 
‘‘(2) DEFINITIONS.—For purposes of this subsection: 
‘‘(A) RESPONSIBLE PERSON.—The term ‘responsible per-
son’ means a person who— 
‘‘(i) has submitted to the Secretary a covered 
application that is pending; or 
42 USC 282 note. 
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121 STAT. 923 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(ii) is the holder of an approved covered applica-
tion. 
‘‘(B) 
COVERED
APPLICATION.—The 
term 
‘covered 
application’ means— 
‘‘(i) an application under subsection (b) for a drug 
that is subject to section 503(b); and 
‘‘(ii) an application under section 351 of the Public 
Health Service Act. 
‘‘(C) NEW
SAFETY
INFORMATION; SERIOUS
RISK.—The 
terms ‘new safety information’, ‘serious risk’, and ‘signal 
of a serious risk’ have the meanings given such terms 
in section 505–1(b). 
‘‘(3) STUDIES AND CLINICAL TRIALS.— 
‘‘(A) IN GENERAL.—For any or all of the purposes speci-
fied in subparagraph (B), the Secretary may, subject to 
subparagraph (D), require a responsible person for a drug 
to conduct a postapproval study or studies of the drug, 
or a postapproval clinical trial or trials of the drug, on 
the basis of scientific data deemed appropriate by the Sec-
retary, including information regarding chemically-related 
or pharmacologically-related drugs. 
‘‘(B) PURPOSES OF STUDY OR CLINICAL TRIAL.—The pur-
poses referred to in this subparagraph with respect to 
a postapproval study or postapproval clinical trial are the 
following: 
‘‘(i) To assess a known serious risk related to the 
use of the drug involved. 
‘‘(ii) To assess signals of serious risk related to 
the use of the drug. 
‘‘(iii) To identify an unexpected serious risk when 
available data indicates the potential for a serious 
risk. 
‘‘(C) ESTABLISHMENT OF REQUIREMENT AFTER APPROVAL 
OF COVERED APPLICATION.—The Secretary may require a 
postapproval study or studies or postapproval clinical trial 
or trials for a drug for which an approved covered applica-
tion is in effect as of the date on which the Secretary 
seeks to establish such requirement only if the Secretary 
becomes aware of new safety information. 
‘‘(D) DETERMINATION BY SECRETARY.— 
‘‘(i) POSTAPPROVAL STUDIES.—The Secretary may 
not require the responsible person to conduct a study 
under this paragraph, unless the Secretary makes a 
determination that the reports under subsection (k)(1) 
and the active postmarket risk identification and anal-
ysis system as available under subsection (k)(3) will 
not be sufficient to meet the purposes set forth in 
subparagraph (B). 
‘‘(ii) POSTAPPROVAL
CLINICAL
TRIALS.—The Sec-
retary may not require the responsible person to con-
duct a clinical trial under this paragraph, unless the 
Secretary makes a determination that a postapproval 
study or studies will not be sufficient to meet the 
purposes set forth in subparagraph (B). 
‘‘(E) NOTIFICATION; TIMETABLES; PERIODIC REPORTS.— 
‘‘(i) NOTIFICATION.—The Secretary shall notify the 
responsible person regarding a requirement under this 
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121 STAT. 924 
PUBLIC LAW 110–85—SEPT. 27, 2007 
paragraph to conduct a postapproval study or clinical 
trial by the target dates for communication of feedback 
from the review team to the responsible person 
regarding proposed labeling and postmarketing study 
commitments as set forth in the letters described in 
section 101(c) of the Food and Drug Administration 
Amendments Act of 2007. 
‘‘(ii) TIMETABLE; PERIODIC
REPORTS.—For each 
study or clinical trial required to be conducted under 
this paragraph, the Secretary shall require that the 
responsible person submit a timetable for completion 
of the study or clinical trial. With respect to each 
study required to be conducted under this paragraph 
or otherwise undertaken by the responsible person to 
investigate a safety issue, the Secretary shall require 
the responsible person to periodically report to the 
Secretary on the status of such study including 
whether any difficulties in completing the study have 
been encountered. With respect to each clinical trial 
required to be conducted under this paragraph or 
otherwise undertaken by the responsible person to 
investigate a safety issue, the Secretary shall require 
the responsible person to periodically report to the 
Secretary on the status of such clinical trial including 
whether enrollment has begun, the number of partici-
pants enrolled, the expected completion date, whether 
any difficulties completing the clinical trial have been 
encountered, and registration information with respect 
to the requirements under section 402(j) of the Public 
Health Service Act. If the responsible person fails to 
comply with such timetable or violates any other 
requirement of this subparagraph, the responsible per-
son shall be considered in violation of this subsection, 
unless the responsible person demonstrates good cause 
for such noncompliance or such other violation. The 
Secretary shall determine what constitutes good cause 
under the preceding sentence. 
‘‘(F) DISPUTE
RESOLUTION.—The responsible person 
may appeal a requirement to conduct a study or clinical 
trial under this paragraph using dispute resolution proce-
dures established by the Secretary in regulation and guid-
ance. 
‘‘(4) SAFETY
LABELING
CHANGES
REQUESTED
BY
SEC-
RETARY.— 
‘‘(A) NEW
SAFETY
INFORMATION.—If the Secretary 
becomes aware of new safety information that the Secretary 
believes should be included in the labeling of the drug, 
the Secretary shall promptly notify the responsible person 
or, if the same drug approved under section 505(b) is not 
currently marketed, the holder of an approved application 
under 505(j). 
‘‘(B) RESPONSE TO NOTIFICATION.—Following notifica-
tion pursuant to subparagraph (A), the responsible person 
or the holder of the approved application under section 
505(j) shall within 30 days— 
‘‘(i) submit a supplement proposing changes to the 
approved labeling to reflect the new safety information, 
Notification. 
Deadlines. 
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121 STAT. 925 
PUBLIC LAW 110–85—SEPT. 27, 2007 
including changes to boxed warnings, contraindica-
tions, warnings, precautions, or adverse reactions; or 
‘‘(ii) notify the Secretary that the responsible per-
son or the holder of the approved application under 
section 505(j) does not believe a labeling change is 
warranted and submit a statement detailing the rea-
sons why such a change is not warranted. 
‘‘(C) REVIEW.—Upon receipt of such supplement, the 
Secretary shall promptly review and act upon such supple-
ment. If the Secretary disagrees with the proposed changes 
in the supplement or with the statement setting forth 
the reasons why no labeling change is necessary, the Sec-
retary shall initiate discussions to reach agreement on 
whether the labeling for the drug should be modified to 
reflect the new safety information, and if so, the contents 
of such labeling changes. 
‘‘(D) DISCUSSIONS.—Such discussions shall not extend 
for more than 30 days after the response to the notification 
under subparagraph (B), unless the Secretary determines 
an extension of such discussion period is warranted. 
‘‘(E) ORDER.—Within 15 days of the conclusion of the 
discussions under subparagraph (D), the Secretary may 
issue an order directing the responsible person or the holder 
of the approved application under section 505(j) to make 
such a labeling change as the Secretary deems appropriate 
to address the new safety information. Within 15 days 
of such an order, the responsible person or the holder 
of the approved application under section 505(j) shall 
submit a supplement containing the labeling change. 
‘‘(F) DISPUTE RESOLUTION.—Within 5 days of receiving 
an order under subparagraph (E), the responsible person 
or the holder of the approved application under section 
505(j) may appeal using dispute resolution procedures 
established by the Secretary in regulation and guidance. 
‘‘(G) VIOLATION.—If the responsible person or the 
holder of the approved application under section 505(j) 
has not submitted a supplement within 15 days of the 
date of such order under subparagraph (E), and there is 
no appeal or dispute resolution proceeding pending, the 
responsible person or holder shall be considered to be in 
violation of this subsection. If at the conclusion of any 
dispute resolution procedures the Secretary determines 
that a supplement must be submitted and such a supple-
ment is not submitted within 15 days of the date of that 
determination, the responsible person or holder shall be 
in violation of this subsection. 
‘‘(H) PUBLIC HEALTH THREAT.—Notwithstanding sub-
paragraphs (A) through (F), if the Secretary concludes that 
such a labeling change is necessary to protect the public 
health, the Secretary may accelerate the timelines in such 
subparagraphs. 
‘‘(I) RULE OF CONSTRUCTION.—This paragraph shall not 
be construed to affect the responsibility of the responsible 
person or the holder of the approved application under 
section 505(j) to maintain its label in accordance with 
existing requirements, including subpart B of part 201 
Notification. 
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121 STAT. 926 
PUBLIC LAW 110–85—SEPT. 27, 2007 
and sections 314.70 and 601.12 of title 21, Code of Federal 
Regulations (or any successor regulations). 
‘‘(5) NON-DELEGATION.—Determinations by the Secretary 
under this subsection for a drug shall be made by individuals 
at or above the level of individuals empowered to approve 
a drug (such as division directors within the Center for Drug 
Evaluation and Research). 
‘‘(p) RISK EVALUATION AND MITIGATION STRATEGY.— 
‘‘(1) IN GENERAL.—A person may not introduce or deliver 
for introduction into interstate commerce a new drug if— 
‘‘(A)(i) the application for such drug is approved under 
subsection (b) or (j) and is subject to section 503(b); or 
‘‘(ii) the application for such drug is approved under 
section 351 of the Public Health Service Act; and 
‘‘(B) a risk evaluation and mitigation strategy is 
required under section 505–1 with respect to the drug 
and the person fails to maintain compliance with the 
requirements of the approved strategy or with other 
requirements under section 505–1, including requirements 
regarding assessments of approved strategies. 
‘‘(2) CERTAIN POSTMARKET STUDIES.—The failure to conduct 
a postmarket study under section 506, subpart H of part 314, 
or subpart E of part 601 of title 21, Code of Federal Regulations 
(or any successor regulations), is deemed to be a violation 
of paragraph (1).’’. 
