H. R. 3580 
One Hundred Tenth Congress 
of the 
United States of America 
AT THE FIRST SESSION 
Begun and held at the City of Washington on Thursday, 
the fourth day of January, two thousand and seven 
An Act 
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the 
user-fee programs for prescription drugs and for medical devices, to enhance 
the postmarket authorities of the Food and Drug Administration with respect 
to the safety of drugs, and for other purposes. 
Be it enacted by the Senate and House of Representatives of 
the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Food and Drug Administration 
Amendments Act of 2007’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents for this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 
Sec. 101. Short title; references in title; finding. 
Sec. 102. Definitions. 
Sec. 103. Authority to assess and use drug fees. 
Sec. 104. Fees relating to advisory review of prescription-drug television adver-
tising. 
Sec. 105. Reauthorization; reporting requirements. 
Sec. 106. Sunset dates. 
Sec. 107. Effective date. 
Sec. 108. Savings clause. 
Sec. 109. Technical amendment; conforming amendment. 
TITLE II—MEDICAL DEVICE USER FEE AMENDMENTS OF 2007 
Sec. 201. Short title; references in title; finding. 
Subtitle A—Fees Related to Medical Devices 
Sec. 211. Definitions. 
Sec. 212. Authority to assess and use device fees. 
Sec. 213. Reauthorization; reporting requirements. 
Sec. 214. Savings clause. 
Sec. 215. Additional authorization of appropriations for postmarket safety informa-
tion. 
Sec. 216. Effective date. 
Sec. 217. Sunset clause. 
Subtitle B—Amendments Regarding Regulation of Medical Devices 
Sec. 221. Extension of authority for third party review of premarket notification. 
Sec. 222. Registration. 
Sec. 223. Filing of lists of drugs and devices manufactured, prepared, propagated, 
and compounded by registrants; statements; accompanying disclosures. 
Sec. 224. Electronic registration and listing. 
Sec. 225. Report by Government Accountability Office. 
Sec. 226. Unique device identification system. 
Sec. 227. Frequency of reporting for certain devices.
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Sec. 228. Inspections by accredited persons. 
Sec. 229. Study of nosocomial infections relating to medical devices. 
Sec. 230. Report by the Food and Drug Administration regarding labeling informa-
tion on the relationship between the use of indoor tanning devices and 
development of skin cancer or other skin damage. 
TITLE III—PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT 
OF 2007 
Sec. 301. Short title. 
Sec. 302. Tracking pediatric device approvals. 
Sec. 303. Modification to humanitarian device exemption. 
Sec. 304. Encouraging pediatric medical device research. 
Sec. 305. Demonstration grants for improving pediatric device availability. 
Sec. 306. Amendments to office of pediatric therapeutics and pediatric advisory 
committee. 
Sec. 307. Postmarket surveillance. 
TITLE IV—PEDIATRIC RESEARCH EQUITY ACT OF 2007 
Sec. 401. Short title. 
Sec. 402. Reauthorization of Pediatric Research Equity Act. 
Sec. 403. Establishment of internal committee. 
Sec. 404. Government Accountability Office report. 
TITLE V—BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007 
Sec. 501. Short title. 
Sec. 502. Reauthorization of Best Pharmaceuticals for Children Act. 
Sec. 503. Training of pediatric pharmacologists. 
TITLE VI—REAGAN-UDALL FOUNDATION 
Sec. 601. The Reagan-Udall Foundation for the Food and Drug Administration. 
Sec. 602. Office of the Chief Scientist. 
Sec. 603. Critical path public-private partnerships. 
TITLE VII—CONFLICTS OF INTEREST 
Sec. 701. Conflicts of interest. 
TITLE VIII—CLINICAL TRIAL DATABASES 
Sec. 801. Expanded clinical trial registry data bank. 
TITLE IX—ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY 
OF DRUGS 
Subtitle A—Postmarket Studies and Surveillance 
Sec. 901. Postmarket studies and clinical trials regarding human drugs; risk eval-
uation and mitigation strategies. 
Sec. 902. Enforcement. 
Sec. 903. No effect on withdrawal or suspension of approval. 
Sec. 904. Benefit-risk assessments. 
Sec. 905. Active postmarket risk identification and analysis. 
Sec. 906. Statement for inclusion in direct-to-consumer advertisements of drugs. 
Sec. 907. No effect on veterinary medicine. 
Sec. 908. Authorization of appropriations. 
Sec. 909. Effective date and applicability. 
Subtitle B—Other Provisions to Ensure Drug Safety and Surveillance 
Sec. 911. Clinical trial guidance for antibiotic drugs. 
Sec. 912. Prohibition against food to which drugs or biological products have been 
added. 
Sec. 913. Assuring pharmaceutical safety. 
Sec. 914. Citizen petitions and petitions for stay of agency action. 
Sec. 915. Postmarket drug safety information for patients and providers. 
Sec. 916. Action package for approval. 
Sec. 917. Risk communication. 
Sec. 918. Referral to advisory committee. 
Sec. 919. Response to the institute of medicine. 
Sec. 920. Database for authorized generic drugs. 
Sec. 921. Adverse drug reaction reports and postmarket safety. 
TITLE X—FOOD SAFETY 
Sec. 1001. Findings.
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Sec. 1002. Ensuring the safety of pet food. 
Sec. 1003. Ensuring efficient and effective communications during a recall. 
Sec. 1004. State and Federal Cooperation. 
Sec. 1005. Reportable Food Registry. 
Sec. 1006. Enhanced aquaculture and seafood inspection. 
Sec. 1007. Consultation regarding genetically engineered seafood products. 
Sec. 1008. Sense of Congress. 
Sec. 1009. Annual report to Congress. 
Sec. 1010. Publication of annual reports. 
Sec. 1011. Rule of construction. 
TITLE XI—OTHER PROVISIONS 
Subtitle A—In General 
Sec. 1101. Policy on the review and clearance of scientific articles published by 
FDA employees. 
Sec. 1102. Priority review to encourage treatments for tropical diseases. 
Sec. 1103. Improving genetic test safety and quality. 
Sec. 1104. NIH Technical amendments. 
Sec. 1105. Severability clause. 
Subtitle B—Antibiotic Access and Innovation 
Sec. 1111. Identification of clinically susceptible concentrations of antimicrobials. 
Sec. 1112. Orphan antibiotic drugs. 
Sec. 1113. Exclusivity of certain drugs containing single enantiomers. 
Sec. 1114. Report. 
TITLE I—PRESCRIPTION DRUG USER 
FEE AMENDMENTS OF 2007 
SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the ‘‘Prescription 
Drug User Fee Amendments of 2007’’. 
(b) REFERENCES
IN
TITLE.—Except as otherwise specified, 
amendments made by this title to a section or other provision 
of law are amendments to such section or other provision of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 
(c) FINDING.—The Congress finds that the fees authorized by 
the amendments made in this title will be dedicated toward expe-
diting the drug development process and the process for the review 
of human drug applications, including postmarket drug safety 
activities, as set forth in the goals identified for purposes of part 
2 of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act, in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Chairman 
of the Committee on Energy and Commerce of the House of Rep-
resentatives, as set forth in the Congressional Record. 
SEC. 102. DEFINITIONS. 
Section 735 (21 U.S.C. 379g) is amended— 
(1) in the matter before paragraph (1), by striking ‘‘For 
purposes of this subchapter’’ and inserting ‘‘For purposes of 
this part’’; 
(2) in paragraph (1)— 
(A) in subparagraph (A), by striking ‘‘505(b)(1),’’ and 
inserting ‘‘505(b), or’’; 
(B) by striking subparagraph (B); 
(C) by redesignating subparagraph (C) as subpara-
graph (B); and
H. R. 3580—4 
(D) in the matter following subparagraph (B), as so 
redesignated, by striking ‘‘subparagraph (C)’’ and inserting 
‘‘subparagraph (B)’’; 
(3) in paragraph (3)(C)— 
(A) by striking ‘‘505(j)(7)(A)’’ and inserting ‘‘505(j)(7)(A) 
(not including the discontinued section of such list)’’; and 
(B) by inserting before the period ‘‘(not including the 
discontinued section of such list)’’; 
(4) in paragraph (4), by inserting before the period at 
the end the following: ‘‘(such as capsules, tablets, or lyophilized 
products before reconstitution)’’; 
(5) by amending paragraph (6)(F) to read as follows: 
‘‘(F) Postmarket safety activities with respect to drugs 
approved under human drug applications or supplements, 
including the following activities: 
‘‘(i) Collecting, developing, and reviewing safety 
information on approved drugs, including adverse 
event reports. 
‘‘(ii) Developing and using improved adverse-event 
data-collection systems, including information tech-
nology systems. 
‘‘(iii) Developing and using improved analytical 
tools to assess potential safety problems, including 
access to external data bases. 
‘‘(iv) Implementing and enforcing section 505(o) 
(relating to postapproval studies and clinical trials and 
labeling changes) and section 505(p) (relating to risk 
evaluation and mitigation strategies). 
‘‘(v) Carrying out section 505(k)(5) (relating to 
adverse event reports and postmarket safety activi-
ties).’’; 
(6) in paragraph (8)— 
(A) by striking ‘‘April of the preceding fiscal year’’ 
and inserting ‘‘October of the preceding fiscal year’’; and 
(B) by striking ‘‘April 1997’’ and inserting ‘‘October 
1996’’; 
(7) by redesignating paragraph (9) as paragraph (11); and 
(8) by inserting after paragraph (8) the following para-
graphs: 
‘‘(9) The term ‘person’ includes an affiliate thereof. 
‘‘(10) The term ‘active’, with respect to a commercial inves-
tigational new drug application, means such an application 
to which information was submitted during the relevant 
period.’’. 
SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES. 
(a) TYPES
OF FEES.—Section 736(a) (21 U.S.C. 379h(a)) is 
amended— 
(1) in the matter preceding paragraph (1), by striking 
‘‘2003’’ and inserting ‘‘2008’’; 
(2) in paragraph (1)— 
(A) in subparagraph (D)— 
(i) in the heading, by inserting ‘‘OR WITHDRAWN 
BEFORE FILING’’ after ‘‘REFUSED FOR FILING’’; and 
(ii) by inserting before the period at the end the 
following: ‘‘or withdrawn without a waiver before 
filing’’;
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(B) by redesignating subparagraphs (E) and (F) as 
subparagraphs (F) and (G), respectively; and 
(C) by inserting after subparagraph (D) the following: 
‘‘(E) FEES FOR APPLICATIONS PREVIOUSLY REFUSED FOR 
FILING
OR
WITHDRAWN
BEFORE
FILING.—A human drug 
application or supplement that was submitted but was 
refused for filing, or was withdrawn before being accepted 
or refused for filing, shall be subject to the full fee under 
subparagraph (A) upon being resubmitted or filed over 
protest, unless the fee is waived or reduced under sub-
section (d).’’; and 
(3) in paragraph (2)— 
(A) in subparagraph (A), by striking ‘‘subparagraph 
(B)’’ and inserting ‘‘subparagraphs (B) and (C)’’; and 
(B) by adding at the end the following: 
‘‘(C) SPECIAL RULES FOR POSITRON EMISSION TOMOG-
RAPHY DRUGS.— 
‘‘(i) IN
GENERAL.—Except as provided in clause 
(ii), each person who is named as the applicant in 
an approved human drug application for a positron 
emission tomography drug shall be subject under 
subparagraph (A) to one-sixth of an annual establish-
ment fee with respect to each such establishment 
identified in the application as producing positron 
emission tomography drugs under the approved 
application. 
‘‘(ii) EXCEPTION
FROM
ANNUAL
ESTABLISHMENT 
FEE.—Each person who is named as the applicant in 
an application described in clause (i) shall not be 
assessed an annual establishment fee for a fiscal year 
if the person certifies to the Secretary, at a time speci-
fied by the Secretary and using procedures specified 
by the Secretary, that— 
‘‘(I) the person is a not-for-profit medical center 
that has only 1 establishment for the production 
of positron emission tomography drugs; and 
‘‘(II) at least 95 percent of the total number 
of doses of each positron emission tomography drug 
produced by such establishment during such fiscal 
year will be used within the medical center. 
‘‘(iii) DEFINITION.—For purposes of this subpara-
graph, the term ‘positron emission tomography drug’ 
has the meaning given to the term ‘compounded 
positron emission tomography drug’ in section 201(ii), 
except that paragraph (1)(B) of such section shall not 
apply.’’. 
(b) FEE REVENUE AMOUNTS.—Section 736(b) (21 U.S.C. 379h(b)) 
is amended to read as follows: 
‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) IN GENERAL.—For each of the fiscal years 2008 through 
2012, fees under subsection (a) shall, except as provided in 
subsections (c), (d), (f), and (g), be established to generate 
a total revenue amount under such subsection that is equal 
to the sum of— 
‘‘(A) $392,783,000; and
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‘‘(B) an amount equal to the modified workload adjust-
ment factor for fiscal year 2007 (as determined under para-
graph (3)). 
‘‘(2) TYPES OF FEES.—Of the total revenue amount deter-
mined for a fiscal year under paragraph (1)— 
‘‘(A) one-third shall be derived from fees under sub-
section (a)(1) (relating to human drug applications and 
supplements); 
‘‘(B) one-third shall be derived from fees under sub-
section (a)(2) (relating to prescription drug establishments); 
and 
‘‘(C) one-third shall be derived from fees under sub-
section (a)(3) (relating to prescription drug products). 
‘‘(3) MODIFIED WORKLOAD ADJUSTMENT FACTOR FOR FISCAL 
YEAR 2007.—For purposes of paragraph (1)(B), the Secretary 
shall determine the modified workload adjustment factor by 
determining the dollar amount that results from applying the 
methodology that was in effect under subsection (c)(2) for fiscal 
year 2007 to the amount $354,893,000, except that, with respect 
to the portion of such determination that is based on the 
change in the total number of commercial investigational new 
drug applications, the Secretary shall count the number of 
such applications that were active during the most recent 12- 
month period for which data on such submissions is available. 
