    [Congressional Bills 110th Congress]
    [From the U.S. Government Publishing Office]
    [H.R. 3580 Considered and Passed House (CPH)]

    110th CONGRESS
      1st Session
                                    H. R. 3580

    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.

    _______________________________________________________________________

                        IN THE HOUSE OF REPRESENTATIVES

                               September 19, 2007

        Mr. Dingell (for himself, Mr. Barton of Texas, and Mr. Pallone)
     introduced the following bill; which was referred to the Committee on
                              Energy and Commerce

                               September 19, 2007

       Committee on Energy and Commerce discharged; considered and passed

    _______________________________________________________________________

                                     A BILL

    To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
     the user-fee programs for prescription drugs and for medical devices,
          to enhance the postmarket authorities of the Food and Drug
       Administration with respect to the safety of drugs, and for other
                                   purposes.

        Be it enacted by the Senate and House of Representatives of the
    United States of America in Congress assembled,

    SECTION 1. SHORT TITLE.

        This Act may be cited as the ``Food and Drug Administration
    Amendments Act of 2007''.

    SEC. 2. TABLE OF CONTENTS.

        The table of contents for this Act is as follows:

    Sec. 1. Short title.
    Sec. 2. Table of contents.
             TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

    Sec. 101. Short title; references in title; finding.
    Sec. 102. Definitions.
    Sec. 103. Authority to assess and use drug fees.
    Sec. 104. Fees relating to advisory review of prescription-drug
                                television 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.
    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.
    Sec. 1002. Ensuring the safety of pet food.
    Sec. 1003. Ensuring efficient and effective communications during a
                                recall.
    Sec. 1004. State and Federal Cooperation.
    Sec. 1005. Reportable Food Registry.
    Sec. 1006. Enhanced aquaculture and seafood inspection.
    Sec. 1007. Consultation regarding genetically engineered seafood
                                products.
    Sec. 1008. Sense of Congress.
    Sec. 1009. Annual report to Congress.
    Sec. 1010. Publication of annual reports.
    Sec. 1011. Rule of construction.
                           TITLE XI--OTHER PROVISIONS

                             Subtitle A--In General

    Sec. 1101. Policy on the review and clearance of scientific articles
                                published by FDA employees.
    Sec. 1102. Priority review to encourage treatments for tropical
                                diseases.
    Sec. 1103. Improving genetic test safety and quality.
    Sec. 1104. NIH Technical amendments.
    Sec. 1105. Severability clause.
                  Subtitle B--Antibiotic Access and Innovation

    Sec. 1111. Identification of clinically susceptible concentrations of
                                antimicrobials.
    Sec. 1112. Orphan antibiotic drugs.
    Sec. 1113. Exclusivity of certain drugs containing single enantiomers.
    Sec. 1114. Report.

             TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

    SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING.

        (a) Short Title.--This title may be cited as the ``Prescription
    Drug User Fee Amendments of 2007''.
        (b) References in Title.--Except as otherwise specified, amendments
    made by this title to a section or other provision of law are
    amendments to such section or other provision of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
        (c) Finding.--The Congress finds that the fees authorized by the
    amendments made in this title will be dedicated toward 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
                        (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'';
                        (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
                        ``(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 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''.
                (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 Secretary shall contract with an
                    independent accounting firm to study the adjustment for
                    changes in review activities applied in setting fees
                    and revenue amounts for fiscal year 2009 and to make
                    recommendations, if warranted, for future changes in
                    the methodology for calculating the adjustment. After
                    review of the 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:
                ``(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
                                    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.--
                ``(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 date.--Paragraph (1) shall take effect as if
            included in section 504 of the Prescription Drug User Fee
            Amendments of 2002 (Public Law 107-188; 116 Stat. 687).

    SEC. 104. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION-DRUG
                  TELEVISION ADVERTISING.

        Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.) is
    amended by adding after section 736 the following:

    ``SEC. 736A. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION-DRUG
                  TELEVISION ADVERTISING.

