[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3580 Engrossed in House (EH)]

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
110th CONGRESS
  1st Session
                                H. R. 3580

_______________________________________________________________________

                                 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 
        subsection (a)(2) and (a)(3) shall be considered incomplete and 
        shall not be accepted by the Secretary until all fees owed by 
        such person have been paid.
            ``(2) No registration.--Registration information submitted 
        under section 510 by an establishment subject to a registration 
        fee shall be considered incomplete and shall not be accepted by 
        the Secretary until the registration fee under subsection 
        (a)(3) owed for the establishment has been paid. Until the fee 
        is paid and the registration is complete, the establishment is 
        deemed to have failed to register in accordance with section 
        510.''.
    (g) Conditions.--Section 738(g) (21 U.S.C. 379j(g)) is amended--
            (1) by striking paragraph (1) and inserting the following:
            ``(1) Performance goals; termination of program.--With 
        respect to the amount that, under the salaries and expenses 
        account of the Food and Drug Administration, is appropriated 
        for a fiscal year for devices and radiological products, fees 
        may not be assessed under subsection (a) for the fiscal year, 
        and the Secretary is not expected to meet any performance goals 
        identified for the fiscal year, if--
                    ``(A) the amount so appropriated for the fiscal 
                year, excluding the amount of fees appropriated for the 
                fiscal year, is more than 1 percent less than 
                $205,720,000 multiplied by the adjustment factor 
                applicable to such fiscal year; or
                    ``(B) fees were not assessed under subsection (a) 
                for the previous fiscal year.''; and
            (2) by amending paragraph (2) to read as follows:
            ``(2) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal year 
        because of paragraph (1) and if at a later date in such fiscal 
        year the Secretary may assess such fees, the Secretary may 
        assess and collect such fees, without any modification in the 
        rate for premarket applications, supplements, premarket 
        reports, premarket notification submissions, 30-day notices, 
        requests for classification information, periodic reporting 
        concerning a class III device, and establishment registrations 
        at any time in such fiscal year, notwithstanding the provisions 
        of subsection (a) relating to the date fees are to be paid.''.
    (h) Crediting and Availability of Fees.--
            (1) Authorization of appropriations.--Section 738(h)(3) (21 
        U.S.C. 379j(h)(3)) is amended to read as follows:
            ``(3) Authorizations of appropriations.--There are 
        authorized to be appropriated for fees under this section--
                    ``(A) $48,431,000 for fiscal year 2008;
                    ``(B) $52,547,000 for fiscal year 2009;
                    ``(C) $57,014,000 for fiscal year 2010;
                    ``(D) $61,860,000 for fiscal year 2011; and
                    ``(E) $67,118,000 for fiscal year 2012.''.
            (2) Offset.--Section 738(h)(4) (21 U.S.C. 379j(h)(3)) is 
        amended to read as follows:
            ``(4) Offset.--If the cumulative amount of fees collected 
        during fiscal years 2008, 2009, and 2010, added to the amount 
        estimated to be collected for fiscal year 2011, which estimate 
        shall be based upon the amount of fees received by the 
        Secretary through June 30, 2011, exceeds the amount of fees 
        specified in aggregate in paragraph (3) for these four fiscal 
        years, the aggregate amount in excess shall be credited to the 
        appropriation account of the Food and Drug Administration as 
        provided in paragraph (1), and shall be subtracted from the 
        amount of fees that would otherwise be authorized to be 
        collected under this section pursuant to appropriation Acts for 
        fiscal year 2012.''.

SEC. 213. REAUTHORIZATION; REPORTING REQUIREMENTS.

    Part 3 of subchapter C of chapter VII is amended by inserting after 
section 738 the following:

``SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS.

    ``(a) Reports.--
            ``(1) Performance report.--For fiscal years 2008 through 
        2012, not later than 120 days after the end of each fiscal year 
        during which fees are collected under this part, the Secretary 
        shall prepare and submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, a report 
        concerning the progress of the Food and Drug Administration in 
        achieving the goals identified in the letters described in 
        section 201(c) of the Food and Drug Administration Amendments 
        Act of 2007 during such fiscal year and the future plans of the 
        Food and Drug Administration for meeting the goals. The report 
        for a fiscal year shall include information on all previous 
        cohorts for which the Secretary has not given a complete 
        response on all device premarket applications and reports, 
        supplements, and premarket notifications in the cohort.
            ``(2) Fiscal report.--For fiscal years 2008 through 2012, 
        not later than 120 days after the end of each fiscal year 
        during which fees are collected under this part, the Secretary 
        shall prepare and submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, a report on the 
        implementation of the authority for such fees during such 
        fiscal year and the use, by the Food and Drug Administration, 
        of the fees collected during such fiscal year for which the 
        report is made.
            ``(3) Public availability.--The Secretary shall make the 
        reports required under paragraphs (1) and (2) available to the 
        public on the Internet Web site of the Food and Drug 
        Administration.
    ``(b) Reauthorization.--
            ``(1) Consultation.--In developing recommendations to 
        present to Congress with respect to the goals, and plans for 
        meeting the goals, for the process for the review of device 
        applications for the first 5 fiscal years after fiscal year 
        2012, and for the reauthorization of this part for such fiscal 
        years, the Secretary shall consult with--
                    ``(A) the Committee on Energy and Commerce of the 
                House of Representatives;
                    ``(B) the Committee on Health, Education, Labor, 
                and Pensions of the Senate;
                    ``(C) scientific and academic experts;
                    ``(D) health care professionals;
                    ``(E) representatives of patient and consumer 
                advocacy groups; and
                    ``(F) the regulated industry.
            ``(2) Prior public input.--Prior to beginning negotiations 
        with the regulated industry on the reauthorization of this 
        part, the Secretary shall--
                    ``(A) publish a notice in the Federal Register 
                requesting public input on the reauthorization;
                    ``(B) hold a public meeting at which the public may 
                present its views on the reauthorization, including 
                specific suggestions for changes to the goals referred 
                to in subsection (a)(1);
                    ``(C) provide a period of 30 days after the public 
                meeting to obtain written comments from the public 
                suggesting changes to this part; and
                    ``(D) publish the comments on the Food and Drug 
                Administration's Internet Web site.
            ``(3) Periodic consultation.--Not less frequently than once 
        every month during negotiations with the regulated industry, 
        the Secretary shall hold discussions with representatives of 
        patient and consumer advocacy groups to continue discussions of 
        their views on the reauthorization and their suggestions for 
        changes to this part as expressed under paragraph (2).
            ``(4) Public review of recommendations.--After negotiations 
        with the regulated industry, the Secretary shall--
                    ``(A) present the recommendations developed under 
                paragraph (1) to the Congressional committees specified 
                in such paragraph;
                    ``(B) publish such recommendations in the Federal 
                Register;
                    ``(C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                    ``(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                    ``(E) after consideration of such public views and 
                comments, revise such recommendations as necessary.
            ``(5) Transmittal of recommendations.--Not later than 
        January 15, 2012, the Secretary shall transmit to Congress the 
        revised recommendations under paragraph (4), a summary of the 
        views and comments received under such paragraph, and any 
        changes made to the recommendations in response to such views 
        and comments.
            ``(6) Minutes of negotiation meetings.--
                    ``(A) Public availability.--Before presenting the 
                recommendations developed under paragraphs (1) through 
                (5) to the Congress, the Secretary shall make publicly 
                available, on the public Web site of the Food and Drug 
                Administration, minutes of all negotiation meetings 
                conducted under this subsection between the Food and 
                Drug Administration and the regulated industry.
                    ``(B) Content.--The minutes described under 
                subparagraph (A) shall summarize any substantive 
                proposal made by any party to the negotiations as well 
                as significant controversies or differences of opinion 
                during the negotiations and their resolution.''.

SEC. 214. SAVINGS CLAUSE.

    Notwithstanding section 107 of the Medical Device User Fee and 
Modernization Act of 2002 (Public Law 107-250), and notwithstanding the 
amendments made by this subtitle, part 3 of subchapter C of chapter VII 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), 
as in effect on the day before the date of the enactment of this 
subtitle, shall continue to be in effect with respect to premarket 
applications, premarket reports, premarket notification submissions, 
and supplements (as defined in such part as of such day) that on or 
after October 1, 2002, but before October 1, 2007, were accepted by the 
Food and Drug Administration for filing with respect to assessing and 
collecting any fee required by such part for a fiscal year prior to 
fiscal year 2008.

SEC. 215. ADDITIONAL AUTHORIZATION OF APPROPRIATIONS FOR POSTMARKET 
              SAFETY INFORMATION.

    For the purpose of collecting, developing, reviewing, and 
evaluating postmarket safety information on medical devices, there are 
authorized to be appropriated to the Food and Drug Administration, in 
addition to the amounts authorized by other provisions of law for such 
purpose--
            (1) $7,100,000 for fiscal year 2008;
            (2) $7,455,000 for fiscal year 2009;
            (3) $7,827,750 for fiscal year 2010;
            (4) $8,219,138 for fiscal year 2011; and
            (5) $8,630,094 for fiscal year 2012.

SEC. 216. EFFECTIVE DATE.

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

SEC. 217. SUNSET CLAUSE.

    The amendments made by this subtitle cease to be effective October 
1, 2012, except that section 738A of the Federal Food, Drug, and 
Cosmetic Act (regarding annual performance and financial reports) 
ceases to be effective January 31, 2013.

     Subtitle B--Amendments Regarding Regulation of Medical Devices

SEC. 221. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF PREMARKET 
              NOTIFICATION.

    Section 523(c) (21 U.S.C. 360m(c)) is amended by striking ``2007'' 
and inserting ``2012''.

SEC. 222. REGISTRATION.

    (a) Annual Registration of Producers of Drugs and Devices.--Section 
510(b) (21 U.S.C. 360(b)) is amended--
            (1) by striking ``(b) On or before'' and inserting ``(b)(1) 
        On or before'';
            (2) by striking ``or a device or devices''; and
            (3) by adding at the end the following:
    ``(2) During the period beginning on October 1 and ending on 
December 31 of each year, every person who owns or operates any 
establishment in any State engaged in the manufacture, preparation, 
propagation, compounding, or processing of a device or devices shall 
register with the Secretary his name, places of business, and all such 
establishments.''.
    (b) Registration of Foreign Establishments.--Section 510(i)(1) (21 
U.S.C. 360(i)(1)) is amended by striking ``On or before December 31'' 
and all that follows and inserting the following: ``Any establishment 
within any foreign country engaged in the manufacture, preparation, 
propagation, compounding, or processing of a drug or device that is 
imported or offered for import into the United States shall, through 
electronic means in accordance with the criteria of the Secretary--
            ``(A) upon first engaging in any such activity, immediately 
        register with the Secretary the name and place of business of 
        the establishment, the name of the United States agent for the 
        establishment, the name of each importer of such drug or device 
        in the United States that is known to the establishment, and 
        the name of each person who imports or offers for import such 
        drug or device to the United States for purposes of 
        importation; and
            ``(B) each establishment subject to the requirements of 
        subparagraph (A) shall thereafter--
                    ``(i) with respect to drugs, register with the 
                Secretary on or before December 31 of each year; and
                    ``(ii) with respect to devices, register with the 
                Secretary during the period beginning on October 1 and 
                ending on December 31 of each year.''.

SEC. 223. FILING OF LISTS OF DRUGS AND DEVICES MANUFACTURED, PREPARED, 
              PROPAGATED, AND COMPOUNDED BY REGISTRANTS; STATEMENTS; 
              ACCOMPANYING DISCLOSURES.

    Section 510(j)(2) (21 U.S.C. 360(j)(2)) is amended, in the matter 
preceding subparagraph (A), by striking ``Each person'' and all that 
follows through ``the following information:'' and inserting ``Each 
person who registers with the Secretary under this section shall report 
to the Secretary, with regard to drugs once during the month of June of 
each year and once during the month of December of each year, and with 
regard to devices once each year during the period beginning on October 
1 and ending on December 31, the following information:''.

SEC. 224. ELECTRONIC REGISTRATION AND LISTING.

    Section 510(p) (21 U.S.C. 360(p)) is amended to read as follows:
    ``(p) Registrations and listings under this section (including the 
submission of updated information) shall be submitted to the Secretary 
by electronic means unless the Secretary grants a request for waiver of 
such requirement because use of electronic means is not reasonable for 
the person requesting such waiver.''.

SEC. 225. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE.

    (a) In General.--The Comptroller General of the United States shall 
conduct a study on the appropriate use of the process under section 
510(k) of the Federal Food, Drug, and Cosmetic Act as part of the 
device classification process to determine whether a new device is as 
safe and effective as a classified device.
    (b) Consideration.--In determining the effectiveness of the 
premarket notification and classification authority under section 
510(k) and subsections (f) and (i) of section 513 of the Federal Food, 
Drug, and Cosmetic Act, the study under subsection (a) shall consider 
the Secretary of Health and Human Services's evaluation of the 
respective intended uses and technologies of such devices, including 
the effectiveness of such Secretary's comparative assessment of 
technological characteristics such as device materials, principles of 
operations, and power sources.
    (c) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Comptroller General shall complete the study under 
subsection (a) and submit to the Congress a report on the results of 
such study.

SEC. 226. UNIQUE DEVICE IDENTIFICATION SYSTEM.

    (a) In General.--Section 519 (21 U.S.C. 360i) is amended--
            (1) by redesignating subsection (f) as subsection (g); and
            (2) by inserting after subsection (e) the following:

                 ``Unique Device Identification System

    ``(f) The Secretary shall promulgate regulations establishing a 
unique device identification system for medical devices requiring the 
label of devices to bear a unique identifier, unless the Secretary 
requires an alternative placement or provides an exception for a 
particular device or type of device. The unique identifier shall 
adequately identify the device through distribution and use, and may 
include information on the lot or serial number.''.
    (b) Conforming Amendment.--Section 303 (21 U.S.C. 333) is amended--
            (1) by redesignating the subsection that follows subsection 
        (e) as subsection (f); and
            (2) in paragraph (1)(B)(ii) of subsection (f), as so 
        redesignated, by striking ``519(f)'' and inserting ``519(g)''.

SEC. 227. FREQUENCY OF REPORTING FOR CERTAIN DEVICES.

    Subparagraph (B) of section 519(a)(1) (21 U.S.C. 360i(a)(1)) is 
amended by striking ``were to recur;'' and inserting the following: 
``were to recur, which report under this subparagraph--
                            ``(i) shall be submitted in accordance with 
                        part 803 of title 21, Code of Federal 
                        Regulations (or successor regulations), unless 
                        the Secretary grants an exemption or variance 
                        from, or an alternative to, a requirement under 
                        such regulations pursuant to section 803.19 of 
                        such part, if the device involved is--
                                    ``(I) a class III device;
                                    ``(II) a class II device that is 
                                permanently implantable, is life 
                                supporting, or is life sustaining; or
                                    ``(III) a type of device which the 
                                Secretary has, by notice published in 
                                the Federal Register or letter to the 
                                person who is the manufacturer or 
                                importer of the device, indicated 
                                should be subject to such part 803 in 
                                order to protect the public health;
                            ``(ii) shall, if the device is not subject 
                        to clause (i), be submitted in accordance with 
                        criteria established by the Secretary for 
                        reports made pursuant to this clause, which 
                        criteria shall require the reports to be in 
                        summary form and made on a quarterly basis; or
                            ``(iii) shall, if the device is imported 
                        into the United States and for which part 803 
                        of title 21, Code of Federal Regulations (or 
                        successor regulations) requires an importer to 
                        submit a report to the manufacturer, be 
                        submitted by the importer to the manufacturer 
                        in accordance with part 803 of title 21, Code 
                        of Federal Regulations (or successor 
                        regulations)''.

SEC. 228. INSPECTIONS BY ACCREDITED PERSONS.

    Section 704(g) (21 U.S.C. 374(g)) is amended--
            (1) in paragraph (1), by striking ``Not later than one year 
        after the date of the enactment of this subsection, the 
        Secretary'' and inserting ``The Secretary'';
            (2) in paragraph (2), by--
                    (A) striking ``Not later than 180 days after the 
                date of enactment of this subsection, the Secretary'' 
                and inserting ``The Secretary''; and
                    (B) striking the fifth sentence;
            (3) in paragraph (3), by adding at the end the following:
            ``(F) Such person shall notify the Secretary of any 
        withdrawal, suspension, restriction, or expiration of 
        certificate of conformance with the quality systems standard 
        referred to in paragraph (7) for any device establishment that 
        such person inspects under this subsection not later than 30 
        days after such withdrawal, suspension, restriction, or 
        expiration.
            ``(G) Such person may conduct audits to establish 
        conformance with the quality systems standard referred to in 
        paragraph (7).'';
            (4) by amending paragraph (6) to read as follows:
    ``(6)(A) Subject to subparagraphs (B) and (C), a device 
establishment is eligible for inspection by persons accredited under 
paragraph (2) if the following conditions are met:
            ``(i) The Secretary classified the results of the most 
        recent inspection of the establishment as `no action indicated' 
        or `voluntary action indicated'.
            ``(ii) With respect to inspections of the establishment to 
        be conducted by an accredited person, the owner or operator of 
        the establishment submits to the Secretary a notice that--
                    ``(I) provides the date of the last inspection of 
                the establishment by the Secretary and the 
                classification of that inspection;
                    ``(II) states the intention of the owner or 
                operator to use an accredited person to conduct 
                inspections of the establishment;
                    ``(III) identifies the particular accredited person 
                the owner or operator intends to select to conduct such 
                inspections; and
                    ``(IV) includes a certification that, with respect 
                to the devices that are manufactured, prepared, 
                propagated, compounded, or processed in the 
                establishment--
                            ``(aa) at least 1 of such devices is 
                        marketed in the United States; and
                            ``(bb) at least 1 of such devices is 
                        marketed, or is intended to be marketed, in 1 
                        or more foreign countries, 1 of which countries 
                        certifies, accredits, or otherwise recognizes 
                        the person accredited under paragraph (2) and 
                        identified under subclause (III) as a person 
                        authorized to conduct inspections of device 
                        establishments.
    ``(B)(i) Except with respect to the requirement of subparagraph 
(A)(i), a device establishment is deemed to have clearance to 
participate in the program and to use the accredited person identified 
in the notice under subparagraph (A)(ii) for inspections of the 
establishment unless the Secretary, not later than 30 days after 
receiving such notice, issues a response that--
            ``(I) denies clearance to participate as provided under 
        subparagraph (C); or
            ``(II) makes a request under clause (ii).
    ``(ii) The Secretary may request from the owner or operator of a 
device establishment in response to the notice under subparagraph 
(A)(ii) with respect to the establishment, or from the particular 
accredited person identified in such notice--
            ``(I) compliance data for the establishment in accordance 
        with clause (iii)(I); or
            ``(II) information concerning the relationship between the 
        owner or operator of the establishment and the accredited 
        person identified in such notice in accordance with clause 
        (iii)(II).
The owner or operator of the establishment, or such accredited person, 
as the case may be, shall respond to such a request not later than 60 
days after receiving such request.
    ``(iii)(I) The compliance data to be submitted by the owner or 
operator of a device establishment in response to a request under 
clause (ii)(I) are data describing whether the quality controls of the 
establishment have been sufficient for ensuring consistent compliance 
with current good manufacturing practice within the meaning of section 
501(h) and with other applicable provisions of this Act. Such data 
shall include complete reports of inspectional findings regarding good 
manufacturing practice or other quality control audits that, during the 
preceding 2-year period, were conducted at the establishment by persons 
other than the owner or operator of the establishment, together with 
all other compliance data the Secretary deems necessary. Data under the 
preceding sentence shall demonstrate to the Secretary whether the 
establishment has facilitated consistent compliance by promptly 
correcting any compliance problems identified in such inspections.
    ``(II) A request to an accredited person under clause (ii)(II) may 
not seek any information that is not required to be maintained by such 
person in records under subsection (f)(1).
    ``(iv) A device establishment is deemed to have clearance to 
participate in the program and to use the accredited person identified 
in the notice under subparagraph (A)(ii) for inspections of the 
establishment unless the Secretary, not later than 60 days after 
receiving the information requested under clause (ii), issues a 
response that denies clearance to participate as provided under 
subparagraph (C).
    ``(C)(i) The Secretary may deny clearance to a device establishment 
if the Secretary has evidence that the certification under subparagraph 
(A)(ii)(IV) is untrue and the Secretary provides to the owner or 
operator of the establishment a statement summarizing such evidence.
    ``(ii) The Secretary may deny clearance to a device establishment 
if the Secretary determines that the establishment has failed to 
demonstrate consistent compliance for purposes of subparagraph 
(B)(iii)(I) and the Secretary provides to the owner or operator of the 
establishment a statement of the reasons for such determination.
    ``(iii)(I) The Secretary may reject the selection of the accredited 
person identified in the notice under subparagraph (A)(ii) if the 
Secretary provides to the owner or operator of the establishment a 
statement of the reasons for such rejection. Reasons for the rejection 
may include that the establishment or the accredited person, as the 
case may be, has failed to fully respond to the request, or that the 
Secretary has concerns regarding the relationship between the 
establishment and such accredited person.
    ``(II) If the Secretary rejects the selection of an accredited 
person by the owner or operator of a device establishment, the owner or 
operator may make an additional selection of an accredited person by 
submitting to the Secretary a notice that identifies the additional 
selection. Clauses (i) and (ii) of subparagraph (B), and subclause (I) 
of this clause, apply to the selection of an accredited person through 
a notice under the preceding sentence in the same manner and to the 
same extent as such provisions apply to a selection of an accredited 
person through a notice under subparagraph (A)(ii).
    ``(iv) In the case of a device establishment that is denied 
clearance under clause (i) or (ii) or with respect to which the 
selection of the accredited person is rejected under clause (iii), the 
Secretary shall designate a person to review the statement of reasons, 
or statement summarizing such evidence, as the case may be, of the 
Secretary under such clause if, during the 30-day period beginning on 
the date on which the owner or operator of the establishment receives 
such statement, the owner or operator requests the review. The review 
shall commence not later than 30 days after the owner or operator 
requests the review, unless the Secretary and the owner or operator 
otherwise agree.'';
            (5) in paragraph (7)--
                    (A) in subparagraph (A), by striking ``(A) 
                Persons'' and all that follows through the end and 
                inserting the following: ``(A) Persons accredited under 
                paragraph (2) to conduct inspections shall record in 
                writing their inspection observations and shall present 
                the observations to the device establishment's 
                designated representative and describe each 
                observation. Additionally, such accredited person shall 
                prepare an inspection report in a form and manner 
                designated by the Secretary to conduct inspections, 
                taking into consideration the goals of international 
                harmonization of quality systems standards. Any 
                official classification of the inspection shall be 
                determined by the Secretary.''; and
                    (B) by adding at the end the following:
    ``(F) For the purpose of setting risk-based inspectional 
priorities, the Secretary shall accept voluntary submissions of reports 
of audits assessing conformance with appropriate quality systems 
standards set by the International Organization for Standardization 
(ISO) and identified by the Secretary in public notice. If the owner or 
operator of an establishment elects to submit audit reports under this 
subparagraph, the owner or operator shall submit all such audit reports 
with respect to the establishment during the preceding 2-year 
periods.''; and
            (6) in paragraph (10)(C)(iii), by striking ``based'' and 
        inserting ``base''.

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

    (a) In General.--The Comptroller General of the United States shall 
conduct a study on--
            (1) the number of nosocomial infections attributable to new 
        and reused medical devices; and
            (2) the causes of such nosocomial infections, including the 
        following:
                    (A) Reprocessed single-use devices.
                    (B) Handling of sterilized medical devices.
                    (C) In-hospital sterilization of medical devices.
                    (D) Health care professionals' practices for 
                patient examination and treatment.
                    (E) Hospital-based policies and procedures for 
                infection control and prevention.
                    (F) Hospital-based practices for handling of 
                medical waste.
                    (G) Other causes.
    (b) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Comptroller General shall complete the study under 
subsection (a) and submit to the Congress a report on the results of 
such study.
    (c) Definition.--In this section, the term ``nosocomial infection'' 
means an infection that is acquired while an individual is a patient at 
a hospital and was neither present nor incubating in the patient prior 
to receiving services in the hospital.

SEC. 230. REPORT BY THE FOOD AND DRUG ADMINISTRATION REGARDING LABELING 
              INFORMATION ON THE RELATIONSHIP BETWEEN THE USE OF INDOOR 
              TANNING DEVICES AND DEVELOPMENT OF SKIN CANCER OR OTHER 
              SKIN DAMAGE.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary''), acting through the 
Commissioner of Food and Drugs, shall determine--
            (1) whether the labeling requirements for indoor tanning 
        devices, including the positioning requirements, provide 
        sufficient information to consumers regarding the risks that 
        the use of such devices pose for the development of 
        irreversible damage to the eyes and skin, including skin 
        cancer; and
            (2)(A) whether modifying the warning label required on 
        tanning beds to read, ``Ultraviolet radiation can cause skin 
        cancer'', or any other additional warning, would communicate 
        the risks of indoor tanning more effectively; or
            (B) whether there is no warning that would be capable of 
        adequately communicating such risks.
    (b) Consumer Testing.--In making the determinations under 
subsection (a), the Secretary shall conduct appropriate consumer 
testing to determine consumer understanding of label warnings.
    (c) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Secretary shall submit to the Congress a report that 
provides the determinations under subsection (a). In addition, the 
Secretary shall include in the report the measures being implemented by 
the Secretary to significantly reduce the risks associated with indoor 
tanning devices.

 TITLE III--PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007

SEC. 301. SHORT TITLE.

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

SEC. 302. TRACKING PEDIATRIC DEVICE APPROVALS.

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

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

    ``(a) New Devices.--
            ``(1) In general.--A person that submits to the Secretary 
        an application under section 520(m), or an application (or 
        supplement to an application) or a product development protocol 
        under section 515, shall include in the application or protocol 
        the information described in paragraph (2).
            ``(2) Required information.--The application or protocol 
        described in paragraph (1) shall include, with respect to the 
        device for which approval is sought and if readily available--
                    ``(A) a description of any pediatric subpopulations 
                that suffer from the disease or condition that the 
                device is intended to treat, diagnose, or cure; and
                    ``(B) the number of affected pediatric patients.
            ``(3) Annual report.--Not later than 18 months after the 
        date of the enactment of this section, and annually thereafter, 
        the Secretary shall submit to the Committee on Health, 
        Education, Labor, and Pensions of the Senate and the Committee 
        on Energy and Commerce of the House of Representatives a report 
        that includes--
                    ``(A) the number of devices approved in the year 
                preceding the year in which the report is submitted, 
                for which there is a pediatric subpopulation that 
                suffers from the disease or condition that the device 
                is intended to treat, diagnose, or cure;
                    ``(B) the number of devices approved in the year 
                preceding the year in which the report is submitted, 
                labeled for use in pediatric patients;
                    ``(C) the number of pediatric devices approved in 
                the year preceding the year in which the report is 
                submitted, exempted from a fee pursuant to section 
                738(a)(2)(B)(v); and
                    ``(D) the review time for each device described in 
                subparagraphs (A), (B), and (C).
    ``(b) Determination of Pediatric Effectiveness Based on Similar 
Course of Disease or Condition or Similar Effect of Device on Adults.--
            ``(1) In general.--If the course of the disease or 
        condition and the effects of the device are sufficiently 
        similar in adults and pediatric patients, the Secretary may 
        conclude that adult data may be used to support a determination 
        of a reasonable assurance of effectiveness in pediatric 
        populations, as appropriate.
            ``(2) Extrapolation between subpopulations.--A study may 
        not be needed in each pediatric subpopulation if data from one 
        subpopulation can be extrapolated to another subpopulation.
    ``(c) Pediatric Subpopulation.--For purposes of this section, the 
term `pediatric subpopulation' has the meaning given the term in 
section 520(m)(6)(E)(ii).''.

SEC. 303. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION.