‘‘(4) ADDITIONAL FEE REVENUES FOR DRUG SAFETY.— 
‘‘(A) IN GENERAL.—For each of the fiscal years 2008 
through 2012, paragraph (1)(A) shall be applied by sub-
stituting the amount determined under subparagraph (B) 
for ‘$392,783,000’. 
‘‘(B) AMOUNT DETERMINED.—For each of the fiscal years 
2008 through 2012, the amount determined under this 
subparagraph is the sum of— 
‘‘(i) $392,783,000; plus 
‘‘(ii)(I) for fiscal year 2008, $25,000,000; 
‘‘(II) for fiscal year 2009, $35,000,000; 
‘‘(III) for fiscal year 2010, $45,000,000; 
‘‘(IV) for fiscal year 2011, $55,000,000; and 
‘‘(V) for fiscal year 2012, $65,000,000.’’. 
(c) ADJUSTMENTS TO FEES.— 
(1) INFLATION ADJUSTMENT.—Section 736(c)(1) (21 U.S.C. 
379h(c)(1)) is amended— 
(A) in the matter preceding subparagraph (A), by 
striking ‘‘The revenues established in subsection (b)’’ and 
inserting ‘‘For fiscal year 2009 and subsequent fiscal years, 
the revenues established in subsection (b)’’; 
(B) in subparagraph (A), by striking ‘‘or’’ at the end; 
(C) in subparagraph (B), by striking the period at 
the end and inserting ‘‘, or’’; 
(D) by inserting after subparagraph (B) the following: 
‘‘(C) the average annual change in the cost, per full- 
time equivalent position of the Food and Drug Administra-
tion, of all personnel compensation and benefits paid with 
respect to such positions for the first 5 years of the pre-
ceding 6 fiscal years.’’; and 
(E) in the matter following subparagraph (C) (as added 
by subparagraph (D)), by striking ‘‘fiscal year 2003’’ and 
inserting ‘‘fiscal year 2008’’.
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(2) WORKLOAD ADJUSTMENT.—Section 736(c)(2) (21 U.S.C. 
379h(c)(2)) is amended— 
(A) in the matter preceding subparagraph (A), by 
striking ‘‘Beginning with fiscal year 2004,’’ and inserting 
‘‘For fiscal year 2009 and subsequent fiscal years,’’; 
(B) in subparagraph (A), in the first sentence— 
(i) by striking ‘‘human drug applications,’’ and 
inserting ‘‘human drug applications (adjusted for 
changes in review activities, as described in the notice 
that the Secretary is required to publish in the Federal 
Register under this subparagraph),’’; 
(ii) by striking ‘‘commercial investigational new 
drug applications,’’; and 
(iii) by inserting before the period the following: 
‘‘, and the change in the total number of active commer-
cial investigational new drug applications (adjusted 
for changes in review activities, as so described) during 
the most recent 12-month period for which data on 
such submissions is available’’; 
(C) in subparagraph (B), by adding at the end the 
following: ‘‘Any adjustment for changes in review activities 
made in setting fees and revenue amounts for fiscal year 
2009 may not result in the total workload adjustment 
being more than 2 percentage points higher than it would 
have been in the absence of the adjustment for changes 
in review activities.’’; and 
(D) by adding at the end the following: 
‘‘(C) The Secretary shall contract with an independent 
accounting firm to study the adjustment for changes in 
review activities applied in setting fees and revenue 
amounts for fiscal year 2009 and to make recommendations, 
if warranted, for future changes in the methodology for 
calculating the adjustment. After review of the rec-
ommendations, the Secretary shall, if warranted, make 
appropriate changes to the methodology, and the changes 
shall be effective for each of the fiscal years 2010 through 
2012. The Secretary shall not make any adjustment for 
changes in review activities for any fiscal year after 2009 
unless such study has been completed.’’. 
(3) RENT AND RENT-RELATED COST ADJUSTMENT.—Section 
736(c) (21 U.S.C. 379h(c)) is amended— 
(A) by redesignating paragraphs (3), (4), and (5) as 
paragraphs (4), (5), and (6), respectively; and 
(B) by inserting after paragraph (2) the following: 
‘‘(3) RENT AND RENT-RELATED COST ADJUSTMENT.—For fiscal 
year 2010 and each subsequent fiscal year, the Secretary shall, 
before making adjustments under paragraphs (1) and (2), 
decrease the fee revenue amount established in subsection (b) 
if actual costs paid for rent and rent-related expenses for the 
preceding fiscal year are less than estimates made for such 
year in fiscal year 2006. Any reduction made under this para-
graph shall not exceed the amount by which such costs fall 
below the estimates made in fiscal year 2006 for such fiscal 
year, and shall not exceed $11,721,000 for any fiscal year.’’. 
(4) FINAL
YEAR
ADJUSTMENT.—Paragraph (4) of section 
736(c) (21 U.S.C. 379h(c)), as redesignated by paragraph (3)(A), 
is amended to read as follows:
H. R. 3580—9 
only if subclauses (I) and (II) of clause (i) apply 
to such fiscal year. 
‘‘(II) RELATION
TO
SUBPARAGRAPH
(A).—The 
Secretary shall limit any decrease under this para-
graph if such a limitation is necessary to provide 
for the 3 months of operating reserves described 
in subparagraph (A).’’. 
(5) LIMIT.—Paragraph (5) of section 736(c) (21 U.S.C. 
379h(c)), as redesignated by paragraph (3)(A), is amended by 
striking ‘‘2002’’ and inserting ‘‘2007’’. 
(d) FEE WAIVER
OR REDUCTION.—Section 736(d) (21 U.S.C. 
379h(d)) is amended— 
(1) in paragraph (1), in the matter preceding subparagraph 
(A)— 
(A) by inserting after ‘‘The Secretary shall grant’’ the 
following: ‘‘to a person who is named as the applicant 
in a human drug application’’; and 
(B) by inserting ‘‘to that person’’ after ‘‘one or more 
fees assessed’’; 
(2) by redesignating paragraphs (2) and (3) as paragraphs 
(3) and (4), respectively; 
(3) by inserting after paragraph (1) the following: 
‘‘(2) CONSIDERATIONS.—In determining whether to grant 
a waiver or reduction of a fee under paragraph (1), the Secretary 
shall consider only the circumstances and assets of the 
applicant involved and any affiliate of the applicant.’’; and 
(4) in paragraph (4) (as redesignated by paragraph (2)), 
in subparagraph (A), by inserting before the period the fol-
lowing: ‘‘, and that does not have a drug product that has 
been approved under a human drug application and introduced 
or delivered for introduction into interstate commerce’’. 
(e) CREDITING AND AVAILABILITY OF FEES.— 
(1) AUTHORIZATION OF APPROPRIATIONS.—Section 736(g)(3) 
(21 U.S.C. 379h(g)(3)) is amended to read as follows: 
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the 
fiscal years 2008 through 2012, there is authorized to be appro-
priated for fees under this section an amount equal to the 
total revenue amount determined under subsection (b) for the 
fiscal year, as adjusted or otherwise affected under subsection 
(c) and paragraph (4) of this subsection.’’. 
(2) OFFSET.—Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is 
amended to read as follows: 
‘‘(4) OFFSET.—If the sum of the cumulative amount of fees 
collected under this section for the fiscal years 2008 through 
2010 and the amount of fees estimated to be collected under 
this section for fiscal year 2011 exceeds the cumulative amount 
appropriated under paragraph (3) for the fiscal years 2008 
through 2011, the excess shall be credited to the appropriation 
account of the Food and Drug Administration as provided in 
paragraph (1), and shall be subtracted from the amount of 
fees that would otherwise be authorized to be collected under 
this section pursuant to appropriation Acts for fiscal year 
2012.’’. 
(f) EXEMPTION FOR ORPHAN DRUGS.—Section 736 (21 U.S.C. 
379h) is further amended by adding at the end the following: 
‘‘(k) ORPHAN DRUGS.—
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‘‘(1) EXEMPTION.—A drug designated under section 526 for 
a rare disease or condition and approved under section 505 
or under section 351 of the Public Health Service Act shall 
be exempt from product and establishment fees under this 
section, if the drug meets all of the following conditions: 
‘‘(A) The drug meets the public health requirements 
contained in this Act as such requirements are applied 
to requests for waivers for product and establishment fees. 
‘‘(B) The drug is owned or licensed and is marketed 
by a company that had less than $50,000,000 in gross 
worldwide revenue during the previous year. 
‘‘(2) EVIDENCE
OF
QUALIFICATION.—An exemption under 
paragraph (1) applies with respect to a drug only if the 
applicant involved submits a certification that its gross annual 
revenues did not exceed $50,000,000 for the preceding 12 
months before the exemption was requested.’’. 
(g) CONFORMING
AMENDMENT.—Section 736(a) (21 U.S.C. 
379h(a)) is amended in paragraphs (1)(A)(i), (1)(A)(ii), (2)(A), and 
(3)(A) by striking ‘‘(c)(4)’’ each place such term appears and inserting 
‘‘(c)(5)’’. 
(h) TECHNICAL AMENDMENT.— 
(1) AMENDMENT.—Section 736(g)(1) (21 U.S.C. 379h(g)(1)) 
is amended by striking the first sentence and inserting the 
following: ‘‘Fees authorized under subsection (a) shall be col-
lected and available for obligation only to the extent and in 
the amount provided in advance in appropriations Acts. Such 
fees are authorized to remain available until expended.’’. 
(2) EFFECTIVE DATE.—Paragraph (1) shall take effect as 
if included in section 504 of the Prescription Drug User Fee 
Amendments of 2002 (Public Law 107–188; 116 Stat. 687). 
SEC. 104. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION- 
DRUG TELEVISION ADVERTISING. 
Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et 
seq.) is amended by adding after section 736 the following: 
‘‘SEC. 736A. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION- 
DRUG TELEVISION ADVERTISING. 
‘‘(a) TYPES
OF DIRECT-TO-CONSUMER TELEVISION ADVERTISE-
MENT REVIEW FEES.—Beginning in fiscal year 2008, the Secretary 
shall assess and collect fees in accordance with this section as 
follows: 
‘‘(1) ADVISORY REVIEW FEE.— 
‘‘(A) IN GENERAL.—With respect to a proposed direct- 
to-consumer television advertisement (referred to in this 
section as a ‘DTC advertisement’), each person that on 
or after October 1, 2007, submits such an advertisement 
for advisory review by the Secretary prior to its initial 
public dissemination shall, except as provided in subpara-
graph (B), be subject to a fee established under subsection 
(c)(3). 
‘‘(B) EXCEPTION FOR REQUIRED SUBMISSIONS.—A DTC 
advertisement that is required to be submitted to the Sec-
retary prior to initial public dissemination is not subject 
to a fee under subparagraph (A) unless the sponsor des-
ignates the submission as a submission for advisory review. 
‘‘(C) 
NOTICE
TO
SECRETARY
OF
NUMBER
OF 
ADVERTISEMENTS.—Not later than June 1 of each fiscal
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year, the Secretary shall publish a notice in the Federal 
Register requesting any person to notify the Secretary 
within 30 days of the number of DTC advertisements the 
person intends to submit for advisory review in the next 
fiscal year. Notwithstanding the preceding sentence, for 
fiscal year 2008, the Secretary shall publish such a notice 
in the Federal Register not later than 30 days after the 
date of the enactment of the Food and Drug Administration 
Amendments Act of 2007. 
‘‘(D) PAYMENT.— 
‘‘(i) IN GENERAL.—The fee required by subpara-
graph (A) (referred to in this section as ‘an advisory 
review fee’) shall be due not later than October 1 
of the fiscal year in which the DTC advertisement 
involved is intended to be submitted for advisory 
review, subject to subparagraph (F)(i). Notwithstanding 
the preceding sentence, the advisory review fee for 
any DTC advertisement that is intended to be sub-
mitted for advisory review during fiscal year 2008 shall 
be due not later than 120 days after the date of the 
enactment of the Food and Drug Administration 
Amendments of 2007 or an earlier date as specified 
by the Secretary. 
‘‘(ii) EFFECT OF SUBMISSION.—Notification of the 
Secretary under subparagraph (C) of the number of 
DTC advertisements a person intends to submit for 
advisory review is a legally binding commitment by 
that person to pay the annual advisory review fee 
for that number of submissions on or before October 
1 of the fiscal year in which the advertisement is 
intended to be submitted. Notwithstanding the pre-
ceding sentence, the commitment shall be a legally 
binding commitment by that person to pay the annual 
advisory review fee for that number of submissions 
for fiscal year 2008 by the date specified in clause 
(i). 
‘‘(iii) NOTICE
REGARDING
CARRYOVER
SUBMIS-
SIONS.—In making a notification under subparagraph 
(C), the person involved shall in addition notify the 
Secretary if under subparagraph (F)(i) the person 
intends to submit a DTC advertisement for which the 
advisory review fee has already been paid. If the person 
does not so notify the Secretary, each DTC advertise-
ment submitted by the person for advisory review in 
the fiscal year involved shall be subject to the advisory 
review fee. 
‘‘(E) MODIFICATION OF ADVISORY REVIEW FEE.— 
‘‘(i) LATE
PAYMENT.—If a person has submitted 
a notification under subparagraph (C) with respect 
to a fiscal year and has not paid all advisory review 
fees due under subparagraph (D) not later than 
November 1 of such fiscal year (or, in the case of 
such a notification submitted with respect to fiscal 
year 2008, not later than 150 days after the date 
of the enactment of the Food and Drug Administration 
Amendments Act of 2007 or an earlier date specified 
by the Secretary), the fees shall be regarded as late
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and an increase in the amount of fees applies in accord-
ance with this clause, notwithstanding any other provi-
sion of this section. For such person, all advisory review 
fees for such fiscal year shall be due and payable 
20 days before any direct-to-consumer advertisement 
is submitted to the Secretary for advisory review, and 
each such fee shall be equal to 150 percent of the 
fee that otherwise would have applied pursuant to 
subsection (c)(3). 