        ``(a) Types of Direct-to-Consumer Television Advertisement Review
    Fees.--Beginning in fiscal year 2008, the Secretary shall assess and
    collect fees in accordance with this section as follows:
                ``(1) Advisory review fee.--
                        ``(A) In general.--With respect to a 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 June 1 of each fiscal
                    year, the Secretary shall publish a notice in the
                    Federal Register requesting any person to notify the
                    Secretary within 30 days of the number of DTC
                    advertisements the person intends to submit for
                    advisory review in the next fiscal year.
                    Notwithstanding the preceding sentence, for fiscal year
                    2008, the Secretary shall publish such a notice in the
                    Federal Register not later than 30 days after the date
                    of the enactment of the Food and Drug Administration
                    Amendments Act of 2007.
                        ``(D) Payment.--
                                ``(i) In general.--The fee required by
                            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 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 and an increase in the amount
                            of fees applies in accordance with this clause,
                            notwithstanding any other provision of this
                            section. For such person, all advisory review
                            fees for such fiscal year shall be due and
                            payable 20 days before any direct-to-consumer
                            advertisement is submitted to the Secretary for
                            advisory review, and each such fee shall be
                            equal to 150 percent of the fee that otherwise
                            would have applied pursuant to subsection
                            (c)(3).
                                ``(ii) Exceeding identified number of
                            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 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 as provided in subparagraph
                    (C), the operating reserve fee shall be due no later
                    than--
                                ``(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). Fees under this subparagraph shall
                    be due 20 days before any DTC advertisement is
                    submitted by such person to the Secretary for advisory
                    review.
                        ``(D) Late payment.--
                                ``(i) In general.--Notwithstanding
                            subparagraph (B), and subject to clause (ii),
                            an operating reserve fee shall be regarded as
                            late if the person required to pay the fee has
                            not paid the complete operating reserve fee
                            by--
                                        ``(I) for fiscal year 2008, 150
                                    days after the date of the enactment of
                                    the Food and Drug Administration
                                    Amendments Act of 2007 or an earlier
                                    date specified by the Secretary; or
                                        ``(II) in any subsequent year,
                                    November 1.
                                ``(ii) Complete payment.--The complete
                            operating reserve fee shall be due and payable
                            20 days before any DTC advertisement is
                            submitted by such person to the Secretary for
                            advisory review.
                                ``(iii) Amount.--Notwithstanding any other
                            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 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 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 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)). 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 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 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 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 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, the
            Secretary has not received at least $11,250,000 in advisory
            review fees and operating reserve fees combined, the program
            under this section shall not commence and all collected fees
            shall be refunded.
                ``(2) Later fiscal years.--Beginning in fiscal year 2009,
            if, on November 1 of the fiscal year, the combination of the
            operating reserves, annual fee revenues from that fiscal year,
            and unobligated fee revenues from prior fiscal years falls
            below $9,000,000, adjusted for inflation (as described in
            subsection (c)(1)), the program under this section shall
            terminate, and the Secretary shall notify all participants,
            retain any money from the unused advisory review fees and the
            operating reserves needed to terminate the program, and refund
            the remainder of the unused fees and operating reserves. To the
            extent required to terminate the program, the Secretary shall
            first use unobligated advisory review fee revenues from prior
            fiscal years, then the operating reserves, and finally, unused
            advisory review fees from the relevant fiscal year.
        ``(g) Crediting and Availability of Fees.--
                ``(1) In general.--Fees authorized under subsection (a)
            shall be collected and available for obligation only to the
            extent and in the amount provided in advance in appropriations
            Acts. Such fees are authorized to remain available until
            expended. Such sums as may be necessary may be transferred from
            the Food and Drug Administration salaries and expenses
            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
            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;
                        ``(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. 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 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;
                        ``(B) the Committee on Health, Education, Labor,
                    and Pensions of the Senate;
                        ``(C) scientific and academic experts;
                        ``(D) health care professionals;
                        ``(E) representatives of patient and consumer
                    advocacy groups; and
                        ``(F) the regulated industry.
                ``(2) Prior public input.--Prior to beginning negotiations
            with the regulated industry on the reauthorization of this
            part, the Secretary shall--
                        ``(A) publish a notice in the Federal Register
                    requesting public input on the reauthorization;
                        ``(B) hold a public meeting at which the public may
                    present its views on the reauthorization, including
                    specific suggestions for changes to the goals referred
                    to in 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) 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) 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 recommendations.--Not later than
            January 15, 2012, the Secretary shall transmit to the Congress
            the revised recommendations under paragraph (4), a summary of
            the views and comments received under such paragraph, and any
            changes made to the recommendations in response to such views
            and comments.
                ``(6) Minutes of negotiation meetings.--
                        ``(A) Public availability.--Before presenting the
                    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 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 amendments made by sections 102, 103, and
    104 cease to be effective October 1, 2012.
        (b) Reporting Requirements.--The amendment made by section 105
    ceases to be effective January 31, 2013.

