[United States Statutes at Large, Volume 121, 110th Congress, 1st Session]
[From the U.S. Government Publishing Office, www.gpo.gov]

121 STAT. 823

Public Law 110-85
110th Congress

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. [NOTE: Sept. 27, 2007 -  [H.R. 3580]

Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, [NOTE: Food and Drug
Administration Amendments Act of 2007.]
SECTION 1. [NOTE: 21 USC 301 note.] 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 advertising.
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 information.
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.


[[Page 824]]
121 STAT. 824


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
information 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 evaluation and mitigation strategies.
Sec. 902. Enforcement.
Sec. 903. No effect on withdrawal or suspension of approval.
Sec. 904. Benefit-risk assessments.
Sec. 905. Active postmarket risk identification and analysis.
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.

[[Page 825]]
121 STAT. 825

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 [NOTE: Prescription Drug User Fee Amendments of
2007.] DRUG USER FEE AMENDMENTS OF 2007
SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING.

(a) Short [NOTE: 21 USC 301 note.] 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 [NOTE: 21 USC 379g note.] Congress finds that
the fees authorized by the amendments made in this title will be
dedicated toward expediting 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 Representatives, 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
subparagraph (B); and

[[Page 826]]
121 STAT. 826

(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 technology 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
activities).'';
(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
paragraphs:
``(9) The term `person' includes an affiliate thereof.
``(10) The term `active', with respect to a commercial
investigational 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'';

[[Page 827]]
121 STAT. 827

(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 subsection (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 tomography
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 establishment 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 specified 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
subparagraph, 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

[[Page 828]]
121 STAT. 828

``(B) an amount equal to the modified workload
adjustment factor for fiscal year 2007 (as determined
under paragraph (3)).
``(2) Types of fees.--Of the total revenue amount determined
for a fiscal year under paragraph (1)--
``(A) one-third shall be derived from fees under
subsection (a)(1) (relating to human drug applications
and supplements);
``(B) one-third shall be derived from fees under
subsection (a)(2) (relating to prescription drug
establishments); and
``(C) one-third shall be derived from fees under
subsection (a)(3) (relating to prescription drug
products).
``(3) Modified workload adjustment 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 [NOTE: Applicability.] each
of the fiscal years 2008 through 2012, paragraph (1)(A)
shall be applied by substituting the amount determined
under subparagraph (B) for `$392,783,000'.
``(B) Amount determined.--For each of the fiscal
years 2008 through 2012, the amount determined under
this subparagraph is the sum of--
``(i) $392,783,000; plus
``(ii)(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
Administration, of all personnel compensation and
benefits paid with respect to such positions for the
first 5 years of the preceding 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''.

[[Page 829]]
121 STAT. 829

(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 commercial 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 [NOTE: Contracts. Study.] 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. [NOTE: Effective date.] After review of
the recommendations, 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 paragraph 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:

[[Page 830]]
121 STAT. 830

``(4) Final year adjustment.--
``(A) Increase in fees.--For fiscal year 2012, the
Secretary may, in addition to adjustments under this
paragraph and paragraphs (1), (2), and (3), further
increase the fee revenues and fees established in
subsection (b) if such an adjustment is necessary to
provide for not more than 3 months of operating reserves
of carryover user fees for the process for the review of
human drug applications for the first 3 months of fiscal
year 2013. If such an adjustment is necessary, the
rationale for the amount of the increase shall be
contained in the annual notice establishing fee revenues
and fees for fiscal year 2012. If the Secretary has
carryover balances for such process in excess of 3
months of such operating reserves, the adjustment under
this subparagraph shall not be made.
``(B) Decrease in fees.--
``(i) In general.--For fiscal year 2012, the
Secretary may, in addition to adjustments under
this paragraph and paragraphs (1), (2), and (3),
decrease the fee revenues and fees established in
subsection (b) by the amount determined in clause
(ii), if, for fiscal year 2009 or 2010--
``(I) the amount of the total
appropriations for the Food and Drug
Administration for such fiscal year
(excluding the amount of fees
appropriated for such fiscal year)
exceeds the amount of the total
appropriations for the Food and Drug
Administration for fiscal year 2008
(excluding the amount of fees
appropriated for such fiscal year),
adjusted as provided under paragraph
(1); and
``(II) the amount of the total
appropriations expended for the process
for the review of human drug
applications at the Food and Drug
Administration for such fiscal year
(excluding the amount of fees
appropriated for such fiscal year)
exceeds the amount of appropriations
expended for the process for the review
of human drug applications at the Food
and Drug Administration for fiscal year
2008 (excluding the amount of fees
appropriated for such fiscal year),
adjusted as provided under paragraph
(1).
``(ii) Amount of decrease.--The amount
determined in this clause is the lesser of--
``(I) the amount equal to the sum of
the amounts that, for each of fiscal
years 2009 and 2010, is the lesser of--
``(aa) the excess amount
described in clause (i)(II) for
such fiscal year; or
``(bb) the amount specified
in subsection (b)(4)(B)(ii) for
such fiscal year; or
``(II) $65,000,000.
``(iii) Limitations.--
``(I) Fiscal year condition.--In
making the determination under clause
(ii), an amount described in subclause
(I) of such clause for fiscal year 2009
or 2010 shall be taken into account

[[Page 831]]
121 STAT. 831

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 paragraph 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 following:
``, and that does not have a drug product that has been approved
under a human drug application and introduced or delivered for
introduction into interstate commerce''.

(e) Crediting and Availability of Fees.--
(1) Authorization of appropriations.--Section 736(g)(3) (21
U.S.C. 379h(g)(3)) is amended to read as follows:
``(3) Authorization of appropriations.--For each of the
fiscal years 2008 through 2012, there is authorized to be
appropriated for fees under this section an amount equal to the
total revenue amount determined under subsection (b) for the
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.--

[[Page 832]]
121 STAT. 832

``(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
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.''.
(2) Effective [NOTE: 21 USC 379h note.] 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. [NOTE: 21 USC 379h-1.] FEES RELATING TO ADVISORY
REVIEW OF PRESCRIPTION-DRUG TELEVISION
ADVERTISING.

``(a) Types of Direct-to-Consumer Television Advertisement Review
Fees.--Beginning [NOTE: Effective date.] 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 subparagraph (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
Secretary prior to initial public dissemination is not
subject to a fee under subparagraph (A) unless the
sponsor designates the submission as a submission for
advisory review.
``(C) Notice to secretary of number of
advertisements.--Not later
than [NOTE: Deadlines. Federal
Register, publication.] June 1 of each fiscal

[[Page 833]]
121 STAT. 833

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) [NOTE: Deadlines.] Payment.--
``(i) In general.--The fee required by
subparagraph (A) (referred to in this section as
`an advisory review fee') shall be due not later
than October 1 of the fiscal year in which the DTC
advertisement 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 submitted 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 preceding 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
submissions.--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 advertisement
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 [NOTE: Applicability.] 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

[[Page 834]]
121 STAT. 834

and an increase in the amount of fees applies in
accordance with this clause, notwithstanding any
other provision of this
section. [NOTE: Deadline.] 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
submissions.--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 [NOTE: Deadline.] 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 subsection (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 advertisement. The advertisement shall
be submitted for review in the fiscal year for
which the fee was assessed, except that a person
may carry over not more than one paid advisory
review submission to the next fiscal year.
Resubmissions may be submitted without regard to
the fiscal year of the initial advisory review
submission.
``(ii) No refunds.--Except as provided by
subsections (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
transferable.--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 [NOTE: Deadlines.] as
provided in subparagraph (C), the operating reserve fee
shall be due no later than--

[[Page 835]]
121 STAT. 835

``(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 established
under paragraph (1)(E)(ii). Fees required by this
subparagraph shall be in addition to any fees required
by subparagraph (A). [NOTE: Deadline.] 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 [NOTE: Deadlines.] 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
provision 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 [NOTE: Effective date. Notice. Federal
Register, publication.] 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 established;
``(B) the total percentage change for the previous
fiscal year in basic pay under the General Schedule in
accordance

[[Page 836]]
121 STAT. 836

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
Administration, of all personnel compensation and
benefits paid with respect to such positions for the
first 5 fiscal years of the previous 6 fiscal years.
The adjustment made each fiscal year by this subsection shall be
added on a compounded basis to the sum of all adjustments made
each fiscal year after fiscal year 2008 under this subsection.
``(2) Workload [NOTE: Effective date.] 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 paragraph (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
Secretary 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 multiplying 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)). [NOTE: Federal
Register, publication.] The Secretary shall publish in
the Federal Register the fee revenues and fees resulting
from the adjustment and the supporting methodologies.
``(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 [NOTE: Deadlines.] 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 previously-
paid carry over submissions. The annual advisory review
fee shall be established by dividing the fee revenue for
a fiscal year (as adjusted pursuant to this subsection)
by the number of DTC 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
subsection, the fee established under subparagraph (A)
for

[[Page 837]]
121 STAT. 837

fiscal year 2008 may not be more than $83,000 per
submission 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
operating 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
operating 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 [NOTE: Deadline.] 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
assessment. 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 subsection (a) shall be
considered incomplete and shall not be accepted for review by the
Secretary until all fees owed by such person under this section have
been paid.
``(f) Effect of Inadequate Funding of Program.--
``(1) Initial [NOTE: Effective date.] 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,

[[Page 838]]
121 STAT. 838

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 [NOTE: Effective date. Notification.] 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
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such fiscal
year limitation. The sums transferred shall be available solely
for the process for the advisory review of prescription drug
advertising.
``(2) Collections and appropriation acts.--
``(A) In general.--The fees authorized by this
section--
``(i) shall be retained in each fiscal year in
an amount not to exceed the amount specified in
appropriation Acts, or otherwise made available
for obligation for such fiscal year; and
``(ii) shall be available for obligation only
if the amounts appropriated as budget authority
for such fiscal year are sufficient to support a
number of full-time equivalent review employees
that is not fewer than the number of such
employees supported in fiscal year 2007.
``(B) Review employees.--For purposes of
subparagraph (A)(ii), the term `full-time equivalent
review employees' means the total combined number of
full-time equivalent employees in--
``(i) the Center for Drug Evaluation and
Research, Division of Drug Marketing, Advertising,
and Communications, Food and Drug Administration;
and
``(ii) the Center for Biologics 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
appropriated for fees under this section an amount equal to the
total revenue amount determined under subsection (b) for the

[[Page 839]]
121 STAT. 839

fiscal year, as adjusted pursuant to subsection (c) and
paragraph (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
Administration 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 subsequent fiscal year.

``(h) Definitions.--For purposes of this section:
``(1) The term `advisory review' means reviewing and
providing 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
successor in interest.
``(8) The term `process for the advisory review of
prescription drug advertising' means the activities necessary to
review and provide advisory comments on DTC advertisements prior
to public 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
Administration, 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 fixtures, furniture, scientific equipment, and other
necessary materials and supplies;

[[Page 840]]
121 STAT. 840

``(D) collection of fees under this section and
accounting for resources allocated for the advisory
review of prescription drug advertising; and
``(E) terminating the program under this section
pursuant to subsection (f)(2) if that becomes necessary.
``(10) The term `resubmission' means a subsequent submission
for advisory review of a direct-to-consumer television
advertisement that has been revised in response to the
Secretary'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
advertisement for which the sponsor voluntarily requests
advisory comments 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. [NOTE: 21 USC 379h-2.] 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 information on all previous cohorts for which the Secretary has
not given a complete response on all human drug applications and
supplements 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 Representatives 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 [NOTE: Website.] 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 Administration.

``(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;

[[Page 841]]
121 STAT. 841

``(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) [NOTE: Federal
Register, publication.] 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 subsection (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) [NOTE: Website.] 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 representatives 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 paragraph (2).
``(4) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under
paragraph (1) to the Congressional committees specified
in such paragraph;
``(B) [NOTE: Federal
Register, publication.] publish such recommendations in
the Federal Register;
``(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
comments, revise such recommendations as necessary.
``(5) Transmittal of [NOTE: Deadline.] 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 [NOTE: Website.] availability.--
Before presenting the recommendations developed under
paragraphs (1) through (5) to the Congress, the
Secretary shall make publicly available, on the public
Web site of the Food and Drug Administration, minutes of
all negotiation meetings conducted under this subsection
between the Food and Drug Administration and the
regulated industry.
``(B) Content.--The minutes described under
subparagraph (A) shall summarize any substantive
proposal made

[[Page 842]]
121 STAT. 842

by any party to the negotiations as well as significant
controversies or differences of opinion during the
negotiations and their resolution.''.
SEC. 106. SUNSET DATES.

(a) Authorization.--The [NOTE: 21 USC 379g note.] amendments made
by sections 102, 103, and 104 cease to be effective October 1, 2012.

(b) Reporting [NOTE: 21 USC 379h-2.] Requirements.--The amendment
made by section 105 ceases to be effective January 31, 2013.
SEC. 107. [NOTE: 21 USC 379g note.] 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. [NOTE: 21 USC 379g note.] SAVINGS CLAUSE.

Notwithstanding section 509 of the Prescription Drug User Fee
Amendments of 2002 (21 U.S.C. 379g note), and notwithstanding the
amendments made by this title, part 2 of subchapter C of chapter VII of
the Federal Food, Drug, and Cosmetic Act, as in effect on the day before
the date of the enactment of this title, shall 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 [NOTE: Medical Device User Fee Amendments of
2007.] DEVICE USER FEE AMENDMENTS OF 2007
SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING.

(a) Short [NOTE: 21 USC 301 note.] 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 [NOTE: 21 USC 379i note.] Congress finds that
the fees authorized under the amendments made by this title will be
dedicated toward expediting the process for the review of device
applications and for assuring the safety and 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 Pensions of
the Senate and the Chairman of the Committee on Energy

[[Page 843]]
121 STAT. 843

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 [NOTE: 21 USC 379i.] 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 requirements 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
establishment that, within the meaning of section
201(ll)(2)(A), performs 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 addition to developing specifications, also
arranges for the manufacturing of devices labeled with
another establishment's name by a contract
manufacturer.''.

[[Page 844]]
121 STAT. 844

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
paragraph (2) to read as follows:
``(2) Premarket application, premarket report, supplement,
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

[[Page 845]]
121 STAT. 845

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
registration under section 510.''.

(b) Fee Amounts.--Section 738(b) (21 U.S.C. 379j(b)) is amended to
read as follows:
``(b) Fee Amounts.--Except as provided in subsections (c), (d), (e),
and (h) the fees under subsection (a) shall be based on the following
fee amounts:



----------------------------------------------------------------------------------------------------------------
Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
Fee Type                          Year 2008  Year 2009  Year 2010  Year 2011  Year 2012
----------------------------------------------------------------------------------------------------------------
Premarket Application....................................   $185,000   $200,725   $217,787   $236,298   $256,384
Establishment Registration...............................     $1,706     $1,851     $2,008     $2,179  $2,364.''
 
----------------------------------------------------------------------------------------------------------------


(c) Annual Fee Setting.--
(1) In general.--Section 738(c) (21 U.S.C. 379j(c)(1)) is
amended--
(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.

[[Page 846]]
121 STAT. 846

(2) Adjustment of annual establishment fee.--Section 738(c)
(21 U.S.C. 379j(c)), as amended by paragraph (1), is further
amended--
(A) by redesignating paragraphs (2) and (3) as
paragraphs (3) and (4), respectively;
(B) by inserting after paragraph (1) the following:
``(2) Adjustment.--
``(A) In general.--When setting fees for fiscal year
2010, the Secretary may increase the fee under
subsection (a)(3)(A) (applicable to establishments
subject to registration) 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 percentage by which the estimate
of establishments submitting fees in fiscal year 2009 is
fewer than 12,750, but in no case may the percentage
increase be more than 8.5 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 [NOTE: Federal
Register, publication.] any adjustment made under
subparagraph (A), the Secretary shall publish in the
Federal Register the Secretary's determination to make
the adjustment and the rationale for the
determination.''; and
(C) in paragraph (4), as redesignated by this
paragraph, in subparagraph (A)--
(i) by striking ``For fiscal years 2006 and
2007, the Secretary'' and inserting ``The
Secretary''; and
(ii) by striking ``for the first month of
fiscal year 2008'' and inserting ``for the first
month of the next fiscal year''.

(d) Small Businesses; Fee Waiver and Fee 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:

[[Page 847]]
121 STAT. 847

``(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 affiliates.''; and
(v) by adding at the end the following:
``(iii) Firms not submitting tax returns to
the united [NOTE: Certification. Federal
Register, publication.] 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 criteria 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
subparagraph (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 classification 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 submissions.--

[[Page 848]]
121 STAT. 848

(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 affiliates.''; and
(v) by adding at the end the following:
``(iii) Firms not submitting tax returns to
the united [NOTE: Certification. Federal
Register, publication.] 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 criteria 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 subsection (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:

[[Page 849]]
121 STAT. 849

``(f) Effect of Failure To Pay Fees.--
``(1) No acceptance of submissions.--A premarket
application, premarket report, supplement, premarket
notification 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 products, 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 multiplied 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.''.

[[Page 850]]
121 STAT. 850

(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 Secretary
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. [NOTE: 21 USC 379j-1.] 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 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
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 Administration, of the
fees collected during such fiscal year for which the report is
made.
``(3) Public [NOTE: Website.] 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--

[[Page 851]]
121 STAT. 851

``(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) [NOTE: Federal
Register, publication.] 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 subsection (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) [NOTE: Website.] 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 representatives 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 paragraph (2).
``(4) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under
paragraph (1) to the Congressional committees specified
in such paragraph;
``(B) [NOTE: Federal
Register, publication.] publish such recommendations in
the Federal Register;
``(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
comments, revise such recommendations as necessary.
``(5) Transmittal [NOTE: Deadline.] 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 [NOTE: Website.] availability.--
Before presenting the recommendations developed under
paragraphs (1) through (5) to the Congress, the
Secretary shall make publicly available, on the public
Web site of the Food and Drug Administration, minutes of
all negotiation meetings conducted under this subsection
between the Food and Drug Administration and the
regulated industry.

[[Page 852]]
121 STAT. 852

``(B) Content.--The minutes described under
subparagraph (A) shall summarize any substantive
proposal made by any party to the negotiations as well
as significant controversies or differences of opinion
during the negotiations and their resolution.''.
SEC. 214. [NOTE: 21 USC 379i note.] SAVINGS CLAUSE.

Notwithstanding section 107 of the Medical Device User Fee and
Modernization Act of 2002 (Public Law 107-250), and notwithstanding the
amendments made by this subtitle, part 3 of subchapter 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 evaluating
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. [NOTE: 21 USC 379i note.] 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. [NOTE: 21 USC 379i note.] 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 financial 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''.

[[Page 853]]
121 STAT. 853

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 establishment, 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. [NOTE: Reports. Deadlines.] FILING OF LISTS OF DRUGS
AND DEVICES MANUFACTURED, PREPARED,
PROPAGATED, AND COMPOUNDED BY REGISTRANTS;
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.''.

[[Page 854]]
121 STAT. 854

SEC. 225. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE.

(a) In General.--The [NOTE: Study.] 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 assessment of
technological characteristics such as device materials, principles of
operations, and power sources.
(c) Report.--Not later than 1 year after the date of the enactment
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 [NOTE: Regulations.] 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
redesignated, 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 successor regulations), unless the Secretary
grants an exemption or variance from, or an
alternative to, a requirement under such
regulations pursuant to section 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) [NOTE: Federal
Register, publication.] a type of
device which the Secretary has, by
notice published in the Federal Register
or letter to the person who is the
manufacturer

[[Page 855]]
121 STAT. 855

or importer of the device, indicated
should be subject 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) [NOTE: Notification. Deadline.] Such person shall
notify the Secretary of any withdrawal, 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
conformance 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
establishment is eligible for inspection by persons accredited under
paragraph (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 `voluntary 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
inspections; and

[[Page 856]]
121 STAT. 856

``(IV) includes a certification that, with respect
to the devices that are manufactured, prepared,
propagated, compounded, 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 countries, 1 of which countries certifies,
accredits, or otherwise recognizes the person
accredited under paragraph (2) and identified
under subclause (III) as a person authorized to
conduct inspections of device establishments.

``(B)(i) [NOTE: Deadline.] Except with respect to the requirement
of subparagraph (A)(i), a device establishment is deemed to have
clearance to participate 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 subparagraph
(A)(ii) with respect to the establishment, or from the particular
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 [NOTE: Deadline.] 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 conducted 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
establishment 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) [NOTE: Deadline.] A device establishment is deemed to have
clearance to participate 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 60 days after
receiving the information requested under clause (ii), issues

[[Page 857]]
121 STAT. 857

a response that denies clearance to participate as provided under
subparagraph (C).

``(C)(i) The Secretary may deny clearance to a device establishment
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 summarizing such evidence.
``(ii) The Secretary may deny clearance to a device establishment 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 determination.
``(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 relationship between the
establishment and such accredited person.
``(II) [NOTE: Notification.] 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. [NOTE: Applicability.] 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 subparagraph (A)(ii).

``(iv) In the case of a device establishment that is denied
clearance 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 [NOTE: Deadline.] 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) [NOTE: Records.] Persons accredited
under paragraph (2) to conduct inspections shall record
in writing their inspection observations and shall
present the observations to the device establishment's
designated representative and describe each observation.
Additionally, [NOTE: Reports.] such accredited person
shall prepare an inspection report in a form and manner
designated 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:

[[Page 858]]
121 STAT. 858

``(F) [NOTE: Audits.] 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 enactment
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 RELATIONSHIP
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
sufficient 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.

[[Page 859]]
121 STAT. 859

(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 enactment
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 [NOTE: Pediatric Medical Device Safety and
Improvement Act of 2007.] MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF
2007
SEC. 301. [NOTE: 21 USC 301 note.] 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. [NOTE: 21 USC 360e-1.] 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,
Education, 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
preceding 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
preceding 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

[[Page 860]]
121 STAT. 860

``(D) the review time for each device described in
subparagraphs (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
appropriate.
``(2) Extrapolation between subpopulations.--A study may not
be needed in each pediatric subpopulation if data from one
subpopulation can be extrapolated to another subpopulation.

``(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
demonstrate continued compliance with the requirements
of this subsection, the Secretary may suspend or
withdraw the exemption from the effectiveness
requirements of sections 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
subpopulation 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
distribution number specified by the Secretary when the
Secretary grants such exemption. The annual distribution number
shall

[[Page 861]]
121 STAT. 861

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 necessary
to treat such individuals. In no case shall the annual
distribution number exceed the number identified in paragraph
(2)(A).
``(iii) [NOTE: Notification.] 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) [NOTE: Deadline.] 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) [NOTE: Applicability.] If a person notifies the Secretary,
or the Secretary determines 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) [NOTE: Annual review.] The Secretary, acting through the
Office of Pediatric Therapeutics and the Center for Devices and
Radiological Health, shall provide for an annual review by the Pediatric
Advisory Committee

[[Page 862]]
121 STAT. 862

of all devices described in paragraph (6) to ensure that the exemption
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 Representatives a report on the impact of
allowing persons granted an exemption under section 520(m)(2) of the
Federal Food, Drug, and Cosmetic 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 subsection (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 [NOTE: Deadline. 21 USC 360j note.] 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

[[Page 863]]
121 STAT. 863

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 [NOTE: Deadline.] 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 development. In
developing such plan, the Secretary of Health and Human Services
shall consult with individuals and organizations 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 effectiveness of pediatric medical
devices.
SEC. 305. [NOTE: 42 USC 282 note.] DEMONSTRATION GRANTS FOR
IMPROVING PEDIATRIC DEVICE AVAILABILITY.

(a) In [NOTE: Deadline.] 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 demonstration
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.

[[Page 864]]
121 STAT. 864

(c) Use of Funds.--A nonprofit consortium that receives a grant or
contract under this section shall facilitate the development,
production, and distribution of pediatric medical devices by--
(1) encouraging innovation and connecting qualified
individuals with pediatric device ideas with potential
manufacturers;
(2) mentoring and managing pediatric device projects through
the development process, including product identification,
prototype design, device development, and marketing;
(3) connecting innovators and physicians to existing Federal
and non-Federal resources, including resources from the Food and
Drug Administration, the National Institutes of Health, the
Small Business Administration, the Department of Energy, the
Department of Education, the National Science Foundation, the
Department of Veterans Affairs, the Agency for Healthcare
Research and Quality, and the National Institute of Standards
and Technology;
(4) assessing the scientific and medical merit of proposed
pediatric device projects; and
(5) providing assistance and advice as needed on business
development, personnel training, prototype development,
postmarket needs, and other activities consistent with the
purposes of this section.

(d) Coordination.--
(1) National institutes of health.--Each consortium that
receives a grant or contract under this section shall--
(A) coordinate with the National Institutes of
Health's pediatric device contact point or office,
designated under section 402(b)(23) of the Public Health
Service Act, as added by section 304(a) of this Act; and
(B) provide to the National Institutes of Health any
identified pediatric device needs that the consortium
lacks sufficient capacity to address or those needs in
which the consortium has been unable to stimulate
manufacturer interest.
(2) Food and drug administration.--Each consortium that
receives a grant or contract under this section shall coordinate
with the Commissioner of Food and Drugs and device companies to
facilitate the application for approval or clearance of devices
labeled for pediatric use.
(3) Effectiveness [NOTE: Reports.] and outcomes.--Each
consortium that receives a grant or contract under this section
shall annually report to the Secretary of Health and Human
Services on the status of pediatric device development,
production, and distribution that has been facilitated by the
consortium.

(e) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $6,000,000 for each of fiscal
years 2008 through 2012.
SEC. 306. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND
PEDIATRIC ADVISORY COMMITTEE.

(a) Office of Pediatric Therapeutics.--Section 6(b) of the Best
Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is amended by
inserting ``, including increasing pediatric access to medical devices''
after ``pediatric issues''.

[[Page 865]]
121 STAT. 865

(b) Pediatric Advisory Committee.--Section 14 of the Best
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended--
(1) in subsection (a), by inserting ``(including drugs and
biological products) and medical devices'' after
``therapeutics''; and
(2) in subsection (b)--
(A) in paragraph (1), by inserting ``(including
drugs and biological products) and medical devices''
after ``therapeutics''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``and
505B'' and inserting ``505B, 510(k), 515, and
520(m)'';
(ii) by striking subparagraph (B) and
inserting the following:
``(B) identification of research priorities related
to therapeutics (including drugs and biological
products) and medical devices for pediatric populations
and the need for additional diagnostics and treatments
for specific pediatric diseases or conditions;''; and
(iii) in subparagraph (C), by inserting
``(including drugs and biological products) and
medical devices'' after ``therapeutics''.
SEC. 307. POSTMARKET SURVEILLANCE.

Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360l) is amended--
(1) by amending the section heading and designation to read
as follows:
``SEC. 522. POSTMARKET SURVEILLANCE.'';
(2) by striking subsection (a) and inserting the following:

``(a) Postmarket Surveillance.--
``(1) In general.--
``(A) Conduct.--The Secretary may by order require a
manufacturer to conduct postmarket surveillance for any
device of the manufacturer that is a class II or class
III device--
``(i) the failure of which would be reasonably
likely to have serious adverse health
consequences;
``(ii) that is expected to have significant
use in pediatric populations; or
``(iii) that is intended to be--
``(I) implanted in the human body
for more than 1 year; or
``(II) a life-sustaining or life-
supporting device used outside a device
user facility.
``(B) Condition.--The Secretary may order a
postmarket surveillance under subparagraph (A) as a
condition to approval or clearance of a device described
in subparagraph (A)(ii).
``(2) Rule of construction.--The provisions of paragraph (1)
shall have no effect on authorities otherwise provided under the
Act or regulations issued under this Act.''; and
(3) in subsection (b)--
(A) by striking ``(b) Surveillance Approval.--Each''
and inserting the following:

``(b) Surveillance Approval.--

[[Page 866]]
121 STAT. 866

``(1) In general.--Each'';
(B) by striking ``The Secretary, in consultation''
and inserting ``Except as provided in paragraph (2), the
Secretary, in consultation'';
(C) by striking ``Any determination'' and inserting
``Except as provided in paragraph (2), any
determination''; and
(D) by adding at the end the following:
``(2) Longer surveillance for pediatric devices.--The
Secretary may by order require a prospective surveillance period
of more than 36 months with respect to a device that is expected
to have significant use in pediatric populations if such period
of more than 36 months is necessary in order to assess the
impact of the device on growth and development, or the effects
of growth, development, activity level, or other factors on the
safety or efficacy of the device.

``(c) Dispute Resolution.--A manufacturer may request review under
section 562 of any order or condition requiring postmarket surveillance
under this section. During the pendency of such review, the device
subject to such a postmarket surveillance order or condition shall not,
because of noncompliance with such order or condition, be deemed in
violation of section 301(q)(1)(C), adulterated under section 501(f)(1),
misbranded under section 502(t)(3), or in violation of, as applicable,
section 510(k) or section 515, unless deemed necessary to protect the
public health.''.

TITLE [NOTE: Pediatric Research Equity Act of 2007.] IV--PEDIATRIC
RESEARCH EQUITY ACT OF 2007
SEC. 401. [NOTE: 21 USC 301 note.] SHORT TITLE.

This title may be cited as the ``Pediatric Research Equity Act of
2007''.
SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQUITY ACT.

(a) In General.--Section 505B of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355c) is amended to read as follows:
``SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL
PRODUCTS.

``(a) New Drugs and Biological Products.--
``(1) In general.--A person that submits, on or after the
date of the enactment of the Pediatric Research Equity Act of
2007, an application (or supplement to an application)--
``(A) under section 505 for a new active ingredient,
new indication, new dosage form, new dosing regimen, or
new route of administration, or
``(B) under section 351 of the Public Health Service
Act (42 U.S.C. 262) for a new active ingredient, new
indication, new dosage form, new dosing regimen, or new
route of administration,
shall submit with the application the assessments described in
paragraph (2).
``(2) Assessments.--
``(A) In general.--The assessments referred to in
paragraph (1) shall contain data, gathered using
appropriate

[[Page 867]]
121 STAT. 867

formulations for each age group for which the assessment
is required, that are adequate--
``(i) to assess the safety and effectiveness
of the drug or the biological product for the
claimed indications in all relevant pediatric
subpopulations; and
``(ii) to support dosing and administration
for each pediatric subpopulation for which the
drug or the biological product is safe and
effective.
``(B) Similar course of disease or similar effect of
drug or biological product.--
``(i) In general.--If the course of the
disease and the effects of the drug are
sufficiently similar in adults and pediatric
patients, the Secretary may conclude that
pediatric effectiveness can be extrapolated from
adequate and well-controlled studies in adults,
usually supplemented with other information
obtained in pediatric patients, such as
pharmacokinetic studies.
``(ii) Extrapolation between age groups.--A
study may not be needed in each pediatric age
group if data from one age group can be
extrapolated to another age group.
``(iii) Information on extrapolation.--A brief
documentation of the scientific data supporting
the conclusion under clauses (i) and (ii) shall be
included in any pertinent reviews for the
application under section 505 of this Act or
section 351 of the Public Health Service Act (42
U.S.C. 262).
``(3) Deferral.--
``(A) In general.--On the initiative of the
Secretary or at the request of the applicant, the
Secretary may defer submission of some or all
assessments required under paragraph (1) until a
specified date after approval of the drug or issuance of
the license for a biological product if--
``(i) the Secretary finds that--
``(I) the drug or biological product
is ready for approval for use in adults
before pediatric studies are complete;
``(II) pediatric studies should be
delayed until additional safety or
effectiveness data have been collected;
or
``(III) there is another appropriate
reason for deferral; and
``(ii) the applicant submits to the
Secretary--
``(I) certification of the grounds
for deferring the assessments;
``(II) a description of the planned
or ongoing studies;
``(III) evidence that the studies
are being conducted or will be conducted
with due diligence and at the earliest
possible time; and
``(IV) a timeline for the completion
of such studies.
``(B) Annual review.--
``(i) In general.--On an annual basis
following the approval of a deferral under
subparagraph (A), the applicant shall submit to
the Secretary the following information:

[[Page 868]]
121 STAT. 868

``(I) Information detailing the
progress made in conducting pediatric
studies.
``(II) If no progress has been made
in conducting such studies, evidence and
documentation that such studies will be
conducted with due diligence and at the
earliest possible time.
``(ii)
Public [NOTE: Website.] availability.--The
information submitted through the annual review
under clause (i) shall promptly be made available
to the public in an easily accessible manner,
including through the Web site of the Food and
Drug Administration.
``(4) Waivers.--
``(A) Full waiver.--On the initiative of the
Secretary or at the request of an applicant, the
Secretary shall grant a full waiver, as appropriate, of
the requirement to submit assessments for a drug or
biological product under this subsection if the
applicant certifies and the Secretary finds that--
``(i) necessary studies are impossible or
highly impracticable (because, for example, the
number of patients is so small or the patients are
geographically dispersed);
``(ii) there is evidence strongly suggesting
that the drug or biological product would be
ineffective or unsafe in all pediatric age groups;
or
``(iii) the drug or biological product--
``(I) does not represent a
meaningful therapeutic benefit over
existing therapies for pediatric
patients; and
``(II) is not likely to be used in a
substantial number of pediatric
patients.
``(B) Partial waiver.--On the initiative of the
Secretary or at the request of an applicant, the
Secretary shall grant a partial waiver, as appropriate,
of the requirement to submit assessments for a drug or
biological product under this subsection with respect to
a specific pediatric age group if the applicant
certifies and the Secretary finds that--
``(i) necessary studies are impossible or
highly impracticable (because, for example, the
number of patients in that age group is so small
or patients in that age group are geographically
dispersed);
``(ii) there is evidence strongly suggesting
that the drug or biological product would be
ineffective or unsafe in that age group;
``(iii) the drug or biological product--
``(I) does not represent a
meaningful therapeutic benefit over
existing therapies for pediatric
patients in that age group; and
``(II) is not likely to be used by a
substantial number of pediatric patients
in that age group; or
``(iv) the applicant can demonstrate that
reasonable attempts to produce a pediatric
formulation necessary for that age group have
failed.
``(C) Pediatric formulation not possible.--If a
waiver is granted on the ground that it is not possible

[[Page 869]]
121 STAT. 869

to develop a pediatric formulation, the waiver shall
cover only the pediatric groups [NOTE: Public
information. Website.] requiring that formulation. An
applicant seeking either a full or partial waiver shall
submit to the Secretary documentation detailing why a
pediatric formulation cannot be developed and, if the
waiver is granted, the applicant's submission shall
promptly be made available to the public in an easily
accessible manner, including through posting on the Web
site of the Food and Drug Administration.
``(D) Labeling requirement.--If the Secretary grants
a full or partial waiver because there is evidence that
a drug or biological product would be ineffective or
unsafe in pediatric populations, the information shall
be included in the labeling for the drug or biological
product.

