II 
110TH CONGRESS 
1ST SESSION H. R. 3580 
IN THE SENATE OF THE UNITED STATES 
SEPTEMBER 19, 2007 
Received 
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. 
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Sec. 227. Frequency of reporting for certain devices. 
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 in-
formation on the relationship between the use of indoor tan-
ning devices and development of skin cancer or other skin dam-
age. 
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 Administra-
tion. 
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 
evaluation 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. 
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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. 
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. 
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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 au-
thorized by the amendments made in this title will be dedi-
cated toward expediting the drug development process and 
the process for the review of human drug applications, in-
cluding 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 Representatives, as set forth in the Con-
gressional Record. 
SEC. 102. DEFINITIONS. 
Section 735 (21 U.S.C. 379g) is amended— 
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(1) in the matter before paragraph (1), by 
striking ‘‘For purposes of this subchapter’’ and in-
serting ‘‘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 
subparagraph (B); and 
(D) in the matter following subparagraph 
(B), as so redesignated, by striking ‘‘subpara-
graph (C)’’ and inserting ‘‘subparagraph (B)’’; 
(3) in paragraph (3)(C)— 
(A) by striking ‘‘505(j)(7)(A)’’ and insert-
ing ‘‘505(j)(7)(A) (not including the discon-
tinued section of such list)’’; and 
(B) by inserting before the period ‘‘(not in-
cluding the discontinued section of such list)’’; 
(4) in paragraph (4), by inserting before the pe-
riod at the end the following: ‘‘(such as capsules, 
tablets, or lyophilized products before reconstitu-
tion)’’; 
(5) by amending paragraph (6)(F) to read as 
follows: 
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‘‘(F) Postmarket safety activities with re-
spect to drugs approved under human drug ap-
plications or supplements, including the fol-
lowing activities: 
‘‘(i) Collecting, developing, and re-
viewing safety information on approved 
drugs, including adverse event reports. 
‘‘(ii) Developing and using improved 
adverse-event data-collection systems, in-
cluding information technology systems. 
‘‘(iii) Developing and using improved 
analytical tools to assess potential safety 
problems, including access to external data 
bases. 
‘‘(iv) Implementing and enforcing sec-
tion 505(o) (relating to postapproval stud-
ies and clinical trials and labeling changes) 
and section 505(p) (relating to risk evalua-
tion and mitigation strategies). 
‘‘(v) Carrying out section 505(k)(5) 
(relating to adverse event reports and 
postmarket safety activities).’’; 
(6) in paragraph (8)— 
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(A) by striking ‘‘April of the preceding fis-
cal year’’ and inserting ‘‘October of the pre-
ceding fiscal year’’; and 
(B) by striking ‘‘April 1997’’ and inserting 
‘‘October 1996’’; 
(7) by redesignating paragraph (9) as para-
graph (11); and 
(8) by inserting after paragraph (8) the fol-
lowing paragraphs: 
‘‘(9) The term ‘person’ includes an affiliate 
thereof. 
‘‘(10) The term ‘active’, with respect to a com-
mercial investigational new drug application, means 
such an application to which information was sub-
mitted 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 ‘‘RE-
FUSED FOR FILING’’; and 
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fee revenues and fees established in sub-
section (b) by the amount determined in 
clause (ii), if, for fiscal year 2009 or 
2010— 
‘‘(I) the amount of the total ap-
propriations for the Food and Drug 
Administration for such fiscal year 
(excluding the amount of fees appro-
priated for such fiscal year) exceeds 
the amount of the total appropriations 
for the Food and Drug Administra-
tion 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 ap-
propriations expended for the process 
for the review of human drug applica-
tions 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 
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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 determined 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 de-
scribed 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 
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account only if subclauses (I) and (II) 
of clause (i) apply to such fiscal year. 