    SEC. 107. EFFECTIVE DATE.

        The amendments made by this title shall take effect on October 1,
    2007, or the date of the enactment of this Act, whichever is later,
    except that fees under part 2 of subchapter C of chapter VII of the
    Federal Food, Drug, and Cosmetic Act shall be assessed for all human
    drug applications received on or after October 1, 2007, regardless of
    the date of the enactment of this Act.

    SEC. 108. SAVINGS CLAUSE.

        Notwithstanding section 509 of the Prescription Drug User Fee
    Amendments of 2002 (21 U.S.C. 379g note), and 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 DEVICE USER FEE AMENDMENTS OF 2007

    SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING.

        (a) Short Title.--This title may be cited as the ``Medical Device
    User Fee Amendments of 2007''.
        (b) References in Title.--Except as otherwise specified, amendments
    made by this title to a section or other provision of law are
    amendments to such section or other provision of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
        (c) Finding.--The Congress finds that the fees authorized under the
    amendments made by this title will be dedicated toward 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 and Commerce of the House of
    Representatives, as set forth in the Congressional Record.

                  Subtitle A--Fees Related to Medical Devices

    SEC. 211. DEFINITIONS.

        Section 737 is amended--
                (1) in the matter preceding paragraph (1), by striking
            ``For purposes of this subchapter'' and inserting ``For
            purposes of this part'';
                (2) by redesignating paragraphs (5), (6), (7), and (8) as
            paragraphs (8), (9), (10), and (12), respectively;
                (3) by inserting after paragraph (4) the following:
                ``(5) The term `30-day notice' means a notice under section
            515(d)(6) that is limited to a request to make modifications to
            manufacturing procedures or methods of manufacture affecting
            the safety and effectiveness of the device.
                ``(6) The term `request for classification information'
            means a request made under section 513(g) for information
            respecting the class in which a device has been classified or
            the 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.''.

    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 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.
                (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 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:
                                ``(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 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.--
                        (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 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:
        ``(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
            subsection (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.''.
                (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. 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 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--
                        ``(A) the Committee on Energy and Commerce of the
                    House of Representatives;
                        ``(B) the Committee on Health, Education, Labor,
                    and Pensions of the Senate;
                        ``(C) scientific and academic experts;
                        ``(D) health care professionals;
                        ``(E) representatives of patient and consumer
                    advocacy groups; and
                        ``(F) the regulated industry.
                ``(2) Prior public input.--Prior to beginning negotiations
            with the regulated industry on the reauthorization of this
            part, the Secretary shall--
                        ``(A) publish a notice in the Federal Register
                    requesting public input on the reauthorization;
                        ``(B) hold a public meeting at which the public may
                    present its views on the reauthorization, including
                    specific suggestions for changes to the goals referred
                    to in 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) 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) 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 recommendations.--Not later than
            January 15, 2012, the Secretary shall transmit to Congress the
            revised recommendations under paragraph (4), a summary of the
            views and comments received under such paragraph, and any
            changes made to the recommendations in response to such views
            and comments.
                ``(6) Minutes of negotiation meetings.--
                        ``(A) Public availability.--Before presenting the
                    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 by any party to the negotiations as well
                    as significant controversies or differences of opinion
                    during the negotiations and their resolution.''.

    SEC. 214. SAVINGS CLAUSE.

        Notwithstanding section 107 of the Medical Device User Fee and
    Modernization Act of 2002 (Public Law 107-250), and 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. EFFECTIVE DATE.

        The amendments made by this subtitle shall take effect on October
    1, 2007, or the date of the enactment of this Act, whichever is later,
    except that fees under part 3 of subchapter C of chapter VII of the
    Federal Food, Drug, and Cosmetic Act shall be assessed for all
    premarket applications, premarket reports, supplements, 30-day notices,
    and premarket notification submissions received on or after October 1,
    2007, regardless of the date of the enactment of this Act.

    SEC. 217. SUNSET CLAUSE.

        The amendments made by this subtitle cease to be effective October
    1, 2012, except that section 738A of the Federal Food, Drug, and
    Cosmetic Act (regarding annual performance and 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''.

