IB 
Union Calendar No. 140 
110TH CONGRESS 
1ST SESSION H. R. 2900 
[Report No. 110–225] 
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 Administra-
tion with respect to the safety of drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 28, 2007 
Mr. DINGELL (for himself, Mr. BARTON of Texas, Mr. PALLONE, Mr. DEAL 
of Georgia, Mr. WAXMAN, Mr. BARROW, Mr. BUTTERFIELD, Mr. GON-
ZALEZ, Mr. GENE GREEN of Texas, Mr. GORDON of Tennessee, Ms. 
SOLIS, Mr. MATHESON, Mr. INSLEE, Ms. ESHOO, Ms. HOOLEY, Ms. 
BALDWIN, Mr. FERGUSON, Mr. ENGEL, Mr. ROSS, Mr. TOWNS, Mr. ROG-
ERS of Michigan, Mr. MARKEY, Ms. DEGETTE, Ms. SCHAKOWSKY, Mr. 
ALLEN, Mr. BURGESS, Mr. TERRY, Mrs. BONO, Mrs. MYRICK, Mrs. 
CAPPS, Mr. UPTON, Mr. MELANCON, and Mr. RUSH) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce 
JULY 11, 2007 
Additional sponsors: Mr. WYNN and Mr. HILL 
JULY 11, 2007 
Committed to the Committee of the Whole House on the State of the Union 
and ordered to be printed 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
revise and extend the user-fee programs for prescription 
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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 Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Food and Drug Ad-
ministration 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. 
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. 
TITLE II—MEDICAL DEVICE USER FEE AMENDMENTS OF 2007 
Sec. 201. Short title; references in title. 
Subtitle A—Fees Related to Medical Devices 
Sec. 211. Definitions. 
Sec. 212. Authority to assess and use device fees. 
Sec. 213. Annual reports. 
Sec. 214. Consultation. 
Sec. 215. Additional authorization of appropriations for postmarket safety in-
formation. 
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 notifica-
tion. 
Sec. 222. Registration. 
Sec. 223. Filing of lists of drugs and devices manufactured, prepared, propa-
gated, and compounded by registrants; statements; accom-
panying disclosures. 
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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. 
Sec. 228. Inspections by accredited persons. 
Sec. 229. Study of nosocomial infections relating to medical devices. 
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 Studies. 
TITLE IV—PEDIATRIC RESEARCH EQUITY ACT OF 2007 
Sec. 401. Short title. 
Sec. 402. Reauthorization of Pediatric Research Equity Act. 
Sec. 403. 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. 
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. Clinical trial registry database and clinical trial results database. 
Sec. 802. Study by Government Accountability Office. 
TITLE IX—ENHANCED AUTHORITIES REGARDING POSTMARKET 
SAFETY OF DRUGS 
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. Postmarket risk identification and analysis system for active surveil-
lance and assessment. 
Sec. 907. Statement for inclusion in direct-to-consumer advertisements of 
drugs. 
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Sec. 908. Clinical trial guidance for antibiotic drugs. 
Sec. 909. Prohibition against food to which drugs or biological products have 
been added. 
Sec. 910. Assuring pharmaceutical safety. 
Sec. 911. Orphan antibiotic drugs. 
Sec. 912. Authorization of appropriations. 
Sec. 913. Effective date and applicability. 
TITLE I—PRESCRIPTION DRUG 
USER FEE AMENDMENTS OF 2007 
SEC. 101. SHORT TITLE; REFERENCES IN TITLE. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Prescription Drug User Fee Amendments of 2007’’. 
(b) REFERENCES IN ACT.—Except as otherwise spec-
ified, 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.). 
SEC. 102. DEFINITIONS. 
Section 735 (21 U.S.C. 379g) is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (A), by striking 
‘‘505(b)(1),’’ and inserting ‘‘505(b), or’’; 
(B) by striking subparagraph (B); and 
(C) by redesignating subparagraph (C) as 
subparagraph (B); 
(2) 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 
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(B) by inserting before the period ‘‘(not in-
cluding the discontinued section of such list)’’; 
(3) in paragraph (4), by inserting before the pe-
riod at the end the following: ‘‘(such as capsules, 
tablets, or lyophilized products before reconstitu-
tion)’’; 
(4) by amending paragraph (6)(F) to read as 
follows: 
‘‘(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) Preparing and making publicly 
available (including on the website of the 
Food and Drug Administration) a sum-
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mary analysis of the adverse drug reaction 
reports received for recently approved 
drugs, including identification of any new 
risks not previously identified, potential 
new risks, or known risks reported in un-
usual number not previously identified 
within 18 months of the drug’s initial mar-
keting or after exposure of 10,000 individ-
uals to the drug, whichever is later. 