‘‘(ii) EXCEEDING
IDENTIFIED
NUMBER
OF
SUBMIS-
SIONS.—If a person submits a number of DTC 
advertisements for advisory review in a fiscal year 
that exceeds the number identified by the person under 
subparagraph (C), an increase in the amount of fees 
applies under this clause for each submission in excess 
of such number, notwithstanding any other provision 
of this section. For each such DTC advertisement, the 
advisory review fee shall be due and payable 20 days 
before the advertisement is submitted to the Secretary, 
and the fee shall be equal to 150 percent of the fee 
that otherwise would have applied pursuant to sub-
section (c)(3). 
‘‘(F) LIMITS.— 
‘‘(i) SUBMISSIONS.—For each advisory review fee 
paid by a person for a fiscal year, the person is entitled 
to acceptance for advisory review by the Secretary 
of one DTC advertisement and acceptance of one 
resubmission for advisory review of the same advertise-
ment. The advertisement shall be submitted for review 
in the fiscal year for which the fee was assessed, except 
that a person may carry over not more than one paid 
advisory review submission to the next fiscal year. 
Resubmissions may be submitted without regard to 
the fiscal year of the initial advisory review submission. 
‘‘(ii) NO
REFUNDS.—Except as provided by sub-
sections (d)(4) and (f), fees paid under this section 
shall not be refunded. 
‘‘(iii) NO WAIVERS, EXEMPTIONS, OR REDUCTIONS.— 
The Secretary shall not grant a waiver, exemption, 
or reduction of any fees due or payable under this 
section. 
‘‘(iv) RIGHT TO ADVISORY REVIEW NOT TRANSFER-
ABLE.—The right to an advisory review under this 
paragraph is not transferable, except to a successor 
in interest. 
‘‘(2) OPERATING RESERVE FEE.— 
‘‘(A) IN GENERAL.—Each person that on or after October 
1, 2007, is assessed an advisory review fee under paragraph 
(1) shall be subject to fee established under subsection 
(d)(2) (referred to in this section as an ‘operating reserve 
fee’) for the first fiscal year in which an advisory review 
fee is assessed to such person. The person is not subject 
to an operating reserve fee for any other fiscal year. 
‘‘(B) PAYMENT.—Except as provided in subparagraph 
(C), the operating reserve fee shall be due no later than—
H. R. 3580—13 
‘‘(i) October 1 of the first fiscal year in which 
the person is required to pay an advisory review fee 
under paragraph (1); or 
‘‘(ii) for fiscal year 2008, 120 days after the date 
of the enactment of the Food and Drug Administration 
Amendments Act of 2007 or an earlier date specified 
by the Secretary. 
‘‘(C) LATE NOTICE OF SUBMISSION.—If, in the first fiscal 
year of a person’s participation in the program under this 
section, that person submits any DTC advertisements for 
advisory review that are in excess of the number identified 
by that person in response to the Federal Register notice 
described in subsection (a)(1)(C), that person shall pay 
an operating reserve fee for each of those advisory reviews 
equal to the advisory review fee for each submission estab-
lished under paragraph (1)(E)(ii). Fees required by this 
subparagraph shall be in addition to any fees required 
by subparagraph (A). Fees under this subparagraph shall 
be due 20 days before any DTC advertisement is submitted 
by such person to the Secretary for advisory review. 
‘‘(D) LATE PAYMENT.— 
‘‘(i) IN GENERAL.—Notwithstanding subparagraph 
(B), and subject to clause (ii), an operating reserve 
fee shall be regarded as late if the person required 
to pay the fee has not paid the complete operating 
reserve fee by— 
‘‘(I) for fiscal year 2008, 150 days after the 
date of the enactment of the Food and Drug 
Administration Amendments Act of 2007 or an 
earlier date specified by the Secretary; or 
‘‘(II) in any subsequent year, November 1. 
‘‘(ii) COMPLETE PAYMENT.—The complete operating 
reserve fee shall be due and payable 20 days before 
any DTC advertisement is submitted by such person 
to the Secretary for advisory review. 
‘‘(iii) AMOUNT.—Notwithstanding any other provi-
sion of this section, an operating reserve fee that is 
regarded as late under this subparagraph shall be 
equal to 150 percent of the operating reserve fee that 
otherwise would have applied pursuant to subsection 
(d). 
‘‘(b) ADVISORY REVIEW FEE REVENUE AMOUNTS.—Fees under 
subsection (a)(1) shall be established to generate revenue amounts 
of $6,250,000 for each of fiscal years 2008 through 2012, as adjusted 
pursuant to subsections (c) and (g)(4). 
‘‘(c) ADJUSTMENTS.— 
‘‘(1) INFLATION ADJUSTMENT.—Beginning with fiscal year 
2009, the revenues established in subsection (b) shall be 
adjusted by the Secretary by notice, published in the Federal 
Register, for a fiscal year to reflect the greater of— 
‘‘(A) the total percentage change that occurred in the 
Consumer Price Index for all urban consumers (all items; 
U.S. city average), for the 12-month period ending June 
30 preceding the fiscal year for which fees are being estab-
lished; 
‘‘(B) the total percentage change for the previous fiscal 
year in basic pay under the General Schedule in accordance
H. R. 3580—14 
with section 5332 of title 5, United States Code, as adjusted 
by any locality-based comparability payment pursuant to 
section 5304 of such title for Federal employees stationed 
in the District of Columbia; or 
‘‘(C) the average annual change in the cost, per full- 
time equivalent position of the Food and Drug Administra-
tion, of all personnel compensation and benefits paid with 
respect to such positions for the first 5 fiscal years of 
the previous 6 fiscal years. 
The adjustment made each fiscal year by this subsection shall 
be added on a compounded basis to the sum of all adjustments 
made each fiscal year after fiscal year 2008 under this sub-
section. 
‘‘(2) WORKLOAD ADJUSTMENT.—Beginning with fiscal year 
2009, after the fee revenues established in subsection (b) are 
adjusted for a fiscal year for inflation in accordance with para-
graph (1), the fee revenues shall be adjusted further for such 
fiscal year to reflect changes in the workload of the Secretary 
with respect to the submission of DTC advertisements for 
advisory review prior to initial dissemination. With respect 
to such adjustment: 
‘‘(A) The adjustment shall be determined by the Sec-
retary based upon the number of DTC advertisements 
identified pursuant to subsection (a)(1)(C) for the upcoming 
fiscal year, excluding allowable previously paid carry over 
submissions. The adjustment shall be determined by multi-
plying the number of such advertisements projected for 
that fiscal year that exceeds 150 by $27,600 (adjusted 
each year beginning with fiscal year 2009 for inflation 
in accordance with paragraph (1)). The Secretary shall 
publish in the Federal Register the fee revenues and fees 
resulting from the adjustment and the supporting meth-
odologies. 
‘‘(B) Under no circumstances shall the adjustment 
result in fee revenues for a fiscal year that are less than 
the fee revenues established for the prior fiscal year. 
‘‘(3) ANNUAL FEE SETTING FOR ADVISORY REVIEW.— 
‘‘(A) IN GENERAL.—Not later than August 1 of each 
fiscal year (or, with respect to fiscal year 2008, not later 
than 90 days after the date of the enactment of the Food 
and Drug Administration Amendments Act of 2007), the 
Secretary shall establish for the next fiscal year the DTC 
advertisement advisory review fee under subsection (a)(1), 
based on the revenue amounts established under subsection 
(b), the adjustments provided under paragraphs (1) and 
(2), and the number of DTC advertisements identified 
pursuant to subsection (a)(1)(C), excluding allowable pre-
viously-paid carry over submissions. The annual advisory 
review fee shall be established by dividing the fee revenue 
for a fiscal year (as adjusted pursuant to this subsection) 
by the number of DTC advertisements so identified, 
excluding allowable previously-paid carry over submissions 
under subsection (a)(1)(F)(i). 
‘‘(B) FISCAL
YEAR
2008
FEE
LIMIT.—Notwithstanding 
subsection (b) and the adjustments pursuant to this sub-
section, the fee established under subparagraph (A) for
H. R. 3580—15 
fiscal year 2008 may not be more than $83,000 per submis-
sion for advisory review. 
‘‘(C) ANNUAL FEE LIMIT.—Notwithstanding subsection 
(b) and the adjustments pursuant to this subsection, the 
fee established under subparagraph (A) for a fiscal year 
after fiscal year 2008 may not be more than 50 percent 
more than the fee established for the prior fiscal year. 
‘‘(D) LIMIT.—The total amount of fees obligated for 
a fiscal year may not exceed the total costs for such fiscal 
year for the resources allocated for the process for the 
advisory review of prescription drug advertising. 
‘‘(d) OPERATING RESERVES.— 
‘‘(1) IN GENERAL.—The Secretary shall establish in the Food 
and Drug Administration salaries and expenses appropriation 
account without fiscal year limitation a Direct-to-Consumer 
Advisory Review Operating Reserve, of at least $6,250,000 in 
fiscal year 2008, to continue the program under this section 
in the event the fees collected in any subsequent fiscal year 
pursuant to subsection (a)(1) do not generate the fee revenue 
amount established for that fiscal year. 
‘‘(2) FEE SETTING.—The Secretary shall establish the oper-
ating reserve fee under subsection (a)(2)(A) for each person 
required to pay the fee by multiplying the number of DTC 
advertisements identified by that person pursuant to subsection 
(a)(1)(C) by the advisory review fee established pursuant to 
subsection (c)(3) for that fiscal year, except that in no case 
shall the operating reserve fee assessed be less than the oper-
ating reserve fee assessed if the person had first participated 
in the program under this section in fiscal year 2008. 
‘‘(3) USE OF OPERATING RESERVE.—The Secretary may use 
funds from the reserves only to the extent necessary in any 
fiscal year to make up the difference between the fee revenue 
amount established for that fiscal year under subsections (b) 
and (c) and the amount of fees actually collected for that fiscal 
year pursuant to subsection (a)(1), or to pay costs of ending 
the program under this section if it is terminated pursuant 
to subsection (f) or not reauthorized beyond fiscal year 2012. 
‘‘(4) REFUND OF OPERATING RESERVES.—Within 120 days 
after the end of fiscal year 2012, or if the program under 
this section ends early pursuant to subsection (f), the Secretary, 
after setting aside sufficient operating reserve amounts to 
terminate the program under this section, shall refund all 
amounts remaining in the operating reserve on a pro rata 
basis to each person that paid an operating reserve fee assess-
ment. In no event shall the refund to any person exceed the 
total amount of operating reserve fees paid by such person 
pursuant to subsection (a)(2). 
‘‘(e) EFFECT OF FAILURE TO PAY FEES.—Notwithstanding any 
other requirement, a submission for advisory review of a DTC 
advertisement submitted by a person subject to fees under sub-
section (a) shall be considered incomplete and shall not be accepted 
for review by the Secretary until all fees owed by such person 
under this section have been paid. 
‘‘(f) EFFECT OF INADEQUATE FUNDING OF PROGRAM.— 
‘‘(1) INITIAL FUNDING.—If on November 1, 2007, or 120 
days after the date of the enactment of the Food and Drug 
Administration Amendments Act of 2007, whichever is later,
H. R. 3580—16 
the Secretary has not received at least $11,250,000 in advisory 
review fees and operating reserve fees combined, the program 
under this section shall not commence and all collected fees 
shall be refunded. 
‘‘(2) LATER FISCAL YEARS.—Beginning in fiscal year 2009, 
if, on November 1 of the fiscal year, the combination of the 
operating reserves, annual fee revenues from that fiscal year, 
and unobligated fee revenues from prior fiscal years falls below 
$9,000,000, adjusted for inflation (as described in subsection 
(c)(1)), the program under this section shall terminate, and 
the Secretary shall notify all participants, retain any money 
from the unused advisory review fees and the operating 
reserves needed to terminate the program, and refund the 
remainder of the unused fees and operating reserves. To the 
extent required to terminate the program, the Secretary shall 
first use unobligated advisory review fee revenues from prior 
fiscal years, then the operating reserves, and finally, unused 
advisory review fees from the relevant fiscal year. 
‘‘(g) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN
GENERAL.—Fees authorized under subsection (a) 
shall be collected and available for obligation only to the extent 
and in the amount provided in advance in appropriations Acts. 
Such fees are authorized to remain available until expended. 
Such sums as may be necessary may be transferred from the 
Food and Drug Administration salaries and expenses appropria-
tion account without fiscal year limitation to such appropriation 
account for salaries and expenses with such fiscal year limita-
tion. The sums transferred shall be available solely for the 
process for the advisory review of prescription drug advertising. 
‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.— 
‘‘(A) IN
GENERAL.—The fees authorized by this sec-
tion— 
‘‘(i) shall be retained in each fiscal year in an 
amount not to exceed the amount specified in appro-
priation Acts, or otherwise made available for obliga-
tion for such fiscal year; and 
‘‘(ii) shall be available for obligation only if the 
amounts appropriated as budget authority for such 
fiscal year are sufficient to support a number of full- 
time equivalent review employees that is not fewer 
than the number of such employees supported in fiscal 
year 2007. 
‘‘(B) REVIEW
EMPLOYEES.—For purposes of subpara-
graph (A)(ii), the term ‘full-time equivalent review 
employees’ means the total combined number of full-time 
equivalent employees in— 
‘‘(i) the Center for Drug Evaluation and Research, 
Division of Drug Marketing, Advertising, and Commu-
nications, Food and Drug Administration; and 
‘‘(ii) the Center for Biologics Evaluation and 
Research, 
Advertising 
and 
Promotional 
Labeling 
Branch, Food and Drug Administration. 
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the 
fiscal years 2008 through 2012, there is authorized to be appro-
priated for fees under this section an amount equal to the 
total revenue amount determined under subsection (b) for the
H. R. 3580—17 
fiscal year, as adjusted pursuant to subsection (c) and para-
graph (4) of this subsection, plus amounts collected for the 
reserve fund under subsection (d). 