(b) REQUIREMENTS REGARDING STRATEGIES.—Chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) 
is amended by inserting after section 505 the following section: 
‘‘SEC. 505–1. RISK EVALUATION AND MITIGATION STRATEGIES. 
‘‘(a) SUBMISSION OF PROPOSED STRATEGY.— 
‘‘(1) INITIAL APPROVAL.—If the Secretary, in consultation 
with the office responsible for reviewing the drug and the 
office responsible for postapproval safety with respect to the 
drug, determines that a risk evaluation and mitigation strategy 
is necessary to ensure that the benefits of the drug outweigh 
the risks of the drug, and informs the person who submits 
such application of such determination, then such person shall 
submit to the Secretary as part of such application a proposed 
risk evaluation and mitigation strategy. In making such a 
determination, the Secretary shall consider the following fac-
tors: 
‘‘(A) The estimated size of the population likely to 
use the drug involved. 
‘‘(B) The seriousness of the disease or condition that 
is to be treated with the drug. 
‘‘(C) The expected benefit of the drug with respect 
to such disease or condition. 
‘‘(D) The expected or actual duration of treatment with 
the drug. 
‘‘(E) The seriousness of any known or potential adverse 
events that may be related to the drug and the background 
incidence of such events in the population likely to use 
the drug. 
‘‘(F) Whether the drug is a new molecular entity. 
‘‘(2) POSTAPPROVAL REQUIREMENT.— 
21 USC 355–1. 
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121 STAT. 927 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(A) IN
GENERAL.—If the Secretary has approved a 
covered application (including an application approved 
before the effective date of this section) and did not when 
approving the application require a risk evaluation and 
mitigation strategy under paragraph (1), the Secretary, 
in consultation with the offices described in paragraph 
(1), may subsequently require such a strategy for the drug 
involved (including when acting on a supplemental applica-
tion seeking approval of a new indication for use of the 
drug) if the Secretary becomes aware of new safety informa-
tion and makes a determination that such a strategy is 
necessary to ensure that the benefits of the drug outweigh 
the risks of the drug. 
‘‘(B) SUBMISSION OF PROPOSED STRATEGY.—Not later 
than 120 days after the Secretary notifies the holder of 
an approved covered application that the Secretary has 
made a determination under subparagraph (A) with respect 
to the drug involved, or within such other reasonable time 
as the Secretary requires to protect the public health, the 
holder shall submit to the Secretary a proposed risk evalua-
tion and mitigation strategy. 
‘‘(3) ABBREVIATED NEW DRUG APPLICATIONS.—The applica-
bility of this section to an application under section 505(j) 
is subject to subsection (i). 
‘‘(4) NON-DELEGATION.—Determinations by the Secretary 
under this subsection for a drug shall be made by individuals 
at or above the level of individuals empowered to approve 
a drug (such as division directors within the Center for Drug 
Evaluation and Research). 
‘‘(b) DEFINITIONS.—For purposes of this section: 
‘‘(1) ADVERSE DRUG EXPERIENCE.—The term ‘adverse drug 
experience’ means any adverse event associated with the use 
of a drug in humans, whether or not considered drug related, 
including— 
‘‘(A) an adverse event occurring in the course of the 
use of the drug in professional practice; 
‘‘(B) an adverse event occurring from an overdose of 
the drug, whether accidental or intentional; 
‘‘(C) an adverse event occurring from abuse of the 
drug; 
‘‘(D) an adverse event occurring from withdrawal of 
the drug; and 
‘‘(E) any failure of expected pharmacological action of 
the drug. 
‘‘(2) COVERED APPLICATION.—The term ‘covered application’ 
means an application referred to in section 505(p)(1)(A). 
‘‘(3) NEW
SAFETY
INFORMATION.—The term ‘new safety 
information’, with respect to a drug, means information derived 
from a clinical trial, an adverse event report, a postapproval 
study (including a study under section 505(o)(3)), or peer- 
reviewed 
biomedical 
literature; 
data 
derived 
from 
the 
postmarket risk identification and analysis system under sec-
tion 505(k); or other scientific data deemed appropriate by 
the Secretary about— 
‘‘(A) a serious risk or an unexpected serious risk associ-
ated with use of the drug that the Secretary has become 
aware of (that may be based on a new analysis of existing 
Applicability. 
Deadline. 
Notification. 
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121 STAT. 928 
PUBLIC LAW 110–85—SEPT. 27, 2007 
information) since the drug was approved, since the risk 
evaluation and mitigation strategy was required, or since 
the last assessment of the approved risk evaluation and 
mitigation strategy for the drug; or 
‘‘(B) the effectiveness of the approved risk evaluation 
and mitigation strategy for the drug obtained since the 
last assessment of such strategy. 
‘‘(4) SERIOUS
ADVERSE
DRUG
EXPERIENCE.—The term 
‘serious adverse drug experience’ is an adverse drug experience 
that— 
‘‘(A) results in— 
‘‘(i) death; 
‘‘(ii) an adverse drug experience that places the 
patient at immediate risk of death from the adverse 
drug experience as it occurred (not including an 
adverse drug experience that might have caused death 
had it occurred in a more severe form); 
‘‘(iii) inpatient hospitalization or prolongation of 
existing hospitalization; 
‘‘(iv) a persistent or significant incapacity or 
substantial disruption of the ability to conduct normal 
life functions; or 
‘‘(v) a congenital anomaly or birth defect; or 
‘‘(B) based on appropriate medical judgment, may jeop-
ardize the patient and may require a medical or surgical 
intervention to prevent an outcome described under 
subparagraph (A). 
‘‘(5) SERIOUS RISK.—The term ‘serious risk’ means a risk 
of a serious adverse drug experience. 
‘‘(6) SIGNAL
OF
A
SERIOUS
RISK.—The term ‘signal of a 
serious risk’ means information related to a serious adverse 
drug experience associated with use of a drug and derived 
from— 
‘‘(A) a clinical trial; 
‘‘(B) adverse event reports; 
‘‘(C) a postapproval study, including a study under 
section 505(o)(3); 
‘‘(D) peer-reviewed biomedical literature; 
‘‘(E) data derived from the postmarket risk identifica-
tion and analysis system under section 505(k)(4); or 
‘‘(F) other scientific data deemed appropriate by the 
Secretary. 
‘‘(7) RESPONSIBLE PERSON.—The term ‘responsible person’ 
means the person submitting a covered application or the holder 
of the approved such application. 
‘‘(8) UNEXPECTED
SERIOUS
RISK.—The term ‘unexpected 
serious risk’ means a serious adverse drug experience that 
is not listed in the labeling of a drug, or that may be sympto-
matically and pathophysiologically related to an adverse drug 
experience identified in the labeling, but differs from such 
adverse drug experience because of greater severity, specificity, 
or prevalence. 
‘‘(c) CONTENTS.—A proposed risk evaluation and mitigation 
strategy under subsection (a) shall— 
‘‘(1) include the timetable required under subsection (d); 
and 
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121 STAT. 929 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(2) to the extent required by the Secretary, in consultation 
with the office responsible for reviewing the drug and the 
office responsible for postapproval safety with respect to the 
drug, include additional elements described in subsections (e) 
and (f). 
‘‘(d) MINIMAL STRATEGY.—For purposes of subsection (c)(1), the 
risk evaluation and mitigation strategy for a drug shall require 
a timetable for submission of assessments of the strategy that— 
‘‘(1) includes an assessment, by the date that is 18 months 
after the strategy is initially approved; 
‘‘(2) includes an assessment by the date that is 3 years 
after the strategy is initially approved; 
‘‘(3) includes an assessment in the seventh year after the 
strategy is so approved; and 
‘‘(4) subject to paragraphs (1), (2), and (3)— 
‘‘(A) is at a frequency specified in the strategy; 
‘‘(B) is increased or reduced in frequency as necessary 
as provided for in subsection (g)(4)(A); and 
‘‘(C) is eliminated after the 3-year period described 
in paragraph (1) if the Secretary determines that serious 
risks of the drug have been adequately identified and 
assessed and are being adequately managed. 
‘‘(e) ADDITIONAL POTENTIAL ELEMENTS OF STRATEGY.— 
‘‘(1) IN GENERAL.—The Secretary, in consultation with the 
offices described in subsection (c)(2), may under such subsection 
require that the risk evaluation and mitigation strategy for 
a drug include 1 or more of the additional elements described 
in this subsection if the Secretary makes the determination 
required with respect to each element involved. 
‘‘(2) MEDICATION
GUIDE; PATIENT
PACKAGE
INSERT.—The 
risk evaluation and mitigation strategy for a drug may require 
that, as applicable, the responsible person develop for distribu-
tion to each patient when the drug is dispensed— 
‘‘(A) a Medication Guide, as provided for under part 
208 of title 21, Code of Federal Regulations (or any suc-
cessor regulations); and 
‘‘(B) a patient package insert, if the Secretary deter-
mines that such insert may help mitigate a serious risk 
of the drug. 
‘‘(3) COMMUNICATION PLAN.—The risk evaluation and miti-
gation strategy for a drug may require that the responsible 
person conduct a communication plan to health care providers, 
if, with respect to such drug, the Secretary determines that 
such plan may support implementation of an element of the 
strategy (including under this paragraph). Such plan may 
include— 
‘‘(A) sending letters to health care providers; 
‘‘(B) disseminating information about the elements of 
the risk evaluation and mitigation strategy to encourage 
implementation by health care providers of components 
that apply to such health care providers, or to explain 
certain safety protocols (such as medical monitoring by 
periodic laboratory tests); or 
‘‘(C) disseminating information to health care providers 
through professional societies about any serious risks of 
the drug and any protocol to assure safe use. 
Deadlines. 