‘‘(v) Conducting regular, bi-weekly 
screening of the Adverse Event Reporting 
System database and developing a report 
every 15 days on any new safety concerns. 
‘‘(vi) Ensuring that the reports avail-
able to the public under the Adverse Event 
Reporting System are updated at least 
every 6 months. 
‘‘(vii) Reporting to the Congress on— 
‘‘(I) the recommendations re-
ceived in consultations with, and re-
ports from, the Office of Surveillance 
and Epidemiology within the Food 
and 
Drug 
Administration 
on 
postmarket safety activities; 
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‘‘(II) a description of the actions 
taken on those recommendations; and 
‘‘(III) if no action is taken, or a 
different action is taken relative to the 
action recommended by the Office of 
Surveillance and Epidemiology, an ex-
planation of why no action or a dif-
ferent action was taken. 
‘‘(viii) On an annual basis, reviewing 
the entire backlog of postmarket safety 
commitments to determine which commit-
ments require revision or should be elimi-
nated, reporting to the Congress on these 
determinations, and assigning start dates 
and estimated completion dates for such 
commitments. 
‘‘(ix) Developing postmarket safety 
performance measures, including those list-
ed in clauses (iv) through (viii), that are as 
measurable and rigorous as the ones al-
ready developed for premarket review.’’; 
(5) in paragraph (8)— 
(A) by striking ‘‘April of the preceding fis-
cal year’’ and inserting ‘‘October of the pre-
ceding fiscal year’’; and 
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(B) by striking ‘‘April 1997’’ and inserting 
‘‘October 1996’’; 
(6) by redesignating paragraph (9) as para-
graph (11); and 
(7) 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 
(ii) by inserting before the period at 
the end the following: ‘‘or withdrawn with-
out a waiver before filing’’; 
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(B) by redesignating subparagraphs (E) 
and (F) as subparagraphs (F) and (G), respec-
tively; and 
(C) by inserting after subparagraph (D) 
the following: 
‘‘(E) 
FEES
FOR
APPLICATIONS
PRE-
VIOUSLY 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 ac-
cepted 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 subsection (d).’’; 
and 
(3) in paragraph (2)— 
(A) in subparagraph (A), by striking ‘‘sub-
paragraph (B)’’ and inserting ‘‘subparagraphs 
(B) and (C)’’; and 
(B) by adding at the end the following: 
‘‘(C) SPECIAL RULES FOR POSITRON EMIS-
SION TOMOGRAPHY DRUGS.— 
‘‘(i) IN
GENERAL.—Except as pro-
vided in clause (ii), each person who is 
named as the applicant in an approved 
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human drug application for a positron 
emission tomography drug shall be subject 
under subparagraph (A) to one-sixth of an 
annual establishment fee with respect to 
each such establishment identified in the 
application as producing positron emission 
tomography drugs under the approved ap-
plication. 
‘‘(ii) EXCEPTION FROM ANNUAL ES-
TABLISHMENT 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 Sec-
retary, at a time specified by the Secretary 
and using procedures specified by the Sec-
retary, that— 
‘‘(I) the person is a not-for-profit 
medical center that has only 1 estab-
lishment 
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 
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by such establishment during such fis-
cal year will be used within the med-
ical center. 
‘‘(iii) DEFINITION.—For purposes of 
this subparagraph, the term ‘positron 
emission tomography drug’ has the mean-
ing given to the term ‘compounded 
positron emission tomography drug’ in sec-
tion 201(ii), except that subparagraph 
(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 
‘‘(B) an amount equal to the modified 
workload adjustment factor for fiscal year 2007 
(as determined under paragraph (3)). 
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‘‘(2) TYPES
OF
FEES.—Of the total revenue 
amount determined for a fiscal year under para-
graph (1)— 
‘‘(A) one-third shall be derived from fees 
under subsection (a)(1) (relating to human 
drug applications and supplements); 
‘‘(B) one-third shall be derived from fees 
under subsection (a)(2) (relating to prescription 
drug establishments); and 
‘‘(C) one-third shall be derived from fees 
under subsection (a)(3) (relating to prescription 
drug products). 