    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. 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.''.

    SEC. 225. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE.

        (a) In General.--The Comptroller General of the United States shall
    conduct a study on the appropriate use of the process under section
    510(k) of the Federal Food, Drug, and Cosmetic Act as part of the
    device classification process to determine whether a new device is as
    safe and effective as a classified device.
        (b) Consideration.--In determining the effectiveness of the
    premarket notification and classification authority under section
    510(k) and subsections (f) and (i) of section 513 of the Federal Food,
    Drug, and Cosmetic Act, the study under subsection (a) shall consider
    the Secretary of Health and Human Services's evaluation of the
    respective intended uses and technologies of such devices, including
    the effectiveness of such Secretary's comparative 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 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) a type of device which the
                                    Secretary has, by notice published in
                                    the Federal Register or letter to the
                                    person who is the manufacturer 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) 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
                        ``(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) 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 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) 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 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) If the Secretary rejects the selection of an accredited
    person by the owner or operator of a device establishment, the owner or
    operator may make an additional selection of an accredited person by
    submitting to the Secretary a notice that identifies the additional
    selection. Clauses (i) and (ii) of subparagraph (B), and subclause (I)
    of this clause, apply to the selection of an accredited person through
    a notice under the preceding sentence in the same manner and to the
    same extent as such provisions apply to a selection of an accredited
    person through a notice under 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 review
    shall commence not later than 30 days after the owner or operator
    requests the review, unless the Secretary and the owner or operator
    otherwise agree.'';
                (5) in paragraph (7)--
                        (A) in subparagraph (A), by striking ``(A)
                    Persons'' and all that follows through the end and
                    inserting the following: ``(A) Persons accredited under
                    paragraph (2) to conduct inspections shall record in
                    writing their inspection observations and shall present
                    the observations to the device establishment's
                    designated representative and describe each
                    observation. Additionally, such accredited person shall
                    prepare an inspection report in a form and manner
                    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:
        ``(F) For the purpose of setting risk-based inspectional
    priorities, the Secretary shall accept voluntary submissions of reports
    of audits assessing conformance with appropriate quality systems
    standards set by the International Organization for Standardization
    (ISO) and identified by the Secretary in public notice. If the owner or
    operator of an establishment elects to submit audit reports under this
    subparagraph, the owner or operator shall submit all such audit reports
    with respect to the establishment during the preceding 2-year
    periods.''; and
                (6) in paragraph (10)(C)(iii), by striking ``based'' and
            inserting ``base''.

    SEC. 229. STUDY OF NOSOCOMIAL INFECTIONS RELATING TO MEDICAL DEVICES.

        (a) In General.--The Comptroller General of the United States shall
    conduct a study on--
                (1) the number of nosocomial infections attributable to new
            and reused medical devices; and
                (2) the causes of such nosocomial infections, including the
            following:
                        (A) Reprocessed single-use devices.
                        (B) Handling of sterilized medical devices.
                        (C) In-hospital sterilization of medical devices.
                        (D) Health care professionals' practices for
                    patient examination and treatment.
                        (E) Hospital-based policies and procedures for
                    infection control and prevention.
                        (F) Hospital-based practices for handling of
                    medical waste.
                        (G) Other causes.
        (b) Report.--Not later than 1 year after the date of the 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.
        (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 MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007

    SEC. 301. SHORT TITLE.

        This title may be cited as the ``Pediatric Medical Device Safety
    and Improvement Act of 2007''.

    SEC. 302. TRACKING PEDIATRIC DEVICE APPROVALS.

        Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    351 et seq.) is amended by inserting after section 515 the following:

    ``SEC. 515A. PEDIATRIC USES OF DEVICES.