‘‘(II) RELATION
TO
SUBPARA-
GRAPH (A).—The Secretary shall limit 
any decrease under this paragraph if 
such a limitation is necessary to pro-
vide for the 3 months of operating re-
serves 
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 appli-
cation’’; 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; 
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(3) by inserting after paragraph (1) the fol-
lowing: 
‘‘(2) CONSIDERATIONS.—In determining wheth-
er 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 para-
graph (2)), in subparagraph (A), by inserting before 
the period the following: ‘‘, 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 amend-
ed to read as follows: 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
For each of the fiscal years 2008 through 2012, 
there is authorized to be appropriated for fees under 
this section an amount equal to the total revenue 
amount determined under subsection (b) for the fis-
cal year, as adjusted or otherwise affected under 
subsection (c) and paragraph (4) of this sub-
section.’’. 
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(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 ap-
propriated under paragraph (3) for the fiscal years 
2008 through 2011, the excess shall be credited to 
the appropriation account of the Food and Drug Ad-
ministration 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.— 
‘‘(1) EXEMPTION.—A drug designated under 
section 526 for a rare disease or condition and ap-
proved 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: 
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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 Pre-
scription Drug User Fee Amendments of 2002 
(Public Law 107–188; 116 Stat. 687). 
SEC. 104. FEES RELATING TO ADVISORY REVIEW OF PRE-
SCRIPTION-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 PRE-
SCRIPTION-DRUG TELEVISION ADVERTISING. 
‘‘(a) TYPES OF DIRECT-TO-CONSUMER TELEVISION 
ADVERTISEMENT 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 pro-
posed direct-to-consumer television advertise-
ment (referred to in this section as a ‘DTC ad-
vertisement’), each person that on or after Oc-
tober 1, 2007, submits such an advertisement 
for advisory review by the Secretary prior to its 
initial public dissemination shall, except as pro-
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vided in subparagraph (B), be subject to a fee 
established under subsection (c)(3). 
‘‘(B) EXCEPTION FOR REQUIRED SUBMIS-
SIONS.—A DTC advertisement that is required 
to be submitted to the Secretary 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 advi-
sory review. 
‘‘(C) NOTICE TO SECRETARY OF NUMBER 
OF ADVERTISEMENTS.—Not later than June 1 
of each fiscal 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 Reg-
ister not later than 30 days after the date of 
the enactment of the Food and Drug Adminis-
tration Amendments Act of 2007. 
‘‘(D) PAYMENT.— 
‘‘(i) IN GENERAL.—The fee required 
by subparagraph (A) (referred to in this 
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section as ‘an advisory review fee’) shall be 
due not later than October 1 of the fiscal 
year in which the DTC advertisement in-
volved is intended to be submitted for advi-
sory review, subject to subparagraph 
(F)(i). Notwithstanding the preceding sen-
tence, 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 Amend-
ments of 2007 or an earlier date as speci-
fied by the Secretary. 
‘‘(ii) EFFECT OF SUBMISSION.—Noti-
fication of the Secretary under subpara-
graph (C) of the number of DTC adver-
tisements a person intends to submit for 
advisory review is a legally binding com-
mitment by that person to pay the annual 
advisory review fee for that number of sub-
missions on or before October 1 of the fis-
cal year in which the advertisement is in-
tended to be submitted. Notwithstanding 
the preceding sentence, the commitment 
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shall be a legally binding commitment by 
that person to pay the annual advisory re-
view fee for that number of submissions 
for fiscal year 2008 by the date specified 
in clause (i). 
‘‘(iii) NOTICE REGARDING CARRYOVER 
SUBMISSIONS.—In making a notification 
under subparagraph (C), the person in-
volved shall in addition notify the Sec-
retary if under subparagraph (F)(i) the 
person intends to submit a DTC advertise-
ment for which the advisory review fee has 
already been paid. If the person does not 
so notify the Secretary, each DTC adver-
tisement submitted by the person for advi-
sory 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 subpara-
graph (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 
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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 and an increase 
in the amount of fees applies in accordance 
with this clause, notwithstanding any other 
provision 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 re-
view, 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
NUM-
BER OF SUBMISSIONS.—If a person sub-
mits a number of DTC advertisements for 
advisory review in a fiscal year that ex-
ceeds the number identified by the person 
under subparagraph (C), an increase in the 
amount of fees applies under this clause 
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for each submission in excess of such num-
ber, notwithstanding any other provision of 
this section. For each such DTC advertise-
ment, the advisory review fee shall be due 
and payable 20 days before the advertise-
ment is submitted to the Secretary, and 
the fee shall be equal to 150 percent of the 
fee that otherwise would have applied pur-
suant to subsection (c)(3). 