    (a) In General.--Section 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)) is amended--
            (1) in paragraph (3), by striking ``No'' and inserting 
        ``Except as provided in paragraph (6), no'';
            (2) in paragraph (5)--
                    (A) by inserting ``, if the Secretary has reason to 
                believe that the requirements of paragraph (6) are no 
                longer met,'' after ``public health''; and
                    (B) by adding at the end the following: ``If the 
                person granted an exemption under paragraph (2) fails 
                to demonstrate continued compliance with the 
                requirements of this subsection, the Secretary may 
                suspend or withdraw the exemption from the 
                effectiveness requirements of sections 514 and 515 for 
                a humanitarian device only after providing notice and 
                an opportunity for an informal hearing.''; and
            (3) by striking paragraph (6) and inserting after paragraph 
        (5) the following new paragraphs:
    ``(6)(A) Except as provided in subparagraph (D), the prohibition in 
paragraph (3) shall not apply with respect to a person granted an 
exemption under paragraph (2) if each of the following conditions 
apply:
            ``(i)(I) The device with respect to which the exemption is 
        granted is intended for the treatment or diagnosis of a disease 
        or condition that occurs in pediatric patients or in a 
        pediatric subpopulation, and such device is labeled for use in 
        pediatric patients or in a pediatric subpopulation in which the 
        disease or condition occurs.
            ``(II) The device was not previously approved under this 
        subsection for the pediatric patients or the pediatric 
        subpopulation described in subclause (I) prior to the date of 
        the enactment of the Pediatric Medical Device Safety and 
        Improvement Act of 2007.
            ``(ii) During any calendar year, the number of such devices 
        distributed during that year does not exceed the annual 
        distribution number specified by the Secretary when the 
        Secretary grants such exemption. The annual distribution number 
        shall be based on the number of individuals affected by the 
        disease or condition that such device is intended to treat, 
        diagnose, or cure, and of that number, the number of 
        individuals likely to use the device, and the number of devices 
        reasonably necessary to treat such individuals. In no case 
        shall the annual distribution number exceed the number 
        identified in paragraph (2)(A).
            ``(iii) Such person immediately notifies the Secretary if 
        the number of such devices distributed during any calendar year 
        exceeds the annual distribution number referred to in clause 
        (ii).
            ``(iv) The request for such exemption is submitted on or 
        before October 1, 2012.
    ``(B) The Secretary may inspect the records relating to the number 
of devices distributed during any calendar year of a person granted an 
exemption under paragraph (2) for which the prohibition in paragraph 
(3) does not apply.
    ``(C) A person may petition the Secretary to modify the annual 
distribution number specified by the Secretary under subparagraph 
(A)(ii) with respect to a device if additional information on the 
number of individuals affected by the disease or condition arises, and 
the Secretary may modify such number but in no case shall the annual 
distribution number exceed the number identified in paragraph (2)(A).
    ``(D) If a person notifies the Secretary, or the Secretary 
determines through an inspection under subparagraph (B), that the 
number of devices distributed during any calendar year exceeds the 
annual distribution number, as required under subparagraph (A)(iii), 
and modified under subparagraph (C), if applicable, then the 
prohibition in paragraph (3) shall apply with respect to such person 
for such device for any sales of such device after such notification.
    ``(E)(i) In this subsection, the term `pediatric patients' means 
patients who are 21 years of age or younger at the time of the 
diagnosis or treatment.
    ``(ii) In this subsection, the term `pediatric subpopulation' means 
1 of the following populations:
            ``(I) Neonates.
            ``(II) Infants.
            ``(III) Children.
            ``(IV) Adolescents.
    ``(7) The Secretary shall refer any report of an adverse event 
regarding a device for which the prohibition under paragraph (3) does 
not apply pursuant to paragraph (6)(A) that the Secretary receives to 
the Office of Pediatric Therapeutics, established under section 6 of 
the Best Pharmaceuticals for Children Act (Public Law 107-109). In 
considering the report, the Director of the Office of Pediatric 
Therapeutics, in consultation with experts in the Center for Devices 
and Radiological Health, shall provide for periodic review of the 
report by the Pediatric Advisory Committee, including obtaining any 
recommendations of such committee regarding whether the Secretary 
should take action under this Act in response to the report.
    ``(8) The Secretary, acting through the Office of Pediatric 
Therapeutics and the Center for Devices and Radiological Health, shall 
provide for an annual review by the Pediatric Advisory Committee of all 
devices described in paragraph (6) to ensure that the exemption under 
paragraph (2) remains appropriate for the pediatric populations for 
which it is granted.''.
    (b) Report.--Not later than January 1, 2012, the Comptroller 
General of the United States shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives a report on the 
impact of allowing persons granted an exemption under section 520(m)(2) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) with 
respect to a device to profit from such device pursuant to section 
520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as amended by subsection 
(a)), including--
            (1) an assessment of whether such section 520(m)(6) (as 
        amended by subsection (a)) has increased the availability of 
        pediatric devices for conditions that occur in small numbers of 
        children, including any increase or decrease in the number of--
                    (A) exemptions granted under such section 520(m)(2) 
                for pediatric devices; and
                    (B) applications approved under section 515 of such 
                Act (21 U.S.C. 360e) for devices intended to treat, 
                diagnose, or cure conditions that occur in pediatric 
                patients or for devices labeled for use in a pediatric 
                population;
            (2) the conditions or diseases the pediatric devices were 
        intended to treat or diagnose and the estimated size of the 
        pediatric patient population for each condition or disease;
            (3) the costs of purchasing pediatric devices, based on a 
        representative sampling of children's hospitals;
            (4) the extent to which the costs of such devices are 
        covered by health insurance;
            (5) the impact, if any, of allowing profit on access to 
        such devices for patients;
            (6) the profits made by manufacturers for each device that 
        receives an exemption;
            (7) an estimate of the extent of the use of the pediatric 
        devices by both adults and pediatric populations for a 
        condition or disease other than the condition or disease on the 
        label of such devices;
            (8) recommendations of the Comptroller General of the 
        United States regarding the effectiveness of such section 
        520(m)(6) (as amended by subsection (a)) and whether any 
        modifications to such section 520(m)(6) (as amended by 
        subsection (a)) should be made;
            (9) existing obstacles to pediatric device development; and
            (10) an evaluation of the demonstration grants described in 
        section 305, which shall include an evaluation of the number of 
        pediatric medical devices--
                    (A) that have been or are being studied in 
                children; and
                    (B) that have been submitted to the Food and Drug 
                Administration for approval, clearance, or review under 
                such section 520(m) (as amended by this Act) and any 
                regulatory actions taken.
    (c) Guidance.--Not later than 180 days after the date of the 
enactment of this Act, the Commissioner of Food and Drugs shall issue 
guidance for institutional review committees on how to evaluate 
requests for approval for devices for which a humanitarian device 
exemption under section 520(m)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted.

SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH.

    (a) Contact Point for Available Funding.--Section 402(b) of the 
Public Health Service Act (42 U.S.C. 282(b)) is amended--
            (1) in paragraph (21), by striking ``and'' after the 
        semicolon at the end;
            (2) in paragraph (22), by striking the period at the end 
        and inserting ``; and''; and
            (3) by inserting after paragraph (22) the following:
            ``(23) shall designate a contact point or office to help 
        innovators and physicians identify sources of funding available 
        for pediatric medical device development.''.
    (b) Plan for Pediatric Medical Device Research.--
            (1) In general.--Not later than 180 days after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services, acting through the Commissioner of Food and Drugs, 
        the Director of the National Institutes of Health, and the 
        Director of the Agency for Healthcare Research and Quality, 
        shall submit to the Committee on Health, Education, Labor, and 
        Pensions of the Senate and the Committee on Energy and Commerce 
        of the House of Representatives a plan for expanding pediatric 
        medical device research and development. In developing such 
        plan, the Secretary of Health and Human Services shall consult 
        with individuals and organizations with appropriate expertise 
        in pediatric medical devices.
            (2) Contents.--The plan under paragraph (1) shall include--
                    (A) the current status of federally funded 
                pediatric medical device research;
                    (B) any gaps in such research, which may include a 
                survey of pediatric medical providers regarding unmet 
                pediatric medical device needs, as needed; and
                    (C) a research agenda for improving pediatric 
                medical device development and Food and Drug 
                Administration clearance or approval of pediatric 
                medical devices, and for evaluating the short- and 
                long-term safety and effectiveness of pediatric medical 
                devices.

SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE 
              AVAILABILITY.

    (a) In General.--
            (1) Request for proposals.--Not later than 90 days after 
        the date of the enactment of this Act, the Secretary of Health 
        and Human Services shall issue a request for proposals for 1 or 
        more grants or contracts to nonprofit consortia for 
        demonstration projects to promote pediatric device development.
            (2) Determination on grants or contracts.--Not later than 
        180 days after the date the Secretary of Health and Human 
        Services issues a request for proposals under paragraph (1), 
        the Secretary shall make a determination on the grants or 
        contracts under this section.
    (b) Application.--A nonprofit consortium that desires to receive a 
grant or contract under this section shall submit an application to the 
Secretary of Health and Human Services at such time, in such manner, 
and containing such information as the Secretary may require.
    (c) Use of Funds.--A nonprofit consortium that receives a grant or 
contract under this section shall facilitate the development, 
production, and distribution of pediatric medical devices by--
            (1) encouraging innovation and connecting qualified 
        individuals with pediatric device ideas with potential 
        manufacturers;
            (2) mentoring and managing pediatric device projects 
        through the development process, including product 
        identification, prototype design, device development, and 
        marketing;
            (3) connecting innovators and physicians to existing 
        Federal and non-Federal resources, including resources from the 
        Food and Drug Administration, the National Institutes of 
        Health, the Small Business Administration, the Department of 
        Energy, the Department of Education, the National Science 
        Foundation, the Department of Veterans Affairs, the Agency for 
        Healthcare Research and Quality, and the National Institute of 
        Standards and Technology;
            (4) assessing the scientific and medical merit of proposed 
        pediatric device projects; and
            (5) providing assistance and advice as needed on business 
        development, personnel training, prototype development, 
        postmarket needs, and other activities consistent with the 
        purposes of this section.
    (d) Coordination.--
            (1) National institutes of health.--Each consortium that 
        receives a grant or contract under this section shall--
                    (A) coordinate with the National Institutes of 
                Health's pediatric device contact point or office, 
                designated under section 402(b)(23) of the Public 
                Health Service Act, as added by section 304(a) of this 
                Act; and
                    (B) provide to the National Institutes of Health 
                any identified pediatric device needs that the 
                consortium lacks sufficient capacity to address or 
                those needs in which the consortium has been unable to 
                stimulate manufacturer interest.
            (2) Food and drug administration.--Each consortium that 
        receives a grant or contract under this section shall 
        coordinate with the Commissioner of Food and Drugs and device 
        companies to facilitate the application for approval or 
        clearance of devices labeled for pediatric use.
            (3) Effectiveness and outcomes.--Each consortium that 
        receives a grant or contract under this section shall annually 
        report to the Secretary of Health and Human Services on the 
        status of pediatric device development, production, and 
        distribution that has been facilitated by the consortium.
    (e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $6,000,000 for each of fiscal 
years 2008 through 2012.

SEC. 306. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND PEDIATRIC 
              ADVISORY COMMITTEE.

    (a) Office of Pediatric Therapeutics.--Section 6(b) of the Best 
Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is amended by 
inserting ``, including increasing pediatric access to medical 
devices'' after ``pediatric issues''.
    (b) Pediatric Advisory Committee.--Section 14 of the Best 
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended--
            (1) in subsection (a), by inserting ``(including drugs and 
        biological products) and medical devices'' after 
        ``therapeutics''; and
            (2) in subsection (b)--
                    (A) in paragraph (1), by inserting ``(including 
                drugs and biological products) and medical devices'' 
                after ``therapeutics''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by striking ``and 
                        505B'' and inserting ``505B, 510(k), 515, and 
                        520(m)'';
                            (ii) by striking subparagraph (B) and 
                        inserting the following:
                    ``(B) identification of research priorities related 
                to therapeutics (including drugs and biological 
                products) and medical devices for pediatric populations 
                and the need for additional diagnostics and treatments 
                for specific pediatric diseases or conditions;''; and
                            (iii) in subparagraph (C), by inserting 
                        ``(including drugs and biological products) and 
                        medical devices'' after ``therapeutics''.

SEC. 307. POSTMARKET SURVEILLANCE.

    Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360l) is amended--
            (1) by amending the section heading and designation to read 
        as follows:

``SEC. 522. POSTMARKET SURVEILLANCE.'';

            (2) by striking subsection (a) and inserting the following:
    ``(a) Postmarket Surveillance.--
            ``(1) In general.--
                    ``(A) Conduct.--The Secretary may by order require 
                a manufacturer to conduct postmarket surveillance for 
                any device of the manufacturer that is a class II or 
                class III device--
                            ``(i) the failure of which would be 
                        reasonably likely to have serious adverse 
                        health consequences;
                            ``(ii) that is expected to have significant 
                        use in pediatric populations; or
                            ``(iii) that is intended to be--
                                    ``(I) implanted in the human body 
                                for more than 1 year; or
                                    ``(II) a life-sustaining or life-
                                supporting device used outside a device 
                                user facility.
                    ``(B) Condition.--The Secretary may order a 
                postmarket surveillance under subparagraph (A) as a 
                condition to approval or clearance of a device 
                described in subparagraph (A)(ii).
            ``(2) Rule of construction.--The provisions of paragraph 
        (1) shall have no effect on authorities otherwise provided 
        under the Act or regulations issued under this Act.''; and
            (3) in subsection (b)--
                    (A) by striking ``(b) Surveillance Approval.--
                Each'' and inserting the following:
    ``(b) Surveillance Approval.--
            ``(1) In general.--Each'';
                    (B) by striking ``The Secretary, in consultation'' 
                and inserting ``Except as provided in paragraph (2), 
                the Secretary, in consultation'';
                    (C) by striking ``Any determination'' and inserting 
                ``Except as provided in paragraph (2), any 
                determination''; and
                    (D) by adding at the end the following:
            ``(2) Longer surveillance for pediatric devices.--The 
        Secretary may by order require a prospective surveillance 
        period of more than 36 months with respect to a device that is 
        expected to have significant use in pediatric populations if 
        such period of more than 36 months is necessary in order to 
        assess the impact of the device on growth and development, or 
        the effects of growth, development, activity level, or other 
        factors on the safety or efficacy of the device.
    ``(c) Dispute Resolution.--A manufacturer may request review under 
section 562 of any order or condition requiring postmarket surveillance 
under this section. During the pendency of such review, the device 
subject to such a postmarket surveillance order or condition shall not, 
because of noncompliance with such order or condition, be deemed in 
violation of section 301(q)(1)(C), adulterated under section 501(f)(1), 
misbranded under section 502(t)(3), or in violation of, as applicable, 
section 510(k) or section 515, unless deemed necessary to protect the 
public health.''.

            TITLE IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007

SEC. 401. SHORT TITLE.

    This title may be cited as the ``Pediatric Research Equity Act of 
2007''.

SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQUITY ACT.

    (a) In General.--Section 505B of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355c) is amended to read as follows:

``SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL 
              PRODUCTS.

    ``(a) New Drugs and Biological Products.--
            ``(1) In general.--A person that submits, on or after the 
        date of the enactment of the Pediatric Research Equity Act of 
        2007, an application (or supplement to an application)--
                    ``(A) under section 505 for a new active 
                ingredient, new indication, new dosage form, new dosing 
                regimen, or new route of administration, or
                    ``(B) under section 351 of the Public Health 
                Service Act (42 U.S.C. 262) for a new active 
                ingredient, new indication, new dosage form, new dosing 
                regimen, or new route of administration,
        shall submit with the application the assessments described in 
        paragraph (2).
            ``(2) Assessments.--
                    ``(A) In general.--The assessments referred to in 
                paragraph (1) shall contain data, gathered using 
                appropriate formulations for each age group for which 
                the assessment is required, that are adequate--
                            ``(i) to assess the safety and 
                        effectiveness of the drug or the biological 
                        product for the claimed indications in all 
                        relevant pediatric subpopulations; and
                            ``(ii) to support dosing and administration 
                        for each pediatric subpopulation for which the 
                        drug or the biological product is safe and 
                        effective.
                    ``(B) Similar course of disease or similar effect 
                of drug or biological product.--
                            ``(i) In general.--If the course of the 
                        disease and the effects of the drug are 
                        sufficiently similar in adults and pediatric 
                        patients, the Secretary may conclude that 
                        pediatric effectiveness can be extrapolated 
                        from adequate and well-controlled studies in 
                        adults, usually supplemented with other 
                        information obtained in pediatric patients, 
                        such as pharmacokinetic studies.
                            ``(ii) Extrapolation between age groups.--A 
                        study may not be needed in each pediatric age 
                        group if data from one age group can be 
                        extrapolated to another age group.
                            ``(iii) Information on extrapolation.--A 
                        brief documentation of the scientific data 
                        supporting the conclusion under clauses (i) and 
                        (ii) shall be included in any pertinent reviews 
                        for the application under section 505 of this 
                        Act or section 351 of the Public Health Service 
                        Act (42 U.S.C. 262).
            ``(3) Deferral.--
                    ``(A) In general.--On the initiative of the 
                Secretary or at the request of the applicant, the 
                Secretary may defer submission of some or all 
                assessments required under paragraph (1) until a 
                specified date after approval of the drug or issuance 
                of the license for a biological product if--
                            ``(i) the Secretary finds that--
                                    ``(I) the drug or biological 
                                product is ready for approval for use 
                                in adults before pediatric studies are 
                                complete;
                                    ``(II) pediatric studies should be 
                                delayed until additional safety or 
                                effectiveness data have been collected; 
                                or
                                    ``(III) there is another 
                                appropriate reason for deferral; and
                            ``(ii) the applicant submits to the 
                        Secretary--
                                    ``(I) certification of the grounds 
                                for deferring the assessments;
                                    ``(II) a description of the planned 
                                or ongoing studies;
                                    ``(III) evidence that the studies 
                                are being conducted or will be 
                                conducted with due diligence and at the 
                                earliest possible time; and
                                    ``(IV) a timeline for the 
                                completion of such studies.
                    ``(B) Annual review.--
                            ``(i) In general.--On an annual basis 
                        following the approval of a deferral under 
                        subparagraph (A), the applicant shall submit to 
                        the Secretary the following information:
                                    ``(I) Information detailing the 
                                progress made in conducting pediatric 
                                studies.
                                    ``(II) If no progress has been made 
                                in conducting such studies, evidence 
                                and documentation that such studies 
                                will be conducted with due diligence 
                                and at the earliest possible time.
                            ``(ii) Public availability.--The 
                        information submitted through the annual review 
                        under clause (i) shall promptly be made 
                        available to the public in an easily accessible 
                        manner, including through the Web site of the 
                        Food and Drug Administration.
            ``(4) Waivers.--
                    ``(A) Full waiver.--On the initiative of the 
                Secretary or at the request of an applicant, the 
                Secretary shall grant a full waiver, as appropriate, of 
                the requirement to submit assessments for a drug or 
                biological product under this subsection if the 
                applicant certifies and the Secretary finds that--
                            ``(i) necessary studies are impossible or 
                        highly impracticable (because, for example, the 
                        number of patients is so small or the patients 
                        are geographically dispersed);
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in all pediatric 
                        age groups; or
                            ``(iii) the drug or biological product--
                                    ``(I) does not represent a 
                                meaningful therapeutic benefit over 
                                existing therapies for pediatric 
                                patients; and
                                    ``(II) is not likely to be used in 
                                a substantial number of pediatric 
                                patients.
                    ``(B) Partial waiver.--On the initiative of the 
                Secretary or at the request of an applicant, the 
                Secretary shall grant a partial waiver, as appropriate, 
                of the requirement to submit assessments for a drug or 
                biological product under this subsection with respect 
                to a specific pediatric age group if the applicant 
                certifies and the Secretary finds that--
                            ``(i) necessary studies are impossible or 
                        highly impracticable (because, for example, the 
                        number of patients in that age group is so 
                        small or patients in that age group are 
                        geographically dispersed);
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in that age 
                        group;
                            ``(iii) the drug or biological product--
                                    ``(I) does not represent a 
                                meaningful therapeutic benefit over 
                                existing therapies for pediatric 
                                patients in that age group; and
                                    ``(II) is not likely to be used by 
                                a substantial number of pediatric 
                                patients in that age group; or
                            ``(iv) the applicant can demonstrate that 
                        reasonable attempts to produce a pediatric 
                        formulation necessary for that age group have 
                        failed.
                    ``(C) Pediatric formulation not possible.--If a 
                waiver is granted on the ground that it is not possible 
                to develop a pediatric formulation, the waiver shall 
                cover only the pediatric groups requiring that 
                formulation. An applicant seeking either a full or 
                partial waiver shall submit to the Secretary 
                documentation detailing why a pediatric formulation 
                cannot be developed and, if the waiver is granted, the 
                applicant's submission shall promptly be made available 
                to the public in an easily accessible manner, including 
                through posting on the Web site of the Food and Drug 
                Administration.
                    ``(D) Labeling requirement.--If the Secretary 
                grants a full or partial waiver because there is 
                evidence that a drug or biological product would be 
                ineffective or unsafe in pediatric populations, the 
                information shall be included in the labeling for the 
                drug or biological product.
    ``(b) Marketed Drugs and Biological Products.--
            ``(1) In general.--After providing notice in the form of a 
        letter (that, for a drug approved under section 505, references 
        a declined written request under section 505A for a labeled 
        indication which written request is not referred under section 
        505A(n)(1)(A) to the Foundation of the National Institutes of 
        Health for the pediatric studies), the Secretary may (by order 
        in the form of a letter) require the sponsor or holder of an 
        approved application for a drug under section 505 or the holder 
        of a license for a biological product under section 351 of the 
        Public Health Service Act to submit by a specified date the 
        assessments described in subsection (a)(2), if the Secretary 
        finds that--
                    ``(A)(i) the drug or biological product is used for 
                a substantial number of pediatric patients for the 
                labeled indications; and
                    ``(ii) adequate pediatric labeling could confer a 
                benefit on pediatric patients;
                    ``(B) there is reason to believe that the drug or 
                biological product would represent a meaningful 
                therapeutic benefit over existing therapies for 
                pediatric patients for 1 or more of the claimed 
                indications; or
                    ``(C) the absence of adequate pediatric labeling 
                could pose a risk to pediatric patients.
            ``(2) Waivers.--
                    ``(A) Full waiver.--At the request of an applicant, 
                the Secretary shall grant a full waiver, as 
                appropriate, of the requirement to submit assessments 
                under this subsection if the applicant certifies and 
                the Secretary finds that--
                            ``(i) necessary studies are impossible or 
                        highly impracticable (because, for example, the 
                        number of patients in that age group is so 
                        small or patients in that age group are 
                        geographically dispersed); or
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in all pediatric 
                        age groups.
                    ``(B) Partial waiver.--At the request of an 
                applicant, the Secretary shall grant a partial waiver, 
                as appropriate, of the requirement to submit 
                assessments under this subsection with respect to a 
                specific pediatric age group if the applicant certifies 
                and the Secretary finds that--
                            ``(i) necessary studies are impossible or 
                        highly impracticable (because, for example, the 
                        number of patients in that age group is so 
                        small or patients in that age group are 
                        geographically dispersed);
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in that age 
                        group;
                            ``(iii)(I) the drug or biological product--
                                    ``(aa) does not represent a 
                                meaningful therapeutic benefit over 
                                existing therapies for pediatric 
                                patients in that age group; and
                                    ``(bb) is not likely to be used in 
                                a substantial number of pediatric 
                                patients in that age group; and
                            ``(II) the absence of adequate labeling 
                        could not pose significant risks to pediatric 
                        patients; or
                            ``(iv) the applicant can demonstrate that 
                        reasonable attempts to produce a pediatric 
                        formulation necessary for that age group have 
                        failed.
                    ``(C) Pediatric formulation not possible.--If a 
                waiver is granted on the ground that it is not possible 
                to develop a pediatric formulation, the waiver shall 
                cover only the pediatric groups requiring that 
                formulation. An applicant seeking either a full or 
                partial waiver shall submit to the Secretary 
                documentation detailing why a pediatric formulation 
                cannot be developed and, if the waiver is granted, the 
                applicant's submission shall promptly be made available 
                to the public in an easily accessible manner, including 
                through posting on the Web site of the Food and Drug 
                Administration.
                    ``(D) Labeling requirement.--If the Secretary 
                grants a full or partial waiver because there is 
                evidence that a drug or biological product would be 
                ineffective or unsafe in pediatric populations, the 
                information shall be included in the labeling for the 
                drug or biological product.
            ``(3) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 552 of 
        title 5 or section 1905 of title 18, United States Code.
    ``(c) Meaningful Therapeutic Benefit.--For the purposes of 
paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a) and 
paragraphs (1)(B) and (2)(B)(iii)(I)(aa) of subsection (b), a drug or 
biological product shall be considered to represent a meaningful 
therapeutic benefit over existing therapies if the Secretary determines 
that--
            ``(1) if approved, the drug or biological product could 
        represent an improvement in the treatment, diagnosis, or 
        prevention of a disease, compared with marketed products 
        adequately labeled for that use in the relevant pediatric 
        population; or
            ``(2) the drug or biological product is in a class of 
        products or for an indication for which there is a need for 
        additional options.
    ``(d) Submission of Assessments.--If a person fails to submit an 
assessment described in subsection (a)(2), or a request for approval of 
a pediatric formulation described in subsection (a) or (b), in 
accordance with applicable provisions of subsections (a) and (b)--
            ``(1) the drug or biological product that is the subject of 
        the assessment or request may be considered misbranded solely 
        because of that failure and subject to relevant enforcement 
        action (except that the drug or biological product shall not be 
        subject to action under section 303); but
            ``(2) the failure to submit the assessment or request shall 
        not be the basis for a proceeding--
                    ``(A) to withdraw approval for a drug under section 
                505(e); or
                    ``(B) to revoke the license for a biological 
                product under section 351 of the Public Health Service 
                Act.
    ``(e) Meetings.--Before and during the investigational process for 
a new drug or biological product, the Secretary shall meet at 
appropriate times with the sponsor of the new drug or biological 
product to discuss--
            ``(1) information that the sponsor submits on plans and 
        timelines for pediatric studies; or
            ``(2) any planned request by the sponsor for waiver or 
        deferral of pediatric studies.
    ``(f) Review of Pediatric Plans, Assessments, Deferrals, and 
Waivers.--
            ``(1) Review.--Beginning not later than 30 days after the 
        date of the enactment of the Pediatric Research Equity Act of 
        2007, the Secretary shall utilize the internal committee 
        established under section 505C to provide consultation to 
        reviewing divisions on all pediatric plans and assessments 
        prior to approval of an application or supplement for which a 
        pediatric assessment is required under this section and all 
        deferral and waiver requests granted pursuant to this section.
            ``(2) Activity by committee.--The committee referred to in 
        paragraph (1) may operate using appropriate members of such 
        committee and need not convene all members of the committee.
            ``(3) Documentation of committee action.--For each drug or 
        biological product, the committee referred to in paragraph (1) 
        shall document, for each activity described in paragraph (4) or 
        (5), which members of the committee participated in such 
        activity.
            ``(4) Review of pediatric plans, assessments, deferrals, 
        and waivers.--Consultation on pediatric plans and assessments 
        by the committee referred to in paragraph (1) pursuant to this 
        section shall occur prior to approval of an application or 
        supplement for which a pediatric assessment is required under 
        this section. The committee shall review all requests for 
        deferrals and waivers from the requirement to submit a 
        pediatric assessment granted under this section and shall 
        provide recommendations as needed to reviewing divisions, 
        including with respect to whether such a supplement, when 
        submitted, shall be considered for priority review.
            ``(5) Retrospective review of pediatric assessments, 
        deferrals, and waivers.--Not later than 1 year after the date 
        of the enactment of the Pediatric Research Equity Act of 2007, 
        the committee referred to in paragraph (1) shall conduct a 
        retrospective review and analysis of a representative sample of 
        assessments submitted and deferrals and waivers approved under 
        this section since the enactment of the Pediatric Research 
        Equity Act of 2003. Such review shall include an analysis of 
        the quality and consistency of pediatric information in 
        pediatric assessments and the appropriateness of waivers and 
        deferrals granted. Based on such review, the Secretary shall 
        issue recommendations to the review divisions for improvements 
        and initiate guidance to industry related to the scope of 
        pediatric studies required under this section.
            ``(6) Tracking of assessments and labeling changes.--The 
        Secretary, in consultation with the committee referred to in 
        paragraph (1), shall track and make available to the public in 
        an easily accessible manner, including through posting on the 
        Web site of the Food and Drug Administration--
                    ``(A) the number of assessments conducted under 
                this section;
                    ``(B) the specific drugs and biological products 
                and their uses assessed under this section;
                    ``(C) the types of assessments conducted under this 
                section, including trial design, the number of 
                pediatric patients studied, and the number of centers 
                and countries involved;
                    ``(D) the total number of deferrals requested and 
                granted under this section and, if granted, the reasons 
                for such deferrals, the timeline for completion, and 
                the number completed and pending by the specified date, 
                as outlined in subsection (a)(3);
                    ``(E) the number of waivers requested and granted 
                under this section and, if granted, the reasons for the 
                waivers;
                    ``(F) the number of pediatric formulations 
                developed and the number of pediatric formulations not 
                developed and the reasons any such formulation was not 
                developed;
                    ``(G) the labeling changes made as a result of 
                assessments conducted under this section;
                    ``(H) an annual summary of labeling changes made as 
                a result of assessments conducted under this section 
                for distribution pursuant to subsection (h)(2);
                    ``(I) an annual summary of information submitted 
                pursuant to subsection (a)(3)(B); and
                    ``(J) the number of times the committee referred to 
                in paragraph (1) made a recommendation to the Secretary 
                under paragraph (4) regarding priority review, the 
                number of times the Secretary followed or did not 
                follow such a recommendation, and, if not followed, the 
                reasons why such a recommendation was not followed.
    ``(g) Labeling Changes.--
            ``(1) Dispute resolution.--
                    ``(A) Request for labeling change and failure to 
                agree.--If, on or after the date of the enactment of 
                the Pediatric Research Equity Act of 2007, the 
                Commissioner determines that a sponsor and the 
                Commissioner have been unable to reach agreement on 
                appropriate changes to the labeling for the drug that 
                is the subject of the application or supplement, not 
                later than 180 days after the date of the submission of 
                the application or supplement--
                            ``(i) the Commissioner shall request that 
                        the sponsor of the application make any 
                        labeling change that the Commissioner 
                        determines to be appropriate; and
                            ``(ii) if the sponsor does not agree within 
                        30 days after the Commissioner's request to 
                        make a labeling change requested by the 
                        Commissioner, the Commissioner shall refer the 
                        matter to the Pediatric Advisory Committee.
                    ``(B) Action by the pediatric advisory committee.--
                Not later than 90 days after receiving a referral under 
                subparagraph (A)(ii), the Pediatric Advisory Committee 
                shall--
                            ``(i) review the pediatric study reports; 
                        and
                            ``(ii) make a recommendation to the 
                        Commissioner concerning appropriate labeling 
                        changes, if any.
                    ``(C) Consideration of recommendations.--The 
                Commissioner shall consider the recommendations of the 
                Pediatric Advisory Committee and, if appropriate, not 
                later than 30 days after receiving the recommendation, 
                make a request to the sponsor of the application or 
                supplement to make any labeling changes that the 
                Commissioner determines to be appropriate.
                    ``(D) Misbranding.--If the sponsor of the 
                application or supplement, within 30 days after 
                receiving a request under subparagraph (C), does not 
                agree to make a labeling change requested by the 
                Commissioner, the Commissioner may deem the drug that 
                is the subject of the application or supplement to be 
                misbranded.
                    ``(E) No effect on authority.--Nothing in this 
                subsection limits the authority of the United States to 
                bring an enforcement action under this Act when a drug 
                lacks appropriate pediatric labeling. Neither course of 
                action (the Pediatric Advisory Committee process or an 
                enforcement action referred to in the preceding 
                sentence) shall preclude, delay, or serve as the basis 
                to stay the other course of action.
            ``(2) Other labeling changes.--If, on or after the date of 
        the enactment of the Pediatric Research Equity Act of 2007, the 
        Secretary makes a determination that a pediatric assessment 
        conducted under this section does or does not demonstrate that 
        the drug that is the subject of such assessment is safe and 
        effective in pediatric populations or subpopulations, including 
        whether such assessment results are inconclusive, the Secretary 
        shall order the label of such product to include information 
        about the results of the assessment and a statement of the 
        Secretary's determination.
    ``(h) Dissemination of Pediatric Information.--
            ``(1) In general.--Not later than 210 days after the date 
        of submission of a pediatric assessment under this section, the 
        Secretary shall make available to the public in an easily 
        accessible manner the medical, statistical, and clinical 
        pharmacology reviews of such pediatric assessments, and shall 
        post such assessments on the Web site of the Food and Drug 
        Administration.
            ``(2) Dissemination of information regarding labeling 
        changes.--Beginning on the date of the enactment of the 
        Pediatric Research Equity Act of 2007, the Secretary shall 
        require that the sponsors of the assessments that result in 
        labeling changes that are reflected in the annual summary 
        developed pursuant to subsection (f)(6)(H) distribute such 
        information to physicians and other health care providers.
            ``(3) Effect of subsection.--Nothing in this subsection 
        shall alter or amend section 301(j) of this Act or section 552 
        of title 5 or section 1905 of title 18, United States Code.
    ``(i) Adverse Event Reporting.--
            ``(1) Reporting in year one.--Beginning on the date of the 
        enactment of the Pediatric Research Equity Act of 2007, during 
        the one-year period beginning on the date a labeling change is 
        made pursuant to subsection (g), the Secretary shall ensure 
        that all adverse event reports that have been received for such 
        drug (regardless of when such report was received) are referred 
        to the Office of Pediatric Therapeutics. In considering such 
        reports, the Director of such Office shall provide for the 
        review of such reports by the Pediatric Advisory Committee, 
        including obtaining any recommendations of such committee 
        regarding whether the Secretary should take action under this 
        Act in response to such reports.
            ``(2) Reporting in subsequent years.--Following the one-
        year period described in paragraph (1), the Secretary shall, as 
        appropriate, refer to the Office of Pediatric Therapeutics all 
        pediatric adverse event reports for a drug for which a 
        pediatric study was conducted under this section. In 
        considering such reports, the Director of such Office may 
        provide for the review of such reports by the Pediatric 
        Advisory Committee, including obtaining any recommendation of 
        such Committee regarding whether the Secretary should take 
        action in response to such reports.
            ``(3) Effect.--The requirements of this subsection shall 
        supplement, not supplant, other review of such adverse event 
        reports by the Secretary.
    ``(j) Scope of Authority.--Nothing in this section provides to the 
Secretary any authority to require a pediatric assessment of any drug 
or biological product, or any assessment regarding other populations or 
uses of a drug or biological product, other than the pediatric 
assessments described in this section.
    ``(k) Orphan Drugs.--Unless the Secretary requires otherwise by 
regulation, this section does not apply to any drug for an indication 
for which orphan designation has been granted under section 526.
    ``(l) Institute of Medicine Study.--
            ``(1) In general.--Not later than three years after the 
        date of the enactment of the Pediatric Research Equity Act of 
        2007, the Secretary shall contract with the Institute of 
        Medicine to conduct a study and report to Congress regarding 
        the pediatric studies conducted pursuant to this section or 
        precursor regulations since 1997 and labeling changes made as a 
        result of such studies.
            ``(2) Content of study.--The study under paragraph (1) 
        shall review and assess the use of extrapolation for pediatric 
        subpopulations, the use of alternative endpoints for pediatric 
        populations, neonatal assessment tools, the number and type of 
        pediatric adverse events, and ethical issues in pediatric 
        clinical trials.
            ``(3) Representative sample.--The Institute of Medicine may 
        devise an appropriate mechanism to review a representative 
        sample of studies conducted pursuant to this section from each 
        review division within the Center for Drug Evaluation and 
        Research in order to make the requested assessment.
    ``(m) Integration With Other Pediatric Studies.--The authority 
under this section shall remain in effect so long as an application 
subject to this section may be accepted for filing by the Secretary on 
or before the date specified in section 505A(q).''.
    (b) Applicability.--
            (1) In general.--Notwithstanding subsection (h) of section 
        505B of the Federal Food, Drug and Cosmetic Act, as in effect 
        on the day before the date of the enactment of this Act, a 
        pending assessment, including a deferred assessment, required 
        under such section 505B shall be deemed to have been required 
        under section 505B of the Federal Food, Drug and Cosmetic Act 
        as in effect on or after the date of the enactment of this Act.
            (2) Certain assessments and waiver requests.--An assessment 
        pending on or after the date that is 1 year prior to the date 
        of the enactment of this Act shall be subject to the tracking 
        and disclosure requirements established under such section 
        505B, as in effect on or after such date of enactment, except 
        that any such assessments submitted or waivers of such 
        assessments requested before such date of enactment shall not 
        be subject to subsections (a)(4)(C), (b)(2)(C), (f)(6)(F), and 
        (h) of such section 505B.