``(b) Marketed Drugs and Biological Products.--
``(1) In general.--After providing notice in the form of a
letter (that, for a drug approved under section 505, references
a declined written request under section 505A for a labeled
indication which written request is not referred under section
505A(n)(1)(A) to the Foundation of the National Institutes of
Health for the pediatric studies), the Secretary may (by order
in the form of a letter) require the sponsor or holder of an
approved application for a drug under section 505 or the holder
of a license for a biological product under section 351 of the
Public Health Service Act to submit by a specified date the
assessments described in subsection (a)(2), if the Secretary
finds that--
``(A)(i) the drug or biological product is used for
a substantial number of pediatric patients for the
labeled indications; and
``(ii) adequate pediatric labeling could confer a
benefit on pediatric patients;
``(B) there is reason to believe that the drug or
biological product would represent a meaningful
therapeutic benefit over existing therapies for
pediatric patients for 1 or more of the claimed
indications; or
``(C) the absence of adequate pediatric labeling
could pose a risk to pediatric patients.
``(2) Waivers.--
``(A) Full waiver.--At the request of an applicant,
the Secretary shall grant a full waiver, as appropriate,
of the requirement to submit assessments under this
subsection if the applicant certifies and the Secretary
finds that--
``(i) necessary studies are impossible or
highly impracticable (because, for example, the
number of patients in that age group is so small
or patients in that age group are geographically
dispersed); or
``(ii) there is evidence strongly suggesting
that the drug or biological product would be
ineffective or unsafe in all pediatric age groups.
``(B) Partial waiver.--At the request of an
applicant, the Secretary shall grant a partial waiver,
as appropriate, of the requirement to submit assessments
under this subsection with respect to a specific
pediatric age group if the applicant certifies and the
Secretary finds that--

[[Page 870]]
121 STAT. 870

``(i) necessary studies are impossible or
highly impracticable (because, for example, the
number of patients in that age group is so small
or patients in that age group are geographically
dispersed);
``(ii) there is evidence strongly suggesting
that the drug or biological product would be
ineffective or unsafe in that age group;
``(iii)(I) the drug or biological product--
``(aa) does not represent a
meaningful therapeutic benefit over
existing therapies for pediatric
patients in that age group; and
``(bb) is not likely to be used in a
substantial number of pediatric patients
in that age group; and
``(II) the absence of adequate labeling could
not pose significant risks to pediatric patients;
or
``(iv) the applicant can demonstrate that
reasonable attempts to produce a pediatric
formulation necessary for that age group have
failed.
``(C) Pediatric formulation not possible.--If a
waiver is granted on the ground that it is not possible
to develop a pediatric formulation, the waiver shall
cover only the pediatric groups [NOTE: Public
information. Website.] requiring that formulation. An
applicant seeking either a full or partial waiver shall
submit to the Secretary documentation detailing why a
pediatric formulation cannot be developed and, if the
waiver is granted, the applicant's submission shall
promptly be made available to the public in an easily
accessible manner, including through posting on the Web
site of the Food and Drug Administration.
``(D) Labeling requirement.--If the Secretary grants
a full or partial waiver because there is evidence that
a drug or biological product would be ineffective or
unsafe in pediatric populations, the information shall
be included in the labeling for the drug or biological
product.
``(3) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section 552 of
title 5 or section 1905 of title 18, United States Code.

``(c) Meaningful Therapeutic Benefit.--For the purposes of paragraph
(4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a) and paragraphs
(1)(B) and (2)(B)(iii)(I)(aa) of subsection (b), a drug or biological
product shall be considered to represent a meaningful therapeutic
benefit over existing therapies if the Secretary determines that--
``(1) if approved, the drug or biological product could
represent an improvement in the treatment, diagnosis, or
prevention of a disease, compared with marketed products
adequately labeled for that use in the relevant pediatric
population; or
``(2) the drug or biological product is in a class of
products or for an indication for which there is a need for
additional options.

``(d) Submission of Assessments.--If a person fails to submit an
assessment described in subsection (a)(2), or a request for approval of
a pediatric formulation described in subsection (a) or (b), in
accordance with applicable provisions of subsections (a) and (b)--

[[Page 871]]
121 STAT. 871

``(1) the drug or biological product that is the subject of
the assessment or request may be considered misbranded solely
because of that failure and subject to relevant enforcement
action (except that the drug or biological product shall not be
subject to action under section 303); but
``(2) the failure to submit the assessment or request shall
not be the basis for a proceeding--
``(A) to withdraw approval for a drug under section
505(e); or
``(B) to revoke the license for a biological product
under section 351 of the Public Health Service Act.

``(e) Meetings.--Before and during the investigational process for a
new drug or biological product, the Secretary shall meet at appropriate
times with the sponsor of the new drug or biological product to
discuss--
``(1) information that the sponsor submits on plans and
timelines for pediatric studies; or
``(2) any planned request by the sponsor for waiver or
deferral of pediatric studies.

``(f) Review of Pediatric Plans, Assessments, Deferrals, and
Waivers.--
``(1) Review.--Beginning [NOTE: Deadline.] not later than
30 days after the date of the enactment of the Pediatric
Research Equity Act of 2007, the Secretary shall utilize the
internal committee established under section 505C to provide
consultation to reviewing divisions on all pediatric plans and
assessments prior to approval of an application or supplement
for which a pediatric assessment is required under this section
and all deferral and waiver requests granted pursuant to this
section.
``(2) Activity by committee.--The committee referred to in
paragraph (1) may operate using appropriate members of such
committee and need not convene all members of the committee.
``(3) Documentation of committee action.--For each drug or
biological product, the committee referred to in paragraph (1)
shall document, for each activity described in paragraph (4) or
(5), which members of the committee participated in such
activity.
``(4) Review of pediatric plans, assessments, deferrals, and
waivers.--Consultation on pediatric plans and assessments by the
committee referred to in paragraph (1) pursuant to this section
shall occur prior to approval of an application or supplement
for which a pediatric assessment is required under this section.
The committee shall review all requests for deferrals and
waivers from the requirement to submit a pediatric assessment
granted under this section and shall provide recommendations as
needed to reviewing divisions, including with respect to whether
such a supplement, when submitted, shall be considered for
priority review.
``(5) Retrospective review of pediatric assessments,
deferrals, and waivers.--Not [NOTE: Deadline.] later than 1
year after the date of the enactment of the Pediatric Research
Equity Act of 2007, the committee referred to in paragraph (1)
shall conduct a retrospective review and analysis of a
representative sample of assessments submitted and deferrals and
waivers approved under this section since the enactment of the
Pediatric Research Equity Act of 2003. Such review shall include
an

[[Page 872]]
121 STAT. 872

analysis of the quality and consistency of pediatric information
in pediatric assessments and the appropriateness of waivers and
deferrals granted. Based [NOTE: Recommen- dations.] on such
review, the Secretary shall issue recommendations to the review
divisions for improvements and initiate guidance to industry
related to the scope of pediatric studies required under this
section.
``(6) Tracking of assessments and labeling changes.--The
Secretary, in [NOTE: Public
information. Website.] consultation with the committee referred
to in paragraph (1), shall track and make available to the
public in an easily accessible manner, including through posting
on the Web site of the Food and Drug Administration--
``(A) the number of assessments conducted under this
section;
``(B) the specific drugs and biological products and
their uses assessed under this section;
``(C) the types of assessments conducted under this
section, including trial design, the number of pediatric
patients studied, and the number of centers and
countries involved;
``(D) the total number of deferrals requested and
granted under this section and, if granted, the reasons
for such deferrals, the timeline for completion, and the
number completed and pending by the specified date, as
outlined in subsection (a)(3);
``(E) the number of waivers requested and granted
under this section and, if granted, the reasons for the
waivers;
``(F) the number of pediatric formulations developed
and the number of pediatric formulations not developed
and the reasons any such formulation was not developed;
``(G) the labeling changes made as a result of
assessments conducted under this section;
``(H) an annual summary of labeling changes made as
a result of assessments conducted under this section for
distribution pursuant to subsection (h)(2);
``(I) an annual summary of information submitted
pursuant to subsection (a)(3)(B); and
``(J) the number of times the committee referred to
in paragraph (1) made a recommendation to the Secretary
under paragraph (4) regarding priority review, the
number of times the Secretary followed or did not follow
such a recommendation, and, if not followed, the reasons
why such a recommendation was not followed.

``(g) Labeling Changes.--
``(1) Dispute resolution.--
``(A) Request for labeling change and failure to
agree.--If, on or after the [NOTE: Deadline.] date of
the enactment of the Pediatric Research Equity Act of
2007, the Commissioner determines that a sponsor and the
Commissioner have been unable to reach agreement on
appropriate changes to the labeling for the drug that is
the subject of the application or supplement, not later
than 180 days after the date of the submission of the
application or supplement--
``(i) the Commissioner shall request that the
sponsor of the application make any labeling
change

[[Page 873]]
121 STAT. 873

that the Commissioner determines to be
appropriate; and
``(ii) [NOTE: Deadline.] if the sponsor does
not agree within 30 days after the Commissioner's
request to make a labeling change requested by the
Commissioner, the Commissioner shall refer the
matter to the Pediatric Advisory Committee.
``(B) Action by the pediatric advisory committee.--
Not later than 90 days [NOTE: Deadline.] after
receiving a referral under subparagraph (A)(ii), the
Pediatric Advisory Committee shall--
``(i) review the pediatric study reports; and
``(ii) make a recommendation to the
Commissioner concerning appropriate labeling
changes, if any.
``(C) Consideration
of [NOTE: Deadline.] recommendations.--The
Commissioner shall consider the recommendations of the
Pediatric Advisory Committee and, if appropriate, not
later than 30 days after receiving the recommendation,
make a request to the sponsor of the application or
supplement to make any labeling changes that the
Commissioner determines to be appropriate.
``(D) Misbranding.--If [NOTE: Deadline.] the
sponsor of the application or supplement, within 30 days
after receiving a request under subparagraph (C), does
not agree to make a labeling change requested by the
Commissioner, the Commissioner may deem the drug that is
the subject of the application or supplement to be
misbranded.
``(E) No effect on authority.--Nothing in this
subsection limits the authority of the United States to
bring an enforcement action under this Act when a drug
lacks appropriate pediatric labeling. Neither course of
action (the Pediatric Advisory Committee process or an
enforcement action referred to in the preceding
sentence) shall preclude, delay, or serve as the basis
to stay the other course of action.
``(2) Other labeling changes.--If, on or after the date of
the enactment of the Pediatric Research Equity Act of 2007, the
Secretary makes a determination that a pediatric assessment
conducted under this section does or does not demonstrate that
the drug that is the subject of such assessment is safe and
effective in pediatric populations or subpopulations, including
whether such assessment results are inconclusive, the Secretary
shall order the label of such product to include information
about the results of the assessment and a statement of the
Secretary's determination.

``(h) Dissemination of Pediatric Information.--
``(1) In general.--Not [NOTE: Deadline. Public
information. Website.] later than 210 days after the date of
submission of a pediatric assessment under this section, the
Secretary shall make available to the public in an easily
accessible manner the medical, statistical, and clinical
pharmacology reviews of such pediatric assessments, and shall
post such assessments on the Web site of the Food and Drug
Administration.
``(2) Dissemination of information regarding labeling
changes.--Beginning on [NOTE: Effective date.] the date of the
enactment of the Pediatric Research Equity Act of 2007, the
Secretary shall require that the sponsors of the assessments
that result in labeling

[[Page 874]]
121 STAT. 874

changes that are reflected in the annual summary developed
pursuant to subsection (f)(6)(H) distribute such information to
physicians and other health care providers.
``(3) Effect of subsection.--Nothing in this subsection
shall alter or amend section 301(j) of this Act or section 552
of title 5 or section 1905 of title 18, United States Code.

``(i) Adverse Event Reporting.--
``(1) Reporting in [NOTE: Effective date.] year one.--
Beginning on the date of the enactment of the Pediatric Research
Equity Act of 2007, during the one-year period beginning on the
date a labeling change is made pursuant to subsection (g), the
Secretary shall ensure that all adverse event reports that have
been received for such drug (regardless of when such report was
received) are referred to the Office of Pediatric Therapeutics.
In considering such reports, the Director of such Office shall
provide for the review of such reports 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 such reports.
``(2) Reporting in subsequent years.--Following the one-year
period described in paragraph (1), the Secretary shall, as
appropriate, refer to the Office of Pediatric Therapeutics all
pediatric adverse event reports for a drug for which a pediatric
study was conducted under this section. In considering such
reports, the Director of such Office may provide for the review
of such reports by the Pediatric Advisory Committee, including
obtaining any recommendation of such Committee regarding whether
the Secretary should take action in response to such reports.
``(3) Effect.--The requirements of this subsection shall
supplement, not supplant, other review of such adverse event
reports by the Secretary.

``(j) Scope of Authority.--Nothing in this section provides to the
Secretary any authority to require a pediatric assessment of any drug or
biological product, or any assessment regarding other populations or
uses of a drug or biological product, other than the pediatric
assessments described in this section.
``(k) Orphan Drugs.--Unless the Secretary requires otherwise by
regulation, this section does not apply to any drug for an indication
for which orphan designation has been granted under section 526.
``(l) Institute of Medicine Study.--
``(1) In general.--
Not [NOTE: Deadline. Contracts. Reports.] later than three
years after the date of the enactment of the Pediatric Research
Equity Act of 2007, the Secretary shall contract with the
Institute of Medicine to conduct a study and report to Congress
regarding the pediatric studies conducted pursuant to this
section or precursor regulations since 1997 and labeling changes
made as a result of such studies.
``(2) Content of study.--The study under paragraph (1) shall
review and assess the use of extrapolation for pediatric
subpopulations, the use of alternative endpoints for pediatric
populations, neonatal assessment tools, the number and type of
pediatric adverse events, and ethical issues in pediatric
clinical trials.

[[Page 875]]
121 STAT. 875

``(3) Representative sample.--The Institute of Medicine may
devise an appropriate mechanism to review a representative
sample of studies conducted pursuant to this section from each
review division within the Center for Drug Evaluation and
Research in order to make the requested assessment.

``(m) Integration With Other Pediatric Studies.--The authority under
this section shall remain in effect so long as an application subject to
this section may be accepted for filing by the Secretary on or before
the date specified in section 505A(q).''.
(b) [NOTE: 21 USC 355c note.] Applicability.--
(1) In general.--Notwithstanding subsection (h) of section
505B of the Federal Food, Drug and Cosmetic Act, as in effect on
the day before the date of the enactment of this Act, a pending
assessment, including a deferred assessment, required under such
section 505B shall be deemed to have been required under section
505B of the Federal Food, Drug and Cosmetic Act as in effect on
or after the date of the enactment of this Act.
(2) Certain assessments and waiver requests.--An assessment
pending on or after the date that is 1 year prior to the date of
the enactment of this Act shall be subject to the tracking and
disclosure requirements established under such section 505B, as
in effect on or after such date of enactment, except that any
such assessments submitted or waivers of such assessments
requested before such date of enactment shall not be subject to
subsections (a)(4)(C), (b)(2)(C), (f)(6)(F), and (h) of such
section 505B.
SEC. 403. ESTABLISHMENT OF INTERNAL COMMITTEE.

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351
et seq.) is amended by inserting after section 505B the following:
``SEC. 505C. [NOTE: Establishment. 21 USC 355d.] INTERNAL
COMMITTEE FOR REVIEW OF PEDIATRIC PLANS,
ASSESSMENTS, DEFERRALS, AND WAIVERS.

``The Secretary shall establish an internal committee within the
Food and Drug Administration to carry out the activities as described in
sections 505A(f) and 505B(f). Such internal committee shall include
employees of the Food and Drug Administration, with expertise in
pediatrics (including representation from the Office of Pediatric
Therapeutics), biopharmacology, statistics, chemistry, legal issues,
pediatric ethics, and the appropriate expertise pertaining to the
pediatric product under review, such as expertise in child and
adolescent psychiatry, and other individuals designated by the
Secretary.''.
SEC. 404. GOVERNMENT ACCOUNTABILITY OFFICE REPORT.

Not later than January 1, 2011, the Comptroller General of the
United States, in consultation with the Secretary of Health and Human
Services, shall submit to the Congress a report that addresses the
effectiveness of sections 505A and 505B of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a, 355c) and section 409I of the Public
Health Service Act (42 U.S.C. 284m) in ensuring that medicines used by
children are tested and properly labeled. Such report shall include--
(1) the number and importance of drugs and biological
products for children that are being tested as a result of the
amendments made by this title and title V and the importance

[[Page 876]]
121 STAT. 876

for children, health care providers, parents, and others of
labeling changes made as a result of such testing;
(2) the number and importance of drugs and biological
products for children that are not being tested for their use
notwithstanding the provisions of this title and title V and
possible reasons for the lack of testing;
(3) the number of drugs and biological products for which
testing is being done and labeling changes required, including
the date labeling changes are made and which labeling changes
required the use of the dispute resolution process established
pursuant to the amendments made by this title, together with a
description of the outcomes of such process, including a
description of the disputes and the recommendations of the
Pediatric Advisory Committee;
(4) any recommendations for modifications to the programs
established under sections 505A and 505B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355a) and section 409I of the
Public Health Service Act (42 U.S.C. 284m) that the Secretary
determines to be appropriate, including a detailed rationale for
each recommendation; and
(5)(A) the efforts made by the Secretary to increase the
number of studies conducted in the neonate population; and
(B) the results of those efforts, including efforts made to
encourage the conduct of appropriate studies in neonates by
companies with products that have sufficient safety and other
information to make the conduct of the studies ethical and safe.

TITLE V--BEST [NOTE: Best Pharmaceuticals for Children Act of
2007.] PHARMACEUTICALS FOR CHILDREN ACT OF 2007
SEC. 501. [NOTE: 21 USC 301 note.] SHORT TITLE.

This title may be cited as the ``Best Pharmaceuticals for Children
Act of 2007''.
SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN
ACT.

(a) Pediatric Studies of Drugs.--
(1) In general.--Section 505A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a) is amended to read as follows:
``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

``(a) Definitions.--As used in this section, the term `pediatric
studies' or `studies' means at least one clinical investigation (that,
at the Secretary's discretion, may include pharmacokinetic studies) in
pediatric age groups (including neonates in appropriate cases) in which
a drug is anticipated to be used, and, at the discretion of the
Secretary, may include preclinical studies.
``(b) Market Exclusivity for New Drugs.--
``(1) In general.--Except as provided in paragraph (2), if,
prior to approval of an application that is submitted under
section 505(b)(1), the Secretary determines that information
relating to the use of a new drug in the pediatric population
may produce health benefits in that population, the Secretary
makes a written request for pediatric studies (which shall

[[Page 877]]
121 STAT. 877

include a timeframe for completing such studies), the applicant
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)(E) 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 subsections
(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)
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 certification 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.

``(c) Market Exclusivity for Already-Marketed Drugs.--
``(1) In general.--Except as provided in paragraph (2), if
the Secretary determines that information relating to the use of
an approved drug in the pediatric population may produce health
benefits in that population and makes a written request to the
holder of an approved application under section

[[Page 878]]
121 STAT. 878

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 certification 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 [NOTE: Deadline.] 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
consultation with the sponsor of an application for an
investigational new drug under section 505(i), the
sponsor of an application for a new drug under section
505(b)(1), or the

[[Page 879]]
121 STAT. 879

holder of an approved application for a drug under
section 505(b)(1), issue to the sponsor or holder a
written request for the conduct of pediatric studies for
such drug. [NOTE: Minorities.] In issuing such
request, the Secretary shall take into account adequate
representation of children of ethnic and racial
minorities. Such [NOTE: Timeframe.] request to conduct
pediatric studies shall be in writing and shall include
a timeframe for such studies and a request to the
sponsor or holder to propose pediatric labeling
resulting from such studies.
``(B) Single written request.--A single written
request--
``(i) may relate to more than one use of a
drug; and
``(ii) may include uses that are both approved
and unapproved.
``(2) Written request for pediatric studies.--
``(A) Request and response.--
``(i) In general.--If the Secretary makes a
written request for pediatric studies (including
neonates, as appropriate) under subsection (b) or
(c), the applicant or holder, not later than 180
days after receiving the written request, shall
respond to the Secretary as to the intention of
the applicant or holder to act on the request by--
``(I) indicating when the pediatric
studies will be initiated, if the
applicant or holder agrees to the
request; or
``(II) indicating that the applicant
or holder does not agree to the request
and stating the reasons for declining
the request.
``(ii) Disagree with request.--If, on or after
the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007, the
applicant or holder does not agree to the request
on the grounds that it is not possible to develop
the appropriate pediatric formulation, the
applicant or holder shall submit to the Secretary
the reasons such pediatric formulation cannot be
developed.
``(B) Adverse event reports.--An applicant or holder
that, on or after the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007, agrees to the
request for such studies shall provide the Secretary, at
the same time as the submission of the reports of such
studies, with all postmarket adverse event reports
regarding the drug that is the subject of such studies
and are available prior to submission of such reports.
``(3) Meeting the [NOTE: Deadline. Notification.] studies
requirement.--Not later than 180 days after the submission of
the reports of the studies, the Secretary shall accept or reject
such reports and so notify the sponsor or holder. The
Secretary's only responsibility in accepting or rejecting the
reports shall be to determine, within the 180-day period,
whether the studies fairly respond to the written request, have
been conducted in accordance with commonly accepted scientific
principles and protocols, and have been reported in accordance
with the requirements of the Secretary for filing.

[[Page 880]]
121 STAT. 880

``(4) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section 552 of
title 5 or section 1905 of title 18, United States Code.

``(e) Notice of Determinations on Studies Requirement.--
``(1) In [NOTE: Publication.] general.--The Secretary
shall publish a notice of any determination, made on or after
the date of the enactment of the Best Pharmaceuticals for
Children Act of 2007, that the requirements of subsection (d)
have been met and that submissions and approvals under
subsection (b)(2) or (j) of section 505 for a drug will be
subject to the provisions of this section.
Such [NOTE: Deadline. Records.] notice shall be published not
later than 30 days after the date of the Secretary's
determination regarding market exclusivity and shall include a
copy of the written request made under subsection (b) or (c).
``(2) Identification of [NOTE: Publication.] certain
drugs.--The Secretary shall publish a notice identifying any
drug for which, on or after the date of the enactment of the
Best Pharmaceuticals for Children Act of 2007, a pediatric
formulation was developed, studied, and found to be safe and
effective in the pediatric population (or specified
subpopulation) if the pediatric formulation for such drug is not
introduced onto the market within one year after the date that
the Secretary publishes the notice described in paragraph
(1). [NOTE: Deadline.] Such notice identifying such drug shall
be published not later than 30 days after the date of the
expiration of such one year period.

``(f) Internal Review of Written Requests and Pediatric Studies.--
``(1) Internal review.--The Secretary shall utilize the
internal review committee established under section 505C to
review all written requests issued on or after the date of the
enactment of the Best Pharmaceuticals for Children Act of 2007,
in accordance with paragraph (2).
``(2) Review of written requests.--The committee referred to
in paragraph (1) shall review all written requests issued
pursuant to this section prior to being issued.
``(3) Review of pediatric studies.--The committee referred
to in paragraph (1) may review studies conducted pursuant to
this section to make a recommendation to the Secretary whether
to accept or reject such reports under subsection (d)(3).
``(4) Activity by committee.--The committee referred to in
paragraph (1) may operate using appropriate members of such
committee and need not convene all members of the committee.
``(5) Documentation of committee action.--For each drug, the
committee referred to in paragraph (1) shall document, for each
activity described in paragraph (2) or (3), which members of the
committee participated in such activity.
``(6) Tracking pediatric studies and labeling changes.--The
Secretary, in [NOTE: Public
information. Website.] consultation with the committee referred
to in paragraph (1), shall track and make available to the
public, in an easily accessible manner, including through
posting on the Web site of the Food and Drug Administration--
``(A) the number of studies conducted under this
section and under section 409I of the Public Health
Service Act;
``(B) the specific drugs and drug uses, including
labeled and off-labeled indications, studied under such
sections;

[[Page 881]]
121 STAT. 881

``(C) the types of studies conducted under such
sections, including trial design, the number of
pediatric patients studied, and the number of centers
and countries involved;
``(D) the number of pediatric formulations developed
and the number of pediatric formulations not developed
and the reasons such formulations were not developed;
``(E) the labeling changes made as a result of
studies conducted under such sections;
``(F) an annual summary of labeling changes made as
a result of studies conducted under such sections for
distribution pursuant to subsection (k)(2); and
``(G) information regarding reports submitted on or
after the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007.

``(g) Limitations.--Notwithstanding subsection (c)(2), a drug to
which the six-month period under subsection (b) or (c) has already been
applied--
``(1) may receive an additional six-month period under
subsection (c)(1)(A)(i)(II) for a supplemental application if
all other requirements under this section are satisfied, except
that such drug may not receive any additional such period under
subsection (c)(1)(B); and
``(2) may not receive any additional such period under
subsection (c)(1)(A)(ii).

``(h) Relationship to Pediatric Research Requirements.--
Notwithstanding any other provision of law, if any pediatric study is
required by a provision of law (including a regulation) other than this
section and such study meets the completeness, timeliness, and other
requirements of this section, such study shall be deemed to satisfy the
requirement for market exclusivity pursuant to this section.
``(i) Labeling Changes.--
``(1) Priority status for pediatric applications and
supplements.--Any application or supplement to an application
under section 505 proposing a labeling change as a result of any
pediatric study conducted pursuant to this section--
``(A) shall be considered to be a priority
application or supplement; and
``(B) shall be subject to the performance goals
established by the Commissioner for priority drugs.
``(2) Dispute resolution.--
``(A) Request for labeling change and failure to
agree.--If, on or after the [NOTE: Deadline.] date of
the enactment of the Best Pharmaceuticals for Children
Act of 2007, the Commissioner determines that the
sponsor and the Commissioner have been unable to reach
agreement on appropriate changes to the labeling for the
drug that is the subject of the application, not later
than 180 days after the date of submission of the
application--
``(i) the Commissioner shall request that the
sponsor of the application make any labeling
change that the Commissioner determines to be
appropriate; and
``(ii) [NOTE: Deadline.] if the sponsor of
the application does not agree within 30 days
after the Commissioner's request to

[[Page 882]]
121 STAT. 882

make a labeling change requested by the
Commissioner, the Commissioner shall refer the
matter to the Pediatric Advisory Committee.
``(B) Action by the pediatric advisory committee.--
Not later [NOTE: Deadline.] than 90 days after
receiving a referral under subparagraph (A)(ii), the
Pediatric Advisory Committee shall--
``(i) review the pediatric study reports; and
``(ii) make a recommendation to the
Commissioner concerning appropriate labeling
changes, if any.
``(C) Consideration
of [NOTE: Deadline.] recommendations.--The
Commissioner shall consider the recommendations of the
Pediatric Advisory Committee and, if appropriate, not
later than 30 days after receiving the recommendation,
make a request to the sponsor of the application to make
any labeling change that the Commissioner determines to
be appropriate.
``(D) Misbranding.--If [NOTE: Deadline.] the
sponsor of the application, within 30 days after
receiving a request under subparagraph (C), does not
agree to make a labeling change requested by the
Commissioner, the Commissioner may deem the drug that is
the subject of the application to be misbranded.
``(E) No effect on authority.--Nothing in this
subsection limits the authority of the United States to
bring an enforcement action under this Act when a drug
lacks appropriate pediatric labeling. Neither course of
action (the Pediatric Advisory Committee process or an
enforcement action referred to in the preceding
sentence) shall preclude, delay, or serve as the basis
to stay the other course of action.

``(j) Other Labeling Changes.--If, on or after the date of the
enactment of the Best Pharmaceuticals for Children Act of 2007, the
Secretary determines that a pediatric study conducted under this section
does or does not demonstrate that the drug that is the subject of the
study is safe and effective, including whether such study results are
inconclusive, in pediatric populations or subpopulations, the Secretary
shall order the labeling of such product to include information about
the results of the study and a statement of the Secretary's
determination.
``(k) Dissemination of Pediatric Information.--
``(1) In general.--Not [NOTE: Deadline. Public
information.] later than 210 days after the date of submission
of a report on a pediatric study under this section, the
Secretary shall make available to the public the medical,
statistical, and clinical pharmacology reviews of pediatric
studies conducted under subsection (b) or (c).
``(2) Dissemination of information regarding labeling
changes.--Beginning on the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007, the Secretary shall
include as a requirement of a written request that the sponsors
of the studies that result in labeling changes that are
reflected in the annual summary developed pursuant to subsection
(f)(3)(F) distribute, at least annually (or more frequently if
the Secretary determines that it would be beneficial to the
public health), such information to physicians and other health
care providers.

[[Page 883]]
121 STAT. 883

``(3) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section 552 of
title 5 or section 1905 of title 18, United States Code.

``(l) Adverse Event Reporting.--
``(1) Reporting [NOTE: Effective date.] in year one.--
Beginning on the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007, during the one-year
period beginning on the date a labeling change is approved
pursuant to subsection (i), the Secretary shall ensure that all
adverse event reports that have been received for such drug
(regardless of when such report was received) are referred to
the Office of Pediatric Therapeutics established under section 6
of the Best Pharmaceuticals for Children Act (Public Law 107-
109). In considering the reports, the Director of such Office
shall provide for the review of the reports 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 such reports.
``(2) Reporting in subsequent years.--Following the one-year
period described in paragraph (1), the Secretary shall, as
appropriate, refer to the Office of Pediatric Therapeutics all
pediatric adverse event reports for a drug for which a pediatric
study was conducted under this section. In considering such
reports, the Director of such Office may provide for the review
of such reports by the Pediatric Advisory Committee, including
obtaining any recommendation of such Committee regarding whether
the Secretary should take action in response to such reports.
``(3) Effect.--The requirements of this subsection shall
supplement, not supplant, other review of such adverse event
reports by the Secretary.

``(m) Clarification of Interaction of Market Exclusivity Under This
Section and Market Exclusivity Awarded to An Applicant for Approval of A
Drug Under Section 505(j).--If a 180-day period under section
505(j)(5)(B)(iv) overlaps with a 6-month exclusivity period under this
section, so that the applicant for approval of a drug under section
505(j) entitled to the 180-day period under that section loses a portion
of the 180-day period to which the applicant is entitled for the drug,
the 180-day period shall be extended from--
``(1) the date on which the 180-day period would have
expired by the number of days of the overlap, if the 180-day
period would, but for the application of this subsection, expire
after the 6-month exclusivity period; or
``(2) the date on which the 6-month exclusivity period
expires, by the number of days of the overlap if the 180-day
period would, but for the application of this subsection, expire
during the six-month exclusivity period.

``(n) Referral if Pediatric Studies Not Completed.--
``(1) In general.--Beginning [NOTE: Effective date.] on
the date of the enactment of the Best Pharmaceuticals for
Children Act of 2007, if pediatric studies of a drug have not
been completed under subsection (d) and if the Secretary,
through the committee established under section 505C, determines
that there is a continuing need for information relating to the
use of the drug in the pediatric population (including neonates,
as appropriate), the Secretary shall carry out the following:

[[Page 884]]
121 STAT. 884

``(A) For a drug for which a listed patent has not
expired, make a determination regarding whether an
assessment shall be required to be submitted under
section
505B(b). [NOTE: Deadline. Certification.] Prior to
making such a determination, the Secretary may not take
more than 30 days to certify whether the Foundation for
the National Institutes of Health has sufficient funding
at the time of such certification to initiate and fund
all of the studies in the written request in their
entirety within the timeframes specified within the
written request. Only if the Secretary makes such
certification in the affirmative, the Secretary shall
refer all pediatric studies in the written request to
the Foundation for the National Institutes of Health for
the conduct of such studies, and such Foundation shall
fund such studies. If no certification has been made at
the end of the 30-day period, or if the Secretary
certifies that funds are not sufficient to initiate and
fund all the studies in their entirety, the Secretary
shall consider whether assessments shall be required
under section 505B(b) for such drug.
``(B) For a drug that has no listed patents or has 1
or more listed patents that have expired, the Secretary
shall refer the drug for inclusion on the list
established under section 409I of the Public Health
Service Act for the conduct of studies.
``(2) Public notice.--The Secretary shall give the public
notice of a decision under paragraph (1)(A) not to require an
assessment under section 505B and the basis for such decision.
``(3) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section 552 of
title 5 or section 1905 of title 18, United States Code.

``(o) Prompt Approval of Drugs Under Section 505(j) When Pediatric
Information Is Added to Labeling.--
``(1) General rule.--A drug for which an application has
been submitted or approved under section 505(j) shall not be
considered ineligible for approval under that section or
misbranded under section 502 on the basis that the labeling of
the drug omits a pediatric indication or any other aspect of
labeling pertaining to pediatric use when the omitted indication
or other aspect is protected by patent or by exclusivity under
clause (iii) or (iv) of section 505(j)(5)(F).
``(2) Labeling.--Notwithstanding clauses (iii) and (iv) of
section 505(j)(5)(F), the Secretary may require that the
labeling of a drug approved under section 505(j) that omits a
pediatric indication or other aspect of labeling as described in
paragraph (1) include--
``(A) a statement that, because of marketing
exclusivity for a manufacturer--
``(i) the drug is not labeled for pediatric
use; or
``(ii) in the case of a drug for which there
is an additional pediatric use not referred to in
paragraph (1), the drug is not labeled for the
pediatric use under paragraph (1); and
``(B) a statement of any appropriate pediatric
contraindications, warnings, or precautions that the
Secretary considers necessary.
``(3) Preservation of pediatric exclusivity and other
provisions.--This subsection does not affect--

[[Page 885]]
121 STAT. 885

``(A) the availability or scope of exclusivity under
this section;
``(B) the availability or scope of exclusivity under
section 505 for pediatric formulations;
``(C) the question of the eligibility for approval
of any application under section 505(j) that omits any
other conditions of approval entitled to exclusivity
under clause (iii) or (iv) of section 505(j)(5)(F); or
``(D) except as expressly provided in paragraphs (1)
and (2), the operation of section 505.

``(p) Institute of [NOTE: Deadline. Contracts. Reports.] Medicine
Study.--Not later than 3 years after the date of the enactment of the
Best Pharmaceuticals for Children Act of 2007, the Secretary shall enter
into a contract with the Institute of Medicine to conduct a study and
report to Congress regarding the written requests made and the studies
conducted pursuant to this section. The Institute of Medicine may devise
an appropriate mechanism to review a representative sample of requests
made and studies conducted pursuant to this section in order to conduct
such study. Such study shall--
``(1) review such representative written requests issued by
the Secretary since 1997 under subsections (b) and (c);
``(2) review and assess such representative pediatric
studies conducted under subsections (b) and (c) since 1997 and
labeling changes made as a result of such studies;
``(3) review the use of extrapolation for pediatric
subpopulations, the use of alternative endpoints for pediatric
populations, neonatal assessment tools, and ethical issues in
pediatric clinical trials;
``(4) review and assess the pediatric studies of biological
products as required under subsections (a) and (b) of section
505B; and
``(5) make recommendations regarding appropriate incentives
for encouraging pediatric studies of biologics.

``(q) Sunset.--A drug may not receive any 6-month period under
subsection (b) or (c) unless--
``(1) [NOTE: Deadline.] on or before October 1, 2012, the
Secretary makes a written request for pediatric studies of the
drug;
``(2) [NOTE: Deadline.] on or before October 1, 2012, an
application for the drug is accepted for filing under section
505(b); and
``(3) all requirements of this section are met.''.
(2) [NOTE: 21 USC 355a note.] Applicability.--
(A) In general.--The amendment made by this
subsection shall apply to written requests under section
505A of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a) issued on or after the date of the
enactment of this Act.
(B) Certain written requests.--A written request
issued under section 505A of the Federal Food, Drug, and
Cosmetic Act, as in effect on the day before the date of
the enactment of this Act, which has been accepted and
for which no determination under subsection (d)(2) of
such section has been made before such date of
enactment, shall be subject to such section 505A, except
that such written requests shall be subject to
subsections (d)(2)(A)(ii), (e)(1) and (2), (f),
(i)(2)(A), (j), (k)(1), (l)(1), and (n) of section 505A
of the Federal Food, Drug, and Cosmetic Act, as

[[Page 886]]
121 STAT. 886

in effect on or after the date of the enactment of this
Act.