‘‘(4) OFFSET.—Any amount of fees collected for a fiscal 
year under this section that exceeds the amount of fees specified 
in appropriation Acts for such fiscal year shall be credited 
to the appropriation account of the Food and Drug Administra-
tion as provided in paragraph (1), and shall be subtracted 
from the amount of fees that would otherwise be collected 
under this section pursuant to appropriation Acts for a subse-
quent fiscal year. 
‘‘(h) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘advisory review’ means reviewing and pro-
viding advisory comments on DTC advertisements regarding 
compliance of a proposed advertisement with the requirements 
of this Act prior to its initial public dissemination. 
‘‘(2) The term ‘advisory review fee’ has the meaning 
indicated for such term in subsection (a)(1)(D). 
‘‘(3) The term ‘carry over submission’ means a submission 
for an advisory review for which a fee was paid in one fiscal 
year that is submitted for review in the following fiscal year. 
‘‘(4) The term ‘direct-to-consumer television advertisement’ 
means an advertisement for a prescription drug product (as 
defined in section 735(3)) intended to be displayed on any 
television channel for less than 3 minutes. 
‘‘(5) The term ‘DTC advertisement’ has the meaning 
indicated for such term in subsection (a)(1)(A). 
‘‘(6) The term ‘operating reserve fee’ has the meaning 
indicated for such term in subsection (a)(2)(A). 
‘‘(7) The term ‘person’ includes an individual, partnership, 
corporation, and association, and any affiliate thereof or suc-
cessor in interest. 
‘‘(8) The term ‘process for the advisory review of prescrip-
tion drug advertising’ means the activities necessary to review 
and provide advisory comments on DTC advertisements prior 
to public dissemination and, to the extent the Secretary has 
additional staff resources available under the program under 
this section that are not necessary for the advisory review 
of DTC advertisements, the activities necessary to review and 
provide advisory comments on other proposed advertisements 
and promotional material prior to public dissemination. 
‘‘(9) The term ‘resources allocated for the process for the 
advisory review of prescription drug advertising’ means the 
expenses incurred in connection with the process for the 
advisory review of prescription drug advertising for— 
‘‘(A) officers and employees of the Food and Drug 
Administration, contractors of the Food and Drug Adminis-
tration, advisory committees, and costs related to such 
officers, employees, and committees, and to contracts with 
such contractors; 
‘‘(B) management of information, and the acquisition, 
maintenance, and repair of computer resources; 
‘‘(C) leasing, maintenance, renovation, and repair of 
facilities and acquisition, maintenance, and repair of fix-
tures, furniture, scientific equipment, and other necessary 
materials and supplies;
H. R. 3580—18 
‘‘(D) collection of fees under this section and accounting 
for resources allocated for the advisory review of prescrip-
tion drug advertising; and 
‘‘(E) terminating the program under this section pursu-
ant to subsection (f)(2) if that becomes necessary. 
‘‘(10) The term ‘resubmission’ means a subsequent submis-
sion for advisory review of a direct-to-consumer television 
advertisement that has been revised in response to the Sec-
retary’s comments on an original submission. A resubmission 
may not introduce significant new concepts or creative themes 
into the television advertisement. 
‘‘(11) The term ‘submission for advisory review’ means an 
original submission of a direct-to-consumer television advertise-
ment for which the sponsor voluntarily requests advisory com-
ments before the advertisement is publicly disseminated.’’. 
SEC. 105. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et 
seq.), as amended by section 104, is further amended by inserting 
after section 736A the following: 
‘‘SEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS. 
‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal year 2008, 
not later than 120 days after the end of each fiscal year for which 
fees are collected under this part, the Secretary shall prepare and 
submit to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Education, Labor, 
and Pensions of the Senate a report concerning the progress of 
the Food and Drug Administration in achieving the goals identified 
in the letters described in section 101(c) of the Food and Drug 
Administration Amendments Act of 2007 during such fiscal year 
and the future plans of the Food and Drug Administration for 
meeting the goals. The report for a fiscal year shall include informa-
tion on all previous cohorts for which the Secretary has not given 
a complete response on all human drug applications and supple-
ments in the cohort. 
‘‘(b) FISCAL REPORT.—Beginning with fiscal year 2008, not later 
than 120 days after the end of each fiscal year for which fees 
are collected under this part, the Secretary shall prepare and submit 
to the Committee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report on the implementation of the 
authority for such fees during such fiscal year and the use, by 
the Food and Drug Administration, of the fees collected for such 
fiscal year. 
‘‘(c) PUBLIC
AVAILABILITY.—The Secretary shall make the 
reports required under subsections (a) and (b) available to the 
public on the Internet Web site of the Food and Drug Administra-
tion. 
‘‘(d) REAUTHORIZATION.— 
‘‘(1) CONSULTATION.—In developing recommendations to 
present to the Congress with respect to the goals, and plans 
for meeting the goals, for the process for the review of human 
drug applications for the first 5 fiscal years after fiscal year 
2012, and for the reauthorization of this part for such fiscal 
years, the Secretary shall consult with— 
‘‘(A) the Committee on Energy and Commerce of the 
House of Representatives;
H. R. 3580—19 
‘‘(B) the Committee on Health, Education, Labor, and 
Pensions of the Senate; 
‘‘(C) scientific and academic experts; 
‘‘(D) health care professionals; 
‘‘(E) representatives of patient and consumer advocacy 
groups; and 
‘‘(F) the regulated industry. 
‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations 
with the regulated industry on the reauthorization of this part, 
the Secretary shall— 
‘‘(A) publish a notice in the Federal Register requesting 
public input on the reauthorization; 
‘‘(B) hold a public meeting at which the public may 
present its views on the reauthorization, including specific 
suggestions for changes to the goals referred to in sub-
section (a); 
‘‘(C) provide a period of 30 days after the public meeting 
to obtain written comments from the public suggesting 
changes to this part; and 
‘‘(D) publish the comments on the Food and Drug 
Administration’s Internet Web site. 
‘‘(3) PERIODIC
CONSULTATION.—Not less frequently than 
once every month during negotiations with the regulated 
industry, the Secretary shall hold discussions with representa-
tives of patient and consumer advocacy groups to continue 
discussions of their views on the reauthorization and their 
suggestions for changes to this part as expressed under para-
graph (2). 
‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotia-
tions with the regulated industry, the Secretary shall— 
‘‘(A) present the recommendations developed under 
paragraph (1) to the Congressional committees specified 
in such paragraph; 
‘‘(B) publish such recommendations in the Federal Reg-
ister; 
‘‘(C) provide for a period of 30 days for the public 
to provide written comments on such recommendations; 
‘‘(D) hold a meeting at which the public may present 
its views on such recommendations; and 
‘‘(E) after consideration of such public views and com-
ments, revise such recommendations as necessary. 
‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 
January 15, 2012, the Secretary shall transmit to the Congress 
the revised recommendations under paragraph (4), a summary 
of the views and comments received under such paragraph, 
and any changes made to the recommendations in response 
to such views and comments. 
‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 
‘‘(A) PUBLIC AVAILABILITY.—Before presenting the rec-
ommendations developed under paragraphs (1) through (5) 
to the Congress, the Secretary shall make publicly avail-
able, on the public Web site of the Food and Drug Adminis-
tration, minutes of all negotiation meetings conducted 
under this subsection between the Food and Drug Adminis-
tration and the regulated industry. 
‘‘(B) CONTENT.—The minutes described under subpara-
graph (A) shall summarize any substantive proposal made
H. R. 3580—20 
by any party to the negotiations as well as significant 
controversies or differences of opinion during the negotia-
tions and their resolution.’’. 
SEC. 106. SUNSET DATES. 
(a) AUTHORIZATION.—The amendments made by sections 102, 
103, and 104 cease to be effective October 1, 2012. 
(b) REPORTING REQUIREMENTS.—The amendment made by sec-
tion 105 ceases to be effective January 31, 2013. 
SEC. 107. EFFECTIVE DATE. 
The amendments made by this title shall take effect on October 
1, 2007, or the date of the enactment of this Act, whichever is 
later, except that fees under part 2 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 
for all human drug applications received on or after October 1, 
2007, regardless of the date of the enactment of this Act. 
SEC. 108. SAVINGS CLAUSE. 
Notwithstanding section 509 of the Prescription Drug User 
Fee Amendments of 2002 (21 U.S.C. 379g note), and notwith-
standing the amendments made by this title, part 2 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic Act, 
as in effect on the day before the date of the enactment of this 
title, shall continue to be in effect with respect to human drug 
applications and supplements (as defined in such part as of such 
day) that on or after October 1, 2002, but before October 1, 2007, 
were accepted by the Food and Drug Administration for filing 
with respect to assessing and collecting any fee required by such 
part for a fiscal year prior to fiscal year 2008. 
SEC. 109. TECHNICAL AMENDMENT; CONFORMING AMENDMENT. 
(a) Section 739 (21 U.S.C. 379j–11) is amended in the matter 
preceding paragraph (1) by striking ‘‘subchapter’’ and inserting 
‘‘part’’. 
(b) Paragraph (11) of section 739 (21 U.S.C. 379j–11) is amended 
by striking ‘‘735(9)’’ and inserting ‘‘735(11)’’. 
TITLE II—MEDICAL DEVICE USER FEE 
AMENDMENTS OF 2007 
SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the ‘‘Medical 
Device User Fee Amendments of 2007’’. 
(b) REFERENCES
IN
TITLE.—Except as otherwise specified, 
amendments made by this title to a section or other provision 
of law are amendments to such section or other provision of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 
(c) FINDING.—The Congress finds that the fees authorized under 
the amendments made by this title will be dedicated toward expe-
diting the process for the review of device applications and for 
assuring the safety and effectiveness of devices, as set forth in 
the goals identified for purposes of part 3 of subchapter C of 
chapter VII of the Federal Food, Drug, and Cosmetic Act in the 
letters from the Secretary of Health and Human Services to the 
Chairman of the Committee on Health, Education, Labor, and Pen-
sions of the Senate and the Chairman of the Committee on Energy
H. R. 3580—21 
and Commerce of the House of Representatives, as set forth in 
the Congressional Record. 
Subtitle A—Fees Related to Medical 
Devices 
SEC. 211. DEFINITIONS. 
Section 737 is amended— 
(1) in the matter preceding paragraph (1), by striking ‘‘For 
purposes of this subchapter’’ and inserting ‘‘For purposes of 
this part’’; 
(2) by redesignating paragraphs (5), (6), (7), and (8) as 
paragraphs (8), (9), (10), and (12), respectively; 
(3) by inserting after paragraph (4) the following: 
‘‘(5) The term ‘30-day notice’ means a notice under section 
515(d)(6) that is limited to a request to make modifications 
to manufacturing procedures or methods of manufacture 
affecting the safety and effectiveness of the device. 
‘‘(6) The term ‘request for classification information’ means 
a request made under section 513(g) for information respecting 
the class in which a device has been classified or the require-
ments applicable to a device. 
‘‘(7) The term ‘annual fee’, for periodic reporting concerning 
a class III device, means the annual fee associated with periodic 
reports required by a premarket application approval order.’’; 
(4) in paragraph (10), as so redesignated— 
(A) by striking ‘‘April of the preceding fiscal year’’ 
and inserting ‘‘October of the preceding fiscal year’’; and 
(B) by striking ‘‘April 2002’’ and inserting ‘‘October 
2001’’; 
(5) by inserting after paragraph (10), as so amended, the 
following: 
‘‘(11) The term ‘person’ includes an affiliate thereof.’’; and 
(6) by inserting after paragraph (12), as so redesignated, 
the following: 
‘‘(13) The term ‘establishment subject to a registration fee’ 
means an establishment that is required to register with the 
Secretary under section 510 and is one of the following types 
of establishments: 
‘‘(A) MANUFACTURER.—An establishment that makes 
by any means any article that is a device, including an 
establishment that sterilizes or otherwise makes such 
article for or on behalf of a specification developer or any 
other person. 
‘‘(B) SINGLE-USE DEVICE REPROCESSOR.—An establish-
ment that, within the meaning of section 201(ll)(2)(A), per-
forms additional processing and manufacturing operations 
on a single-use device that has previously been used on 
a patient. 
‘‘(C) SPECIFICATION
DEVELOPER.—An establishment 
that develops specifications for a device that is distributed 
under the establishment’s name but which performs no 
manufacturing, including an establishment that, in addi-
tion to developing specifications, also arranges for the 
manufacturing of devices labeled with another establish-
ment’s name by a contract manufacturer.’’.
H. R. 3580—22 
SEC. 212. AUTHORITY TO ASSESS AND USE DEVICE FEES. 
(a) TYPES OF FEES.— 
(1) IN
GENERAL.—Section 738(a) (21 U.S.C. 379j(a)) is 
amended— 
(A) in paragraph (1), by striking ‘‘Beginning on the 
date of the enactment of the Medical Device User Fee 
and Modernization Act of 2002’’ and inserting ‘‘Beginning 
in fiscal year 2008’’; and 
(B) by amending the designation and heading of para-
graph (2) to read as follows: 
‘‘(2) PREMARKET APPLICATION, PREMARKET REPORT, SUPPLE-
MENT, AND SUBMISSION FEE, AND ANNUAL FEE FOR PERIODIC 
REPORTING CONCERNING A CLASS III DEVICE.—’’. 
(2) 
FEE
AMOUNTS.—Section 
738(a)(2)(A) 
(21 
U.S.C. 
379j(a)(2)(A)) is amended— 
(A) in clause (iii), by striking ‘‘a fee equal to the fee 
that applies’’ and inserting ‘‘a fee equal to 75 percent 
of the fee that applies’’; 
(B) in clause (iv), by striking ‘‘21.5 percent’’ and 
inserting ‘‘15 percent’’; 
(C) in clause (v), by striking ‘‘7.2 percent’’ and inserting 
‘‘7 percent’’; 
(D) by redesignating clauses (vi) and (vii) as clauses 
(vii) and (viii), respectively; 
(E) by inserting after clause (v) the following: 
‘‘(vi) For a 30-day notice, a fee equal to 1.6 percent 
of the fee that applies under clause (i).’’; 
(F) in clause (viii), as so redesignated— 
(i) by striking ‘‘1.42 percent’’ and inserting ‘‘1.84 
percent’’; and 
(ii) by striking ‘‘, subject to any adjustment under 
subsection (e)(2)(C)(ii)’’; and 
(G) by inserting after such clause (viii) the following: 
‘‘(ix) For a request for classification information, 
a fee equal to 1.35 percent of the fee that applies 
under clause (i). 