‘‘(F) LIMITS.— 
‘‘(i) SUBMISSIONS.—For each advi-
sory review fee paid by a person for a fis-
cal year, the person is entitled to accept-
ance for advisory review by the Secretary 
of one DTC advertisement and acceptance 
of one resubmission for advisory review of 
the same advertisement. 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 submis-
sion. 
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‘‘(B) PAYMENT.—Except as provided in 
subparagraph (C), the operating reserve fee 
shall be due no later than— 
‘‘(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 Amend-
ments Act of 2007 or an earlier date speci-
fied 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 identi-
fied 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 sub-
mission established under paragraph (1)(E)(ii). 
Fees required by this subparagraph shall be in 
addition to any fees required by subparagraph 
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(A). Fees under this subparagraph shall be due 
20 days before any DTC advertisement is sub-
mitted by such person to the Secretary for advi-
sory review. 
‘‘(D) LATE PAYMENT.— 
‘‘(i) IN
GENERAL.—Notwithstanding 
subparagraph (B), and subject to clause 
(ii), an operating reserve fee shall be re-
garded as late if the person required to 
pay the fee has not paid the complete oper-
ating 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 ear-
lier date specified by the Secretary; or 
‘‘(II) in any subsequent year, No-
vember 1. 
‘‘(ii) 
COMPLETE
PAYMENT.—The 
complete operating reserve fee shall be due 
and payable 20 days before any DTC ad-
vertisement is submitted by such person to 
the Secretary for advisory review. 
‘‘(iii) AMOUNT.—Notwithstanding any 
other provision of this section, an oper-
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ating 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 pursu-
ant to subsection (d). 
‘‘(b) ADVISORY REVIEW FEE REVENUE AMOUNTS.— 
Fees under subsection (a)(1) shall be established to gen-
erate revenue amounts of $6,250,000 for each of fiscal 
years 2008 through 2012, as adjusted pursuant to sub-
sections (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 oc-
curred in the Consumer Price Index for all 
urban consumers (all items; U.S. city average), 
for the 12-month period ending June 30 pre-
ceding the fiscal year for which fees are being 
established; 
‘‘(B) the total percentage change for the 
previous fiscal year in basic pay under the Gen-
eral Schedule in accordance with section 5332 
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of title 5, United States Code, as adjusted by 
any locality-based comparability payment pur-
suant 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 Administration, 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 sub-
section shall be added on a compounded basis to the 
sum of all adjustments made each fiscal year after 
fiscal year 2008 under this subsection. 
‘‘(2) 
WORKLOAD
ADJUSTMENT.—Beginning 
with fiscal year 2009, after the fee revenues estab-
lished in subsection (b) are adjusted for a fiscal year 
for inflation in accordance with paragraph (1), the 
fee revenues shall be adjusted further for such fiscal 
year to reflect changes in the workload of the Sec-
retary with respect to the submission of DTC adver-
tisements for advisory review prior to initial dissemi-
nation. With respect to such adjustment: 
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‘‘(A) The adjustment shall be determined 
by the Secretary based upon the number of 
DTC advertisements identified pursuant to sub-
section (a)(1)(C) for the upcoming fiscal year, 
excluding allowable previously paid carry over 
submissions. The adjustment shall be deter-
mined by multiplying the number of such adver-
tisements projected for that fiscal year that ex-
ceeds 150 by $27,600 (adjusted each year be-
ginning 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 adjust-
ment and the supporting methodologies. 