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121 STAT. 930 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(f) PROVIDING SAFE ACCESS FOR PATIENTS TO DRUGS WITH 
KNOWN SERIOUS RISKS THAT WOULD OTHERWISE BE UNAVAIL-
ABLE.— 
‘‘(1) ALLOWING SAFE ACCESS TO DRUGS WITH KNOWN SERIOUS 
RISKS.—The Secretary, in consultation with the offices described 
in subsection (c)(2), may require that the risk evaluation and 
mitigation strategy for a drug include such elements as are 
necessary to assure safe use of the drug, because of its inherent 
toxicity or potential harmfulness, if the Secretary determines 
that— 
‘‘(A) the drug, which has been shown to be effective, 
but is associated with a serious adverse drug experience, 
can be approved only if, or would be withdrawn unless, 
such elements are required as part of such strategy to 
mitigate a specific serious risk listed in the labeling of 
the drug; and 
‘‘(B) for a drug initially approved without elements 
to assure safe use, other elements under subsections (c), 
(d), and (e) are not sufficient to mitigate such serious 
risk. 
‘‘(2) ASSURING ACCESS AND MINIMIZING BURDEN.—Such ele-
ments to assure safe use under paragraph (1) shall— 
‘‘(A) be commensurate with the specific serious risk 
listed in the labeling of the drug; 
‘‘(B) within 30 days of the date on which any element 
under paragraph (1) is imposed, be posted publicly by the 
Secretary with an explanation of how such elements will 
mitigate the observed safety risk; 
‘‘(C) considering such risk, not be unduly burdensome 
on patient access to the drug, considering in particular— 
‘‘(i) patients with serious or life-threatening dis-
eases or conditions; and 
‘‘(ii) patients who have difficulty accessing health 
care (such as patients in rural or medically under-
served areas); and 
‘‘(D) to the extent practicable, so as to minimize the 
burden on the health care delivery system— 
‘‘(i) conform with elements to assure safe use for 
other drugs with similar, serious risks; and 
‘‘(ii) be designed to be compatible with established 
distribution, procurement, and dispensing systems for 
drugs. 
‘‘(3) ELEMENTS
TO
ASSURE
SAFE
USE.—The elements to 
assure safe use under paragraph (1) shall include 1 or more 
goals to mitigate a specific serious risk listed in the labeling 
of the drug and, to mitigate such risk, may require that— 
‘‘(A) health care providers who prescribe the drug have 
particular training or experience, or are specially certified 
(the opportunity to obtain such training or certification 
with respect to the drug shall be available to any willing 
provider from a frontier area in a widely available training 
or certification method (including an on-line course or via 
mail) as approved by the Secretary at reasonable cost to 
the provider); 
Deadline. 
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121 STAT. 931 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(B) pharmacies, practitioners, or health care settings 
that dispense the drug are specially certified (the oppor-
tunity to obtain such certification shall be available to 
any willing provider from a frontier area); 
‘‘(C) the drug be dispensed to patients only in certain 
health care settings, such as hospitals; 
‘‘(D) the drug be dispensed to patients with evidence 
or other documentation of safe-use conditions, such as lab-
oratory test results; 
‘‘(E) each patient using the drug be subject to certain 
monitoring; or 
‘‘(F) each patient using the drug be enrolled in a reg-
istry. 
‘‘(4) IMPLEMENTATION SYSTEM.—The elements to assure safe 
use under paragraph (1) that are described in subparagraphs 
(B), (C), and (D) of paragraph (3) may include a system through 
which the applicant is able to take reasonable steps to— 
‘‘(A) monitor and evaluate implementation of such ele-
ments by health care providers, pharmacists, and other 
parties in the health care system who are responsible for 
implementing such elements; and 
‘‘(B) work to improve implementation of such elements 
by such persons. 
‘‘(5) EVALUATION OF ELEMENTS TO ASSURE SAFE USE.—The 
Secretary, through the Drug Safety and Risk Management 
Advisory Committee (or successor committee) of the Food and 
Drug Administration, shall— 
‘‘(A) seek input from patients, physicians, pharmacists, 
and other health care providers about how elements to 
assure safe use under this subsection for 1 or more drugs 
may be standardized so as not to be— 
‘‘(i) unduly burdensome on patient access to the 
drug; and 
‘‘(ii) to the extent practicable, minimize the burden 
on the health care delivery system; 
‘‘(B) at least annually, evaluate, for 1 or more drugs, 
the elements to assure safe use of such drug to assess 
whether the elements— 
‘‘(i) assure safe use of the drug; 
‘‘(ii) are not unduly burdensome on patient access 
to the drug; and 
‘‘(iii) to the extent practicable, minimize the burden 
on the health care delivery system; and 
‘‘(C) considering such input and evaluations— 
‘‘(i) issue or modify agency guidance about how 
to implement the requirements of this subsection; and 
‘‘(ii) modify elements under this subsection for 1 
or more drugs as appropriate. 
‘‘(6) ADDITIONAL
MECHANISMS
TO
ASSURE
ACCESS.—The 
mechanisms under section 561 to provide for expanded access 
for patients with serious or life-threatening diseases or condi-
tions may be used to provide access for patients with a serious 
or life-threatening disease or condition, the treatment of which 
is not an approved use for the drug, to a drug that is subject 
to elements to assure safe use under this subsection. The Sec-
retary shall promulgate regulations for how a physician may 
provide the drug under the mechanisms of section 561. 
Regulations. 
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121 STAT. 932 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(7) WAIVER IN PUBLIC HEALTH EMERGENCIES.—The Sec-
retary may waive any requirement of this subsection during 
the period described in section 319(a) of the Public Health 
Service Act with respect to a qualified countermeasure 
described under section 319F–1(a)(2) of such Act, to which 
a requirement under this subsection has been applied, if the 
Secretary has— 
‘‘(A) declared a public health emergency under such 
section 319; and 
‘‘(B) determined that such waiver is required to miti-
gate the effects of, or reduce the severity of, such public 
health emergency. 
‘‘(8) LIMITATION.—No holder of an approved covered 
application shall use any element to assure safe use required 
by the Secretary under this subsection to block or delay 
approval of an application under section 505(b)(2) or (j) or 
to prevent application of such element under subsection (i)(1)(B) 
to a drug that is the subject of an abbreviated new drug 
application. 
‘‘(g) ASSESSMENT AND MODIFICATION OF APPROVED STRATEGY.— 
‘‘(1) VOLUNTARY
ASSESSMENTS.—After the approval of a 
risk evaluation and mitigation strategy under subsection (a), 
the responsible person involved may, subject to paragraph (2), 
submit to the Secretary an assessment of, and propose a modi-
fication to, the approved strategy for the drug involved at 
any time. 
‘‘(2) REQUIRED ASSESSMENTS.—A responsible person shall, 
subject to paragraph (5), submit an assessment of, and may 
propose a modification to, the approved risk evaluation and 
mitigation strategy for a drug— 
‘‘(A) when submitting a supplemental application for 
a new indication for use under section 505(b) or under 
section 351 of the Public Health Service Act, unless the 
drug is not subject to section 503(b) and the risk evaluation 
and mitigation strategy for the drug includes only the 
timetable under subsection (d); 
‘‘(B) when required by the strategy, as provided for 
in such timetable under subsection (d); 
‘‘(C) within a time period to be determined by the 
Secretary, if the Secretary, in consultation with the offices 
described in subsection (c)(2), determines that new safety 
or effectiveness information indicates that— 
‘‘(i) an element under subsection (d) or (e) should 
be modified or included in the strategy; or 
‘‘(ii) an element under subsection (f) should be 
modified or included in the strategy; or 
‘‘(D) within 15 days when ordered by the Secretary, 
in consultation with the offices described in subsection 
(c)(2), if the Secretary determines that there may be a 
cause for action by the Secretary under section 505(e). 
‘‘(3) REQUIREMENTS
FOR
ASSESSMENTS.—An assessment 
under paragraph (1) or (2) of an approved risk evaluation 
and mitigation strategy for a drug shall include— 
‘‘(A) with respect to any goal under subsection (f), 
an assessment of the extent to which the elements to 
assure safe use are meeting the goal or whether the goal 
or such elements should be modified; 
Deadline. 
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121 STAT. 933 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(B) with respect to any postapproval study required 
under section 505(o) or otherwise undertaken by the 
responsible person to investigate a safety issue, the status 
of such study, including whether any difficulties completing 
the study have been encountered; and 
‘‘(C) with respect to any postapproval clinical trial 
required under section 505(o) or otherwise undertaken by 
the responsible party to investigate a safety issue, the 
status of such clinical trial, including whether enrollment 
has begun, the number of participants enrolled, the 
expected completion date, whether any difficulties com-
pleting the clinical trial have been encountered, and reg-
istration information with respect to requirements under 
subsections (i) and (j) of section 402 of the Public Health 
Service Act. 
‘‘(4) MODIFICATION.—A modification (whether an enhance-
ment or a reduction) to the approved risk evaluation and mitiga-
tion strategy for a drug may include the addition or modification 
of any element under subsection (d) or the addition, modifica-
tion, or removal of any element under subsection (e) or (f), 
such as— 
‘‘(A) modifying the timetable for assessments of the 
strategy as provided in subsection (d)(3), including to elimi-
nate assessments; or 
‘‘(B) adding, modifying, or removing an element to 
assure safe use under subsection (f). 
‘‘(h) REVIEW
OF PROPOSED STRATEGIES; REVIEW
OF ASSESS-
MENTS OF APPROVED STRATEGIES.— 
‘‘(1) IN GENERAL.—The Secretary, in consultation with the 
offices described in subsection (c)(2), shall promptly review 
each proposed risk evaluation and mitigation strategy for a 
drug submitted under subsection (a) and each assessment of 
an approved risk evaluation and mitigation strategy for a drug 
submitted under subsection (g). 
‘‘(2) DISCUSSION.—The Secretary, in consultation with the 
offices described in subsection (c)(2), shall initiate discussions 
with the responsible person for purposes of this subsection 
to determine a strategy not later than 60 days after any such 
assessment is submitted or, in the case of an assessment sub-
mitted under subsection (g)(2)(D), not later than 30 days after 
such assessment is submitted. 