(b) Program for Pediatric Studies of Drugs.--Section 409I of the
Public Health Service Act (42 U.S.C. 284m) is amended to read as
follows:
``SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

``(a) List of Priority Issues in Pediatric Therapeutics.--
``(1) In general.--
Not [NOTE: Deadline. Publication.] later than one year after
the date of the enactment of the Best Pharmaceuticals for
Children Act of 2007, the Secretary, acting through the Director
of the National Institutes of Health and in consultation with
the Commissioner of Food and Drugs and experts in pediatric
research, shall develop and publish a priority list of needs in
pediatric therapeutics, including drugs or indications that
require study. The list shall be revised every three years.
``(2) Consideration of available information.--In developing
and prioritizing the list under paragraph (1), the Secretary
shall consider--
``(A) therapeutic gaps in pediatrics that may
include developmental pharmacology, pharmacogenetic
determinants of drug response, metabolism of drugs and
biologics in children, and pediatric clinical trials;
``(B) particular pediatric diseases, disorders or
conditions where more complete knowledge and testing of
therapeutics, including drugs and biologics, may be
beneficial in pediatric populations; and
``(C) the adequacy of necessary infrastructure to
conduct pediatric pharmacological research, including
research networks and trained pediatric investigators.

``(b) Pediatric Studies and Research.--The Secretary, acting through
the National Institutes of Health, shall award funds to entities that
have the expertise to conduct pediatric clinical trials or other
research (including qualified universities, hospitals, laboratories,
contract research organizations, practice groups, federally funded
programs such as pediatric pharmacology research units, other public or
private institutions, or individuals) to enable the entities to conduct
the drug studies or other research on the issues described in subsection
(a). The Secretary may use contracts, grants, or other appropriate
funding mechanisms to award funds under this subsection.
``(c) Process for Proposed Pediatric Study Requests and Labeling
Changes.--
``(1) Submission of proposed pediatric study request.--The
Director of the National Institutes of Health shall, as
appropriate, submit proposed pediatric study requests for
consideration by the Commissioner of Food and Drugs for
pediatric studies of a specific pediatric indication identified
under subsection (a). Such a proposed pediatric study request
shall be made in a manner equivalent to a written request made
under subsection (b) or (c) of section 505A of the Federal Food,
Drug, and Cosmetic Act, including with respect to the
information provided on the pediatric studies to be conducted
pursuant to the request. The Director of the National Institutes
of Health may submit a proposed pediatric study request for a
drug for which--

[[Page 887]]
121 STAT. 887

``(A)(i) there is an approved application under
section 505(j) of the Federal Food, Drug, and Cosmetic
Act; or
``(ii) there is a submitted application that could
be approved under the criteria of such section; and
``(B) there is no patent protection or market
exclusivity protection for at least one form of the drug
under the Federal Food, Drug, and Cosmetic Act; and
``(C) additional studies are needed to assess the
safety and effectiveness of the use of the drug in the
pediatric population.
``(2) Written request to holders of approved applications
for drugs lacking exclusivity.--The Commissioner of Food and
Drugs, in consultation with the Director of the National
Institutes of Health, may issue a written request based on the
proposed pediatric study request for the indication or
indications submitted pursuant to paragraph (1) (which shall
include a timeframe for negotiations for an agreement) for
pediatric studies concerning a drug identified under subsection
(a) to all holders of an approved application for the drug under
section 505 of the Federal Food, Drug, and Cosmetic Act. Such a
written request shall be made in a manner equivalent to the
manner in which a written request is made under subsection (b)
or (c) of section 505A of such Act, including with respect to
information provided on the pediatric studies to be conducted
pursuant to the request and using appropriate formulations for
each age group for which the study is requested.
``(3) Requests
for [NOTE: Deadline. Publication.] proposals.--If the
Commissioner of Food and Drugs does not receive a response to a
written request issued under paragraph (2) not later than 30
days after the date on which a request was issued, the
Secretary, acting through the Director of the National
Institutes of Health and in consultation with the Commissioner
of Food and Drugs, shall publish a request for proposals to
conduct the pediatric studies described in the written request
in accordance with subsection (b).
``(4) Disqualification.--A holder that receives a first
right of refusal shall not be entitled to respond to a request
for proposals under paragraph (3).
``(5) Contracts, grants, or other funding mechanisms.--A
contract, grant, or other funding may be awarded under this
section only if a proposal is submitted to the Secretary in such
form and manner, and containing such agreements, assurances, and
information as the Secretary determines to be necessary to carry
out this section.
``(6) Reporting of studies.--
``(A) In general.--On completion of a pediatric
study in accordance with an award under this section, a
report concerning the study shall be submitted to the
Director of the National Institutes of Health and the
Commissioner of Food and Drugs. The report shall include
all data generated in connection with the study,
including a written request if issued.
``(B) Availability of reports.--Each report
submitted under subparagraph (A) shall be considered to
be in the public domain (subject to section 505A(d)(4)
of the Federal Food, Drug, and Cosmetic Act) and shall
be assigned a

[[Page 888]]
121 STAT. 888

docket number by the Commissioner of Food and Drugs. An
interested person may submit written comments concerning
such pediatric studies to the Commissioner of Food and
Drugs, and the written comments shall become part of the
docket file with respect to each of the drugs.
``(C) Action by commissioner.--The Commissioner of
Food and Drugs shall take appropriate action in response
to the reports submitted under subparagraph (A) in
accordance with paragraph (7).
``(7) Requests for labeling change.--During the 180-day
period after the date on which a report is submitted under
paragraph (6)(A), the Commissioner of Food and Drugs shall--
``(A) review the report and such other data as are
available concerning the safe and effective use in the
pediatric population of the drug studied;
``(B) negotiate with the holders of approved
applications for the drug studied for any labeling
changes that the Commissioner of Food and Drugs
determines to be appropriate and requests the holders to
make; and
``(C)(i) place in the public docket file a copy of
the report and of any requested labeling changes; and
``(ii) [NOTE: Federal
Register, publication. Website.] publish in the Federal
Register and through a posting on the Web site of the
Food and Drug Administration a summary of the report and
a copy of any requested labeling changes.
``(8) Dispute resolution.--
``(A) Referral to pediatric advisory committee.--If,
not later than the [NOTE: Deadline.] end of the 180-
day period specified in paragraph (7), the holder of an
approved application for the drug involved does not
agree to any labeling change requested by the
Commissioner of Food and Drugs under that paragraph, the
Commissioner of Food and Drugs shall refer the request
to the Pediatric Advisory Committee.
``(B) Action by the pediatric advisory committee.--
Not later [NOTE: Deadline.] than 90 days after
receiving a referral under subparagraph (A), the
Pediatric Advisory Committee shall--
``(i) review the available information on the
safe and effective use of the drug in the
pediatric population, including study reports
submitted under this section; and
``(ii) [NOTE: Recommen- dations.] make a
recommendation to the Commissioner of Food and
Drugs as to appropriate labeling changes, if any.
``(9) FDA [NOTE: Deadline.] determination.--Not later than
30 days after receiving a recommendation from the Pediatric
Advisory Committee under paragraph (8)(B)(ii) with respect to a
drug, the Commissioner of Food and Drugs shall consider the
recommendation and, if appropriate, make a request to the
holders of approved applications for the drug to make any
labeling change that the Commissioner of Food and Drugs
determines to be appropriate.
``(10) Failure to [NOTE: Deadline.] agree.--If a holder of
an approved application for a drug, within 30 days after
receiving a request to make a labeling change under paragraph
(9), does not agree to make a requested labeling change, the
Commissioner of

[[Page 889]]
121 STAT. 889

Food and Drugs may deem the drug to be misbranded under the
Federal Food, Drug, and Cosmetic Act.
``(11) No effect on authority.--Nothing in this subsection
limits the authority of the United States to bring an
enforcement action under the Federal Food, Drug, and Cosmetic
Act when a drug lacks appropriate pediatric labeling. Neither
course of action (the Pediatric Advisory Committee process or an
enforcement action referred to in the preceding sentence) shall
preclude, delay, or serve as the basis to stay the other course
of action.

``(d) Dissemination of [NOTE: Deadline. Reports.] Pediatric
Information.--Not later than one year after the date of the enactment of
the Best Pharmaceuticals for Children Act of 2007, the Secretary, acting
through the Director of the National Institutes of Health, shall study
the feasibility of establishing a compilation of information on
pediatric drug use and report the findings to Congress.

``(e) Authorization of Appropriations.--
``(1) In general.--There are authorized to be appropriated
to carry out this section--
``(A) $200,000,000 for fiscal year 2008; and
``(B) such sums as are necessary for each of the
four succeeding fiscal years.
``(2) Availability.--Any amount appropriated under paragraph
(1) shall remain available to carry out this section until
expended.''.

(c) Foundation for the National Institutes of Health.--Section
499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 290b(c)(1)(C))
is amended by striking ``and studies listed by the Secretary pursuant to
section 409I(a)(1)(A) of this Act and referred under section
505A(d)(4)(C) of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
355(a)(d)(4)(C)' '' and inserting ``and studies for which the Secretary
issues a certification in the affirmative under section 505A(n)(1)(A) of
the Federal Food, Drug, and Cosmetic Act''.
(d) Continuation of Operation of Committee.--Section 14 of the Best
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended by
adding at the end the following new subsection:
``(d) Continuation of Operation of Committee.--Notwithstanding
section 14 of the Federal Advisory Committee Act, the advisory committee
shall continue to operate during the five-year period beginning on the
date of the enactment of the Best Pharmaceuticals for Children Act of
2007.''.
(e) Pediatric Subcommittee of the Oncologic Drugs Advisory
Committee.--Section 15 of the Best Pharmaceuticals for Children Act (42
U.S.C. 284m note) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) in subparagraph (B), by striking ``and''
after the semicolon;
(ii) in subparagraph (C), by striking the
period at the end and inserting ``; and''; and
(iii) by adding at the end the following new
subparagraph:
``(D) provide recommendations to the internal review
committee created under section 505B(f) of the Federal
Food, Drug, and Cosmetic Act regarding the
implementation of amendments to sections 505A and 505B
of the

[[Page 890]]
121 STAT. 890

Federal Food, Drug, and Cosmetic Act with respect to the
treatment of pediatric cancers.''; and
(B) by adding at the end the following new
paragraph:
``(3) Continuation of operation of subcommittee.--
Notwithstanding section 14 of the Federal Advisory Committee
Act, the Subcommittee shall continue to operate during the five-
year period beginning on the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007.''; and
(2) in subsection (d), by striking ``2003'' and inserting
``2009''.

(f) Effective Date and Limitation for Rule Relating to Toll-Free
Number for Adverse Events on Labeling for Human Drug Products.--
(1) In general.--Notwithstanding subchapter II of chapter 5,
and chapter 7, of title 5, United States Code (commonly known as
the ``Administrative Procedure Act'') and any other provision of
law, the proposed rule issued by the Commissioner of Food and
Drugs entitled ``Toll-Free Number for Reporting Adverse Events
on Labeling for Human Drug Products,'' 69 Fed. Reg. 21778,
(April 22, 2004) shall take effect on January 1, 2008, unless
such Commissioner issues the final rule before such date.
(2) Limitation.--The proposed rule that takes effect under
subsection (a), or the final rule described under subsection
(a), shall, notwithstanding section 17(a) of the Best
Pharmaceuticals for Children Act (21 U.S.C. 355b(a)), not apply
to a drug--
(A) for which an application is approved under
section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355);
(B) that is not described under section 503(b)(1) of
such Act (21 U.S.C. 353(b)(1)); and
(C) the packaging of which includes a toll-free
number through which consumers can report complaints to
the manufacturer or distributor of the drug.
SEC. 503. TRAINING OF PEDIATRIC PHARMACOLOGISTS.

(a) Investment in Tomorrow's Pediatric Researchers.--Section 452G(2)
of the Public Health Service Act (42 U.S.C. 285g-10(2)) is amended by
adding before the period at the end the following: ``, including
pediatric pharmacological research''.
(b) Pediatric Research Loan Repayment Program.--Section 487F(a)(1)
of the Public Health Service Act (42 U.S.C. 288-6(a)(1)) is amended by
inserting ``including pediatric pharmacological research,'' after
``pediatric research,''.

TITLE VI--REAGAN-UDALL FOUNDATION

SEC. 601. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG
ADMINISTRATION.

(a) In General.--Chapter VII of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 371 et seq.) is amended by adding at the end the
following:

[[Page 891]]
121 STAT. 891

``Subchapter I--Reagan-Udall Foundation for the Food and Drug
Administration

``SEC. 770. [NOTE: 21 USC 379dd.] ESTABLISHMENT AND FUNCTIONS OF
THE FOUNDATION.

``(a) In General.--A nonprofit corporation to be known as the
Reagan-Udall Foundation for the Food and Drug Administration (referred
to in this subchapter as the `Foundation') shall be established in
accordance with this section. The Foundation shall be headed by an
Executive Director, appointed by the members of the Board of Directors
under subsection (e). The Foundation shall not be an agency or
instrumentality of the United States Government.
``(b) Purpose of Foundation.--The purpose of the Foundation is to
advance the mission of the Food and Drug Administration to modernize
medical, veterinary, food, food ingredient, and cosmetic product
development, accelerate innovation, and enhance product safety.
``(c) Duties of the Foundation.--The Foundation shall--
``(1) taking into consideration the Critical Path reports
and priorities published by the Food and Drug Administration,
identify unmet needs in the development, manufacture, and
evaluation of the safety and effectiveness, including
postapproval, of devices, including diagnostics, biologics, and
drugs, and the safety of food, food ingredients, and cosmetics,
and including the incorporation of more sensitive and predictive
tools and devices to measure safety;
``(2) establish goals and priorities in order to meet the
unmet needs identified in paragraph (1);
``(3) in consultation with the Secretary, identify existing
and proposed Federal intramural and extramural research and
development programs relating to the goals and priorities
established under paragraph (2), coordinate Foundation
activities with such programs, and minimize Foundation
duplication of existing efforts;
``(4) [NOTE: Grants. Contracts. Memorandums.] award grants
to, or enter into contracts, memoranda of understanding, or
cooperative agreements with, scientists and entities, which may
include the Food and Drug Administration, university consortia,
public-private partnerships, institutions of higher education,
entities described in section 501(c)(3) of the Internal Revenue
Code (and exempt from tax under section 501(a) of such Code),
and industry, to efficiently and effectively advance the goals
and priorities established under paragraph (2);
``(5) recruit meeting participants and hold or sponsor (in
whole or in part) meetings as appropriate to further the goals
and priorities established under paragraph (2);
``(6) [NOTE: Publication.] release and publish information
and data and, to the extent practicable, license, distribute,
and release material, reagents, and techniques to maximize,
promote, and coordinate the availability of such material,
reagents, and techniques for use by the Food and Drug
Administration, nonprofit organizations, and academic and
industrial researchers to further the goals and priorities
established under paragraph (2);
``(7) ensure that--
``(A) action is taken as necessary to obtain patents
for inventions developed by the Foundation or with funds
from the Foundation;

[[Page 892]]
121 STAT. 892

``(B) action is taken as necessary to enable the
licensing of inventions developed by the Foundation or
with funds from the Foundation; and
``(C) executed licenses, memoranda of understanding,
material transfer agreements, contracts, and other such
instruments, promote, to the maximum extent practicable,
the broadest conversion to commercial and noncommercial
applications of licensed and patented inventions of the
Foundation to further the goals and priorities
established under paragraph (2);
``(8) provide objective clinical and scientific information
to the Food and Drug Administration and, upon request, to other
Federal agencies to assist in agency determinations of how to
ensure that regulatory policy accommodates scientific advances
and meets the agency's public health mission;
``(9) conduct annual assessments of the unmet needs
identified in paragraph (1); and
``(10) carry out such other activities consistent with the
purposes of the Foundation as the Board determines appropriate.

``(d) Board of Directors.--
``(1) Establishment.--
``(A) In general.--The Foundation shall have a Board
of Directors (referred to in this subchapter as the
`Board'), which shall be composed of ex officio and
appointed members in accordance with this subsection.
All appointed members of the Board shall be voting
members.
``(B) Ex officio members.--The ex officio members of
the Board shall be the following individuals or their
designees:
``(i) The Commissioner.
``(ii) The Director of the National Institutes
of Health.
``(iii) The Director of the Centers for
Disease Control and Prevention.
``(iv) The Director of the Agency for
Healthcare Research and Quality.
``(C) Appointed members.--
``(i) In general.--The ex officio members of
the Board under subparagraph (B) shall, by
majority vote, appoint to the Board 14
individuals, of which 9 shall be from a list of
candidates to be provided by the National Academy
of Sciences and 5 shall be from lists of
candidates provided by patient and consumer
advocacy groups, professional scientific and
medical societies, and industry trade
organizations. Of such appointed members--
``(I) 4 shall be representatives of
the general pharmaceutical, device,
food, cosmetic, and biotechnology
industries;
``(II) 3 shall be representatives of
academic research organizations;
``(III) 2 shall be representatives
of patient or consumer advocacy
organizations;
``(IV) 1 shall be a representative
of health care providers; and

[[Page 893]]
121 STAT. 893

``(V) 4 shall be at-large members
with expertise or experience relevant to
the purpose of the Foundation.
``(ii) Requirements.--
``(I) Expertise.--The ex officio
members shall ensure the Board
membership includes individuals with
expertise in areas including the
sciences of developing, manufacturing,
and evaluating the safety and
effectiveness of devices, including
diagnostics, biologics, and drugs, and
the safety of food, food ingredients,
and cosmetics.
``(II) Federal employees.--No
employee of the Federal Government shall
be appointed as a member of the Board
under this subparagraph or under
paragraph (3)(B).
``(D) Initial meeting.--
``(i) In [NOTE: Deadline.] general.--Not
later than 30 days after the date of the enactment
of this subchapter, the Secretary shall convene a
meeting of the ex officio members of the Board
to--
``(I) incorporate the Foundation;
and
``(II) appoint the members of the
Board in accordance with subparagraph
(C).
``(ii) Service of ex officio members.--Upon
the appointment of the members of the Board under
clause (i)(II)--
``(I) the terms of service of the
Director of the Centers for Disease
Control and Prevention and of the
Director of the Agency for Healthcare
Research and Quality as ex officio
members of the Board shall terminate;
and
``(II) the Commissioner and the
Director of the National Institutes of
Health shall continue to serve as ex
officio members of the Board, but shall
be nonvoting members.
``(iii) Chair.--The ex officio members of the
Board under subparagraph (B) shall designate an
appointed member of the Board to serve as the
Chair of the Board.
``(2) Duties of board.--The Board shall--
``(A) establish bylaws for the Foundation that--
``(i) [NOTE: Federal
Register, publication.] are published in the
Federal Register and available for public comment;
``(ii) establish policies for the selection of
the officers, employees, agents, and contractors
of the Foundation;
``(iii) establish policies, including ethical
standards, for the acceptance, solicitation, and
disposition of donations and grants to the
Foundation and for the disposition of the assets
of the Foundation, including appropriate limits on
the ability of donors to designate, by stipulation
or restriction, the use or recipient of donated
funds;
``(iv) establish policies that would subject
all employees, fellows, and trainees of the
Foundation to the conflict of interest standards
under section 208 of title 18, United States Code;

[[Page 894]]
121 STAT. 894

``(v) establish licensing, distribution, and
publication policies that support the widest and
least restrictive use by the public of information
and inventions developed by the Foundation or with
Foundation funds to carry out the duties described
in paragraphs (6) and (7) of subsection (c), and
may include charging cost-based fees for published
material produced by the Foundation;
``(vi) specify principles for the review of
proposals and awarding of grants and contracts
that include peer review and that are consistent
with those of the Foundation for the National
Institutes of Health, to the extent determined
practicable and appropriate by the Board;
``(vii) specify a cap on administrative
expenses for recipients of a grant, contract, or
cooperative agreement from the Foundation;
``(viii) establish policies for the execution
of memoranda of understanding and cooperative
agreements between the Foundation and other
entities, including the Food and Drug
Administration;
``(ix) establish policies for funding training
fellowships, whether at the Foundation, academic
or scientific institutions, or the Food and Drug
Administration, for scientists, doctors, and other
professionals who are not employees of regulated
industry, to foster greater understanding of and
expertise in new scientific tools, diagnostics,
manufacturing techniques, and potential barriers
to translating basic research into clinical and
regulatory practice;
``(x) specify a process for annual Board
review of the operations of the Foundation; and
``(xi) establish specific duties of the
Executive Director;
``(B) prioritize and provide overall direction to
the activities of the Foundation;
``(C) evaluate the performance of the Executive
Director; and
``(D) carry out any other necessary activities
regarding the functioning of the Foundation.
``(3) Terms and vacancies.--
``(A) Term.--The term of office of each member of
the Board appointed under paragraph (1)(C) shall be 4
years, except that the terms of offices for the initial
appointed members of the Board shall expire on a
staggered basis as determined by the ex officio members.
``(B) Vacancy.--Any vacancy in the membership of the
Board--
``(i) shall not affect the power of the
remaining members to execute the duties of the
Board; and
``(ii) shall be filled by appointment by the
appointed members described in paragraph (1)(C) by
majority vote.
``(C) Partial term.--If a member of the Board does
not serve the full term applicable under subparagraph
(A), the individual appointed under subparagraph (B) to
fill

[[Page 895]]
121 STAT. 895

the resulting vacancy shall be appointed for the
remainder of the term of the predecessor of the
individual.
``(D) Serving past term.--A member of the Board may
continue to serve after the expiration of the term of
the member until a successor is appointed.
``(4) Compensation.--Members of the Board may not receive
compensation for service on the Board. Such members may be
reimbursed for travel, subsistence, and other necessary expenses
incurred in carrying out the duties of the Board, as set forth
in the bylaws issued by the Board.

``(e) Incorporation.--The ex officio members of the Board shall
serve as incorporators and shall take whatever actions necessary to
incorporate the Foundation.
``(f) Nonprofit Status.--In carrying out subsection (b), the Board
shall establish such policies and bylaws under subsection (d), and the
Executive Director shall carry out such activities under subsection (g),
as may be necessary to ensure that the Foundation maintains status as an
organization that--
``(1) is described in subsection (c)(3) of section 501 of
the Internal Revenue Code of 1986; and
``(2) is, under subsection (a) of such section, exempt from
taxation.

``(g) Executive Director.--
``(1) In general.--The Board shall appoint an Executive
Director who shall serve at the pleasure of the Board. The
Executive Director shall be responsible for the day-to-day
operations of the Foundation and shall have such specific duties
and responsibilities as the Board shall prescribe.
``(2) Compensation.--The compensation of the Executive
Director shall be fixed by the Board but shall not be greater
than the compensation of the Commissioner.

``(h) Administrative Powers.--In carrying out this subchapter, the
Board, acting through the Executive Director, may--
``(1) adopt, alter, and use a corporate seal, which shall be
judicially noticed;
``(2) hire, promote, compensate, and discharge 1 or more
officers, employees, and agents, as may be necessary, and define
their duties;
``(3) prescribe the manner in which--
``(A) real or personal property of the Foundation is
acquired, held, and transferred;
``(B) general operations of the Foundation are to be
conducted; and
``(C) the privileges granted to the Board by law are
exercised and enjoyed;
``(4) with the consent of the applicable executive
department or independent agency, use the information, services,
and facilities of such department or agencies in carrying out
this section;
``(5) enter into contracts with public and private
organizations for the writing, editing, printing, and publishing
of books and other material;
``(6) hold, administer, invest, and spend any gift, devise,
or bequest of real or personal property made to the Foundation
under subsection (i);
``(7) enter into such other contracts, leases, cooperative
agreements, and other transactions as the Board considers
appropriate to conduct the activities of the Foundation;

[[Page 896]]
121 STAT. 896

``(8) modify or consent to the modification of any contract
or agreement to which it is a party or in which it has an
interest under this subchapter;
``(9) take such action as may be necessary to obtain patents
and licenses for devices and procedures developed by the
Foundation and its employees;
``(10) sue and be sued in its corporate name, and complain
and defend in courts of competent jurisdiction;
``(11) appoint other groups of advisors as may be determined
necessary to carry out the functions of the Foundation; and
``(12) exercise other powers as set forth in this section,
and such other incidental powers as are necessary to carry out
its powers, duties, and functions in accordance with this
subchapter.

``(i) Acceptance of Funds From Other Sources.--The Executive
Director may solicit and accept on behalf of the Foundation, any funds,
gifts, grants, devises, or bequests of real or personal property made to
the Foundation, including from private entities, for the purposes of
carrying out the duties of the Foundation.
``(j) Service of Federal Employees.--Federal Government employees
may serve on committees advisory to the Foundation and otherwise
cooperate with and assist the Foundation in carrying out its functions,
so long as such employees do not direct or control Foundation
activities.
``(k) Detail of Government Employees; Fellowships.--
``(1) Detail from federal agencies.--Federal Government
employees may be detailed from Federal agencies with or without
reimbursement to those agencies to the Foundation at any time,
and such detail shall be without interruption or loss of civil
service status or privilege. Each such employee shall abide by
the statutory, regulatory, ethical, and procedural standards
applicable to the employees of the agency from which such
employee is detailed and those of the Foundation.
``(2) Voluntary service; acceptance of federal employees.--
``(A) Foundation.--The Executive Director of the
Foundation may accept the services of employees detailed
from Federal agencies with or without reimbursement to
those agencies.
``(B) Food and drug administration.--The
Commissioner may accept the uncompensated services of
Foundation fellows or trainees. Such services shall be
considered to be undertaking an activity under contract
with the Secretary as described in section 708.

``(l) Annual Reports.--
``(1) Reports to foundation.--Any recipient of a grant,
contract, fellowship, memorandum of understanding, or
cooperative agreement from the Foundation under this section
shall submit to the Foundation a report on an annual basis for
the duration of such grant, contract, fellowship, memorandum of
understanding, or cooperative agreement, that describes the
activities carried out under such grant, contract, fellowship,
memorandum of understanding, or cooperative agreement.
``(2) Report to congress and the fda.--Beginning with fiscal
year 2009, the Executive Director shall submit to Congress and
the Commissioner an annual report that--

[[Page 897]]
121 STAT. 897

``(A) describes the activities of the Foundation and
the progress of the Foundation in furthering the goals
and priorities established under subsection (c)(2),
including the practical impact of the Foundation on
regulated product development;
``(B) provides a specific accounting of the source
and use of all funds used by the Foundation to carry out
such activities; and
``(C) provides information on how the results of
Foundation activities could be incorporated into the
regulatory and product review activities of the Food and
Drug Administration.

``(m) Separation of Funds.--The Executive Director shall ensure that
the funds received from the Treasury are held in separate accounts from
funds received from entities under subsection (i).
``(n) Funding.--From amounts appropriated to the Food and Drug
Administration for each fiscal year, the Commissioner shall transfer not
less than $500,000 and not more than $1,250,000, to the Foundation to
carry out subsections (a), (b), and (d) through (m).''.
(b) Other Foundation Provisions.--Chapter VII of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) (as amended by subsection
(a)) is amended by adding at the end the following:
``SEC. 771. [NOTE: 21 USC 379dd-1.] LOCATION OF FOUNDATION.

``The Foundation shall, if practicable, be located not more than 20
miles from the District of Columbia.
``SEC. 772. [NOTE: 21 USC 379dd-2.] ACTIVITIES OF THE FOOD AND
DRUG ADMINISTRATION.

``(a) In General.--The Commissioner shall receive and assess the
report submitted to the Commissioner by the Executive Director of the
Foundation under section 770(l)(2).
``(b) Report to Congress.--Beginning with fiscal year 2009, the
Commissioner shall submit to Congress an annual report summarizing the
incorporation of the information provided by the Foundation in the
report described under section 770(l)(2) and by other recipients of
grants, contracts, memoranda of understanding, or cooperative agreements
into regulatory and product review activities of the Food and Drug
Administration.
``(c) Extramural Grants.--The provisions of this subchapter and
section 566 shall have no effect on any grant, contract, memorandum of
understanding, or cooperative agreement between the Food and Drug
Administration and any other entity entered into before, on, or after
the date of the enactment of this subchapter.''.
(c) Conforming Amendment.--Section 742(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379l(b)) is amended by adding at the end the
following: ``Any such fellowships and training programs under this
section or under section 770(d)(2)(A)(ix) may include provision by such
scientists and physicians of services on a voluntary and uncompensated
basis, as the Secretary determines appropriate. Such scientists and
physicians shall be subject to all legal and ethical requirements
otherwise applicable to officers or employees of the Department of
Health and Human Services.''.

[[Page 898]]
121 STAT. 898

SEC. 602. OFFICE OF THE CHIEF SCIENTIST.

Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
391 et seq.) is amended by adding at the end the following:
``SEC. 910. [NOTE: 21 USC 399a.] OFFICE OF THE CHIEF SCIENTIST.

``(a) Establishment; Appointment.--The Secretary shall establish
within the Office of the Commissioner an office to be known as the
Office of the Chief Scientist. The Secretary shall appoint a Chief
Scientist to lead such Office.
``(b) Duties of the Office.--The Office of the Chief Scientist
shall--
``(1) oversee, coordinate, and ensure quality and regulatory
focus of the intramural research programs of the Food and Drug
Administration;
``(2) track and, to the extent necessary, coordinate
intramural research awards made by each center of the
Administration or science-based office within the Office of the
Commissioner, and ensure that there is no duplication of
research efforts supported by the Reagan-Udall Foundation for
the Food and Drug Administration;
``(3) develop and advocate for a budget to support
intramural research;
``(4) develop a peer review process by which intramural
research can be evaluated;
``(5) identify and solicit intramural research proposals
from across the Food and Drug Administration through an advisory
board composed of employees of the Administration that shall
include--
``(A) representatives of each of the centers and the
science-based offices within the Office of the
Commissioner; and
``(B) experts on trial design, epidemiology,
demographics, pharmacovigilance, basic science, and
public health; and
``(6) develop postmarket safety performance measures that
are as measurable and rigorous as the ones already developed for
premarket review.''.
SEC. 603. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.

Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the
following:
``SEC. 566. [NOTE: 21 USC 360bbb-5.] CRITICAL PATH PUBLIC-
PRIVATE PARTNERSHIPS.

``(a) Establishment.--The Secretary, acting through the Commissioner
of Food and Drugs, may enter into collaborative agreements, to be known
as Critical Path Public-Private Partnerships, with one or more eligible
entities to implement the Critical Path Initiative of the Food and Drug
Administration by developing innovative, collaborative projects in
research, education, and outreach for the purpose of fostering medical
product innovation, enabling the acceleration of medical product
development, manufacturing, and translational therapeutics, and
enhancing medical product safety.
``(b) Eligible Entity.--In this section, the term `eligible entity'
means an entity that meets each of the following:
``(1) The entity is--

[[Page 899]]
121 STAT. 899

``(A) an institution of higher education (as such
term is defined in section 101 of the Higher Education
Act of 1965) or a consortium of such institutions; or
``(B) an organization described in section 501(c)(3)
of the Internal Revenue Code of 1986 and exempt from tax
under section 501(a) of such Code.
``(2) The entity has experienced personnel and clinical and
other technical expertise in the biomedical sciences, which may
include graduate training programs in areas relevant to
priorities of the Critical Path Initiative.
``(3) The entity demonstrates to the Secretary's
satisfaction that the entity is capable of--
``(A) developing and critically evaluating tools,
methods, and processes--
``(i) to increase efficiency, predictability,
and productivity of medical product development;
and
``(ii) to more accurately identify the
benefits and risks of new and existing medical
products;
``(B) establishing partnerships, consortia, and
collaborations with health care practitioners and other
providers of health care goods or services; pharmacists;
pharmacy benefit managers and purchasers; health
maintenance organizations and other managed health care
organizations; health care insurers; government
agencies; patients and consumers; manufacturers of
prescription drugs, biological products, diagnostic
technologies, and devices; and academic scientists; and
``(C) securing funding for the projects of a
Critical Path Public-Private Partnership from Federal
and nonfederal governmental sources, foundations, and
private individuals.

``(c) Funding.--The Secretary may not enter into a collaborative
agreement under subsection (a) unless the eligible entity involved
provides an assurance that the entity will not accept funding for a
Critical Path Public-Private Partnership project from any organization
that manufactures or distributes products regulated by the Food and Drug
Administration unless the entity provides assurances in its agreement
with the Food and Drug Administration that the results of the Critical
Path Public-Private Partnership project will not be influenced by any
source of funding.
``(d) Annual Report.--Not later than 18 months after the date of the
enactment of this section, and annually thereafter, the Secretary, in
collaboration with the parties to each Critical Path Public-Private
Partnership, shall submit a report to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives--
``(1) reviewing the operations and activities of the
Partnerships in the previous year; and
``(2) addressing such other issues relating to this section
as the Secretary determines to be appropriate.

``(e) Definition.--In this section, the term `medical product'
includes a drug, a biological product as defined in section 351 of the
Public Health Service Act, a device, and any combination of such
products.
``(f) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $5,000,000 for fiscal

[[Page 900]]
121 STAT. 900

year 2008 and such sums as may be necessary for each of fiscal years
2009 through 2012.''.

TITLE VII--CONFLICTS OF INTEREST

SEC. 701. CONFLICTS OF INTEREST.

(a) In General.--Subchapter A of chapter VII of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by inserting
at the end the following:
``SEC. 712. [NOTE: 21 USC 379d-1.] CONFLICTS OF INTEREST.

``(a) Definitions.--For purposes of this section:
``(1) Advisory committee.--The term `advisory committee'
means an advisory committee under the Federal Advisory Committee
Act that provides advice or recommendations to the Secretary
regarding activities of the Food and Drug Administration.
``(2) Financial interest.--The term `financial interest'
means a financial interest under section 208(a) of title 18,
United States Code.

``(b) Appointments to Advisory Committees.--
``(1) Recruitment.--
``(A) In general.--The Secretary shall--
``(i) develop and implement strategies on
effective outreach to potential members of
advisory committees at universities, colleges,
other academic research centers, professional and
medical societies, and patient and consumer
groups;
``(ii) seek input from professional medical
and scientific societies to determine the most
effective informational and recruitment
activities; and
``(iii) take into account the advisory
committees with the greatest number of vacancies.
``(B) Recruitment activities.--The recruitment
activities under subparagraph (A) may include--
``(i) advertising the process for becoming an
advisory committee member at medical and
scientific society conferences;
``(ii) making widely available, including by
using existing electronic communications channels,
the contact information for the Food and Drug
Administration point of contact regarding advisory
committee nominations; and
``(iii) developing a method through which an
entity receiving funding from the National
Institutes of Health, the Agency for Healthcare
Research and Quality, the Centers for Disease
Control and Prevention, or the Veterans Health
Administration can identify a person who the Food
and Drug Administration can contact regarding the
nomination of individuals to serve on advisory
committees.
``(2) Evaluation and criteria.--When considering a term
appointment to an advisory committee, the Secretary shall review
the expertise of the individual and the financial disclosure
report filed by the individual pursuant to the Ethics in
Government Act of 1978 for each individual under consideration

[[Page 901]]
121 STAT. 901

for the appointment, so as to reduce the likelihood that an
appointed individual will later require a written determination
as referred to in section 208(b)(1) of title 18, United States
Code, a written certification as referred to in section
208(b)(3) of title 18, United States Code, or a waiver as
referred to in subsection (c)(2) of this section for service on
the committee at a meeting of the committee.