‘‘(B) Under no circumstances shall the ad-
justment 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 RE-
VIEW.— 
‘‘(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 Admin-
istration Amendments Act of 2007), the Sec-
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retary 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), ex-
cluding allowable previously-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 advertise-
ments so identified, excluding allowable pre-
viously-paid carry over submissions under sub-
section (a)(1)(F)(i). 
‘‘(B) FISCAL YEAR 2008 FEE LIMIT.—Not-
withstanding subsection (b) and the adjust-
ments pursuant to this subsection, the fee es-
tablished under subparagraph (A) for fiscal 
year 2008 may not be more than $83,000 per 
submission for advisory review. 
‘‘(C) 
ANNUAL
FEE
LIMIT.—Notwith-
standing subsection (b) and the adjustments 
pursuant to this subsection, the fee established 
under subparagraph (A) for a fiscal year after 
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fiscal year 2008 may not be more than 50 per-
cent more than the fee established for the prior 
fiscal year. 
‘‘(D) LIMIT.—The total amount of fees ob-
ligated 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 estab-
lish in the Food and Drug Administration salaries 
and expenses appropriation account without fiscal 
year limitation a Direct-to-Consumer Advisory Re-
view 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 subse-
quent 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 estab-
lish the operating reserve fee under subsection 
(a)(2)(A) for each person required to pay the fee by 
multiplying the number of DTC advertisements iden-
tified by that person pursuant to subsection 
(a)(1)(C) by the advisory review fee established pur-
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serve fees paid by such person pursuant to sub-
section (a)(2). 
‘‘(e) EFFECT OF FAILURE TO PAY FEES.—Notwith-
standing any other requirement, a submission for advisory 
review of a DTC advertisement submitted by a person sub-
ject to fees under subsection (a) shall be considered incom-
plete 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 PRO-
GRAM.— 
‘‘(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, the Secretary has 
not received at least $11,250,000 in advisory review 
fees and operating reserve fees combined, the pro-
gram under this section shall not commence and all 
collected fees shall be refunded. 
‘‘(2) LATER FISCAL YEARS.—Beginning in fis-
cal 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 
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subsection (c)(1)), the program under this section 
shall terminate, and the Secretary shall notify all 
participants, retain any money from the unused ad-
visory review fees and the operating reserves needed 
to terminate the program, and refund the remainder 
of the unused fees and operating reserves. To the ex-
tent required to terminate the program, the Sec-
retary 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 sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
thorized to remain available until expended. Such 
sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries 
and expenses with such fiscal year limitation. The 
sums transferred shall be available solely for the 
process for the advisory review of prescription drug 
advertising. 
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‘‘(2) 
COLLECTIONS
AND
APPROPRIATION 
ACTS.— 
‘‘(A) IN
GENERAL.—The fees authorized 
by this section— 
‘‘(i) shall be retained in each fiscal 
year in an amount not to exceed the 
amount specified in appropriation Acts, or 
otherwise made available for obligation 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 fis-
cal year 2007. 
‘‘(B) REVIEW EMPLOYEES.—For purposes 
of subparagraph (A)(ii), the term ‘full-time 
equivalent review employees’ means the total 
combined number of full-time equivalent em-
ployees in— 
‘‘(i) the Center for Drug Evaluation 
and Research, Division of Drug Marketing, 
Advertising, and Communications, Food 
and Drug Administration; and 
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‘‘(ii) the Center for Biologics Evalua-
tion and Research, Advertising and Pro-
motional Labeling Branch, Food and Drug 
Administration. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
For each of the fiscal years 2008 through 2012, 
there is authorized to be appropriated for fees under 
this section an amount equal to the total revenue 
amount determined under subsection (b) for the fis-
cal year, as adjusted pursuant to subsection (c) and 
paragraph (4) of this subsection, plus amounts col-
lected 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 appropria-
tion account of the Food and Drug Administration 
as provided in paragraph (1), and shall be sub-
tracted from the amount of fees that would other-
wise be collected under this section pursuant to ap-
propriation Acts for a subsequent fiscal year. 