‘‘(3) ACTION.— 
‘‘(A) IN
GENERAL.—Unless the dispute resolution 
process described under paragraph (4) or (5) applies, the 
Secretary, in consultation with the offices described in sub-
section (c)(2), shall describe any required risk evaluation 
and mitigation strategy for a drug, or any modification 
to any required strategy— 
‘‘(i) as part of the action letter on the application, 
when a proposed strategy is submitted under sub-
section (a) or a modification to the strategy is proposed 
as part of an assessment of the strategy submitted 
under subsection (g)(1); or 
‘‘(ii) in an order issued not later than 90 days 
after the date discussions of such modification begin 
under paragraph (2), when a modification to the 
strategy is proposed as part of an assessment of the 
Deadline. 
Deadlines. 
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121 STAT. 934 
PUBLIC LAW 110–85—SEPT. 27, 2007 
strategy submitted under subsection (g)(1) or under 
any of subparagraphs (B) through (D) of subsection 
(g)(2). 
‘‘(B) INACTION.—An approved risk evaluation and miti-
gation strategy shall remain in effect until the Secretary 
acts, if the Secretary fails to act as provided under subpara-
graph (A). 
‘‘(C) PUBLIC AVAILABILITY.—Any action letter described 
in subparagraph (A)(i) or order described in subparagraph 
(A)(ii) shall be made publicly available. 
‘‘(4) DISPUTE RESOLUTION AT INITIAL APPROVAL.—If a pro-
posed risk evaluation and mitigation strategy is submitted 
under subsection (a)(1) in an application for initial approval 
of a drug and there is a dispute about the strategy, the respon-
sible person shall use the major dispute resolution procedures 
as set forth in the letters described in section 101(c) of the 
Food and Drug Administration Amendments Act of 2007. 
‘‘(5) DISPUTE RESOLUTION IN ALL OTHER CASES.— 
‘‘(A) REQUEST FOR REVIEW.— 
‘‘(i) IN GENERAL.—Not earlier than 15 days, and 
not later than 35 days, after discussions under para-
graph (2) have begun, the responsible person may 
request in writing that a dispute about the strategy 
be reviewed by the Drug Safety Oversight Board under 
subsection (j), except that the determination of the 
Secretary to require a risk evaluation and mitigation 
strategy is not subject to review under this paragraph. 
The preceding sentence does not prohibit review under 
this paragraph of the particular elements of such a 
strategy. 
‘‘(ii) SCHEDULING.—Upon receipt of a request under 
clause (i), the Secretary shall schedule the dispute 
involved for review under subparagraph (B) and, not 
later than 5 business days of scheduling the dispute 
for review, shall publish by posting on the Internet 
or otherwise a notice that the dispute will be reviewed 
by the Drug Safety Oversight Board. 
‘‘(B) SCHEDULING
REVIEW.—If a responsible person 
requests review under subparagraph (A), the Secretary— 
‘‘(i) shall schedule the dispute for review at 1 of 
the next 2 regular meetings of the Drug Safety Over-
sight Board, whichever meeting date is more prac-
ticable; or 
‘‘(ii) may convene a special meeting of the Drug 
Safety Oversight Board to review the matter more 
promptly, including to meet an action deadline on an 
application (including a supplemental application). 
‘‘(C) AGREEMENT AFTER DISCUSSION OR ADMINISTRATIVE 
APPEALS.— 
‘‘(i) FURTHER
DISCUSSION
OR
ADMINISTRATIVE 
APPEALS.—A request for review under subparagraph 
(A) shall not preclude further discussions to reach 
agreement on the risk evaluation and mitigation 
strategy, and such a request shall not preclude the 
use of administrative appeals within the Food and 
Drug Administration to reach agreement on the 
strategy, including appeals as described in the letters 
Deadlines. 
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121 STAT. 935 
PUBLIC LAW 110–85—SEPT. 27, 2007 
described in section 101(c) of the Food and Drug 
Administration Amendments Act of 2007 for procedural 
or scientific matters involving the review of human 
drug applications and supplemental applications that 
cannot be resolved at the divisional level. At the time 
a review has been scheduled under subparagraph (B) 
and notice of such review has been posted, the respon-
sible person shall either withdraw the request under 
subparagraph (A) or terminate the use of such adminis-
trative appeals. 
‘‘(ii) AGREEMENT
TERMINATES
DISPUTE
RESOLU-
TION.—At any time before a decision and order is issued 
under subparagraph (G) , the Secretary (in consultation 
with the offices described in subsection (c)(2)) and the 
responsible person may reach an agreement on the 
risk evaluation and mitigation strategy through further 
discussion or administrative appeals, terminating the 
dispute resolution process, and the Secretary shall 
issue an action letter or order, as appropriate, that 
describes the strategy. 
‘‘(D) MEETING OF THE BOARD.—At a meeting of the 
Drug Safety Oversight Board described in subparagraph 
(B), the Board shall— 
‘‘(i) hear from both parties via written or oral 
presentation; and 
‘‘(ii) review the dispute. 
‘‘(E) RECORD
OF
PROCEEDINGS.—The Secretary shall 
ensure that the proceedings of any such meeting are 
recorded, transcribed, and made public within 90 days of 
the meeting. The Secretary shall redact the transcript to 
protect any trade secrets and other information that is 
exempted from disclosure under section 552 of title 5, 
United States Code, or section 552a of title 5, United 
States Code. 
‘‘(F) RECOMMENDATION OF THE BOARD.—Not later than 
5 days after any such meeting, the Drug Safety Oversight 
Board shall provide a written recommendation on resolving 
the dispute to the Secretary. Not later than 5 days after 
the Board provides such written recommendation to the 
Secretary, the Secretary shall make the recommendation 
available to the public. 
‘‘(G) ACTION BY THE SECRETARY.— 
‘‘(i) ACTION LETTER.—With respect to a proposal 
or assessment referred to in paragraph (1), the Sec-
retary shall issue an action letter that resolves the 
dispute not later than the later of— 
‘‘(I) the action deadline for the action letter 
on the application; or 
‘‘(II) 7 days after receiving the recommenda-
tion of the Drug Safety Oversight Board. 
‘‘(ii) ORDER.—With respect to an assessment of 
an approved risk evaluation and mitigation strategy 
under subsection (g)(1) or under any of subparagraphs 
(B) through (D) of subsection (g)(2), the Secretary shall 
issue an order, which shall be made public, that 
resolves the dispute not later than 7 days after 
Deadlines. 
Deadlines. 
Public 
information. 
Public 
information. 
Deadline. 
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121 STAT. 936 
PUBLIC LAW 110–85—SEPT. 27, 2007 
receiving the recommendation of the Drug Safety Over-
sight Board. 
‘‘(H) INACTION.—An approved risk evaluation and miti-
gation strategy shall remain in effect until the Secretary 
acts, if the Secretary fails to act as provided for under 
subparagraph (G). 
‘‘(I) EFFECT ON ACTION DEADLINE.—With respect to a 
proposal or assessment referred to in paragraph (1), the 
Secretary shall be considered to have met the action dead-
line for the action letter on the application if the responsible 
person requests the dispute resolution process described 
in this paragraph and if the Secretary— 
‘‘(i) has initiated the discussions described under 
paragraph (2) not less than 60 days before such action 
deadline; and 
‘‘(ii) has complied with the timing requirements 
of scheduling review by the Drug Safety Oversight 
Board, providing a written recommendation, and 
issuing an action letter under subparagraphs (B), (F), 
and (G), respectively. 
‘‘(J) DISQUALIFICATION.—No individual who is an 
employee of the Food and Drug Administration and who 
reviews a drug or who participated in an administrative 
appeal under subparagraph (C)(i) with respect to such drug 
may serve on the Drug Safety Oversight Board at a meeting 
under subparagraph (D) to review a dispute about the 
risk evaluation and mitigation strategy for such drug. 
‘‘(K) ADDITIONAL EXPERTISE.—The Drug Safety Over-
sight Board may add members with relevant expertise 
from the Food and Drug Administration, including the 
Office of Pediatrics, the Office of Women’s Health, or the 
Office of Rare Diseases, or from other Federal public health 
or health care agencies, for a meeting under subparagraph 
(D) of the Drug Safety Oversight Board. 
‘‘(6) USE OF ADVISORY COMMITTEES.—The Secretary may 
convene a meeting of 1 or more advisory committees of the 
Food and Drug Administration to— 
‘‘(A) review a concern about the safety of a drug or 
class of drugs, including before an assessment of the risk 
evaluation and mitigation strategy or strategies of such 
drug or drugs is required to be submitted under any of 
subparagraphs (B) through (D) of subsection (g)(2); 
‘‘(B) review the risk evaluation and mitigation strategy 
or strategies of a drug or group of drugs; or 
‘‘(C) review a dispute under paragraph (4) or (5). 
‘‘(7) PROCESS FOR ADDRESSING DRUG CLASS EFFECTS.— 
‘‘(A) IN GENERAL.—When a concern about a serious 
risk of a drug may be related to the pharmacological class 
of the drug, the Secretary, in consultation with the offices 
described in subsection (c)(2), may defer assessments of 
the approved risk evaluation and mitigation strategies for 
such drugs until the Secretary has convened 1 or more 
public meetings to consider possible responses to such con-
cern. 
‘‘(B) NOTICE.—If the Secretary defers an assessment 
under subparagraph (A), the Secretary shall— 
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121 STAT. 937 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(i) give notice of the deferral to the holder of 
the approved covered application not later than 5 days 
after the deferral; 
‘‘(ii) publish the deferral in the Federal Register; 
and 
‘‘(iii) give notice to the public of any public 
meetings to be convened under subparagraph (A), 
including a description of the deferral. 