``(c) Disclosures; Prohibitions on Participation; Waivers.--
``(1) Disclosure of financial interest.--Prior to a meeting
of an advisory committee regarding a `particular matter' (as
that term is used in section 208 of title 18, United States
Code), each member of the committee who is a full-time
Government employee or special Government employee shall
disclose to the Secretary financial interests in accordance with
subsection (b) of such section 208.
``(2) Prohibitions and waivers on participation.--
``(A) In general.--Except as provided under
subparagraph (B), a member of an advisory committee may
not participate with respect to a particular matter
considered in an advisory committee meeting if such
member (or an immediate family member of such member)
has a financial interest that could be affected by the
advice given to the Secretary with respect to such
matter, excluding interests exempted in regulations
issued by the Director of the Office of Government
Ethics as too remote or inconsequential to affect the
integrity of the services of the Government officers or
employees to which such regulations apply.
``(B) Waiver.--If the Secretary determines it
necessary to afford the advisory committee essential
expertise, the Secretary may grant a waiver of the
prohibition in subparagraph (A) to permit a member
described in such subparagraph to--
``(i) participate as a non-voting member with
respect to a particular matter considered in a
committee meeting; or
``(ii) participate as a voting member with
respect to a particular matter considered in a
committee meeting.
``(C) Limitation on waivers and other exceptions.--
``(i) Definition.--For purposes of this
subparagraph, the term `exception' means each of
the following with respect to members of advisory
committees:
``(I) A waiver under section
505(n)(4) (as in effect on the day
before the date of the enactment of the
Food and Drug Administration Amendments
Act of 2007).
``(II) A written determination under
section 208(b) of title 18, United
States Code.
``(III) A written certification
under section 208(b)(3) of such title.
``(ii) Determination of total number of
members slots and member exceptions during fiscal
year 2007.--The Secretary shall determine--
``(I)(aa) for each meeting held by
any advisory committee during fiscal
year 2007, the number of members who
participated in the meeting; and

[[Page 902]]
121 STAT. 902

``(bb) the sum of the respective
numbers determined under item (aa)
(referred to in this subparagraph as the
``total number of 2007 meeting slots'');
and
``(II)(aa) for each meeting held by
any advisory committee during fiscal
year 2007, the number of members who
received an exception for the meeting;
and
``(bb) the sum of the respective
numbers determined under item (aa)
(referred to in this subparagraph as the
``total number of 2007 meeting
exceptions'').
``(iii) Determination of percentage regarding
exceptions during fiscal year 2007.--The Secretary
shall determine the percentage constituted by--
``(I) the total number of 2007
meeting exceptions; divided by
``(II) the total number of 2007
meeting slots.
``(iv) Limitation for fiscal years 2008
through 2012.--The number of exceptions at the
Food and Drug Administration for members of
advisory committees for a fiscal year may not
exceed the following:
``(I) For fiscal year 2008, 95
percent of the percentage determined
under clause (iii) (referred to in this
clause as the ``base percentage'').
``(II) For fiscal year 2009, 90
percent of the base percentage.
``(III) For fiscal year 2010, 85
percent of the base percentage.
``(IV) For fiscal year 2011, 80
percent of the base percentage.
``(V) For fiscal year 2012, 75
percent of the base percentage.
``(v) Allocation of exceptions.--The
exceptions authorized under clause (iv) for a
fiscal year may be allocated within the centers or
other organizational units of the Food and Drug
Administration as determined appropriate by the
Secretary.
``(3) Disclosure
of [NOTE: Applicability. Website.] waiver.--Notwithstanding
section 107(a)(2) of the Ethics in Government Act (5 U.S.C.
App.), the following shall apply:
``(A) 15 or more days in advance.--As soon as
practicable, but (except as provided in subparagraph
(B)) not later than 15 days prior to a meeting of an
advisory committee to which a written determination as
referred to in section 208(b)(1) of title 18, United
States Code, a written certification as referred to in
section 208(b)(3) of title 18, United States Code, or a
waiver as referred to in paragraph (2)(B) applies, the
Secretary shall disclose (other than information
exempted from disclosure under section 552 of title 5,
United States Code, and section 552a of title 5, United
States Code (popularly known as the Freedom of
Information Act and the Privacy Act of 1974,
respectively)) on the Internet Web site of the Food and
Drug Administration--
``(i) the type, nature, and magnitude of the
financial interests of the advisory committee
member to

[[Page 903]]
121 STAT. 903

which such determination, certification, or waiver
applies; and
``(ii) the reasons of the Secretary for such
determination, certification, or waiver.
``(B) Less than 30 days in advance.--In the case of
a financial interest that becomes known to the Secretary
less than 30 days prior to a meeting of an advisory
committee to which a written determination as referred
to in section 208(b)(1) of title 18, United States Code,
a written certification as referred to in section
208(b)(3) of title 18, United States Code, or a waiver
as referred to in paragraph (2)(B) applies, the
Secretary shall disclose (other than information
exempted from disclosure under section 552 of title 5,
United States Code, and section 552a of title 5, United
States Code) on the Internet Web site of the Food and
Drug Administration, the information described in
clauses (i) and (ii) of subparagraph (A) as soon as
practicable after the Secretary makes such
determination, certification, or waiver, but in no case
later than the date of such meeting.

``(d) Public Record.--The Secretary shall ensure that the public
record and transcript of each meeting of an advisory committee includes
the disclosure required under subsection (c)(3) (other than information
exempted from disclosure under section 552 of title 5, United States
Code, and section 552a of title 5, United States Code).
``(e) Annual Report.--Not later than February 1 of each year, the
Secretary shall submit to the Committee on Appropriations and the
Committee on Health, Education, Labor, and Pensions of the Senate, and
the Committee on Appropriations and the Committee on Energy and Commerce
of the House of Representatives a report that describes--
``(1) with respect to the fiscal year that ended on
September 30 of the previous year, the number of vacancies on
each advisory committee, the number of nominees received for
each committee, and the number of such nominees willing to
serve;
``(2) with respect to such year, the aggregate number of
disclosures required under subsection (c)(3) for each meeting of
each advisory committee and the percentage of individuals to
whom such disclosures did not apply who served on such committee
for each such meeting;
``(3) with respect to such year, the number of times the
disclosures required under subsection (c)(3) occurred under
subparagraph (B) of such subsection; and
``(4) how the Secretary plans to reduce the number of
vacancies reported under paragraph (1) during the fiscal year
following such year, and mechanisms to encourage the nomination
of individuals for service on an advisory committee, including
those who are classified by the Food and Drug Administration as
academicians or practitioners.

``(f) Periodic Review of Guidance.--Not less than once every 5
years, the Secretary shall review guidance of the Food and Drug
Administration regarding conflict of interest waiver determinations with
respect to advisory committees and update such guidance as necessary.''.
(b) Conforming Amendments.--Section 505(n) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended by--

[[Page 904]]
121 STAT. 904

(1) striking paragraph (4); and
(2) redesignating paragraphs (5), (6), (7), and (8) as
paragraphs (4), (5), (6), and (7), respectively.

(c) Effective [NOTE: 21 USC 355 note.] Date.--The amendments made
by this section shall take effect on October 1, 2007.

TITLE VIII--CLINICAL TRIAL DATABASES

SEC. 801. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.

(a) In General.--Section 402 of the Public Health Service Act (42
U.S.C. 282) is amended by--
(1) redesignating subsections (j) and (k) as subsections (k)
and (l), respectively; and
(2) inserting after subsection (i) the following:

``(j) Expanded Clinical Trial Registry Data Bank.--
``(1) Definitions; requirement.--
``(A) Definitions.--In this subsection:
``(i) Applicable clinical trial.--The term
`applicable clinical trial' means an applicable
device clinical trial or an applicable drug
clinical trial.
``(ii) Applicable device clinical trial.--The
term `applicable device clinical trial' means--
``(I) a prospective clinical study
of health outcomes comparing an
intervention with a device subject to
section 510(k), 515, or 520(m) of the
Federal Food, Drug, and Cosmetic Act
against a control in human subjects
(other than a small clinical trial to
determine the feasibility of a device,
or a clinical trial to test prototype
devices where the primary outcome
measure relates to feasibility and not
to health outcomes); and
``(II) a pediatric postmarket
surveillance as required under section
522 of the Federal Food, Drug, and
Cosmetic Act.
``(iii) Applicable drug clinical trial.--
``(I) In general.--The term
`applicable drug clinical trial' means a
controlled clinical investigation, other
than a phase I clinical investigation,
of a drug subject to section 505 of the
Federal Food, Drug, and Cosmetic Act or
to section 351 of this Act.
``(II) Clinical investigation.--For
purposes of subclause (I), the term
`clinical investigation' has the meaning
given that term in section 312.3 of
title 21, Code of Federal Regulations
(or any successor regulation).
``(III) Phase i.--For purposes of
subclause (I), the term `phase I' has
the meaning given that term in section
312.21 of title 21, Code of Federal
Regulations (or any successor
regulation).
``(iv) Clinical trial information.--The term
`clinical trial information' means, with respect
to an applicable clinical trial, those data
elements that the responsible party is required to
submit under paragraph (2) or under paragraph (3).

[[Page 905]]
121 STAT. 905

``(v) Completion date.--The term `completion
date' means, with respect to an applicable
clinical trial, the date that the final subject
was examined or received an intervention for the
purposes of final collection of data for the
primary outcome, whether the clinical trial
concluded according to the prespecified protocol
or was terminated.
``(vi) Device.--The term `device' means a
device as defined in section 201(h) of the Federal
Food, Drug, and Cosmetic Act.
``(vii) Drug.--The term `drug' means a drug as
defined in section 201(g) of the Federal Food,
Drug, and Cosmetic Act or a biological product as
defined in section 351 of this Act.
``(viii) Ongoing.--The term `ongoing' means,
with respect to a clinical trial of a drug or a
device and to a date, that--
``(I) 1 or more patients is enrolled
in the clinical trial; and
``(II) the date is before the
completion date of the clinical trial.
``(ix) Responsible party.--The term
`responsible party', with respect to a clinical
trial of a drug or device, means--
``(I) the sponsor of the clinical
trial (as defined in section 50.3 of
title 21, Code of Federal Regulations
(or any successor regulation)); or
``(II) the principal investigator of
such clinical trial if so designated by
a sponsor, grantee, contractor, or
awardee, so long as the principal
investigator is responsible for
conducting the trial, has access to and
control over the data from the clinical
trial, has the right to publish the
results of the trial, and has the
ability to meet all of the requirements
under this subsection for the submission
of clinical trial information.
``(B) Requirement.--The Secretary shall develop a
mechanism by which the responsible party for each
applicable clinical trial shall submit the identity and
contact information of such responsible party to the
Secretary at the time of submission of clinical trial
information under paragraph (2).
``(2) Expansion of clinical trial registry data bank with
respect to clinical trial information.--
``(A) In general.--
``(i) Expansion of data bank.--To enhance
patient enrollment and provide a mechanism to
track subsequent progress of clinical trials, the
Secretary, acting through the Director of NIH,
shall expand, in accordance with this subsection,
the clinical trials registry of the data bank
described under subsection (i)(1) (referred to in
this subsection as the `registry data bank').
The [NOTE: Public
information. Internet.] Director of NIH shall
ensure that the registry data bank is made
publicly available through the Internet.

[[Page 906]]
121 STAT. 906

``(ii) Content.--The clinical trial
information required to be submitted under this
paragraph for an applicable clinical trial shall
include--
``(I) descriptive information,
including--
``(aa) a brief title,
intended for the lay public;
``(bb) a brief summary,
intended for the lay public;
``(cc) the primary purpose;
``(dd) the study design;
``(ee) for an applicable
drug clinical trial, the study
phase;
``(ff) study type;
``(gg) the primary disease
or condition being studied, or
the focus of the study;
``(hh) the intervention name
and intervention type;
``(ii) the study start date;
``(jj) the expected
completion date;
``(kk) the target number of
subjects; and
``(ll) outcomes, including
primary and secondary outcome
measures;
``(II) recruitment information,
including--
``(aa) eligibility criteria;
``(bb) gender;
``(cc) age limits;
``(dd) whether the trial
accepts healthy volunteers;
``(ee) overall recruitment
status;
``(ff) individual site
status; and
``(gg) in the case of an
applicable drug clinical trial,
if the drug is not approved
under section 505 of the Federal
Food, Drug, and Cosmetic Act or
licensed under section 351 of
this Act, specify whether or not
there is expanded access to the
drug under section 561 of the
Federal Food, Drug, and Cosmetic
Act for those who do not qualify
for enrollment in the clinical
trial and how to obtain
information about such access;
``(III) location and contact
information, including--
``(aa) the name of the
sponsor;
``(bb) the responsible
party, by official title; and
``(cc) the facility name and
facility contact information
(including the city, State, and
zip code for each clinical trial
location, or a toll-free number
through which such location
information may be accessed);
and
``(IV) administrative data (which
the Secretary may make publicly
available as necessary), including--
``(aa) the unique protocol
identification number;
``(bb) other protocol
identification numbers, if any;
and

[[Page 907]]
121 STAT. 907

``(cc) the Food and Drug
Administration IND/IDE protocol
number and the record
verification date.
``(iii) Modifications.--The Secretary may by
regulation modify the requirements for clinical
trial information under this paragraph, if the
Secretary provides a rationale for why such a
modification improves and does not reduce such
clinical trial information.
``(B) Format and structure.--
``(i) Searchable categories.--The Director of
NIH shall ensure that the public may, in addition
to keyword searching, search the entries in the
registry data bank by 1 or more of the following
criteria:
``(I) The disease or condition being
studied in the clinical trial, using
Medical Subject Headers (MeSH)
descriptors.
``(II) The name of the intervention,
including any drug or device being
studied in the clinical trial.
``(III) The location of the clinical
trial.
``(IV) The age group studied in the
clinical trial, including pediatric
subpopulations.
``(V) The study phase of the
clinical trial.
``(VI) The sponsor of the clinical
trial, which may be the National
Institutes of Health or another Federal
agency, a private industry source, or a
university or other organization.
``(VII) The recruitment status of
the clinical trial.
``(VIII) The National Clinical Trial
number or other study identification for
the clinical trial.
``(ii)
Additional [NOTE: Deadline.] searchable
category.--Not later than 18 months after the date
of the enactment of the Food and Drug
Administration Amendments Act of 2007, the
Director of NIH shall ensure that the public may
search the entries of the registry data bank by
the safety issue, if any, being studied in the
clinical trial as a primary or secondary outcome.
``(iii) Other elements.--The Director of NIH
shall also ensure that the public may search the
entries of the registry data bank by such other
elements as the Director deems necessary on an
ongoing basis.
``(iv) Format.--The Director of the NIH shall
ensure that the registry data bank is easily used
by the public, and that entries are easily
compared.
``(C) Data [NOTE: Deadlines.] submission.--The
responsible party for an applicable clinical trial,
including an applicable drug clinical trial for a
serious or life-threatening disease or condition, that
is initiated after, or is ongoing on the date that is 90
days after, the date of the enactment of the Food and
Drug Administration Amendments Act of 2007, shall submit
to the Director of NIH for inclusion in the registry
data bank the clinical trial information described in of
subparagraph (A)(ii) not later than the later of--
``(i) 90 days after such date of enactment;
``(ii) 21 days after the first patient is
enrolled in such clinical trial; or

[[Page 908]]
121 STAT. 908

``(iii) in the case of a clinical trial that
is not for a serious or life-threatening disease
or condition and that is ongoing on such date of
enactment, 1 year after such date of enactment.
``(D) Posting [NOTE: Deadlines.] of data.--
``(i) Applicable drug clinical trial.--The
Director of NIH shall ensure that clinical trial
information for an applicable drug clinical trial
submitted in accordance with this paragraph is
posted in the registry data bank not later than 30
days after such submission.
``(ii) Applicable device clinical trial.--The
Director of NIH shall ensure that clinical trial
information for an applicable device clinical
trial submitted in accordance with this paragraph
is posted publicly in the registry data bank--
``(I) not earlier than the date of
clearance under section 510(k) of the
Federal Food, Drug, and Cosmetic Act, or
approval under section 515 or 520(m) of
such Act, as applicable, for a device
that was not previously cleared or
approved, and not later than 30 days
after such date; or
``(II) for a device that was
previously cleared or approved, not
later than 30 days after the clinical
trial information under paragraph (3)(C)
is required to be posted by the
Secretary.
``(3) Expansion of registry data bank to include results of
clinical trials.--
``(A) Linking registry data bank to existing
results.--
``(i) In [NOTE: Deadlines.] general.--
Beginning not later than 90 days after the date of
the enactment of the Food and Drug Administration
Amendments Act of 2007, for those clinical trials
that form the primary basis of an efficacy claim
or are conducted after the drug involved is
approved or after the device involved is cleared
or approved, the Secretary shall ensure that the
registry data bank includes links to results
information as described in clause (ii) for such
clinical trial--
``(I) not earlier than 30 days after
the date of the approval of the drug
involved or clearance or approval of the
device involved; or
``(II) not later than 30 days after
the results information described in
clause (ii) becomes publicly available.
``(ii) Required information.--
``(I) FDA information.--The
Secretary shall ensure that the registry
data bank includes links to the
following information:
``(aa) If an advisory
committee considered at a
meeting an applicable clinical
trial, any posted Food and Drug
Administration summary document
regarding such applicable
clinical trial.
``(bb) If an applicable drug
clinical trial was conducted
under section 505A or 505B of
the Federal Food, Drug, and
Cosmetic Act,

[[Page 909]]
121 STAT. 909

a link to the posted Food and
Drug Administration assessment
of the results of such trial.
``(cc) Food and Drug
Administration public health
advisories regarding the drug or
device that is the subject of
the applicable clinical trial,
if any.
``(dd) For an applicable
drug clinical trial, the Food
and Drug Administration action
package for approval document
required under section 505(l)(2)
of the Federal Food, Drug, and
Cosmetic Act.
``(ee) For an applicable
device clinical trial, in the
case of a premarket application
under section 515 of the Federal
Food, Drug, and Cosmetic Act,
the detailed summary of
information respecting the
safety and effectiveness of the
device required under section
520(h)(1) of such Act, or, in
the case of a report under
section 510(k) of such Act, the
section 510(k) summary of the
safety and effectiveness data
required under section 807.95(d)
of title 21, Code of Federal
Regulations (or any successor
regulation).
``(II) NIH information.--The
Secretary shall ensure that the registry
data bank includes links to the
following information:
``(aa) Medline citations to
any publications focused on the
results of an applicable
clinical trial.
``(bb) The entry for the
drug that is the subject of an
applicable drug clinical trial
in the National Library of
Medicine database of structured
product labels, if available.
``(iii) Results for existing data bank
entries.--The Secretary may include the links
described in clause (ii) for data bank entries for
clinical trials submitted to the data bank prior
to enactment of the Food and Drug Administration
Amendments Act of 2007, as available.
``(B) Inclusion of results.--The Secretary, acting
through the Director of NIH, shall--
``(i) expand the registry data bank to include
the results of applicable clinical trials
(referred to in this subsection as the `registry
and results data bank');
``(ii) [NOTE: Public
information. Internet.] ensure that such results
are made publicly available through the Internet;
``(iii) post publicly a glossary for the lay
public explaining technical terms related to the
results of clinical trials; and
``(iv) in consultation with experts on risk
communication, provide information with the
information included under subparagraph (C) in the
registry and results data bank to help ensure that
such information does not mislead the patients or
the public.
``(C) Basic [NOTE: Deadline.] results.--Not later
than 1 year after the date of the enactment of the Food
and Drug Administration Amendments Act of 2007, the
Secretary shall include in

[[Page 910]]
121 STAT. 910

the registry and results data bank the following
elements for drugs that are approved under section 505
of the Federal Food, Drug, and Cosmetic Act or licensed
under section 351 of this Act and devices that are
cleared under section 510(k) of the Federal Food, Drug,
and Cosmetic Act or approved under section 515 or 520(m)
of such Act:
``(i) Demographic and baseline characteristics
of patient sample.--A table of the demographic and
baseline data collected overall and for each arm
of the clinical trial to describe the patients who
participated in the clinical trial, including the
number of patients who dropped out of the clinical
trial and the number of patients excluded from the
analysis, if any.
``(ii) Primary and secondary outcomes.--The
primary and secondary outcome measures as
submitted under paragraph (2)(A)(ii)(I)(ll), and a
table of values for each of the primary and
secondary outcome measures for each arm of the
clinical trial, including the results of
scientifically appropriate tests of the
statistical significance of such outcome measures.
``(iii) Point of contact.--A point of contact
for scientific information about the clinical
trial results.
``(iv) Certain agreements.--Whether there
exists an agreement (other than an agreement
solely to comply with applicable provisions of law
protecting the privacy of participants) between
the sponsor or its agent and the principal
investigator (unless the sponsor is an employer of
the principal investigator) that restricts in any
manner the ability of the principal investigator,
after the completion date of the trial, to discuss
the results of the trial at a scientific meeting
or any other public or private forum, or to
publish in a scientific or academic journal
information concerning the results of the trial.
``(D) Expanded registry and results data bank.--
``(i) Expansion
by [NOTE: Deadline.] rulemaking.--To provide
more complete results information and to enhance
patient access to and understanding of the results
of clinical trials, not later than 3 years after
the date of the enactment of the Food and Drug
Administration Amendments Act of 2007, the
Secretary shall by regulation expand the registry
and results data bank as provided under this
subparagraph.
``(ii) Clinical trials.--
``(I) Approved products.--The
regulations under this subparagraph
shall require the inclusion of the
results information described in clause
(iii) for--
``(aa) each applicable drug
clinical trial for a drug that
is approved under section 505 of
the Federal Food, Drug, and
Cosmetic Act or licensed under
section 351 of this Act; and
``(bb) each applicable
device clinical trial for a
device that is cleared under
section 510(k) of the Federal
Food, Drug, and Cosmetic Act or
approved under section 515 or
520(m) of such Act.

[[Page 911]]
121 STAT. 911

``(II) Unapproved products.--The
regulations under this subparagraph
shall establish whether or not the
results information described in clause
(iii) shall be required for--
``(aa) an applicable drug
clinical trial for a drug that
is not approved under section
505 of the Federal Food, Drug,
and Cosmetic Act and not
licensed under section 351 of
this Act (whether approval or
licensure was sought or not);
and
``(bb) an applicable device
clinical trial for a device that
is not cleared under section
510(k) of the Federal Food,
Drug, and Cosmetic Act and not
approved under section 515 or
section 520(m) of such Act
(whether clearance or approval
was sought or not).
``(iii) Required elements.--The regulations
under this subparagraph shall require, in addition
to the elements described in subparagraph (C),
information within each of the following
categories:
``(I) A summary of the clinical
trial and its results that is written in
non-technical, understandable language
for patients, if the Secretary
determines that such types of summary
can be included without being misleading
or promotional.
``(II) A summary of the clinical
trial and its results that is technical
in nature, if the Secretary determines
that such types of summary can be
included without being misleading or
promotional.
``(III) The full protocol or such
information on the protocol for the
trial as may be necessary to help to
evaluate the results of the trial.
``(IV) Such other categories as the
Secretary determines appropriate.
``(iv)
Results [NOTE: Regulations.] submission.--The
results information described in clause (iii)
shall be submitted to the Director of NIH for
inclusion in the registry and results data bank as
provided by subparagraph (E), except that the
Secretary shall by regulation determine--
``(I) whether the 1-year period for
submission of clinical trial information
described in subparagraph (E)(i) should
be increased from 1 year to a period not
to exceed 18 months;
``(II) whether the clinical trial
information described in clause (iii)
should be required to be submitted for
an applicable clinical trial for which
the clinical trial information described
in subparagraph (C) is submitted to the
registry and results data bank before
the effective date of the regulations
issued under this subparagraph; and
``(III) in the case when the
clinical trial information described in
clause (iii) is required to be submitted
for the applicable clinical trials
described in clause (ii)(II), the date
by which such clinical trial information
shall be required to be submitted,
taking into account--

[[Page 912]]
121 STAT. 912

``(aa) the certification
process under subparagraph
(E)(iii) when approval,
licensure, or clearance is
sought; and
``(bb) whether there should
be a delay of submission when
approval, licensure, or
clearance will not be sought.
``(v) Additional provisions.--The regulations
under this subparagraph shall also establish--
``(I) a standard format for the
submission of clinical trial information
under this paragraph to the registry and
results data bank;
``(II) additional information on
clinical trials and results that is
written in nontechnical, understandable
language for patients;

``(III) [NOTE: Procedures.] considering
the experience under the pilot quality
control project described in paragraph
(5)(C), procedures for quality control,
including using representative samples,
with respect to completeness and content
of clinical trial information under this
subsection, to help ensure that data
elements are not false or misleading and
are non-promotional;
``(IV) the appropriate timing and
requirements for updates of clinical
trial information, and whether and, if
so, how such updates should be tracked;
``(V) a statement to accompany the
entry for an applicable clinical trial
when the primary and secondary outcome
measures for such clinical trial are
submitted under paragraph (4)(A) after
the date specified for the submission of
such information in paragraph (2)(C);
and
``(VI) additions or modifications to
the manner of reporting of the data
elements established under subparagraph
(C).
``(vi) Consideration of world health
organization data set.--The Secretary shall
consider the status of the consensus data elements
set for reporting clinical trial results of the
World Health Organization when issuing the
regulations under this subparagraph.
``(vii) Public [NOTE: Deadline.] meeting.--
The Secretary shall hold a public meeting no later
than 18 months after the date of the enactment of
the Food and Drug Administration Amendments Act of
2007 to provide an opportunity for input from
interested parties with regard to the regulations
to be issued under this subparagraph.
``(E) Submission of results information.--
``(i) In [NOTE: Deadline.] general.--Except
as provided in clauses (iii), (iv), (v), and (vi)
the responsible party for an applicable clinical
trial that is described in clause (ii) shall
submit to the Director of NIH for inclusion in the
registry and results data bank the clinical trial
information described in subparagraph (C) not
later than 1 year, or such other period as may be
provided by regulation under subparagraph (D),
after the earlier of--

[[Page 913]]
121 STAT. 913

``(I) the estimated completion date
of the trial as described in paragraph
(2)(A)(ii)(I)(jj)); or
``(II) the actual date of
completion.
``(ii) Clinical trials described.--An
applicable clinical trial described in this clause
is an applicable clinical trial subject to--
``(I) paragraph (2)(C); and
``(II)(aa) subparagraph (C); or
``(bb) the regulations issued under
subparagraph (D).
``(iii) Delayed submission of results with
certification.--If the responsible party for an
applicable clinical trial submits a certification
that clause (iv) or (v) applies to such clinical
trial, the responsible party shall submit to the
Director of NIH for inclusion in the registry and
results data bank the clinical trial information
described in subparagraphs (C) and (D) as required
under the applicable clause.
``(iv) Seeking [NOTE: Deadline.] initial
approval of a drug or device.--With respect to an
applicable clinical trial that is completed before
the drug is initially approved under section 505
of the Federal Food, Drug, and Cosmetic Act or
initially licensed under section 351 of this Act,
or the device is initially cleared under section
510(k) or initially approved under section 515 or
520(m) of the Federal Food, Drug, and Cosmetic
Act, the responsible party shall submit to the
Director of NIH for inclusion in the registry and
results data bank the clinical trial information
described in subparagraphs (C) and (D) not later
than 30 days after the drug or device is approved
under such section 505, licensed under such
section 351, cleared under such section 510(k), or
approved under such section 515 or 520(m), as
applicable.
``(v) Seeking approval of a new use for the
drug or device.--
``(I)
In [NOTE: Deadlines.] general.--With
respect to an applicable clinical trial
where the manufacturer of the drug or
device is the sponsor of an applicable
clinical trial, and such manufacturer
has filed, or will file within 1 year,
an application seeking approval under
section 505 of the Federal Food, Drug,
and Cosmetic Act, licensing under
section 351 of this Act, or clearance
under section 510(k), or approval under
section 515 or 520(m), of the Federal
Food, Drug, and Cosmetic Act for the use
studied in such clinical trial (which
use is not included in the labeling of
the approved drug or device), then the
responsible party shall submit to the
Director of NIH for inclusion in the
registry and results data bank the
clinical trial information described in
subparagraphs (C) and (D) on the earlier
of the date that is 30 days after the
date--
``(aa) the new use of the
drug or device is approved under
such section 505, licensed under
such section 351, cleared under
such

[[Page 914]]
121 STAT. 914

section 510(k), or approved
under such section 515 or
520(m);
``(bb) the Secretary issues
a letter, such as a complete
response letter, not approving
the submission or not clearing
the submission, a not approvable
letter, or a not substantially
equivalent letter for the new
use of the drug or device under
such section 505, 351, 510(k),
515, or 520(m); or
``(cc) except as provided in
subclause (III), the application
or premarket notification under
such section 505, 351, 510(k),
515, or 520(m) is withdrawn
without resubmission for no less
than 210 days.
``(II) Requirement that each
clinical trial in application be treated
the same.--If a manufacturer makes a
certification under clause (iii) that
this clause applies with respect to a
clinical trial, the manufacturer shall
make such a certification with respect
to each applicable clinical trial that
is required to be submitted in an
application or report for licensure,
approval, or clearance (under section
351 of this Act or section 505, 510(k),
515, or 520(m) of the Federal Food,
Drug, and Cosmetic Act, as applicable)
of the use studied in the clinical
trial.
``(III) Two-year limitation.--The
responsible party shall submit to the
Director of NIH for inclusion in the
registry and results data bank the
clinical trial information subject to
subclause (I) on the date that is 2
years after the date a certification
under clause (iii) was made to the
Director of NIH, if an action referred
to in item (aa), (bb), or (cc) of
subclause (I) has not occurred by such
date.
``(vi) Extensions.--The Director of NIH may
provide an extension of the deadline for
submission of clinical trial information under
clause (i) if the responsible party for the trial
submits to the Director a written request that
demonstrates good cause for the extension and
provides an estimate of the date on which the
information will be submitted. The Director of NIH
may grant more than one such extension for a
clinical trial.
``(F) Notice to [NOTE: Deadline.] director of
nih.--The Commissioner of Food and Drugs shall notify
the Director of NIH when there is an action described in
subparagraph (E)(iv) or item (aa), (bb), or (cc) of
subparagraph (E)(v)(I) with respect to an application or
a report that includes a certification required under
paragraph (5)(B) of such action not later than 30 days
after such action.
``(G) Posting of [NOTE: Public
information. Deadline.] data.--The Director of NIH
shall ensure that the clinical trial information
described in subparagraphs (C) and (D) for an applicable
clinical trial submitted in accordance with this
paragraph is posted publicly in the registry and results
database not later than 30 days after such submission.