‘‘(h) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘advisory review’ means review-
ing and providing advisory comments on DTC adver-
tisements regarding compliance of a proposed adver-
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tisement 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 re-
view in the following fiscal year. 
‘‘(4) The term ‘direct-to-consumer television ad-
vertisement’ means an advertisement for a prescrip-
tion drug product (as defined in section 735(3)) in-
tended 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 successor in interest. 
‘‘(8) The term ‘process for the advisory review 
of prescription drug advertising’ means the activities 
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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 re-
view 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 proc-
ess for the advisory review of prescription drug ad-
vertising’ means the expenses incurred in connection 
with the process for the advisory review of prescrip-
tion drug advertising for— 
‘‘(A) officers and employees of the Food 
and Drug Administration, contractors of the 
Food and Drug Administration, advisory com-
mittees, and costs related to such officers, em-
ployees, and committees, and to contracts with 
such contractors; 
‘‘(B) management of information, and the 
acquisition, maintenance, and repair of com-
puter resources; 
‘‘(C) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance, 
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graph, and any changes made to the recommenda-
tions in response to such views and comments. 
‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 
‘‘(A) PUBLIC AVAILABILITY.—Before pre-
senting the recommendations developed under 
paragraphs (1) through (5) to the Congress, the 
Secretary shall make publicly available, on the 
public Web site of the Food and Drug Adminis-
tration, minutes of all negotiation meetings con-
ducted under this subsection between the Food 
and Drug Administration and the regulated in-
dustry. 
‘‘(B) CONTENT.—The minutes described 
under subparagraph (A) shall summarize any 
substantive proposal made by any party to the 
negotiations as well as significant controversies 
or differences of opinion during the negotiations 
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 section 105 ceases to be effective January 31, 
2013. 
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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, regard-
less 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 notwithstanding 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 con-
tinue to be in effect with respect to human drug applica-
tions 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 Administra-
tion for filing with respect to assessing and collecting any 
fee required by such part for a fiscal year prior to fiscal 
year 2008. 
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SEC. 109. TECHNICAL AMENDMENT; CONFORMING AMEND-
MENT. 
(a) Section 739 (21 U.S.C. 379j–11) is amended in 
the matter preceding paragraph (1) by striking ‘‘sub-
chapter’’ 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 au-
thorized under the amendments made by this title will be 
dedicated toward expediting the process for the review of 
device applications and for assuring the safety and effec-
tiveness 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 Chair-
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man of the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Chairman of the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives, 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 in-
serting ‘‘For purposes of this part’’; 
(2) by redesignating paragraphs (5), (6), (7), 
and (8) as paragraphs (8), (9), (10), and (12), re-
spectively; 
(3) by inserting after paragraph (4) the fol-
lowing: 
‘‘(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 infor-
mation’ means a request made under section 513(g) 
for information respecting the class in which a de-
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vice has been classified or the requirements applica-
ble to a device. 
‘‘(7) The term ‘annual fee’, for periodic report-
ing 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 fis-
cal year’’ and inserting ‘‘October of the pre-
ceding 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 re-
designated, the following: 
‘‘(13) The term ‘establishment subject to a reg-
istration fee’ means an establishment that is re-
quired to register with the Secretary under section 
510 and is one of the following types of establish-
ments: 
‘‘(A) MANUFACTURER.—An establishment 
that makes by any means any article that is a 
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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
REPROC-
ESSOR.—An establishment that, within the 
meaning of section 201(ll)(2)(A), performs ad-
ditional processing and manufacturing oper-
ations on a single-use device that has previously 
been used on a patient. 
‘‘(C) SPECIFICATION DEVELOPER.—An es-
tablishment that develops specifications for a 
device that is distributed under the establish-
ment’s name but which performs no manufac-
turing, including an establishment that, in addi-
tion to developing specifications, also arranges 
for the manufacturing of devices labeled with 
another establishment’s name by a contract 
manufacturer.’’. 
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 ‘‘Begin-
ning on the date of the enactment of the Med-
ical Device User Fee and Modernization Act of 
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pended on the review of the portions sub-
mitted. 