‘‘(3) MODIFIED WORKLOAD ADJUSTMENT FAC-
TOR
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 por-
tion of such determination that is based on the 
change in the total number of commercial investiga-
tional new drug applications, the Secretary shall 
count the number of such applications that were ac-
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tive 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, subject to subparagraph (C), be applied 
by substituting 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) an amount equal to— 
‘‘(I)(aa) for fiscal year 2008, 
$25,000,000; 
‘‘(bb) 
for 
fiscal 
year 
2009, 
$35,000,000; 
‘‘(cc) 
for 
fiscal 
year 
2010, 
$45,000,000; 
‘‘(dd) 
for 
fiscal 
year 
2011, 
$55,000,000; and 
‘‘(ee) 
for 
fiscal 
year 
2012, 
$65,000,000; minus 
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‘‘(II) the amount equal to the ex-
cess amount in item (bb), provided 
that— 
‘‘(aa) the amount of the 
total appropriation 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 appropriation 
for the Food and Drug Adminis-
tration for fiscal year 2007 (ex-
cluding the amount of fees appro-
priated for such fiscal year), ad-
justed as provided under sub-
section (c)(1); and 
‘‘(bb) the amount of the 
total appropriations for the proc-
ess of human drug review at the 
Food and Drug Administration 
for such fiscal year (excluding 
the amount of fees appropriated 
for such fiscal year) exceeds the 
amount of appropriations for the 
process of human drug review at 
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the Food and Drug Administra-
tion for fiscal year 2007 (exclud-
ing the amount of fees appro-
priated for such fiscal year), ad-
justed as provided under sub-
section (c)(1). 
In making the adjustment under sub-
clause (II) for any of fiscal years 
2008 through 2012, subsection (c)(1) 
shall be applied by substituting ‘2007’ 
for ‘2008’. 
‘‘(C) LIMITATION.—This paragraph shall 
not apply for any fiscal year if the amount de-
scribed under subparagraph (B)(ii) is less than 
0.’’. 
(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; 
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(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 Administration, 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 under this paragraph), by strik-
ing ‘‘fiscal year 2003’’ and inserting ‘‘fiscal 
year 2008’’. 
(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 sen-
tence— 
(i) by striking ‘‘human drug applica-
tions,’’ and inserting ‘‘human drug applica-
tions (adjusted for changes in review ac-
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tivities, as described in the notice that the 
Secretary is required to publish in the 
Federal Register under this subpara-
graph),’’; 
(ii) by striking ‘‘commercial investiga-
tional new drug applications,’’; and 
(iii) by inserting before the period the 
following: ‘‘, and the change in the total 
number of active commercial investiga-
tional new drug applications (adjusted for 
changes in review activities, as so de-
scribed) 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 rev-
enue amounts for fiscal year 2009 may not re-
sult in the total workload adjustment being 
more than 2 percentage points higher than it 
would have been in the absence of the adjust-
ment 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 ad-
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justment 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 method-
ology for calculating the adjustment. After re-
view of the recommendations, the Secretary 
shall, if warranted, make appropriate changes 
to the methodology, and the changes shall be ef-
fective for each of the fiscal years 2010 through 
2012. The Secretary shall not make any adjust-
ment for changes in review activities for any 
fiscal year after 2009 unless such study has 
been completed.’’. 
(3) RENT AND RENT-RELATED COST ADJUST-
MENT.—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), respec-
tively; and 
(B) by inserting after paragraph (2) the 
following: 
‘‘(3) RENT AND RENT-RELATED COST ADJUST-
MENT.—For fiscal year 2010 and each subsequent 
fiscal year, the Secretary shall, before making ad-
justments under paragraphs (1) and (2), decrease 
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the fee revenue amount established in subsection (b) 
if actual costs paid for rent and rent-related ex-
penses for the preceding fiscal year are less than es-
timates made for such year in fiscal year 2006. Any 
reduction made under this paragraph shall not ex-
ceed 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.—Section 736(c) 
(21 U.S.C. 379h(c)) is amended— 
(A) in paragraph (4) (as redesignated by 
paragraph (3)(A))— 
(i) by striking ‘‘2007’’ each place it 
appears and inserting ‘‘2012’’; 
(ii) by striking ‘‘paragraphs (1) and 
(2)’’ and inserting ‘‘paragraphs (1), (2), 
and (3)’’; and 
(iii) by striking ‘‘2008’’ and inserting 
‘‘2013’’; and 
(B) in paragraph (5) (as so redesignated), 
by striking ‘‘2002’’ and inserting ‘‘2007’’. 