[[Page 915]]
121 STAT. 915

``(H) Waivers regarding certain clinical trial
results.--The Secretary may waive any applicable
requirements of this paragraph for an applicable
clinical trial, upon a written request from the
responsible party, if the Secretary determines that
extraordinary circumstances justify the waiver and that
providing the waiver is consistent with the protection
of public health, or in the interest of national
security. [NOTE: Deadline. Notification.] Not later
than 30 days after any part of a waiver is granted, the
Secretary shall notify, in writing, the appropriate
committees of Congress of the waiver and provide an
explanation for why the waiver was granted.
``(I) Adverse events.--
``(i) Regulations.--
Not [NOTE: Deadline.] later than 18 months after
the date of the enactment of the Food and Drug
Administration Amendments Act of 2007, the
Secretary shall by regulation determine the best
method for including in the registry and results
data bank appropriate results information on
serious adverse and frequent adverse events for
drugs described in subparagraph (C) in a manner
and form that is useful and not misleading to
patients, physicians, and scientists.
``(ii) Default.--If the [NOTE: Effective
date.] Secretary fails to issue the regulation
required by clause (i) by the date that is 24
months after the date of the enactment of the Food
and Drug Administration Amendments Act of 2007,
clause (iii) shall take effect.
``(iii) Additional elements.--Upon the
application of clause (ii), the Secretary shall
include in the registry and results data bank for
drugs described in subparagraph (C), in addition
to the clinical trial information described in
subparagraph (C), the following elements:
``(I) Serious adverse events.--A
table of anticipated and unanticipated
serious adverse events grouped by organ
system, with number and frequency of
such event in each arm of the clinical
trial.
``(II) Frequent adverse events.--A
table of anticipated and unanticipated
adverse events that are not included in
the table described in subclause (I)
that exceed a frequency of 5 percent
within any arm of the clinical trial,
grouped by organ system, with number and
frequency of such event in each arm of
the clinical trial.
``(iv) Posting of other information.--In
carrying out clause (iii), the Secretary shall, in
consultation with experts in risk communication,
post with the tables information to enhance
patient understanding and to ensure such tables do
not mislead patients or the lay public.
``(v) Relation to subparagraph (c).--Clinical
trial information included in the registry and
results data bank pursuant to this subparagraph is
deemed to be clinical trial information included
in such data bank pursuant to subparagraph (C).
``(4) Additional submissions of clinical trial
information.--

[[Page 916]]
121 STAT. 916

``(A) Voluntary submissions.--A responsible party
for a clinical trial that is not an applicable clinical
trial, or that is an applicable clinical trial that is
not subject to paragraph (2)(C), may submit complete
clinical trial information described in paragraph (2) or
paragraph (3) provided the responsible party submits
clinical trial information for each applicable clinical
trial that is required to be submitted under section 351
or under section 505, 510(k), 515, or 520(m) of the
Federal Food, Drug, and Cosmetic Act in an application
or report for licensure, approval, or clearance of the
drug or device for the use studied in the clinical
trial.
``(B) Required submissions.--
``(i) In general.--Notwithstanding paragraphs
(2) and (3) and subparagraph (A), in any case in
which the Secretary determines for a specific
clinical trial described in clause (ii) that
posting in the registry and results data bank of
clinical trial information for such clinical trial
is necessary to protect the public health--
``(I) the Secretary may require by
notification that such information be
submitted to the Secretary in accordance
with paragraphs (2) and (3) except with
regard to timing of submission;
``(II) [NOTE: Deadline.] unless
the responsible party submits a
certification under paragraph
(3)(E)(iii), such information shall be
submitted not later than 30 days after
the date specified by the Secretary in
the notification; and
``(III) failure to comply with the
requirements under subclauses (I) and
(II) shall be treated as a violation of
the corresponding requirement of such
paragraphs.
``(ii) Clinical trials described.--A clinical
trial described in this clause is--
``(I) an applicable clinical trial
for a drug that is approved under
section 505 of the Federal Food, Drug,
and Cosmetic Act or licensed under
section 351 of this Act or for a device
that is cleared under section 510(k) of
the Federal Food, Drug, and Cosmetic Act
or approved under section 515 or section
520(m) of such Act, whose completion
date is on or after the date 10 years
before the date of the enactment of the
Food and Drug Administration Amendments
Act of 2007; or
``(II) an applicable clinical trial
that is described by both by paragraph
(2)(C) and paragraph (3)(D)(ii)(II)).
``(C) Updates to clinical trial data bank.--
``(i) Submission
of [NOTE: Deadlines.] updates.--The responsible
party for an applicable clinical trial shall
submit to the Director of NIH for inclusion in the
registry and results data bank updates to reflect
changes to the clinical trial information
submitted under paragraph (2). Such updates--
``(I) shall be provided not less
than once every 12 months, unless there
were no changes to the

[[Page 917]]
121 STAT. 917

clinical trial information during the
preceding 12-month period;
``(II) shall include identification
of the dates of any such changes;
``(III) not later than 30 days after
the recruitment status of such clinical
trial changes, shall include an update
of the recruitment status; and
``(IV) not later than 30 days after
the completion date of the clinical
trial, shall include notification to the
Director that such clinical trial is
complete.
``(ii) Public availability of updates.--The
Director of NIH shall make updates submitted under
clause (i) publicly available in the registry data
bank. Except with regard to overall recruitment
status, individual site status, location, and
contact information, the Director of NIH shall
ensure that updates to elements required under
subclauses (I) to (V) of paragraph (2)(A)(ii) do
not result in the removal of any information from
the original submissions or any preceding updates,
and information in such databases is presented in
a manner that enables users to readily access each
original element submission and to track the
changes made by the updates. The Director of NIH
shall provide a link from the table of primary and
secondary outcomes required under paragraph
(3)(C)(ii) to the tracked history required under
this clause of the primary and secondary outcome
measures submitted under paragraph
(2)(A)(ii)(I)(ll).
``(5) Coordination and compliance.--
``(A) Clinical trials supported by grants from
federal agencies.--
``(i) Grants
from [NOTE: Certification.] certain federal
agencies.--If an applicable clinical trial is
funded in whole or in part by a grant from any
agency of the Department of Health and Human
Services, including the Food and Drug
Administration, the National Institutes of Health,
or the Agency for Healthcare Research and Quality,
any grant or progress report forms required under
such grant shall include a certification that the
responsible party has made all required
submissions to the Director of NIH under
paragraphs (2) and (3).
``(ii) Verification by federal agencies.--The
heads of the agencies referred to in clause (i),
as applicable, shall verify that the clinical
trial information for each applicable clinical
trial for which a grantee is the responsible party
has been submitted under paragraphs (2) and (3)
before releasing any remaining funding for a grant
or funding for a future grant to such grantee.
``(iii) Notice
and [NOTE: Deadline.] opportunity to remedy.--If
the head of an agency referred to in clause (i),
as applicable, verifies that a grantee has not
submitted clinical trial information as described
in clause (ii), such agency head shall provide
notice to such grantee of such non-compliance and
allow such grantee 30 days

[[Page 918]]
121 STAT. 918

to correct such non-compliance and submit the
required clinical trial information.
``(iv) Consultation with other federal
agencies.--The Secretary shall--
``(I) consult with other agencies
that conduct research involving human
subjects in accordance with any section
of part 46 of title 45, Code of Federal
Regulations (or any successor
regulations), to determine if any such
research is an applicable clinical
trial; and
``(II) [NOTE: Procedures.] develop
with such agencies procedures comparable
to those described in clauses (i), (ii),
and (iii) to ensure that clinical trial
information for such applicable clinical
trial is submitted under paragraphs (2)
and (3).
``(B) Certification to accompany drug, biological
product, and device submissions.--At the time of
submission of an application under section 505 of the
Federal Food, Drug, and Cosmetic Act, section 515 of
such Act, section 520(m) of such Act, or section 351 of
this Act, or submission of a report under section 510(k)
of such Act, such application or submission shall be
accompanied by a certification that all applicable
requirements of this subsection have been met. Where
available, such certification shall include the
appropriate National Clinical Trial control numbers.
``(C) Quality control.--
``(i) Pilot quality control project.--Until
the effective date of the regulations issued under
paragraph (3)(D), the Secretary, acting through
the Director of NIH and the Commissioner of Food
and Drugs, shall conduct a pilot project to
determine the optimal method of verification to
help to ensure that the clinical trial information
submitted under paragraph (3)(C) is non-
promotional and is not false or misleading in any
particular under subparagraph (D). The Secretary
shall use the publicly available information
described in paragraph (3)(A) and any other
information available to the Secretary about
applicable clinical trials to verify the accuracy
of the clinical trial information submitted under
paragraph (3)(C).
``(ii) Notice
of [NOTE: Deadline.] compliance.--If the
Secretary determines that any clinical trial
information was not submitted as required under
this subsection, or was submitted but is false or
misleading in any particular, the Secretary shall
notify the responsible party and give such party
an opportunity to remedy such noncompliance by
submitting the required revised clinical trial
information not later than 30 days after such
notification.
``(D) Truthful clinical trial information.--
``(i) In general.--The clinical trial
information submitted by a responsible party under
this subsection shall not be false or misleading
in any particular.
``(ii) Effect.--Clause (i) shall not have the
effect of--

[[Page 919]]
121 STAT. 919

``(I) requiring clinical trial
information with respect to an
applicable clinical trial to include
information from any source other than
such clinical trial involved; or
``(II) requiring clinical trial
information described in paragraph
(3)(D) to be submitted for purposes of
paragraph (3)(C).
``(E) Public notices.--
``(i) Notice of violations.--If the
responsible party for an applicable clinical trial
fails to submit clinical trial information for
such clinical trial as required under paragraphs
(2) or (3), the Director of NIH shall include in
the registry and results data bank entry for such
clinical trial a notice--
``(I) that the responsible party is
not in compliance with this Act by--
``(aa) failing to submit
required clinical trial
information; or
``(bb) submitting false or
misleading clinical trial
information;
``(II) of the penalties imposed for
the violation, if any; and
``(III) whether the responsible
party has corrected the clinical trial
information in the registry and results
data bank.
``(ii) Notice of failure to submit primary and
secondary outcomes.--If the responsible party for
an applicable clinical trial fails to submit the
primary and secondary outcomes as required under
section 2(A)(ii)(I)(ll), the Director of NIH shall
include in the registry and results data bank
entry for such clinical trial a notice that the
responsible party is not in compliance by failing
to register the primary and secondary outcomes in
accordance with this act, and that the primary and
secondary outcomes were not publicly disclosed in
the database before conducting the clinical trial.
``(iii) Failure to submit statement.--The
notice under clause (i) for a violation described
in clause (i)(I)(aa) shall include the following
statement: `The entry for this clinical trial was
not complete at the time of submission, as
required by law. This may or may not have any
bearing on the accuracy of the information in the
entry.'.
``(iv) Submission of false information
statement.--The notice under clause (i) for a
violation described in clause (i)(I)(bb) shall
include the following statement: `The entry for
this clinical trial was found to be false or
misleading and therefore not in compliance with
the law.'.
``(v) Non-submission of statement.--The notice
under clause (ii) for a violation described in
clause (ii) shall include the following statement:
`The entry for this clinical trial did not contain
information on the primary and secondary outcomes
at the time of submission, as required by law.
This may or may not

[[Page 920]]
121 STAT. 920

have any bearing on the accuracy of the
information in the entry.'.
``(vi) Compliance searches.--The Director of
NIH shall provide that the public may easily
search the registry and results data bank for
entries that include notices required under this
subparagraph.
``(6) Limitation on disclosure of clinical trial
information.--
``(A) In general.--Nothing in this subsection (or
under section 552 of title 5, United States Code) shall
require the Secretary to publicly disclose, by any means
other than the registry and results data bank,
information described in subparagraph (B).
``(B) Information described.--Information described
in this subparagraph is--
``(i) information submitted to the Director of
NIH under this subsection, or information of the
same general nature as (or integrally associated
with) the information so submitted; and
``(ii) information not otherwise publicly
available, including because it is protected from
disclosure under section 552 of title 5, United
States Code.
``(7) Authorization of appropriations.--There are authorized
to be appropriated to carry out this subsection $10,000,000 for
each fiscal year.''.

(b) Conforming Amendments.--
(1) Prohibited acts.--Section 301 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end
the following:

``(jj)(1) The failure to submit the certification required by
section 402(j)(5)(B) of the Public Health Service Act, or knowingly
submitting a false certification under such section.
``(2) The failure to submit clinical trial information required
under subsection (j) of section 402 of the Public Health Service Act.
``(3) The submission of clinical trial information under subsection
(j) of section 402 of the Public Health Service Act that is false or
misleading in any particular under paragraph (5)(D) of such subsection
(j).''.
(2) Civil money penalties.--Subsection (f) of section 303 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), as
redesignated by section 226, is amended--
(A) by redesignating paragraphs (3), (4), and (5) as
paragraphs (5), (6), and (7), respectively;
(B) by inserting after paragraph (2) the following:

``(3)(A) [NOTE: Penalties.] Any person who violates section
301(jj) shall be subject to a civil monetary penalty of not more than
$10,000 for all violations adjudicated in a single proceeding.

``(B) [NOTE: Deadline.] If a violation of section 301(jj) is not
corrected within the 30-day period following notification under section
402(j)(5)(C)(ii), the person shall, in addition to any penalty under
subparagraph (A), be subject to a civil monetary penalty of not more
than $10,000 for each day of the violation after such period until the
violation is corrected.'';
(C) in paragraph (2)(C), by striking ``paragraph
(3)(A)'' and inserting ``paragraph (5)(A)'';

[[Page 921]]
121 STAT. 921

(D) in paragraph (5), as so redesignated, by
striking ``paragraph (1) or (2)'' each place it appears
and inserting ``paragraph (1), (2), or (3)'';
(E) in paragraph (6), as so redesignated, by
striking ``paragraph (3)(A)'' and inserting ``paragraph
(5)(A)''; and
(F) in paragraph (7), as so redesignated, by
striking ``paragraph (4)'' each place it appears and
inserting ``paragraph (6)''.
(3) New [NOTE: Certification.] drugs and devices.--
(A) Investigational new drugs.--Section 505(i) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(i)) is amended in paragraph (4), by adding at the
end the following:
``The [NOTE: Regulations.] Secretary shall update such
regulations to require inclusion in the informed consent
documents and process a statement that clinical trial
information for such clinical investigation has been or
will be submitted for inclusion in the registry data
bank pursuant to subsection (j) of section 402 of the
Public Health Service Act.''.
(B) New drug applications.--Section 505(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b))
is amended by adding at the end the following:
``(6) An application submitted under this subsection shall
be accompanied by the certification required under section
402(j)(5)(B) of the Public Health Service Act. Such
certification shall not be considered an element of such
application.''.
(C) Device reports under section 510(k).--Section
510(k) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360(k)) is amended by adding at the end the
following:

``A notification submitted under this subsection that contains clinical
trial data for an applicable device clinical trial (as defined in
section 402(j)(1) of the Public Health Service Act) shall be accompanied
by the certification required under section 402(j)(5)(B) of such Act.
Such certification shall not be considered an element of such
notification.''.
(D) Device premarket approval application.--Section
515(c)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e(c)(1)) is amended--
(i) in subparagraph (F), by striking ``; and''
and inserting a semicolon;
(ii) by redesignating subparagraph (G) as
subparagraph (H); and
(iii) by inserting after subparagraph (F) the
following:
``(G) the certification required under section
402(j)(5)(B) of the Public Health Service Act (which
shall not be considered an element of such application);
and''.
(E) Humanitarian device exemption.--Section
520(m)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e(c)) [NOTE: 21 USC 360j.] is amended in
the first sentence in the matter following subparagraph
(C), by inserting at the end before the period ``and
such application shall include the certification
required under section 402(j)(5)(B) of the Public Health
Service Act (which shall not be considered an element of
such application)''.

(c) Surveillances.--Not [NOTE: Deadline. Guidance. 42 USC 282
note.] later than 12 months after the date of the enactment of this
Act, the Secretary of Health and Human

[[Page 922]]
121 STAT. 922

Services shall issue guidance on how the requirements of section 402(j)
of the Public Health Service Act, as added by this section, apply to a
pediatric postmarket surveillance described in paragraph (1)(A)(ii)(II)
of such section 402(j) that is not a clinical trial.

(d) [NOTE: 42 USC 282 note.] Preemption.--
(1) In general.--Upon the expansion of the registry and
results data bank under section 402(j)(3)(D) of the Public
Health Service Act, as added by this section, no State or
political subdivision of a State may establish or continue in
effect any requirement for the registration of clinical trials
or for the inclusion of information relating to the results of
clinical trials in a database.
(2) Rule of construction.--The fact of submission of
clinical trial information, if submitted in compliance with
subsection (j) of section 402 of the Public Health Service Act
(as amended by this section), that relates to a use of a drug or
device not included in the official labeling of the approved
drug or device shall not be construed by the Secretary of Health
and Human Services or in any administrative or judicial
proceeding, as evidence of a new intended use of the drug or
device that is different from the intended use of the drug or
device set forth in the official labeling of the drug or device.
The availability of clinical trial information through the
registry and results data bank under such subsection (j), if
submitted in compliance with such subsection, shall not be
considered as labeling, adulteration, or misbranding of the drug
or device under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.).

TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS

Subtitle A--Postmarket Studies and Surveillance

SEC. 901. POSTMARKET STUDIES AND CLINICAL TRIALS REGARDING HUMAN
DRUGS; RISK EVALUATION AND MITIGATION
STRATEGIES.

(a) In General.--Section 505 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355) is amended by adding at the end the following
subsections:
``(o) Postmarket Studies and Clinical Trials; Labeling.--
``(1) In general.--A responsible person may not introduce or
deliver for introduction into interstate commerce the new drug
involved if the person is in violation of a requirement
established under paragraph (3) or (4) with respect to the drug.
``(2) Definitions.--For purposes of this subsection:
``(A) Responsible person.--The term `responsible
person' means a person who--
``(i) has submitted to the Secretary a covered
application that is pending; or

[[Page 923]]
121 STAT. 923

``(ii) is the holder of an approved covered
application.
``(B) Covered application.--The term `covered
application' means--
``(i) an application under subsection (b) for
a drug that is subject to section 503(b); and
``(ii) an application under section 351 of the
Public Health Service Act.
``(C) New safety information; serious risk.--The
terms `new safety information', `serious risk', and
`signal of a serious risk' have the meanings given such
terms in section 505-1(b).
``(3) Studies and clinical trials.--
``(A) In general.--For any or all of the purposes
specified in subparagraph (B), the Secretary may,
subject to subparagraph (D), require a responsible
person for a drug to conduct a postapproval study or
studies of the drug, or a postapproval clinical trial or
trials of the drug, on the basis of scientific data
deemed appropriate by the Secretary, including
information regarding chemically-related or
pharmacologically-related drugs.
``(B) Purposes of study or clinical trial.--The
purposes referred to in this subparagraph with respect
to a postapproval study or postapproval clinical trial
are the following:
``(i) To assess a known serious risk related
to the use of the drug involved.
``(ii) To assess signals of serious risk
related to the use of the drug.
``(iii) To identify an unexpected serious risk
when available data indicates the potential for a
serious risk.
``(C) Establishment of requirement after approval of
covered application.--The Secretary may require a
postapproval study or studies or postapproval clinical
trial or trials for a drug for which an approved covered
application is in effect as of the date on which the
Secretary seeks to establish such requirement only if
the Secretary becomes aware of new safety information.
``(D) Determination by secretary.--
``(i) Postapproval studies.--The Secretary may
not require the responsible person to conduct a
study under this paragraph, unless the Secretary
makes a determination that the reports under
subsection (k)(1) and the active postmarket risk
identification and analysis system as available
under subsection (k)(3) will not be sufficient to
meet the purposes set forth in subparagraph (B).
``(ii) Postapproval clinical trials.--The
Secretary may not require the responsible person
to conduct a clinical trial under this paragraph,
unless the Secretary makes a determination that a
postapproval study or studies will not be
sufficient to meet the purposes set forth in
subparagraph (B).
``(E) Notification; timetables; periodic reports.--
``(i) Notification.--The Secretary shall
notify the responsible person regarding a
requirement under this

[[Page 924]]
121 STAT. 924

paragraph to conduct a postapproval study or
clinical trial by the target dates for
communication of feedback from the review team to
the responsible person regarding proposed labeling
and postmarketing study commitments as set forth
in the letters described in section 101(c) of the
Food and Drug Administration Amendments Act of
2007.
``(ii) Timetable; periodic reports.--For each
study or clinical trial required to be conducted
under this paragraph, the Secretary shall require
that the responsible person submit a timetable for
completion of the study or clinical trial. With
respect to each study required to be conducted
under this paragraph or otherwise undertaken by
the responsible person to investigate a safety
issue, the Secretary shall require the responsible
person to periodically report to the Secretary on
the status of such study including whether any
difficulties in completing the study have been
encountered. With respect to each clinical trial
required to be conducted under this paragraph or
otherwise undertaken by the responsible person to
investigate a safety issue, the Secretary shall
require the responsible person to periodically
report to the Secretary on the status of such
clinical trial including whether enrollment has
begun, the number of participants enrolled, the
expected completion date, whether any difficulties
completing the clinical trial have been
encountered, and registration information with
respect to the requirements under section 402(j)
of the Public Health Service Act. If the
responsible person fails to comply with such
timetable or violates any other requirement of
this subparagraph, the responsible person shall be
considered in violation of this subsection, unless
the responsible person demonstrates good cause for
such noncompliance or such other violation. The
Secretary shall determine what constitutes good
cause under the preceding sentence.
``(F) Dispute resolution.--The responsible person
may appeal a requirement to conduct a study or clinical
trial under this paragraph using dispute resolution
procedures established by the Secretary in regulation
and guidance.
``(4) Safety [NOTE: Deadlines.] labeling changes requested
by secretary.--
``(A) New [NOTE: Notification.] safety
information.--If the Secretary becomes aware of new
safety information that the Secretary believes should be
included in the labeling of the drug, the Secretary
shall promptly notify the responsible person or, if the
same drug approved under section 505(b) is not currently
marketed, the holder of an approved application under
505(j).
``(B) Response to notification.--Following
notification pursuant to subparagraph (A), the
responsible person or the holder of the approved
application under section 505(j) shall within 30 days--
``(i) submit a supplement proposing changes to
the approved labeling to reflect the new safety
information,

[[Page 925]]
121 STAT. 925

including changes to boxed warnings,
contraindications, warnings, precautions, or
adverse reactions; or
``(ii) [NOTE: Notification.] notify the
Secretary that the responsible person or the
holder of the approved application under section
505(j) does not believe a labeling change is
warranted and submit a statement detailing the
reasons why such a change is not warranted.
``(C) Review.--Upon receipt of such supplement, the
Secretary shall promptly review and act upon such
supplement. If the Secretary disagrees with the proposed
changes in the supplement or with the statement setting
forth the reasons why no labeling change is necessary,
the Secretary shall initiate discussions to reach
agreement on whether the labeling for the drug should be
modified to reflect the new safety information, and if
so, the contents of such labeling changes.
``(D) Discussions.--Such discussions shall not
extend for more than 30 days after the response to the
notification under subparagraph (B), unless the
Secretary determines an extension of such discussion
period is warranted.
``(E) Order.--Within 15 days of the conclusion of
the discussions under subparagraph (D), the Secretary
may issue an order directing the responsible person or
the holder of the approved application under section
505(j) to make such a labeling change as the Secretary
deems appropriate to address the new safety information.
Within 15 days of such an order, the responsible person
or the holder of the approved application under section
505(j) shall submit a supplement containing the labeling
change.
``(F) Dispute resolution.--Within 5 days of
receiving an order under subparagraph (E), the
responsible person or the holder of the approved
application under section 505(j) may appeal using
dispute resolution procedures established by the
Secretary in regulation and guidance.
``(G) Violation.--If the responsible person or the
holder of the approved application under section 505(j)
has not submitted a supplement within 15 days of the
date of such order under subparagraph (E), and there is
no appeal or dispute resolution proceeding pending, the
responsible person or holder shall be considered to be
in violation of this subsection. If at the conclusion of
any dispute resolution procedures the Secretary
determines that a supplement must be submitted and such
a supplement is not submitted within 15 days of the date
of that determination, the responsible person or holder
shall be in violation of this subsection.
``(H) Public health threat.--Notwithstanding
subparagraphs (A) through (F), if the Secretary
concludes that such a labeling change is necessary to
protect the public health, the Secretary may accelerate
the timelines in such subparagraphs.
``(I) Rule of construction.--This paragraph shall
not be construed to affect the responsibility of the
responsible person or the holder of the approved
application under section 505(j) to maintain its label
in accordance with existing requirements, including
subpart B of part 201

[[Page 926]]
121 STAT. 926

and sections 314.70 and 601.12 of title 21, Code of
Federal Regulations (or any successor regulations).
``(5) Non-delegation.--Determinations by the Secretary under
this subsection for a drug shall be made by individuals at or
above the level of individuals empowered to approve a drug (such
as division directors within the Center for Drug Evaluation and
Research).

``(p) Risk Evaluation and Mitigation Strategy.--
``(1) In general.--A person may not introduce or deliver for
introduction into interstate commerce a new drug if--
``(A)(i) the application for such drug is approved
under subsection (b) or (j) and is subject to section
503(b); or
``(ii) the application for such drug is approved
under section 351 of the Public Health Service Act; and
``(B) a risk evaluation and mitigation strategy is
required under section 505-1 with respect to the drug
and the person fails to maintain compliance with the
requirements of the approved strategy or with other
requirements under section 505-1, including requirements
regarding assessments of approved strategies.
``(2) Certain postmarket studies.--The failure to conduct a
postmarket study under section 506, subpart H of part 314, or
subpart E of part 601 of title 21, Code of Federal Regulations
(or any successor regulations), is deemed to be a violation of
paragraph (1).''.

(b) Requirements Regarding Strategies.--Chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by
inserting after section 505 the following section:
``SEC. 505-1. [NOTE: 21 USC 355-1.] RISK EVALUATION AND
MITIGATION STRATEGIES.

``(a) Submission of Proposed Strategy.--
``(1) Initial approval.--If the Secretary, in consultation
with the office responsible for reviewing the drug and the
office responsible for postapproval safety with respect to the
drug, determines that a risk evaluation and mitigation strategy
is necessary to ensure that the benefits of the drug outweigh
the risks of the drug, and informs the person who submits such
application of such determination, then such person shall submit
to the Secretary as part of such application a proposed risk
evaluation and mitigation strategy. In making such a
determination, the Secretary shall consider the following
factors:
``(A) The estimated size of the population likely to
use the drug involved.
``(B) The seriousness of the disease or condition
that is to be treated with the drug.
``(C) The expected benefit of the drug with respect
to such disease or condition.
``(D) The expected or actual duration of treatment
with the drug.
``(E) The seriousness of any known or potential
adverse events that may be related to the drug and the
background incidence of such events in the population
likely to use the drug.
``(F) Whether the drug is a new molecular entity.
``(2) Postapproval requirement.--

[[Page 927]]
121 STAT. 927

``(A) In general.--If the Secretary has approved a
covered application (including an application approved
before the effective date of this section) and did not
when approving the application require a risk evaluation
and mitigation strategy under paragraph (1), the
Secretary, in consultation with the offices described in
paragraph (1), may subsequently require such a strategy
for the drug involved (including when acting on a
supplemental application seeking approval of a new
indication for use of the drug) if the Secretary becomes
aware of new safety information and makes a
determination that such a strategy is necessary to
ensure that the benefits of the drug outweigh the risks
of the drug.
``(B) Submission
of [NOTE: Deadline. Notification.] proposed
strategy.--Not later than 120 days after the Secretary
notifies the holder of an approved covered application
that the Secretary has made a determination under
subparagraph (A) with respect to the drug involved, or
within such other reasonable time as the Secretary
requires to protect the public health, the holder shall
submit to the Secretary a proposed risk evaluation and
mitigation strategy.
``(3) Abbreviated [NOTE: Applicability.] new drug
applications.--The applicability of this section to an
application under section 505(j) is subject to subsection (i).
``(4) Non-delegation.--Determinations by the Secretary under
this subsection for a drug shall be made by individuals at or
above the level of individuals empowered to approve a drug (such
as division directors within the Center for Drug Evaluation and
Research).

``(b) Definitions.--For purposes of this section:
``(1) Adverse drug experience.--The term `adverse drug
experience' means any adverse event associated with the use of a
drug in humans, whether or not considered drug related,
including--
``(A) an adverse event occurring in the course of
the use of the drug in professional practice;
``(B) an adverse event occurring from an overdose of
the drug, whether accidental or intentional;
``(C) an adverse event occurring from abuse of the
drug;
``(D) an adverse event occurring from withdrawal of
the drug; and
``(E) any failure of expected pharmacological action
of the drug.
``(2) Covered application.--The term `covered application'
means an application referred to in section 505(p)(1)(A).
``(3) New safety information.--The term `new safety
information', with respect to a drug, means information derived
from a clinical trial, an adverse event report, a postapproval
study (including a study under section 505(o)(3)), or peer-
reviewed biomedical literature; data derived from the postmarket
risk identification and analysis system under section 505(k); or
other scientific data deemed appropriate by the Secretary
about--
``(A) a serious risk or an unexpected serious risk
associated with use of the drug that the Secretary has
become aware of (that may be based on a new analysis of
existing

[[Page 928]]
121 STAT. 928

information) since the drug was approved, since the risk
evaluation and mitigation strategy was required, or
since the last assessment of the approved risk
evaluation and mitigation strategy for the drug; or
``(B) the effectiveness of the approved risk
evaluation and mitigation strategy for the drug obtained
since the last assessment of such strategy.
``(4) Serious adverse drug experience.--The term `serious
adverse drug experience' is an adverse drug experience that--
``(A) results in--
``(i) death;
``(ii) an adverse drug experience that places
the patient at immediate risk of death from the
adverse drug experience as it occurred (not
including an adverse drug experience that might
have caused death had it occurred in a more severe
form);
``(iii) inpatient hospitalization or
prolongation of existing hospitalization;
``(iv) a persistent or significant incapacity
or substantial disruption of the ability to
conduct normal life functions; or
``(v) a congenital anomaly or birth defect; or
``(B) based on appropriate medical judgment, may
jeopardize the patient and may require a medical or
surgical intervention to prevent an outcome described
under subparagraph (A).
``(5) Serious risk.--The term `serious risk' means a risk of
a serious adverse drug experience.
``(6) Signal of a serious risk.--The term `signal of a
serious risk' means information related to a serious adverse
drug experience associated with use of a drug and derived from--
``(A) a clinical trial;
``(B) adverse event reports;
``(C) a postapproval study, including a study under
section 505(o)(3);
``(D) peer-reviewed biomedical literature;
``(E) data derived from the postmarket risk
identification and analysis system under section
505(k)(4); or
``(F) other scientific data deemed appropriate by
the Secretary.
``(7) Responsible person.--The term `responsible person'
means the person submitting a covered application or the holder
of the approved such application.
``(8) Unexpected serious risk.--The term `unexpected serious
risk' means a serious adverse drug experience that is not listed
in the labeling of a drug, or that may be symptomatically and
pathophysiologically related to an adverse drug experience
identified in the labeling, but differs from such adverse drug
experience because of greater severity, specificity, or
prevalence.

``(c) Contents.--A proposed risk evaluation and mitigation strategy
under subsection (a) shall--
``(1) include the timetable required under subsection (d);
and

[[Page 929]]
121 STAT. 929

``(2) to the extent required by the Secretary, in
consultation with the office responsible for reviewing the drug
and the office responsible for postapproval safety with respect
to the drug, include additional elements described in
subsections (e) and (f).

``(d) Minimal [NOTE: Deadlines.] Strategy.--For purposes of
subsection (c)(1), the risk evaluation and mitigation strategy for a
drug shall require a timetable for submission of assessments of the
strategy that--
``(1) includes an assessment, by the date that is 18 months
after the strategy is initially approved;
``(2) includes an assessment by the date that is 3 years
after the strategy is initially approved;
``(3) includes an assessment in the seventh year after the
strategy is so approved; and
``(4) subject to paragraphs (1), (2), and (3)--
``(A) is at a frequency specified in the strategy;
``(B) is increased or reduced in frequency as
necessary as provided for in subsection (g)(4)(A); and
``(C) is eliminated after the 3-year period
described in paragraph (1) if the Secretary determines
that serious risks of the drug have been adequately
identified and assessed and are being adequately
managed.

``(e) Additional Potential Elements of Strategy.--
``(1) In general.--The Secretary, in consultation with the
offices described in subsection (c)(2), may under such
subsection require that the risk evaluation and mitigation
strategy for a drug include 1 or more of the additional elements
described in this subsection if the Secretary makes the
determination required with respect to each element involved.
``(2) Medication guide; patient package insert.--The risk
evaluation and mitigation strategy for a drug may require that,
as applicable, the responsible person develop for distribution
to each patient when the drug is dispensed--
``(A) a Medication Guide, as provided for under part
208 of title 21, Code of Federal Regulations (or any
successor regulations); and
``(B) a patient package insert, if the Secretary
determines that such insert may help mitigate a serious
risk of the drug.
``(3) Communication plan.--The risk evaluation and
mitigation strategy for a drug may require that the responsible
person conduct a communication plan to health care providers,
if, with respect to such drug, the Secretary determines that
such plan may support implementation of an element of the
strategy (including under this paragraph). Such plan may
include--
``(A) sending letters to health care providers;
``(B) disseminating information about the elements
of the risk evaluation and mitigation strategy to
encourage implementation by health care providers of
components that apply to such health care providers, or
to explain certain safety protocols (such as medical
monitoring by periodic laboratory tests); or
``(C) disseminating information to health care
providers through professional societies about any
serious risks of the drug and any protocol to assure
safe use.

[[Page 930]]
121 STAT. 930

``(f) Providing Safe Access for Patients to Drugs With Known Serious
Risks That Would Otherwise Be Unavailable.--
``(1) Allowing safe access to drugs with known serious
risks.--The Secretary, in consultation with the offices
described in subsection (c)(2), may require that the risk
evaluation and mitigation strategy for a drug include such
elements as are necessary to assure safe use of the drug,
because of its inherent toxicity or potential harmfulness, if
the Secretary determines that--
``(A) the drug, which has been shown to be
effective, but is associated with a serious adverse drug
experience, can be approved only if, or would be
withdrawn unless, such elements are required as part of
such strategy to mitigate a specific serious risk listed
in the labeling of the drug; and
``(B) for a drug initially approved without elements
to assure safe use, other elements under subsections
(c), (d), and (e) are not sufficient to mitigate such
serious risk.
``(2) Assuring access and minimizing burden.--Such elements
to assure safe use under paragraph (1) shall--
``(A) be commensurate with the specific serious risk
listed in the labeling of the drug;
``(B) [NOTE: Deadline.] within 30 days of the date
on which any element under paragraph (1) is imposed, be
posted publicly by the Secretary with an explanation of
how such elements will mitigate the observed safety
risk;
``(C) considering such risk, not be unduly
burdensome on patient access to the drug, considering in
particular--
``(i) patients with serious or life-
threatening diseases or conditions; and
``(ii) patients who have difficulty accessing
health care (such as patients in rural or
medically underserved areas); and
``(D) to the extent practicable, so as to minimize
the burden on the health care delivery system--
``(i) conform with elements to assure safe use
for other drugs with similar, serious risks; and
``(ii) be designed to be compatible with
established distribution, procurement, and
dispensing systems for drugs.
``(3) Elements to assure safe use.--The elements to assure
safe use under paragraph (1) shall include 1 or more goals to
mitigate a specific serious risk listed in the labeling of the
drug and, to mitigate such risk, may require that--
``(A) health care providers who prescribe the drug
have particular training or experience, or are specially
certified (the opportunity to obtain such training or
certification with respect to the drug shall be
available to any willing provider from a frontier area
in a widely available training or certification method
(including an on-line course or via mail) as approved by
the Secretary at reasonable cost to the provider);

[[Page 931]]
121 STAT. 931

``(B) pharmacies, practitioners, or health care
settings that dispense the drug are specially certified
(the opportunity to obtain such certification shall be
available to any willing provider from a frontier area);
``(C) the drug be dispensed to patients only in
certain health care settings, such as hospitals;
``(D) the drug be dispensed to patients with
evidence or other documentation of safe-use conditions,
such as laboratory test results;
``(E) each patient using the drug be subject to
certain monitoring; or
``(F) each patient using the drug be enrolled in a
registry.
``(4) Implementation system.--The elements to assure safe
use under paragraph (1) that are described in subparagraphs (B),
(C), and (D) of paragraph (3) may include a system through which
the applicant is able to take reasonable steps to--
``(A) monitor and evaluate implementation of such
elements by health care providers, pharmacists, and
other parties in the health care system who are
responsible for implementing such elements; and
``(B) work to improve implementation of such
elements by such persons.
``(5) Evaluation of elements to assure safe use.--The
Secretary, through the Drug Safety and Risk Management Advisory
Committee (or successor committee) of the Food and Drug
Administration, shall--
``(A) seek input from patients, physicians,
pharmacists, and other health care providers about how
elements to assure safe use under this subsection for 1
or more drugs may be standardized so as not to be--
``(i) unduly burdensome on patient access to
the drug; and
``(ii) to the extent practicable, minimize the
burden on the health care delivery system;
``(B) at least annually, evaluate, for 1 or more
drugs, the elements to assure safe use of such drug to
assess whether the elements--
``(i) assure safe use of the drug;
``(ii) are not unduly burdensome on patient
access to the drug; and
``(iii) to the extent practicable, minimize
the burden on the health care delivery system; and
``(C) considering such input and evaluations--
``(i) issue or modify agency guidance about
how to implement the requirements of this
subsection; and
``(ii) modify elements under this subsection
for 1 or more drugs as appropriate.
``(6) Additional mechanisms to assure access.--The
mechanisms under section 561 to provide for expanded access for
patients with serious or life-threatening diseases or conditions
may be used to provide access for patients with a serious or
life-threatening disease or condition, the treatment of which is
not an approved use for the drug, to a drug that is subject to
elements to assure safe use under
this [NOTE: Regulations.] subsection. The Secretary shall
promulgate regulations for how a physician may provide the drug
under the mechanisms of section 561.

[[Page 932]]
121 STAT. 932

``(7) Waiver in public health emergencies.--The Secretary
may waive any requirement of this subsection during the period
described in section 319(a) of the Public Health Service Act
with respect to a qualified countermeasure described under
section 319F-1(a)(2) of such Act, to which a requirement under
this subsection has been applied, if the Secretary has--
``(A) declared a public health emergency under such
section 319; and
``(B) determined that such waiver is required to
mitigate the effects of, or reduce the severity of, such
public health emergency.
``(8)  Limitation.--No holder of an approved covered
application shall use any element to assure safe use required by
the Secretary under this subsection to block or delay approval
of an application under section 505(b)(2) or (j) or to prevent
application of such element under subsection (i)(1)(B) to a drug
that is the subject of an abbreviated new drug application.

