[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3580 Enrolled Bill (ENR)]

        H.R.3580

                       One Hundred Tenth Congress

                                 of the

                        United States of America


                          AT THE FIRST SESSION

          Begun and held at the City of Washington on Thursday,
            the fourth day of January, two thousand and seven


                                 An Act


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

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
    This Act may be cited as the ``Food and Drug Administration 
Amendments Act of 2007''.
SEC. 2. TABLE OF CONTENTS.
    The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.

         TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

Sec. 101. Short title; references in title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Fees relating to advisory review of prescription-drug 
          television 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 subsections (a)(2) and (a)(3) shall be 
    considered incomplete and shall not be accepted by the Secretary 
    until all fees owed by such person have been paid.
        ``(2) No registration.--Registration information submitted 
    under section 510 by an establishment subject to a registration fee 
    shall be considered incomplete and shall not be accepted by the 
    Secretary until the registration fee under subsection (a)(3) owed 
    for the establishment has been paid. Until the fee is paid and the 
    registration is complete, the establishment is deemed to have 
    failed to register in accordance with section 510.''.
    (g) Conditions.--Section 738(g) (21 U.S.C. 379j(g)) is amended--
        (1) by striking paragraph (1) and inserting the following:
        ``(1) Performance goals; termination of program.--With respect 
    to the amount that, under the salaries and expenses account of the 
    Food and Drug Administration, is appropriated for a fiscal year for 
    devices and radiological products, fees may not be assessed under 
    subsection (a) for the fiscal year, and the Secretary is not 
    expected to meet any performance goals identified for the fiscal 
    year, if--
            ``(A) the amount so appropriated for the fiscal year, 
        excluding the amount of fees appropriated for the fiscal year, 
        is more than 1 percent less than $205,720,000 multiplied by the 
        adjustment factor applicable to such fiscal year; or
            ``(B) fees were not assessed under subsection (a) for the 
        previous fiscal year.''; and
        (2) by amending paragraph (2) to read as follows:
        ``(2) Authority.--If the Secretary does not assess fees under 
    subsection (a) during any portion of a fiscal year because of 
    paragraph (1) and if at a later date in such fiscal year the 
    Secretary may assess such fees, the Secretary may assess and 
    collect such fees, without any modification in the rate for 
    premarket applications, supplements, premarket reports, premarket 
    notification submissions, 30-day notices, requests for 
    classification information, periodic reporting concerning a class 
    III device, and establishment registrations at any time in such 
    fiscal year, notwithstanding the provisions of subsection (a) 
    relating to the date fees are to be paid.''.
    (h) Crediting and Availability of Fees.--
        (1) Authorization of appropriations.--Section 738(h)(3) (21 
    U.S.C. 379j(h)(3)) is amended to read as follows:
        ``(3) Authorizations of appropriations.--There are authorized 
    to be appropriated for fees under this section--
            ``(A) $48,431,000 for fiscal year 2008;
            ``(B) $52,547,000 for fiscal year 2009;
            ``(C) $57,014,000 for fiscal year 2010;
            ``(D) $61,860,000 for fiscal year 2011; and
            ``(E) $67,118,000 for fiscal year 2012.''.
        (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 clauses (iii), 
            (iv), (v), and (vi) the responsible party for an applicable 
            clinical trial that is described in clause (ii) shall 
            submit to the Director of NIH for inclusion in the registry 
            and results data bank the clinical trial information 
            described in subparagraph (C) not later than 1 year, or 
            such other period as may be provided by regulation under 
            subparagraph (D), after the earlier of--

                    ``(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 
            paragraphs (2) and (3).
                ``(ii) Verification by federal agencies.--The heads of 
            the agencies referred to in clause (i), as applicable, 
            shall verify that the clinical trial information for each 
            applicable clinical trial for which a grantee is the 
            responsible party has been submitted under paragraphs (2) 
            and (3) before releasing any remaining funding for a grant 
            or funding for a future grant to such grantee.
                ``(iii) Notice and 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 
                paragraphs (2) and (3).

            ``(B) Certification to accompany drug, biological product, 
        and device submissions.--At the time of submission of an 
        application under section 505 of the Federal Food, Drug, and 
        Cosmetic Act, section 515 of such Act, section 520(m) of such 
        Act, or section 351 of this Act, or submission of a report 
        under section 510(k) of such Act, such application or 
        submission shall be accompanied by a certification that all 
        applicable requirements of this subsection have been met. Where 
        available, such certification shall include the appropriate 
        National Clinical Trial control numbers.
            ``(C) Quality control.--
                ``(i) Pilot quality control project.--Until the 
            effective date of the regulations issued under paragraph 
            (3)(D), the Secretary, acting through the Director of NIH 
            and the Commissioner of Food and Drugs, shall conduct a 
            pilot project to determine the optimal method of 
            verification to help to ensure that the clinical trial 
            information submitted under paragraph (3)(C) is non-
            promotional and is not false or misleading in any 
            particular under subparagraph (D). The Secretary shall use 
            the publicly available information described in paragraph 
            (3)(A) and any other information available to the Secretary 
            about applicable clinical trials to verify the accuracy of 
            the clinical trial information submitted under paragraph 
            (3)(C).
                ``(ii) Notice of 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:
5``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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.