‘‘(C) PUBLIC
MEETINGS.—Such public meetings may 
include— 
‘‘(i) 1 or more meetings of the responsible person 
for such drugs; 
‘‘(ii) 1 or more meetings of 1 or more advisory 
committees of the Food and Drug Administration, as 
provided for under paragraph (6); or 
‘‘(iii) 1 or more workshops of scientific experts and 
other stakeholders. 
‘‘(D) ACTION.—After considering the discussions from 
any meetings under subparagraph (A), the Secretary may— 
‘‘(i) announce in the Federal Register a planned 
regulatory action, including a modification to each risk 
evaluation and mitigation strategy, for drugs in the 
pharmacological class; 
‘‘(ii) seek public comment about such action; and 
‘‘(iii) after seeking such comment, issue an order 
addressing such regulatory action. 
‘‘(8) INTERNATIONAL COORDINATION.—The Secretary, in con-
sultation with the offices described in subsection (c)(2), may 
coordinate the timetable for submission of assessments under 
subsection (d), or a study or clinical trial under section 505(o)(3), 
with efforts to identify and assess the serious risks of such 
drug by the marketing authorities of other countries whose 
drug approval and risk management processes the Secretary 
deems comparable to the drug approval and risk management 
processes of the United States. If the Secretary takes action 
to coordinate such timetable, the Secretary shall give notice 
to the responsible person. 
‘‘(9) EFFECT.—Use of the processes described in paragraphs 
(7) and (8) shall not be the sole source of delay of action 
on an application or a supplement to an application for a 
drug. 
‘‘(i) ABBREVIATED NEW DRUG APPLICATIONS.— 
‘‘(1) IN GENERAL.—A drug that is the subject of an abbre-
viated new drug application under section 505(j) is subject 
to only the following elements of the risk evaluation and mitiga-
tion strategy required under subsection (a) for the applicable 
listed drug: 
‘‘(A) A Medication Guide or patient package insert, 
if required under subsection (e) for the applicable listed 
drug. 
‘‘(B) Elements to assure safe use, if required under 
subsection (f) for the listed drug. A drug that is the subject 
of an abbreviated new drug application and the listed drug 
shall use a single, shared system under subsection (f). 
The Secretary may waive the requirement under the pre-
ceding sentence for a drug that is the subject of an abbre-
viated new drug application, and permit the applicant to 
Public 
information. 
Federal Register, 
publication. 
Deadline. 
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121 STAT. 938 
PUBLIC LAW 110–85—SEPT. 27, 2007 
use a different, comparable aspect of the elements to assure 
safe use, if the Secretary determines that— 
‘‘(i) the burden of creating a single, shared system 
outweighs the benefit of a single, system, taking into 
consideration the impact on health care providers, 
patients, the applicant for the abbreviated new drug 
application, and the holder of the reference drug 
product; or 
‘‘(ii) an aspect of the elements to assure safe use 
for the applicable listed drug is claimed by a patent 
that has not expired or is a method or process that, 
as a trade secret, is entitled to protection, and the 
applicant for the abbreviated new drug application cer-
tifies that it has sought a license for use of an aspect 
of the elements to assure safe use for the applicable 
listed drug and that it was unable to obtain a license. 
A certification under clause (ii) shall include a description 
of the efforts made by the applicant for the abbreviated 
new drug application to obtain a license. In a case described 
in clause (ii), the Secretary may seek to negotiate a vol-
untary agreement with the owner of the patent, method, 
or process for a license under which the applicant for 
such abbreviated new drug application may use an aspect 
of the elements to assure safe use, if required under sub-
section (f) for the applicable listed drug, that is claimed 
by a patent that has not expired or is a method or process 
that as a trade secret is entitled to protection. 
‘‘(2) ACTION BY SECRETARY.—For an applicable listed drug 
for which a drug is approved under section 505(j), the Sec-
retary— 
‘‘(A) shall undertake any communication plan to health 
care providers required under subsection (e)(3) for the 
applicable listed drug; and 
‘‘(B) shall inform the responsible person for the drug 
that is so approved if the risk evaluation and mitigation 
strategy for the applicable listed drug is modified. 
‘‘(j) DRUG SAFETY OVERSIGHT BOARD.— 
‘‘(1) IN GENERAL.—There is established a Drug Safety Over-
sight Board. 
‘‘(2) COMPOSITION; MEETINGS.—The Drug Safety Oversight 
Board shall— 
‘‘(A) be composed of scientists and health care practi-
tioners appointed by the Secretary, each of whom is an 
employee of the Federal Government; 
‘‘(B) include representatives from offices throughout 
the Food and Drug Administration, including the offices 
responsible for postapproval safety of drugs; 
‘‘(C) include at least 1 representative each from the 
National Institutes of Health and the Department of Health 
and Human Services (other than the Food and Drug 
Administration); 
‘‘(D) include such representatives as the Secretary shall 
designate from other appropriate agencies that wish to 
provide representatives; and 
‘‘(E) meet at least monthly to provide oversight and 
advice to the Secretary on the management of important 
drug safety issues.’’. 
Establishment. 
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121 STAT. 939 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(c) REGULATION OF BIOLOGICAL PRODUCTS.—Section 351 of the 
Public Health Service Act (42 U.S.C. 262) is amended— 
(1) in subsection (a)(2), by adding at the end the following: 
‘‘(D) POSTMARKET STUDIES AND CLINICAL TRIALS; LABELING; 
RISK EVALUATION AND MITIGATION STRATEGY.—A person that sub-
mits an application for a license under this paragraph is subject 
to sections 505(o), 505(p), and 505–1 of the Federal Food, Drug, 
and Cosmetic Act.’’; and 
(2) in subsection (j), by inserting ‘‘, including the require-
ments under sections 505(o), 505(p), and 505–1 of such Act,’’ 
after ‘‘, and Cosmetic Act’’. 
(d) ADVERTISEMENTS OF DRUGS.—The Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.), as amended by section 801(b), 
is amended— 
(1) in section 301 (21 U.S.C. 331), by adding at the end 
the following: 
‘‘(kk) The dissemination of a television advertisement without 
complying with section 503B.’’; and 
(2) by inserting after section 503A the following: 
‘‘SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS. 
‘‘(a) IN GENERAL.—The Secretary may require the submission 
of any television advertisement for a drug (including any script, 
story board, rough, or a completed video production of the television 
advertisement) to the Secretary for review under this section not 
later than 45 days before dissemination of the television advertise-
ment. 
‘‘(b) REVIEW.—In conducting a review of a television advertise-
ment under this section, the Secretary may make recommendations 
with respect to information included in the label of the drug— 
‘‘(1) on changes that are— 
‘‘(A) necessary to protect the consumer good and well- 
being; or 
‘‘(B) consistent with prescribing information for the 
product under review; and 
‘‘(2) if appropriate and if information exists, on statements 
for inclusion in the advertisement to address the specific effi-
cacy of the drug as it relates to specific population groups, 
including elderly populations, children, and racial and ethnic 
minorities. 
‘‘(c) NO AUTHORITY TO REQUIRE CHANGES.—Except as provided 
by subsection (e), this section does not authorize the Secretary 
to make or direct changes in any material submitted pursuant 
to subsection (a). 
‘‘(d) ELDERLY POPULATIONS, CHILDREN, RACIALLY
AND ETH-
NICALLY DIVERSE COMMUNITIES.—In formulating recommendations 
under subsection (b), the Secretary shall take into consideration 
the impact of the advertised drug on elderly populations, children, 
and racially and ethnically diverse communities. 
‘‘(e) SPECIFIC DISCLOSURES.— 
‘‘(1) SERIOUS
RISK; SAFETY
PROTOCOL.—In conducting a 
review of a television advertisement under this section, if the 
Secretary determines that the advertisement would be false 
or misleading without a specific disclosure about a serious 
risk listed in the labeling of the drug involved, the Secretary 
may require inclusion of such disclosure in the advertisement. 
Deadline. 
21 USC 353b. 
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121 STAT. 940 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(2) DATE OF APPROVAL.—In conducting a review of a tele-
vision advertisement under this section, the Secretary may 
require the advertisement to include, for a period not to exceed 
2 years from the date of the approval of the drug under section 
505 or section 351 of the Public Health Service Act, a specific 
disclosure of such date of approval if the Secretary determines 
that the advertisement would otherwise be false or misleading. 
‘‘(f) RULE OF CONSTRUCTION.—Nothing in this section may be 
construed as having any effect on requirements under section 502(n) 
or on the authority of the Secretary under section 314.550, 314.640, 
601.45, or 601.94 of title 21, Code of Federal Regulations (or suc-
cessor regulations).’’. 
(3) DIRECT-TO-CONSUMER ADVERTISEMENTS.— 
(A) IN GENERAL.—Section 502(n) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended 
by adding at the end the following: ‘‘In the case of an 
advertisement for a drug subject to section 503(b)(1) pre-
sented directly to consumers in television or radio format 
and stating the name of the drug and its conditions of 
use, the major statement relating to side effects and contra-
indications shall be presented in a clear, conspicuous, and 
neutral manner.’’. 
(B) REGULATIONS TO DETERMINE CLEAR, CONSPICUOUS, 
AND NEUTRAL MANNER.—Not later than 30 months after 
the date of the enactment of the Food and Drug Administra-
tion Amendments Act of 2007, the Secretary of Health 
and Human Services shall by regulation establish stand-
ards for determining whether a major statement relating 
to side effects and contraindications of a drug, described 
in section 502(n) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352(n)) (as amended by subparagraph (A)) 
is presented in the manner required under such section. 