‘‘(x) For periodic reporting concerning a class III 
device, an annual fee equal to 3.5 percent of the fee 
that applies under clause (i).’’. 
(3) PAYMENT.—Section 738(a)(2)(C) (21 U.S.C. 379j(a)(2)(C)) 
is amended to read as follows: 
‘‘(C) PAYMENT.—The fee required by subparagraph (A) 
shall be due upon submission of the premarket application, 
premarket report, supplement, premarket notification 
submission, 
30-day 
notice, 
request 
for 
classification 
information, or periodic reporting concerning a class III 
device. Applicants submitting portions of applications 
pursuant to section 515(c)(4) shall pay such fees upon 
submission of the first portion of such applications.’’. 
(4) REFUNDS.—Section 738(a)(2)(D) (21 U.S.C. 379j(a)(2)(D)) 
is amended— 
(A) in clause (iii), by striking the last two sentences; 
and 
(B) by adding after clause (iii) the following: 
‘‘(iv) MODULAR APPLICATIONS WITHDRAWN BEFORE 
FIRST ACTION.—The Secretary shall refund 75 percent 
of the application fee paid for an application submitted
H. R. 3580—23 
under section 515(c)(4) that is withdrawn before a 
second portion is submitted and before a first action 
on the first portion. 
‘‘(v) LATER WITHDRAWN MODULAR APPLICATIONS.— 
If an application submitted under section 515(c)(4) is 
withdrawn after a second or subsequent portion is 
submitted but before any first action, the Secretary 
may return a portion of the fee. The amount of refund, 
if any, shall be based on the level of effort already 
expended on the review of the portions submitted. 
‘‘(vi) SOLE DISCRETION TO REFUND.—The Secretary 
shall have sole discretion to refund a fee or portion 
of the fee under clause (iii) or (v). A determination 
by the Secretary concerning a refund under clause 
(iii) or (v) shall not be reviewable.’’. 
(5) ANNUAL
ESTABLISHMENT
REGISTRATION
FEE.—Section 
738(a) (21 U.S.C. 379j(a)) is amended by adding after paragraph 
(2) the following: 
‘‘(3) ANNUAL ESTABLISHMENT REGISTRATION FEE.— 
‘‘(A) IN GENERAL.—Except as provided in subparagraph 
(B), each establishment subject to a registration fee shall 
be subject to a fee for each initial or annual registration 
under section 510 beginning with its registration for fiscal 
year 2008. 
‘‘(B) EXCEPTION.—No fee shall be required under 
subparagraph (A) for an establishment operated by a State 
or Federal governmental entity or an Indian tribe (as 
defined in the Indian Self Determination and Educational 
Assistance Act), unless a device manufactured by the 
establishment is to be distributed commercially. 
‘‘(C) PAYMENT.—The fee required under subparagraph 
(A) shall be due once each fiscal year, upon the initial 
registration of the establishment or upon the annual reg-
istration under section 510.’’. 
(b) FEE
AMOUNTS.—Section 738(b) (21 U.S.C. 379j(b)) is 
amended to read as follows: 
‘‘(b) FEE AMOUNTS.—Except as provided in subsections (c), (d), 
(e), and (h) the fees under subsection (a) shall be based on the 
following fee amounts: 
Fee Type 
Fiscal 
Year 
2008 
Fiscal 
Year 
2009 
Fiscal 
Year 
2010 
Fiscal 
Year 
2011 
Fiscal 
Year 
2012 
Premarket Application ....
$185,000 
$200,725 
$217,787 
$236,298 
$256,384
................
Establishment Registra-
tion ................................
$1,706 
$1,851 
$2,008 
$2,179 
$2,364.’’. 
(c) ANNUAL FEE SETTING.— 
(1) IN GENERAL.—Section 738(c) (21 U.S.C. 379j(c)(1)) is 
amended— 
(A) in the subsection heading, by striking ‘‘Annual 
Fee Setting’’ and inserting ‘‘ANNUAL FEE SETTING’’; and 
(B) in paragraph (1), by striking the last sentence.
H. R. 3580—24 
(2) ADJUSTMENT OF ANNUAL ESTABLISHMENT FEE.—Section 
738(c) (21 U.S.C. 379j(c)), as amended by paragraph (1), is 
further amended— 
(A) by redesignating paragraphs (2) and (3) as para-
graphs (3) and (4), respectively; 
(B) by inserting after paragraph (1) the following: 
‘‘(2) ADJUSTMENT.— 
‘‘(A) IN GENERAL.—When setting fees for fiscal year 
2010, the Secretary may increase the fee under subsection 
(a)(3)(A) (applicable to establishments subject to registra-
tion) only if the Secretary estimates that the number of 
establishments submitting fees for fiscal year 2009 is fewer 
than 12,250. The percentage increase shall be the percent-
age by which the estimate of establishments submitting 
fees in fiscal year 2009 is fewer than 12,750, but in no 
case may the percentage increase be more than 8.5 percent 
over that specified in subsection (b) for fiscal year 2010. 
If the Secretary makes any adjustment to the fee under 
subsection (a)(3)(A) for fiscal year 2010, then such fee for 
fiscal years 2011 and 2012 shall be adjusted so that such 
fee for fiscal year 2011 is equal to the adjusted fee for 
fiscal year 2010 increased by 8.5 percent, and such fee 
for fiscal year 2012 is equal to the adjusted fee for fiscal 
year 2011 increased by 8.5 percent. 
‘‘(B) PUBLICATION.—For any adjustment made under 
subparagraph (A), the Secretary shall publish in the Fed-
eral Register the Secretary’s determination to make the 
adjustment and the rationale for the determination.’’; and 
(C) in paragraph (4), as redesignated by this para-
graph, in subparagraph (A)— 
(i) by striking ‘‘For fiscal years 2006 and 2007, 
the Secretary’’ and inserting ‘‘The Secretary’’; and 
(ii) by striking ‘‘for the first month of fiscal year 
2008’’ and inserting ‘‘for the first month of the next 
fiscal year’’. 
(d) SMALL BUSINESSES; FEE WAIVER
AND FEE REDUCTION 
REGARDING PREMARKET APPROVAL.— 
(1) IN GENERAL.—Section 738(d)(1) (21 U.S.C. 379j(d)(1)) 
is amended— 
(A) by striking ‘‘, partners, and parent firms’’; and 
(B) by striking ‘‘clauses (i) through (vi) of subsection 
(a)(2)(A)’’ and inserting ‘‘clauses (i) through (v) and clauses 
(vii), (ix), and (x) of subsection (a)(2)(A)’’. 
(2) RULES RELATING TO PREMARKET APPROVAL FEES.— 
(A) 
DEFINITION.—Section 
738(d)(2)(A) 
(21 
U.S.C. 
379j(d)(2)(A)) is amended by striking ‘‘, partners, and 
parent firms’’. 
(B) EVIDENCE OF QUALIFICATION.—Section 738(d)(2)(B) 
(21 U.S.C. 379j(d)(2)(B)) is amended— 
(i) by striking ‘‘(B) EVIDENCE OF QUALIFICATION.— 
An applicant’’ and inserting the following: 
‘‘(B) EVIDENCE OF QUALIFICATION.— 
‘‘(i) IN GENERAL.—An applicant’’; 
(ii) by striking ‘‘The applicant shall support its 
claim’’ and inserting the following:
H. R. 3580—25 
‘‘(ii) FIRMS
SUBMITTING
TAX
RETURNS
TO
THE 
UNITED
STATES
INTERNAL
REVENUE
SERVICE.—The 
applicant shall support its claim’’; 
(iii) by striking ‘‘, partners, and parent firms’’ each 
place it appears; 
(iv) by striking the last sentence and inserting 
‘‘If no tax forms are submitted for any affiliate, the 
applicant shall certify that the applicant has no affili-
ates.’’; and 
(v) by adding at the end the following: 
‘‘(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE 
UNITED STATES INTERNAL REVENUE SERVICE.—In the 
case of an applicant that has not previously submitted 
a Federal income tax return, the applicant and each 
of its affiliates shall demonstrate that it meets the 
definition under subparagraph (A) by submission of 
a signed certification, in such form as the Secretary 
may direct through a notice published in the Federal 
Register, that the applicant or affiliate meets the cri-
teria for a small business and a certification, in 
English, from the national taxing authority of the 
country in which the applicant or, if applicable, affiliate 
is headquartered. The certification from such taxing 
authority shall bear the official seal of such taxing 
authority and shall provide the applicant’s or affiliate’s 
gross receipts or sales for the most recent year in 
both the local currency of such country and in United 
States dollars, the exchange rate used in converting 
such local currency to dollars, and the dates during 
which these receipts or sales were collected. The 
applicant shall also submit a statement signed by the 
head of the applicant’s firm or by its chief financial 
officer that the applicant has submitted certifications 
for all of its affiliates, or that the applicant has no 
affiliates.’’. 
(3) 
REDUCED
FEES.—Section 
738(d)(2)(C) 
(21 
U.S.C. 
379j(d)(2)(C)) is amended to read as follows: 
‘‘(C) REDUCED FEES.—Where the Secretary finds that 
the applicant involved meets the definition under subpara-
graph (A), the fees established under subsection (c)(1) may 
be paid at a reduced rate of— 
‘‘(i) 25 percent of the fee established under such 
subsection for a premarket application, a premarket 
report, a supplement, or periodic reporting concerning 
a class III device; and 
‘‘(ii) 50 percent of the fee established under such 
subsection for a 30-day notice or a request for classifica-
tion information.’’. 
(e) SMALL BUSINESSES; FEE REDUCTION REGARDING PREMARKET 
NOTIFICATION SUBMISSIONS.— 
(1) IN GENERAL.—Section 738(e)(1) (21 U.S.C. 379j(e)(1)) 
is amended— 
(A) by striking ‘‘2004’’ and inserting ‘‘2008’’; and 
(B) 
by 
striking 
‘‘(a)(2)(A)(vii)’’ 
and 
inserting 
‘‘(a)(2)(A)(viii)’’. 
(2) RULES RELATING TO PREMARKET NOTIFICATION SUBMIS-
SIONS.—
H. R. 3580—26 
(A) 
DEFINITION.—Section 
738(e)(2)(A) 
(21 
U.S.C. 
379j(e)(2)(A)) is amended by striking ‘‘, partners, and parent 
firms’’. 
(B) EVIDENCE OF QUALIFICATION.—Section 738(e)(2)(B) 
(21 U.S.C. 379j(e)(2)(B)) is amended— 
(i) by striking ‘‘(B) EVIDENCE OF QUALIFICATION.— 
An applicant’’ and inserting the following: 
‘‘(B) EVIDENCE OF QUALIFICATION.— 
‘‘(i) IN GENERAL.—An applicant’’; 
(ii) by striking ‘‘The applicant shall support its 
claim’’ and inserting the following: 
‘‘(ii) FIRMS
SUBMITTING
TAX
RETURNS
TO
THE 
UNITED
STATES
INTERNAL
REVENUE
SERVICE.—The 
applicant shall support its claim’’; 
(iii) by striking ‘‘, partners, and parent firms’’ each 
place it appears; 
(iv) by striking the last sentence and inserting 
‘‘If no tax forms are submitted for any affiliate, the 
applicant shall certify that the applicant has no affili-
ates.’’; and 
(v) by adding at the end the following: 
‘‘(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE 
UNITED STATES INTERNAL REVENUE SERVICE.—In the 
case of an applicant that has not previously submitted 
a Federal income tax return, the applicant and each 
of its affiliates shall demonstrate that it meets the 
definition under subparagraph (A) by submission of 
a signed certification, in such form as the Secretary 
may direct through a notice published in the Federal 
Register, that the applicant or affiliate meets the cri-
teria for a small business and a certification, in 
English, from the national taxing authority of the 
country in which the applicant or, if applicable, affiliate 
is headquartered. The certification from such taxing 
authority shall bear the official seal of such taxing 
authority and shall provide the applicant’s or affiliate’s 
gross receipts or sales for the most recent year in 
both the local currency of such country and in United 
States dollars, the exchange rate used in converting 
such local currency to dollars, and the dates during 
which these receipts or sales were collected. The 
applicant shall also submit a statement signed by the 
head of the applicant’s firm or by its chief financial 
officer that the applicant has submitted certifications 
for all of its affiliates, or that the applicant has no 
affiliates.’’. 
(3) 
REDUCED
FEES.—Section 
738(e)(2)(C) 
(21 
U.S.C. 
379j(e)(2)(C)) is amended to read as follows: 
‘‘(C) REDUCED FEES.—For fiscal year 2008 and each 
subsequent fiscal year, where the Secretary finds that the 
applicant involved meets the definition under subparagraph 
(A), the fee for a premarket notification submission may 
be paid at 50 percent of the fee that applies under sub-
section (a)(2)(A)(viii), and as established under subsection 
(c)(1).’’. 
(f) EFFECT OF FAILURE TO PAY FEES.—Section 738(f) (21 U.S.C. 
379j(f)) is amended to read as follows:
H. R. 3580—27 
‘‘(f) EFFECT OF FAILURE TO PAY FEES.— 
‘‘(1) NO
ACCEPTANCE
OF
SUBMISSIONS.—A premarket 
application, premarket report, supplement, premarket notifica-
tion submission, 30-day notice, request for classification 
information, or periodic reporting concerning a class III device 
submitted by a person subject to fees under subsections (a)(2) 
and (a)(3) shall be considered incomplete and shall not be 
accepted by the Secretary until all fees owed by such person 
have been paid. 