SEC. 403. ESTABLISHMENT OF INTERNAL COMMITTEE.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 505B the following:

``SEC. 505C. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC PLANS, 
              ASSESSMENTS, DEFERRALS, AND WAIVERS.

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

SEC. 404. GOVERNMENT ACCOUNTABILITY OFFICE REPORT.

    Not later than January 1, 2011, the Comptroller General of the 
United States, in consultation with the Secretary of Health and Human 
Services, shall submit to the Congress a report that addresses the 
effectiveness of sections 505A and 505B of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a, 355c) and section 409I of the Public 
Health Service Act (42 U.S.C. 284m) in ensuring that medicines used by 
children are tested and properly labeled. Such report shall include--
            (1) the number and importance of drugs and biological 
        products for children that are being tested as a result of the 
        amendments made by this title and title V and the importance 
        for children, health care providers, parents, and others of 
        labeling changes made as a result of such testing;
            (2) the number and importance of drugs and biological 
        products for children that are not being tested for their use 
        notwithstanding the provisions of this title and title V and 
        possible reasons for the lack of testing;
            (3) the number of drugs and biological products for which 
        testing is being done and labeling changes required, including 
        the date labeling changes are made and which labeling changes 
        required the use of the dispute resolution process established 
        pursuant to the amendments made by this title, together with a 
        description of the outcomes of such process, including a 
        description of the disputes and the recommendations of the 
        Pediatric Advisory Committee;
            (4) any recommendations for modifications to the programs 
        established under sections 505A and 505B of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355a) and section 409I of the 
        Public Health Service Act (42 U.S.C. 284m) that the Secretary 
        determines to be appropriate, including a detailed rationale 
        for each recommendation; and
            (5)(A) the efforts made by the Secretary to increase the 
        number of studies conducted in the neonate population; and
            (B) the results of those efforts, including efforts made to 
        encourage the conduct of appropriate studies in neonates by 
        companies with products that have sufficient safety and other 
        information to make the conduct of the studies ethical and 
        safe.

         TITLE V--BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007

SEC. 501. SHORT TITLE.

    This title may be cited as the ``Best Pharmaceuticals for Children 
Act of 2007''.

SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN ACT.

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

``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

    ``(a) Definitions.--As used in this section, the term `pediatric 
studies' or `studies' means at least one clinical investigation (that, 
at the Secretary's discretion, may include pharmacokinetic studies) in 
pediatric age groups (including neonates in appropriate cases) in which 
a drug is anticipated to be used, and, at the discretion of the 
Secretary, may include preclinical studies.
    ``(b) Market Exclusivity for New Drugs.--
            ``(1) In general.--Except as provided in paragraph (2), if, 
        prior to approval of an application that is submitted under 
        section 505(b)(1), the Secretary determines that information 
        relating to the use of a new drug in the pediatric population 
        may produce health benefits in that population, the Secretary 
        makes a written request for pediatric studies (which shall 
        include a timeframe for completing such studies), the applicant 
        agrees to the request, such studies are completed using 
        appropriate formulations for each age group for which the study 
        is requested within any such timeframe, and the reports thereof 
        are submitted and accepted in accordance with subsection 
        (d)(3)--
                    ``(A)(i)(I) the period referred to in subsection 
                (c)(3)(E)(ii) of section 505, and in subsection 
                (j)(5)(F)(ii) of such section, is deemed to be five 
                years and six months rather than five years, and the 
                references in subsections (c)(3)(E)(ii) and 
                (j)(5)(F)(ii) of such section to four years, to forty-
                eight months, and to seven and one-half years are 
                deemed to be four and one-half years, fifty-four 
                months, and eight years, respectively; or
                    ``(II) the period referred to in clauses (iii) and 
                (iv) of subsection (c)(3)(E) of such section, and in 
                clauses (iii) and (iv) of subsection (j)(5)(F) of such 
                section, is deemed to be three years and six months 
                rather than three years; and
                    ``(ii) if the drug is designated under section 526 
                for a rare disease or condition, the period referred to 
                in section 527(a) is deemed to be seven years and six 
                months rather than seven years; and
                    ``(B)(i) if the drug is the subject of--
                            ``(I) a listed patent for which a 
                        certification has been submitted under 
                        subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) 
                        of section 505 and for which pediatric studies 
                        were submitted prior to the expiration of the 
                        patent (including any patent extensions); or
                            ``(II) a listed patent for which a 
                        certification has been submitted under 
                        subsections (b)(2)(A)(iii) or 
                        (j)(2)(A)(vii)(III) of section 505,
                the period during which an application may not be 
                approved under section 505(c)(3) or section 
                505(j)(5)(B) shall be extended by a period of six 
                months after the date the patent expires (including any 
                patent extensions); or
                    ``(ii) if the drug is the subject of a listed 
                patent for which a certification has been submitted 
                under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
                section 505, and in the patent infringement litigation 
                resulting from the certification the court determines 
                that the patent is valid and would be infringed, the 
                period during which an application may not be approved 
                under section 505(c)(3) or section 505(j)(5)(B) shall 
                be extended by a period of six months after the date 
                the patent expires (including any patent extensions).
            ``(2) Exception.--The Secretary shall not extend the period 
        referred to in paragraph (1)(A) or (1)(B) if the determination 
        made under subsection (d)(3) is made later than 9 months prior 
        to the expiration of such period.
    ``(c) Market Exclusivity for Already-Marketed Drugs.--
            ``(1) In general.--Except as provided in paragraph (2), if 
        the Secretary determines that information relating to the use 
        of an approved drug in the pediatric population may produce 
        health benefits in that population and makes a written request 
        to the holder of an approved application under section 
        505(b)(1) for pediatric studies (which shall include a 
        timeframe for completing such studies), the holder agrees to 
        the request, such studies are completed using appropriate 
        formulations for each age group for which the study is 
        requested within any such timeframe, and the reports thereof 
        are submitted and accepted in accordance with subsection 
        (d)(3)--
                    ``(A)(i)(I) the period referred to in subsection 
                (c)(3)(E)(ii) of section 505, and in subsection 
                (j)(5)(F)(ii) of such section, is deemed to be five 
                years and six months rather than five years, and the 
                references in subsections (c)(3)(E)(ii) and 
                (j)(5)(F)(ii) of such section to four years, to forty-
                eight months, and to seven and one-half years are 
                deemed to be four and one-half years, fifty-four 
                months, and eight years, respectively; or
                    ``(II) the period referred to in clauses (iii) and 
                (iv) of subsection (c)(3)(D) of such section, and in 
                clauses (iii) and (iv) of subsection (j)(5)(F) of such 
                section, is deemed to be three years and six months 
                rather than three years; and
                    ``(ii) if the drug is designated under section 526 
                for a rare disease or condition, the period referred to 
                in section 527(a) is deemed to be seven years and six 
                months rather than seven years; and
                    ``(B)(i) if the drug is the subject of--
                            ``(I) a listed patent for which a 
                        certification has been submitted under 
                        subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) 
                        of section 505 and for which pediatric studies 
                        were submitted prior to the expiration of the 
                        patent (including any patent extensions); or
                            ``(II) a listed patent for which a 
                        certification has been submitted under 
                        subsection (b)(2)(A)(iii) or 
                        (j)(2)(A)(vii)(III) of section 505,
                the period during which an application may not be 
                approved under section 505(c)(3) or section 
                505(j)(5)(B)(ii) shall be extended by a period of six 
                months after the date the patent expires (including any 
                patent extensions); or
                    ``(ii) if the drug is the subject of a listed 
                patent for which a certification has been submitted 
                under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
                section 505, and in the patent infringement litigation 
                resulting from the certification the court determines 
                that the patent is valid and would be infringed, the 
                period during which an application may not be approved 
                under section 505(c)(3) or section 505(j)(5)(B) shall 
                be extended by a period of six months after the date 
                the patent expires (including any patent extensions).
            ``(2) Exception.--The Secretary shall not extend the period 
        referred to in paragraph (1)(A) or (1)(B) if the determination 
        made under subsection (d)(3) is made later than 9 months prior 
        to the expiration of such period.
    ``(d) Conduct of Pediatric Studies.--
            ``(1) Request for studies.--
                    ``(A) In general.--The Secretary may, after 
                consultation with the sponsor of an application for an 
                investigational new drug under section 505(i), the 
                sponsor of an application for a new drug under section 
                505(b)(1), or the holder of an approved application for 
                a drug under section 505(b)(1), issue to the sponsor or 
                holder a written request for the conduct of pediatric 
                studies for such drug. In issuing such request, the 
                Secretary shall take into account adequate 
                representation of children of ethnic and racial 
                minorities. Such request to conduct pediatric studies 
                shall be in writing and shall include a timeframe for 
                such studies and a request to the sponsor or holder to 
                propose pediatric labeling resulting from such studies.
                    ``(B) Single written request.--A single written 
                request--
                            ``(i) may relate to more than one use of a 
                        drug; and
                            ``(ii) may include uses that are both 
                        approved and unapproved.
            ``(2) Written request for pediatric studies.--
                    ``(A) Request and response.--
                            ``(i) In general.--If the Secretary makes a 
                        written request for pediatric studies 
                        (including neonates, as appropriate) under 
                        subsection (b) or (c), the applicant or holder, 
                        not later than 180 days after receiving the 
                        written request, shall respond to the Secretary 
                        as to the intention of the applicant or holder 
                        to act on the request by--
                                    ``(I) indicating when the pediatric 
                                studies will be initiated, if the 
                                applicant or holder agrees to the 
                                request; or
                                    ``(II) indicating that the 
                                applicant or holder does not agree to 
                                the request and stating the reasons for 
                                declining the request.
                            ``(ii) Disagree with request.--If, on or 
                        after the date of the enactment of the Best 
                        Pharmaceuticals for Children Act of 2007, the 
                        applicant or holder does not agree to the 
                        request on the grounds that it is not possible 
                        to develop the appropriate pediatric 
                        formulation, the applicant or holder shall 
                        submit to the Secretary the reasons such 
                        pediatric formulation cannot be developed.
                    ``(B) Adverse event reports.--An applicant or 
                holder that, on or after the date of the enactment of 
                the Best Pharmaceuticals for Children Act of 2007, 
                agrees to the request for such studies shall provide 
                the Secretary, at the same time as the submission of 
                the reports of such studies, with all postmarket 
                adverse event reports regarding the drug that is the 
                subject of such studies and are available prior to 
                submission of such reports.
            ``(3) Meeting the studies requirement.--Not later than 180 
        days after the submission of the reports of the studies, the 
        Secretary shall accept or reject such reports and so notify the 
        sponsor or holder. The Secretary's only responsibility in 
        accepting or rejecting the reports shall be to determine, 
        within the 180-day period, whether the studies fairly respond 
        to the written request, have been conducted in accordance with 
        commonly accepted scientific principles and protocols, and have 
        been reported in accordance with the requirements of the 
        Secretary for filing.
            ``(4) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 552 of 
        title 5 or section 1905 of title 18, United States Code.
    ``(e) Notice of Determinations on Studies Requirement.--
            ``(1) In general.--The Secretary shall publish a notice of 
        any determination, made on or after the date of the enactment 
        of the Best Pharmaceuticals for Children Act of 2007, that the 
        requirements of subsection (d) have been met and that 
        submissions and approvals under subsection (b)(2) or (j) of 
        section 505 for a drug will be subject to the provisions of 
        this section. Such notice shall be published not later than 30 
        days after the date of the Secretary's determination regarding 
        market exclusivity and shall include a copy of the written 
        request made under subsection (b) or (c).
            ``(2) Identification of certain drugs.--The Secretary shall 
        publish a notice identifying any drug for which, on or after 
        the date of the enactment of the Best Pharmaceuticals for 
        Children Act of 2007, a pediatric formulation was developed, 
        studied, and found to be safe and effective in the pediatric 
        population (or specified subpopulation) if the pediatric 
        formulation for such drug is not introduced onto the market 
        within one year after the date that the Secretary publishes the 
        notice described in paragraph (1). Such notice identifying such 
        drug shall be published not later than 30 days after the date 
        of the expiration of such one year period.
    ``(f) Internal Review of Written Requests and Pediatric Studies.--
            ``(1) Internal review.--The Secretary shall utilize the 
        internal review committee established under section 505C to 
        review all written requests issued on or after the date of the 
        enactment of the Best Pharmaceuticals for Children Act of 2007, 
        in accordance with paragraph (2).
            ``(2) Review of written requests.--The committee referred 
        to in paragraph (1) shall review all written requests issued 
        pursuant to this section prior to being issued.
            ``(3) Review of pediatric studies.--The committee referred 
        to in paragraph (1) may review studies conducted pursuant to 
        this section to make a recommendation to the Secretary whether 
        to accept or reject such reports under subsection (d)(3).
            ``(4) Activity by committee.--The committee referred to in 
        paragraph (1) may operate using appropriate members of such 
        committee and need not convene all members of the committee.
            ``(5) Documentation of committee action.--For each drug, 
        the committee referred to in paragraph (1) shall document, for 
        each activity described in paragraph (2) or (3), which members 
        of the committee participated in such activity.
            ``(6) Tracking pediatric studies and labeling changes.--The 
        Secretary, in consultation with the committee referred to in 
        paragraph (1), shall track and make available to the public, in 
        an easily accessible manner, including through posting on the 
        Web site of the Food and Drug Administration--
                    ``(A) the number of studies conducted under this 
                section and under section 409I of the Public Health 
                Service Act;
                    ``(B) the specific drugs and drug uses, including 
                labeled and off-labeled indications, studied under such 
                sections;
                    ``(C) the types of studies conducted under such 
                sections, including trial design, the number of 
                pediatric patients studied, and the number of centers 
                and countries involved;
                    ``(D) the number of pediatric formulations 
                developed and the number of pediatric formulations not 
                developed and the reasons such formulations were not 
                developed;
                    ``(E) the labeling changes made as a result of 
                studies conducted under such sections;
                    ``(F) an annual summary of labeling changes made as 
                a result of studies conducted under such sections for 
                distribution pursuant to subsection (k)(2); and
                    ``(G) information regarding reports submitted on or 
                after the date of the enactment of the Best 
                Pharmaceuticals for Children Act of 2007.
    ``(g) Limitations.--Notwithstanding subsection (c)(2), a drug to 
which the six-month period under subsection (b) or (c) has already been 
applied--
            ``(1) may receive an additional six-month period under 
        subsection (c)(1)(A)(i)(II) for a supplemental application if 
        all other requirements under this section are satisfied, except 
        that such drug may not receive any additional such period under 
        subsection (c)(1)(B); and
            ``(2) may not receive any additional such period under 
        subsection (c)(1)(A)(ii).
    ``(h) Relationship to Pediatric Research Requirements.--
Notwithstanding any other provision of law, if any pediatric study is 
required by a provision of law (including a regulation) other than this 
section and such study meets the completeness, timeliness, and other 
requirements of this section, such study shall be deemed to satisfy the 
requirement for market exclusivity pursuant to this section.
    ``(i) Labeling Changes.--
            ``(1) Priority status for pediatric applications and 
        supplements.--Any application or supplement to an application 
        under section 505 proposing a labeling change as a result of 
        any pediatric study conducted pursuant to this section--
                    ``(A) shall be considered to be a priority 
                application or supplement; and
                    ``(B) shall be subject to the performance goals 
                established by the Commissioner for priority drugs.
            ``(2) Dispute resolution.--
                    ``(A) Request for labeling change and failure to 
                agree.--If, on or after the date of the enactment of 
                the Best Pharmaceuticals for Children Act of 2007, the 
                Commissioner determines that the sponsor and the 
                Commissioner have been unable to reach agreement on 
                appropriate changes to the labeling for the drug that 
                is the subject of the application, not later than 180 
                days after the date of submission of the application--
                            ``(i) the Commissioner shall request that 
                        the sponsor of the application make any 
                        labeling change that the Commissioner 
                        determines to be appropriate; and
                            ``(ii) if the sponsor of the application 
                        does not agree within 30 days after the 
                        Commissioner's request to make a labeling 
                        change requested by the Commissioner, the 
                        Commissioner shall refer the matter to the 
                        Pediatric Advisory Committee.
                    ``(B) Action by the pediatric advisory committee.--
                Not later than 90 days after receiving a referral under 
                subparagraph (A)(ii), the Pediatric Advisory Committee 
                shall--
                            ``(i) review the pediatric study reports; 
                        and
                            ``(ii) make a recommendation to the 
                        Commissioner concerning appropriate labeling 
                        changes, if any.
                    ``(C) Consideration of recommendations.--The 
                Commissioner shall consider the recommendations of the 
                Pediatric Advisory Committee and, if appropriate, not 
                later than 30 days after receiving the recommendation, 
                make a request to the sponsor of the application to 
                make any labeling change that the Commissioner 
                determines to be appropriate.
                    ``(D) Misbranding.--If the sponsor of the 
                application, within 30 days after receiving a request 
                under subparagraph (C), does not agree to make a 
                labeling change requested by the Commissioner, the 
                Commissioner may deem the drug that is the subject of 
                the application to be misbranded.
                    ``(E) No effect on authority.--Nothing in this 
                subsection limits the authority of the United States to 
                bring an enforcement action under this Act when a drug 
                lacks appropriate pediatric labeling. Neither course of 
                action (the Pediatric Advisory Committee process or an 
                enforcement action referred to in the preceding 
                sentence) shall preclude, delay, or serve as the basis 
                to stay the other course of action.
    ``(j) Other Labeling Changes.--If, on or after the date of the 
enactment of the Best Pharmaceuticals for Children Act of 2007, the 
Secretary determines that a pediatric study conducted under this 
section does or does not demonstrate that the drug that is the subject 
of the study is safe and effective, including whether such study 
results are inconclusive, in pediatric populations or subpopulations, 
the Secretary shall order the labeling of such product to include 
information about the results of the study and a statement of the 
Secretary's determination.
    ``(k) Dissemination of Pediatric Information.--
            ``(1) In general.--Not later than 210 days after the date 
        of submission of a report on a pediatric study under this 
        section, the Secretary shall make available to the public the 
        medical, statistical, and clinical pharmacology reviews of 
        pediatric studies conducted under subsection (b) or (c).
            ``(2) Dissemination of information regarding labeling 
        changes.--Beginning on the date of the enactment of the Best 
        Pharmaceuticals for Children Act of 2007, the Secretary shall 
        include as a requirement of a written request that the sponsors 
        of the studies that result in labeling changes that are 
        reflected in the annual summary developed pursuant to 
        subsection (f)(3)(F) distribute, at least annually (or more 
        frequently if the Secretary determines that it would be 
        beneficial to the public health), such information to 
        physicians and other health care providers.
            ``(3) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 552 of 
        title 5 or section 1905 of title 18, United States Code.
    ``(l) Adverse Event Reporting.--
            ``(1) Reporting in year one.--Beginning on the date of the 
        enactment of the Best Pharmaceuticals for Children Act of 2007, 
        during the one-year period beginning on the date a labeling 
        change is approved pursuant to subsection (i), the Secretary 
        shall ensure that all adverse event reports that have been 
        received for such drug (regardless of when such report was 
        received) are referred to the Office of Pediatric Therapeutics 
        established under section 6 of the Best Pharmaceuticals for 
        Children Act (Public Law 107-109). In considering the reports, 
        the Director of such Office shall provide for the review of the 
        reports by the Pediatric Advisory Committee, including 
        obtaining any recommendations of such Committee regarding 
        whether the Secretary should take action under this Act in 
        response to such reports.
            ``(2) Reporting in subsequent years.--Following the one-
        year period described in paragraph (1), the Secretary shall, as 
        appropriate, refer to the Office of Pediatric Therapeutics all 
        pediatric adverse event reports for a drug for which a 
        pediatric study was conducted under this section. In 
        considering such reports, the Director of such Office may 
        provide for the review of such reports by the Pediatric 
        Advisory Committee, including obtaining any recommendation of 
        such Committee regarding whether the Secretary should take 
        action in response to such reports.
            ``(3) Effect.--The requirements of this subsection shall 
        supplement, not supplant, other review of such adverse event 
        reports by the Secretary.
    ``(m) Clarification of Interaction of Market Exclusivity Under This 
Section and Market Exclusivity Awarded to An Applicant for Approval of 
A Drug Under Section 505(j).--If a 180-day period under section 
505(j)(5)(B)(iv) overlaps with a 6-month exclusivity period under this 
section, so that the applicant for approval of a drug under section 
505(j) entitled to the 180-day period under that section loses a 
portion of the 180-day period to which the applicant is entitled for 
the drug, the 180-day period shall be extended from--
            ``(1) the date on which the 180-day period would have 
        expired by the number of days of the overlap, if the 180-day 
        period would, but for the application of this subsection, 
        expire after the 6-month exclusivity period; or
            ``(2) the date on which the 6-month exclusivity period 
        expires, by the number of days of the overlap if the 180-day 
        period would, but for the application of this subsection, 
        expire during the six-month exclusivity period.
    ``(n) Referral if Pediatric Studies Not Completed.--
            ``(1) In general.--Beginning on the date of the enactment 
        of the Best Pharmaceuticals for Children Act of 2007, if 
        pediatric studies of a drug have not been completed under 
        subsection (d) and if the Secretary, through the committee 
        established under section 505C, determines that there is a 
        continuing need for information relating to the use of the drug 
        in the pediatric population (including neonates, as 
        appropriate), the Secretary shall carry out the following:
                    ``(A) For a drug for which a listed patent has not 
                expired, make a determination regarding whether an 
                assessment shall be required to be submitted under 
                section 505B(b). Prior to making such a determination, 
                the Secretary may not take more than 30 days to certify 
                whether the Foundation for the National Institutes of 
                Health has sufficient funding at the time of such 
                certification to initiate and fund all of the studies 
                in the written request in their entirety within the 
                timeframes specified within the written request. Only 
                if the Secretary makes such certification in the 
                affirmative, the Secretary shall refer all pediatric 
                studies in the written request to the Foundation for 
                the National Institutes of Health for the conduct of 
                such studies, and such Foundation shall fund such 
                studies. If no certification has been made at the end 
                of the 30-day period, or if the Secretary certifies 
                that funds are not sufficient to initiate and fund all 
                the studies in their entirety, the Secretary shall 
                consider whether assessments shall be required under 
                section 505B(b) for such drug.
                    ``(B) For a drug that has no listed patents or has 
                1 or more listed patents that have expired, the 
                Secretary shall refer the drug for inclusion on the 
                list established under section 409I of the Public 
                Health Service Act for the conduct of studies.
            ``(2) Public notice.--The Secretary shall give the public 
        notice of a decision under paragraph (1)(A) not to require an 
        assessment under section 505B and the basis for such decision.
            ``(3) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 552 of 
        title 5 or section 1905 of title 18, United States Code.
    ``(o) Prompt Approval of Drugs Under Section 505(j) When Pediatric 
Information Is Added to Labeling.--
            ``(1) General rule.--A drug for which an application has 
        been submitted or approved under section 505(j) shall not be 
        considered ineligible for approval under that section or 
        misbranded under section 502 on the basis that the labeling of 
        the drug omits a pediatric indication or any other aspect of 
        labeling pertaining to pediatric use when the omitted 
        indication or other aspect is protected by patent or by 
        exclusivity under clause (iii) or (iv) of section 505(j)(5)(F).
            ``(2) Labeling.--Notwithstanding clauses (iii) and (iv) of 
        section 505(j)(5)(F), the Secretary may require that the 
        labeling of a drug approved under section 505(j) that omits a 
        pediatric indication or other aspect of labeling as described 
        in paragraph (1) include--
                    ``(A) a statement that, because of marketing 
                exclusivity for a manufacturer--
                            ``(i) the drug is not labeled for pediatric 
                        use; or
                            ``(ii) in the case of a drug for which 
                        there is an additional pediatric use not 
                        referred to in paragraph (1), the drug is not 
                        labeled for the pediatric use under paragraph 
                        (1); and
                    ``(B) a statement of any appropriate pediatric 
                contraindications, warnings, or precautions that the 
                Secretary considers necessary.
            ``(3) Preservation of pediatric exclusivity and other 
        provisions.--This subsection does not affect--
                    ``(A) the availability or scope of exclusivity 
                under this section;
                    ``(B) the availability or scope of exclusivity 
                under section 505 for pediatric formulations;
                    ``(C) the question of the eligibility for approval 
                of any application under section 505(j) that omits any 
                other conditions of approval entitled to exclusivity 
                under clause (iii) or (iv) of section 505(j)(5)(F); or
                    ``(D) except as expressly provided in paragraphs 
                (1) and (2), the operation of section 505.
    ``(p) Institute of Medicine Study.--Not later than 3 years after 
the date of the enactment of the Best Pharmaceuticals for Children Act 
of 2007, the Secretary shall enter into a contract with the Institute 
of Medicine to conduct a study and report to Congress regarding the 
written requests made and the studies conducted pursuant to this 
section. The Institute of Medicine may devise an appropriate mechanism 
to review a representative sample of requests made and studies 
conducted pursuant to this section in order to conduct such study. Such 
study shall--
            ``(1) review such representative written requests issued by 
        the Secretary since 1997 under subsections (b) and (c);
            ``(2) review and assess such representative pediatric 
        studies conducted under subsections (b) and (c) since 1997 and 
        labeling changes made as a result of such studies;
            ``(3) review the use of extrapolation for pediatric 
        subpopulations, the use of alternative endpoints for pediatric 
        populations, neonatal assessment tools, and ethical issues in 
        pediatric clinical trials;
            ``(4) review and assess the pediatric studies of biological 
        products as required under subsections (a) and (b) of section 
        505B; and
            ``(5) make recommendations regarding appropriate incentives 
        for encouraging pediatric studies of biologics.
    ``(q) Sunset.--A drug may not receive any 6-month period under 
subsection (b) or (c) unless--
            ``(1) on or before October 1, 2012, the Secretary makes a 
        written request for pediatric studies of the drug;
            ``(2) on or before October 1, 2012, an application for the 
        drug is accepted for filing under section 505(b); and
            ``(3) all requirements of this section are met.''.
            (2) Applicability.--
                    (A) In general.--The amendment made by this 
                subsection shall apply to written requests under 
                section 505A of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 355a) issued on or after the date of the 
                enactment of this Act.
                    (B) Certain written requests.--A written request 
                issued under section 505A of the Federal Food, Drug, 
                and Cosmetic Act, as in effect on the day before the 
                date of the enactment of this Act, which has been 
                accepted and for which no determination under 
                subsection (d)(2) of such section has been made before 
                such date of enactment, shall be subject to such 
                section 505A, except that such written requests shall 
                be subject to subsections (d)(2)(A)(ii), (e)(1) and 
                (2), (f), (i)(2)(A), (j), (k)(1), (l)(1), and (n) of 
                section 505A of the Federal Food, Drug, and Cosmetic 
                Act, as in effect on or after the date of the enactment 
                of this Act.
    (b) Program for Pediatric Studies of Drugs.--Section 409I of the 
Public Health Service Act (42 U.S.C. 284m) is amended to read as 
follows:

``SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

    ``(a) List of Priority Issues in Pediatric Therapeutics.--
            ``(1) In general.--Not later than one year after the date 
        of the enactment of the Best Pharmaceuticals for Children Act 
        of 2007, the Secretary, acting through the Director of the 
        National Institutes of Health and in consultation with the 
        Commissioner of Food and Drugs and experts in pediatric 
        research, shall develop and publish a priority list of needs in 
        pediatric therapeutics, including drugs or indications that 
        require study. The list shall be revised every three years.
            ``(2) Consideration of available information.--In 
        developing and prioritizing the list under paragraph (1), the 
        Secretary shall consider--
                    ``(A) therapeutic gaps in pediatrics that may 
                include developmental pharmacology, pharmacogenetic 
                determinants of drug response, metabolism of drugs and 
                biologics in children, and pediatric clinical trials;
                    ``(B) particular pediatric diseases, disorders or 
                conditions where more complete knowledge and testing of 
                therapeutics, including drugs and biologics, may be 
                beneficial in pediatric populations; and
                    ``(C) the adequacy of necessary infrastructure to 
                conduct pediatric pharmacological research, including 
                research networks and trained pediatric investigators.
    ``(b) Pediatric Studies and Research.--The Secretary, acting 
through the National Institutes of Health, shall award funds to 
entities that have the expertise to conduct pediatric clinical trials 
or other research (including qualified universities, hospitals, 
laboratories, contract research organizations, practice groups, 
federally funded programs such as pediatric pharmacology research 
units, other public or private institutions, or individuals) to enable 
the entities to conduct the drug studies or other research on the 
issues described in subsection (a). The Secretary may use contracts, 
grants, or other appropriate funding mechanisms to award funds under 
this subsection.
    ``(c) Process for Proposed Pediatric Study Requests and Labeling 
Changes.--
            ``(1) Submission of proposed pediatric study request.--The 
        Director of the National Institutes of Health shall, as 
        appropriate, submit proposed pediatric study requests for 
        consideration by the Commissioner of Food and Drugs for 
        pediatric studies of a specific pediatric indication identified 
        under subsection (a). Such a proposed pediatric study request 
        shall be made in a manner equivalent to a written request made 
        under subsection (b) or (c) of section 505A of the Federal 
        Food, Drug, and Cosmetic Act, including with respect to the 
        information provided on the pediatric studies to be conducted 
        pursuant to the request. The Director of the National 
        Institutes of Health may submit a proposed pediatric study 
        request for a drug for which--
                    ``(A)(i) there is an approved application under 
                section 505(j) of the Federal Food, Drug, and Cosmetic 
                Act; or
                    ``(ii) there is a submitted application that could 
                be approved under the criteria of such section; and
                    ``(B) there is no patent protection or market 
                exclusivity protection for at least one form of the 
                drug under the Federal Food, Drug, and Cosmetic Act; 
                and
                    ``(C) additional studies are needed to assess the 
                safety and effectiveness of the use of the drug in the 
                pediatric population.
            ``(2) Written request to holders of approved applications 
        for drugs lacking exclusivity.--The Commissioner of Food and 
        Drugs, in consultation with the Director of the National 
        Institutes of Health, may issue a written request based on the 
        proposed pediatric study request for the indication or 
        indications submitted pursuant to paragraph (1) (which shall 
        include a timeframe for negotiations for an agreement) for 
        pediatric studies concerning a drug identified under subsection 
        (a) to all holders of an approved application for the drug 
        under section 505 of the Federal Food, Drug, and Cosmetic Act. 
        Such a written request shall be made in a manner equivalent to 
        the manner in which a written request is made under subsection 
        (b) or (c) of section 505A of such Act, including with respect 
        to information provided on the pediatric studies to be 
        conducted pursuant to the request and using appropriate 
        formulations for each age group for which the study is 
        requested.
            ``(3) Requests for proposals.--If the Commissioner of Food 
        and Drugs does not receive a response to a written request 
        issued under paragraph (2) not later than 30 days after the 
        date on which a request was issued, the Secretary, acting 
        through the Director of the National Institutes of Health and 
        in consultation with the Commissioner of Food and Drugs, shall 
        publish a request for proposals to conduct the pediatric 
        studies described in the written request in accordance with 
        subsection (b).
            ``(4) Disqualification.--A holder that receives a first 
        right of refusal shall not be entitled to respond to a request 
        for proposals under paragraph (3).
            ``(5) Contracts, grants, or other funding mechanisms.--A 
        contract, grant, or other funding may be awarded under this 
        section only if a proposal is submitted to the Secretary in 
        such form and manner, and containing such agreements, 
        assurances, and information as the Secretary determines to be 
        necessary to carry out this section.
            ``(6) Reporting of studies.--
                    ``(A) In general.--On completion of a pediatric 
                study in accordance with an award under this section, a 
                report concerning the study shall be submitted to the 
                Director of the National Institutes of Health and the 
                Commissioner of Food and Drugs. The report shall 
                include all data generated in connection with the 
                study, including a written request if issued.
                    ``(B) Availability of reports.--Each report 
                submitted under subparagraph (A) shall be considered to 
                be in the public domain (subject to section 505A(d)(4) 
                of the Federal Food, Drug, and Cosmetic Act) and shall 
                be assigned a docket number by the Commissioner of Food 
                and Drugs. An interested person may submit written 
                comments concerning such pediatric studies to the 
                Commissioner of Food and Drugs, and the written 
                comments shall become part of the docket file with 
                respect to each of the drugs.
                    ``(C) Action by commissioner.--The Commissioner of 
                Food and Drugs shall take appropriate action in 
                response to the reports submitted under subparagraph 
                (A) in accordance with paragraph (7).
            ``(7) Requests for labeling change.--During the 180-day 
        period after the date on which a report is submitted under 
        paragraph (6)(A), the Commissioner of Food and Drugs shall--
                    ``(A) review the report and such other data as are 
                available concerning the safe and effective use in the 
                pediatric population of the drug studied;
                    ``(B) negotiate with the holders of approved 
                applications for the drug studied for any labeling 
                changes that the Commissioner of Food and Drugs 
                determines to be appropriate and requests the holders 
                to make; and
                    ``(C)(i) place in the public docket file a copy of 
                the report and of any requested labeling changes; and
                    ``(ii) publish in the Federal Register and through 
                a posting on the Web site of the Food and Drug 
                Administration a summary of the report and a copy of 
                any requested labeling changes.
            ``(8) Dispute resolution.--
                    ``(A) Referral to pediatric advisory committee.--
                If, not later than the end of the 180-day period 
                specified in paragraph (7), the holder of an approved 
                application for the drug involved does not agree to any 
                labeling change requested by the Commissioner of Food 
                and Drugs under that paragraph, the Commissioner of 
                Food and Drugs shall refer the request to the Pediatric 
                Advisory Committee.
                    ``(B) Action by the pediatric advisory committee.--
                Not later than 90 days after receiving a referral under 
                subparagraph (A), the Pediatric Advisory Committee 
                shall--
                            ``(i) review the available information on 
                        the safe and effective use of the drug in the 
                        pediatric population, including study reports 
                        submitted under this section; and
                            ``(ii) make a recommendation to the 
                        Commissioner of Food and Drugs as to 
                        appropriate labeling changes, if any.
            ``(9) FDA determination.--Not later than 30 days after 
        receiving a recommendation from the Pediatric Advisory 
        Committee under paragraph (8)(B)(ii) with respect to a drug, 
        the Commissioner of Food and Drugs shall consider the 
        recommendation and, if appropriate, make a request to the 
        holders of approved applications for the drug to make any 
        labeling change that the Commissioner of Food and Drugs 
        determines to be appropriate.
            ``(10) Failure to agree.--If a holder of an approved 
        application for a drug, within 30 days after receiving a 
        request to make a labeling change under paragraph (9), does not 
        agree to make a requested labeling change, the Commissioner of 
        Food and Drugs may deem the drug to be misbranded under the 
        Federal Food, Drug, and Cosmetic Act.
            ``(11) No effect on authority.--Nothing in this subsection 
        limits the authority of the United States to bring an 
        enforcement action under the Federal Food, Drug, and Cosmetic 
        Act when a drug lacks appropriate pediatric labeling. Neither 
        course of action (the Pediatric Advisory Committee process or 
        an enforcement action referred to in the preceding sentence) 
        shall preclude, delay, or serve as the basis to stay the other 
        course of action.
    ``(d) Dissemination of Pediatric Information.--Not later than one 
year after the date of the enactment of the Best Pharmaceuticals for 
Children Act of 2007, the Secretary, acting through the Director of the 
National Institutes of Health, shall study the feasibility of 
establishing a compilation of information on pediatric drug use and 
report the findings to Congress.
    ``(e) Authorization of Appropriations.--
            ``(1) In general.--There are authorized to be appropriated 
        to carry out this section--
                    ``(A) $200,000,000 for fiscal year 2008; and
                    ``(B) such sums as are necessary for each of the 
                four succeeding fiscal years.
            ``(2) Availability.--Any amount appropriated under 
        paragraph (1) shall remain available to carry out this section 
        until expended.''.
    (c) Foundation for the National Institutes of Health.--Section 
499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 290b(c)(1)(C)) 
is amended by striking ``and studies listed by the Secretary pursuant 
to section 409I(a)(1)(A) of this Act and referred under section 
505A(d)(4)(C) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 
355(a)(d)(4)(C)''' and inserting ``and studies for which the Secretary 
issues a certification in the affirmative under section 505A(n)(1)(A) 
of the Federal Food, Drug, and Cosmetic Act''.
    (d) Continuation of Operation of Committee.--Section 14 of the Best 
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended by 
adding at the end the following new subsection:
    ``(d) Continuation of Operation of Committee.--Notwithstanding 
section 14 of the Federal Advisory Committee Act, the advisory 
committee shall continue to operate during the five-year period 
beginning on the date of the enactment of the Best Pharmaceuticals for 
Children Act of 2007.''.
    (e) Pediatric Subcommittee of the Oncologic Drugs Advisory 
Committee.--Section 15 of the Best Pharmaceuticals for Children Act (42 
U.S.C. 284m note) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                            (i) in subparagraph (B), by striking 
                        ``and'' after the semicolon;
                            (ii) in subparagraph (C), by striking the 
                        period at the end and inserting ``; and''; and
                            (iii) by adding at the end the following 
                        new subparagraph:
                    ``(D) provide recommendations to the internal 
                review committee created under section 505B(f) of the 
                Federal Food, Drug, and Cosmetic Act regarding the 
                implementation of amendments to sections 505A and 505B 
                of the Federal Food, Drug, and Cosmetic Act with 
                respect to the treatment of pediatric cancers.''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(3) Continuation of operation of subcommittee.--
        Notwithstanding section 14 of the Federal Advisory Committee 
        Act, the Subcommittee shall continue to operate during the 
        five-year period beginning on the date of the enactment of the 
        Best Pharmaceuticals for Children Act of 2007.''; and
            (2) in subsection (d), by striking ``2003'' and inserting 
        ``2009''.
    (f) Effective Date and Limitation for Rule Relating to Toll-Free 
Number for Adverse Events on Labeling for Human Drug Products.--
            (1) In general.--Notwithstanding subchapter II of chapter 
        5, and chapter 7, of title 5, United States Code (commonly 
        known as the ``Administrative Procedure Act'') and any other 
        provision of law, the proposed rule issued by the Commissioner 
        of Food and Drugs entitled ``Toll-Free Number for Reporting 
        Adverse Events on Labeling for Human Drug Products,'' 69 Fed. 
        Reg. 21778, (April 22, 2004) shall take effect on January 1, 
        2008, unless such Commissioner issues the final rule before 
        such date.
            (2) Limitation.--The proposed rule that takes effect under 
        subsection (a), or the final rule described under subsection 
        (a), shall, notwithstanding section 17(a) of the Best 
        Pharmaceuticals for Children Act (21 U.S.C. 355b(a)), not apply 
        to a drug--
                    (A) for which an application is approved under 
                section 505 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 355);
                    (B) that is not described under section 503(b)(1) 
                of such Act (21 U.S.C. 353(b)(1)); and
                    (C) the packaging of which includes a toll-free 
                number through which consumers can report complaints to 
                the manufacturer or distributor of the drug.

SEC. 503. TRAINING OF PEDIATRIC PHARMACOLOGISTS.

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

                   TITLE VI--REAGAN-UDALL FOUNDATION

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

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

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

``SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUNDATION.

    ``(a) In General.--A nonprofit corporation to be known as the 
Reagan-Udall Foundation for the Food and Drug Administration (referred 
to in this subchapter as the `Foundation') shall be established in 
accordance with this section. The Foundation shall be headed by an 
Executive Director, appointed by the members of the Board of Directors 
under subsection (e). The Foundation shall not be an agency or 
instrumentality of the United States Government.
    ``(b) Purpose of Foundation.--The purpose of the Foundation is to 
advance the mission of the Food and Drug Administration to modernize 
medical, veterinary, food, food ingredient, and cosmetic product 
development, accelerate innovation, and enhance product safety.
    ``(c) Duties of the Foundation.--The Foundation shall--
            ``(1) taking into consideration the Critical Path reports 
        and priorities published by the Food and Drug Administration, 
        identify unmet needs in the development, manufacture, and 
        evaluation of the safety and effectiveness, including 
        postapproval, of devices, including diagnostics, biologics, and 
        drugs, and the safety of food, food ingredients, and cosmetics, 
        and including the incorporation of more sensitive and 
        predictive tools and devices to measure safety;
            ``(2) establish goals and priorities in order to meet the 
        unmet needs identified in paragraph (1);
            ``(3) in consultation with the Secretary, identify existing 
        and proposed Federal intramural and extramural research and 
        development programs relating to the goals and priorities 
        established under paragraph (2), coordinate Foundation 
        activities with such programs, and minimize Foundation 
        duplication of existing efforts;
            ``(4) award grants to, or enter into contracts, memoranda 
        of understanding, or cooperative agreements with, scientists 
        and entities, which may include the Food and Drug 
        Administration, university consortia, public-private 
        partnerships, institutions of higher education, entities 
        described in section 501(c)(3) of the Internal Revenue Code 
        (and exempt from tax under section 501(a) of such Code), and 
        industry, to efficiently and effectively advance the goals and 
        priorities established under paragraph (2);
            ``(5) recruit meeting participants and hold or sponsor (in 
        whole or in part) meetings as appropriate to further the goals 
        and priorities established under paragraph (2);
            ``(6) release and publish information and data and, to the 
        extent practicable, license, distribute, and release material, 
        reagents, and techniques to maximize, promote, and coordinate 
        the availability of such material, reagents, and techniques for 
        use by the Food and Drug Administration, nonprofit 
        organizations, and academic and industrial researchers to 
        further the goals and priorities established under paragraph 
        (2);
            ``(7) ensure that--
                    ``(A) action is taken as necessary to obtain 
                patents for inventions developed by the Foundation or 
                with funds from the Foundation;
                    ``(B) action is taken as necessary to enable the 
                licensing of inventions developed by the Foundation or 
                with funds from the Foundation; and
                    ``(C) executed licenses, memoranda of 
                understanding, material transfer agreements, contracts, 
                and other such instruments, promote, to the maximum 
                extent practicable, the broadest conversion to 
                commercial and noncommercial applications of licensed 
                and patented inventions of the Foundation to further 
                the goals and priorities established under paragraph 
                (2);
            ``(8) provide objective clinical and scientific information 
        to the Food and Drug Administration and, upon request, to other 
        Federal agencies to assist in agency determinations of how to 
        ensure that regulatory policy accommodates scientific advances 
        and meets the agency's public health mission;
            ``(9) conduct annual assessments of the unmet needs 
        identified in paragraph (1); and
            ``(10) carry out such other activities consistent with the 
        purposes of the Foundation as the Board determines appropriate.
    ``(d) Board of Directors.--
            ``(1) Establishment.--
                    ``(A) In general.--The Foundation shall have a 
                Board of Directors (referred to in this subchapter as 
                the `Board'), which shall be composed of ex officio and 
                appointed members in accordance with this subsection. 
                All appointed members of the Board shall be voting 
                members.
                    ``(B) Ex officio members.--The ex officio members 
                of the Board shall be the following individuals or 
                their designees:
                            ``(i) The Commissioner.
                            ``(ii) The Director of the National 
                        Institutes of Health.
                            ``(iii) The Director of the Centers for 
                        Disease Control and Prevention.
                            ``(iv) The Director of the Agency for 
                        Healthcare Research and Quality.
                    ``(C) Appointed members.--
                            ``(i) In general.--The ex officio members 
                        of the Board under subparagraph (B) shall, by 
                        majority vote, appoint to the Board 14 
                        individuals, of which 9 shall be from a list of 
                        candidates to be provided by the National 
                        Academy of Sciences and 5 shall be from lists 
                        of candidates provided by patient and consumer 
                        advocacy groups, professional scientific and 
                        medical societies, and industry trade 
                        organizations. Of such appointed members--
                                    ``(I) 4 shall be representatives of 
                                the general pharmaceutical, device, 
                                food, cosmetic, and biotechnology 
                                industries;
                                    ``(II) 3 shall be representatives 
                                of academic research organizations;
                                    ``(III) 2 shall be representatives 
                                of patient or consumer advocacy 
                                organizations;
                                    ``(IV) 1 shall be a representative 
                                of health care providers; and
                                    ``(V) 4 shall be at-large members 
                                with expertise or experience relevant 
                                to the purpose of the Foundation.
                            ``(ii) Requirements.--
                                    ``(I) Expertise.--The ex officio 
                                members shall ensure the Board 
                                membership includes individuals with 
                                expertise in areas including the 
                                sciences of developing, manufacturing, 
                                and evaluating the safety and 
                                effectiveness of devices, including 
                                diagnostics, biologics, and drugs, and 
                                the safety of food, food ingredients, 
                                and cosmetics.
                                    ``(II) Federal employees.--No 
                                employee of the Federal Government 
                                shall be appointed as a member of the 
                                Board under this subparagraph or under 
                                paragraph (3)(B).
                    ``(D) Initial meeting.--
                            ``(i) In general.--Not later than 30 days 
                        after the date of the enactment of this 
                        subchapter, the Secretary shall convene a 
                        meeting of the ex officio members of the Board 
                        to--
                                    ``(I) incorporate the Foundation; 
                                and
                                    ``(II) appoint the members of the 
                                Board in accordance with subparagraph 
                                (C).
                            ``(ii) Service of ex officio members.--Upon 
                        the appointment of the members of the Board 
                        under clause (i)(II)--
                                    ``(I) the terms of service of the 
                                Director of the Centers for Disease 
                                Control and Prevention and of the 
                                Director of the Agency for Healthcare 
                                Research and Quality as ex officio 
                                members of the Board shall terminate; 
                                and
                                    ``(II) the Commissioner and the 
                                Director of the National Institutes of 
                                Health shall continue to serve as ex 
                                officio members of the Board, but shall 
                                be nonvoting members.
                            ``(iii) Chair.--The ex officio members of 
                        the Board under subparagraph (B) shall 
                        designate an appointed member of the Board to 
                        serve as the Chair of the Board.
            ``(2) Duties of board.--The Board shall--
                    ``(A) establish bylaws for the Foundation that--
                            ``(i) are published in the Federal Register 
                        and available for public comment;
                            ``(ii) establish policies for the selection 
                        of the officers, employees, agents, and 
                        contractors of the Foundation;
                            ``(iii) establish policies, including 
                        ethical standards, for the acceptance, 
                        solicitation, and disposition of donations and 
                        grants to the Foundation and for the 
                        disposition of the assets of the Foundation, 
                        including appropriate limits on the ability of 
                        donors to designate, by stipulation or 
                        restriction, the use or recipient of donated 
                        funds;
                            ``(iv) establish policies that would 
                        subject all employees, fellows, and trainees of 
                        the Foundation to the conflict of interest 
                        standards under section 208 of title 18, United 
                        States Code;
                            ``(v) establish licensing, distribution, 
                        and publication policies that support the 
                        widest and least restrictive use by the public 
                        of information and inventions developed by the 
                        Foundation or with Foundation funds to carry 
                        out the duties described in paragraphs (6) and 
                        (7) of subsection (c), and may include charging 
                        cost-based fees for published material produced 
                        by the Foundation;
                            ``(vi) specify principles for the review of 
                        proposals and awarding of grants and contracts 
                        that include peer review and that are 
                        consistent with those of the Foundation for the 
                        National Institutes of Health, to the extent 
                        determined practicable and appropriate by the 
                        Board;
                            ``(vii) specify a cap on administrative 
                        expenses for recipients of a grant, contract, 
                        or cooperative agreement from the Foundation;
                            ``(viii) establish policies for the 
                        execution of memoranda of understanding and 
                        cooperative agreements between the Foundation 
                        and other entities, including the Food and Drug 
                        Administration;
                            ``(ix) establish policies for funding 
                        training fellowships, whether at the 
                        Foundation, academic or scientific 
                        institutions, or the Food and Drug 
                        Administration, for scientists, doctors, and 
                        other professionals who are not employees of 
                        regulated industry, to foster greater 
                        understanding of and expertise in new 
                        scientific tools, diagnostics, manufacturing 
                        techniques, and potential barriers to 
                        translating basic research into clinical and 
                        regulatory practice;
                            ``(x) specify a process for annual Board 
                        review of the operations of the Foundation; and
                            ``(xi) establish specific duties of the 
                        Executive Director;
                    ``(B) prioritize and provide overall direction to 
                the activities of the Foundation;
                    ``(C) evaluate the performance of the Executive 
                Director; and
                    ``(D) carry out any other necessary activities 
                regarding the functioning of the Foundation.
            ``(3) Terms and vacancies.--
                    ``(A) Term.--The term of office of each member of 
                the Board appointed under paragraph (1)(C) shall be 4 
                years, except that the terms of offices for the initial 
                appointed members of the Board shall expire on a 
                staggered basis as determined by the ex officio 
                members.
                    ``(B) Vacancy.--Any vacancy in the membership of 
                the Board--
                            ``(i) shall not affect the power of the 
                        remaining members to execute the duties of the 
                        Board; and
                            ``(ii) shall be filled by appointment by 
                        the appointed members described in paragraph 
                        (1)(C) by majority vote.
                    ``(C) Partial term.--If a member of the Board does 
                not serve the full term applicable under subparagraph 
                (A), the individual appointed under subparagraph (B) to 
                fill the resulting vacancy shall be appointed for the 
                remainder of the term of the predecessor of the 
                individual.
                    ``(D) Serving past term.--A member of the Board may 
                continue to serve after the expiration of the term of 
                the member until a successor is appointed.
            ``(4) Compensation.--Members of the Board may not receive 
        compensation for service on the Board. Such members may be 
        reimbursed for travel, subsistence, and other necessary 
        expenses incurred in carrying out the duties of the Board, as 
        set forth in the bylaws issued by the Board.
    ``(e) Incorporation.--The ex officio members of the Board shall 
serve as incorporators and shall take whatever actions necessary to 
incorporate the Foundation.
    ``(f) Nonprofit Status.--In carrying out subsection (b), the Board 
shall establish such policies and bylaws under subsection (d), and the 
Executive Director shall carry out such activities under subsection 
(g), as may be necessary to ensure that the Foundation maintains status 
as an organization that--
            ``(1) is described in subsection (c)(3) of section 501 of 
        the Internal Revenue Code of 1986; and
            ``(2) is, under subsection (a) of such section, exempt from 
        taxation.
    ``(g) Executive Director.--
            ``(1) In general.--The Board shall appoint an Executive 
        Director who shall serve at the pleasure of the Board. The 
        Executive Director shall be responsible for the day-to-day 
        operations of the Foundation and shall have such specific 
        duties and responsibilities as the Board shall prescribe.
            ``(2) Compensation.--The compensation of the Executive 
        Director shall be fixed by the Board but shall not be greater 
        than the compensation of the Commissioner.
    ``(h) Administrative Powers.--In carrying out this subchapter, the 
Board, acting through the Executive Director, may--
            ``(1) adopt, alter, and use a corporate seal, which shall 
        be judicially noticed;
            ``(2) hire, promote, compensate, and discharge 1 or more 
        officers, employees, and agents, as may be necessary, and 
        define their duties;
            ``(3) prescribe the manner in which--
                    ``(A) real or personal property of the Foundation 
                is acquired, held, and transferred;
                    ``(B) general operations of the Foundation are to 
                be conducted; and
                    ``(C) the privileges granted to the Board by law 
                are exercised and enjoyed;
            ``(4) with the consent of the applicable executive 
        department or independent agency, use the information, 
        services, and facilities of such department or agencies in 
        carrying out this section;
            ``(5) enter into contracts with public and private 
        organizations for the writing, editing, printing, and 
        publishing of books and other material;
            ``(6) hold, administer, invest, and spend any gift, devise, 
        or bequest of real or personal property made to the Foundation 
        under subsection (i);
            ``(7) enter into such other contracts, leases, cooperative 
        agreements, and other transactions as the Board considers 
        appropriate to conduct the activities of the Foundation;
            ``(8) modify or consent to the modification of any contract 
        or agreement to which it is a party or in which it has an 
        interest under this subchapter;
            ``(9) take such action as may be necessary to obtain 
        patents and licenses for devices and procedures developed by 
        the Foundation and its employees;
            ``(10) sue and be sued in its corporate name, and complain 
        and defend in courts of competent jurisdiction;
            ``(11) appoint other groups of advisors as may be 
        determined necessary to carry out the functions of the 
        Foundation; and
            ``(12) exercise other powers as set forth in this section, 
        and such other incidental powers as are necessary to carry out 
        its powers, duties, and functions in accordance with this 
        subchapter.
    ``(i) Acceptance of Funds From Other Sources.--The Executive 
Director may solicit and accept on behalf of the Foundation, any funds, 
gifts, grants, devises, or bequests of real or personal property made 
to the Foundation, including from private entities, for the purposes of 
carrying out the duties of the Foundation.
    ``(j) Service of Federal Employees.--Federal Government employees 
may serve on committees advisory to the Foundation and otherwise 
cooperate with and assist the Foundation in carrying out its functions, 
so long as such employees do not direct or control Foundation 
activities.
    ``(k) Detail of Government Employees; Fellowships.--
            ``(1) Detail from federal agencies.--Federal Government 
        employees may be detailed from Federal agencies with or without 
        reimbursement to those agencies to the Foundation at any time, 
        and such detail shall be without interruption or loss of civil 
        service status or privilege. Each such employee shall abide by 
        the statutory, regulatory, ethical, and procedural standards 
        applicable to the employees of the agency from which such 
        employee is detailed and those of the Foundation.
            ``(2) Voluntary service; acceptance of federal employees.--
                    ``(A) Foundation.--The Executive Director of the 
                Foundation may accept the services of employees 
                detailed from Federal agencies with or without 
                reimbursement to those agencies.
                    ``(B) Food and drug administration.--The 
                Commissioner may accept the uncompensated services of 
                Foundation fellows or trainees. Such services shall be 
                considered to be undertaking an activity under contract 
                with the Secretary as described in section 708.
    ``(l) Annual Reports.--
            ``(1) Reports to foundation.--Any recipient of a grant, 
        contract, fellowship, memorandum of understanding, or 
        cooperative agreement from the Foundation under this section 
        shall submit to the Foundation a report on an annual basis for 
        the duration of such grant, contract, fellowship, memorandum of 
        understanding, or cooperative agreement, that describes the 
        activities carried out under such grant, contract, fellowship, 
        memorandum of understanding, or cooperative agreement.
            ``(2) Report to congress and the fda.--Beginning with 
        fiscal year 2009, the Executive Director shall submit to 
        Congress and the Commissioner an annual report that--
                    ``(A) describes the activities of the Foundation 
                and the progress of the Foundation in furthering the 
                goals and priorities established under subsection 
                (c)(2), including the practical impact of the 
                Foundation on regulated product development;
                    ``(B) provides a specific accounting of the source 
                and use of all funds used by the Foundation to carry 
                out such activities; and
                    ``(C) provides information on how the results of 
                Foundation activities could be incorporated into the 
                regulatory and product review activities of the Food 
                and Drug Administration.
    ``(m) Separation of Funds.--The Executive Director shall ensure 
that the funds received from the Treasury are held in separate accounts 
from funds received from entities under subsection (i).
    ``(n) Funding.--From amounts appropriated to the Food and Drug 
Administration for each fiscal year, the Commissioner shall transfer 
not less than $500,000 and not more than $1,250,000, to the Foundation 
to carry out subsections (a), (b), and (d) through (m).''.
    (b) Other Foundation Provisions.--Chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) (as amended by 
subsection (a)) is amended by adding at the end the following:

``SEC. 771. LOCATION OF FOUNDATION.

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

``SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION.

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

SEC. 602. OFFICE OF THE CHIEF SCIENTIST.

    Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
391 et seq.) is amended by adding at the end the following:

``SEC. 910. OFFICE OF THE CHIEF SCIENTIST.

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

SEC. 603. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.

    Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the 
following:

``SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.

    ``(a) Establishment.--The Secretary, acting through the 
Commissioner of Food and Drugs, may enter into collaborative 
agreements, to be known as Critical Path Public-Private Partnerships, 
with one or more eligible entities to implement the Critical Path 
Initiative of the Food and Drug Administration by developing 
innovative, collaborative projects in research, education, and outreach 
for the purpose of fostering medical product innovation, enabling the 
acceleration of medical product development, manufacturing, and 
translational therapeutics, and enhancing medical product safety.
    ``(b) Eligible Entity.--In this section, the term `eligible entity' 
means an entity that meets each of the following:
            ``(1) The entity is--
                    ``(A) an institution of higher education (as such 
                term is defined in section 101 of the Higher Education 
                Act of 1965) or a consortium of such institutions; or
                    ``(B) an organization described in section 
                501(c)(3) of the Internal Revenue Code of 1986 and 
                exempt from tax under section 501(a) of such Code.
            ``(2) The entity has experienced personnel and clinical and 
        other technical expertise in the biomedical sciences, which may 
        include graduate training programs in areas relevant to 
        priorities of the Critical Path Initiative.
            ``(3) The entity demonstrates to the Secretary's 
        satisfaction that the entity is capable of--
                    ``(A) developing and critically evaluating tools, 
                methods, and processes--
                            ``(i) to increase efficiency, 
                        predictability, and productivity of medical 
                        product development; and
                            ``(ii) to more accurately identify the 
                        benefits and risks of new and existing medical 
                        products;
                    ``(B) establishing partnerships, consortia, and 
                collaborations with health care practitioners and other 
                providers of health care goods or services; 
                pharmacists; pharmacy benefit managers and purchasers; 
                health maintenance organizations and other managed 
                health care organizations; health care insurers; 
                government agencies; patients and consumers; 
                manufacturers of prescription drugs, biological 
                products, diagnostic technologies, and devices; and 
                academic scientists; and
                    ``(C) securing funding for the projects of a 
                Critical Path Public-Private Partnership from Federal 
                and nonfederal governmental sources, foundations, and 
                private individuals.
    ``(c) Funding.--The Secretary may not enter into a collaborative 
agreement under subsection (a) unless the eligible entity involved 
provides an assurance that the entity will not accept funding for a 
Critical Path Public-Private Partnership project from any organization 
that manufactures or distributes products regulated by the Food and 
Drug Administration unless the entity provides assurances in its 
agreement with the Food and Drug Administration that the results of the 
Critical Path Public-Private Partnership project will not be influenced 
by any source of funding.
    ``(d) Annual Report.--Not later than 18 months after the date of 
the enactment of this section, and annually thereafter, the Secretary, 
in collaboration with the parties to each Critical Path Public-Private 
Partnership, shall submit a report to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives--
            ``(1) reviewing the operations and activities of the 
        Partnerships in the previous year; and
            ``(2) addressing such other issues relating to this section 
        as the Secretary determines to be appropriate.
    ``(e) Definition.--In this section, the term `medical product' 
includes a drug, a biological product as defined in section 351 of the 
Public Health Service Act, a device, and any combination of such 
products.
    ``(f) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $5,000,000 for fiscal year 2008 
and such sums as may be necessary for each of fiscal years 2009 through 
2012.''.