(4) CIVIL
PENALTIES.—Section 303 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333), as amended by section 
801(b), is amended by adding at the end the following: 
‘‘(g)(1) With respect to a person who is a holder of an approved 
application under section 505 for a drug subject to section 503(b) 
or under section 351 of the Public Health Service Act, any such 
person who disseminates or causes another party to disseminate 
a direct-to-consumer advertisement that is false or misleading shall 
be liable to the United States for a civil penalty in an amount 
not to exceed $250,000 for the first such violation in any 3-year 
period, and not to exceed $500,000 for each subsequent violation 
in any 3-year period. No other civil monetary penalties in this 
Act (including the civil penalty in section 303(f)(4)) shall apply 
to a violation regarding direct-to-consumer advertising. For pur-
poses of this paragraph: (A) Repeated dissemination of the same 
or similar advertisement prior to the receipt of the written notice 
referred to in paragraph (2) for such advertisements shall be consid-
ered one violation. (B) On and after the date of the receipt of 
such a notice, all violations under this paragraph occurring in 
a single day shall be considered one violation. With respect to 
advertisements that appear in magazines or other publications that 
are published less frequently than daily, each issue date (whether 
weekly or monthly) shall be treated as a single day for the purpose 
of calculating the number of violations under this paragraph. 
Deadline. 
21 USC 352 note. 
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121 STAT. 941 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(2) A civil penalty under paragraph (1) shall be assessed 
by the Secretary by an order made on the record after providing 
written notice to the person to be assessed a civil penalty and 
an opportunity for a hearing in accordance with this paragraph 
and section 554 of title 5, United States Code. If upon receipt 
of the written notice, the person to be assessed a civil penalty 
objects and requests a hearing, then in the course of any investiga-
tion related to such hearing, the Secretary may issue subpoenas 
requiring the attendance and testimony of witnesses and the produc-
tion of evidence that relates to the matter under investigation, 
including information pertaining to the factors described in para-
graph (3). 
‘‘(3) The Secretary, in determining the amount of the civil 
penalty under paragraph (1), shall take into account the nature, 
circumstances, extent, and gravity of the violation or violations, 
including the following factors: 
‘‘(A) Whether the person submitted the advertisement or 
a similar advertisement for review under section 736A. 
‘‘(B) Whether the person submitted the advertisement for 
review if required under section 503B. 
‘‘(C) Whether, after submission of the advertisement as 
described in subparagraph (A) or (B), the person disseminated 
or caused another party to disseminate the advertisement 
before the end of the 45-day comment period. 
‘‘(D) Whether the person incorporated any comments made 
by the Secretary with regard to the advertisement into the 
advertisement prior to its dissemination. 
‘‘(E) Whether the person ceased distribution of the 
advertisement upon receipt of the written notice referred to 
in paragraph (2) for such advertisement. 
‘‘(F) Whether the person had the advertisement reviewed 
by qualified medical, regulatory, and legal reviewers prior to 
its dissemination. 
‘‘(G) Whether the violations were material. 
‘‘(H) Whether the person who created the advertisement 
or caused the advertisement to be created acted in good faith. 
‘‘(I) Whether the person who created the advertisement 
or caused the advertisement to be created has been assessed 
a civil penalty under this provision within the previous 1- 
year period. 
‘‘(J) The scope and extent of any voluntary, subsequent 
remedial action by the person. 
‘‘(K) Such other matters, as justice may require. 
‘‘(4)(A) Subject to subparagraph (B), no person shall be required 
to pay a civil penalty under paragraph (1) if the person submitted 
the advertisement to the Secretary and disseminated or caused 
another party to disseminate such advertisement after incorporating 
each comment received from the Secretary. 
‘‘(B) The Secretary may retract or modify any prior comments 
the Secretary has provided to an advertisement submitted to the 
Secretary based on new information or changed circumstances, so 
long as the Secretary provides written notice to the person of 
the new views of the Secretary on the advertisement and provides 
a reasonable time for modification or correction of the advertisement 
prior to seeking any civil penalty under paragraph (1). 
‘‘(5) The Secretary may compromise, modify, or remit, with 
or without conditions, any civil penalty which may be assessed 
Public record. 
Notification. 
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121 STAT. 942 
PUBLIC LAW 110–85—SEPT. 27, 2007 
under paragraph (1). The amount of such penalty, when finally 
determined, or the amount charged upon in compromise, may be 
deducted from any sums owed by the United States to the person 
charged. 
‘‘(6) Any person who requested, in accordance with paragraph 
(2), a hearing with respect to the assessment of a civil penalty 
and who is aggrieved by an order assessing a civil penalty, may 
file a petition for de novo judicial review of such order with the 
United States Court of Appeals for the District of Columbia Circuit 
or for any other circuit in which such person resides or transacts 
business. Such a petition may only be filed within the 60-day 
period beginning on the date the order making such assessments 
was issued. 
‘‘(7) If any person fails to pay an assessment of a civil penalty 
under paragraph (1)— 
‘‘(A) after the order making the assessment becomes final, 
and if such person does not file a petition for judicial review 
of the order in accordance with paragraph (6), or 
‘‘(B) after a court in an action brought under paragraph 
(6) has entered a final judgment in favor of the Secretary, 
the Attorney General of the United States shall recover the amount 
assessed (plus interest at currently prevailing rates from the date 
of the expiration of the 60-day period referred to in paragraph 
(6) or the date of such final judgment, as the case may be) in 
an action brought in any appropriate district court of the United 
States. In such an action, the validity, amount, and appropriateness 
of such penalty shall not be subject to review.’’. 
(5) REPORT
ON
DIRECT-TO-CONSUMER
ADVERTISING.—Not 
later than 24 months after the date of the enactment of this 
Act, the Secretary of Health and Human Services shall report 
to the Congress on direct-to-consumer advertising and its ability 
to communicate to subsets of the general population, including 
elderly populations, children, and racial and ethnic minority 
communities. The Secretary shall utilize the Advisory Com-
mittee on Risk Communication established under this Act to 
advise the Secretary with respect to such report. The Advisory 
Committee shall study direct-to-consumer advertising as it 
relates to increased access to health information and decreased 
health disparities for these populations. The report required 
by this paragraph shall recommend effective ways to present 
and disseminate information to these populations. Such report 
shall also make recommendations regarding impediments to 
the participation of elderly populations, children, racially and 
ethnically diverse communities, and medically underserved 
populations in clinical drug trials and shall recommend best 
practice approaches for increasing the inclusion of such subsets 
of the general population. The Secretary of Health and Human 
Services shall submit the report under this paragraph to the 
Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the 
House of Representatives. 
(6) RULEMAKING.—Section 502(n) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended by 
striking ‘‘the procedure specified in section 701(e) of this Act’’ 
and inserting ‘‘section 701(a)’’. 
(e) RULE OF CONSTRUCTION REGARDING PEDIATRIC STUDIES.— 
This title and the amendments made by this title may not be 
21 USC 355a 
note. 
Deadline. 
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121 STAT. 943 
PUBLIC LAW 110–85—SEPT. 27, 2007 
construed as affecting the authority of the Secretary of Health 
and Human Services to request pediatric studies under section 
505A of the Federal Food, Drug, and Cosmetic Act or to require 
such studies under section 505B of such Act. 
SEC. 902. ENFORCEMENT. 
(a) MISBRANDING.—Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end 
the following: 
‘‘(y) If it is a drug subject to an approved risk evaluation 
and mitigation strategy pursuant to section 505(p) and the respon-
sible person (as such term is used in section 505–1) fails to comply 
with a requirement of such strategy provided for under subsection 
(d), (e), or (f) of section 505–1. 
‘‘(z) If it is a drug, and the responsible person (as such term 
is used in section 505(o)) is in violation of a requirement established 
under paragraph (3) (relating to postmarket studies and clinical 
trials) or paragraph (4) (relating to labeling) of section 505(o) with 
respect to such drug.’’. 
(b) CIVIL PENALTIES.—Section 303(f) of the Federal Food, Drug, 
and Cosmetic Act, as amended by section 801(b), is amended— 
(1) by inserting after paragraph (3), as added by section 
801(b)(2), the following: 
‘‘(4)(A) Any responsible person (as such term is used in section 
505–1) that violates a requirement of section 505(o), 505(p), or 
505–1 shall be subject to a civil monetary penalty of— 
‘‘(i) not more than $250,000 per violation, and not to exceed 
$1,000,000 for all such violations adjudicated in a single pro-
ceeding; or 
‘‘(ii) in the case of a violation that continues after the 
Secretary provides written notice to the responsible person, 
the responsible person shall be subject to a civil monetary 
penalty of $250,000 for the first 30-day period (or any portion 
thereof) that the responsible person continues to be in violation, 
and such amount shall double for every 30-day period thereafter 
that the violation continues, not to exceed $1,000,000 for any 
30-day period, and not to exceed $10,000,000 for all such viola-
tions adjudicated in a single proceeding. 
‘‘(B) In determining the amount of a civil penalty under 
subparagraph (A)(ii), the Secretary shall take into consideration 
whether the responsible person is making efforts toward correcting 
the violation of the requirement of section 505(o), 505(p), or 505– 
1 for which the responsible person is subject to such civil penalty.’’; 
and 
(2) in paragraph (5), as redesignated by section 801(b)(2)(A), 
by striking ‘‘paragraph (1), (2), or (3)’’ each place it appears 
and inserting ‘‘paragraph (1), (2), (3), or (4)’’. 
SEC. 903. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL. 
Section 505(e) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(e)) is amended by adding at the end the following: 
‘‘The Secretary may withdraw the approval of an application sub-
mitted under this section, or suspend the approval of such an 
application, as provided under this subsection, without first ordering 
the applicant to submit an assessment of the approved risk evalua-
tion and mitigation strategy for the drug under section 505– 
1(g)(2)(D).’’. 
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121 STAT. 944 
PUBLIC LAW 110–85—SEPT. 27, 2007 
SEC. 904. BENEFIT-RISK ASSESSMENTS. 