‘‘(2) NO REGISTRATION.—Registration information submitted 
under section 510 by an establishment subject to a registration 
fee shall be considered incomplete and shall not be accepted 
by the Secretary until the registration fee under subsection 
(a)(3) owed for the establishment has been paid. Until the 
fee is paid and the registration is complete, the establishment 
is deemed to have failed to register in accordance with section 
510.’’. 
(g) 
CONDITIONS.—Section 
738(g) 
(21 
U.S.C. 
379j(g)) 
is 
amended— 
(1) by striking paragraph (1) and inserting the following: 
‘‘(1) PERFORMANCE
GOALS; TERMINATION
OF
PROGRAM.— 
With respect to the amount that, under the salaries and 
expenses account of the Food and Drug Administration, is 
appropriated for a fiscal year for devices and radiological prod-
ucts, fees may not be assessed under subsection (a) for the 
fiscal year, and the Secretary is not expected to meet any 
performance goals identified for the fiscal year, if— 
‘‘(A) the amount so appropriated for the fiscal year, 
excluding the amount of fees appropriated for the fiscal 
year, is more than 1 percent less than $205,720,000 multi-
plied by the adjustment factor applicable to such fiscal 
year; or 
‘‘(B) fees were not assessed under subsection (a) for 
the previous fiscal year.’’; and 
(2) by amending paragraph (2) to read as follows: 
‘‘(2) AUTHORITY.—If the Secretary does not assess fees 
under subsection (a) during any portion of a fiscal year because 
of paragraph (1) and if at a later date in such fiscal year 
the Secretary may assess such fees, the Secretary may assess 
and collect such fees, without any modification in the rate 
for premarket applications, supplements, premarket reports, 
premarket notification submissions, 30-day notices, requests 
for classification information, periodic reporting concerning a 
class III device, and establishment registrations at any time 
in such fiscal year, notwithstanding the provisions of subsection 
(a) relating to the date fees are to be paid.’’. 
(h) CREDITING AND AVAILABILITY OF FEES.— 
(1) AUTHORIZATION OF APPROPRIATIONS.—Section 738(h)(3) 
(21 U.S.C. 379j(h)(3)) is amended to read as follows: 
‘‘(3) AUTHORIZATIONS
OF
APPROPRIATIONS.—There are 
authorized to be appropriated for fees under this section— 
‘‘(A) $48,431,000 for fiscal year 2008; 
‘‘(B) $52,547,000 for fiscal year 2009; 
‘‘(C) $57,014,000 for fiscal year 2010; 
‘‘(D) $61,860,000 for fiscal year 2011; and 
‘‘(E) $67,118,000 for fiscal year 2012.’’.
H. R. 3580—28 
(2) OFFSET.—Section 738(h)(4) (21 U.S.C. 379j(h)(3)) is 
amended to read as follows: 
‘‘(4) OFFSET.—If the cumulative amount of fees collected 
during fiscal years 2008, 2009, and 2010, added to the amount 
estimated to be collected for fiscal year 2011, which estimate 
shall be based upon the amount of fees received by the Sec-
retary through June 30, 2011, exceeds the amount of fees 
specified in aggregate in paragraph (3) for these four fiscal 
years, the aggregate amount in excess shall be credited to 
the appropriation account of the Food and Drug Administration 
as provided in paragraph (1), and shall be subtracted from 
the amount of fees that would otherwise be authorized to be 
collected under this section pursuant to appropriation Acts 
for fiscal year 2012.’’. 
SEC. 213. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Part 3 of subchapter C of chapter VII is amended by inserting 
after section 738 the following: 
‘‘SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS. 
‘‘(a) REPORTS.— 
‘‘(1) PERFORMANCE REPORT.—For fiscal years 2008 through 
2012, not later than 120 days after the end of each fiscal 
year during which fees are collected under this part, the Sec-
retary shall prepare and submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Representa-
tives, a report concerning the progress of the Food and Drug 
Administration in achieving the goals identified in the letters 
described in section 201(c) of the Food and Drug Administration 
Amendments Act of 2007 during such fiscal year and the future 
plans of the Food and Drug Administration for meeting the 
goals. The report for a fiscal year shall include information 
on all previous cohorts for which the Secretary has not given 
a complete response on all device premarket applications and 
reports, supplements, and premarket notifications in the cohort. 
‘‘(2) FISCAL REPORT.—For fiscal years 2008 through 2012, 
not later than 120 days after the end of each fiscal year during 
which fees are collected under this part, the Secretary shall 
prepare and submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives, a report 
on the implementation of the authority for such fees during 
such fiscal year and the use, by the Food and Drug Administra-
tion, of the fees collected during such fiscal year for which 
the report is made. 
‘‘(3) PUBLIC AVAILABILITY.—The Secretary shall make the 
reports required under paragraphs (1) and (2) available to 
the public on the Internet Web site of the Food and Drug 
Administration. 
‘‘(b) REAUTHORIZATION.— 
‘‘(1) CONSULTATION.—In developing recommendations to 
present to Congress with respect to the goals, and plans for 
meeting the goals, for the process for the review of device 
applications for the first 5 fiscal years after fiscal year 2012, 
and for the reauthorization of this part for such fiscal years, 
the Secretary shall consult with—
H. R. 3580—29 
‘‘(A) the Committee on Energy and Commerce of the 
House of Representatives; 
‘‘(B) the Committee on Health, Education, Labor, and 
Pensions of the Senate; 
‘‘(C) scientific and academic experts; 
‘‘(D) health care professionals; 
‘‘(E) representatives of patient and consumer advocacy 
groups; and 
‘‘(F) the regulated industry. 
‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations 
with the regulated industry on the reauthorization of this part, 
the Secretary shall— 
‘‘(A) publish a notice in the Federal Register requesting 
public input on the reauthorization; 
‘‘(B) hold a public meeting at which the public may 
present its views on the reauthorization, including specific 
suggestions for changes to the goals referred to in sub-
section (a)(1); 
‘‘(C) provide a period of 30 days after the public meeting 
to obtain written comments from the public suggesting 
changes to this part; and 
‘‘(D) publish the comments on the Food and Drug 
Administration’s Internet Web site. 
‘‘(3) PERIODIC
CONSULTATION.—Not less frequently than 
once every month during negotiations with the regulated 
industry, the Secretary shall hold discussions with representa-
tives of patient and consumer advocacy groups to continue 
discussions of their views on the reauthorization and their 
suggestions for changes to this part as expressed under para-
graph (2). 
‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotia-
tions with the regulated industry, the Secretary shall— 
‘‘(A) present the recommendations developed under 
paragraph (1) to the Congressional committees specified 
in such paragraph; 
‘‘(B) publish such recommendations in the Federal Reg-
ister; 
‘‘(C) provide for a period of 30 days for the public 
to provide written comments on such recommendations; 
‘‘(D) hold a meeting at which the public may present 
its views on such recommendations; and 
‘‘(E) after consideration of such public views and com-
ments, revise such recommendations as necessary. 
‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 
January 15, 2012, the Secretary shall transmit to Congress 
the revised recommendations under paragraph (4), a summary 
of the views and comments received under such paragraph, 
and any changes made to the recommendations in response 
to such views and comments. 
‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 
‘‘(A) PUBLIC AVAILABILITY.—Before presenting the rec-
ommendations developed under paragraphs (1) through (5) 
to the Congress, the Secretary shall make publicly avail-
able, on the public Web site of the Food and Drug Adminis-
tration, minutes of all negotiation meetings conducted 
under this subsection between the Food and Drug Adminis-
tration and the regulated industry.
H. R. 3580—30 
‘‘(B) CONTENT.—The minutes described under subpara-
graph (A) shall summarize any substantive proposal made 
by any party to the negotiations as well as significant 
controversies or differences of opinion during the negotia-
tions and their resolution.’’. 
SEC. 214. SAVINGS CLAUSE. 
Notwithstanding section 107 of the Medical Device User Fee 
and Modernization Act of 2002 (Public Law 107–250), and notwith-
standing the amendments made by this subtitle, part 3 of sub-
chapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379i et seq.), as in effect on the day before the 
date of the enactment of this subtitle, shall continue to be in 
effect with respect to premarket applications, premarket reports, 
premarket notification submissions, and supplements (as defined 
in such part as of such day) that on or after October 1, 2002, 
but before October 1, 2007, were accepted by the Food and Drug 
Administration for filing with respect to assessing and collecting 
any fee required by such part for a fiscal year prior to fiscal 
year 2008. 
SEC. 215. ADDITIONAL AUTHORIZATION OF APPROPRIATIONS FOR 
POSTMARKET SAFETY INFORMATION. 
For the purpose of collecting, developing, reviewing, and evalu-
ating postmarket safety information on medical devices, there are 
authorized to be appropriated to the Food and Drug Administration, 
in addition to the amounts authorized by other provisions of law 
for such purpose— 
(1) $7,100,000 for fiscal year 2008; 
(2) $7,455,000 for fiscal year 2009; 
(3) $7,827,750 for fiscal year 2010; 
(4) $8,219,138 for fiscal year 2011; and 
(5) $8,630,094 for fiscal year 2012. 
SEC. 216. EFFECTIVE DATE. 
The amendments made by this subtitle shall take effect on 
October 1, 2007, or the date of the enactment of this Act, whichever 
is later, except that fees under part 3 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 
for all premarket applications, premarket reports, supplements, 
30-day notices, and premarket notification submissions received 
on or after October 1, 2007, regardless of the date of the enactment 
of this Act. 
SEC. 217. SUNSET CLAUSE. 
The amendments made by this subtitle cease to be effective 
October 1, 2012, except that section 738A of the Federal Food, 
Drug, and Cosmetic Act (regarding annual performance and finan-
cial reports) ceases to be effective January 31, 2013. 
Subtitle B—Amendments Regarding 
Regulation of Medical Devices 
SEC. 221. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF 
PREMARKET NOTIFICATION. 
Section 523(c) (21 U.S.C. 360m(c)) is amended by striking 
‘‘2007’’ and inserting ‘‘2012’’.
H. R. 3580—31 
SEC. 222. REGISTRATION. 
(a) ANNUAL REGISTRATION
OF PRODUCERS
OF DRUGS
AND 
DEVICES.—Section 510(b) (21 U.S.C. 360(b)) is amended— 
(1) by striking ‘‘(b) On or before’’ and inserting ‘‘(b)(1) 
On or before’’; 
(2) by striking ‘‘or a device or devices’’; and 
(3) by adding at the end the following: 
‘‘(2) During the period beginning on October 1 and ending 
on December 31 of each year, every person who owns or operates 
any establishment in any State engaged in the manufacture, 
preparation, propagation, compounding, or processing of a device 
or devices shall register with the Secretary his name, places of 
business, and all such establishments.’’. 
(b) REGISTRATION
OF
FOREIGN
ESTABLISHMENTS.—Section 
510(i)(1) (21 U.S.C. 360(i)(1)) is amended by striking ‘‘On or before 
December 31’’ and all that follows and inserting the following: 
‘‘Any establishment within any foreign country engaged in the 
manufacture, preparation, propagation, compounding, or processing 
of a drug or device that is imported or offered for import into 
the United States shall, through electronic means in accordance 
with the criteria of the Secretary— 
‘‘(A) upon first engaging in any such activity, immediately 
register with the Secretary the name and place of business 
of the establishment, the name of the United States agent 
for the establishment, the name of each importer of such drug 
or device in the United States that is known to the establish-
ment, and the name of each person who imports or offers 
for import such drug or device to the United States for purposes 
of importation; and 
‘‘(B) each establishment subject to the requirements of 
subparagraph (A) shall thereafter— 
‘‘(i) with respect to drugs, register with the Secretary 
on or before December 31 of each year; and 
‘‘(ii) with respect to devices, register with the Secretary 
during the period beginning on October 1 and ending on 
December 31 of each year.’’. 
SEC. 223. FILING OF LISTS OF DRUGS AND DEVICES MANUFACTURED, 
PREPARED, PROPAGATED, AND COMPOUNDED BY REG-
ISTRANTS; STATEMENTS; ACCOMPANYING DISCLOSURES. 
Section 510(j)(2) (21 U.S.C. 360(j)(2)) is amended, in the matter 
preceding subparagraph (A), by striking ‘‘Each person’’ and all 
that follows through ‘‘the following information:’’ and inserting 
‘‘Each person who registers with the Secretary under this section 
shall report to the Secretary, with regard to drugs once during 
the month of June of each year and once during the month of 
December of each year, and with regard to devices once each year 
during the period beginning on October 1 and ending on December 
31, the following information:’’. 
SEC. 224. ELECTRONIC REGISTRATION AND LISTING. 
Section 510(p) (21 U.S.C. 360(p)) is amended to read as follows: 
‘‘(p) Registrations and listings under this section (including 
the submission of updated information) shall be submitted to the 
Secretary by electronic means unless the Secretary grants a request 
for waiver of such requirement because use of electronic means 
is not reasonable for the person requesting such waiver.’’.
H. R. 3580—32 
SEC. 225. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE. 
(a) IN GENERAL.—The Comptroller General of the United States 
shall conduct a study on the appropriate use of the process under 
section 510(k) of the Federal Food, Drug, and Cosmetic Act as 
part of the device classification process to determine whether a 
new device is as safe and effective as a classified device. 
(b) CONSIDERATION.—In determining the effectiveness of the 
premarket notification and classification authority under section 
510(k) and subsections (f) and (i) of section 513 of the Federal 
Food, Drug, and Cosmetic Act, the study under subsection (a) shall 
consider the Secretary of Health and Human Services’s evaluation 
of the respective intended uses and technologies of such devices, 
including the effectiveness of such Secretary’s comparative assess-
ment of technological characteristics such as device materials, prin-
ciples of operations, and power sources. 
(c) REPORT.—Not later than 1 year after the date of the enact-
ment of this Act, the Comptroller General shall complete the study 
under subsection (a) and submit to the Congress a report on the 
results of such study. 
SEC. 226. UNIQUE DEVICE IDENTIFICATION SYSTEM. 