                    TITLE VII--CONFLICTS OF INTEREST

SEC. 701. CONFLICTS OF INTEREST.

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

``SEC. 712. CONFLICTS OF INTEREST.

    ``(a) Definitions.--For purposes of this section:
            ``(1) Advisory committee.--The term `advisory committee' 
        means an advisory committee under the Federal Advisory 
        Committee Act that provides advice or recommendations to the 
        Secretary regarding activities of the Food and Drug 
        Administration.
            ``(2) Financial interest.--The term `financial interest' 
        means a financial interest under section 208(a) of title 18, 
        United States Code.
    ``(b) Appointments to Advisory Committees.--
            ``(1) Recruitment.--
                    ``(A) In general.--The Secretary shall--
                            ``(i) develop and implement strategies on 
                        effective outreach to potential members of 
                        advisory committees at universities, colleges, 
                        other academic research centers, professional 
                        and medical societies, and patient and consumer 
                        groups;
                            ``(ii) seek input from professional medical 
                        and scientific societies to determine the most 
                        effective informational and recruitment 
                        activities; and
                            ``(iii) take into account the advisory 
                        committees with the greatest number of 
                        vacancies.
                    ``(B) Recruitment activities.--The recruitment 
                activities under subparagraph (A) may include--
                            ``(i) advertising the process for becoming 
                        an advisory committee member at medical and 
                        scientific society conferences;
                            ``(ii) making widely available, including 
                        by using existing electronic communications 
                        channels, the contact information for the Food 
                        and Drug Administration point of contact 
                        regarding advisory committee nominations; and
                            ``(iii) developing a method through which 
                        an entity receiving funding from the National 
                        Institutes of Health, the Agency for Healthcare 
                        Research and Quality, the Centers for Disease 
                        Control and Prevention, or the Veterans Health 
                        Administration can identify a person who the 
                        Food and Drug Administration can contact 
                        regarding the nomination of individuals to 
                        serve on advisory committees.
            ``(2) Evaluation and criteria.--When considering a term 
        appointment to an advisory committee, the Secretary shall 
        review the expertise of the individual and the financial 
        disclosure report filed by the individual pursuant to the 
        Ethics in Government Act of 1978 for each individual under 
        consideration for the appointment, so as to reduce the 
        likelihood that an appointed individual will later require a 
        written determination as referred to in section 208(b)(1) of 
        title 18, United States Code, a written certification as 
        referred to in section 208(b)(3) of title 18, United States 
        Code, or a waiver as referred to in subsection (c)(2) of this 
        section for service on the committee at a meeting of the 
        committee.
    ``(c) Disclosures; Prohibitions on Participation; Waivers.--
            ``(1) Disclosure of financial interest.--Prior to a meeting 
        of an advisory committee regarding a `particular matter' (as 
        that term is used in section 208 of title 18, United States 
        Code), each member of the committee who is a full-time 
        Government employee or special Government employee shall 
        disclose to the Secretary financial interests in accordance 
        with subsection (b) of such section 208.
            ``(2) Prohibitions and waivers on participation.--
                    ``(A) In general.--Except as provided under 
                subparagraph (B), a member of an advisory committee may 
                not participate with respect to a particular matter 
                considered in an advisory committee meeting if such 
                member (or an immediate family member of such member) 
                has a financial interest that could be affected by the 
                advice given to the Secretary with respect to such 
                matter, excluding interests exempted in regulations 
                issued by the Director of the Office of Government 
                Ethics as too remote or inconsequential to affect the 
                integrity of the services of the Government officers or 
                employees to which such regulations apply.
                    ``(B) Waiver.--If the Secretary determines it 
                necessary to afford the advisory committee essential 
                expertise, the Secretary may grant a waiver of the 
                prohibition in subparagraph (A) to permit a member 
                described in such subparagraph to--
                            ``(i) participate as a non-voting member 
                        with respect to a particular matter considered 
                        in a committee meeting; or
                            ``(ii) participate as a voting member with 
                        respect to a particular matter considered in a 
                        committee meeting.
                    ``(C) Limitation on waivers and other exceptions.--
                            ``(i) Definition.--For purposes of this 
                        subparagraph, the term `exception' means each 
                        of the following with respect to members of 
                        advisory committees:
                                    ``(I) A waiver under section 
                                505(n)(4) (as in effect on the day 
                                before the date of the enactment of the 
                                Food and Drug Administration Amendments 
                                Act of 2007).
                                    ``(II) A written determination 
                                under section 208(b) of title 18, 
                                United States Code.
                                    ``(III) A written certification 
                                under section 208(b)(3) of such title.
                            ``(ii) Determination of total number of 
                        members slots and member exceptions during 
                        fiscal year 2007.--The Secretary shall 
                        determine--
                                    ``(I)(aa) for each meeting held by 
                                any advisory committee during fiscal 
                                year 2007, the number of members who 
                                participated in the meeting; and
                                    ``(bb) the sum of the respective 
                                numbers determined under item (aa) 
                                (referred to in this subparagraph as 
                                the ``total number of 2007 meeting 
                                slots''); and
                                    ``(II)(aa) for each meeting held by 
                                any advisory committee during fiscal 
                                year 2007, the number of members who 
                                received an exception for the meeting; 
                                and
                                    ``(bb) the sum of the respective 
                                numbers determined under item (aa) 
                                (referred to in this subparagraph as 
                                the ``total number of 2007 meeting 
                                exceptions'').
                            ``(iii) Determination of percentage 
                        regarding exceptions during fiscal year 2007.--
                        The Secretary shall determine the percentage 
                        constituted by--
                                    ``(I) the total number of 2007 
                                meeting exceptions; divided by
                                    ``(II) the total number of 2007 
                                meeting slots.
                            ``(iv) Limitation for fiscal years 2008 
                        through 2012.--The number of exceptions at the 
                        Food and Drug Administration for members of 
                        advisory committees for a fiscal year may not 
                        exceed the following:
                                    ``(I) For fiscal year 2008, 95 
                                percent of the percentage determined 
                                under clause (iii) (referred to in this 
                                clause as the ``base percentage'').
                                    ``(II) For fiscal year 2009, 90 
                                percent of the base percentage.
                                    ``(III) For fiscal year 2010, 85 
                                percent of the base percentage.
                                    ``(IV) For fiscal year 2011, 80 
                                percent of the base percentage.
                                    ``(V) For fiscal year 2012, 75 
                                percent of the base percentage.
                            ``(v) Allocation of exceptions.--The 
                        exceptions authorized under clause (iv) for a 
                        fiscal year may be allocated within the centers 
                        or other organizational units of the Food and 
                        Drug Administration as determined appropriate 
                        by the Secretary.
            ``(3) Disclosure of waiver.--Notwithstanding section 
        107(a)(2) of the Ethics in Government Act (5 U.S.C. App.), the 
        following shall apply:
                    ``(A) 15 or more days in advance.--As soon as 
                practicable, but (except as provided in subparagraph 
                (B)) not later than 15 days prior to a meeting of an 
                advisory committee to which a written determination as 
                referred to in section 208(b)(1) of title 18, United 
                States Code, a written certification as referred to in 
                section 208(b)(3) of title 18, United States Code, or a 
                waiver as referred to in paragraph (2)(B) applies, the 
                Secretary shall disclose (other than information 
                exempted from disclosure under section 552 of title 5, 
                United States Code, and section 552a of title 5, United 
                States Code (popularly known as the Freedom of 
                Information Act and the Privacy Act of 1974, 
                respectively)) on the Internet Web site of the Food and 
                Drug Administration--
                            ``(i) the type, nature, and magnitude of 
                        the financial interests of the advisory 
                        committee member to which such determination, 
                        certification, or waiver applies; and
                            ``(ii) the reasons of the Secretary for 
                        such determination, certification, or waiver.
                    ``(B) Less than 30 days in advance.--In the case of 
                a financial interest that becomes known to the 
                Secretary less than 30 days prior to a meeting of an 
                advisory committee to which a written determination as 
                referred to in section 208(b)(1) of title 18, United 
                States Code, a written certification as referred to in 
                section 208(b)(3) of title 18, United States Code, or a 
                waiver as referred to in paragraph (2)(B) applies, the 
                Secretary shall disclose (other than information 
                exempted from disclosure under section 552 of title 5, 
                United States Code, and section 552a of title 5, United 
                States Code) on the Internet Web site of the Food and 
                Drug Administration, the information described in 
                clauses (i) and (ii) of subparagraph (A) as soon as 
                practicable after the Secretary makes such 
                determination, certification, or waiver, but in no case 
                later than the date of such meeting.
    ``(d) Public Record.--The Secretary shall ensure that the public 
record and transcript of each meeting of an advisory committee includes 
the disclosure required under subsection (c)(3) (other than information 
exempted from disclosure under section 552 of title 5, United States 
Code, and section 552a of title 5, United States Code).
    ``(e) Annual Report.--Not later than February 1 of each year, the 
Secretary shall submit to the Committee on Appropriations and the 
Committee on Health, Education, Labor, and Pensions of the Senate, and 
the Committee on Appropriations and the Committee on Energy and 
Commerce of the House of Representatives a report that describes--
            ``(1) with respect to the fiscal year that ended on 
        September 30 of the previous year, the number of vacancies on 
        each advisory committee, the number of nominees received for 
        each committee, and the number of such nominees willing to 
        serve;
            ``(2) with respect to such year, the aggregate number of 
        disclosures required under subsection (c)(3) for each meeting 
        of each advisory committee and the percentage of individuals to 
        whom such disclosures did not apply who served on such 
        committee for each such meeting;
            ``(3) with respect to such year, the number of times the 
        disclosures required under subsection (c)(3) occurred under 
        subparagraph (B) of such subsection; and
            ``(4) how the Secretary plans to reduce the number of 
        vacancies reported under paragraph (1) during the fiscal year 
        following such year, and mechanisms to encourage the nomination 
        of individuals for service on an advisory committee, including 
        those who are classified by the Food and Drug Administration as 
        academicians or practitioners.
    ``(f) Periodic Review of Guidance.--Not less than once every 5 
years, the Secretary shall review guidance of the Food and Drug 
Administration regarding conflict of interest waiver determinations 
with respect to advisory committees and update such guidance as 
necessary.''.
    (b) Conforming Amendments.--Section 505(n) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended by--
            (1) striking paragraph (4); and
            (2) redesignating paragraphs (5), (6), (7), and (8) as 
        paragraphs (4), (5), (6), and (7), respectively.
    (c) Effective Date.--The amendments made by this section shall take 
effect on October 1, 2007.

                  TITLE VIII--CLINICAL TRIAL DATABASES

SEC. 801. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.