``(g) Assessment and Modification of Approved Strategy.--
``(1) Voluntary assessments.--After the approval of a risk
evaluation and mitigation strategy under subsection (a), the
responsible person involved may, subject to paragraph (2),
submit to the Secretary an assessment of, and propose a
modification to, the approved strategy for the drug involved at
any time.
``(2) Required assessments.--A responsible person shall,
subject to paragraph (5), submit an assessment of, and may
propose a modification to, the approved risk evaluation and
mitigation strategy for a drug--
``(A) when submitting a supplemental application for
a new indication for use under section 505(b) or under
section 351 of the Public Health Service Act, unless the
drug is not subject to section 503(b) and the risk
evaluation and mitigation strategy for the drug includes
only the timetable under subsection (d);
``(B) when required by the strategy, as provided for
in such timetable under subsection (d);
``(C) within a time period to be determined by the
Secretary, if the Secretary, in consultation with the
offices described in subsection (c)(2), determines that
new safety or effectiveness information indicates that--
``(i) an element under subsection (d) or (e)
should be modified or included in the strategy; or
``(ii) an element under subsection (f) should
be modified or included in the strategy; or
``(D) [NOTE: Deadline.] within 15 days when
ordered by the Secretary, in consultation with the
offices described in subsection (c)(2), if the Secretary
determines that there may be a cause for action by the
Secretary under section 505(e).
``(3) Requirements for assessments.--An assessment under
paragraph (1) or (2) of an approved risk evaluation and
mitigation strategy for a drug shall include--
``(A) with respect to any goal under subsection (f),
an assessment of the extent to which the elements to
assure safe use are meeting the goal or whether the goal
or such elements should be modified;

[[Page 933]]
121 STAT. 933

``(B) with respect to any postapproval study
required under section 505(o) or otherwise undertaken by
the responsible person to investigate a safety issue,
the status of such study, including whether any
difficulties completing the study have been encountered;
and
``(C) with respect to any postapproval clinical
trial required under section 505(o) or otherwise
undertaken by the responsible party to investigate a
safety issue, the status of such clinical trial,
including whether enrollment has begun, the number of
participants enrolled, the expected completion date,
whether any difficulties completing the clinical trial
have been encountered, and registration information with
respect to requirements under subsections (i) and (j) of
section 402 of the Public Health Service Act.
``(4) Modification.--A modification (whether an enhancement
or a reduction) to the approved risk evaluation and mitigation
strategy for a drug may include the addition or modification of
any element under subsection (d) or the addition, modification,
or removal of any element under subsection (e) or (f), such as--
``(A) modifying the timetable for assessments of the
strategy as provided in subsection (d)(3), including to
eliminate assessments; or
``(B) adding, modifying, or removing an element to
assure safe use under subsection (f).

``(h) Review of Proposed Strategies; Review of Assessments of
Approved Strategies.--
``(1) In general.--The Secretary, in consultation with the
offices described in subsection (c)(2), shall promptly review
each proposed risk evaluation and mitigation strategy for a drug
submitted under subsection (a) and each assessment of an
approved risk evaluation and mitigation strategy for a drug
submitted under subsection (g).
``(2) Discussion.--The [NOTE: Deadlines.] Secretary, in
consultation with the offices described in subsection (c)(2),
shall initiate discussions with the responsible person for
purposes of this subsection to determine a strategy not later
than 60 days after any such assessment is submitted or, in the
case of an assessment submitted under subsection (g)(2)(D), not
later than 30 days after such assessment is submitted.
``(3) Action.--
``(A) In general.--Unless the dispute resolution
process described under paragraph (4) or (5) applies,
the Secretary, in consultation with the offices
described in subsection (c)(2), shall describe any
required risk evaluation and mitigation strategy for a
drug, or any modification to any required strategy--
``(i) as part of the action letter on the
application, when a proposed strategy is submitted
under subsection (a) or a modification to the
strategy is proposed as part of an assessment of
the strategy submitted under subsection (g)(1); or
``(ii) [NOTE: Deadline.] in an order issued
not later than 90 days after the date discussions
of such modification begin under paragraph (2),
when a modification to the strategy is proposed as
part of an assessment of the

[[Page 934]]
121 STAT. 934

strategy submitted under subsection (g)(1) or
under any of subparagraphs (B) through (D) of
subsection (g)(2).
``(B) Inaction.--An approved risk evaluation and
mitigation strategy shall remain in effect until the
Secretary acts, if the Secretary fails to act as
provided under subparagraph (A).
``(C) Public availability.--Any action letter
described in subparagraph (A)(i) or order described in
subparagraph (A)(ii) shall be made publicly available.
``(4) Dispute resolution at initial approval.--If a proposed
risk evaluation and mitigation strategy is submitted under
subsection (a)(1) in an application for initial approval of a
drug and there is a dispute about the strategy, the responsible
person shall use the major dispute resolution procedures as set
forth in the letters described in section 101(c) of the Food and
Drug Administration Amendments Act of 2007.
``(5) Dispute resolution in all other cases.--
``(A) Request [NOTE: Deadlines.] for review.--
``(i) In general.--Not earlier than 15 days,
and not later than 35 days, after discussions
under paragraph (2) have begun, the responsible
person may request in writing that a dispute about
the strategy be reviewed by the Drug Safety
Oversight Board under subsection (j), except that
the determination of the Secretary to require a
risk evaluation and mitigation strategy is not
subject to review under this paragraph. The
preceding sentence does not prohibit review under
this paragraph of the particular elements of such
a strategy.
``(ii) Scheduling.--Upon receipt of a request
under clause (i), the Secretary shall schedule the
dispute involved for review under subparagraph (B)
and, not later than 5 business days of scheduling
the dispute for review, shall publish by posting
on the Internet or otherwise a notice that the
dispute will be reviewed by the Drug Safety
Oversight Board.
``(B) Scheduling review.--If a responsible person
requests review under subparagraph (A), the Secretary--
``(i) shall schedule the dispute for review at
1 of the next 2 regular meetings of the Drug
Safety Oversight Board, whichever meeting date is
more practicable; or
``(ii) may convene a special meeting of the
Drug Safety Oversight Board to review the matter
more promptly, including to meet an action
deadline on an application (including a
supplemental application).
``(C) Agreement after discussion or administrative
appeals.--
``(i) Further discussion or administrative
appeals.--A request for review under subparagraph
(A) shall not preclude further discussions to
reach agreement on the risk evaluation and
mitigation strategy, and such a request shall not
preclude the use of administrative appeals within
the Food and Drug Administration to reach
agreement on the strategy, including appeals as
described in the letters

[[Page 935]]
121 STAT. 935

described in section 101(c) of the Food and Drug
Administration Amendments Act of 2007 for
procedural or scientific matters involving the
review of human drug applications and supplemental
applications that cannot be resolved at the
divisional level. At the time a review has been
scheduled under subparagraph (B) and notice of
such review has been posted, the responsible
person shall either withdraw the request under
subparagraph (A) or terminate the use of such
administrative appeals.
``(ii) Agreement terminates dispute
resolution.--At any time before a decision and
order is issued under subparagraph (G) , the
Secretary (in consultation with the offices
described in subsection (c)(2)) and the
responsible person may reach an agreement on the
risk evaluation and mitigation strategy through
further discussion or administrative appeals,
terminating the dispute resolution process, and
the Secretary shall issue an action letter or
order, as appropriate, that describes the
strategy.
``(D) Meeting of the board.--At a meeting of the
Drug Safety Oversight Board described in subparagraph
(B), the Board shall--
``(i) hear from both parties via written or
oral presentation; and
``(ii) review the dispute.
``(E) Record of [NOTE: Public
information. Deadline.] proceedings.--The Secretary
shall ensure that the proceedings of any such meeting
are recorded, transcribed, and made public within 90
days of the meeting. The Secretary shall redact the
transcript to protect any trade secrets and other
information that is exempted from disclosure under
section 552 of title 5, United States Code, or section
552a of title 5, United States Code.
``(F) Recommendation of [NOTE: Deadlines. Public
information.] the board.--Not later than 5 days after
any such meeting, the Drug Safety Oversight Board shall
provide a written recommendation on resolving the
dispute to the Secretary. Not later than 5 days after
the Board provides such written recommendation to the
Secretary, the Secretary shall make the recommendation
available to the public.
``(G) Action [NOTE: Deadlines.] by the
secretary.--
``(i) Action letter.--With respect to a
proposal or assessment referred to in paragraph
(1), the Secretary shall issue an action letter
that resolves the dispute not later than the later
of--
``(I) the action deadline for the
action letter on the application; or
``(II) 7 days after receiving the
recommendation of the Drug Safety
Oversight Board.
``(ii) Order.--With respect to an assessment
of an approved risk evaluation and mitigation
strategy under subsection (g)(1) or under any of
subparagraphs (B) through (D) of subsection
(g)(2), the Secretary shall issue an order, which
shall be made public, that resolves the dispute
not later than 7 days after

[[Page 936]]
121 STAT. 936

receiving the recommendation of the Drug Safety
Oversight Board.
``(H) Inaction.--An approved risk evaluation and
mitigation strategy shall remain in effect until the
Secretary acts, if the Secretary fails to act as
provided for under subparagraph (G).
``(I) Effect on action deadline.--With respect to a
proposal or assessment referred to in paragraph (1), the
Secretary shall be considered to have met the action
deadline for the action letter on the application if the
responsible person requests the dispute resolution
process described in this paragraph and if the
Secretary--
``(i) has initiated the discussions described
under paragraph (2) not less than 60 days before
such action deadline; and
``(ii) has complied with the timing
requirements of scheduling review by the Drug
Safety Oversight Board, providing a written
recommendation, and issuing an action letter under
subparagraphs (B), (F), and (G), respectively.
``(J) Disqualification.--No individual who is an
employee of the Food and Drug Administration and who
reviews a drug or who participated in an administrative
appeal under subparagraph (C)(i) with respect to such
drug may serve on the Drug Safety Oversight Board at a
meeting under subparagraph (D) to review a dispute about
the risk evaluation and mitigation strategy for such
drug.
``(K) Additional expertise.--The Drug Safety
Oversight Board may add members with relevant expertise
from the Food and Drug Administration, including the
Office of Pediatrics, the Office of Women's Health, or
the Office of Rare Diseases, or from other Federal
public health or health care agencies, for a meeting
under subparagraph (D) of the Drug Safety Oversight
Board.
``(6) Use of advisory committees.--The Secretary may convene
a meeting of 1 or more advisory committees of the Food and Drug
Administration to--
``(A) review a concern about the safety of a drug or
class of drugs, including before an assessment of the
risk evaluation and mitigation strategy or strategies of
such drug or drugs is required to be submitted under any
of subparagraphs (B) through (D) of subsection (g)(2);
``(B) review the risk evaluation and mitigation
strategy or strategies of a drug or group of drugs; or
``(C) review a dispute under paragraph (4) or (5).
``(7) Process for addressing drug class effects.--
``(A) In general.--When a concern about a serious
risk of a drug may be related to the pharmacological
class of the drug, the Secretary, in consultation with
the offices described in subsection (c)(2), may defer
assessments of the approved risk evaluation and
mitigation strategies for such drugs until the Secretary
has convened 1 or more public meetings to consider
possible responses to such concern.
``(B) Notice.--If the Secretary defers an assessment
under subparagraph (A), the Secretary shall--

[[Page 937]]
121 STAT. 937

``(i) [NOTE: Deadline.] give notice of the
deferral to the holder of the approved covered
application not later than 5 days after the
deferral;
``(ii) [NOTE: Federal
Register, publication.] publish the deferral in
the Federal Register; and
``(iii) [NOTE: Public information.] give
notice to the public of any public meetings to be
convened under subparagraph (A), including a
description of the deferral.
``(C) Public meetings.--Such public meetings may
include--
``(i) 1 or more meetings of the responsible
person for such drugs;
``(ii) 1 or more meetings of 1 or more
advisory committees of the Food and Drug
Administration, as provided for under paragraph
(6); or
``(iii) 1 or more workshops of scientific
experts and other stakeholders.
``(D) Action.--After considering the discussions
from any meetings under subparagraph (A), the Secretary
may--
``(i) announce in the Federal Register a
planned regulatory action, including a
modification to each risk evaluation and
mitigation strategy, for drugs in the
pharmacological class;
``(ii) seek public comment about such action;
and
``(iii) after seeking such comment, issue an
order addressing such regulatory action.
``(8) International coordination.--The Secretary, in
consultation with the offices described in subsection (c)(2),
may coordinate the timetable for submission of assessments under
subsection (d), or a study or clinical trial under section
505(o)(3), with efforts to identify and assess the serious risks
of such drug by the marketing authorities of other countries
whose drug approval and risk management processes the Secretary
deems comparable to the drug approval and risk management
processes of the United States. If the Secretary takes action to
coordinate such timetable, the Secretary shall give notice to
the responsible person.
``(9) Effect.--Use of the processes described in paragraphs
(7) and (8) shall not be the sole source of delay of action on
an application or a supplement to an application for a drug.

``(i) Abbreviated New Drug Applications.--
``(1) In general.--A drug that is the subject of an
abbreviated new drug application under section 505(j) is subject
to only the following elements of the risk evaluation and
mitigation strategy required under subsection (a) for the
applicable listed drug:
``(A) A Medication Guide or patient package insert,
if required under subsection (e) for the applicable
listed drug.
``(B) Elements to assure safe use, if required under
subsection (f) for the listed drug. A drug that is the
subject of an abbreviated new drug application and the
listed drug shall use a single, shared system under
subsection (f). The Secretary may waive the requirement
under the preceding sentence for a drug that is the
subject of an abbreviated new drug application, and
permit the applicant to

[[Page 938]]
121 STAT. 938

use a different, comparable aspect of the elements to
assure safe use, if the Secretary determines that--
``(i) the burden of creating a single, shared
system outweighs the benefit of a single, system,
taking into consideration the impact on health
care providers, patients, the applicant for the
abbreviated new drug application, and the holder
of the reference drug product; or
``(ii) an aspect of the elements to assure
safe use for the applicable listed drug is claimed
by a patent that has not expired or is a method or
process that, as a trade secret, is entitled to
protection, and the applicant for the abbreviated
new drug application certifies that it has sought
a license for use of an aspect of the elements to
assure safe use for the applicable listed drug and
that it was unable to obtain a license.
A certification under clause (ii) shall include a
description of the efforts made by the applicant for the
abbreviated new drug application to obtain a license. In
a case described in clause (ii), the Secretary may seek
to negotiate a voluntary agreement with the owner of the
patent, method, or process for a license under which the
applicant for such abbreviated new drug application may
use an aspect of the elements to assure safe use, if
required under subsection (f) for the applicable listed
drug, that is claimed by a patent that has not expired
or is a method or process that as a trade secret is
entitled to protection.
``(2) Action by secretary.--For an applicable listed drug
for which a drug is approved under section 505(j), the
Secretary--
``(A) shall undertake any communication plan to
health care providers required under subsection (e)(3)
for the applicable listed drug; and
``(B) shall inform the responsible person for the
drug that is so approved if the risk evaluation and
mitigation strategy for the applicable listed drug is
modified.

``(j) Drug [NOTE: Establishment.] Safety Oversight Board.--
``(1) In general.--There is established a Drug Safety
Oversight Board.
``(2) Composition; meetings.--The Drug Safety Oversight
Board shall--
``(A) be composed of scientists and health care
practitioners appointed by the Secretary, each of whom
is an employee of the Federal Government;
``(B) include representatives from offices
throughout the Food and Drug Administration, including
the offices responsible for postapproval safety of
drugs;
``(C) include at least 1 representative each from
the National Institutes of Health and the Department of
Health and Human Services (other than the Food and Drug
Administration);
``(D) include such representatives as the Secretary
shall designate from other appropriate agencies that
wish to provide representatives; and
``(E) meet at least monthly to provide oversight and
advice to the Secretary on the management of important
drug safety issues.''.

[[Page 939]]
121 STAT. 939

(c) Regulation of Biological Products.--Section 351 of the Public
Health Service Act (42 U.S.C. 262) is amended--
(1) in subsection (a)(2), by adding at the end the
following:

``(D) Postmarket Studies and Clinical Trials; Labeling; Risk
Evaluation and Mitigation Strategy.--A person that submits an
application for a license under this paragraph is subject to sections
505(o), 505(p), and 505-1 of the Federal Food, Drug, and Cosmetic
Act.''; and
(2) in subsection (j), by inserting ``, including the
requirements under sections 505(o), 505(p), and 505-1 of such
Act,'' after ``, and Cosmetic Act''.

(d) Advertisements of Drugs.--The Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.), as amended by section 801(b), is amended--
(1) in section 301 (21 U.S.C. 331), by adding at the end the
following:

``(kk) The dissemination of a television advertisement without
complying with section 503B.''; and
(2) by inserting after section 503A the following:
``SEC. 503B. [NOTE: 21 USC 353b.] PREREVIEW OF TELEVISION
ADVERTISEMENTS.

``(a) In [NOTE: Deadline.] General.--The Secretary may require the
submission of any television advertisement for a drug (including any
script, story board, rough, or a completed video production of the
television advertisement) to the Secretary for review under this section
not later than 45 days before dissemination of the television
advertisement.

``(b) Review.--In conducting a review of a television advertisement
under this section, the Secretary may make recommendations with respect
to information included in the label of the drug--
``(1) on changes that are--
``(A) necessary to protect the consumer good and
well-being; or
``(B) consistent with prescribing information for
the product under review; and
``(2) if appropriate and if information exists, on
statements for inclusion in the advertisement to address the
specific efficacy of the drug as it relates to specific
population groups, including elderly populations, children, and
racial and ethnic minorities.

``(c) No Authority to Require Changes.--Except as provided by
subsection (e), this section does not authorize the Secretary to make or
direct changes in any material submitted pursuant to subsection (a).
``(d) Elderly Populations, Children, Racially and Ethnically Diverse
Communities.--In formulating recommendations under subsection (b), the
Secretary shall take into consideration the impact of the advertised
drug on elderly populations, children, and racially and ethnically
diverse communities.
``(e) Specific Disclosures.--
``(1) Serious risk; safety protocol.--In conducting a review
of a television advertisement under this section, if the
Secretary determines that the advertisement would be false or
misleading without a specific disclosure about a serious risk
listed in the labeling of the drug involved, the Secretary may
require inclusion of such disclosure in the advertisement.

[[Page 940]]
121 STAT. 940

``(2) Date of approval.--In conducting a review of a
television advertisement under this section, the Secretary may
require the advertisement to include, for a period not to exceed
2 years from the date of the approval of the drug under section
505 or section 351 of the Public Health Service Act, a specific
disclosure of such date of approval if the Secretary determines
that the advertisement would otherwise be false or misleading.

``(f) Rule of Construction.--Nothing in this section may be
construed as having any effect on requirements under section 502(n) or
on the authority of the Secretary under section 314.550, 314.640,
601.45, or 601.94 of title 21, Code of Federal Regulations (or successor
regulations).''.
(3) Direct-to-consumer advertisements.--
(A) In general.--Section 502(n) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended by
adding at the end the following: ``In the case of an
advertisement for a drug subject to section 503(b)(1)
presented directly to consumers in television or radio
format and stating the name of the drug and its
conditions of use, the major statement relating to side
effects and contraindications shall be presented in a
clear, conspicuous, and neutral manner.''.
(B) Regulations to [NOTE: Deadline. 21 USC 352
note.] determine clear, conspicuous, and neutral
manner.--Not later than 30 months after the date of the
enactment of the Food and Drug Administration Amendments
Act of 2007, the Secretary of Health and Human Services
shall by regulation establish standards for determining
whether a major statement relating to side effects and
contraindications of a drug, described in section 502(n)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
352(n)) (as amended by subparagraph (A)) is presented in
the manner required under such section.
(4) Civil penalties.--Section 303 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 333), as amended by section 801(b),
is amended by adding at the end the following:

``(g)(1) With respect to a person who is a holder of an approved
application under section 505 for a drug subject to section 503(b) or
under section 351 of the Public Health Service Act, any such person who
disseminates or causes another party to disseminate a direct-to-consumer
advertisement that is false or misleading shall be liable to the United
States for a civil penalty in an amount not to exceed $250,000 for the
first such violation in any 3-year period, and not to exceed $500,000
for each subsequent violation in any 3-year period. No other civil
monetary penalties in this Act (including the civil penalty in section
303(f)(4)) shall apply to a violation regarding direct-to-consumer
advertising. For purposes of this paragraph: (A) Repeated dissemination
of the same or similar advertisement prior to the receipt of the written
notice referred to in paragraph (2) for such advertisements shall be
considered one violation. (B) On and after the date of the receipt of
such a notice, all violations under this paragraph occurring in a single
day shall be considered one violation. With respect to advertisements
that appear in magazines or other publications that are published less
frequently than daily, each issue date (whether weekly or monthly) shall
be treated as a single day for the purpose of calculating the number of
violations under this paragraph.

[[Page 941]]
121 STAT. 941

``(2) [NOTE: Public record. Notification.] A civil penalty under
paragraph (1) shall be assessed by the Secretary by an order made on the
record after providing written notice to the person to be assessed a
civil penalty and an opportunity for a hearing in accordance with this
paragraph and section 554 of title 5, United States Code. If upon
receipt of the written notice, the person to be assessed a civil penalty
objects and requests a hearing, then in the course of any investigation
related to such hearing, the Secretary may issue subpoenas requiring the
attendance and testimony of witnesses and the production of evidence
that relates to the matter under investigation, including information
pertaining to the factors described in paragraph (3).

``(3) The Secretary, in determining the amount of the civil penalty
under paragraph (1), shall take into account the nature, circumstances,
extent, and gravity of the violation or violations, including the
following factors:
``(A) Whether the person submitted the advertisement or a
similar advertisement for review under section 736A.
``(B) Whether the person submitted the advertisement for
review if required under section 503B.
``(C) Whether, after submission of the advertisement as
described in subparagraph (A) or (B), the person disseminated or
caused another party to disseminate the advertisement before the
end of the 45-day comment period.
``(D) Whether the person incorporated any comments made by
the Secretary with regard to the advertisement into the
advertisement prior to its dissemination.
``(E) Whether the person ceased distribution of the
advertisement upon receipt of the written notice referred to in
paragraph (2) for such advertisement.
``(F) Whether the person had the advertisement reviewed by
qualified medical, regulatory, and legal reviewers prior to its
dissemination.
``(G) Whether the violations were material.
``(H) Whether the person who created the advertisement or
caused the advertisement to be created acted in good faith.
``(I) Whether the person who created the advertisement or
caused the advertisement to be created has been assessed a civil
penalty under this provision within the previous 1-year period.
``(J) The scope and extent of any voluntary, subsequent
remedial action by the person.
``(K) Such other matters, as justice may require.

``(4)(A) Subject to subparagraph (B), no person shall be required to
pay a civil penalty under paragraph (1) if the person submitted the
advertisement to the Secretary and disseminated or caused another party
to disseminate such advertisement after incorporating each comment
received from the Secretary.
``(B) The Secretary may retract or modify any prior comments the
Secretary has provided to an advertisement submitted to the Secretary
based on new information or changed circumstances, so long as the
Secretary provides written notice to the person of the new views of the
Secretary on the advertisement and provides a reasonable time for
modification or correction of the advertisement prior to seeking any
civil penalty under paragraph (1).
``(5) The Secretary may compromise, modify, or remit, with or
without conditions, any civil penalty which may be assessed

[[Page 942]]
121 STAT. 942

under paragraph (1). The amount of such penalty, when finally
determined, or the amount charged upon in compromise, may be deducted
from any sums owed by the United States to the person charged.
``(6) Any person who requested, in accordance with paragraph (2), a
hearing with respect to the assessment of a civil penalty and who is
aggrieved by an order assessing a civil penalty, may file a petition for
de novo judicial review of such order with the United States Court of
Appeals for the District of Columbia Circuit or for any other circuit in
which such person resides or transacts
business. [NOTE: Deadline.] Such a petition may only be filed within
the 60-day period beginning on the date the order making such
assessments was issued.

``(7) If any person fails to pay an assessment of a civil penalty
under paragraph (1)--
``(A) after the order making the assessment becomes final,
and if such person does not file a petition for judicial review
of the order in accordance with paragraph (6), or
``(B) after a court in an action brought under paragraph (6)
has entered a final judgment in favor of the Secretary,

the Attorney General of the United States shall recover the amount
assessed (plus interest at currently prevailing rates from the date of
the expiration of the 60-day period referred to in paragraph (6) or the
date of such final judgment, as the case may be) in an action brought in
any appropriate district court of the United States. In such an action,
the validity, amount, and appropriateness of such penalty shall not be
subject to review.''.
(5) Report on direct-to-consumer advertising.--Not later
than 24 months after the date of the enactment of this Act, the
Secretary of Health and Human Services shall report to the
Congress on direct-to-consumer advertising and its ability to
communicate to subsets of the general population, including
elderly populations, children, and racial and ethnic minority
communities. The Secretary shall utilize the Advisory Committee
on Risk Communication established under this Act to advise the
Secretary with respect to such report. The Advisory Committee
shall study direct-to-consumer advertising as it relates to
increased access to health information and decreased health
disparities for these populations. The report required by this
paragraph shall recommend effective ways to present and
disseminate information to these populations. Such report shall
also make recommendations regarding impediments to the
participation of elderly populations, children, racially and
ethnically diverse communities, and medically underserved
populations in clinical drug trials and shall recommend best
practice approaches for increasing the inclusion of such subsets
of the general population. The Secretary of Health and Human
Services shall submit the report under this paragraph to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives.
(6) Rulemaking.--Section 502(n) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352(n)) is amended by striking ``the
procedure specified in section 701(e) of this Act'' and
inserting ``section 701(a)''.

(e) Rule of [NOTE: 21 USC 355a note.] Construction Regarding
Pediatric Studies.--This title and the amendments made by this title may
not be

[[Page 943]]
121 STAT. 943

construed as affecting the authority of the Secretary of Health and
Human Services to request pediatric studies under section 505A of the
Federal Food, Drug, and Cosmetic Act or to require such studies under
section 505B of such Act.
SEC. 902. ENFORCEMENT.

(a) Misbranding.--Section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the
following:
``(y) If it is a drug subject to an approved risk evaluation and
mitigation strategy pursuant to section 505(p) and the responsible
person (as such term is used in section 505-1) fails to comply with a
requirement of such strategy provided for under subsection (d), (e), or
(f) of section 505-1.
``(z) If it is a drug, and the responsible person (as such term is
used in section 505(o)) is in violation of a requirement established
under paragraph (3) (relating to postmarket studies and clinical trials)
or paragraph (4) (relating to labeling) of section 505(o) with respect
to such drug.''.
(b) Civil Penalties.--Section 303(f) of the Federal Food, Drug, and
Cosmetic Act, as amended by section 801(b), is amended--
(1) by inserting after paragraph (3), as added by section
801(b)(2), the following:

``(4)(A) Any responsible person (as such term is used in section
505-1) that violates a requirement of section 505(o), 505(p), or 505-1
shall be subject to a civil monetary penalty of--
``(i) not more than $250,000 per violation, and not to
exceed $1,000,000 for all such violations adjudicated in a
single proceeding; or
``(ii) in the case of a violation that continues after the
Secretary provides written notice to the responsible person, the
responsible person shall be subject to a civil monetary penalty
of $250,000 for the first 30-day period (or any portion thereof)
that the responsible person continues to be in violation, and
such amount shall double for every 30-day period thereafter that
the violation continues, not to exceed $1,000,000 for any 30-day
period, and not to exceed $10,000,000 for all such violations
adjudicated in a single proceeding.

``(B) In determining the amount of a civil penalty under
subparagraph (A)(ii), the Secretary shall take into consideration
whether the responsible person is making efforts toward correcting the
violation of the requirement of section 505(o), 505(p), or 505-1 for
which the responsible person is subject to such civil penalty.''; and
(2) in paragraph (5), as redesignated by section
801(b)(2)(A), by striking ``paragraph (1), (2), or (3)'' each
place it appears and inserting ``paragraph (1), (2), (3), or
(4)''.
SEC. 903. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL.

Section 505(e) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(e)) is amended by adding at the end the following: ``The
Secretary may withdraw the approval of an application submitted under
this section, or suspend the approval of such an application, as
provided under this subsection, without first ordering the applicant to
submit an assessment of the approved risk evaluation and mitigation
strategy for the drug under section 505-1(g)(2)(D).''.

[[Page 944]]
121 STAT. 944

SEC. 904. [NOTE: Deadline. Reports.] BENEFIT-RISK ASSESSMENTS.

Not later than 1 year after the date of the enactment of this Act,
the Commissioner of Food and Drugs shall submit to the Congress a report
on how best to communicate to the public the risks and benefits of new
drugs and the role of the risk evaluation and mitigation strategy in
assessing such risks and benefits. As part of such study, the
Commissioner may consider the possibility of including in the labeling
and any direct-to-consumer advertisements of a newly approved drug or
indication a unique symbol indicating the newly approved status of the
drug or indication for a period after approval.
SEC. 905. ACTIVE POSTMARKET RISK IDENTIFICATION AND ANALYSIS.

(a) In General.--Subsection (k) of section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end
the following:
``(3) Active postmarket risk identification.--
``(A) Definition.--In this paragraph, the term
`data' refers to information with respect to a drug
approved under this section or under section 351 of the
Public Health Service Act, including claims data,
patient survey data, standardized analytic files that
allow for the pooling and analysis of data from
disparate data environments, and any other data deemed
appropriate by the Secretary.
``(B) Development of [NOTE: Deadline.] postmarket
risk identification and analysis methods.--The Secretary
shall, not later than 2 years after the date of the
enactment of the Food and Drug Administration Amendments
Act of 2007, in collaboration with public, academic, and
private entities--
``(i) develop methods to obtain access to
disparate data sources including the data sources
specified in subparagraph (C);
``(ii) develop validated methods for the
establishment of a postmarket risk identification
and analysis system to link and analyze safety
data from multiple sources, with the goals of
including, in aggregate--
``(I) at least 25,000,000 patients
by July 1, 2010; and
``(II) at least 100,000,000 patients
by July 1, 2012; and
``(iii) [NOTE: Committee.] convene a
committee of experts, including individuals who
are recognized in the field of protecting data
privacy and security, to make recommendations to
the Secretary on the development of tools and
methods for the ethical and scientific uses for,
and communication of, postmarketing data specified
under subparagraph (C), including recommendations
on the development of effective research methods
for the study of drug safety questions.
``(C) Establishment of the postmarket risk
identification and analysis system.--
``(i)
In [NOTE: Deadline. Procedures.] general.--The
Secretary shall, not later than 1 year after the
development of the risk identification and
analysis methods under subparagraph (B), establish
and maintain procedures--

[[Page 945]]
121 STAT. 945

``(I) for risk identification and
analysis based on electronic health
data, in compliance with the regulations
promulgated under section 264(c) of the
Health Insurance Portability and
Accountability Act of 1996, and in a
manner that does not disclose
individually identifiable health
information in violation of paragraph
(4)(B);
``(II) for the reporting (in a
standardized form) of data on all
serious adverse drug experiences (as
defined in section 505-1(b)) submitted
to the Secretary under paragraph (1),
and those adverse events submitted by
patients, providers, and drug sponsors,
when appropriate;
``(III) to provide for active
adverse event surveillance using the
following data sources, as available:
``(aa) Federal health-
related electronic data (such as
data from the Medicare program
and the health systems of the
Department of Veterans Affairs);
``(bb) private sector
health-related electronic data
(such as pharmaceutical purchase
data and health insurance claims
data); and
``(cc) other data as the
Secretary deems necessary to
create a robust system to
identify adverse events and
potential drug safety signals;
``(IV) to identify certain trends
and patterns with respect to data
accessed by the system;
``(V) [NOTE: Reports.] to provide
regular reports to the Secretary
concerning adverse event trends, adverse
event patterns, incidence and prevalence
of adverse events, and other information
the Secretary determines appropriate,
which may include data on comparative
national adverse event trends; and
``(VI) to enable the program to
export data in a form appropriate for
further aggregation, statistical
analysis, and reporting.
``(ii) Timeliness of reporting.--The
procedures established under clause (i) shall
ensure that such data are accessed, analyzed, and
reported in a timely, routine, and systematic
manner, taking into consideration the need for
data completeness, coding, cleansing, and
standardized analysis and transmission.
``(iii) Private [NOTE: Deadline.] sector
resources.--To ensure the establishment of the
active postmarket risk identification and analysis
system under this subsection not later than 1 year
after the development of the risk identification
and analysis methods under subparagraph (B), as
required under clause (i), the Secretary may, on a
temporary or permanent basis, implement systems or
products developed by private entities.
``(iv) Complementary approaches.--To the
extent the active postmarket risk identification
and analysis system under this subsection is not
sufficient to gather data and information relevant
to a priority drug safety question, the Secretary
shall develop, support, and

[[Page 946]]
121 STAT. 946

participate in complementary approaches to gather
and analyze such data and information, including--
``(I) approaches that are
complementary with respect to assessing
the safety of use of a drug in domestic
populations not included, or
underrepresented, in the trials used to
approve the drug (such as older people,
people with comorbidities, pregnant
women, or children); and
``(II) existing approaches such as
the Vaccine Adverse Event Reporting
System and the Vaccine Safety Datalink
or successor databases.
``(v) Authority for contracts.--The Secretary
may enter into contracts with public and private
entities to fulfill the requirements of this
subparagraph.
``(4) Advanced analysis of drug safety data.--
``(A) Purpose.--The Secretary shall establish
collaborations with public, academic, and private
entities, which may include the Centers for Education
and Research on Therapeutics under section 912 of the
Public Health Service Act, to provide for advanced
analysis of drug safety data described in paragraph
(3)(C) and other information that is publicly available
or is provided by the Secretary, in order to--
``(i) improve the quality and efficiency of
postmarket drug safety risk-benefit analysis;
``(ii) provide the Secretary with routine
access to outside expertise to study advanced drug
safety questions; and
``(iii) enhance the ability of the Secretary
to make timely assessments based on drug safety
data.
``(B) Privacy.--Such analysis shall not disclose
individually identifiable health information when
presenting such drug safety signals and trends or when
responding to inquiries regarding such drug safety
signals and trends.
``(C) Public process for priority questions.--At
least biannually, the Secretary shall seek
recommendations from the Drug Safety and Risk Management
Advisory Committee (or any successor committee) and from
other advisory committees, as appropriate, to the Food
and Drug Administration on--
``(i) priority drug safety questions; and
``(ii) mechanisms for answering such
questions, including through--
``(I) active risk identification
under paragraph (3); and
``(II) when such risk identification
is not sufficient, postapproval studies
and clinical trials under subsection
(o)(3).
``(D) Procedures for the development of drug safety
collaborations.--
``(i) In [NOTE: Deadline.] general.--Not
later than 180 days after the date of the
establishment of the active postmarket risk
identification and analysis system under this
subsection, the Secretary shall establish and
implement procedures under which the Secretary may
routinely contract with one or more qualified
entities to--

[[Page 947]]
121 STAT. 947

``(I) classify, analyze, or
aggregate data described in paragraph
(3)(C) and information that is publicly
available or is provided by the
Secretary;
``(II) allow for prompt
investigation of priority drug safety
questions, including--
``(aa) unresolved safety
questions for drugs or classes
of drugs; and
``(bb) for a newly-approved
drugs, safety signals from
clinical trials used to approve
the drug and other preapproval
trials; rare, serious drug side
effects; and the safety of use
in domestic populations not
included, or underrepresented,
in the trials used to approve
the drug (such as older people,
people with comorbidities,
pregnant women, or children);
``(III) perform advanced research
and analysis on identified drug safety
risks;
``(IV) focus postapproval studies
and clinical trials under subsection
(o)(3) more effectively on cases for
which reports under paragraph (1) and
other safety signal detection is not
sufficient to resolve whether there is
an elevated risk of a serious adverse
event associated with the use of a drug;
and
``(V) carry out other activities as
the Secretary deems necessary to carry
out the purposes of this paragraph.
``(ii) Request for specific methodology.--The
procedures described in clause (i) shall permit
the Secretary to request that a specific
methodology be used by the qualified entity. The
qualified entity shall work with the Secretary to
finalize the methodology to be used.
``(E) Use of analyses.--The Secretary shall provide
the analyses described in this paragraph, including the
methods and results of such analyses, about a drug to
the sponsor or sponsors of such drug.
``(F) Qualified [NOTE: Contracts.] entities.--
``(i) In general.--The Secretary shall enter
into contracts with a sufficient number of
qualified entities to develop and provide
information to the Secretary in a timely manner.
``(ii) Qualification.--The Secretary shall
enter into a contract with an entity under clause
(i) only if the Secretary determines that the
entity has a significant presence in the United
States and has one or more of the following
qualifications:
``(I) The research, statistical,
epidemiologic, or clinical capability
and expertise to conduct and complete
the activities under this paragraph,
including the capability and expertise
to provide the Secretary de-identified
data consistent with the requirements of
this subsection.
``(II) An information technology
infrastructure in place to support
electronic data and operational
standards to provide security for such
data.