(a) IN GENERAL.—Section 519 (21 U.S.C. 360i) is amended— 
(1) by redesignating subsection (f) as subsection (g); and 
(2) by inserting after subsection (e) the following: 
‘‘Unique Device Identification System 
‘‘(f) The Secretary shall promulgate regulations establishing 
a unique device identification system for medical devices requiring 
the label of devices to bear a unique identifier, unless the Secretary 
requires an alternative placement or provides an exception for 
a particular device or type of device. The unique identifier shall 
adequately identify the device through distribution and use, and 
may include information on the lot or serial number.’’. 
(b) CONFORMING AMENDMENT.—Section 303 (21 U.S.C. 333) 
is amended— 
(1) by redesignating the subsection that follows subsection 
(e) as subsection (f); and 
(2) in paragraph (1)(B)(ii) of subsection (f), as so redesig-
nated, by striking ‘‘519(f)’’ and inserting ‘‘519(g)’’. 
SEC. 227. FREQUENCY OF REPORTING FOR CERTAIN DEVICES. 
Subparagraph (B) of section 519(a)(1) (21 U.S.C. 360i(a)(1)) 
is amended by striking ‘‘were to recur;’’ and inserting the following: 
‘‘were to recur, which report under this subparagraph— 
‘‘(i) shall be submitted in accordance with part 
803 of title 21, Code of Federal Regulations (or suc-
cessor regulations), unless the Secretary grants an 
exemption or variance from, or an alternative to, a 
requirement under such regulations pursuant to sec-
tion 803.19 of such part, if the device involved is— 
‘‘(I) a class III device; 
‘‘(II) a class II device that is permanently 
implantable, is life supporting, or is life sustaining; 
or 
‘‘(III) a type of device which the Secretary 
has, by notice published in the Federal Register 
or letter to the person who is the manufacturer
H. R. 3580—33 
or importer of the device, indicated should be sub-
ject to such part 803 in order to protect the public 
health; 
‘‘(ii) shall, if the device is not subject to clause 
(i), be submitted in accordance with criteria established 
by the Secretary for reports made pursuant to this 
clause, which criteria shall require the reports to be 
in summary form and made on a quarterly basis; or 
‘‘(iii) shall, if the device is imported into the United 
States and for which part 803 of title 21, Code of 
Federal Regulations (or successor regulations) requires 
an importer to submit a report to the manufacturer, 
be submitted by the importer to the manufacturer in 
accordance with part 803 of title 21, Code of Federal 
Regulations (or successor regulations)’’. 
SEC. 228. INSPECTIONS BY ACCREDITED PERSONS. 
Section 704(g) (21 U.S.C. 374(g)) is amended— 
(1) in paragraph (1), by striking ‘‘Not later than one year 
after the date of the enactment of this subsection, the Secretary’’ 
and inserting ‘‘The Secretary’’; 
(2) in paragraph (2), by— 
(A) striking ‘‘Not later than 180 days after the date 
of enactment of this subsection, the Secretary’’ and 
inserting ‘‘The Secretary’’; and 
(B) striking the fifth sentence; 
(3) in paragraph (3), by adding at the end the following: 
‘‘(F) Such person shall notify the Secretary of any with-
drawal, suspension, restriction, or expiration of certificate of 
conformance with the quality systems standard referred to 
in paragraph (7) for any device establishment that such person 
inspects under this subsection not later than 30 days after 
such withdrawal, suspension, restriction, or expiration. 
‘‘(G) Such person may conduct audits to establish conform-
ance with the quality systems standard referred to in paragraph 
(7).’’; 
(4) by amending paragraph (6) to read as follows: 
‘‘(6)(A) Subject to subparagraphs (B) and (C), a device establish-
ment is eligible for inspection by persons accredited under para-
graph (2) if the following conditions are met: 
‘‘(i) The Secretary classified the results of the most recent 
inspection of the establishment as ‘no action indicated’ or ‘vol-
untary action indicated’. 
‘‘(ii) With respect to inspections of the establishment to 
be conducted by an accredited person, the owner or operator 
of the establishment submits to the Secretary a notice that— 
‘‘(I) provides the date of the last inspection of the 
establishment by the Secretary and the classification of 
that inspection; 
‘‘(II) states the intention of the owner or operator to 
use an accredited person to conduct inspections of the 
establishment; 
‘‘(III) identifies the particular accredited person the 
owner or operator intends to select to conduct such inspec-
tions; and
H. R. 3580—34 
‘‘(IV) includes a certification that, with respect to the 
devices that are manufactured, prepared, propagated, com-
pounded, or processed in the establishment— 
‘‘(aa) at least 1 of such devices is marketed in 
the United States; and 
‘‘(bb) at least 1 of such devices is marketed, or 
is intended to be marketed, in 1 or more foreign coun-
tries, 1 of which countries certifies, accredits, or other-
wise recognizes the person accredited under paragraph 
(2) and identified under subclause (III) as a person 
authorized to conduct inspections of device establish-
ments. 
‘‘(B)(i) Except with respect to the requirement of subparagraph 
(A)(i), a device establishment is deemed to have clearance to partici-
pate in the program and to use the accredited person identified 
in the notice under subparagraph (A)(ii) for inspections of the 
establishment unless the Secretary, not later than 30 days after 
receiving such notice, issues a response that— 
‘‘(I) denies clearance to participate as provided under 
subparagraph (C); or 
‘‘(II) makes a request under clause (ii). 
‘‘(ii) The Secretary may request from the owner or operator 
of a device establishment in response to the notice under subpara-
graph (A)(ii) with respect to the establishment, or from the par-
ticular accredited person identified in such notice— 
‘‘(I) compliance data for the establishment in accordance 
with clause (iii)(I); or 
‘‘(II) information concerning the relationship between the 
owner or operator of the establishment and the accredited 
person identified in such notice in accordance with clause 
(iii)(II). 
The owner or operator of the establishment, or such accredited 
person, as the case may be, shall respond to such a request not 
later than 60 days after receiving such request. 
‘‘(iii)(I) The compliance data to be submitted by the owner 
or operator of a device establishment in response to a request 
under clause (ii)(I) are data describing whether the quality controls 
of the establishment have been sufficient for ensuring consistent 
compliance with current good manufacturing practice within the 
meaning of section 501(h) and with other applicable provisions 
of this Act. Such data shall include complete reports of inspectional 
findings regarding good manufacturing practice or other quality 
control audits that, during the preceding 2-year period, were con-
ducted at the establishment by persons other than the owner or 
operator of the establishment, together with all other compliance 
data the Secretary deems necessary. Data under the preceding 
sentence shall demonstrate to the Secretary whether the establish-
ment has facilitated consistent compliance by promptly correcting 
any compliance problems identified in such inspections. 
‘‘(II) A request to an accredited person under clause (ii)(II) 
may not seek any information that is not required to be maintained 
by such person in records under subsection (f)(1). 
‘‘(iv) A device establishment is deemed to have clearance to 
participate in the program and to use the accredited person identi-
fied in the notice under subparagraph (A)(ii) for inspections of 
the establishment unless the Secretary, not later than 60 days 
after receiving the information requested under clause (ii), issues
H. R. 3580—35 
a response that denies clearance to participate as provided under 
subparagraph (C). 
‘‘(C)(i) The Secretary may deny clearance to a device establish-
ment if the Secretary has evidence that the certification under 
subparagraph (A)(ii)(IV) is untrue and the Secretary provides to 
the owner or operator of the establishment a statement summa-
rizing such evidence. 
‘‘(ii) The Secretary may deny clearance to a device establish-
ment if the Secretary determines that the establishment has failed 
to demonstrate consistent compliance for purposes of subparagraph 
(B)(iii)(I) and the Secretary provides to the owner or operator of 
the establishment a statement of the reasons for such determina-
tion. 
‘‘(iii)(I) The Secretary may reject the selection of the accredited 
person identified in the notice under subparagraph (A)(ii) if the 
Secretary provides to the owner or operator of the establishment 
a statement of the reasons for such rejection. Reasons for the 
rejection may include that the establishment or the accredited 
person, as the case may be, has failed to fully respond to the 
request, or that the Secretary has concerns regarding the relation-
ship between the establishment and such accredited person. 
‘‘(II) If the Secretary rejects the selection of an accredited 
person by the owner or operator of a device establishment, the 
owner or operator may make an additional selection of an accredited 
person by submitting to the Secretary a notice that identifies the 
additional selection. Clauses (i) and (ii) of subparagraph (B), and 
subclause (I) of this clause, apply to the selection of an accredited 
person through a notice under the preceding sentence in the same 
manner and to the same extent as such provisions apply to a 
selection of an accredited person through a notice under subpara-
graph (A)(ii). 
‘‘(iv) In the case of a device establishment that is denied clear-
ance under clause (i) or (ii) or with respect to which the selection 
of the accredited person is rejected under clause (iii), the Secretary 
shall designate a person to review the statement of reasons, or 
statement summarizing such evidence, as the case may be, of the 
Secretary under such clause if, during the 30-day period beginning 
on the date on which the owner or operator of the establishment 
receives such statement, the owner or operator requests the review. 
The review shall commence not later than 30 days after the owner 
or operator requests the review, unless the Secretary and the owner 
or operator otherwise agree.’’; 
(5) in paragraph (7)— 
(A) in subparagraph (A), by striking ‘‘(A) Persons’’ and 
all that follows through the end and inserting the following: 
‘‘(A) Persons accredited under paragraph (2) to conduct 
inspections shall record in writing their inspection observa-
tions and shall present the observations to the device 
establishment’s designated representative and describe 
each observation. Additionally, such accredited person shall 
prepare an inspection report in a form and manner des-
ignated by the Secretary to conduct inspections, taking 
into consideration the goals of international harmonization 
of quality systems standards. Any official classification of 
the inspection shall be determined by the Secretary.’’; and 
(B) by adding at the end the following:
H. R. 3580—36 
‘‘(F) For the purpose of setting risk-based inspectional priorities, 
the Secretary shall accept voluntary submissions of reports of audits 
assessing conformance with appropriate quality systems standards 
set by the International Organization for Standardization (ISO) 
and identified by the Secretary in public notice. If the owner or 
operator of an establishment elects to submit audit reports under 
this subparagraph, the owner or operator shall submit all such 
audit reports with respect to the establishment during the preceding 
2-year periods.’’; and 
(6) in paragraph (10)(C)(iii), by striking ‘‘based’’ and 
inserting ‘‘base’’. 
SEC. 229. STUDY OF NOSOCOMIAL INFECTIONS RELATING TO MEDICAL 
DEVICES. 
(a) IN GENERAL.—The Comptroller General of the United States 
shall conduct a study on— 
(1) the number of nosocomial infections attributable to 
new and reused medical devices; and 
(2) the causes of such nosocomial infections, including the 
following: 
(A) Reprocessed single-use devices. 
(B) Handling of sterilized medical devices. 
(C) In-hospital sterilization of medical devices. 
(D) Health care professionals’ practices for patient 
examination and treatment. 
(E) Hospital-based policies and procedures for infection 
control and prevention. 
(F) Hospital-based practices for handling of medical 
waste. 
(G) Other causes. 
(b) REPORT.—Not later than 1 year after the date of the enact-
ment of this Act, the Comptroller General shall complete the study 
under subsection (a) and submit to the Congress a report on the 
results of such study. 
(c) DEFINITION.—In this section, the term ‘‘nosocomial infection’’ 
means an infection that is acquired while an individual is a patient 
at a hospital and was neither present nor incubating in the patient 
prior to receiving services in the hospital. 
SEC. 230. REPORT BY THE FOOD AND DRUG ADMINISTRATION 
REGARDING LABELING INFORMATION ON THE RELATION-
SHIP BETWEEN THE USE OF INDOOR TANNING DEVICES 
AND DEVELOPMENT OF SKIN CANCER OR OTHER SKIN 
DAMAGE. 
(a) IN GENERAL.—The Secretary of Health and Human Services 
(referred to in this section as the ‘‘Secretary’’), acting through the 
Commissioner of Food and Drugs, shall determine— 
(1) whether the labeling requirements for indoor tanning 
devices, including the positioning requirements, provide suffi-
cient information to consumers regarding the risks that the 
use of such devices pose for the development of irreversible 
damage to the eyes and skin, including skin cancer; and 
(2)(A) whether modifying the warning label required on 
tanning beds to read, ‘‘Ultraviolet radiation can cause skin 
cancer’’, or any other additional warning, would communicate 
the risks of indoor tanning more effectively; or 
(B) whether there is no warning that would be capable 
of adequately communicating such risks.
H. R. 3580—37 
(b) CONSUMER TESTING.—In making the determinations under 
subsection (a), the Secretary shall conduct appropriate consumer 
testing to determine consumer understanding of label warnings. 
(c) REPORT.—Not later than 1 year after the date of the enact-
ment of this Act, the Secretary shall submit to the Congress a 
report that provides the determinations under subsection (a). In 
addition, the Secretary shall include in the report the measures 
being implemented by the Secretary to significantly reduce the 
risks associated with indoor tanning devices. 
TITLE III—PEDIATRIC MEDICAL DEVICE 
SAFETY AND IMPROVEMENT ACT OF 
2007 
SEC. 301. SHORT TITLE. 
This title may be cited as the ‘‘Pediatric Medical Device Safety 
and Improvement Act of 2007’’. 
SEC. 302. TRACKING PEDIATRIC DEVICE APPROVALS. 
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 351 et seq.) is amended by inserting after section 515 the 
following: 
‘‘SEC. 515A. PEDIATRIC USES OF DEVICES. 
‘‘(a) NEW DEVICES.— 
‘‘(1) IN GENERAL.—A person that submits to the Secretary 
an application under section 520(m), or an application (or 
supplement to an application) or a product development protocol 
under section 515, shall include in the application or protocol 
the information described in paragraph (2). 
‘‘(2) REQUIRED INFORMATION.—The application or protocol 
described in paragraph (1) shall include, with respect to the 
device for which approval is sought and if readily available— 
‘‘(A) a description of any pediatric subpopulations that 
suffer from the disease or condition that the device is 
intended to treat, diagnose, or cure; and 
‘‘(B) the number of affected pediatric patients. 