‘‘(vi) 
SOLE
DISCRETION
TO
RE-
FUND.—The Secretary shall have sole dis-
cretion 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 review-
able.’’. 
(5) ANNUAL
ESTABLISHMENT
REGISTRATION 
FEE.—Section 738(a) (21 U.S.C. 379j(a)) is amend-
ed 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 re-
quired under subparagraph (A) for an estab-
lishment operated by a State or Federal govern-
mental entity or an Indian tribe (as defined in 
the Indian Self Determination and Educational 
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Assistance Act), unless a device manufactured 
by the establishment is to be distributed com-
mercially. 
‘‘(C) PAYMENT.—The fee required under 
subparagraph (A) shall be due once each fiscal 
year, upon the initial registration of the estab-
lishment or upon the annual registration 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 sub-
section (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 Appli-
cation ..............
$185,000 
$200,725 
$217,787 
$236,298 
$256,384
................
Establishment 
Registration ....
$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— 
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(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. 
(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 paragraphs (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 es-
tablishments subject to registration) only if the 
Secretary estimates that the number of estab-
lishments submitting fees for fiscal year 2009 is 
fewer than 12,250. The percentage increase 
shall be the percentage 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 per-
cent over that specified in subsection (b) for fis-
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cal year 2010. If the Secretary makes any ad-
justment 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 ad-
justed 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 Federal Register the Sec-
retary’s determination to make the adjustment 
and the rationale for the determination.’’; and 
(C) in paragraph (4), as redesignated by 
this paragraph, 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 RE-
DUCTION REGARDING PREMARKET APPROVAL.— 
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(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
AP-
PROVAL FEES.— 
(A) DEFINITION.—Section 738(d)(2)(A) 
(21 U.S.C. 379j(d)(2)(A)) is amended by strik-
ing ‘‘, partners, and parent firms’’. 
(B) EVIDENCE OF QUALIFICATION.—Sec-
tion 738(d)(2)(B) (21 U.S.C. 379j(d)(2)(B)) is 
amended— 
(i) by striking ‘‘(B) EVIDENCE
OF 
QUALIFICATION.—An applicant’’ and in-
serting the following: 
‘‘(B) EVIDENCE OF QUALIFICATION.— 
‘‘(i) IN GENERAL.—An applicant’’; 
(ii) by striking ‘‘The applicant shall 
support its claim’’ and inserting the fol-
lowing: 
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‘‘(ii) FIRMS
SUBMITTING
TAX
RE-
TURNS TO THE UNITED STATES INTERNAL 
REVENUE
SERVICE.—The applicant shall 
support its claim’’; 
(iii) by striking ‘‘, partners, and par-
ent 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 affiliates.’’; and 
(v) by adding at the end the following: 
‘‘(iii) FIRMS
NOT
SUBMITTING
TAX 
RETURNS TO THE UNITED STATES INTER-
NAL 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 subpara-
graph (A) by submission of a signed cer-
tification, in such form as the Secretary 
may direct through a notice published in 
the Federal Register, that the applicant or 
affiliate meets the criteria for a small busi-
ness and a certification, in English, from 
the national taxing authority of the coun-
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‘‘(A) a description of any pediatric sub-
populations that suffer from the disease or con-
dition that the device is intended to treat, diag-
nose, or cure; and 
‘‘(B) the number of affected pediatric pa-
tients. 
‘‘(3) ANNUAL
REPORT.—Not later than 18 
months after the date of the enactment of this sec-
tion, and annually thereafter, the Secretary shall 
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 
Representatives a report that includes— 
‘‘(A) the number of devices approved in the 
year preceding the year in which the report is 
submitted, for which there is a pediatric sub-
population that suffers from the disease or con-
dition that the device is intended to treat, diag-
nose, or cure; 
‘‘(B) the number of devices approved in 
the year preceding the year in which the report 
is submitted, labeled for use in pediatric pa-
tients; 
‘‘(C) the number of pediatric devices ap-
proved in the year preceding the year in which 
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