(d) FEE WAIVER OR REDUCTION.—Section 736(d) 
(21 U.S.C. 379h(d)) is amended— 
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(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; 
(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.— 
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(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.’’. 
(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 
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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.—A drug designated under sec-
tion 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 facil-
ity fees under this section, provided that the drug meets 
all of the following: 
‘‘(1) The drug had United States sales in the 
previous year of less than $25,000,000 for the active 
moiety, for all indications, dosage forms, and 
strengths for which the drug is approved and for 
any off-label uses. 
‘‘(2) The drug meets the public health require-
ments contained in this Act as such requirements 
are applied to requests for waivers for product and 
facility fees. 
‘‘(3) The drug is owned or licensed and mar-
keted 
by 
a 
company 
that 
had 
less 
than 
$100,000,000 in gross worldwide revenue during the 
previous year.’’. 
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(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)’’. 
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 broadcast (referred to in this sec-
tion as ‘prebroadcast advisory review’) shall, ex-
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cept as provided in subparagraph (B), be sub-
ject to a fee established under subsection (c)(3). 
‘‘(B) EXCEPTION FOR REQUIRED SUBMIS-
SIONS.—A DTC advertisement that is required 
under section 502(n) to be submitted to the 
Secretary prior to initial public broadcast is not 
subject to a fee under subparagraph (A) unless 
the sponsor designates the submission as a sub-
mission for prebroadcast advisory 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 prebroadcast advisory re-
view in the next fiscal year. 
‘‘(D) PAYMENT.— 
‘‘(i) IN GENERAL.—The fee required 
by subparagraph (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 in-
volved is intended be submitted for 
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prebroadcast advisory review, subject to 
subparagraph (F)(i). 
‘‘(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 
prebroadcast 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 Octo-
ber 1 of the fiscal year in which the adver-
tisement is intended to be submitted. 
‘‘(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 
prebroadcast advisory review in the fiscal 
year involved shall be subject to the advi-
sory review fee. 
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‘‘(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) on or before No-
vember 1 of such fiscal year, the fees are 
regarded as late and a revised due date 
and an increase in the amount of fees ap-
plies in accordance with this clause, not-
withstanding any other provision of this 
section. For such person, the advisory re-
view fee for each DTC advertisement sub-
mitted in such fiscal year for prebroadcast 
advisory review shall be due and payable 
20 days before the advertisement is sub-
mitted to the Secretary, and each such fee 
shall be revised to be equal to 150 percent 
of the fee that otherwise would have ap-
plied pursuant to subsection (c)(3). 
‘‘(ii) EXCEEDING
IDENTIFIED
NUM-
BER OF SUBMISSIONS.—If a person sub-
mits 
a 
number 
of 
DTC 
ads 
for 
prebroadcast advisory review in a fiscal 
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year that exceeds the number identified by 
the person under subparagraph (C), a re-
vised due date and an increase in the 
amount of fees applies under this clause 
for each submission in excess of such num-
ber, notwithstanding any other provision of 
this section. For each such DTC ad, the 
advisory review fee shall be due and pay-
able 20 days before the advertisement is 
submitted to the Secretary, and the fee 
shall be revised to be equal to 150 percent 
of the fee that otherwise would have ap-
plied pursuant 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 
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to the next fiscal year. Resubmissions may 
be submitted without regard to the fiscal 
year of the initial advisory review submis-
sion. 
‘‘(ii) NO REFUNDS.—Except as pro-
vided by subsection (f), fees paid under 
subparagraph (A) 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 TRANSFERABLE.—The right to an ad-
visory review under this paragraph is not 
transferable, except to a successor in inter-
est. 
‘‘(2) OPERATING RESERVE FEE.— 
‘‘(A) IN GENERAL.—Each person that on 
or after October 1, 2007, is assessed an advi-
sory review fee under paragraph (1) shall be 
subject to fee established under subsection 
(d)(2) referred to in this section as an ‘oper-
ating reserve fee’ for the first fiscal year in 
which an advisory review fee is assessed to such 
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person. The person is not subject to an oper-
ating 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 October 1 of the first 
fiscal year in which the person is required to 
pay an advisory review fee under paragraph (1). 