‘‘(3) ANNUAL REPORT.—Not later than 18 months after the 
date of the enactment of this section, and annually thereafter, 
the Secretary shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives 
a report that includes— 
‘‘(A) the number of devices approved in the year pre-
ceding the year in which the report is submitted, for which 
there is a pediatric subpopulation that suffers from the 
disease or condition that the device is intended to treat, 
diagnose, or cure; 
‘‘(B) the number of devices approved in the year pre-
ceding the year in which the report is submitted, labeled 
for use in pediatric patients; 
‘‘(C) the number of pediatric devices approved in the 
year preceding the year in which the report is submitted, 
exempted from a fee pursuant to section 738(a)(2)(B)(v); 
and
H. R. 3580—38 
‘‘(D) the review time for each device described in sub-
paragraphs (A), (B), and (C). 
‘‘(b) DETERMINATION OF PEDIATRIC EFFECTIVENESS BASED ON 
SIMILAR COURSE OF DISEASE OR CONDITION OR SIMILAR EFFECT 
OF DEVICE ON ADULTS.— 
‘‘(1) IN GENERAL.—If the course of the disease or condition 
and the effects of the device are sufficiently similar in adults 
and pediatric patients, the Secretary may conclude that adult 
data may be used to support a determination of a reasonable 
assurance of effectiveness in pediatric populations, as appro-
priate. 
‘‘(2) EXTRAPOLATION BETWEEN SUBPOPULATIONS.—A study 
may not be needed in each pediatric subpopulation if data 
from one subpopulation can be extrapolated to another sub-
population. 
‘‘(c) PEDIATRIC SUBPOPULATION.—For purposes of this section, 
the term ‘pediatric subpopulation’ has the meaning given the term 
in section 520(m)(6)(E)(ii).’’. 
SEC. 303. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION. 
(a) IN GENERAL.—Section 520(m) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360j(m)) is amended— 
(1) in paragraph (3), by striking ‘‘No’’ and inserting ‘‘Except 
as provided in paragraph (6), no’’; 
(2) in paragraph (5)— 
(A) by inserting ‘‘, if the Secretary has reason to believe 
that the requirements of paragraph (6) are no longer met,’’ 
after ‘‘public health’’; and 
(B) by adding at the end the following: ‘‘If the person 
granted an exemption under paragraph (2) fails to dem-
onstrate continued compliance with the requirements of 
this subsection, the Secretary may suspend or withdraw 
the exemption from the effectiveness requirements of sec-
tions 514 and 515 for a humanitarian device only after 
providing notice and an opportunity for an informal 
hearing.’’; and 
(3) by striking paragraph (6) and inserting after paragraph 
(5) the following new paragraphs: 
‘‘(6)(A) Except as provided in subparagraph (D), the prohibition 
in paragraph (3) shall not apply with respect to a person granted 
an exemption under paragraph (2) if each of the following conditions 
apply: 
‘‘(i)(I) The device with respect to which the exemption is 
granted is intended for the treatment or diagnosis of a disease 
or condition that occurs in pediatric patients or in a pediatric 
subpopulation, and such device is labeled for use in pediatric 
patients or in a pediatric subpopulation in which the disease 
or condition occurs. 
‘‘(II) The device was not previously approved under this 
subsection for the pediatric patients or the pediatric subpopula-
tion described in subclause (I) prior to the date of the enactment 
of the Pediatric Medical Device Safety and Improvement Act 
of 2007. 
‘‘(ii) During any calendar year, the number of such devices 
distributed during that year does not exceed the annual dis-
tribution number specified by the Secretary when the Secretary 
grants such exemption. The annual distribution number shall
H. R. 3580—39 
be based on the number of individuals affected by the disease 
or condition that such device is intended to treat, diagnose, 
or cure, and of that number, the number of individuals likely 
to use the device, and the number of devices reasonably nec-
essary to treat such individuals. In no case shall the annual 
distribution number exceed the number identified in paragraph 
(2)(A). 
‘‘(iii) Such person immediately notifies the Secretary if 
the number of such devices distributed during any calendar 
year exceeds the annual distribution number referred to in 
clause (ii). 
‘‘(iv) The request for such exemption is submitted on or 
before October 1, 2012. 
‘‘(B) The Secretary may inspect the records relating to the 
number of devices distributed during any calendar year of a person 
granted an exemption under paragraph (2) for which the prohibition 
in paragraph (3) does not apply. 
‘‘(C) A person may petition the Secretary to modify the annual 
distribution number specified by the Secretary under subparagraph 
(A)(ii) with respect to a device if additional information on the 
number of individuals affected by the disease or condition arises, 
and the Secretary may modify such number but in no case shall 
the annual distribution number exceed the number identified in 
paragraph (2)(A). 
‘‘(D) If a person notifies the Secretary, or the Secretary deter-
mines through an inspection under subparagraph (B), that the 
number of devices distributed during any calendar year exceeds 
the annual distribution number, as required under subparagraph 
(A)(iii), and modified under subparagraph (C), if applicable, then 
the prohibition in paragraph (3) shall apply with respect to such 
person for such device for any sales of such device after such 
notification. 
‘‘(E)(i) In this subsection, the term ‘pediatric patients’ means 
patients who are 21 years of age or younger at the time of the 
diagnosis or treatment. 
‘‘(ii) In this subsection, the term ‘pediatric subpopulation’ means 
1 of the following populations: 
‘‘(I) Neonates. 
‘‘(II) Infants. 
‘‘(III) Children. 
‘‘(IV) Adolescents. 
‘‘(7) The Secretary shall refer any report of an adverse event 
regarding a device for which the prohibition under paragraph (3) 
does not apply pursuant to paragraph (6)(A) that the Secretary 
receives to the Office of Pediatric Therapeutics, established under 
section 6 of the Best Pharmaceuticals for Children Act (Public 
Law 107–109). In considering the report, the Director of the Office 
of Pediatric Therapeutics, in consultation with experts in the Center 
for Devices and Radiological Health, shall provide for periodic 
review of the report by the Pediatric Advisory Committee, including 
obtaining any recommendations of such committee regarding 
whether the Secretary should take action under this Act in response 
to the report. 
‘‘(8) The Secretary, acting through the Office of Pediatric Thera-
peutics and the Center for Devices and Radiological Health, shall 
provide for an annual review by the Pediatric Advisory Committee
H. R. 3580—40 
of all devices described in paragraph (6) to ensure that the exemp-
tion under paragraph (2) remains appropriate for the pediatric 
populations for which it is granted.’’. 
(b) REPORT.—Not later than January 1, 2012, the Comptroller 
General of the United States shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of Representa-
tives a report on the impact of allowing persons granted an exemp-
tion under section 520(m)(2) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j(m)(2)) with respect to a device to profit 
from such device pursuant to section 520(m)(6) of such Act (21 
U.S.C. 360j(m)(6)) (as amended by subsection (a)), including— 
(1) an assessment of whether such section 520(m)(6) (as 
amended by subsection (a)) has increased the availability of 
pediatric devices for conditions that occur in small numbers 
of children, including any increase or decrease in the number 
of— 
(A) exemptions granted under such section 520(m)(2) 
for pediatric devices; and 
(B) applications approved under section 515 of such 
Act (21 U.S.C. 360e) for devices intended to treat, diagnose, 
or cure conditions that occur in pediatric patients or for 
devices labeled for use in a pediatric population; 
(2) the conditions or diseases the pediatric devices were 
intended to treat or diagnose and the estimated size of the 
pediatric patient population for each condition or disease; 
(3) the costs of purchasing pediatric devices, based on a 
representative sampling of children’s hospitals; 
(4) the extent to which the costs of such devices are covered 
by health insurance; 
(5) the impact, if any, of allowing profit on access to such 
devices for patients; 
(6) the profits made by manufacturers for each device that 
receives an exemption; 
(7) an estimate of the extent of the use of the pediatric 
devices by both adults and pediatric populations for a condition 
or disease other than the condition or disease on the label 
of such devices; 
(8) recommendations of the Comptroller General of the 
United States regarding the effectiveness of such section 
520(m)(6) (as amended by subsection (a)) and whether any 
modifications to such section 520(m)(6) (as amended by sub-
section (a)) should be made; 
(9) existing obstacles to pediatric device development; and 
(10) an evaluation of the demonstration grants described 
in section 305, which shall include an evaluation of the number 
of pediatric medical devices— 
(A) that have been or are being studied in children; 
and 
(B) that have been submitted to the Food and Drug 
Administration for approval, clearance, or review under 
such section 520(m) (as amended by this Act) and any 
regulatory actions taken. 
(c) GUIDANCE.—Not later than 180 days after the date of the 
enactment of this Act, the Commissioner of Food and Drugs shall 
issue guidance for institutional review committees on how to 
evaluate requests for approval for devices for which a humanitarian
H. R. 3580—41 
device exemption under section 520(m)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted. 
SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH. 
(a) CONTACT POINT FOR AVAILABLE FUNDING.—Section 402(b) 
of the Public Health Service Act (42 U.S.C. 282(b)) is amended— 
(1) in paragraph (21), by striking ‘‘and’’ after the semicolon 
at the end; 
(2) in paragraph (22), by striking the period at the end 
and inserting ‘‘; and’’; and 
(3) by inserting after paragraph (22) the following: 
‘‘(23) shall designate a contact point or office to help 
innovators and physicians identify sources of funding available 
for pediatric medical device development.’’. 
(b) PLAN FOR PEDIATRIC MEDICAL DEVICE RESEARCH.— 
(1) IN GENERAL.—Not later than 180 days after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services, acting through the Commissioner of Food 
and Drugs, the Director of the National Institutes of Health, 
and the Director of the Agency for Healthcare Research and 
Quality, shall submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives a plan 
for expanding pediatric medical device research and develop-
ment. In developing such plan, the Secretary of Health and 
Human Services shall consult with individuals and organiza-
tions with appropriate expertise in pediatric medical devices. 
(2) CONTENTS.—The plan under paragraph (1) shall 
include— 
(A) the current status of federally funded pediatric 
medical device research; 
(B) any gaps in such research, which may include 
a survey of pediatric medical providers regarding unmet 
pediatric medical device needs, as needed; and 
(C) a research agenda for improving pediatric medical 
device development and Food and Drug Administration 
clearance or approval of pediatric medical devices, and 
for evaluating the short- and long-term safety and effective-
ness of pediatric medical devices. 
SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC 
DEVICE AVAILABILITY. 
(a) IN GENERAL.— 
(1) REQUEST FOR PROPOSALS.—Not later than 90 days after 
the date of the enactment of this Act, the Secretary of Health 
and Human Services shall issue a request for proposals for 
1 or more grants or contracts to nonprofit consortia for dem-
onstration projects to promote pediatric device development. 
(2) DETERMINATION ON GRANTS OR CONTRACTS.—Not later 
than 180 days after the date the Secretary of Health and 
Human Services issues a request for proposals under paragraph 
(1), the Secretary shall make a determination on the grants 
or contracts under this section. 
(b) APPLICATION.—A nonprofit consortium that desires to 
receive a grant or contract under this section shall submit an 
application to the Secretary of Health and Human Services at 
such time, in such manner, and containing such information as 
the Secretary may require.
H. R. 3580—56 
505(b)(1) for pediatric studies (which shall include a timeframe 
for completing such studies), the holder agrees to the request, 
such studies are completed using appropriate formulations for 
each age group for which the study is requested within any 
such timeframe, and the reports thereof are submitted and 
accepted in accordance with subsection (d)(3)— 
‘‘(A)(i)(I) the period referred to in subsection (c)(3)(E)(ii) 
of section 505, and in subsection (j)(5)(F)(ii) of such section, 
is deemed to be five years and six months rather than 
five years, and the references in subsections (c)(3)(E)(ii) 
and (j)(5)(F)(ii) of such section to four years, to forty-eight 
months, and to seven and one-half years are deemed to 
be four and one-half years, fifty-four months, and eight 
years, respectively; or 
‘‘(II) the period referred to in clauses (iii) and (iv) 
of subsection (c)(3)(D) of such section, and in clauses (iii) 
and (iv) of subsection (j)(5)(F) of such section, is deemed 
to be three years and six months rather than three years; 
and 
‘‘(ii) if the drug is designated under section 526 for 
a rare disease or condition, the period referred to in section 
527(a) is deemed to be seven years and six months rather 
than seven years; and 
‘‘(B)(i) if the drug is the subject of— 
‘‘(I) a listed patent for which a certification has 
been submitted under subsection (b)(2)(A)(ii) or 
(j)(2)(A)(vii)(II) of section 505 and for which pediatric 
studies were submitted prior to the expiration of the 
patent (including any patent extensions); or 
‘‘(II) a listed patent for which a certification has 
been submitted under subsection (b)(2)(A)(iii) or 
(j)(2)(A)(vii)(III) of section 505, 
the period during which an application may not be 
approved under section 505(c)(3) or section 505(j)(5)(B)(ii) 
shall be extended by a period of six months after the 
date the patent expires (including any patent extensions); 
or 
‘‘(ii) if the drug is the subject of a listed patent for 
which a certification has been submitted under subsection 
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the 
patent infringement litigation resulting from the certifi-
cation the court determines that the patent is valid and 
would be infringed, the period during which an application 
may not be approved under section 505(c)(3) or section 
505(j)(5)(B) shall be extended by a period of six months 
after the date the patent expires (including any patent 
extensions). 
‘‘(2) EXCEPTION.—The Secretary shall not extend the period 
referred to in paragraph (1)(A) or (1)(B) if the determination 
made under subsection (d)(3) is made later than 9 months 
prior to the expiration of such period. 
‘‘(d) CONDUCT OF PEDIATRIC STUDIES.— 
‘‘(1) REQUEST FOR STUDIES.— 
‘‘(A) IN GENERAL.—The Secretary may, after consulta-
tion with the sponsor of an application for an investiga-
tional new drug under section 505(i), the sponsor of an 
application for a new drug under section 505(b)(1), or the