Not later than 1 year after the date of the enactment of this 
Act, the Commissioner of Food and Drugs shall submit to the 
Congress a report on how best to communicate to the public the 
risks and benefits of new drugs and the role of the risk evaluation 
and mitigation strategy in assessing such risks and benefits. As 
part of such study, the Commissioner may consider the possibility 
of 
including 
in 
the 
labeling 
and 
any 
direct-to-consumer 
advertisements of a newly approved drug or indication a unique 
symbol indicating the newly approved status of the drug or indica-
tion for a period after approval. 
SEC. 905. ACTIVE POSTMARKET RISK IDENTIFICATION AND ANALYSIS. 
(a) IN GENERAL.—Subsection (k) of section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 
adding at the end the following: 
‘‘(3) ACTIVE POSTMARKET RISK IDENTIFICATION.— 
‘‘(A) DEFINITION.—In this paragraph, the term ‘data’ 
refers to information with respect to a drug approved under 
this section or under section 351 of the Public Health 
Service Act, including claims data, patient survey data, 
standardized analytic files that allow for the pooling and 
analysis of data from disparate data environments, and 
any other data deemed appropriate by the Secretary. 
‘‘(B) DEVELOPMENT OF POSTMARKET RISK IDENTIFICA-
TION
AND
ANALYSIS
METHODS.—The Secretary shall, not 
later than 2 years after the date of the enactment of 
the Food and Drug Administration Amendments Act of 
2007, in collaboration with public, academic, and private 
entities— 
‘‘(i) develop methods to obtain access to disparate 
data sources including the data sources specified in 
subparagraph (C); 
‘‘(ii) develop validated methods for the establish-
ment of a postmarket risk identification and analysis 
system to link and analyze safety data from multiple 
sources, with the goals of including, in aggregate— 
‘‘(I) at least 25,000,000 patients by July 1, 
2010; and 
‘‘(II) at least 100,000,000 patients by July 1, 
2012; and 
‘‘(iii) convene a committee of experts, including 
individuals who are recognized in the field of protecting 
data privacy and security, to make recommendations 
to the Secretary on the development of tools and 
methods for the ethical and scientific uses for, and 
communication of, postmarketing data specified under 
subparagraph (C), including recommendations on the 
development of effective research methods for the study 
of drug safety questions. 
‘‘(C) ESTABLISHMENT OF THE POSTMARKET RISK IDENTI-
FICATION AND ANALYSIS SYSTEM.— 
‘‘(i) IN GENERAL.—The Secretary shall, not later 
than 1 year after the development of the risk identifica-
tion and analysis methods under subparagraph (B), 
establish and maintain procedures— 
Deadline. 
Procedures. 
Committee. 
Deadline. 
Deadline. 
Reports. 
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121 STAT. 945 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(I) for risk identification and analysis based 
on electronic health data, in compliance with the 
regulations promulgated under section 264(c) of 
the Health Insurance Portability and Account-
ability Act of 1996, and in a manner that does 
not 
disclose 
individually 
identifiable 
health 
information in violation of paragraph (4)(B); 
‘‘(II) for the reporting (in a standardized form) 
of data on all serious adverse drug experiences 
(as defined in section 505–1(b)) submitted to the 
Secretary under paragraph (1), and those adverse 
events submitted by patients, providers, and drug 
sponsors, when appropriate; 
‘‘(III) to provide for active adverse event 
surveillance using the following data sources, as 
available: 
‘‘(aa) Federal health-related electronic 
data (such as data from the Medicare program 
and the health systems of the Department 
of Veterans Affairs); 
‘‘(bb) private sector health-related elec-
tronic data (such as pharmaceutical purchase 
data and health insurance claims data); and 
‘‘(cc) other data as the Secretary deems 
necessary to create a robust system to identify 
adverse events and potential drug safety sig-
nals; 
‘‘(IV) to identify certain trends and patterns 
with respect to data accessed by the system; 
‘‘(V) to provide regular reports to the Secretary 
concerning adverse event trends, adverse event 
patterns, incidence and prevalence of adverse 
events, and other information the Secretary deter-
mines appropriate, which may include data on 
comparative national adverse event trends; and 
‘‘(VI) to enable the program to export data 
in a form appropriate for further aggregation, 
statistical analysis, and reporting. 
‘‘(ii) TIMELINESS OF REPORTING.—The procedures 
established under clause (i) shall ensure that such 
data are accessed, analyzed, and reported in a timely, 
routine, and systematic manner, taking into consider-
ation the need for data completeness, coding, cleansing, 
and standardized analysis and transmission. 
‘‘(iii) PRIVATE SECTOR RESOURCES.—To ensure the 
establishment of the active postmarket risk identifica-
tion and analysis system under this subsection not 
later than 1 year after the development of the risk 
identification and analysis methods under subpara-
graph (B), as required under clause (i), the Secretary 
may, on a temporary or permanent basis, implement 
systems or products developed by private entities. 
‘‘(iv) COMPLEMENTARY APPROACHES.—To the extent 
the active postmarket risk identification and analysis 
system under this subsection is not sufficient to gather 
data and information relevant to a priority drug safety 
question, the Secretary shall develop, support, and 
Deadline. 
Reports. 
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121 STAT. 946 
PUBLIC LAW 110–85—SEPT. 27, 2007 
participate in complementary approaches to gather and 
analyze such data and information, including— 
‘‘(I) approaches that are complementary with 
respect to assessing the safety of use of a drug 
in domestic populations not included, or underrep-
resented, in the trials used to approve the drug 
(such as older people, people with comorbidities, 
pregnant women, or children); and 
‘‘(II) existing approaches such as the Vaccine 
Adverse Event Reporting System and the Vaccine 
Safety Datalink or successor databases. 
‘‘(v) AUTHORITY
FOR
CONTRACTS.—The Secretary 
may enter into contracts with public and private enti-
ties to fulfill the requirements of this subparagraph. 
‘‘(4) ADVANCED ANALYSIS OF DRUG SAFETY DATA.— 
‘‘(A) PURPOSE.—The Secretary shall establish collabora-
tions with public, academic, and private entities, which 
may include the Centers for Education and Research on 
Therapeutics under section 912 of the Public Health Service 
Act, to provide for advanced analysis of drug safety data 
described in paragraph (3)(C) and other information that 
is publicly available or is provided by the Secretary, in 
order to— 
‘‘(i) 
improve 
the 
quality 
and 
efficiency 
of 
postmarket drug safety risk-benefit analysis; 
‘‘(ii) provide the Secretary with routine access to 
outside expertise to study advanced drug safety ques-
tions; and 
‘‘(iii) enhance the ability of the Secretary to make 
timely assessments based on drug safety data. 
‘‘(B) PRIVACY.—Such analysis shall not disclose individ-
ually identifiable health information when presenting such 
drug safety signals and trends or when responding to 
inquiries regarding such drug safety signals and trends. 
‘‘(C) PUBLIC
PROCESS
FOR
PRIORITY
QUESTIONS.—At 
least biannually, the Secretary shall seek recommendations 
from the Drug Safety and Risk Management Advisory Com-
mittee (or any successor committee) and from other 
advisory committees, as appropriate, to the Food and Drug 
Administration on— 
‘‘(i) priority drug safety questions; and 
‘‘(ii) mechanisms for answering such questions, 
including through— 
‘‘(I) active risk identification under paragraph 
(3); and 
‘‘(II) when such risk identification is not suffi-
cient, postapproval studies and clinical trials under 
subsection (o)(3). 
‘‘(D) PROCEDURES
FOR
THE
DEVELOPMENT
OF
DRUG 
SAFETY COLLABORATIONS.— 
‘‘(i) IN GENERAL.—Not later than 180 days after 
the date of the establishment of the active postmarket 
risk identification and analysis system under this sub-
section, the Secretary shall establish and implement 
procedures under which the Secretary may routinely 
contract with one or more qualified entities to— 
Deadline. 
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121 STAT. 947 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(I) classify, analyze, or aggregate data 
described in paragraph (3)(C) and information that 
is publicly available or is provided by the Sec-
retary; 
‘‘(II) allow for prompt investigation of priority 
drug safety questions, including— 
‘‘(aa) unresolved safety questions for drugs 
or classes of drugs; and 
‘‘(bb) for a newly-approved drugs, safety 
signals from clinical trials used to approve 
the drug and other preapproval trials; rare, 
serious drug side effects; and the safety of 
use in domestic populations not included, or 
underrepresented, in the trials used to approve 
the drug (such as older people, people with 
comorbidities, pregnant women, or children); 
‘‘(III) perform advanced research and analysis 
on identified drug safety risks; 
‘‘(IV) focus postapproval studies and clinical 
trials under subsection (o)(3) more effectively on 
cases for which reports under paragraph (1) and 
other safety signal detection is not sufficient to 
resolve whether there is an elevated risk of a 
serious adverse event associated with the use of 
a drug; and 
‘‘(V) carry out other activities as the Secretary 
deems necessary to carry out the purposes of this 
paragraph. 
‘‘(ii) REQUEST FOR SPECIFIC METHODOLOGY.—The 
procedures described in clause (i) shall permit the Sec-
retary to request that a specific methodology be used 
by the qualified entity. The qualified entity shall work 
with the Secretary to finalize the methodology to be 
used. 
‘‘(E) USE OF ANALYSES.—The Secretary shall provide 
the analyses described in this paragraph, including the 
methods and results of such analyses, about a drug to 
the sponsor or sponsors of such drug. 
‘‘(F) QUALIFIED ENTITIES.— 
‘‘(i) IN GENERAL.—The Secretary shall enter into 
contracts with a sufficient number of qualified entities 
to develop and provide information to the Secretary 
in a timely manner. 
‘‘(ii) QUALIFICATION.—The Secretary shall enter 
into a contract with an entity under clause (i) only 
if the Secretary determines that the entity has a 
significant presence in the United States and has one 
or more of the following qualifications: 
‘‘(I) The research, statistical, epidemiologic, or 
clinical capability and expertise to conduct and 
complete the activities under this paragraph, 
including the capability and expertise to provide 
the Secretary de-identified data consistent with 
the requirements of this subsection. 