‘‘(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 
prebroadcast advisory review that are in excess 
of the number identified by that person in re-
sponse to the Federal Register notice described 
in subsection (a)(1)(C), that person shall pay 
an operating reserve fee for each of those advi-
sory reviews equal to the advisory review fee for 
each submission established under paragraph 
(1)(D)(ii). Fees required by this subparagraph 
shall be in addition to any fees required by sub-
paragraph (A). Fees under this subparagraph 
shall be due 20 days before any DTC advertise-
ment is submitted by such person to the Sec-
retary for prebroadcast advisory review. 
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‘‘(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 
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 
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‘‘(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 will 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 broad-
cast. With respect to such adjustment: 
‘‘(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-
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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, the Secretary shall estab-
lish for the next fiscal year the DTC advertise-
ment advisory review fee under subsection 
(a)(1), based on the revenue amounts estab-
lished under subsection (b), the adjustments 
provided under paragraphs (1) and (2), and the 
number of DTC advertisements identified pur-
suant to subsection (a)(1)(C), excluding allow-
able previously-paid carry over submissions. 
The annual advisory review fee shall be estab-
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lished by dividing the fee revenue for a fiscal 
year (as adjusted pursuant to this subsection) 
by the number of DTC advertisements so iden-
tified, excluding allowable previously-paid carry 
over submissions. 
‘‘(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 
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.— 
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‘‘(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-
suant to subsection (c)(3) for that fiscal year, except 
that in no case shall the operating reserve fee as-
sessed be less than the operating reserve fee as-
sessed if the person had first participated in the pro-
gram under this section in fiscal year 2008. 
‘‘(3) USE OF OPERATING RESERVE.—The Sec-
retary 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 estab-
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lished 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 reau-
thorized beyond fiscal year 2012. 
‘‘(4) REFUND
OF
OPERATING
RESERVES.— 
Within 120 days of the end of fiscal year 2012, or 
if the program under this section ends early pursu-
ant to subsection (f), the Secretary, after setting 
aside sufficient operating reserve amounts to termi-
nate 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 re-
serve fee assessment. In no event shall the refund to 
any person exceed the total amount of operating re-
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 
prebroadcast advisory review of a DTC advertisement sub-
mitted by a person subject to fees under subsection (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. 
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‘‘(f) EFFECT OF INADEQUATE FUNDING OF PRO-
GRAM.— 
‘‘(1) INITIAL
FUNDING.—If on November 1, 
2007, or 120 days after enactment of this provision, 
whichever is later, the Secretary has not received at 
least $11,250,000 in advisory review fees and oper-
ating reserve fees combined, the program 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 
subsection (c)(1)), the program under this section 
shall cease to exist, and the Secretary shall notify all 
participants, retain any money from the unused ad-
visory review fees and the operating reserves needed 
to close down the program under this section, and 
refund the remainder of the unused fees and oper-
ating reserves. To the extent required to close down 
the program under this section, the Secretary shall 
first use unobligated advisory review fee revenues 
from prior fiscal years, then the operating reserves, 
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and finally, unused advisory review fees from the rel-
evant fiscal year. 
‘‘(g) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) of this section 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 appropriation account without 
fiscal year limitation to such appropriation account 
for salaries and expenses with such fiscal year limi-
tation. The sums transferred shall be available solely 
for the process for the advisory review of prescrip-
tion drug advertising. 
‘‘(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 
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‘‘(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 
‘‘(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-
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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 sub-
chapter: 
‘‘(1) The term ‘advisory review’ means review-
ing and providing advisory comments on a proposed 
advertisement prior to its initial public broadcast. 
‘‘(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. 
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‘‘(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 ‘prebroadcast advisory review’ 
has the meaning indicated for such term in sub-
section (a)(1)(A). 
‘‘(9) The term ‘process for the advisory review 
of prescription drug advertising’ means the activities 
necessary to review and provide advisory comments 
on DTC advertisements prior to public broadcast 
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 
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to review and provide advisory comments on other 
proposed advertisements and promotional material 
prior to public broadcast. 
‘‘(10) The term ‘resources allocated for the 
process for the advisory review of prescription drug 
advertising’ means the expenses incurred in connec-
tion with the process for the advisory review of pre-
scription 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, 
and repair of fixtures, furniture, scientific 
equipment, and other necessary materials and 
supplies; 
‘‘(D) collection of fees under this section 
and accounting for resources allocated for the 
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