        ``(a) New Devices.--
                ``(1) In general.--A person that submits to the Secretary
            an application under section 520(m), or an application (or
            supplement to an application) or a product development protocol
            under section 515, shall include in the application or protocol
            the information described in paragraph (2).
                ``(2) Required information.--The application or protocol
            described in paragraph (1) shall include, with respect to the
            device for which approval is sought and if readily available--
                        ``(A) a description of any pediatric subpopulations
                    that suffer from the disease or condition that the
                    device is intended to treat, diagnose, or cure; and
                        ``(B) the number of affected pediatric patients.
                ``(3) Annual report.--Not later than 18 months after the
            date of the enactment of this section, and annually thereafter,
            the Secretary shall submit to the Committee on Health,
            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
                        ``(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 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) Such person immediately notifies the Secretary if
            the number of such devices distributed during any calendar year
            exceeds the annual distribution number referred to in clause
            (ii).
                ``(iv) The request for such exemption is submitted on or
            before October 1, 2012.
        ``(B) The Secretary may inspect the records relating to the number
    of devices distributed during any calendar year of a person granted an
    exemption under paragraph (2) for which the prohibition in paragraph
    (3) does not apply.
        ``(C) A person may petition the Secretary to modify the annual
    distribution number specified by the Secretary under subparagraph
    (A)(ii) with respect to a device if additional information on the
    number of individuals affected by the disease or condition arises, and
    the Secretary may modify such number but in no case shall the annual
    distribution number exceed the number identified in paragraph (2)(A).
        ``(D) If a person notifies the Secretary, or the Secretary
    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) 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 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 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 device
    exemption under section 520(m)(2) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted.

    SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH.

        (a) Contact Point for Available Funding.--Section 402(b) of the
    Public Health Service Act (42 U.S.C. 282(b)) is amended--
                (1) in paragraph (21), by striking ``and'' after the
            semicolon at the end;
                (2) in paragraph (22), by striking the period at the end
            and inserting ``; and''; and
                (3) by inserting after paragraph (22) the following:
                ``(23) shall designate a contact point or office to help
            innovators and physicians identify sources of funding available
            for pediatric medical device development.''.
        (b) Plan for Pediatric Medical Device Research.--
                (1) In general.--Not later than 180 days after the date of
            the enactment of this Act, the Secretary of Health and Human
            Services, acting through the Commissioner of Food and Drugs,
            the Director of the National Institutes of Health, and the
            Director of the Agency for Healthcare Research and Quality,
            shall submit to the Committee on Health, Education, Labor, and
            Pensions of the Senate and the Committee on Energy and Commerce
            of the House of Representatives a plan for expanding pediatric
            medical device research and 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. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE
                  AVAILABILITY.

        (a) In General.--
                (1) Request for proposals.--Not later than 90 days after
            the date of the enactment of this Act, the Secretary of Health
            and Human Services shall issue a request for proposals for 1 or
            more grants or contracts to nonprofit consortia for
            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.
        (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 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''.
        (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.--
                ``(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 IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007

    SEC. 401. 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 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:
                                        ``(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 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
                    to develop a pediatric formulation, the waiver shall
                    cover only the pediatric groups 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--
                                ``(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 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)--
                ``(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 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 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 analysis of
            the quality and consistency of pediatric information in
            pediatric assessments and the appropriateness of waivers and
            deferrals granted. Based 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 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 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 that the Commissioner
                            determines to be appropriate; and
                                ``(ii) 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 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 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 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 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 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 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 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 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.
                ``(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) 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. 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
            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 PHARMACEUTICALS FOR CHILDREN ACT OF 2007

    SEC. 501. 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
            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
            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 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 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. In issuing such request, the
                    Secretary shall take into account adequate
                    representation of children of ethnic and racial
                    minorities. Such 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 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.
                ``(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 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 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 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). 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 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;
                        ``(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 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) if the sponsor of the application
                            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 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 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 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 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.
                ``(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 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 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:
                        ``(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). 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--
                        ``(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 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) on or before October 1, 2012, the Secretary makes a
            written request for pediatric studies of the drug;
                ``(2) 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) 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 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 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--
                        ``(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 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 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) 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 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 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) make a recommendation to the
                            Commissioner of Food and Drugs as to
                            appropriate labeling changes, if any.
                ``(9) FDA 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 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
            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 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 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:

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

    ``SEC. 770. 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) 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) 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;
                        ``(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
                                        ``(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 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) 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;
                                ``(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 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;
                ``(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--
                        ``(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. LOCATION OF FOUNDATION.

        ``The Foundation shall, if practicable, be located not more than 20
    miles from the District of Columbia.

    ``SEC. 772. 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.''.