[[Page 948]]
121 STAT. 948

``(III) Experience with, and
expertise on, the development of drug
safety and effectiveness research using
electronic population data.
``(IV) An understanding of drug
development or risk/benefit balancing in
a clinical setting.
``(V) Other expertise which the
Secretary deems necessary to fulfill the
activities under this paragraph.
``(G) Contract requirements.--Each contract with a
qualified entity under subparagraph (F)(i) shall contain
the following requirements:
``(i) Ensuring privacy.--The qualified entity
shall ensure that the entity will not use data
under this subsection in a manner that--
``(I) violates the regulations
promulgated under section 264(c) of the
Health Insurance Portability and
Accountability Act of 1996;
``(II) violates sections 552 or 552a
of title 5, United States Code, with
regard to the privacy of individually-
identifiable beneficiary health
information; or
``(III) discloses individually
identifiable health information when
presenting drug safety signals and
trends or when responding to inquiries
regarding drug safety signals and
trends.
Nothing in this clause prohibits lawful disclosure
for other purposes.
``(ii) Component of another organization.--If
a qualified entity is a component of another
organization--
``(I) the qualified entity shall
establish appropriate security measures
to maintain the confidentiality and
privacy of such data; and
``(II) the entity shall not make an
unauthorized disclosure of such data to
the other components of the organization
in breach of such confidentiality and
privacy requirement.
``(iii) Termination
or [NOTE: Applicability.] nonrenewal.--If a
contract with a qualified entity under this
subparagraph is terminated or not renewed, the
following requirements shall apply:
``(I) Confidentiality and privacy
protections.--The entity shall continue
to comply with the confidentiality and
privacy requirements under this
paragraph with respect to all data
disclosed to the entity.
``(II) Disposition of data.--The
entity shall return any data disclosed
to such entity under this subsection to
which it would not otherwise have access
or, if returning the data is not
practicable, destroy the data.
``(H) Competitive procedures.--The Secretary shall
use competitive procedures (as defined in section 4(5)
of the Federal Procurement Policy Act) to enter into
contracts under subparagraph (G).
``(I) Review of contract in the event of a merger or
acquisition.--The Secretary shall review the contract

[[Page 949]]
121 STAT. 949

with a qualified entity under this paragraph in the
event of a merger or acquisition of the entity in order
to ensure that the requirements under this paragraph
will continue to be met.
``(J) Coordination.--In carrying out this paragraph,
the Secretary shall provide for appropriate
communications to the public, scientific, public health,
and medical communities, and other key stakeholders, and
to the extent practicable shall coordinate with the
activities of private entities, professional
associations, or other entities that may have sources of
drug safety data.''.

(b) Rule of [NOTE: 21 USC 355 note.] Construction.--Nothing in
this section or the amendment made by this section shall be construed to
prohibit the lawful disclosure or use of data or information by an
entity other than as described in paragraph (4)(B) or (4)(G) of section
505(k) of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a).

(c) Report to Congress.--Not later than 4 years after the date of
the enactment of this Act, the Secretary shall report to the Congress on
the ways in which the Secretary has used the active postmarket risk
identification and analysis system described in paragraphs (3) and (4)
of section 505(k) of the Federal Food, Drug, and Cosmetic Act, as added
by subsection (a), to identify specific drug safety signals and to
better understand the outcomes associated with drugs marketed in the
United States.
(d) Authorization of Appropriations.--To carry out activities under
the amendment made by this section for which funds are made available
under section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h), there are authorized to be appropriated to carry out the
amendment made by this section, in addition to such funds, $25,000,000
for each of fiscal years 2008 through 2012.
(e) GAO Report.--Not later than 18 months after the date of the
enactment of this Act, the Comptroller General of the United States
shall evaluate data privacy, confidentiality, and security issues
relating to accessing, transmitting, and maintaining data for the active
postmarket risk identification and analysis system described in
paragraphs (3) and (4) of section 505(k) of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), and make recommendations to
the Committee on Energy and Commerce of the House of Representatives and
the Committee on Health, Education, Labor and Pensions of the Senate,
and any other congressional committees of relevant jurisdiction,
regarding the need for any additional legislative or regulatory actions
to ensure privacy, confidentiality, and security of this data or
otherwise address privacy, confidentiality, and security issues to
ensure the effective operation of such active postmarket identification
and analysis system.
SEC. 906. STATEMENT FOR INCLUSION IN DIRECT-TO-CONSUMER
ADVERTISEMENTS OF DRUGS.

(a) Published Direct-to-Consumer Advertisements.--Section 502(n) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352), as amended by
section 901(d)(6), is further amended by inserting ``and in the case of
published direct-to-consumer advertisements the following statement
printed in conspicuous text: `You are encouraged to report negative side
effects of prescription

[[Page 950]]
121 STAT. 950

drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-
1088.','' after ``section 701(a),''.
(b) [NOTE: 21 USC 352 note.] Study.--
(1) In [NOTE: Deadline.] general.--In the case of direct-
to-consumer television advertisements, the Secretary of Health
and Human Services, in consultation with the Advisory Committee
on Risk Communication under section 567 of the Federal Food,
Drug, and Cosmetic Act (as added by section 917), shall, not
later than 6 months after the date of the enactment of this Act,
conduct a study to determine if the statement in section 502(n)
of such Act (as added by subsection (a)) required with respect
to published direct-to-consumer advertisements is appropriate
for inclusion in such television advertisements.
(2) Content.--As part of the study under paragraph (1), such
Secretary shall consider whether the information in the
statement described in paragraph (1) would detract from the
presentation of risk information in a direct-to-consumer
television advertisement. If such Secretary determines the
inclusion of such statement is appropriate in direct-to-consumer
television advertisements, such Secretary shall issue
regulations requiring the implementation of such statement in
direct-to-consumer television advertisements, including
determining a reasonable length of time for displaying the
statement in such advertisements. [NOTE: Reports.] The
Secretary shall report to the appropriate committees of Congress
the findings of such study and any plans to issue regulations
under this paragraph.
SEC. 907. [NOTE: 21 USC 355 note.] NO EFFECT ON VETERINARY
MEDICINE.

This subtitle, and the amendments made by this subtitle, shall have
no effect on the use of drugs approved under section 505 of the Federal
Food, Drug, and Cosmetic Act by, or on the lawful written or oral order
of, a licensed veterinarian within the context of a veterinarian-client-
patient relationship, as provided for under section 512(a)(5) of such
Act.
SEC. 908. AUTHORIZATION OF APPROPRIATIONS.

(a) In General.--For carrying out this subtitle and the amendments
made by this subtitle, there is authorized to be appropriated
$25,000,000 for each of fiscal years 2008 through 2012.
(b) Relation to Other Funding.--The authorization of appropriations
under subsection (a) is in addition to any other funds available for
carrying out this subtitle and the amendments made by this subtitle.
SEC. 909. [NOTE: 21 USC 331 note.] EFFECTIVE DATE AND
APPLICABILITY.

(a) Effective Date.--This subtitle takes effect 180 days after the
date of the enactment of this Act.
(b) Drugs Deemed to Have Risk Evaluation and Mitigation
Strategies.--
(1) In general.--A drug that was approved before the
effective date of this Act is, in accordance with paragraph (2),
deemed to have in effect an approved risk evaluation and
mitigation strategy under section 505-1 of the Federal Food,
Drug, and Cosmetic Act (as added by section 901) (referred to in
this section as the ``Act'') if there are in effect on the
effective date of this Act elements to assure safe use--
(A) required under section 314.520 or section 601.42
of title 21, Code of Federal Regulations; or

[[Page 951]]
121 STAT. 951

(B) otherwise agreed to by the applicant and the
Secretary for such drug.
(2) Elements of strategy; enforcement.--The approved risk
evaluation and mitigation strategy in effect for a drug under
paragraph (1)--
(A) is deemed to consist of the timetable required
under section 505-1(d) and any additional elements under
subsections (e) and (f) of such section in effect for
such drug on the effective date of this Act; and
(B) is subject to enforcement by the Secretary to
the same extent as any other risk evaluation and
mitigation strategy under section 505-1 of the Act,
except that sections 303(f)(4) and 502(y) and (z) of the
Act (as added by section 902) shall not apply to such
strategy before the Secretary has completed review of,
and acted on, the first assessment of such strategy
under such section 505-1.
(3) Submission.--Not [NOTE: Deadline.] later than 180 days
after the effective date of this Act, the holder of an approved
application for which a risk evaluation and mitigation strategy
is deemed to be in effect under paragraph (1) shall submit to
the Secretary a proposed risk evaluation and mitigation
strategy. Such proposed strategy is subject to section 505-1 of
the Act as if included in such application at the time of
submission of the application to the Secretary.

Subtitle B--Other Provisions to Ensure Drug Safety and Surveillance

SEC. 911. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS.

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351
et seq.) is amended by inserting after section 510 the following:
``SEC. 511. [NOTE: Deadlines. 21 USC 360a.] CLINICAL TRIAL
GUIDANCE FOR ANTIBIOTIC DRUGS.

``(a) In General.--Not later than 1 year after the date of the
enactment of this section, the Secretary shall issue guidance for the
conduct of clinical trials with respect to antibiotic drugs, including
antimicrobials to treat acute bacterial sinusitis, acute bacterial
otitis media, and acute bacterial exacerbation of chronic bronchitis.
Such guidance shall indicate the appropriate models and valid surrogate
markers.
``(b) Review.--Not later than 5 years after the date of the
enactment of this section, the Secretary shall review and update the
guidance described under subsection (a) to reflect developments in
scientific and medical information and technology.''.
SEC. 912. PROHIBITION AGAINST FOOD TO WHICH DRUGS OR BIOLOGICAL
PRODUCTS HAVE BEEN ADDED.

(a) Prohibition.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331), as amended by section 901(d), is amended
by adding at the end the following:
``(ll) The introduction or delivery for introduction into interstate
commerce of any food to which has been added a drug approved under
section 505, a biological product licensed under section 351 of the
Public Health Service Act, or a drug or a biological product for which
substantial clinical investigations have been instituted

[[Page 952]]
121 STAT. 952

and for which the existence of such investigations has been made public,
unless--
``(1) such drug or such biological product was marketed in
food before any approval of the drug under section 505, before
licensure of the biological product under such section 351, and
before any substantial clinical investigations involving the
drug or the biological product have been instituted;
``(2) the Secretary, in the Secretary's discretion, has
issued a regulation, after notice and comment, approving the use
of such drug or such biological product in the food;
``(3) the use of the drug or the biological product in the
food is to enhance the safety of the food to which the drug or
the biological product is added or applied and not to have
independent biological or therapeutic effects on humans, and the
use is in conformity with--
``(A) a regulation issued under section 409
prescribing conditions of safe use in food;
``(B) a regulation listing or affirming conditions
under which the use of the drug or the biological
product in food is generally recognized as safe;
``(C) the conditions of use identified in a
notification to the Secretary of a claim of exemption
from the premarket approval requirements for food
additives based on the notifier's determination that the
use of the drug or the biological product in food is
generally recognized as safe, provided that the
Secretary has not questioned the general recognition of
safety determination in a letter to the notifier;
``(D) a food contact substance notification that is
effective under section 409(h); or
``(E) such drug or biological product had been
marketed for smoking cessation prior to the date of the
enactment of the Food and Drug Administration Amendments
Act of 2007; or
``(4) the drug is a new animal drug whose use is not unsafe
under section 512.''.

(b) Conforming Changes.--The Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.) is amended--
(1) [NOTE: 21 USC 334.] in section 304(a)(1), by striking
``section 404 or 505'' and inserting ``section 301(ll), 404, or
505''; and
(2) [NOTE: 21 USC 381.] in section 801(a), by striking
``is adulterated, misbranded, or in violation of section 505,''
and inserting ``is adulterated, misbranded, or in violation of
section 505, or prohibited from introduction or delivery for
introduction into interstate commerce under section 301(ll),''.
SEC. 913. ASSURING PHARMACEUTICAL SAFETY.

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351
et seq.), as amended in section 403, is amended by inserting after
section 505C the following:
``SEC. 505D. [NOTE: 21 USC 355e.] PHARMACEUTICAL SECURITY.

``(a) In [NOTE: Standards.] General.--The Secretary shall develop
standards and identify and validate effective technologies for the
purpose of securing the drug supply chain against counterfeit, diverted,
subpotent, substandard, adulterated, misbranded, or expired drugs.

``(b) Standards Development.--

[[Page 953]]
121 STAT. 953

``(1) In general.--The Secretary shall, in consultation with
the agencies specified in paragraph (4), manufacturers,
distributors, pharmacies, and other supply chain stakeholders,
prioritize and develop standards for the identification,
validation, authentication, and tracking and tracing of
prescription drugs.
``(2) Standardized [NOTE: Deadline.] numeral identifier.--
Not later than 30 months after the date of the enactment of the
Food and Drug Administration Amendments Act of 2007, the
Secretary shall develop a standardized numerical identifier
(which, to the extent practicable, shall be harmonized with
international consensus standards for such an identifier) to be
applied to a prescription drug at the point of manufacturing and
repackaging (in which case the numerical identifier shall be
linked to the numerical identifier applied at the point of
manufacturing) at the package or pallet level, sufficient to
facilitate the identification, validation, authentication, and
tracking and tracing of the prescription drug.
``(3) Promising technologies.--The standards developed under
this subsection shall address promising technologies, which may
include--
``(A) radio frequency identification technology;
``(B) nanotechnology;
``(C) encryption technologies; and
``(D) other track-and-trace or authentication
technologies.
``(4) Interagency collaboration.--In carrying out this
subsection, the Secretary shall consult with Federal health and
security agencies, including--
``(A) the Department of Justice;
``(B) the Department of Homeland Security;
``(C) the Department of Commerce; and
``(D) other appropriate Federal and State agencies.

``(c) Inspection and Enforcement.--
``(1) In general.--The Secretary shall expand and enhance
the resources and facilities of agency components of the Food
and Drug Administration involved with regulatory and criminal
enforcement of this Act to secure the drug supply chain against
counterfeit, diverted, subpotent, substandard, adulterated,
misbranded, or expired drugs including biological products and
active pharmaceutical ingredients from domestic and foreign
sources.
``(2) Activities.--The Secretary shall undertake enhanced
and joint enforcement activities with other Federal and State
agencies, and establish regional capacities for the validation
of prescription drugs and the inspection of the prescription
drug supply chain.

``(d) Definition.--In this section, the term `prescription drug'
means a drug subject to section 503(b)(1).''.
SEC. 914. CITIZEN PETITIONS AND PETITIONS FOR STAY OF AGENCY
ACTION.

(a) In General.--Section 505 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355), as amended by section 901(a), is amended by adding
at the end the following:
``(q) Petitions and Civil Actions Regarding Approval of Certain
Applications.--

[[Page 954]]
121 STAT. 954

``(1) In general.--
``(A) Determination.--The Secretary shall not delay
approval of a pending application submitted under
subsection (b)(2) or (j) because of any request to take
any form of action relating to the application, either
before or during consideration of the request, unless--
``(i) the request is in writing and is a
petition submitted to the Secretary pursuant to
section 10.30 or 10.35 of title 21, Code of
Federal Regulations (or any successor
regulations); and
``(ii) the Secretary determines, upon
reviewing the petition, that a delay is necessary
to protect the public health.
``(B) Notification.--If
the [NOTE: Deadline.] Secretary determines under
subparagraph (A) that a delay is necessary with respect
to an application, the Secretary shall provide to the
applicant, not later than 30 days after making such
determination, the following information:
``(i) Notification of the fact that a
determination under subparagraph (A) has been
made.
``(ii) If applicable, any clarification or
additional data that the applicant should submit
to the docket on the petition to allow the
Secretary to review the petition promptly.
``(iii) A brief summary of the specific
substantive issues raised in the petition which
form the basis of the determination.
``(C) Format.--The information described in
subparagraph (B) shall be conveyed via either, at the
discretion of the Secretary--
``(i) a document; or
``(ii) a meeting with the applicant involved.
``(D) Public disclosure.--Any information conveyed
by the Secretary under subparagraph (C) shall be
considered part of the application and shall be subject
to the disclosure requirements applicable to information
in such application.
``(E) Denial based on intent to delay.--If the
Secretary determines that a petition or a supplement to
the petition was submitted with the primary purpose of
delaying the approval of an application and the petition
does not on its face raise valid scientific or
regulatory issues, the Secretary may deny the petition
at any point based on such determination. The Secretary
may issue guidance to describe the factors that will be
used to determine under this subparagraph whether a
petition is submitted with the primary purpose of
delaying the approval of an application.
``(F) Final [NOTE: Deadline.] agency action.--The
Secretary shall take final agency action on a petition
not later than 180 days after the date on which the
petition is submitted. The Secretary shall not extend
such period for any reason, including--
``(i) any determination made under
subparagraph (A);

[[Page 955]]
121 STAT. 955

``(ii) the submission of comments relating to
the petition or supplemental information supplied
by the petitioner; or
``(iii) the consent of the petitioner.
``(G) Extension of 30-month period.--If the filing
of an application resulted in first-applicant status
under subsection (j)(5)(D)(i)(IV) and approval of the
application was delayed because of a petition, the 30-
month period under such subsection is deemed to be
extended by a period of time equal to the period
beginning on the date on which the Secretary received
the petition and ending on the date of final agency
action on the petition (inclusive of such beginning and
ending dates), without regard to whether the Secretary
grants, in whole or in part, or denies, in whole or in
part, the petition.
``(H) Certification.--The Secretary shall not
consider a petition for review unless the party
submitting such petition does so in written form and the
subject document is signed and contains the following
certification: `I certify that, to my best knowledge and
belief: (a) this petition includes all information and
views upon which the petition relies; (b) this petition
includes representative data and/or information known to
the petitioner which are unfavorable to the petition;
and (c) I have taken reasonable steps to ensure that any
representative data and/or information which are
unfavorable to the petition were disclosed to me. I
further certify that the information upon which I have
based the action requested herein first became known to
the party on whose behalf this petition is submitted on
or about the following date: __________. If I received
or expect to receive payments, including cash and other
forms of consideration, to file this information or its
contents, I received or expect to receive those payments
from the following persons or organizations:
_____________. I verify under penalty of perjury that
the foregoing is true and correct as of the date of the
submission of this petition.', with the date on which
such information first became known to such party and
the names of such persons or organizations inserted in
the first and second blank space, respectively.
``(I) Verification.--The Secretary shall not accept
for review any supplemental information or comments on a
petition unless the party submitting such information or
comments does so in written form and the subject
document is signed and contains the following
verification: `I certify that, to my best knowledge and
belief: (a) I have not intentionally delayed submission
of this document or its contents; and (b) the
information upon which I have based the action requested
herein first became known to me on or about __________.
If I received or expect to receive payments, including
cash and other forms of consideration, to file this
information or its contents, I received or expect to
receive those payments from the following persons or
organizations: _____. I verify under penalty of perjury
that the foregoing is true and correct as of the date of
the submission of this petition.', with the date on
which such information first became known

[[Page 956]]
121 STAT. 956

to the party and the names of such persons or
organizations inserted in the first and second blank
space, respectively.
``(2) Exhaustion of administrative remedies.--
``(A) Final agency action within 180 days.--The
Secretary shall be considered to have taken final agency
action on a petition if--
``(i) during the 180-day period referred to in
paragraph (1)(F), the Secretary makes a final
decision within the meaning of section 10.45(d) of
title 21, Code of Federal Regulations (or any
successor regulation); or
``(ii) such period expires without the
Secretary having made such a final decision.
``(B) Dismissal of [NOTE: Courts.] certain civil
actions.--If a civil action is filed against the
Secretary with respect to any issue raised in the
petition before the Secretary has taken final agency
action on the petition within the meaning of
subparagraph (A), the court shall dismiss without
prejudice the action for failure to exhaust
administrative remedies.
``(C) Administrative record.--For purposes of
judicial review related to the approval of an
application for which a petition under paragraph (1) was
submitted, the administrative record regarding any issue
raised by the petition shall include--
``(i) the petition filed under paragraph (1)
and any supplements and comments thereto;
``(ii) the Secretary's response to such
petition, if issued; and
``(iii) other information, as designated by
the Secretary, related to the Secretary's
determinations regarding the issues raised in such
petition, as long as the information was
considered by the agency no later than the date of
final agency action as defined under subparagraph
(2)(A), and regardless of whether the Secretary
responded to the petition at or before the
approval of the application at issue in the
petition.
``(3) Annual report on delays in approvals per petitions.--
The Secretary shall annually submit to the Congress a report
that specifies--
``(A) the number of applications that were approved
during the preceding 12-month period;
``(B) the number of such applications whose
effective dates were delayed by petitions referred to in
paragraph (1) during such period;
``(C) the number of days by which such applications
were so delayed; and
``(D) the number of such petitions that were
submitted during such period.
``(4) Exceptions.--This subsection does not apply to--
``(A) a petition that relates solely to the timing
of the approval of an application pursuant to subsection
(j)(5)(B)(iv); or
``(B) a petition that is made by the sponsor of an
application and that seeks only to have the Secretary
take or refrain from taking any form of action with
respect to that application.

[[Page 957]]
121 STAT. 957

``(5) Definitions.--
``(A) Application.--For purposes of this subsection,
the term `application' means an application submitted
under subsection (b)(2) or (j).
``(B) Petition.--For purposes of this subsection,
other than paragraph (1)(A)(i), the term `petition'
means a request described in paragraph (1)(A)(i).''.

(b) Report.--Not later than 1 year after the date of the enactment
of this Act, the Secretary of Health and Human Services shall submit a
report to the Congress on ways to encourage the early submission of
petitions under section 505(q), as added by subsection (a).
SEC. 915. POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND
PROVIDERS.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355), as amended by section 914(a), is amended by adding at the end the
following:
``(r) Postmarket Drug Safety Information for Patients and
Providers.--
``(1) Establishment.--Not [NOTE: Deadline. Website.] later
than 1 year after the date of the enactment of the Food and Drug
Administration Amendments Act of 2007, the Secretary shall
improve the transparency of information about drugs and allow
patients and health care providers better access to information
about drugs by developing and maintaining an Internet Web site
that--
``(A) provides links to drug safety information
listed in paragraph (2) for prescription drugs that are
approved under this section or licensed under section
351 of the Public Health Service Act; and
``(B) improves communication of drug safety
information to patients and providers.
``(2) Internet web site.--The Secretary shall carry out
paragraph (1) by--
``(A) developing and maintaining an accessible,
consolidated Internet Web site with easily searchable
drug safety information, including the information found
on United States Government Internet Web sites, such as
the United States National Library of Medicine's Daily
Med and Medline Plus Web sites, in addition to other
such Web sites maintained by the Secretary;
``(B) ensuring that the information provided on the
Internet Web site is comprehensive and includes, when
available and appropriate--
``(i) patient labeling and patient packaging
inserts;
``(ii) a link to a list of each drug, whether
approved under this section or licensed under such
section 351, for which a Medication Guide, as
provided for under part 208 of title 21, Code of
Federal Regulations (or any successor
regulations), is required;
``(iii) a link to the registry and results
data bank provided for under subsections (i) and
(j) of section 402 of the Public Health Service
Act;
``(iv) the most recent safety information and
alerts issued by the Food and Drug Administration
for drugs approved by the Secretary under this
section, such as product recalls, warning letters,
and import alerts;

[[Page 958]]
121 STAT. 958

``(v) publicly available information about
implemented RiskMAPs and risk evaluation and
mitigation strategies under subsection (o);
``(vi) guidance documents and regulations
related to drug safety; and
``(vii) other material determined appropriate
by the Secretary;
``(C) providing access to summaries of the assessed
and aggregated data collected from the active
surveillance infrastructure under subsection (k)(3) to
provide information of known and serious side-effects
for drugs approved under this section or licensed under
such section 351;
``(D) [NOTE: Reports.] preparing, by 18 months
after approval of a drug or after use of the drug by
10,000 individuals, whichever is later, a summary
analysis of the adverse drug reaction reports received
for the drug, including identification of any new risks
not previously identified, potential new risks, or known
risks reported in unusual number;
``(E) [NOTE: Reports.] enabling patients,
providers, and drug sponsors to submit adverse event
reports through the Internet Web site;
``(F) providing educational materials for patients
and providers about the appropriate means of disposing
of expired, damaged, or unusable medications; and
``(G) supporting initiatives that the Secretary
determines to be useful to fulfill the purposes of the
Internet Web site.
``(3) Posting of [NOTE: Deadline.] drug labeling.--The
Secretary shall post on the Internet Web site established under
paragraph (1) the approved professional labeling and any
required patient labeling of a drug approved under this section
or licensed under such section 351 not later than 21 days after
the date the drug is approved or licensed, including in a
supplemental application with respect to a labeling change.
``(4) Private sector resources.--To ensure development of
the Internet Web site by the date described in paragraph (1),
the Secretary may, on a temporary or permanent basis, implement
systems or products developed by private entities.
``(5) Authority for contracts.--The Secretary may enter into
contracts with public and private entities to fulfill the
requirements of this subsection.
``(6) Review.--The Advisory Committee on Risk Communication
under section 567 shall, on a regular basis, perform a
comprehensive review and evaluation of the types of risk
communication information provided on the Internet Web site
established under paragraph (1) and, through other means, shall
identify, clarify, and define the purposes and types of
information available to facilitate the efficient flow of
information to patients and providers, and shall recommend ways
for the Food and Drug Administration to work with outside
entities to help facilitate the dispensing of risk communication
information to patients and providers.''.
SEC. 916. ACTION PACKAGE FOR APPROVAL.

Section 505(l) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(l)) is amended by--

[[Page 959]]
121 STAT. 959

(1) redesignating paragraphs (1), (2), (3), (4), and (5) as
subparagraphs (A), (B), (C), (D), and (E), respectively;
(2) striking ``(l) Safety and'' and inserting ``(l)(1)
Safety and''; and
(3) adding at the end the following:

``(2) Action [NOTE: Publication. Website. Deadlines.] Package for
Approval.--
``(A) Action package.--The Secretary shall publish the
action package for approval of an application under subsection
(b) or section 351 of the Public Health Service Act on the
Internet Web site of the Food and Drug Administration--
``(i) not later than 30 days after the date of
approval of such application for a drug no active
ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other
application under this section or section 351 of the
Public Health Service Act; and
``(ii) not later than 30 days after the third
request for such action package for approval received
under section 552 of title 5, United States Code, for
any other drug.
``(B) Immediate publication of summary review.--
Notwithstanding subparagraph (A), the Secretary shall publish,
on the Internet Web site of the Food and Drug Administration,
the materials described in subparagraph (C)(iv) not later than
48 hours after the date of approval of the drug, except where
such materials require redaction by the Secretary.
``(C) Contents.--An action package for approval of an
application under subparagraph (A) shall be dated and shall
include the following:
``(i) Documents generated by the Food and Drug
Administration related to review of the application.
``(ii) Documents pertaining to the format and
content of the application generated during drug
development.
``(iii) Labeling submitted by the applicant.
``(iv) A summary review that documents conclusions
from all reviewing disciplines about the drug, noting
any critical issues and disagreements with the applicant
and within the review team and how they were resolved,
recommendations for action, and an explanation of any
nonconcurrence with review conclusions.
``(v) The Division Director and Office Director's
decision document which includes--
``(I) a brief statement of concurrence with
the summary review;
``(II) a separate review or addendum to the
review if disagreeing with the summary review; and
``(III) a separate review or addendum to the
review to add further analysis.
``(vi) Identification by name of each officer or
employee of the Food and Drug Administration who--
``(I) participated in the decision to approve
the application; and
``(II) consents to have his or her name
included in the package.
``(D) Review.--A scientific review of an application is
considered the work of the reviewer and shall not be altered by
management or the reviewer once final.

[[Page 960]]
121 STAT. 960

``(E) Confidential information.--This paragraph does not
authorize the disclosure of any trade secret, confidential
commercial or financial information, or other matter listed in
section 552(b) of title 5, United States Code.''.
SEC. 917. RISK COMMUNICATION.

Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb et seq.), as amended by section 603, is amended by
adding at the end the following:
``SEC. 567. [NOTE: 21 USC 360bbb-6.] RISK COMMUNICATION.

``(a) Advisory [NOTE: Establishment.] Committee on Risk
Communication.--
``(1) In general.--The Secretary shall establish an advisory
committee to be known as the `Advisory Committee on Risk
Communication' (referred to in this section as the `Committee').
``(2) Duties of committee.--The Committee shall advise the
Commissioner on methods to effectively communicate risks
associated with the products regulated by the Food and Drug
Administration.
``(3) Members.--The Secretary shall ensure that the
Committee is composed of experts on risk communication, experts
on the risks described in subsection (b), and representatives of
patient, consumer, and health professional organizations.
``(4) Permanence of committee.--Section 14 of the Federal
Advisory Committee Act shall not apply to the Committee
established under this subsection.

``(b) Partnerships for Risk Communication.--
``(1) In general.--The Secretary shall partner with
professional medical societies, medical schools, academic
medical centers, and other stakeholders to develop robust and
multi-faceted systems for communication to health care providers
about emerging postmarket drug risks.
``(2) Partnerships.--The systems developed under paragraph
(1) shall--
``(A) account for the diversity among physicians in
terms of practice, willingness to adopt technology, and
medical specialty; and
``(B) include the use of existing communication
channels, including electronic communications, in place
at the Food and Drug Administration.''.
SEC. 918. [NOTE: 21 USC 355.] REFERRAL TO ADVISORY COMMITTEE.

Section 505 of the Federal Food, Drug, and Cosmetic Act, as amended
by section 915, is further amended by adding at the end the following:
``(s) Referral to Advisory Committee.--Prior to the approval of a
drug no active ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other application under
this section or section 351 of the Public Health Service Act, the
Secretary shall--
``(1) refer such drug to a Food and Drug Administration
advisory committee for review at a meeting of such advisory
committee; or
``(2) if the Secretary does not refer such a drug to a Food
and Drug Administration advisory committee prior to the approval
of the drug, provide in the action letter on the application for
the drug a summary of the reasons why the Secretary

[[Page 961]]
121 STAT. 961

did not refer the drug to an advisory committee prior to
approval.''.
SEC. 919. RESPONSE TO THE INSTITUTE OF MEDICINE.

(a) In [NOTE: Deadline. Reports.] General.--Not later than 1 year
after the date of the enactment of this title, the Secretary shall issue
a report responding to the 2006 report of the Institute of Medicine
entitled ``The Future of Drug Safety--Promoting and Protecting the
Health of the Public''.

(b) Content of Report.--The report issued by the Secretary under
subsection (a) shall include--
(1) an update on the implementation by the Food and Drug
Administration of its plan to respond to the Institute of
Medicine report described under such subsection; and
(2) an assessment of how the Food and Drug Administration
has implemented--
(A) the recommendations described in such Institute
of Medicine report; and
(B) the requirement under section 505-1(c)(2) of the
Federal Food, Drug, and Cosmetic Act (as added by this
title), that the appropriate office responsible for
reviewing a drug and the office responsible for
postapproval safety with respect to the drug work
together to assess, implement, and ensure compliance
with the requirements of such section 505-1.
SEC. 920. DATABASE FOR AUTHORIZED GENERIC DRUGS.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355), as amended by section 918, is further amended by adding at the end
the following:
``(t) Database for Authorized Generic Drugs.--
``(1) In general.--
``(A) Publication.--
The [NOTE: Deadlines.] Commissioner shall--
``(i) not later than 9 months after the date
of the enactment of the Food and Drug
Administration Amendments Act of 2007, publish a
complete list on the Internet Web site of the Food
and Drug Administration of all authorized generic
drugs (including drug trade name, brand company
manufacturer, and the date the authorized generic
drug entered the market); and
``(ii) update the list quarterly to include
each authorized generic drug included in an annual
report submitted to the Secretary by the sponsor
of a listed drug during the preceding 3-month
period.
``(B) Notification.--The Commissioner shall notify
relevant Federal agencies, including the Centers for
Medicare & Medicaid Services and the Federal Trade
Commission, when the Commissioner first publishes the
information described in subparagraph (A) that the
information has been published and that the information
will be updated quarterly.
``(2) Inclusion.--The Commissioner shall include in the list
described in paragraph (1) each authorized generic drug included
in an annual report submitted to the Secretary by the sponsor of
a listed drug after January 1, 1999.
``(3) Authorized generic drug.--In this section, the term
`authorized generic drug' means a listed drug (as that term is
used in subsection (j)) that--

[[Page 962]]
121 STAT. 962

``(A) has been approved under subsection (c); and
``(B) is marketed, sold, or distributed directly or
indirectly to retail class of trade under a different
labeling, packaging (other than repackaging as the
listed drug in blister packs, unit doses, or similar
packaging for use in institutions), product code,
labeler code, trade name, or trade mark than the listed
drug.''.
SEC. 921. ADVERSE DRUG REACTION REPORTS AND POSTMARKET SAFETY.

Subsection (k) of section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355), as amended by section 905, is amended by
adding at the end the following:
``(5) The Secretary shall--
``(A) conduct regular, bi-weekly screening of the
Adverse Event Reporting System database and post a
quarterly report on the Adverse Event Reporting System
Web site of any new safety information or potential
signal of a serious risk identified by Adverse Event
Reporting System within the last quarter;
``(B) report to Congress not later than 2 year after
the date of the enactment of the Food and Drug
Administration Amendments Act of 2007 on procedures and
processes of the Food and Drug Administration for
addressing ongoing post market safety issues identified
by the Office of Surveillance and Epidemiology and how
recommendations of the Office of Surveillance and
Epidemiology are handled within the agency; and
``(C) on an annual basis, review the entire backlog
of postmarket safety commitments to determine which
commitments require revision or should be eliminated,
report to the Congress on these determinations, and
assign start dates and estimated completion dates for
such commitments.''.

TITLE X--FOOD SAFETY

SEC. 1001. [NOTE: 21 USC 2101.] FINDINGS.

Congress finds that--
(1) the safety and integrity of the United States food
supply are vital to public health, to public confidence in the
food supply, and to the success of the food sector of the
Nation's economy;
(2) illnesses and deaths of individuals and companion
animals caused by contaminated food--
(A) have contributed to a loss of public confidence
in food safety; and
(B) have caused significant economic losses to
manufacturers and producers not responsible for
contaminated food items;
(3) the task of preserving the safety of the food supply of
the United States faces tremendous pressures with regard to--
(A) emerging pathogens and other contaminants and
the ability to detect all forms of contamination;

[[Page 963]]
121 STAT. 963

(B) an increasing volume of imported food from a
wide variety of countries; and
(C) a shortage of adequate resources for monitoring
and inspection;
(4) according to the Economic Research Service of the
Department of Agriculture, the United States is increasing the
amount of food that it imports such that--
(A) from 2003 to 2007, the value of food imports has
increased from $45,600,000,000 to $64,000,000,000; and
(B) imported food accounts for 13 percent of the
average American diet including 31 percent of fruits,
juices, and nuts, 9.5 percent of red meat, and 78.6
percent of fish and shellfish; and
(5) the number of full-time equivalent Food and Drug
Administration employees conducting inspections has decreased
from 2003 to 2007.
SEC. 1002. [NOTE: 21 USC 2102.] ENSURING THE SAFETY OF PET FOOD.

