I 
110TH CONGRESS 
1ST SESSION H. R. 2900 
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 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
revise and extend the user-fee programs for prescription 
drugs and for medical devices, to enhance the postmarket 
authorities of the Food and Drug Administration with 
respect to the safety of drugs, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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. 
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. 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6211
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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. 
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. 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6211
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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 
(B) by inserting before the period ‘‘(not in-
cluding the discontinued section of such list)’’; 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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-
mary analysis of the adverse drug reaction 
reports received for recently approved 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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; 
‘‘(II) a description of the actions 
taken on those recommendations; and 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
‘‘(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 
(B) by striking ‘‘April 1997’’ and inserting 
‘‘October 1996’’; 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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’’; 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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)). 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
‘‘(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-
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
‘‘(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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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; 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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-
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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-
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00017
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00018
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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— 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00019
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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.— 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00021
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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.’’. 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00022
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
(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-
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00023
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS
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 
VerDate Aug 31 2005 
03:24 Jun 29, 2007
Jkt 059200
PO 00000
Frm 00024
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.IH
H2900
bajohnson on PROD1PC77 with BILLS