    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. 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. 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--
                        ``(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 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. 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 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
                                        ``(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 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 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--
                (1) striking paragraph (4); and
                (2) redesignating paragraphs (5), (6), (7), and (8) as
            paragraphs (4), (5), (6), and (7), respectively.
        (c) Effective 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).
                                ``(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 Director of NIH
                            shall ensure that the registry data bank is
                            made publicly available through the Internet.
                                ``(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
                                                ``(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 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 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
                                ``(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 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 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, 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) 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 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 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 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.
                                        ``(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 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--
                                                ``(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) 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 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 general.--Except as provided in
                            clause (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--
                                        ``(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 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 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 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 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 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.
                        ``(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. 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 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 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.--
                        ``(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) 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 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 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 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 paragraph (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
                            paragraph (2) and (3) before releasing any
                            remaining funding for a grant or funding for a
                            future grant to such grantee.
                                ``(iii) Notice and 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
                            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) 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
                                    paragraph (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 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--
                                        ``(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 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) 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) 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)'';
                        (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 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 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)) 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 later than 12 months after the date of the
    enactment of this Act, the Secretary of Health and Human 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) 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
                                ``(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 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 labeling changes requested by secretary.--
                        ``(A) New 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, including changes to boxed
                            warnings, contraindications, warnings,
                            precautions, or adverse reactions; or
                                ``(ii) 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 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. 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.--
                        ``(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 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 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 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
                ``(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 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.
        ``(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) 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);
                        ``(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 subsection.
            The Secretary shall promulgate regulations for how a physician
            may provide the drug under the mechanisms of section 561.
                ``(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) 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;
                        ``(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 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) 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 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 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 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 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 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 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 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--
                                ``(i) give notice of the deferral to the
                            holder of the approved covered application not
                            later than 5 days after the deferral;
                                ``(ii) publish the deferral in the Federal
                            Register; and
                                ``(iii) 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 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 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.''.
        (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. PREREVIEW OF TELEVISION ADVERTISEMENTS.

        ``(a) In 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.
                ``(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 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.
        ``(2) 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 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. 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 Construction Regarding Pediatric Studies.--This title
    and the amendments made by this title may not be 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).''.

    SEC. 904. 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 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) 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 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--
                                        ``(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) 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 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 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 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--
                                        ``(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 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.
                                        ``(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 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 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 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 drugs to the FDA. Visit www.fda.gov/
    medwatch, or call 1-800-FDA-1088.','' after ``section 701(a),''.
        (b) Study.--
                (1) In 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. 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. 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. 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
                        (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 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. 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 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) in section 304(a)(1), by striking ``section 404 or
            505'' and inserting ``section 301(ll), 404, or 505''; and
                (2) 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. PHARMACEUTICAL SECURITY.

        ``(a) In 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.--
                ``(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 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.--
                ``(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 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 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);
                                ``(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 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 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.
                ``(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 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;
                                ``(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) 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) 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 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--
                (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 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.
                ``(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. RISK COMMUNICATION.

        ``(a) Advisory 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. 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 did not refer the drug to an advisory committee prior
            to approval.''.

    SEC. 919. RESPONSE TO THE INSTITUTE OF MEDICINE.

        (a) In 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 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--
                        ``(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. 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;
                        (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. ENSURING THE SAFETY OF PET FOOD.

        (a) Processing and 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 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. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS DURING A
                  RECALL.

        The Secretary shall, during an ongoing recall of human or pet food
    regulated by the Secretary--
                (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) 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. 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. 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.
                (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. 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 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 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.
                ``(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 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).
                ``(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 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:
        ``(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 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 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 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. 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. CONSULTATION REGARDING GENETICALLY ENGINEERED SEAFOOD
                  PRODUCTS.

        The Commissioner of Food and Drugs shall consult with the Assistant
    Administrator of the National Marine Fisheries Service 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. 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. 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. PUBLICATION OF ANNUAL REPORTS.

        (a) In 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 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. 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. 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 Secretary, through the Commissioner of Food
    and Drugs, shall establish and make publicly available clear 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. 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.
                        ``(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 after the date of the enactment of the Food
                    and Drug Administration Amendments Act of 2007.
                ``(4) Notification.--The 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 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 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) in section 319C-2(j)(3)(B), by striking ``section 319C-
            1(h)'' and inserting ``section 319C-1(i)'';
                (2) in section 402(b)(4), by inserting ``minority and
            other'' after ``reducing'';
                (3) 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) as section 403D; and
                (5) 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. 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. 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 information
    is reasonably available) and periodically update clinically susceptible
    concentrations.
        (c) Public 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) 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--
                                ``(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 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
                (2) prevented or delayed timely generic drug entry into the
            market.
                                     <all>