(a) Processing and [NOTE: Deadline. Regulations.] Ingredient
Standards.--Not later than 2 years after the date of the enactment of
this Act, the Secretary of Health and Human Services (referred to in
this title as the ``Secretary''), in consultation with the Association
of American Feed Control Officials and other relevant stakeholder
groups, including veterinary medical associations, animal health
organizations, and pet food manufacturers, shall by regulation
establish--
(1) ingredient standards and definitions with respect to pet
food;
(2) processing standards for pet food; and
(3) updated standards for the labeling of pet food that
include nutritional and ingredient information.

(b) Early [NOTE: Deadline.] Warning Surveillance Systems and
Notification During Pet Food Recalls.--Not later than 1 year after the
date of the enactment of this Act, the Secretary shall establish an
early warning and surveillance system to identify adulteration of the
pet food supply and outbreaks of illness associated with pet food. In
establishing such system, the Secretary shall--
(1) consider using surveillance and monitoring mechanisms
similar to, or in coordination with, those used to monitor human
or animal health, such as the Foodborne Diseases Active
Surveillance Network (FoodNet) and PulseNet of the Centers for
Disease Control and Prevention, the Food Emergency Response
Network of the Food and Drug Administration and the Department
of Agriculture, and the National Animal Health Laboratory
Network of the Department of Agriculture;
(2) consult with relevant professional associations and
private sector veterinary hospitals;
(3) work with the National Companion Animal Surveillance
Program, the Health Alert Network, or other notification
networks as appropriate to inform veterinarians and relevant
stakeholders during any recall of pet food; and
(4) use such information and conduct such other activities
as the Secretary deems appropriate.
SEC. 1003. [NOTE: 21 USC 2103.] ENSURING EFFICIENT AND EFFECTIVE
COMMUNICATIONS DURING A RECALL.

The Secretary shall, during an ongoing recall of human or pet food
regulated by the Secretary--

[[Page 964]]
121 STAT. 964

(1) work with companies, relevant professional associations,
and other organizations to collect and aggregate information
pertaining to the recall;
(2) use existing networks of communication, including
electronic forms of information dissemination, to enhance the
quality and speed of communication with the public; and
(3) [NOTE: Website.] post information regarding recalled
human and pet foods on the Internet Web site of the Food and
Drug Administration in a single location, which shall include a
searchable database of recalled human foods and a searchable
database of recalled pet foods, that is easily accessed and
understood by the public.
SEC. 1004. [NOTE: 21 USC 2104.] STATE AND FEDERAL COOPERATION.

(a) In General.--The Secretary shall work with the States in
undertaking activities and programs that assist in improving the safety
of food, including fresh and processed produce, so that State food
safety programs and activities conducted by the Secretary function in a
coordinated and cost-effective manner. With the assistance provided
under subsection (b), the Secretary shall encourage States to--
(1) establish, continue, or strengthen State food safety
programs, especially with respect to the regulation of retail
commercial food establishments; and
(2) establish procedures and requirements for ensuring that
processed produce under the jurisdiction of State food safety
programs is not unsafe for human consumption.

(b) Assistance.--The Secretary may provide to a State, for planning,
developing, and implementing such a food safety program--
(1) advisory assistance;
(2) technical assistance, training, and laboratory
assistance (including necessary materials and equipment); and
(3) financial and other assistance.

(c) Service Agreements.--The Secretary may, under an agreement
entered into with a Federal, State, or local agency, use, on a
reimbursable basis or otherwise, the personnel, services, and facilities
of the agency to carry out the responsibilities of the agency under this
section. An agreement entered into with a State agency under this
subsection may provide for training of State employees.
SEC. 1005. [NOTE: 21 USC 350f note.] REPORTABLE FOOD REGISTRY.

(a) Findings.--Congress makes the following findings:
(1) In 1994, Congress passed the Dietary Supplement Health
and Education Act of 1994 (Public Law 103-417) to provide the
Food and Drug Administration the legal framework which is
intended to ensure that dietary supplements are safe and
properly labeled foods.
(2) In 2006, Congress passed the Dietary Supplement and
Nonprescription Drug Consumer Protection Act (Public Law 109-
462) to establish a mandatory reporting system of serious
adverse events for nonprescription drugs and dietary supplements
sold and consumed in the United States.
(3) The adverse event reporting system created under the
Dietary Supplement and Nonprescription Drug Consumer Protection
Act is intended to serve as an early warning system for
potential public health issues associated with the use of these
products.

[[Page 965]]
121 STAT. 965

(4) A reliable mechanism to track patterns of adulteration
in food would support efforts by the Food and Drug
Administration to target limited inspection resources to protect
the public health.

(b) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the
following:
``SEC. 417. [NOTE: 21 USC 350f.] REPORTABLE FOOD REGISTRY.

``(a) Definitions.--In this section:
``(1) Responsible party.--The term `responsible party', with
respect to an article of food, means a person that submits the
registration under section 415(a) for a food facility that is
required to register under section 415(a), at which such article
of food is manufactured, processed, packed, or held.
``(2) Reportable food.--The term `reportable food' means an
article of food (other than infant formula) for which there is a
reasonable probability that the use of, or exposure to, such
article of food will cause serious adverse health consequences
or death to humans or animals.

``(b) Establishment.--
``(1) In [NOTE: Deadline.] general.--Not later than 1 year
after the date of the enactment of this section, the Secretary
shall establish within the Food and Drug Administration a
Reportable Food Registry to which instances of reportable food
may be submitted by the Food and Drug Administration after
receipt of reports under subsection (d), via an electronic
portal, from--
``(A) Federal, State, and local public health
officials; or
``(B) responsible parties.
``(2) Review by secretary.--The Secretary shall promptly
review and assess the information submitted under paragraph (1)
for the purposes of identifying reportable food, submitting
entries to the Reportable Food Registry, acting under subsection
(c), and exercising other existing food safety authorities under
this Act to protect the public health.

``(c) Issuance of an Alert by the Secretary.--
``(1) In general.--The Secretary shall issue, or cause to be
issued, an alert or a notification with respect to a reportable
food using information from the Reportable Food Registry as the
Secretary deems necessary to protect the public health.
``(2) Effect.--Paragraph (1) shall not affect the authority
of the Secretary to issue an alert or a notification under any
other provision of this Act.

``(d) Reporting and Notification.--
``(1) In [NOTE: Deadline.] general.--Except as provided in
paragraph (2), as soon as practicable, but in no case later than
24 hours after a responsible party determines that an article of
food is a reportable food, the responsible party shall--
``(A) submit a report to the Food and Drug
Administration through the electronic portal established
under subsection (b) that includes the data elements
described in subsection (e) (except the elements
described in paragraphs (8), (9), and (10) of such
subsection); and
``(B) investigate the cause of the adulteration if
the adulteration of the article of food may have
originated with the responsible party.

[[Page 966]]
121 STAT. 966

``(2) No report required.--A responsible party is not
required to submit a report under paragraph (1) if--
``(A) the adulteration originated with the
responsible party;
``(B) the responsible party detected the
adulteration prior to any transfer to another person of
such article of food; and
``(C) the responsible party--
``(i) corrected such adulteration; or
``(ii) destroyed or caused the destruction of
such article of food.
``(3) Reports by public health officials.--A Federal, State,
or local public health official may submit a report about a
reportable food to the Food and Drug Administration through the
electronic portal established under subsection (b) that includes
the data elements described in subsection (e) that the official
is able to provide.
``(4) Report number.--The Secretary shall ensure that, upon
submission of a report under paragraph (1) or (3), a unique
number is issued through the electronic portal established under
subsection (b) to the person submitting such report, by which
the Secretary is able to link reports about the reportable food
submitted and amended under this subsection and identify the
supply chain for such reportable food.
``(5) Review.--The Secretary shall promptly review a report
submitted under paragraph (1) or (3).
``(6) Response to report submitted by a responsible party.--
After consultation with the responsible party that submitted a
report under paragraph (1), the Secretary may require such
responsible party to perform, as soon as practicable, but in no
case later than a time specified by the Secretary, 1 or more of
the following:
``(A) Amend the report submitted by the responsible
party under paragraph (1) to include the data element
described in subsection (e)(9).
``(B) Provide a notification--
``(i) to the immediate previous source of the
article of food, if the Secretary deems necessary;
``(ii) to the immediate subsequent recipient
of the article of food, if the Secretary deems
necessary; and
``(iii) that includes--
``(I) the data elements described in
subsection (e) that the Secretary deems
necessary;
``(II) the actions described under
paragraph (7) that the recipient of the
notification shall perform, as required
by the Secretary; and
``(III) any other information that
the Secretary may require.
``(7) Subsequent reports and notifications.--Except as
provided in paragraph (8), the Secretary may require a
responsible party to perform, as soon as practicable, but in no
case later than a time specified by the Secretary, after the
responsible party receives a notification under subparagraph (C)
or paragraph (6)(B), 1 or more of the following:
``(A) Submit a report to the Food and Drug
Administration through the electronic portal established
under subsection (b) that includes those data elements
described

[[Page 967]]
121 STAT. 967

in subsection (e) and other information that the
Secretary deems necessary.
``(B) Investigate the cause of the adulteration if
the adulteration of the article of food may have
originated with the responsible party.
``(C) Provide a notification--
``(i) to the immediate previous source of the
article of food, if the Secretary deems necessary;
``(ii) to the immediate subsequent recipient
of the article of food, if the Secretary deems
necessary; and
``(iii) that includes--
``(I) the data elements described in
subsection (e) that the Secretary deems
necessary;
``(II) the actions described under
this paragraph that the recipient of the
notification shall perform, as required
by the Secretary; and
``(III) any other information that
the Secretary may require.
``(8) Amended report.--If a responsible party receives a
notification under paragraph (6)(B) or paragraph (7)(C) with
respect to an article of food after the responsible party has
submitted a report to the Food and Drug Administration under
paragraph (1) with respect to such article of food--
``(A) the responsible party is not required to
submit an additional report or make a notification under
paragraph (7); and
``(B) the responsible party shall amend the report
submitted by the responsible party under paragraph (1)
to include the data elements described in paragraph (9),
and, with respect to both such notification and such
report, paragraph (11) of subsection (e).

``(e) Data Elements.--The data elements described in this subsection
are the following:
``(1) The registration numbers of the responsible party
under section 415(a)(3).
``(2) The date on which an article of food was determined to
be a reportable food.
``(3) A description of the article of food including the
quantity or amount.
``(4) The extent and nature of the adulteration.
``(5) If the adulteration of the article of food may have
originated with the responsible party, the results of the
investigation required under paragraph (1)(B) or (7)(B) of
subsection (d), as applicable and when known.
``(6) The disposition of the article of food, when known.
``(7) Product information typically found on packaging
including product codes, use-by dates, and names of
manufacturers, packers, or distributors sufficient to identify
the article of food.
``(8) Contact information for the responsible party.
``(9) The contact information for parties directly linked in
the supply chain and notified under paragraph (6)(B) or (7)(C)
of subsection (d), as applicable.
``(10) The information required by the Secretary to be
included in a notification provided by the responsible party
involved under paragraph (6)(B) or (7)(C) of subsection (d) or
required in a report under subsection (d)(7)(A).

[[Page 968]]
121 STAT. 968

``(11) The unique number described in subsection (d)(4).

``(f) Coordination of Federal, State, and Local Efforts.--
``(1) Department of agriculture.--In implementing this
section, the Secretary shall--
``(A) share information and coordinate regulatory
efforts with the Department of Agriculture; and
``(B) if the Secretary receives a report submitted
about a food within the jurisdiction of the Department
of Agriculture, promptly provide such report to the
Department of Agriculture.
``(2) States and localities.--In implementing this section,
the Secretary shall work with the State and local public health
officials to share information and coordinate regulatory
efforts, in order to--
``(A) help to ensure coverage of the safety of the
food supply chain, including those food establishments
regulated by the States and localities that are not
required to register under section 415; and
``(B) reduce duplicative regulatory efforts.

``(g) Maintenance and Inspection of Records.--The responsible party
shall maintain records related to each report received, notification
made, and report submitted to the Food and Drug Administration under
this section for 2 years. A responsible party shall, at the request of
the Secretary, permit inspection of such records as provided for section
414.
``(h) Request for [NOTE: Applicability.] Information.--Except as
provided by section 415(a)(4), section 552 of title 5, United States
Code, shall apply to any request for information regarding a record in
the Reportable Food Registry.

``(i) Safety Report.--A report or notification under subsection (d)
shall be considered to be a safety report under section 756 and may be
accompanied by a statement, which shall be part of any report released
for public disclosure, that denies that the report or the notification
constitutes an admission that the product involved caused or contributed
to a death, serious injury, or serious illness.
``(j) Admission.--A report or notification under this section shall
not be considered an admission that the article of food involved is
adulterated or caused or contributed to a death, serious injury, or
serious illness.
``(k) Homeland Security Notification.--If, after receiving a report
under subsection (d), the Secretary believes such food may have been
deliberately adulterated, the Secretary shall immediately notify the
Secretary of Homeland Security. The Secretary shall make relevant
information from the Reportable Food Registry available to the Secretary
of Homeland Security.''.
(c) Definition.--Section 201(ff) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(ff)) is amended by striking ``section
201(g)'' and inserting ``sections 201(g) and 417''.
(d) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331), as amended by section 912, is further
amended--
(1) in subsection (e), by--
(A) striking ``414,'' and inserting ``414,
417(g),''; and
(B) striking ``414(b)'' and inserting ``414(b),
417''; and
(2) by adding at the end the following:

[[Page 969]]
121 STAT. 969

``(mm) The failure to submit a report or provide a notification
required under section 417(d).
``(nn) The falsification of a report or notification required under
section 417(d).''.
(e) Effective [NOTE: 21 USC 350f note.] Date.--The requirements of
section 417(d) of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a), shall become effective 1 year after the date of the
enactment of this Act.

(f) Guidance.--Not [NOTE: Deadline. 21 USC 350f note.] later than
9 months after the date of the enactment of this Act, the Secretary
shall issue a guidance to industry about submitting reports to the
electronic portal established under section 417 of the Federal Food,
Drug, and Cosmetic Act (as added by this section) and providing
notifications to other persons in the supply chain of an article of food
under such section 417.

(g) Effect.--Nothing [NOTE: 21 USC 2110 note.] in this title, or
an amendment made by this title, shall be construed to alter the
jurisdiction between the Secretaries of Agriculture and of Health and
Human Services, under applicable statutes and regulations.
SEC. 1006. [NOTE: 21 USC 2105.] ENHANCED AQUACULTURE AND SEAFOOD
INSPECTION.

(a) Findings.--Congress finds the following:
(1) In 2007, there has been an overwhelming increase in the
volume of aquaculture and seafood that has been found to contain
substances that are not approved for use in food in the United
States.
(2) As of May 2007, inspection programs are not able to
satisfactorily accomplish the goals of ensuring the food safety
of the United States.
(3) To protect the health and safety of consumers in the
United States, the ability of the Secretary to perform
inspection functions must be enhanced.

(b) Heightened Inspections.--The Secretary is authorized to enhance,
as necessary, the inspection regime of the Food and Drug Administration
for aquaculture and seafood, consistent with obligations of the United
States under international agreements and United States law.
(c) Report to Congress.--Not later than 180 days after the date of
the enactment of this Act, the Secretary shall submit to Congress a
report that--
(1) describes the specifics of the aquaculture and seafood
inspection program;
(2) describes the feasibility of developing a traceability
system for all catfish and seafood products, both domestic and
imported, for the purpose of identifying the processing plant of
origin of such products; and
(3) provides for an assessment of the risks associated with
particular contaminants and banned substances.

(d) Partnerships With States.--Upon the request by any State, the
Secretary may enter into partnership agreements, as soon as practicable
after the request is made, to implement inspection programs to Federal
standards regarding the importation of aquaculture and seafood.
SEC. 1007. [NOTE: Reports. 21 USC 2106.] CONSULTATION REGARDING
GENETICALLY ENGINEERED SEAFOOD PRODUCTS.

The Commissioner of Food and Drugs shall consult with the Assistant
Administrator of the National Marine Fisheries Service

[[Page 970]]
121 STAT. 970

of the National Oceanic and Atmospheric Administration to produce a
report on any environmental risks associated with genetically engineered
seafood products, including the impact on wild fish stocks.
SEC. 1008. [NOTE: 21 USC 2107.] SENSE OF CONGRESS.

It is the sense of Congress that--
(1) it is vital for Congress to provide the Food and Drug
Administration with additional resources, authorities, and
direction with respect to ensuring the safety of the food supply
of the United States;
(2) additional inspectors are required to improve the Food
and Drug Administration's ability to safeguard the food supply
of the United States;
(3) because of the increasing volume of international trade
in food products the Secretary should make it a priority to
enter into agreements with the trading partners of the United
States with respect to food safety; and
(4) Congress should work to develop a comprehensive response
to the issue of food safety.
SEC. 1009. [NOTE: 21 USC 2108.] ANNUAL REPORT TO CONGRESS.

The Secretary shall, on an annual basis, submit to the Committee on
Health, Education, Labor, and Pensions and the Committee on
Appropriations of the Senate and the Committee on Energy and Commerce
and the Committee on Appropriations of the House of Representatives a
report that includes, with respect to the preceding 1-year period--
(1) the number and amount of food products regulated by the
Food and Drug Administration imported into the United States,
aggregated by country and type of food;
(2) a listing of the number of Food and Drug Administration
inspectors of imported food products referenced in paragraph (1)
and the number of Food and Drug Administration inspections
performed on such products; and
(3) aggregated data on the findings of such inspections,
including data related to violations of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 201 et seq.), and enforcement
actions used to follow-up on such findings and violations.
SEC. 1010. [NOTE: 21 USC 2109.] PUBLICATION OF ANNUAL REPORTS.

(a) In [NOTE: Website.] General.--The Commissioner of Food and
Drugs shall annually submit to Congress and publish on the Internet Web
site of the Food and Drug Administration, a report concerning the
results of the Administration's pesticide residue monitoring program,
that includes--
(1) information and analysis similar to that contained in
the report entitled ``Food and Drug Administration Pesticide
Program Residue Monitoring 2003'' as released in June of 2005;
(2) based on an analysis of previous samples, an
identification of products or countries (for imports) that
require special attention and additional study based on a
comparison with equivalent products manufactured, distributed,
or sold in the United States (including details on the plans for
such additional studies), including in the initial report (and
subsequent reports as determined necessary) the results and
analysis of the Ginseng Dietary Supplements Special Survey as
described on page

[[Page 971]]
121 STAT. 971

13 of the report entitled ``Food and Drug Administration
Pesticide Program Residue Monitoring 2003'';
(3) information on the relative number of interstate and
imported shipments of each tested commodity that were sampled,
including recommendations on whether sampling is statistically
significant, provides confidence intervals or other related
statistical information, and whether the number of samples
should be increased and the details of any plans to provide for
such increase; and
(4) a description of whether certain commodities are being
improperly imported as another commodity, including a
description of additional steps that are being planned to
prevent such smuggling.

(b) Initial Reports.--Annual reports under subsection (a) for fiscal
years 2004 through 2006 may be combined into a single report, by not
later than June 1, 2008, for purposes of publication under subsection
(a). Thereafter such reports shall be completed by June 1 of each year
for the data collected for the year that was 2-years prior to the year
in which the report is published.
(c) Memorandum of Understanding.--The Commissioner of Food and
Drugs, the Administrator of the Food Safety and Inspection Service, the
Department of Commerce, and the head of the Agricultural Marketing
Service shall enter into a memorandum of understanding to permit
inclusion of data in the reports under subsection (a) relating to
testing carried out by the Food Safety and Inspection Service and the
Agricultural Marketing Service on meat, poultry, eggs, and certain raw
agricultural products, respectively.
SEC. 1011. [NOTE: 21 USC 2110.] RULE OF CONSTRUCTION.

Nothing in this title (or an amendment made by this title) shall be
construed to affect--
(1) the regulation of dietary supplements under the Dietary
Supplement Health and Education Act of 1994 (Public Law 103-
417); or
(2) the adverse event reporting system for dietary
supplements created under the Dietary Supplement and
Nonprescription Drug Consumer Protection Act (Public Law 109-
462).

TITLE XI--OTHER PROVISIONS

Subtitle A--In General

SEC. 1101. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC
ARTICLES PUBLISHED BY FDA EMPLOYEES.

Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 371 et seq.), as amended by section 701, is further
amended by adding at the end the following:
``SEC. 713. [NOTE: 21 USC 379d-2.] POLICY ON THE REVIEW AND
CLEARANCE OF SCIENTIFIC ARTICLES PUBLISHED
BY FDA EMPLOYEES.

``(a) Definition.--In this section, the term `article' means a
paper, poster, abstract, book, book chapter, or other published writing.
``(b) Policies.--The [NOTE: Public information.] Secretary,
through the Commissioner of Food and Drugs, shall establish and make
publicly available clear

[[Page 972]]
121 STAT. 972

written policies to implement this section and govern the timely
submission, review, clearance, and disclaimer requirements for articles.

``(c) Timing of Submission for Review.--If an officer or employee,
including a Staff Fellow and a contractor who performs staff work, of
the Food and Drug Administration is directed by the policies established
under subsection (b) to submit an article to the supervisor of such
officer or employee, or to some other official of the Food and Drug
Administration, for review and clearance before such officer or employee
may seek to publish or present such an article at a conference, such
officer or employee shall submit such article for such review and
clearance not less than 30 days before submitting the article for
publication or presentation.
``(d) Timing for Review and Clearance.--The supervisor or other
reviewing official shall review such article and provide written
clearance, or written clearance on the condition of specified changes
being made, to such officer or employee not later than 30 days after
such officer or employee submitted such article for review.
``(e) Non-Timely Review.--If, 31 days after such submission under
subsection (c), the supervisor or other reviewing official has not
cleared or has not reviewed such article and provided written clearance,
such officer or employee may consider such article not to have been
cleared and may submit the article for publication or presentation with
an appropriate disclaimer as specified in the policies established under
subsection (b).
``(f) Effect.--Nothing in this section shall be construed as
affecting any restrictions on such publication or presentation provided
by other provisions of law.''.
SEC. 1102. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL
DISEASES.

Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by adding at the end the
following:
``SEC. 524. [NOTE: 21 USC 360n.] PRIORITY REVIEW TO ENCOURAGE
TREATMENTS FOR TROPICAL DISEASES.

``(a)  Definitions.--In this section:
``(1) Priority review.--The term `priority review', with
respect to a human drug application as defined in section
735(1), means review and action by the Secretary on such
application not later than 6 months after receipt by the
Secretary of such application, as described in the Manual of
Policies and Procedures of the Food and Drug Administration and
goals identified in the letters described in section 101(c) of
the Food and Drug Administration Amendments Act of 2007.
``(2) Priority review voucher.--The term `priority review
voucher' means a voucher issued by the Secretary to the sponsor
of a tropical disease product application that entitles the
holder of such voucher to priority review of a single human drug
application submitted under section 505(b)(1) or section 351 of
the Public Health Service Act after the date of approval of the
tropical disease product application.
``(3) Tropical disease.--The term `tropical disease' means
any of the following:
``(A) Tuberculosis.
``(B) Malaria.
``(C) Blinding trachoma.

[[Page 973]]
121 STAT. 973

``(D) Buruli Ulcer.
``(E) Cholera.
``(F) Dengue/dengue haemorrhagic fever.
``(G) Dracunculiasis (guinea-worm disease).
``(H) Fascioliasis.
``(I) Human African trypanosomiasis.
``(J) Leishmaniasis.
``(K) Leprosy.
``(L) Lymphatic filariasis.
``(M) Onchocerciasis.
``(N) Schistosomiasis.
``(O) Soil transmitted helmithiasis.
``(P) Yaws.
``(Q) Any other infectious disease for which there
is no significant market in developed nations and that
disproportionately affects poor and marginalized
populations, designated by regulation by the Secretary.
``(4) Tropical disease product application.--The term
`tropical disease product application' means an application
that--
``(A) is a human drug application as defined in
section 735(1)--
``(i) for prevention or treatment of a
tropical disease; and
``(ii) the Secretary deems eligible for
priority review;
``(B) is approved after the date of the enactment of
the Food and Drug Administration Amendments Act of 2007,
by the Secretary for use in the prevention, detection,
or treatment of a tropical disease; and
``(C) is for a human drug, no active ingredient
(including any ester or salt of the active ingredient)
of which has been approved in any other application
under section 505(b)(1) or section 351 of the Public
Health Service Act.

``(b) Priority Review Voucher.--
``(1) In general.--The Secretary shall award a priority
review voucher to the sponsor of a tropical disease product
application upon approval by the Secretary of such tropical
disease product application.
``(2) Transferability.--The sponsor of a tropical disease
product that receives a priority review voucher under this
section may transfer (including by sale) the entitlement to such
voucher to a sponsor of a human drug for which an application
under section 505(b)(1) or section 351 of the Public Health
Service Act will be submitted after the date of the approval of
the tropical disease product application.
``(3) Limitation.--
``(A) No award for prior approved application.--A
sponsor of a tropical disease product may not receive a
priority review voucher under this section if the
tropical disease product application was submitted to
the Secretary prior to the date of the enactment of this
section.
``(B) One-year waiting period.--The Secretary shall
issue a priority review voucher to the sponsor of a
tropical disease product no earlier than the date that
is 1 year

[[Page 974]]
121 STAT. 974

after the date of the enactment of the Food and Drug
Administration Amendments Act of 2007.
``(4) Notification.--The [NOTE: Deadline.] sponsor of a
human drug application shall notify the Secretary not later than
365 days prior to submission of the human drug application that
is the subject of a priority review voucher of an intent to
submit the human drug application, including the date on which
the sponsor intends to submit the application. Such notification
shall be a legally binding commitment to pay for the user fee to
be assessed in accordance with this section.

``(c) Priority Review User Fee.--
``(1) In general.--The Secretary shall establish a user fee
program under which a sponsor of a human drug application that
is the subject of a priority review voucher shall pay to the
Secretary a fee determined under paragraph (2). Such fee shall
be in addition to any fee required to be submitted by the
sponsor under chapter VII.
``(2) Fee amount.--The amount of the priority review user
fee shall be determined each fiscal year by the Secretary and
based on the average cost incurred by the agency in the review
of a human drug application subject to priority review in the
previous fiscal year.
``(3) Annual fee setting.--The Secretary shall establish,
before the beginning of each fiscal year beginning after
September 30, 2007, for that fiscal year, the amount of the
priority review user fee.
``(4) Payment.--
``(A) In general.--The priority review user fee
required by this subsection shall be due upon the
submission of a human drug application under section
505(b)(1) or section 351 of the Public Health Services
Act for which the priority review voucher is used.
``(B) Complete application.--An application
described under subparagraph (A) for which the sponsor
requests the use of a priority review voucher shall be
considered incomplete if the fee required by this
subsection and all other applicable user fees are not
paid in accordance with the Secretary's procedures for
paying such fees.
``(C) No waivers, exemptions, reductions, or
refunds.--The Secretary may not grant a waiver,
exemption, reduction, or refund of any fees due and
payable under this section.
``(5) Offsetting collections.--Fees collected pursuant to
this subsection for any fiscal year--
``(A) shall be deposited and credited as offsetting
collections to the account providing appropriations to
the Food and Drug Administration; and
``(B) shall not be collected for any fiscal year
except to the extent provided in advance in
appropriation Acts.''.
SEC. 1103. IMPROVING GENETIC TEST SAFETY AND QUALITY.

(a) Report.--If the [NOTE: Contracts. Study.] Secretary's Advisory
Committee on Genetics, Health, and Society does not complete and submit
the Regulatory Oversight of Genetic/Genomic Testing Report & Action
Recommendations to the Secretary of Health and Human Services (referred
to in this section as the ``Secretary'') by July of 2008, the Secretary
shall enter into a contract with the Institute of

[[Page 975]]
121 STAT. 975

Medicine to conduct a study to assess the overall safety and quality of
genetic tests and prepare a report that includes recommendations to
improve Federal oversight and regulation of genetic tests. Such study
shall take into consideration relevant reports by the Secretary's
Advisory Committee on Genetics, Health, and Society and other groups and
shall be completed not later than 1 year after the date on which the
Secretary entered into such contract.

(b) Rule of Construction.--Nothing in this section shall be
construed as requiring Federal efforts with respect to regulatory
oversight of genetic tests to cease or be limited or delayed pending
completion of the report by the Secretary's Advisory Committee on
Genetics, Health, and Society or the Institute of Medicine.
SEC. 1104. NIH TECHNICAL AMENDMENTS.

The Public Health Service Act (42 U.S.C. 201 et seq.) is amended--
(1) [NOTE: 42 USC 247d-3b.] in section 319C-2(j)(3)(B), by
striking ``section 319C-1(h)'' and inserting ``section 319C-
1(i)'';
(2) [NOTE: 42 USC 282.] in section 402(b)(4), by inserting
``minority and other'' after ``reducing'';
(3) [NOTE: 42 USC 283.] in section 403(a)(4)(C)(iv)(III),
by inserting ``and postdoctoral training funded through research
grants'' before the semicolon;
(4) by designating the second section 403C (relating to the
drug diethylstilbestrol) [NOTE: 42 USC 283a-3.] as section
403D; and
(5) [NOTE: 42 USC 283a-2.] in section 403C(a)--
(A) in the matter preceding paragraph (1)--
(i) by inserting ``graduate students supported
by the National Institutes of Health'' after
``with respect to''; and
(ii) by deleting ``each degree-granting
program'';
(B) in paragraph (1), by inserting ``such'' after
``percentage of''; and
(C) in paragraph (2), by inserting ``(not including
any leaves of absence)'' after ``average time''.
SEC. 1105. [NOTE: 21 USC 301 note.] SEVERABILITY CLAUSE.

If any provision of this Act, an amendment made this Act, or the
application of such provision or amendment to any person or circumstance
is held to be unconstitutional, the remainder of this Act, the
amendments made by this Act, and the application of the provisions of
such to any person or circumstances shall not be affected thereby.

Subtitle B--Antibiotic Access and Innovation

SEC. 1111. [NOTE: 42 USC 247d-5a.] IDENTIFICATION OF CLINICALLY
SUSCEPTIBLE CONCENTRATIONS OF
ANTIMICROBIALS.

(a) Definition.--In this section, the term ``clinically susceptible
concentrations'' means specific values which characterize bacteria as
clinically susceptible, intermediate, or resistant to the drug (or
drugs) tested.
(b) Identification.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), through the
Commissioner of Food and Drugs, shall identify (where such

[[Page 976]]
121 STAT. 976

information is reasonably available) and periodically update clinically
susceptible concentrations.
(c) Public [NOTE: Deadline.] Availability.--The Secretary, through
the Commissioner of Food and Drugs, shall make such clinically
susceptible concentrations publicly available, such as by posting on the
Internet, not later than 30 days after the date of identification and
any update under this section.

(d) Effect.--Nothing in this section shall be construed to restrict,
in any manner, the prescribing of antibiotics by physicians, or to limit
the practice of medicine, including for diseases such as Lyme and tick-
borne diseases.
SEC. 1112. ORPHAN ANTIBIOTIC DRUGS.

(a) Public Meeting.--The Commissioner of Food and Drugs shall
convene a public meeting regarding which serious and life threatening
infectious diseases, such as diseases due to gram-negative bacteria and
other diseases due to antibiotic-resistant bacteria, potentially qualify
for available grants and contracts under section 5(a) of the Orphan Drug
Act (21 U.S.C. 360ee(a)) or other incentives for development.
(b) Grants and Contracts for the Development of Orphan Drugs.--
Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended to
read as follows:
``(c) [NOTE: Appropriation authorization.] For grants and
contracts under subsection (a), there is authorized to be appropriated
$30,000,000 for each of fiscal years 2008 through 2012.''.
SEC. 1113. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE
ENANTIOMERS.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355), as amended by section 920, is further amended by adding at the end
the following:
``(u) Certain Drugs Containing Single Enantiomers.--
``(1) In general.--For purposes of subsections (c)(3)(E)(ii)
and (j)(5)(F)(ii), if an application is submitted under
subsection (b) for a non-racemic drug containing as an active
ingredient (including any ester or salt of the active
ingredient) a single enantiomer that is contained in a racemic
drug approved in another application under subsection (b), the
applicant may, in the application for such non-racemic drug,
elect to have the single enantiomer not be considered the same
active ingredient as that contained in the approved racemic
drug, if--
``(A)(i) the single enantiomer has not been
previously approved except in the approved racemic drug;
and
``(ii) the application submitted under subsection
(b) for such non-racemic drug--
``(I) includes full reports of new clinical
investigations (other than bioavailability
studies)--
``(aa) necessary for the approval of
the application under subsections (c)
and (d); and
``(bb) conducted or sponsored by the
applicant; and
``(II) does not rely on any investigations
that are part of an application submitted under
subsection (b) for approval of the approved
racemic drug; and
``(B) the application submitted under subsection (b)
for such non-racemic drug is not submitted for approval
of a condition of use--

[[Page 977]]
121 STAT. 977

``(i) in a therapeutic category in which the
approved racemic drug has been approved; or
``(ii) for which any other enantiomer of the
racemic drug has been approved.
``(2) Limitation.--
``(A) No approval in certain therapeutic
categories.--Until the date that is 10 years after the
date of approval of a non-racemic drug described in
paragraph (1) and with respect to which the applicant
has made the election provided for by such paragraph,
the Secretary shall not approve such non-racemic drug
for any condition of use in the therapeutic category in
which the racemic drug has been approved.
``(B) Labeling.--If applicable, the labeling of a
non-racemic drug described in paragraph (1) and with
respect to which the applicant has made the election
provided for by such paragraph shall include a statement
that the non-racemic drug is not approved, and has not
been shown to be safe and effective, for any condition
of use of the racemic drug.
``(3) Definition.--
``(A) In general.--For purposes of this subsection,
the term `therapeutic category' means a therapeutic
category identified in the list developed by the United
States Pharmacopeia pursuant to section 1860D-
4(b)(3)(C)(ii) of the Social Security Act and as in
effect on the date of the enactment of this subsection.
``(B) Publication by secretary.--The Secretary shall
publish the list described in subparagraph (A) and may
amend such list by regulation.
``(4) Availability.--The [NOTE: Deadline.] election
referred to in paragraph (1) may be made only in an application
that is submitted to the Secretary after the date of the
enactment of this subsection and before October 1, 2012.''.
SEC. 1114. REPORT.

Not later than January 1, 2012, the Comptroller General of the
United States shall submit a report to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives that examines whether and
how this subtitle has--
(1) encouraged the development of new antibiotics and other
drugs; and


[[Page 978]]
121 STAT. 978

(2) prevented or delayed timely generic drug entry into the
market.

Approved September 27, 2007.

LEGISLATIVE HISTORY--H.R. 3580:
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CONGRESSIONAL RECORD, Vol. 153 (2007):
Sept. 19, considered and passed House.
Sept. 20, considered and passed Senate.