‘‘(II) An information technology infrastructure 
in place to support electronic data and operational 
standards to provide security for such data. 
Contracts. 
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121 STAT. 948 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(III) Experience with, and expertise on, the 
development of drug safety and effectiveness 
research using electronic population data. 
‘‘(IV) An understanding of drug development 
or risk/benefit balancing in a clinical setting. 
‘‘(V) Other expertise which the Secretary 
deems necessary to fulfill the activities under this 
paragraph. 
‘‘(G) CONTRACT REQUIREMENTS.—Each contract with a 
qualified entity under subparagraph (F)(i) shall contain 
the following requirements: 
‘‘(i) ENSURING PRIVACY.—The qualified entity shall 
ensure that the entity will not use data under this 
subsection in a manner that— 
‘‘(I) violates the regulations promulgated under 
section 264(c) of the Health Insurance Portability 
and Accountability Act of 1996; 
‘‘(II) violates sections 552 or 552a of title 5, 
United States Code, with regard to the privacy 
of 
individually-identifiable 
beneficiary 
health 
information; or 
‘‘(III) discloses individually identifiable health 
information when presenting drug safety signals 
and trends or when responding to inquiries 
regarding drug safety signals and trends. 
Nothing in this clause prohibits lawful disclosure for 
other purposes. 
‘‘(ii) COMPONENT OF ANOTHER ORGANIZATION.—If 
a qualified entity is a component of another organiza-
tion— 
‘‘(I) the qualified entity shall establish appro-
priate security measures to maintain the confiden-
tiality and privacy of such data; and 
‘‘(II) the entity shall not make an unauthorized 
disclosure of such data to the other components 
of the organization in breach of such confidentiality 
and privacy requirement. 
‘‘(iii) TERMINATION OR NONRENEWAL.—If a contract 
with a qualified entity under this subparagraph is 
terminated or not renewed, the following requirements 
shall apply: 
‘‘(I) CONFIDENTIALITY
AND
PRIVACY
PROTEC-
TIONS.—The entity shall continue to comply with 
the confidentiality and privacy requirements under 
this paragraph with respect to all data disclosed 
to the entity. 
‘‘(II) DISPOSITION OF DATA.—The entity shall 
return any data disclosed to such entity under 
this subsection to which it would not otherwise 
have access or, if returning the data is not prac-
ticable, destroy the data. 
‘‘(H) COMPETITIVE PROCEDURES.—The Secretary shall 
use competitive procedures (as defined in section 4(5) of 
the Federal Procurement Policy Act) to enter into contracts 
under subparagraph (G). 
‘‘(I) REVIEW OF CONTRACT IN THE EVENT OF A MERGER 
OR ACQUISITION.—The Secretary shall review the contract 
Applicability. 
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121 STAT. 949 
PUBLIC LAW 110–85—SEPT. 27, 2007 
with a qualified entity under this paragraph in the event 
of a merger or acquisition of the entity in order to ensure 
that the requirements under this paragraph will continue 
to be met. 
‘‘(J) COORDINATION.—In carrying out this paragraph, 
the Secretary shall provide for appropriate communications 
to the public, scientific, public health, and medical commu-
nities, and other key stakeholders, and to the extent prac-
ticable shall coordinate with the activities of private enti-
ties, professional associations, or other entities that may 
have sources of drug safety data.’’. 
(b) RULE OF CONSTRUCTION.—Nothing in this section or the 
amendment made by this section shall be construed to prohibit 
the lawful disclosure or use of data or information by an entity 
other than as described in paragraph (4)(B) or (4)(G) of section 
505(k) of the Federal Food, Drug, and Cosmetic Act, as added 
by subsection (a). 
(c) REPORT TO CONGRESS.—Not later than 4 years after the 
date of the enactment of this Act, the Secretary shall report to 
the Congress on the ways in which the Secretary has used the 
active postmarket risk identification and analysis system described 
in paragraphs (3) and (4) of section 505(k) of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a), to identify 
specific drug safety signals and to better understand the outcomes 
associated with drugs marketed in the United States. 
(d) AUTHORIZATION OF APPROPRIATIONS.—To carry out activities 
under the amendment made by this section for which funds are 
made available under section 736 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h), there are authorized to be appro-
priated to carry out the amendment made by this section, in addi-
tion 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 
described in paragraphs (3) and (4) of section 505(k) of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection (a), and 
make recommendations to the Committee on Energy and Commerce 
of the House of Representatives and the Committee on Health, 
Education, Labor and Pensions of the Senate, and any other 
congressional committees of relevant jurisdiction, regarding the 
need for any additional legislative or regulatory actions to ensure 
privacy, confidentiality, and security of this data or otherwise 
address privacy, confidentiality, and security issues to ensure the 
effective operation of such active postmarket identification and anal-
ysis system. 
SEC. 906. STATEMENT FOR INCLUSION IN DIRECT-TO-CONSUMER 
ADVERTISEMENTS OF DRUGS. 
(a) PUBLISHED DIRECT-TO-CONSUMER ADVERTISEMENTS.—Sec-
tion 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 
21 USC 355 note. 
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121 STAT. 950 
PUBLIC LAW 110–85—SEPT. 27, 2007 
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-consumer tele-
vision 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 the information in the 
statement described in paragraph (1) would detract from the 
presentation of risk information in a direct-to-consumer tele-
vision advertisement. If such Secretary determines the inclusion 
of such statement is appropriate in direct-to-consumer tele-
vision 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 appropriate 
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 subtitle, shall 
have no effect on the use of drugs approved under section 505 
of the Federal Food, Drug, and Cosmetic Act by, or on the lawful 
written or oral order of, a licensed veterinarian within the context 
of a veterinarian-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 amend-
ments made by this subtitle, there is authorized to be appropriated 
$25,000,000 for each of fiscal years 2008 through 2012. 
(b) RELATION TO OTHER FUNDING.—The authorization of appro-
priations 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 approved risk evaluation and 
mitigation strategy under section 505–1 of the Federal Food, 
Drug, and Cosmetic 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 section 601.42 
of title 21, Code of Federal Regulations; or 
21 USC 331 note. 
21 USC 355 note. 
Reports. 
Deadline. 
21 USC 352 note. 
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121 STAT. 951 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(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 
Deadlines. 
21 USC 360a. 
Deadline. 
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121 STAT. 952 
PUBLIC LAW 110–85—SEPT. 27, 2007 
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.— 
Standards. 
21 USC 355e. 
21 USC 381. 
21 USC 334. 
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121 STAT. 953 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(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.— 
Deadline. 
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121 STAT. 954 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(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); 
Deadline. 
Deadline. 
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121 STAT. 955 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(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 
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121 STAT. 956 
PUBLIC LAW 110–85—SEPT. 27, 2007 
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. 
Courts. 
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121 STAT. 957 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(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; 
Deadline. 
Web site. 
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121 STAT. 958 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(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— 
Deadline. 
Reports. 
Reports. 
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121 STAT. 959 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(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. 
Publication. 
Web site. 
Deadlines. 
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121 STAT. 960 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(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 
21 USC 355. 
Establishment. 
21 USC 
360bbb–6. 
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121 STAT. 961 
PUBLIC LAW 110–85—SEPT. 27, 2007 
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— 
Deadlines. 
Deadline. 
Reports. 
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121 STAT. 962 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(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; 
21 USC 2101. 
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121 STAT. 963 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(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— 
21 USC 2103. 
Deadline. 
Deadline. 
Regulations. 
21 USC 2102. 
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121 STAT. 964 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(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. 
21 USC 350f 
note. 
21 USC 2104. 
Web site. 
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121 STAT. 965 
PUBLIC LAW 110–85—SEPT. 27, 2007 
(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. 
Deadline. 
Deadline. 
21 USC 350f. 
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121 STAT. 966 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(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 
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121 STAT. 967 
PUBLIC LAW 110–85—SEPT. 27, 2007 
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). 
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121 STAT. 968 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(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: 
Applicability. 
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121 STAT. 969 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(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 
Reports. 
21 USC 2106. 
21 USC 2105. 
21 USC 2110 
note. 
Deadline. 
21 USC 350f 
note. 
21 USC 350f 
note. 
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121 STAT. 970 
PUBLIC LAW 110–85—SEPT. 27, 2007 
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 
Web site. 
21 USC 2109. 
21 USC 2108. 
21 USC 2107. 
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121 STAT. 971 
PUBLIC LAW 110–85—SEPT. 27, 2007 
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 
Public 
information. 
21 USC 379d–2. 
21 USC 2110. 
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121 STAT. 972 
PUBLIC LAW 110–85—SEPT. 27, 2007 
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. 
21 USC 360n. 
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121 STAT. 973 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(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 
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121 STAT. 974 
PUBLIC LAW 110–85—SEPT. 27, 2007 
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 
Contracts. 
Study. 
Deadline. 
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121 STAT. 975 
PUBLIC LAW 110–85—SEPT. 27, 2007 
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 
42 USC 247d–5a. 
21 USC 301 note. 
42 USC 283a–2. 
42 USC 283a–3. 
42 USC 283. 
42 USC 282. 
42 USC 247d–3b. 
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121 STAT. 976 
PUBLIC LAW 110–85—SEPT. 27, 2007 
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— 
Appropriation 
authorization. 
Deadline. 
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121 STAT. 977 
PUBLIC LAW 110–85—SEPT. 27, 2007 
‘‘(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 
Deadline. 
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121 STAT. 978 
PUBLIC LAW 110–85—SEPT. 27, 2007 
LEGISLATIVE HISTORY—H.R. 3580: 
CONGRESSIONAL RECORD, Vol. 153 (2007): 
Sept. 19, considered and passed House. 
Sept. 20, considered and passed Senate. 
(2) prevented or delayed timely generic drug entry into 
the market. 
Approved September 27, 2007. 
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