II 
Calendar No. 270 
110TH CONGRESS 
1ST SESSION H. R. 2900 
IN THE SENATE OF THE UNITED STATES 
JULY 16, 2007 
Received; read twice and placed on the calendar 
AN ACT 
To amend the Federal Food, Drug, and Cosmetic Act to 
revise and extend the user-fee programs for prescription 
drugs and for medical devices, to enhance the postmarket 
authorities of the Food and Drug Administration with 
respect to the safety of drugs, and for other purposes. 
Be it enacted by the Senate and House of 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 
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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. 
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 
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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. Citizen petitions and petitions for stay of agency action. 
Sec. 913. Authorization of appropriations. 
Sec. 914. 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 
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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)’’; 
(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-
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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) 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 
drugs, including identification of any new 
risks not previously identified, potential 
new risks, or known risks reported in un-
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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. 
‘‘(vi) Conducting regular, bi-weekly 
screening of the Adverse Event Reporting 
System database and developing a report 
every 15 days on any new safety concerns. 
‘‘(vii) Ensuring that the reports avail-
able to the public under the Adverse Event 
Reporting System are updated at least 
every 6 months. 
‘‘(viii) 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 
‘‘(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-
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planation of why no action or a dif-
ferent action was taken. 
‘‘(ix) 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. 
‘‘(x) Developing postmarket safety 
performance measures, including those list-
ed in clauses (v) through (ix), 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’’; 
(6) by redesignating paragraph (9) as para-
graph (11); and 
(7) by inserting after paragraph (8) the fol-
lowing paragraphs: 
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‘‘(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’’; 
(B) by redesignating subparagraphs (E) 
and (F) as subparagraphs (F) and (G), respec-
tively; and 
(C) by inserting after subparagraph (D) 
the following: 
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‘‘(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 
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 
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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 
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 
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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)). 
‘‘(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); 
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‘‘(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-
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 
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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 
‘‘(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 
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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 
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). 
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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; 
(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 
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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-
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 
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(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-
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 
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