    (a) In General.--Section 402 of the Public Health Service Act (42 
U.S.C. 282) is amended by--
            (1) redesignating subsections (j) and (k) as subsections 
        (k) and (l), respectively; and
            (2) inserting after subsection (i) the following:
    ``(j) Expanded Clinical Trial Registry Data Bank.--
            ``(1) Definitions; requirement.--
                    ``(A) Definitions.--In this subsection:
                            ``(i) Applicable clinical trial.--The term 
                        `applicable clinical trial' means an applicable 
                        device clinical trial or an applicable drug 
                        clinical trial.
                            ``(ii) Applicable device clinical trial.--
                        The term `applicable device clinical trial' 
                        means--
                                    ``(I) a prospective clinical study 
                                of health outcomes comparing an 
                                intervention with a device subject to 
                                section 510(k), 515, or 520(m) of the 
                                Federal Food, Drug, and Cosmetic Act 
                                against a control in human subjects 
                                (other than a small clinical trial to 
                                determine the feasibility of a device, 
                                or a clinical trial to test prototype 
                                devices where the primary outcome 
                                measure relates to feasibility and not 
                                to health outcomes); and
                                    ``(II) a pediatric postmarket 
                                surveillance as required under section 
                                522 of the Federal Food, Drug, and 
                                Cosmetic Act.
                            ``(iii) Applicable drug clinical trial.--
                                    ``(I) In general.--The term 
                                `applicable drug clinical trial' means 
                                a controlled clinical investigation, 
                                other than a phase I clinical 
                                investigation, of a drug subject to 
                                section 505 of the Federal Food, Drug, 
                                and Cosmetic Act or to section 351 of 
                                this Act.
                                    ``(II) Clinical investigation.--For 
                                purposes of subclause (I), the term 
                                `clinical investigation' has the 
                                meaning given that term in section 
                                312.3 of title 21, Code of Federal 
                                Regulations (or any successor 
                                regulation).
                                    ``(III) Phase i.--For purposes of 
                                subclause (I), the term `phase I' has 
                                the meaning given that term in section 
                                312.21 of title 21, Code of Federal 
                                Regulations (or any successor 
                                regulation).
                            ``(iv) Clinical trial information.--The 
                        term `clinical trial information' means, with 
                        respect to an applicable clinical trial, those 
                        data elements that the responsible party is 
                        required to submit under paragraph (2) or under 
                        paragraph (3).
                            ``(v) Completion date.--The term 
                        `completion date' means, with respect to an 
                        applicable clinical trial, the date that the 
                        final subject was examined or received an 
                        intervention for the purposes of final 
                        collection of data for the primary outcome, 
                        whether the clinical trial concluded according 
                        to the prespecified protocol or was terminated.
                            ``(vi) Device.--The term `device' means a 
                        device as defined in section 201(h) of the 
                        Federal Food, Drug, and Cosmetic Act.
                            ``(vii) Drug.--The term `drug' means a drug 
                        as defined in section 201(g) of the Federal 
                        Food, Drug, and Cosmetic Act or a biological 
                        product as defined in section 351 of this Act.
                            ``(viii) Ongoing.--The term `ongoing' 
                        means, with respect to a clinical trial of a 
                        drug or a device and to a date, that--
                                    ``(I) 1 or more patients is 
                                enrolled in the clinical trial; and
                                    ``(II) the date is before the 
                                completion date of the clinical trial.
                            ``(ix) Responsible party.--The term 
                        `responsible party', with respect to a clinical 
                        trial of a drug or device, means--
                                    ``(I) the sponsor of the clinical 
                                trial (as defined in section 50.3 of 
                                title 21, Code of Federal Regulations 
                                (or any successor regulation)); or
                                    ``(II) the principal investigator 
                                of such clinical trial if so designated 
                                by a sponsor, grantee, contractor, or 
                                awardee, so long as the principal 
                                investigator is responsible for 
                                conducting the trial, has access to and 
                                control over the data from the clinical 
                                trial, has the right to publish the 
                                results of the trial, and has the 
                                ability to meet all of the requirements 
                                under this subsection for the 
                                submission of clinical trial 
                                information.
                    ``(B) Requirement.--The Secretary shall develop a 
                mechanism by which the responsible party for each 
                applicable clinical trial shall submit the identity and 
                contact information of such responsible party to the 
                Secretary at the time of submission of clinical trial 
                information under paragraph (2).
            ``(2) Expansion of clinical trial registry data bank with 
        respect to clinical trial information.--
                    ``(A) In general.--
                            ``(i) Expansion of data bank.--To enhance 
                        patient enrollment and provide a mechanism to 
                        track subsequent progress of clinical trials, 
                        the Secretary, acting through the Director of 
                        NIH, shall expand, in accordance with this 
                        subsection, the clinical trials registry of the 
                        data bank described under subsection (i)(1) 
                        (referred to in this subsection as the 
                        `registry data bank'). The Director of NIH 
                        shall ensure that the registry data bank is 
                        made publicly available through the Internet.
                            ``(ii) Content.--The clinical trial 
                        information required to be submitted under this 
                        paragraph for an applicable clinical trial 
                        shall include--
                                    ``(I) descriptive information, 
                                including--
                                            ``(aa) a brief title, 
                                        intended for the lay public;
                                            ``(bb) a brief summary, 
                                        intended for the lay public;
                                            ``(cc) the primary purpose;
                                            ``(dd) the study design;
                                            ``(ee) for an applicable 
                                        drug clinical trial, the study 
                                        phase;
                                            ``(ff) study type;
                                            ``(gg) the primary disease 
                                        or condition being studied, or 
                                        the focus of the study;
                                            ``(hh) the intervention 
                                        name and intervention type;
                                            ``(ii) the study start 
                                        date;
                                            ``(jj) the expected 
                                        completion date;
                                            ``(kk) the target number of 
                                        subjects; and
                                            ``(ll) outcomes, including 
                                        primary and secondary outcome 
                                        measures;
                                    ``(II) recruitment information, 
                                including--
                                            ``(aa) eligibility 
                                        criteria;
                                            ``(bb) gender;
                                            ``(cc) age limits;
                                            ``(dd) whether the trial 
                                        accepts healthy volunteers;
                                            ``(ee) overall recruitment 
                                        status;
                                            ``(ff) individual site 
                                        status; and
                                            ``(gg) in the case of an 
                                        applicable drug clinical trial, 
                                        if the drug is not approved 
                                        under section 505 of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act or licensed under 
                                        section 351 of this Act, 
                                        specify whether or not there is 
                                        expanded access to the drug 
                                        under section 561 of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act for those who do 
                                        not qualify for enrollment in 
                                        the clinical trial and how to 
                                        obtain information about such 
                                        access;
                                    ``(III) location and contact 
                                information, including--
                                            ``(aa) the name of the 
                                        sponsor;
                                            ``(bb) the responsible 
                                        party, by official title; and
                                            ``(cc) the facility name 
                                        and facility contact 
                                        information (including the 
                                        city, State, and zip code for 
                                        each clinical trial location, 
                                        or a toll-free number through 
                                        which such location information 
                                        may be accessed); and
                                    ``(IV) administrative data (which 
                                the Secretary may make publicly 
                                available as necessary), including--
                                            ``(aa) the unique protocol 
                                        identification number;
                                            ``(bb) other protocol 
                                        identification numbers, if any; 
                                        and
                                            ``(cc) the Food and Drug 
                                        Administration IND/IDE protocol 
                                        number and the record 
                                        verification date.
                            ``(iii) Modifications.--The Secretary may 
                        by regulation modify the requirements for 
                        clinical trial information under this 
                        paragraph, if the Secretary provides a 
                        rationale for why such a modification improves 
                        and does not reduce such clinical trial 
                        information.
                    ``(B) Format and structure.--
                            ``(i) Searchable categories.--The Director 
                        of NIH shall ensure that the public may, in 
                        addition to keyword searching, search the 
                        entries in the registry data bank by 1 or more 
                        of the following criteria:
                                    ``(I) The disease or condition 
                                being studied in the clinical trial, 
                                using Medical Subject Headers (MeSH) 
                                descriptors.
                                    ``(II) The name of the 
                                intervention, including any drug or 
                                device being studied in the clinical 
                                trial.
                                    ``(III) The location of the 
                                clinical trial.
                                    ``(IV) The age group studied in the 
                                clinical trial, including pediatric 
                                subpopulations.
                                    ``(V) The study phase of the 
                                clinical trial.
                                    ``(VI) The sponsor of the clinical 
                                trial, which may be the National 
                                Institutes of Health or another Federal 
                                agency, a private industry source, or a 
                                university or other organization.
                                    ``(VII) The recruitment status of 
                                the clinical trial.
                                    ``(VIII) The National Clinical 
                                Trial number or other study 
                                identification for the clinical trial.
                            ``(ii) Additional searchable category.--Not 
                        later than 18 months after the date of the 
                        enactment of the Food and Drug Administration 
                        Amendments Act of 2007, the Director of NIH 
                        shall ensure that the public may search the 
                        entries of the registry data bank by the safety 
                        issue, if any, being studied in the clinical 
                        trial as a primary or secondary outcome.
                            ``(iii) Other elements.--The Director of 
                        NIH shall also ensure that the public may 
                        search the entries of the registry data bank by 
                        such other elements as the Director deems 
                        necessary on an ongoing basis.
                            ``(iv) Format.--The Director of the NIH 
                        shall ensure that the registry data bank is 
                        easily used by the public, and that entries are 
                        easily compared.
                    ``(C) Data submission.--The responsible party for 
                an applicable clinical trial, including an applicable 
                drug clinical trial for a serious or life-threatening 
                disease or condition, that is initiated after, or is 
                ongoing on the date that is 90 days after, the date of 
                the enactment of the Food and Drug Administration 
                Amendments Act of 2007, shall submit to the Director of 
                NIH for inclusion in the registry data bank the 
                clinical trial information described in of subparagraph 
                (A)(ii) not later than the later of--
                            ``(i) 90 days after such date of enactment;
                            ``(ii) 21 days after the first patient is 
                        enrolled in such clinical trial; or
                            ``(iii) in the case of a clinical trial 
                        that is not for a serious or life-threatening 
                        disease or condition and that is ongoing on 
                        such date of enactment, 1 year after such date 
                        of enactment.
                    ``(D) Posting of data.--
                            ``(i) Applicable drug clinical trial.--The 
                        Director of NIH shall ensure that clinical 
                        trial information for an applicable drug 
                        clinical trial submitted in accordance with 
                        this paragraph is posted in the registry data 
                        bank not later than 30 days after such 
                        submission.
                            ``(ii) Applicable device clinical trial.--
                        The Director of NIH shall ensure that clinical 
                        trial information for an applicable device 
                        clinical trial submitted in accordance with 
                        this paragraph is posted publicly in the 
                        registry data bank--
                                    ``(I) not earlier than the date of 
                                clearance under section 510(k) of the 
                                Federal Food, Drug, and Cosmetic Act, 
                                or approval under section 515 or 520(m) 
                                of such Act, as applicable, for a 
                                device that was not previously cleared 
                                or approved, and not later than 30 days 
                                after such date; or
                                    ``(II) for a device that was 
                                previously cleared or approved, not 
                                later than 30 days after the clinical 
                                trial information under paragraph 
                                (3)(C) is required to be posted by the 
                                Secretary.
            ``(3) Expansion of registry data bank to include results of 
        clinical trials.--
                    ``(A) Linking registry data bank to existing 
                results.--
                            ``(i) In general.--Beginning not later than 
                        90 days after the date of the enactment of the 
                        Food and Drug Administration Amendments Act of 
                        2007, for those clinical trials that form the 
                        primary basis of an efficacy claim or are 
                        conducted after the drug involved is approved 
                        or after the device involved is cleared or 
                        approved, the Secretary shall ensure that the 
                        registry data bank includes links to results 
                        information as described in clause (ii) for 
                        such clinical trial--
                                    ``(I) not earlier than 30 days 
                                after the date of the approval of the 
                                drug involved or clearance or approval 
                                of the device involved; or
                                    ``(II) not later than 30 days after 
                                the results information described in 
                                clause (ii) becomes publicly available.
                            ``(ii) Required information.--
                                    ``(I) FDA information.--The 
                                Secretary shall ensure that the 
                                registry data bank includes links to 
                                the following information:
                                            ``(aa) If an advisory 
                                        committee considered at a 
                                        meeting an applicable clinical 
                                        trial, any posted Food and Drug 
                                        Administration summary document 
                                        regarding such applicable 
                                        clinical trial.
                                            ``(bb) If an applicable 
                                        drug clinical trial was 
                                        conducted under section 505A or 
                                        505B of the Federal Food, Drug, 
                                        and Cosmetic Act, a link to the 
                                        posted Food and Drug 
                                        Administration assessment of 
                                        the results of such trial.
                                            ``(cc) Food and Drug 
                                        Administration public health 
                                        advisories regarding the drug 
                                        or device that is the subject 
                                        of the applicable clinical 
                                        trial, if any.
                                            ``(dd) For an applicable 
                                        drug clinical trial, the Food 
                                        and Drug Administration action 
                                        package for approval document 
                                        required under section 
                                        505(l)(2) of the Federal Food, 
                                        Drug, and Cosmetic Act.
                                            ``(ee) For an applicable 
                                        device clinical trial, in the 
                                        case of a premarket application 
                                        under section 515 of the 
                                        Federal Food, Drug, and 
                                        Cosmetic Act, the detailed 
                                        summary of information 
                                        respecting the safety and 
                                        effectiveness of the device 
                                        required under section 
                                        520(h)(1) of such Act, or, in 
                                        the case of a report under 
                                        section 510(k) of such Act, the 
                                        section 510(k) summary of the 
                                        safety and effectiveness data 
                                        required under section 
                                        807.95(d) of title 21, Code of 
                                        Federal Regulations (or any 
                                        successor regulation).
                                    ``(II) NIH information.--The 
                                Secretary shall ensure that the 
                                registry data bank includes links to 
                                the following information:
                                            ``(aa) Medline citations to 
                                        any publications focused on the 
                                        results of an applicable 
                                        clinical trial.
                                            ``(bb) The entry for the 
                                        drug that is the subject of an 
                                        applicable drug clinical trial 
                                        in the National Library of 
                                        Medicine database of structured 
                                        product labels, if available.
                            ``(iii) Results for existing data bank 
                        entries.--The Secretary may include the links 
                        described in clause (ii) for data bank entries 
                        for clinical trials submitted to the data bank 
                        prior to enactment of the Food and Drug 
                        Administration Amendments Act of 2007, as 
                        available.
                    ``(B) Inclusion of results.--The Secretary, acting 
                through the Director of NIH, shall--
                            ``(i) expand the registry data bank to 
                        include the results of applicable clinical 
                        trials (referred to in this subsection as the 
                        `registry and results data bank');
                            ``(ii) ensure that such results are made 
                        publicly available through the Internet;
                            ``(iii) post publicly a glossary for the 
                        lay public explaining technical terms related 
                        to the results of clinical trials; and
                            ``(iv) in consultation with experts on risk 
                        communication, provide information with the 
                        information included under subparagraph (C) in 
                        the registry and results data bank to help 
                        ensure that such information does not mislead 
                        the patients or the public.
                    ``(C) Basic results.--Not later than 1 year after 
                the date of the enactment of the Food and Drug 
                Administration Amendments Act of 2007, the Secretary 
                shall include in the registry and results data bank the 
                following elements for drugs that are approved under 
                section 505 of the Federal Food, Drug, and Cosmetic Act 
                or licensed under section 351 of this Act and devices 
                that are cleared under section 510(k) of the Federal 
                Food, Drug, and Cosmetic Act or approved under section 
                515 or 520(m) of such Act:
                            ``(i) Demographic and baseline 
                        characteristics of patient sample.--A table of 
                        the demographic and baseline data collected 
                        overall and for each arm of the clinical trial 
                        to describe the patients who participated in 
                        the clinical trial, including the number of 
                        patients who dropped out of the clinical trial 
                        and the number of patients excluded from the 
                        analysis, if any.
                            ``(ii) Primary and secondary outcomes.--The 
                        primary and secondary outcome measures as 
                        submitted under paragraph (2)(A)(ii)(I)(ll), 
                        and a table of values for each of the primary 
                        and secondary outcome measures for each arm of 
                        the clinical trial, including the results of 
                        scientifically appropriate tests of the 
                        statistical significance of such outcome 
                        measures.
                            ``(iii) Point of contact.--A point of 
                        contact for scientific information about the 
                        clinical trial results.
                            ``(iv) Certain agreements.--Whether there 
                        exists an agreement (other than an agreement 
                        solely to comply with applicable provisions of 
                        law protecting the privacy of participants) 
                        between the sponsor or its agent and the 
                        principal investigator (unless the sponsor is 
                        an employer of the principal investigator) that 
                        restricts in any manner the ability of the 
                        principal investigator, after the completion 
                        date of the trial, to discuss the results of 
                        the trial at a scientific meeting or any other 
                        public or private forum, or to publish in a 
                        scientific or academic journal information 
                        concerning the results of the trial.
                    ``(D) Expanded registry and results data bank.--
                            ``(i) Expansion by rulemaking.--To provide 
                        more complete results information and to 
                        enhance patient access to and understanding of 
                        the results of clinical trials, not later than 
                        3 years after the date of the enactment of the 
                        Food and Drug Administration Amendments Act of 
                        2007, the Secretary shall by regulation expand 
                        the registry and results data bank as provided 
                        under this subparagraph.
                            ``(ii) Clinical trials.--
                                    ``(I) Approved products.--The 
                                regulations under this subparagraph 
                                shall require the inclusion of the 
                                results information described in clause 
                                (iii) for--
                                            ``(aa) each applicable drug 
                                        clinical trial for a drug that 
                                        is approved under section 505 
                                        of the Federal Food, Drug, and 
                                        Cosmetic Act or licensed under 
                                        section 351 of this Act; and
                                            ``(bb) each applicable 
                                        device clinical trial for a 
                                        device that is cleared under 
                                        section 510(k) of the Federal 
                                        Food, Drug, and Cosmetic Act or 
                                        approved under section 515 or 
                                        520(m) of such Act.
                                    ``(II) Unapproved products.--The 
                                regulations under this subparagraph 
                                shall establish whether or not the 
                                results information described in clause 
                                (iii) shall be required for--
                                            ``(aa) an applicable drug 
                                        clinical trial for a drug that 
                                        is not approved under section 
                                        505 of the Federal Food, Drug, 
                                        and Cosmetic Act and not 
                                        licensed under section 351 of 
                                        this Act (whether approval or 
                                        licensure was sought or not); 
                                        and
                                            ``(bb) an applicable device 
                                        clinical trial for a device 
                                        that is not cleared under 
                                        section 510(k) of the Federal 
                                        Food, Drug, and Cosmetic Act 
                                        and not approved under section 
                                        515 or section 520(m) of such 
                                        Act (whether clearance or 
                                        approval was sought or not).
                            ``(iii) Required elements.--The regulations 
                        under this subparagraph shall require, in 
                        addition to the elements described in 
                        subparagraph (C), information within each of 
                        the following categories:
                                    ``(I) A summary of the clinical 
                                trial and its results that is written 
                                in non-technical, understandable 
                                language for patients, if the Secretary 
                                determines that such types of summary 
                                can be included without being 
                                misleading or promotional.
                                    ``(II) A summary of the clinical 
                                trial and its results that is technical 
                                in nature, if the Secretary determines 
                                that such types of summary can be 
                                included without being misleading or 
                                promotional.
                                    ``(III) The full protocol or such 
                                information on the protocol for the 
                                trial as may be necessary to help to 
                                evaluate the results of the trial.
                                    ``(IV) Such other categories as the 
                                Secretary determines appropriate.
                            ``(iv) Results submission.--The results 
                        information described in clause (iii) shall be 
                        submitted to the Director of NIH for inclusion 
                        in the registry and results data bank as 
                        provided by subparagraph (E), except that the 
                        Secretary shall by regulation determine--
                                    ``(I) whether the 1-year period for 
                                submission of clinical trial 
                                information described in subparagraph 
                                (E)(i) should be increased from 1 year 
                                to a period not to exceed 18 months;
                                    ``(II) whether the clinical trial 
                                information described in clause (iii) 
                                should be required to be submitted for 
                                an applicable clinical trial for which 
                                the clinical trial information 
                                described in subparagraph (C) is 
                                submitted to the registry and results 
                                data bank before the effective date of 
                                the regulations issued under this 
                                subparagraph; and
                                    ``(III) in the case when the 
                                clinical trial information described in 
                                clause (iii) is required to be 
                                submitted for the applicable clinical 
                                trials described in clause (ii)(II), 
                                the date by which such clinical trial 
                                information shall be required to be 
                                submitted, taking into account--
                                            ``(aa) the certification 
                                        process under subparagraph 
                                        (E)(iii) when approval, 
                                        licensure, or clearance is 
                                        sought; and
                                            ``(bb) whether there should 
                                        be a delay of submission when 
                                        approval, licensure, or 
                                        clearance will not be sought.
                            ``(v) Additional provisions.--The 
                        regulations under this subparagraph shall also 
                        establish--
                                    ``(I) a standard format for the 
                                submission of clinical trial 
                                information under this paragraph to the 
                                registry and results data bank;
                                    ``(II) additional information on 
                                clinical trials and results that is 
                                written in nontechnical, understandable 
                                language for patients;
                                    ``(III) considering the experience 
                                under the pilot quality control project 
                                described in paragraph (5)(C), 
                                procedures for quality control, 
                                including using representative samples, 
                                with respect to completeness and 
                                content of clinical trial information 
                                under this subsection, to help ensure 
                                that data elements are not false or 
                                misleading and are non-promotional;
                                    ``(IV) the appropriate timing and 
                                requirements for updates of clinical 
                                trial information, and whether and, if 
                                so, how such updates should be tracked;
                                    ``(V) a statement to accompany the 
                                entry for an applicable clinical trial 
                                when the primary and secondary outcome 
                                measures for such clinical trial are 
                                submitted under paragraph (4)(A) after 
                                the date specified for the submission 
                                of such information in paragraph 
                                (2)(C); and
                                    ``(VI) additions or modifications 
                                to the manner of reporting of the data 
                                elements established under subparagraph 
                                (C).
                            ``(vi) Consideration of world health 
                        organization data set.--The Secretary shall 
                        consider the status of the consensus data 
                        elements set for reporting clinical trial 
                        results of the World Health Organization when 
                        issuing the regulations under this 
                        subparagraph.
                            ``(vii) Public meeting.--The Secretary 
                        shall hold a public meeting no later than 18 
                        months after the date of the enactment of the 
                        Food and Drug Administration Amendments Act of 
                        2007 to provide an opportunity for input from 
                        interested parties with regard to the 
                        regulations to be issued under this 
                        subparagraph.
                    ``(E) Submission of results information.--
                            ``(i) In general.--Except as provided in 
                        clause (iii), (iv), (v), and (vi) the 
                        responsible party for an applicable clinical 
                        trial that is described in clause (ii) shall 
                        submit to the Director of NIH for inclusion in 
                        the registry and results data bank the clinical 
                        trial information described in subparagraph (C) 
                        not later than 1 year, or such other period as 
                        may be provided by regulation under 
                        subparagraph (D), after the earlier of--
                                    ``(I) the estimated completion date 
                                of the trial as described in paragraph 
                                (2)(A)(ii)(I)(jj)); or
                                    ``(II) the actual date of 
                                completion.
                            ``(ii) Clinical trials described.--An 
                        applicable clinical trial described in this 
                        clause is an applicable clinical trial subject 
                        to--
                                    ``(I) paragraph (2)(C); and
                                    ``(II)(aa) subparagraph (C); or
                                    ``(bb) the regulations issued under 
                                subparagraph (D).
                            ``(iii) Delayed submission of results with 
                        certification.--If the responsible party for an 
                        applicable clinical trial submits a 
                        certification that clause (iv) or (v) applies 
                        to such clinical trial, the responsible party 
                        shall submit to the Director of NIH for 
                        inclusion in the registry and results data bank 
                        the clinical trial information described in 
                        subparagraphs (C) and (D) as required under the 
                        applicable clause.
                            ``(iv) Seeking initial approval of a drug 
                        or device.--With respect to an applicable 
                        clinical trial that is completed before the 
                        drug is initially approved under section 505 of 
                        the Federal Food, Drug, and Cosmetic Act or 
                        initially licensed under section 351 of this 
                        Act, or the device is initially cleared under 
                        section 510(k) or initially approved under 
                        section 515 or 520(m) of the Federal Food, 
                        Drug, and Cosmetic Act, the responsible party 
                        shall submit to the Director of NIH for 
                        inclusion in the registry and results data bank 
                        the clinical trial information described in 
                        subparagraphs (C) and (D) not later than 30 
                        days after the drug or device is approved under 
                        such section 505, licensed under such section 
                        351, cleared under such section 510(k), or 
                        approved under such section 515 or 520(m), as 
                        applicable.
                            ``(v) Seeking approval of a new use for the 
                        drug or device.--
                                    ``(I) In general.--With respect to 
                                an applicable clinical trial where the 
                                manufacturer of the drug or device is 
                                the sponsor of an applicable clinical 
                                trial, and such manufacturer has filed, 
                                or will file within 1 year, an 
                                application seeking approval under 
                                section 505 of the Federal Food, Drug, 
                                and Cosmetic Act, licensing under 
                                section 351 of this Act, or clearance 
                                under section 510(k), or approval under 
                                section 515 or 520(m), of the Federal 
                                Food, Drug, and Cosmetic Act for the 
                                use studied in such clinical trial 
                                (which use is not included in the 
                                labeling of the approved drug or 
                                device), then the responsible party 
                                shall submit to the Director of NIH for 
                                inclusion in the registry and results 
                                data bank the clinical trial 
                                information described in subparagraphs 
                                (C) and (D) on the earlier of the date 
                                that is 30 days after the date--
                                            ``(aa) the new use of the 
                                        drug or device is approved 
                                        under such section 505, 
                                        licensed under such section 
                                        351, cleared under such section 
                                        510(k), or approved under such 
                                        section 515 or 520(m);
                                            ``(bb) the Secretary issues 
                                        a letter, such as a complete 
                                        response letter, not approving 
                                        the submission or not clearing 
                                        the submission, a not 
                                        approvable letter, or a not 
                                        substantially equivalent letter 
                                        for the new use of the drug or 
                                        device under such section 505, 
                                        351, 510(k), 515, or 520(m); or
                                            ``(cc) except as provided 
                                        in subclause (III), the 
                                        application or premarket 
                                        notification under such section 
                                        505, 351, 510(k), 515, or 
                                        520(m) is withdrawn without 
                                        resubmission for no less than 
                                        210 days.
                                    ``(II) Requirement that each 
                                clinical trial in application be 
                                treated the same.--If a manufacturer 
                                makes a certification under clause 
                                (iii) that this clause applies with 
                                respect to a clinical trial, the 
                                manufacturer shall make such a 
                                certification with respect to each 
                                applicable clinical trial that is 
                                required to be submitted in an 
                                application or report for licensure, 
                                approval, or clearance (under section 
                                351 of this Act or section 505, 510(k), 
                                515, or 520(m) of the Federal Food, 
                                Drug, and Cosmetic Act, as applicable) 
                                of the use studied in the clinical 
                                trial.
                                    ``(III) Two-year limitation.--The 
                                responsible party shall submit to the 
                                Director of NIH for inclusion in the 
                                registry and results data bank the 
                                clinical trial information subject to 
                                subclause (I) on the date that is 2 
                                years after the date a certification 
                                under clause (iii) was made to the 
                                Director of NIH, if an action referred 
                                to in item (aa), (bb), or (cc) of 
                                subclause (I) has not occurred by such 
                                date.
                            ``(vi) Extensions.--The Director of NIH may 
                        provide an extension of the deadline for 
                        submission of clinical trial information under 
                        clause (i) if the responsible party for the 
                        trial submits to the Director a written request 
                        that demonstrates good cause for the extension 
                        and provides an estimate of the date on which 
                        the information will be submitted. The Director 
                        of NIH may grant more than one such extension 
                        for a clinical trial.
                    ``(F) Notice to director of nih.--The Commissioner 
                of Food and Drugs shall notify the Director of NIH when 
                there is an action described in subparagraph (E)(iv) or 
                item (aa), (bb), or (cc) of subparagraph (E)(v)(I) with 
                respect to an application or a report that includes a 
                certification required under paragraph (5)(B) of such 
                action not later than 30 days after such action.
                    ``(G) Posting of data.--The Director of NIH shall 
                ensure that the clinical trial information described in 
                subparagraphs (C) and (D) for an applicable clinical 
                trial submitted in accordance with this paragraph is 
                posted publicly in the registry and results database 
                not later than 30 days after such submission.
                    ``(H) Waivers regarding certain clinical trial 
                results.--The Secretary may waive any applicable 
                requirements of this paragraph for an applicable 
                clinical trial, upon a written request from the 
                responsible party, if the Secretary determines that 
                extraordinary circumstances justify the waiver and that 
                providing the waiver is consistent with the protection 
                of public health, or in the interest of national 
                security. Not later than 30 days after any part of a 
                waiver is granted, the Secretary shall notify, in 
                writing, the appropriate committees of Congress of the 
                waiver and provide an explanation for why the waiver 
                was granted.
                    ``(I) Adverse events.--
                            ``(i) Regulations.--Not later than 18 
                        months after the date of the enactment of the 
                        Food and Drug Administration Amendments Act of 
                        2007, the Secretary shall by regulation 
                        determine the best method for including in the 
                        registry and results data bank appropriate 
                        results information on serious adverse and 
                        frequent adverse events for drugs described in 
                        subparagraph (C) in a manner and form that is 
                        useful and not misleading to patients, 
                        physicians, and scientists.
                            ``(ii) Default.--If the Secretary fails to 
                        issue the regulation required by clause (i) by 
                        the date that is 24 months after the date of 
                        the enactment of the Food and Drug 
                        Administration Amendments Act of 2007, clause 
                        (iii) shall take effect.
                            ``(iii) Additional elements.--Upon the 
                        application of clause (ii), the Secretary shall 
                        include in the registry and results data bank 
                        for drugs described in subparagraph (C), in 
                        addition to the clinical trial information 
                        described in subparagraph (C), the following 
                        elements:
                                    ``(I) Serious adverse events.--A 
                                table of anticipated and unanticipated 
                                serious adverse events grouped by organ 
                                system, with number and frequency of 
                                such event in each arm of the clinical 
                                trial.
                                    ``(II) Frequent adverse events.--A 
                                table of anticipated and unanticipated 
                                adverse events that are not included in 
                                the table described in subclause (I) 
                                that exceed a frequency of 5 percent 
                                within any arm of the clinical trial, 
                                grouped by organ system, with number 
                                and frequency of such event in each arm 
                                of the clinical trial.
                            ``(iv) Posting of other information.--In 
                        carrying out clause (iii), the Secretary shall, 
                        in consultation with experts in risk 
                        communication, post with the tables information 
                        to enhance patient understanding and to ensure 
                        such tables do not mislead patients or the lay 
                        public.
                            ``(v) Relation to subparagraph (C).--
                        Clinical trial information included in the 
                        registry and results data bank pursuant to this 
                        subparagraph is deemed to be clinical trial 
                        information included in such data bank pursuant 
                        to subparagraph (C).
            ``(4) Additional submissions of clinical trial 
        information.--
                    ``(A) Voluntary submissions.--A responsible party 
                for a clinical trial that is not an applicable clinical 
                trial, or that is an applicable clinical trial that is 
                not subject to paragraph (2)(C), may submit complete 
                clinical trial information described in paragraph (2) 
                or paragraph (3) provided the responsible party submits 
                clinical trial information for each applicable clinical 
                trial that is required to be submitted under section 
                351 or under section 505, 510(k), 515, or 520(m) of the 
                Federal Food, Drug, and Cosmetic Act in an application 
                or report for licensure, approval, or clearance of the 
                drug or device for the use studied in the clinical 
                trial.
                    ``(B) Required submissions.--
                            ``(i) In general.--Notwithstanding 
                        paragraphs (2) and (3) and subparagraph (A), in 
                        any case in which the Secretary determines for 
                        a specific clinical trial described in clause 
                        (ii) that posting in the registry and results 
                        data bank of clinical trial information for 
                        such clinical trial is necessary to protect the 
                        public health--
                                    ``(I) the Secretary may require by 
                                notification that such information be 
                                submitted to the Secretary in 
                                accordance with paragraphs (2) and (3) 
                                except with regard to timing of 
                                submission;
                                    ``(II) unless the responsible party 
                                submits a certification under paragraph 
                                (3)(E)(iii), such information shall be 
                                submitted not later than 30 days after 
                                the date specified by the Secretary in 
                                the notification; and
                                    ``(III) failure to comply with the 
                                requirements under subclauses (I) and 
                                (II) shall be treated as a violation of 
                                the corresponding requirement of such 
                                paragraphs.
                            ``(ii) Clinical trials described.--A 
                        clinical trial described in this clause is--
                                    ``(I) an applicable clinical trial 
                                for a drug that is approved under 
                                section 505 of the Federal Food, Drug, 
                                and Cosmetic Act or licensed under 
                                section 351 of this Act or for a device 
                                that is cleared under section 510(k) of 
                                the Federal Food, Drug, and Cosmetic 
                                Act or approved under section 515 or 
                                section 520(m) of such Act, whose 
                                completion date is on or after the date 
                                10 years before the date of the 
                                enactment of the Food and Drug 
                                Administration Amendments Act of 2007; 
                                or
                                    ``(II) an applicable clinical trial 
                                that is described by both by paragraph 
                                (2)(C) and paragraph (3)(D)(ii)(II)).
                    ``(C) Updates to clinical trial data bank.--
                            ``(i) Submission of updates.--The 
                        responsible party for an applicable clinical 
                        trial shall submit to the Director of NIH for 
                        inclusion in the registry and results data bank 
                        updates to reflect changes to the clinical 
                        trial information submitted under paragraph 
                        (2). Such updates--
                                    ``(I) shall be provided not less 
                                than once every 12 months, unless there 
                                were no changes to the clinical trial 
                                information during the preceding 12-
                                month period;
                                    ``(II) shall include identification 
                                of the dates of any such changes;
                                    ``(III) not later than 30 days 
                                after the recruitment status of such 
                                clinical trial changes, shall include 
                                an update of the recruitment status; 
                                and
                                    ``(IV) not later than 30 days after 
                                the completion date of the clinical 
                                trial, shall include notification to 
                                the Director that such clinical trial 
                                is complete.
                            ``(ii) Public availability of updates.--The 
                        Director of NIH shall make updates submitted 
                        under clause (i) publicly available in the 
                        registry data bank. Except with regard to 
                        overall recruitment status, individual site 
                        status, location, and contact information, the 
                        Director of NIH shall ensure that updates to 
                        elements required under subclauses (I) to (V) 
                        of paragraph (2)(A)(ii) do not result in the 
                        removal of any information from the original 
                        submissions or any preceding updates, and 
                        information in such databases is presented in a 
                        manner that enables users to readily access 
                        each original element submission and to track 
                        the changes made by the updates. The Director 
                        of NIH shall provide a link from the table of 
                        primary and secondary outcomes required under 
                        paragraph (3)(C)(ii) to the tracked history 
                        required under this clause of the primary and 
                        secondary outcome measures submitted under 
                        paragraph (2)(A)(ii)(I)(ll).
            ``(5) Coordination and compliance.--
                    ``(A) Clinical trials supported by grants from 
                federal agencies.--
                            ``(i) Grants from certain federal 
                        agencies.--If an applicable clinical trial is 
                        funded in whole or in part by a grant from any 
                        agency of the Department of Health and Human 
                        Services, including the Food and Drug 
                        Administration, the National Institutes of 
                        Health, or the Agency for Healthcare Research 
                        and Quality, any grant or progress report forms 
                        required under such grant shall include a 
                        certification that the responsible party has 
                        made all required submissions to the Director 
                        of NIH under paragraph (2) and (3).
                            ``(ii) Verification by federal agencies.--
                        The heads of the agencies referred to in clause 
                        (i), as applicable, shall verify that the 
                        clinical trial information for each applicable 
                        clinical trial for which a grantee is the 
                        responsible party has been submitted under 
                        paragraph (2) and (3) before releasing any 
                        remaining funding for a grant or funding for a 
                        future grant to such grantee.
                            ``(iii) Notice and opportunity to remedy.--
                        If the head of an agency referred to in clause 
                        (i), as applicable, verifies that a grantee has 
                        not submitted clinical trial information as 
                        described in clause (ii), such agency head 
                        shall provide notice to such grantee of such 
                        non-compliance and allow such grantee 30 days 
                        to correct such non-compliance and submit the 
                        required clinical trial information.
                            ``(iv) Consultation with other federal 
                        agencies.--The Secretary shall--
                                    ``(I) consult with other agencies 
                                that conduct research involving human 
                                subjects in accordance with any section 
                                of part 46 of title 45, Code of Federal 
                                Regulations (or any successor 
                                regulations), to determine if any such 
                                research is an applicable clinical 
                                trial; and
                                    ``(II) develop with such agencies 
                                procedures comparable to those 
                                described in clauses (i), (ii), and 
                                (iii) to ensure that clinical trial 
                                information for such applicable 
                                clinical trial is submitted under 
                                paragraph (2) and (3).
                    ``(B) Certification to accompany drug, biological 
                product, and device submissions.--At the time of 
                submission of an application under section 505 of the 
                Federal Food, Drug, and Cosmetic Act, section 515 of 
                such Act, section 520(m) of such Act, or section 351 of 
                this Act, or submission of a report under section 
                510(k) of such Act, such application or submission 
                shall be accompanied by a certification that all 
                applicable requirements of this subsection have been 
                met. Where available, such certification shall include 
                the appropriate National Clinical Trial control 
                numbers.
                    ``(C) Quality control.--
                            ``(i) Pilot quality control project.--Until 
                        the effective date of the regulations issued 
                        under paragraph (3)(D), the Secretary, acting 
                        through the Director of NIH and the 
                        Commissioner of Food and Drugs, shall conduct a 
                        pilot project to determine the optimal method 
                        of verification to help to ensure that the 
                        clinical trial information submitted under 
                        paragraph (3)(C) is non-promotional and is not 
                        false or misleading in any particular under 
                        subparagraph (D). The Secretary shall use the 
                        publicly available information described in 
                        paragraph (3)(A) and any other information 
                        available to the Secretary about applicable 
                        clinical trials to verify the accuracy of the 
                        clinical trial information submitted under 
                        paragraph (3)(C).
                            ``(ii) Notice of compliance.--If the 
                        Secretary determines that any clinical trial 
                        information was not submitted as required under 
                        this subsection, or was submitted but is false 
                        or misleading in any particular, the Secretary 
                        shall notify the responsible party and give 
                        such party an opportunity to remedy such 
                        noncompliance by submitting the required 
                        revised clinical trial information not later 
                        than 30 days after such notification.
                    ``(D) Truthful clinical trial information.--
                            ``(i) In general.--The clinical trial 
                        information submitted by a responsible party 
                        under this subsection shall not be false or 
                        misleading in any particular.
                            ``(ii) Effect.--Clause (i) shall not have 
                        the effect of--
                                    ``(I) requiring clinical trial 
                                information with respect to an 
                                applicable clinical trial to include 
                                information from any source other than 
                                such clinical trial involved; or
                                    ``(II) requiring clinical trial 
                                information described in paragraph 
                                (3)(D) to be submitted for purposes of 
                                paragraph (3)(C).
                    ``(E) Public notices.--
                            ``(i) Notice of violations.--If the 
                        responsible party for an applicable clinical 
                        trial fails to submit clinical trial 
                        information for such clinical trial as required 
                        under paragraphs (2) or (3), the Director of 
                        NIH shall include in the registry and results 
                        data bank entry for such clinical trial a 
                        notice--
                                    ``(I) that the responsible party is 
                                not in compliance with this Act by--
                                            ``(aa) failing to submit 
                                        required clinical trial 
                                        information; or
                                            ``(bb) submitting false or 
                                        misleading clinical trial 
                                        information;
                                    ``(II) of the penalties imposed for 
                                the violation, if any; and
                                    ``(III) whether the responsible 
                                party has corrected the clinical trial 
                                information in the registry and results 
                                data bank.
                            ``(ii) Notice of failure to submit primary 
                        and secondary outcomes.--If the responsible 
                        party for an applicable clinical trial fails to 
                        submit the primary and secondary outcomes as 
                        required under section 2(A)(ii)(I)(ll), the 
                        Director of NIH shall include in the registry 
                        and results data bank entry for such clinical 
                        trial a notice that the responsible party is 
                        not in compliance by failing to register the 
                        primary and secondary outcomes in accordance 
                        with this act, and that the primary and 
                        secondary outcomes were not publicly disclosed 
                        in the database before conducting the clinical 
                        trial.
                            ``(iii) Failure to submit statement.--The 
                        notice under clause (i) for a violation 
                        described in clause (i)(I)(aa) shall include 
                        the following statement: `The entry for this 
                        clinical trial was not complete at the time of 
                        submission, as required by law. This may or may 
                        not have any bearing on the accuracy of the 
                        information in the entry.'.
                            ``(iv) Submission of false information 
                        statement.--The notice under clause (i) for a 
                        violation described in clause (i)(I)(bb) shall 
                        include the following statement: `The entry for 
                        this clinical trial was found to be false or 
                        misleading and therefore not in compliance with 
                        the law.'.
                            ``(v) Non-submission of statement.--The 
                        notice under clause (ii) for a violation 
                        described in clause (ii) shall include the 
                        following statement: `The entry for this 
                        clinical trial did not contain information on 
                        the primary and secondary outcomes at the time 
                        of submission, as required by law. This may or 
                        may not have any bearing on the accuracy of the 
                        information in the entry.'.
                            ``(vi) Compliance searches.--The Director 
                        of NIH shall provide that the public may easily 
                        search the registry and results data bank for 
                        entries that include notices required under 
                        this subparagraph.
            ``(6) Limitation on disclosure of clinical trial 
        information.--
                    ``(A) In general.--Nothing in this subsection (or 
                under section 552 of title 5, United States Code) shall 
                require the Secretary to publicly disclose, by any 
                means other than the registry and results data bank, 
                information described in subparagraph (B).
                    ``(B) Information described.--Information described 
                in this subparagraph is--
                            ``(i) information submitted to the Director 
                        of NIH under this subsection, or information of 
                        the same general nature as (or integrally 
                        associated with) the information so submitted; 
                        and
                            ``(ii) information not otherwise publicly 
                        available, including because it is protected 
                        from disclosure under section 552 of title 5, 
                        United States Code.
            ``(7) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this subsection 
        $10,000,000 for each fiscal year.''.
    (b) Conforming Amendments.--
            (1) Prohibited acts.--Section 301 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at 
        the end the following:
    ``(jj)(1) The failure to submit the certification required by 
section 402(j)(5)(B) of the Public Health Service Act, or knowingly 
submitting a false certification under such section.
    ``(2) The failure to submit clinical trial information required 
under subsection (j) of section 402 of the Public Health Service Act.
    ``(3) The submission of clinical trial information under subsection 
(j) of section 402 of the Public Health Service Act that is false or 
misleading in any particular under paragraph (5)(D) of such subsection 
(j).''.
            (2) Civil money penalties.--Subsection (f) of section 303 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), as 
        redesignated by section 226, is amended--
                    (A) by redesignating paragraphs (3), (4), and (5) 
                as paragraphs (5), (6), and (7), respectively;
                    (B) by inserting after paragraph (2) the following:
    ``(3)(A) Any person who violates section 301(jj) shall be subject 
to a civil monetary penalty of not more than $10,000 for all violations 
adjudicated in a single proceeding.
    ``(B) If a violation of section 301(jj) is not corrected within the 
30-day period following notification under section 402(j)(5)(C)(ii), 
the person shall, in addition to any penalty under subparagraph (A), be 
subject to a civil monetary penalty of not more than $10,000 for each 
day of the violation after such period until the violation is 
corrected.'';
                    (C) in paragraph (2)(C), by striking ``paragraph 
                (3)(A)'' and inserting ``paragraph (5)(A)'';
                    (D) in paragraph (5), as so redesignated, by 
                striking ``paragraph (1) or (2)'' each place it appears 
                and inserting ``paragraph (1), (2),or (3)'';
                    (E) in paragraph (6), as so redesignated, by 
                striking ``paragraph (3)(A)'' and inserting ``paragraph 
                (5)(A)''; and
                    (F) in paragraph (7), as so redesignated, by 
                striking ``paragraph (4)'' each place it appears and 
                inserting ``paragraph (6)''.
            (3) New drugs and devices.--
                    (A) Investigational new drugs.--Section 505(i) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(i)) is amended in paragraph (4), by adding at the 
                end the following: ``The Secretary shall update such 
                regulations to require inclusion in the informed 
                consent documents and process a statement that clinical 
                trial information for such clinical investigation has 
                been or will be submitted for inclusion in the registry 
                data bank pursuant to subsection (j) of section 402 of 
                the Public Health Service Act.''.
                    (B) New drug applications.--Section 505(b) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) 
                is amended by adding at the end the following:
            ``(6) An application submitted under this subsection shall 
        be accompanied by the certification required under section 
        402(j)(5)(B) of the Public Health Service Act. Such 
        certification shall not be considered an element of such 
        application.''.
                    (C) Device reports under section 510(k).--Section 
                510(k) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 360(k)) is amended by adding at the end the 
                following:
``A notification submitted under this subsection that contains clinical 
trial data for an applicable device clinical trial (as defined in 
section 402(j)(1) of the Public Health Service Act) shall be 
accompanied by the certification required under section 402(j)(5)(B) of 
such Act. Such certification shall not be considered an element of such 
notification.''.
                    (D) Device premarket approval application.--Section 
                515(c)(1) of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 360e(c)(1)) is amended--
                            (i) in subparagraph (F), by striking ``; 
                        and'' and inserting a semicolon;
                            (ii) by redesignating subparagraph (G) as 
                        subparagraph (H); and
                            (iii) by inserting after subparagraph (F) 
                        the following:
                    ``(G) the certification required under section 
                402(j)(5)(B) of the Public Health Service Act (which 
                shall not be considered an element of such 
                application); and''.
                    (E) Humanitarian device exemption.--Section 
                520(m)(2) of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 360e(c)) is amended in the first sentence in 
                the matter following subparagraph (C), by inserting at 
                the end before the period ``and such application shall 
                include the certification required under section 
                402(j)(5)(B) of the Public Health Service Act (which 
                shall not be considered an element of such 
                application)''.
    (c) Surveillances.--Not later than 12 months after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
issue guidance on how the requirements of section 402(j) of the Public 
Health Service Act, as added by this section, apply to a pediatric 
postmarket surveillance described in paragraph (1)(A)(ii)(II) of such 
section 402(j) that is not a clinical trial.
    (d) Preemption.--
            (1) In general.--Upon the expansion of the registry and 
        results data bank under section 402(j)(3)(D) of the Public 
        Health Service Act, as added by this section, no State or 
        political subdivision of a State may establish or continue in 
        effect any requirement for the registration of clinical trials 
        or for the inclusion of information relating to the results of 
        clinical trials in a database.
            (2) Rule of construction.--The fact of submission of 
        clinical trial information, if submitted in compliance with 
        subsection (j) of section 402 of the Public Health Service Act 
        (as amended by this section), that relates to a use of a drug 
        or device not included in the official labeling of the approved 
        drug or device shall not be construed by the Secretary of 
        Health and Human Services or in any administrative or judicial 
        proceeding, as evidence of a new intended use of the drug or 
        device that is different from the intended use of the drug or 
        device set forth in the official labeling of the drug or 
        device. The availability of clinical trial information through 
        the registry and results data bank under such subsection (j), 
        if submitted in compliance with such subsection, shall not be 
        considered as labeling, adulteration, or misbranding of the 
        drug or device under the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 301 et seq.).

  TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS

            Subtitle A--Postmarket Studies and Surveillance

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

    (a) In General.--Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the 
following subsections:
    ``(o) Postmarket Studies and Clinical Trials; Labeling.--
            ``(1) In general.--A responsible person may not introduce 
        or deliver for introduction into interstate commerce the new 
        drug involved if the person is in violation of a requirement 
        established under paragraph (3) or (4) with respect to the 
        drug.
            ``(2) Definitions.--For purposes of this subsection:
                    ``(A) Responsible person.--The term `responsible 
                person' means a person who--
                            ``(i) has submitted to the Secretary a 
                        covered application that is pending; or
                            ``(ii) is the holder of an approved covered 
                        application.
                    ``(B) Covered application.--The term `covered 
                application' means--
                            ``(i) an application under subsection (b) 
                        for a drug that is subject to section 503(b); 
                        and
                            ``(ii) an application under section 351 of 
                        the Public Health Service Act.
                    ``(C) New safety information; serious risk.--The 
                terms `new safety information', `serious risk', and 
                `signal of a serious risk' have the meanings given such 
                terms in section 505-1(b).
            ``(3) Studies and clinical trials.--
                    ``(A) In general.--For any or all of the purposes 
                specified in subparagraph (B), the Secretary may, 
                subject to subparagraph (D), require a responsible 
                person for a drug to conduct a postapproval study or 
                studies of the drug, or a postapproval clinical trial 
                or trials of the drug, on the basis of scientific data 
                deemed appropriate by the Secretary, including 
                information regarding chemically-related or 
                pharmacologically-related drugs.
                    ``(B) Purposes of study or clinical trial.--The 
                purposes referred to in this subparagraph with respect 
                to a postapproval study or postapproval clinical trial 
                are the following:
                            ``(i) To assess a known serious risk 
                        related to the use of the drug involved.
                            ``(ii) To assess signals of serious risk 
                        related to the use of the drug.
                            ``(iii) To identify an unexpected serious 
                        risk when available data indicates the 
                        potential for a serious risk.
                    ``(C) Establishment of requirement after approval 
                of covered application.--The Secretary may require a 
                postapproval study or studies or postapproval clinical 
                trial or trials for a drug for which an approved 
                covered application is in effect as of the date on 
                which the Secretary seeks to establish such requirement 
                only if the Secretary becomes aware of new safety 
                information.
                    ``(D) Determination by secretary.--
                            ``(i) Postapproval studies.--The Secretary 
                        may not require the responsible person to 
                        conduct a study under this paragraph, unless 
                        the Secretary makes a determination that the 
                        reports under subsection (k)(1) and the active 
                        postmarket risk identification and analysis 
                        system as available under subsection (k)(3) 
                        will not be sufficient to meet the purposes set 
                        forth in subparagraph (B).
                            ``(ii) Postapproval clinical trials.--The 
                        Secretary may not require the responsible 
                        person to conduct a clinical trial under this 
                        paragraph, unless the Secretary makes a 
                        determination that a postapproval study or 
                        studies will not be sufficient to meet the 
                        purposes set forth in subparagraph (B).
                    ``(E) Notification; timetables; periodic reports.--
                            ``(i) Notification.--The Secretary shall 
                        notify the responsible person regarding a 
                        requirement under this paragraph to conduct a 
                        postapproval study or clinical trial by the 
                        target dates for communication of feedback from 
                        the review team to the responsible person 
                        regarding proposed labeling and postmarketing 
                        study commitments as set forth in the letters 
                        described in section 101(c) of the Food and 
                        Drug Administration Amendments Act of 2007.
                            ``(ii) Timetable; periodic reports.--For 
                        each study or clinical trial required to be 
                        conducted under this paragraph, the Secretary 
                        shall require that the responsible person 
                        submit a timetable for completion of the study 
                        or clinical trial. With respect to each study 
                        required to be conducted under this paragraph 
                        or otherwise undertaken by the responsible 
                        person to investigate a safety issue, the 
                        Secretary shall require the responsible person 
                        to periodically report to the Secretary on the 
                        status of such study including whether any 
                        difficulties in completing the study have been 
                        encountered. With respect to each clinical 
                        trial required to be conducted under this 
                        paragraph or otherwise undertaken by the 
                        responsible person to investigate a safety 
                        issue, the Secretary shall require the 
                        responsible person to periodically report to 
                        the Secretary on the status of such clinical 
                        trial including whether enrollment has begun, 
                        the number of participants enrolled, the 
                        expected completion date, whether any 
                        difficulties completing the clinical trial have 
                        been encountered, and registration information 
                        with respect to the requirements under section 
                        402(j) of the Public Health Service Act. If the 
                        responsible person fails to comply with such 
                        timetable or violates any other requirement of 
                        this subparagraph, the responsible person shall 
                        be considered in violation of this subsection, 
                        unless the responsible person demonstrates good 
                        cause for such noncompliance or such other 
                        violation. The Secretary shall determine what 
                        constitutes good cause under the preceding 
                        sentence.
                    ``(F) Dispute resolution.--The responsible person 
                may appeal a requirement to conduct a study or clinical 
                trial under this paragraph using dispute resolution 
                procedures established by the Secretary in regulation 
                and guidance.
            ``(4) Safety labeling changes requested by secretary.--
                    ``(A) New safety information.--If the Secretary 
                becomes aware of new safety information that the 
                Secretary believes should be included in the labeling 
                of the drug, the Secretary shall promptly notify the 
                responsible person or, if the same drug approved under 
                section 505(b) is not currently marketed, the holder of 
                an approved application under 505(j).
                    ``(B) Response to notification.--Following 
                notification pursuant to subparagraph (A), the 
                responsible person or the holder of the approved 
                application under section 505(j) shall within 30 days--
                            ``(i) submit a supplement proposing changes 
                        to the approved labeling to reflect the new 
                        safety information, including changes to boxed 
                        warnings, contraindications, warnings, 
                        precautions, or adverse reactions; or
                            ``(ii) notify the Secretary that the 
                        responsible person or the holder of the 
                        approved application under section 505(j) does 
                        not believe a labeling change is warranted and 
                        submit a statement detailing the reasons why 
                        such a change is not warranted.
                    ``(C) Review.--Upon receipt of such supplement, the 
                Secretary shall promptly review and act upon such 
                supplement. If the Secretary disagrees with the 
                proposed changes in the supplement or with the 
                statement setting forth the reasons why no labeling 
                change is necessary, the Secretary shall initiate 
                discussions to reach agreement on whether the labeling 
                for the drug should be modified to reflect the new 
                safety information, and if so, the contents of such 
                labeling changes.
                    ``(D) Discussions.--Such discussions shall not 
                extend for more than 30 days after the response to the 
                notification under subparagraph (B), unless the 
                Secretary determines an extension of such discussion 
                period is warranted.
                    ``(E) Order.--Within 15 days of the conclusion of 
                the discussions under subparagraph (D), the Secretary 
                may issue an order directing the responsible person or 
                the holder of the approved application under section 
                505(j) to make such a labeling change as the Secretary 
                deems appropriate to address the new safety 
                information. Within 15 days of such an order, the 
                responsible person or the holder of the approved 
                application under section 505(j) shall submit a 
                supplement containing the labeling change.
                    ``(F) Dispute resolution.--Within 5 days of 
                receiving an order under subparagraph (E), the 
                responsible person or the holder of the approved 
                application under section 505(j) may appeal using 
                dispute resolution procedures established by the 
                Secretary in regulation and guidance.
                    ``(G) Violation.--If the responsible person or the 
                holder of the approved application under section 505(j) 
                has not submitted a supplement within 15 days of the 
                date of such order under subparagraph (E), and there is 
                no appeal or dispute resolution proceeding pending, the 
                responsible person or holder shall be considered to be 
                in violation of this subsection. If at the conclusion 
                of any dispute resolution procedures the Secretary 
                determines that a supplement must be submitted and such 
                a supplement is not submitted within 15 days of the 
                date of that determination, the responsible person or 
                holder shall be in violation of this subsection.
                    ``(H) Public health threat.--Notwithstanding 
                subparagraphs (A) through (F), if the Secretary 
                concludes that such a labeling change is necessary to 
                protect the public health, the Secretary may accelerate 
                the timelines in such subparagraphs.
                    ``(I) Rule of construction.--This paragraph shall 
                not be construed to affect the responsibility of the 
                responsible person or the holder of the approved 
                application under section 505(j) to maintain its label 
                in accordance with existing requirements, including 
                subpart B of part 201 and sections 314.70 and 601.12 of 
                title 21, Code of Federal Regulations (or any successor 
                regulations).
            ``(5) Non-delegation.--Determinations by the Secretary 
        under this subsection for a drug shall be made by individuals 
        at or above the level of individuals empowered to approve a 
        drug (such as division directors within the Center for Drug 
        Evaluation and Research).
    ``(p) Risk Evaluation and Mitigation Strategy.--
            ``(1) In general.--A person may not introduce or deliver 
        for introduction into interstate commerce a new drug if--
                    ``(A)(i) the application for such drug is approved 
                under subsection (b) or (j) and is subject to section 
                503(b); or
                    ``(ii) the application for such drug is approved 
                under section 351 of the Public Health Service Act; and
                    ``(B) a risk evaluation and mitigation strategy is 
                required under section 505-1 with respect to the drug 
                and the person fails to maintain compliance with the 
                requirements of the approved strategy or with other 
                requirements under section 505-1, including 
                requirements regarding assessments of approved 
                strategies.
            ``(2) Certain postmarket studies.--The failure to conduct a 
        postmarket study under section 506, subpart H of part 314, or 
        subpart E of part 601 of title 21, Code of Federal Regulations 
        (or any successor regulations), is deemed to be a violation of 
        paragraph (1).''.
    (b) Requirements Regarding Strategies.--Chapter V of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
inserting after section 505 the following section:

``SEC. 505-1. RISK EVALUATION AND MITIGATION STRATEGIES.

    ``(a) Submission of Proposed Strategy.--
            ``(1) Initial approval.--If the Secretary, in consultation 
        with the office responsible for reviewing the drug and the 
        office responsible for postapproval safety with respect to the 
        drug, determines that a risk evaluation and mitigation strategy 
        is necessary to ensure that the benefits of the drug outweigh 
        the risks of the drug, and informs the person who submits such 
        application of such determination, then such person shall 
        submit to the Secretary as part of such application a proposed 
        risk evaluation and mitigation strategy. In making such a 
        determination, the Secretary shall consider the following 
        factors:
                    ``(A) The estimated size of the population likely 
                to use the drug involved.
                    ``(B) The seriousness of the disease or condition 
                that is to be treated with the drug.
                    ``(C) The expected benefit of the drug with respect 
                to such disease or condition.
                    ``(D) The expected or actual duration of treatment 
                with the drug.
                    ``(E) The seriousness of any known or potential 
                adverse events that may be related to the drug and the 
                background incidence of such events in the population 
                likely to use the drug.
                    ``(F) Whether the drug is a new molecular entity.
            ``(2) Postapproval requirement.--
                    ``(A) In general.--If the Secretary has approved a 
                covered application (including an application approved 
                before the effective date of this section) and did not 
                when approving the application require a risk 
                evaluation and mitigation strategy under paragraph (1), 
                the Secretary, in consultation with the offices 
                described in paragraph (1), may subsequently require 
                such a strategy for the drug involved (including when 
                acting on a supplemental application seeking approval 
                of a new indication for use of the drug) if the 
                Secretary becomes aware of new safety information and 
                makes a determination that such a strategy is necessary 
                to ensure that the benefits of the drug outweigh the 
                risks of the drug.
                    ``(B) Submission of proposed strategy.--Not later 
                than 120 days after the Secretary notifies the holder 
                of an approved covered application that the Secretary 
                has made a determination under subparagraph (A) with 
                respect to the drug involved, or within such other 
                reasonable time as the Secretary requires to protect 
                the public health, the holder shall submit to the 
                Secretary a proposed risk evaluation and mitigation 
                strategy.
            ``(3) Abbreviated new drug applications.--The applicability 
        of this section to an application under section 505(j) is 
        subject to subsection (i).
            ``(4) Non-delegation.--Determinations by the Secretary 
        under this subsection for a drug shall be made by individuals 
        at or above the level of individuals empowered to approve a 
        drug (such as division directors within the Center for Drug 
        Evaluation and Research).
    ``(b) Definitions.--For purposes of this section:
            ``(1) Adverse drug experience.--The term `adverse drug 
        experience' means any adverse event associated with the use of 
        a drug in humans, whether or not considered drug related, 
        including--
                    ``(A) an adverse event occurring in the course of 
                the use of the drug in professional practice;
                    ``(B) an adverse event occurring from an overdose 
                of the drug, whether accidental or intentional;
                    ``(C) an adverse event occurring from abuse of the 
                drug;
                    ``(D) an adverse event occurring from withdrawal of 
                the drug; and
                    ``(E) any failure of expected pharmacological 
                action of the drug.
            ``(2) Covered application.--The term `covered application' 
        means an application referred to in section 505(p)(1)(A).
            ``(3) New safety information.--The term `new safety 
        information', with respect to a drug, means information derived 
        from a clinical trial, an adverse event report, a postapproval 
        study (including a study under section 505(o)(3)), or peer-
        reviewed biomedical literature; data derived from the 
        postmarket risk identification and analysis system under 
        section 505(k); or other scientific data deemed appropriate by 
        the Secretary about--
                    ``(A) a serious risk or an unexpected serious risk 
                associated with use of the drug that the Secretary has 
                become aware of (that may be based on a new analysis of 
                existing information) since the drug was approved, 
                since the risk evaluation and mitigation strategy was 
                required, or since the last assessment of the approved 
                risk evaluation and mitigation strategy for the drug; 
                or
                    ``(B) the effectiveness of the approved risk 
                evaluation and mitigation strategy for the drug 
                obtained since the last assessment of such strategy.
            ``(4) Serious adverse drug experience.--The term `serious 
        adverse drug experience' is an adverse drug experience that--
                    ``(A) results in--
                            ``(i) death;
                            ``(ii) an adverse drug experience that 
                        places the patient at immediate risk of death 
                        from the adverse drug experience as it occurred 
                        (not including an adverse drug experience that 
                        might have caused death had it occurred in a 
                        more severe form);
                            ``(iii) inpatient hospitalization or 
                        prolongation of existing hospitalization;
                            ``(iv) a persistent or significant 
                        incapacity or substantial disruption of the 
                        ability to conduct normal life functions; or
                            ``(v) a congenital anomaly or birth defect; 
                        or
                    ``(B) based on appropriate medical judgment, may 
                jeopardize the patient and may require a medical or 
                surgical intervention to prevent an outcome described 
                under subparagraph (A).
            ``(5) Serious risk.--The term `serious risk' means a risk 
        of a serious adverse drug experience.
            ``(6) Signal of a serious risk.--The term `signal of a 
        serious risk' means information related to a serious adverse 
        drug experience associated with use of a drug and derived 
        from--
                    ``(A) a clinical trial;
                    ``(B) adverse event reports;
                    ``(C) a postapproval study, including a study under 
                section 505(o)(3);
                    ``(D) peer-reviewed biomedical literature;
                    ``(E) data derived from the postmarket risk 
                identification and analysis system under section 
                505(k)(4); or
                    ``(F) other scientific data deemed appropriate by 
                the Secretary.
            ``(7) Responsible person.--The term `responsible person' 
        means the person submitting a covered application or the holder 
        of the approved such application.
            ``(8) Unexpected serious risk.--The term `unexpected 
        serious risk' means a serious adverse drug experience that is 
        not listed in the labeling of a drug, or that may be 
        symptomatically and pathophysiologically related to an adverse 
        drug experience identified in the labeling, but differs from 
        such adverse drug experience because of greater severity, 
        specificity, or prevalence.
    ``(c) Contents.--A proposed risk evaluation and mitigation strategy 
under subsection (a) shall--
            ``(1) include the timetable required under subsection (d); 
        and
            ``(2) to the extent required by the Secretary, in 
        consultation with the office responsible for reviewing the drug 
        and the office responsible for postapproval safety with respect 
        to the drug, include additional elements described in 
        subsections (e) and (f).
    ``(d) Minimal Strategy.--For purposes of subsection (c)(1), the 
risk evaluation and mitigation strategy for a drug shall require a 
timetable for submission of assessments of the strategy that--
            ``(1) includes an assessment, by the date that is 18 months 
        after the strategy is initially approved;
            ``(2) includes an assessment by the date that is 3 years 
        after the strategy is initially approved;
            ``(3) includes an assessment in the seventh year after the 
        strategy is so approved; and
            ``(4) subject to paragraphs (1), (2), and (3)--
                    ``(A) is at a frequency specified in the strategy;
                    ``(B) is increased or reduced in frequency as 
                necessary as provided for in subsection (g)(4)(A); and
                    ``(C) is eliminated after the 3-year period 
                described in paragraph (1) if the Secretary determines 
                that serious risks of the drug have been adequately 
                identified and assessed and are being adequately 
                managed.
    ``(e) Additional Potential Elements of Strategy.--
            ``(1) In general.--The Secretary, in consultation with the 
        offices described in subsection (c)(2), may under such 
        subsection require that the risk evaluation and mitigation 
        strategy for a drug include 1 or more of the additional 
        elements described in this subsection if the Secretary makes 
        the determination required with respect to each element 
        involved.
            ``(2) Medication guide; patient package insert.--The risk 
        evaluation and mitigation strategy for a drug may require that, 
        as applicable, the responsible person develop for distribution 
        to each patient when the drug is dispensed--
                    ``(A) a Medication Guide, as provided for under 
                part 208 of title 21, Code of Federal Regulations (or 
                any successor regulations); and
                    ``(B) a patient package insert, if the Secretary 
                determines that such insert may help mitigate a serious 
                risk of the drug.
            ``(3) Communication plan.--The risk evaluation and 
        mitigation strategy for a drug may require that the responsible 
        person conduct a communication plan to health care providers, 
        if, with respect to such drug, the Secretary determines that 
        such plan may support implementation of an element of the 
        strategy (including under this paragraph). Such plan may 
        include--
                    ``(A) sending letters to health care providers;
                    ``(B) disseminating information about the elements 
                of the risk evaluation and mitigation strategy to 
                encourage implementation by health care providers of 
                components that apply to such health care providers, or 
                to explain certain safety protocols (such as medical 
                monitoring by periodic laboratory tests); or
                    ``(C) disseminating information to health care 
                providers through professional societies about any 
                serious risks of the drug and any protocol to assure 
                safe use.
    ``(f) Providing Safe Access for Patients to Drugs With Known 
Serious Risks That Would Otherwise Be Unavailable.--
            ``(1) Allowing safe access to drugs with known serious 
        risks.--The Secretary, in consultation with the offices 
        described in subsection (c)(2), may require that the risk 
        evaluation and mitigation strategy for a drug include such 
        elements as are necessary to assure safe use of the drug, 
        because of its inherent toxicity or potential harmfulness, if 
        the Secretary determines that--
                    ``(A) the drug, which has been shown to be 
                effective, but is associated with a serious adverse 
                drug experience, can be approved only if, or would be 
                withdrawn unless, such elements are required as part of 
                such strategy to mitigate a specific serious risk 
                listed in the labeling of the drug; and
                    ``(B) for a drug initially approved without 
                elements to assure safe use, other elements under 
                subsections (c), (d), and (e) are not sufficient to 
                mitigate such serious risk.
            ``(2) Assuring access and minimizing burden.--Such elements 
        to assure safe use under paragraph (1) shall--
                    ``(A) be commensurate with the specific serious 
                risk listed in the labeling of the drug;
                    ``(B) within 30 days of the date on which any 
                element under paragraph (1) is imposed, be posted 
                publicly by the Secretary with an explanation of how 
                such elements will mitigate the observed safety risk;
                    ``(C) considering such risk, not be unduly 
                burdensome on patient access to the drug, considering 
                in particular--
                            ``(i) patients with serious or life-
                        threatening diseases or conditions; and
                            ``(ii) patients who have difficulty 
                        accessing health care (such as patients in 
                        rural or medically underserved areas); and
                    ``(D) to the extent practicable, so as to minimize 
                the burden on the health care delivery system--
                            ``(i) conform with elements to assure safe 
                        use for other drugs with similar, serious 
                        risks; and
                            ``(ii) be designed to be compatible with 
                        established distribution, procurement, and 
                        dispensing systems for drugs.
            ``(3) Elements to assure safe use.--The elements to assure 
        safe use under paragraph (1) shall include 1 or more goals to 
        mitigate a specific serious risk listed in the labeling of the 
        drug and, to mitigate such risk, may require that--
                    ``(A) health care providers who prescribe the drug 
                have particular training or experience, or are 
                specially certified (the opportunity to obtain such 
                training or certification with respect to the drug 
                shall be available to any willing provider from a 
                frontier area in a widely available training or 
                certification method (including an on-line course or 
                via mail) as approved by the Secretary at reasonable 
                cost to the provider);
                    ``(B) pharmacies, practitioners, or health care 
                settings that dispense the drug are specially certified 
                (the opportunity to obtain such certification shall be 
                available to any willing provider from a frontier 
                area);
                    ``(C) the drug be dispensed to patients only in 
                certain health care settings, such as hospitals;
                    ``(D) the drug be dispensed to patients with 
                evidence or other documentation of safe-use conditions, 
                such as laboratory test results;
                    ``(E) each patient using the drug be subject to 
                certain monitoring; or
                    ``(F) each patient using the drug be enrolled in a 
                registry.
            ``(4) Implementation system.--The elements to assure safe 
        use under paragraph (1) that are described in subparagraphs 
        (B), (C), and (D) of paragraph (3) may include a system through 
        which the applicant is able to take reasonable steps to--
                    ``(A) monitor and evaluate implementation of such 
                elements by health care providers, pharmacists, and 
                other parties in the health care system who are 
                responsible for implementing such elements; and
                    ``(B) work to improve implementation of such 
                elements by such persons.
            ``(5) Evaluation of elements to assure safe use.--The 
        Secretary, through the Drug Safety and Risk Management Advisory 
        Committee (or successor committee) of the Food and Drug 
        Administration, shall--
                    ``(A) seek input from patients, physicians, 
                pharmacists, and other health care providers about how 
                elements to assure safe use under this subsection for 1 
                or more drugs may be standardized so as not to be--
                            ``(i) unduly burdensome on patient access 
                        to the drug; and
                            ``(ii) to the extent practicable, minimize 
                        the burden on the health care delivery system;
                    ``(B) at least annually, evaluate, for 1 or more 
                drugs, the elements to assure safe use of such drug to 
                assess whether the elements--
                            ``(i) assure safe use of the drug;
                            ``(ii) are not unduly burdensome on patient 
                        access to the drug; and
                            ``(iii) to the extent practicable, minimize 
                        the burden on the health care delivery system; 
                        and
                    ``(C) considering such input and evaluations--
                            ``(i) issue or modify agency guidance about 
                        how to implement the requirements of this 
                        subsection; and
                            ``(ii) modify elements under this 
                        subsection for 1 or more drugs as appropriate.
            ``(6) Additional mechanisms to assure access.--The 
        mechanisms under section 561 to provide for expanded access for 
        patients with serious or life-threatening diseases or 
        conditions may be used to provide access for patients with a 
        serious or life-threatening disease or condition, the treatment 
        of which is not an approved use for the drug, to a drug that is 
        subject to elements to assure safe use under this subsection. 
        The Secretary shall promulgate regulations for how a physician 
        may provide the drug under the mechanisms of section 561.
            ``(7) Waiver in public health emergencies.--The Secretary 
        may waive any requirement of this subsection during the period 
        described in section 319(a) of the Public Health Service Act 
        with respect to a qualified countermeasure described under 
        section 319F-1(a)(2) of such Act, to which a requirement under 
        this subsection has been applied, if the Secretary has--
                    ``(A) declared a public health emergency under such 
                section 319; and
                    ``(B) determined that such waiver is required to 
                mitigate the effects of, or reduce the severity of, 
                such public health emergency.
            ``(8)  Limitation.--No holder of an approved covered 
        application shall use any element to assure safe use required 
        by the Secretary under this subsection to block or delay 
        approval of an application under section 505(b)(2) or (j) or to 
        prevent application of such element under subsection (i)(1)(B) 
        to a drug that is the subject of an abbreviated new drug 
        application.
    ``(g) Assessment and Modification of Approved Strategy.--
            ``(1) Voluntary assessments.--After the approval of a risk 
        evaluation and mitigation strategy under subsection (a), the 
        responsible person involved may, subject to paragraph (2), 
        submit to the Secretary an assessment of, and propose a 
        modification to, the approved strategy for the drug involved at 
        any time.
            ``(2) Required assessments.--A responsible person shall, 
        subject to paragraph (5), submit an assessment of, and may 
        propose a modification to, the approved risk evaluation and 
        mitigation strategy for a drug--
                    ``(A) when submitting a supplemental application 
                for a new indication for use under section 505(b) or 
                under section 351 of the Public Health Service Act, 
                unless the drug is not subject to section 503(b) and 
                the risk evaluation and mitigation strategy for the 
                drug includes only the timetable under subsection (d);
                    ``(B) when required by the strategy, as provided 
                for in such timetable under subsection (d);
                    ``(C) within a time period to be determined by the 
                Secretary, if the Secretary, in consultation with the 
                offices described in subsection (c)(2), determines that 
                new safety or effectiveness information indicates 
                that--
                            ``(i) an element under subsection (d) or 
                        (e) should be modified or included in the 
                        strategy; or
                            ``(ii) an element under subsection (f) 
                        should be modified or included in the strategy; 
                        or
                    ``(D) within 15 days when ordered by the Secretary, 
                in consultation with the offices described in 
                subsection (c)(2), if the Secretary determines that 
                there may be a cause for action by the Secretary under 
                section 505(e).
            ``(3) Requirements for assessments.--An assessment under 
        paragraph (1) or (2) of an approved risk evaluation and 
        mitigation strategy for a drug shall include--
                    ``(A) with respect to any goal under subsection 
                (f), an assessment of the extent to which the elements 
                to assure safe use are meeting the goal or whether the 
                goal or such elements should be modified;
                    ``(B) with respect to any postapproval study 
                required under section 505(o) or otherwise undertaken 
                by the responsible person to investigate a safety 
                issue, the status of such study, including whether any 
                difficulties completing the study have been 
                encountered; and
                    ``(C) with respect to any postapproval clinical 
                trial required under section 505(o) or otherwise 
                undertaken by the responsible party to investigate a 
                safety issue, the status of such clinical trial, 
                including whether enrollment has begun, the number of 
                participants enrolled, the expected completion date, 
                whether any difficulties completing the clinical trial 
                have been encountered, and registration information 
                with respect to requirements under subsections (i) and 
                (j) of section 402 of the Public Health Service Act.
            ``(4) Modification.--A modification (whether an enhancement 
        or a reduction) to the approved risk evaluation and mitigation 
        strategy for a drug may include the addition or modification of 
        any element under subsection (d) or the addition, modification, 
        or removal of any element under subsection (e) or (f), such 
        as--
                    ``(A) modifying the timetable for assessments of 
                the strategy as provided in subsection (d)(3), 
                including to eliminate assessments; or
                    ``(B) adding, modifying, or removing an element to 
                assure safe use under subsection (f).
    ``(h) Review of Proposed Strategies; Review of Assessments of 
Approved Strategies.--
            ``(1) In general.--The Secretary, in consultation with the 
        offices described in subsection (c)(2), shall promptly review 
        each proposed risk evaluation and mitigation strategy for a 
        drug submitted under subsection (a) and each assessment of an 
        approved risk evaluation and mitigation strategy for a drug 
        submitted under subsection (g).
            ``(2) Discussion.--The Secretary, in consultation with the 
        offices described in subsection (c)(2), shall initiate 
        discussions with the responsible person for purposes of this 
        subsection to determine a strategy not later than 60 days after 
        any such assessment is submitted or, in the case of an 
        assessment submitted under subsection (g)(2)(D), not later than 
        30 days after such assessment is submitted.
            ``(3) Action.--
                    ``(A) In general.--Unless the dispute resolution 
                process described under paragraph (4) or (5) applies, 
                the Secretary, in consultation with the offices 
                described in subsection (c)(2), shall describe any 
                required risk evaluation and mitigation strategy for a 
                drug, or any modification to any required strategy--
                            ``(i) as part of the action letter on the 
                        application, when a proposed strategy is 
                        submitted under subsection (a) or a 
                        modification to the strategy is proposed as 
                        part of an assessment of the strategy submitted 
                        under subsection (g)(1); or
                            ``(ii) in an order issued not later than 90 
                        days after the date discussions of such 
                        modification begin under paragraph (2), when a 
                        modification to the strategy is proposed as 
                        part of an assessment of the strategy submitted 
                        under subsection (g)(1) or under any of 
                        subparagraphs (B) through (D) of subsection 
                        (g)(2).
                    ``(B) Inaction.--An approved risk evaluation and 
                mitigation strategy shall remain in effect until the 
                Secretary acts, if the Secretary fails to act as 
                provided under subparagraph (A).
                    ``(C) Public availability.--Any action letter 
                described in subparagraph (A)(i) or order described in 
                subparagraph (A)(ii) shall be made publicly available.
            ``(4) Dispute resolution at initial approval.--If a 
        proposed risk evaluation and mitigation strategy is submitted 
        under subsection (a)(1) in an application for initial approval 
        of a drug and there is a dispute about the strategy, the 
        responsible person shall use the major dispute resolution 
        procedures as set forth in the letters described in section 
        101(c) of the Food and Drug Administration Amendments Act of 
        2007.
            ``(5) Dispute resolution in all other cases.--
                    ``(A) Request for review.--
                            ``(i) In general.--Not earlier than 15 
                        days, and not later than 35 days, after 
                        discussions under paragraph (2) have begun, the 
                        responsible person may request in writing that 
                        a dispute about the strategy be reviewed by the 
                        Drug Safety Oversight Board under subsection 
                        (j), except that the determination of the 
                        Secretary to require a risk evaluation and 
                        mitigation strategy is not subject to review 
                        under this paragraph. The preceding sentence 
                        does not prohibit review under this paragraph 
                        of the particular elements of such a strategy.
                            ``(ii) Scheduling.--Upon receipt of a 
                        request under clause (i), the Secretary shall 
                        schedule the dispute involved for review under 
                        subparagraph (B) and, not later than 5 business 
                        days of scheduling the dispute for review, 
                        shall publish by posting on the Internet or 
                        otherwise a notice that the dispute will be 
                        reviewed by the Drug Safety Oversight Board.
                    ``(B) Scheduling review.--If a responsible person 
                requests review under subparagraph (A), the Secretary--
                            ``(i) shall schedule the dispute for review 
                        at 1 of the next 2 regular meetings of the Drug 
                        Safety Oversight Board, whichever meeting date 
                        is more practicable; or
                            ``(ii) may convene a special meeting of the 
                        Drug Safety Oversight Board to review the 
                        matter more promptly, including to meet an 
                        action deadline on an application (including a 
                        supplemental application).
                    ``(C) Agreement after discussion or administrative 
                appeals.--
                            ``(i) Further discussion or administrative 
                        appeals.--A request for review under 
                        subparagraph (A) shall not preclude further 
                        discussions to reach agreement on the risk 
                        evaluation and mitigation strategy, and such a 
                        request shall not preclude the use of 
                        administrative appeals within the Food and Drug 
                        Administration to reach agreement on the 
                        strategy, including appeals as described in the 
                        letters described in section 101(c) of the Food 
                        and Drug Administration Amendments Act of 2007 
                        for procedural or scientific matters involving 
                        the review of human drug applications and 
                        supplemental applications that cannot be 
                        resolved at the divisional level. At the time a 
                        review has been scheduled under subparagraph 
                        (B) and notice of such review has been posted, 
                        the responsible person shall either withdraw 
                        the request under subparagraph (A) or terminate 
                        the use of such administrative appeals.
                            ``(ii) Agreement terminates dispute 
                        resolution.--At any time before a decision and 
                        order is issued under subparagraph (G) , the 
                        Secretary (in consultation with the offices 
                        described in subsection (c)(2)) and the 
                        responsible person may reach an agreement on 
                        the risk evaluation and mitigation strategy 
                        through further discussion or administrative 
                        appeals, terminating the dispute resolution 
                        process, and the Secretary shall issue an 
                        action letter or order, as appropriate, that 
                        describes the strategy.
                    ``(D) Meeting of the board.--At a meeting of the 
                Drug Safety Oversight Board described in subparagraph 
                (B), the Board shall--
                            ``(i) hear from both parties via written or 
                        oral presentation; and
                            ``(ii) review the dispute.
                    ``(E) Record of proceedings.--The Secretary shall 
                ensure that the proceedings of any such meeting are 
                recorded, transcribed, and made public within 90 days 
                of the meeting. The Secretary shall redact the 
                transcript to protect any trade secrets and other 
                information that is exempted from disclosure under 
                section 552 of title 5, United States Code, or section 
                552a of title 5, United States Code.
                    ``(F) Recommendation of the board.--Not later than 
                5 days after any such meeting, the Drug Safety 
                Oversight Board shall provide a written recommendation 
                on resolving the dispute to the Secretary. Not later 
                than 5 days after the Board provides such written 
                recommendation to the Secretary, the Secretary shall 
                make the recommendation available to the public.
                    ``(G) Action by the secretary.--
                            ``(i) Action letter.--With respect to a 
                        proposal or assessment referred to in paragraph 
                        (1), the Secretary shall issue an action letter 
                        that resolves the dispute not later than the 
                        later of--
                                    ``(I) the action deadline for the 
                                action letter on the application; or
                                    ``(II) 7 days after receiving the 
                                recommendation of the Drug Safety 
                                Oversight Board.
                            ``(ii) Order.--With respect to an 
                        assessment of an approved risk evaluation and 
                        mitigation strategy under subsection (g)(1) or 
                        under any of subparagraphs (B) through (D) of 
                        subsection (g)(2), the Secretary shall issue an 
                        order, which shall be made public, that 
                        resolves the dispute not later than 7 days 
                        after receiving the recommendation of the Drug 
                        Safety Oversight Board.
                    ``(H) Inaction.--An approved risk evaluation and 
                mitigation strategy shall remain in effect until the 
                Secretary acts, if the Secretary fails to act as 
                provided for under subparagraph (G).
                    ``(I) Effect on action deadline.--With respect to a 
                proposal or assessment referred to in paragraph (1), 
                the Secretary shall be considered to have met the 
                action deadline for the action letter on the 
                application if the responsible person requests the 
                dispute resolution process described in this paragraph 
                and if the Secretary--
                            ``(i) has initiated the discussions 
                        described under paragraph (2) not less than 60 
                        days before such action deadline; and
                            ``(ii) has complied with the timing 
                        requirements of scheduling review by the Drug 
                        Safety Oversight Board, providing a written 
                        recommendation, and issuing an action letter 
                        under subparagraphs (B), (F), and (G), 
                        respectively.
                    ``(J) Disqualification.--No individual who is an 
                employee of the Food and Drug Administration and who 
                reviews a drug or who participated in an administrative 
                appeal under subparagraph (C)(i) with respect to such 
                drug may serve on the Drug Safety Oversight Board at a 
                meeting under subparagraph (D) to review a dispute 
                about the risk evaluation and mitigation strategy for 
                such drug.
                    ``(K) Additional expertise.--The Drug Safety 
                Oversight Board may add members with relevant expertise 
                from the Food and Drug Administration, including the 
                Office of Pediatrics, the Office of Women's Health, or 
                the Office of Rare Diseases, or from other Federal 
                public health or health care agencies, for a meeting 
                under subparagraph (D) of the Drug Safety Oversight 
                Board.
            ``(6) Use of advisory committees.--The Secretary may 
        convene a meeting of 1 or more advisory committees of the Food 
        and Drug Administration to--
                    ``(A) review a concern about the safety of a drug 
                or class of drugs, including before an assessment of 
                the risk evaluation and mitigation strategy or 
                strategies of such drug or drugs is required to be 
                submitted under any of subparagraphs (B) through (D) of 
                subsection (g)(2);
                    ``(B) review the risk evaluation and mitigation 
                strategy or strategies of a drug or group of drugs; or
                    ``(C) review a dispute under paragraph (4) or (5).
            ``(7) Process for addressing drug class effects.--
                    ``(A) In general.--When a concern about a serious 
                risk of a drug may be related to the pharmacological 
                class of the drug, the Secretary, in consultation with 
                the offices described in subsection (c)(2), may defer 
                assessments of the approved risk evaluation and 
                mitigation strategies for such drugs until the 
                Secretary has convened 1 or more public meetings to 
                consider possible responses to such concern.
                    ``(B) Notice.--If the Secretary defers an 
                assessment under subparagraph (A), the Secretary 
                shall--
                            ``(i) give notice of the deferral to the 
                        holder of the approved covered application not 
                        later than 5 days after the deferral;
                            ``(ii) publish the deferral in the Federal 
                        Register; and
                            ``(iii) give notice to the public of any 
                        public meetings to be convened under 
                        subparagraph (A), including a description of 
                        the deferral.
                    ``(C) Public meetings.--Such public meetings may 
                include--
                            ``(i) 1 or more meetings of the responsible 
                        person for such drugs;
                            ``(ii) 1 or more meetings of 1 or more 
                        advisory committees of the Food and Drug 
                        Administration, as provided for under paragraph 
                        (6); or
                            ``(iii) 1 or more workshops of scientific 
                        experts and other stakeholders.
                    ``(D) Action.--After considering the discussions 
                from any meetings under subparagraph (A), the Secretary 
                may--
                            ``(i) announce in the Federal Register a 
                        planned regulatory action, including a 
                        modification to each risk evaluation and 
                        mitigation strategy, for drugs in the 
                        pharmacological class;
                            ``(ii) seek public comment about such 
                        action; and
                            ``(iii) after seeking such comment, issue 
                        an order addressing such regulatory action.
            ``(8) International coordination.--The Secretary, in 
        consultation with the offices described in subsection (c)(2), 
        may coordinate the timetable for submission of assessments 
        under subsection (d), or a study or clinical trial under 
        section 505(o)(3), with efforts to identify and assess the 
        serious risks of such drug by the marketing authorities of 
        other countries whose drug approval and risk management 
        processes the Secretary deems comparable to the drug approval 
        and risk management processes of the United States. If the 
        Secretary takes action to coordinate such timetable, the 
        Secretary shall give notice to the responsible person.
            ``(9) Effect.--Use of the processes described in paragraphs 
        (7) and (8) shall not be the sole source of delay of action on 
        an application or a supplement to an application for a drug.
    ``(i) Abbreviated New Drug Applications.--
            ``(1) In general.--A drug that is the subject of an 
        abbreviated new drug application under section 505(j) is 
        subject to only the following elements of the risk evaluation 
        and mitigation strategy required under subsection (a) for the 
        applicable listed drug:
                    ``(A) A Medication Guide or patient package insert, 
                if required under subsection (e) for the applicable 
                listed drug.
                    ``(B) Elements to assure safe use, if required 
                under subsection (f) for the listed drug. A drug that 
                is the subject of an abbreviated new drug application 
                and the listed drug shall use a single, shared system 
                under subsection (f). The Secretary may waive the 
                requirement under the preceding sentence for a drug 
                that is the subject of an abbreviated new drug 
                application, and permit the applicant to use a 
                different, comparable aspect of the elements to assure 
                safe use, if the Secretary determines that--
                            ``(i) the burden of creating a single, 
                        shared system outweighs the benefit of a 
                        single, system, taking into consideration the 
                        impact on health care providers, patients, the 
                        applicant for the abbreviated new drug 
                        application, and the holder of the reference 
                        drug product; or
                            ``(ii) an aspect of the elements to assure 
                        safe use for the applicable listed drug is 
                        claimed by a patent that has not expired or is 
                        a method or process that, as a trade secret, is 
                        entitled to protection, and the applicant for 
                        the abbreviated new drug application certifies 
                        that it has sought a license for use of an 
                        aspect of the elements to assure safe use for 
                        the applicable listed drug and that it was 
                        unable to obtain a license.
                A certification under clause (ii) shall include a 
                description of the efforts made by the applicant for 
                the abbreviated new drug application to obtain a 
                license. In a case described in clause (ii), the 
                Secretary may seek to negotiate a voluntary agreement 
                with the owner of the patent, method, or process for a 
                license under which the applicant for such abbreviated 
                new drug application may use an aspect of the elements 
                to assure safe use, if required under subsection (f) 
                for the applicable listed drug, that is claimed by a 
                patent that has not expired or is a method or process 
                that as a trade secret is entitled to protection.
            ``(2) Action by secretary.--For an applicable listed drug 
        for which a drug is approved under section 505(j), the 
        Secretary--
                    ``(A) shall undertake any communication plan to 
                health care providers required under subsection (e)(3) 
                for the applicable listed drug; and
                    ``(B) shall inform the responsible person for the 
                drug that is so approved if the risk evaluation and 
                mitigation strategy for the applicable listed drug is 
                modified.
    ``(j) Drug Safety Oversight Board.--
            ``(1) In general.--There is established a Drug Safety 
        Oversight Board.
            ``(2) Composition; meetings.--The Drug Safety Oversight 
        Board shall--
                    ``(A) be composed of scientists and health care 
                practitioners appointed by the Secretary, each of whom 
                is an employee of the Federal Government;
                    ``(B) include representatives from offices 
                throughout the Food and Drug Administration, including 
                the offices responsible for postapproval safety of 
                drugs;
                    ``(C) include at least 1 representative each from 
                the National Institutes of Health and the Department of 
                Health and Human Services (other than the Food and Drug 
                Administration);
                    ``(D) include such representatives as the Secretary 
                shall designate from other appropriate agencies that 
                wish to provide representatives; and
                    ``(E) meet at least monthly to provide oversight 
                and advice to the Secretary on the management of 
                important drug safety issues.''.
    (c) Regulation of Biological Products.--Section 351 of the Public 
Health Service Act (42 U.S.C. 262) is amended--
            (1) in subsection (a)(2), by adding at the end the 
        following:
    ``(D) Postmarket Studies and Clinical Trials; Labeling; Risk 
Evaluation and Mitigation Strategy.--A person that submits an 
application for a license under this paragraph is subject to sections 
505(o), 505(p), and 505-1 of the Federal Food, Drug, and Cosmetic 
Act.''; and
            (2) in subsection (j), by inserting ``, including the 
        requirements under sections 505(o), 505(p), and 505-1 of such 
        Act,'' after ``, and Cosmetic Act''.
    (d) Advertisements of Drugs.--The Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.), as amended by section 801(b), is amended--
            (1) in section 301 (21 U.S.C. 331), by adding at the end 
        the following:
    ``(kk) The dissemination of a television advertisement without 
complying with section 503B.''; and
            (2) by inserting after section 503A the following:

``SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS.

    ``(a) In General.--The Secretary may require the submission of any 
television advertisement for a drug (including any script, story board, 
rough, or a completed video production of the television advertisement) 
to the Secretary for review under this section not later than 45 days 
before dissemination of the television advertisement.
    ``(b) Review.--In conducting a review of a television advertisement 
under this section, the Secretary may make recommendations with respect 
to information included in the label of the drug--
            ``(1) on changes that are--
                    ``(A) necessary to protect the consumer good and 
                well-being; or
                    ``(B) consistent with prescribing information for 
                the product under review; and
            ``(2) if appropriate and if information exists, on 
        statements for inclusion in the advertisement to address the 
        specific efficacy of the drug as it relates to specific 
        population groups, including elderly populations, children, and 
        racial and ethnic minorities.
    ``(c) No Authority to Require Changes.--Except as provided by 
subsection (e), this section does not authorize the Secretary to make 
or direct changes in any material submitted pursuant to subsection (a).
    ``(d) Elderly Populations, Children, Racially and Ethnically 
Diverse Communities.--In formulating recommendations under subsection 
(b), the Secretary shall take into consideration the impact of the 
advertised drug on elderly populations, children, and racially and 
ethnically diverse communities.
    ``(e) Specific Disclosures.--
            ``(1) Serious risk; safety protocol.--In conducting a 
        review of a television advertisement under this section, if the 
        Secretary determines that the advertisement would be false or 
        misleading without a specific disclosure about a serious risk 
        listed in the labeling of the drug involved, the Secretary may 
        require inclusion of such disclosure in the advertisement.
            ``(2) Date of approval.--In conducting a review of a 
        television advertisement under this section, the Secretary may 
        require the advertisement to include, for a period not to 
        exceed 2 years from the date of the approval of the drug under 
        section 505 or section 351 of the Public Health Service Act, a 
        specific disclosure of such date of approval if the Secretary 
        determines that the advertisement would otherwise be false or 
        misleading.
    ``(f) Rule of Construction.--Nothing in this section may be 
construed as having any effect on requirements under section 502(n) or 
on the authority of the Secretary under section 314.550, 314.640, 
601.45, or 601.94 of title 21, Code of Federal Regulations (or 
successor regulations).''.
            (3) Direct-to-consumer advertisements.--
                    (A) In general.--Section 502(n) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is 
                amended by adding at the end the following: ``In the 
                case of an advertisement for a drug subject to section 
                503(b)(1) presented directly to consumers in television 
                or radio format and stating the name of the drug and 
                its conditions of use, the major statement relating to 
                side effects and contraindications shall be presented 
                in a clear, conspicuous, and neutral manner.''.
                    (B) Regulations to determine clear, conspicuous, 
                and neutral manner.--Not later than 30 months after the 
                date of the enactment of the Food and Drug 
                Administration Amendments Act of 2007, the Secretary of 
                Health and Human Services shall by regulation establish 
                standards for determining whether a major statement 
                relating to side effects and contraindications of a 
                drug, described in section 502(n) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 352(n)) (as amended 
                by subparagraph (A)) is presented in the manner 
                required under such section.
            (4) Civil penalties.--Section 303 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 333), as amended by section 
        801(b), is amended by adding at the end the following:
    ``(g)(1) With respect to a person who is a holder of an approved 
application under section 505 for a drug subject to section 503(b) or 
under section 351 of the Public Health Service Act, any such person who 
disseminates or causes another party to disseminate a direct-to-
consumer advertisement that is false or misleading shall be liable to 
the United States for a civil penalty in an amount not to exceed 
$250,000 for the first such violation in any 3-year period, and not to 
exceed $500,000 for each subsequent violation in any 3-year period. No 
other civil monetary penalties in this Act (including the civil penalty 
in section 303(f)(4)) shall apply to a violation regarding direct-to-
consumer advertising. For purposes of this paragraph: (A) Repeated 
dissemination of the same or similar advertisement prior to the receipt 
of the written notice referred to in paragraph (2) for such 
advertisements shall be considered one violation. (B) On and after the 
date of the receipt of such a notice, all violations under this 
paragraph occurring in a single day shall be considered one violation. 
With respect to advertisements that appear in magazines or other 
publications that are published less frequently than daily, each issue 
date (whether weekly or monthly) shall be treated as a single day for 
the purpose of calculating the number of violations under this 
paragraph.
    ``(2) A civil penalty under paragraph (1) shall be assessed by the 
Secretary by an order made on the record after providing written notice 
to the person to be assessed a civil penalty and an opportunity for a 
hearing in accordance with this paragraph and section 554 of title 5, 
United States Code. If upon receipt of the written notice, the person 
to be assessed a civil penalty objects and requests a hearing, then in 
the course of any investigation related to such hearing, the Secretary 
may issue subpoenas requiring the attendance and testimony of witnesses 
and the production of evidence that relates to the matter under 
investigation, including information pertaining to the factors 
described in paragraph (3).
    ``(3) The Secretary, in determining the amount of the civil penalty 
under paragraph (1), shall take into account the nature, circumstances, 
extent, and gravity of the violation or violations, including the 
following factors:
            ``(A) Whether the person submitted the advertisement or a 
        similar advertisement for review under section 736A.
            ``(B) Whether the person submitted the advertisement for 
        review if required under section 503B.
            ``(C) Whether, after submission of the advertisement as 
        described in subparagraph (A) or (B), the person disseminated 
        or caused another party to disseminate the advertisement before 
        the end of the 45-day comment period.
            ``(D) Whether the person incorporated any comments made by 
        the Secretary with regard to the advertisement into the 
        advertisement prior to its dissemination.
            ``(E) Whether the person ceased distribution of the 
        advertisement upon receipt of the written notice referred to in 
        paragraph (2) for such advertisement.
            ``(F) Whether the person had the advertisement reviewed by 
        qualified medical, regulatory, and legal reviewers prior to its 
        dissemination.
            ``(G) Whether the violations were material.
            ``(H) Whether the person who created the advertisement or 
        caused the advertisement to be created acted in good faith.
            ``(I) Whether the person who created the advertisement or 
        caused the advertisement to be created has been assessed a 
        civil penalty under this provision within the previous 1-year 
        period.
            ``(J) The scope and extent of any voluntary, subsequent 
        remedial action by the person.
            ``(K) Such other matters, as justice may require.
    ``(4)(A) Subject to subparagraph (B), no person shall be required 
to pay a civil penalty under paragraph (1) if the person submitted the 
advertisement to the Secretary and disseminated or caused another party 
to disseminate such advertisement after incorporating each comment 
received from the Secretary.
    ``(B) The Secretary may retract or modify any prior comments the 
Secretary has provided to an advertisement submitted to the Secretary 
based on new information or changed circumstances, so long as the 
Secretary provides written notice to the person of the new views of the 
Secretary on the advertisement and provides a reasonable time for 
modification or correction of the advertisement prior to seeking any 
civil penalty under paragraph (1).
    ``(5) The Secretary may compromise, modify, or remit, with or 
without conditions, any civil penalty which may be assessed under 
paragraph (1). The amount of such penalty, when finally determined, or 
the amount charged upon in compromise, may be deducted from any sums 
owed by the United States to the person charged.
    ``(6) Any person who requested, in accordance with paragraph (2), a 
hearing with respect to the assessment of a civil penalty and who is 
aggrieved by an order assessing a civil penalty, may file a petition 
for de novo judicial review of such order with the United States Court 
of Appeals for the District of Columbia Circuit or for any other 
circuit in which such person resides or transacts business. Such a 
petition may only be filed within the 60-day period beginning on the 
date the order making such assessments was issued.
    ``(7) If any person fails to pay an assessment of a civil penalty 
under paragraph (1)--
            ``(A) after the order making the assessment becomes final, 
        and if such person does not file a petition for judicial review 
        of the order in accordance with paragraph (6), or
            ``(B) after a court in an action brought under paragraph 
        (6) has entered a final judgment in favor of the Secretary,
the Attorney General of the United States shall recover the amount 
assessed (plus interest at currently prevailing rates from the date of 
the expiration of the 60-day period referred to in paragraph (6) or the 
date of such final judgment, as the case may be) in an action brought 
in any appropriate district court of the United States. In such an 
action, the validity, amount, and appropriateness of such penalty shall 
not be subject to review.''.
            (5) Report on direct-to-consumer advertising.--Not later 
        than 24 months after the date of the enactment of this Act, the 
        Secretary of Health and Human Services shall report to the 
        Congress on direct-to-consumer advertising and its ability to 
        communicate to subsets of the general population, including 
        elderly populations, children, and racial and ethnic minority 
        communities. The Secretary shall utilize the Advisory Committee 
        on Risk Communication established under this Act to advise the 
        Secretary with respect to such report. The Advisory Committee 
        shall study direct-to-consumer advertising as it relates to 
        increased access to health information and decreased health 
        disparities for these populations. The report required by this 
        paragraph shall recommend effective ways to present and 
        disseminate information to these populations. Such report shall 
        also make recommendations regarding impediments to the 
        participation of elderly populations, children, racially and 
        ethnically diverse communities, and medically underserved 
        populations in clinical drug trials and shall recommend best 
        practice approaches for increasing the inclusion of such 
        subsets of the general population. The Secretary of Health and 
        Human Services shall submit the report under this paragraph to 
        the Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives.
            (6) Rulemaking.--Section 502(n) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 352(n)) is amended by striking 
        ``the procedure specified in section 701(e) of this Act'' and 
        inserting ``section 701(a)''.
    (e) Rule of Construction Regarding Pediatric Studies.--This title 
and the amendments made by this title may not be construed as affecting 
the authority of the Secretary of Health and Human Services to request 
pediatric studies under section 505A of the Federal Food, Drug, and 
Cosmetic Act or to require such studies under section 505B of such Act.

SEC. 902. ENFORCEMENT.

    (a) Misbranding.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(y) If it is a drug subject to an approved risk evaluation and 
mitigation strategy pursuant to section 505(p) and the responsible 
person (as such term is used in section 505-1) fails to comply with a 
requirement of such strategy provided for under subsection (d), (e), or 
(f) of section 505-1.
    ``(z) If it is a drug, and the responsible person (as such term is 
used in section 505(o)) is in violation of a requirement established 
under paragraph (3) (relating to postmarket studies and clinical 
trials) or paragraph (4) (relating to labeling) of section 505(o) with 
respect to such drug.''.
    (b) Civil Penalties.--Section 303(f) of the Federal Food, Drug, and 
Cosmetic Act, as amended by section 801(b), is amended--
            (1) by inserting after paragraph (3), as added by section 
        801(b)(2), the following:
    ``(4)(A) Any responsible person (as such term is used in section 
505-1) that violates a requirement of section 505(o), 505(p), or 505-1 
shall be subject to a civil monetary penalty of--
            ``(i) not more than $250,000 per violation, and not to 
        exceed $1,000,000 for all such violations adjudicated in a 
        single proceeding; or
            ``(ii) in the case of a violation that continues after the 
        Secretary provides written notice to the responsible person, 
        the responsible person shall be subject to a civil monetary 
        penalty of $250,000 for the first 30-day period (or any portion 
        thereof) that the responsible person continues to be in 
        violation, and such amount shall double for every 30-day period 
        thereafter that the violation continues, not to exceed 
        $1,000,000 for any 30-day period, and not to exceed $10,000,000 
        for all such violations adjudicated in a single proceeding.
    ``(B) In determining the amount of a civil penalty under 
subparagraph (A)(ii), the Secretary shall take into consideration 
whether the responsible person is making efforts toward correcting the 
violation of the requirement of section 505(o), 505(p), or 505-1 for 
which the responsible person is subject to such civil penalty.''; and
            (2) in paragraph (5), as redesignated by section 
        801(b)(2)(A), by striking ``paragraph (1), (2), or (3)'' each 
        place it appears and inserting ``paragraph (1), (2), (3), or 
        (4)''.

SEC. 903. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL.

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

SEC. 904. BENEFIT-RISK ASSESSMENTS.

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

SEC. 905. ACTIVE POSTMARKET RISK IDENTIFICATION AND ANALYSIS.

    (a) In General.--Subsection (k) of section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end 
the following:
            ``(3) Active postmarket risk identification.--
                    ``(A) Definition.--In this paragraph, the term 
                `data' refers to information with respect to a drug 
                approved under this section or under section 351 of the 
                Public Health Service Act, including claims data, 
                patient survey data, standardized analytic files that 
                allow for the pooling and analysis of data from 
                disparate data environments, and any other data deemed 
                appropriate by the Secretary.
                    ``(B) Development of postmarket risk identification 
                and analysis methods.--The Secretary shall, not later 
                than 2 years after the date of the enactment of the 
                Food and Drug Administration Amendments Act of 2007, in 
                collaboration with public, academic, and private 
                entities--
                            ``(i) develop methods to obtain access to 
                        disparate data sources including the data 
                        sources specified in subparagraph (C);
                            ``(ii) develop validated methods for the 
                        establishment of a postmarket risk 
                        identification and analysis system to link and 
                        analyze safety data from multiple sources, with 
                        the goals of including, in aggregate--
                                    ``(I) at least 25,000,000 patients 
                                by July 1, 2010; and
                                    ``(II) at least 100,000,000 
                                patients by July 1, 2012; and
                            ``(iii) convene a committee of experts, 
                        including individuals who are recognized in the 
                        field of protecting data privacy and security, 
                        to make recommendations to the Secretary on the 
                        development of tools and methods for the 
                        ethical and scientific uses for, and 
                        communication of, postmarketing data specified 
                        under subparagraph (C), including 
                        recommendations on the development of effective 
                        research methods for the study of drug safety 
                        questions.
                    ``(C) Establishment of the postmarket risk 
                identification and analysis system.--
                            ``(i) In general.--The Secretary shall, not 
                        later than 1 year after the development of the 
                        risk identification and analysis methods under 
                        subparagraph (B), establish and maintain 
                        procedures--
                                    ``(I) for risk identification and 
                                analysis based on electronic health 
                                data, in compliance with the 
                                regulations promulgated under section 
                                264(c) of the Health Insurance 
                                Portability and Accountability Act of 
                                1996, and in a manner that does not 
                                disclose individually identifiable 
                                health information in violation of 
                                paragraph (4)(B);
                                    ``(II) for the reporting (in a 
                                standardized form) of data on all 
                                serious adverse drug experiences (as 
                                defined in section 505-1(b)) submitted 
                                to the Secretary under paragraph (1), 
                                and those adverse events submitted by 
                                patients, providers, and drug sponsors, 
                                when appropriate;
                                    ``(III) to provide for active 
                                adverse event surveillance using the 
                                following data sources, as available:
                                            ``(aa) Federal health-
                                        related electronic data (such 
                                        as data from the Medicare 
                                        program and the health systems 
                                        of the Department of Veterans 
                                        Affairs);
                                            ``(bb) private sector 
                                        health-related electronic data 
                                        (such as pharmaceutical 
                                        purchase data and health 
                                        insurance claims data); and
                                            ``(cc) other data as the 
                                        Secretary deems necessary to 
                                        create a robust system to 
                                        identify adverse events and 
                                        potential drug safety signals;
                                    ``(IV) to identify certain trends 
                                and patterns with respect to data 
                                accessed by the system;
                                    ``(V) to provide regular reports to 
                                the Secretary concerning adverse event 
                                trends, adverse event patterns, 
                                incidence and prevalence of adverse 
                                events, and other information the 
                                Secretary determines appropriate, which 
                                may include data on comparative 
                                national adverse event trends; and
                                    ``(VI) to enable the program to 
                                export data in a form appropriate for 
                                further aggregation, statistical 
                                analysis, and reporting.
                            ``(ii) Timeliness of reporting.--The 
                        procedures established under clause (i) shall 
                        ensure that such data are accessed, analyzed, 
                        and reported in a timely, routine, and 
                        systematic manner, taking into consideration 
                        the need for data completeness, coding, 
                        cleansing, and standardized analysis and 
                        transmission.
                            ``(iii) Private sector resources.--To 
                        ensure the establishment of the active 
                        postmarket risk identification and analysis 
                        system under this subsection not later than 1 
                        year after the development of the risk 
                        identification and analysis methods under 
                        subparagraph (B), as required under clause (i), 
                        the Secretary may, on a temporary or permanent 
                        basis, implement systems or products developed 
                        by private entities.
                            ``(iv) Complementary approaches.--To the 
                        extent the active postmarket risk 
                        identification and analysis system under this 
                        subsection is not sufficient to gather data and 
                        information relevant to a priority drug safety 
                        question, the Secretary shall develop, support, 
                        and participate in complementary approaches to 
                        gather and analyze such data and information, 
                        including--
                                    ``(I) approaches that are 
                                complementary with respect to assessing 
                                the safety of use of a drug in domestic 
                                populations not included, or 
                                underrepresented, in the trials used to 
                                approve the drug (such as older people, 
                                people with comorbidities, pregnant 
                                women, or children); and
                                    ``(II) existing approaches such as 
                                the Vaccine Adverse Event Reporting 
                                System and the Vaccine Safety Datalink 
                                or successor databases.
                            ``(v) Authority for contracts.--The 
                        Secretary may enter into contracts with public 
                        and private entities to fulfill the 
                        requirements of this subparagraph.
            ``(4) Advanced analysis of drug safety data.--
                    ``(A) Purpose.--The Secretary shall establish 
                collaborations with public, academic, and private 
                entities, which may include the Centers for Education 
                and Research on Therapeutics under section 912 of the 
                Public Health Service Act, to provide for advanced 
                analysis of drug safety data described in paragraph 
                (3)(C) and other information that is publicly available 
                or is provided by the Secretary, in order to--
                            ``(i) improve the quality and efficiency of 
                        postmarket drug safety risk-benefit analysis;
                            ``(ii) provide the Secretary with routine 
                        access to outside expertise to study advanced 
                        drug safety questions; and
                            ``(iii) enhance the ability of the 
                        Secretary to make timely assessments based on 
                        drug safety data.
                    ``(B) Privacy.--Such analysis shall not disclose 
                individually identifiable health information when 
                presenting such drug safety signals and trends or when 
                responding to inquiries regarding such drug safety 
                signals and trends.
                    ``(C) Public process for priority questions.--At 
                least biannually, the Secretary shall seek 
                recommendations from the Drug Safety and Risk 
                Management Advisory Committee (or any successor 
                committee) and from other advisory committees, as 
                appropriate, to the Food and Drug Administration on--
                            ``(i) priority drug safety questions; and
                            ``(ii) mechanisms for answering such 
                        questions, including through--
                                    ``(I) active risk identification 
                                under paragraph (3); and
                                    ``(II) when such risk 
                                identification is not sufficient, 
                                postapproval studies and clinical 
                                trials under subsection (o)(3).
                    ``(D) Procedures for the development of drug safety 
                collaborations.--
                            ``(i) In general.--Not later than 180 days 
                        after the date of the establishment of the 
                        active postmarket risk identification and 
                        analysis system under this subsection, the 
                        Secretary shall establish and implement 
                        procedures under which the Secretary may 
                        routinely contract with one or more qualified 
                        entities to--
                                    ``(I) classify, analyze, or 
                                aggregate data described in paragraph 
                                (3)(C) and information that is publicly 
                                available or is provided by the 
                                Secretary;
                                    ``(II) allow for prompt 
                                investigation of priority drug safety 
                                questions, including--
                                            ``(aa) unresolved safety 
                                        questions for drugs or classes 
                                        of drugs; and
                                            ``(bb) for a newly-approved 
                                        drugs, safety signals from 
                                        clinical trials used to approve 
                                        the drug and other preapproval 
                                        trials; rare, serious drug side 
                                        effects; and the safety of use 
                                        in domestic populations not 
                                        included, or underrepresented, 
                                        in the trials used to approve 
                                        the drug (such as older people, 
                                        people with comorbidities, 
                                        pregnant women, or children);
                                    ``(III) perform advanced research 
                                and analysis on identified drug safety 
                                risks;
                                    ``(IV) focus postapproval studies 
                                and clinical trials under subsection 
                                (o)(3) more effectively on cases for 
                                which reports under paragraph (1) and 
                                other safety signal detection is not 
                                sufficient to resolve whether there is 
                                an elevated risk of a serious adverse 
                                event associated with the use of a 
                                drug; and
                                    ``(V) carry out other activities as 
                                the Secretary deems necessary to carry 
                                out the purposes of this paragraph.
                            ``(ii) Request for specific methodology.--
                        The procedures described in clause (i) shall 
                        permit the Secretary to request that a specific 
                        methodology be used by the qualified entity. 
                        The qualified entity shall work with the 
                        Secretary to finalize the methodology to be 
                        used.
                    ``(E) Use of analyses.--The Secretary shall provide 
                the analyses described in this paragraph, including the 
                methods and results of such analyses, about a drug to 
                the sponsor or sponsors of such drug.
                    ``(F) Qualified entities.--
                            ``(i) In general.--The Secretary shall 
                        enter into contracts with a sufficient number 
                        of qualified entities to develop and provide 
                        information to the Secretary in a timely 
                        manner.
                            ``(ii) Qualification.--The Secretary shall 
                        enter into a contract with an entity under 
                        clause (i) only if the Secretary determines 
                        that the entity has a significant presence in 
                        the United States and has one or more of the 
                        following qualifications:
                                    ``(I) The research, statistical, 
                                epidemiologic, or clinical capability 
                                and expertise to conduct and complete 
                                the activities under this paragraph, 
                                including the capability and expertise 
                                to provide the Secretary de-identified 
                                data consistent with the requirements 
                                of this subsection.
                                    ``(II) An information technology 
                                infrastructure in place to support 
                                electronic data and operational 
                                standards to provide security for such 
                                data.
                                    ``(III) Experience with, and 
                                expertise on, the development of drug 
                                safety and effectiveness research using 
                                electronic population data.
                                    ``(IV) An understanding of drug 
                                development or risk/benefit balancing 
                                in a clinical setting.
                                    ``(V) Other expertise which the 
                                Secretary deems necessary to fulfill 
                                the activities under this paragraph.
                    ``(G) Contract requirements.--Each contract with a 
                qualified entity under subparagraph (F)(i) shall 
                contain the following requirements:
                            ``(i) Ensuring privacy.--The qualified 
                        entity shall ensure that the entity will not 
                        use data under this subsection in a manner 
                        that--
                                    ``(I) violates the regulations 
                                promulgated under section 264(c) of the 
                                Health Insurance Portability and 
                                Accountability Act of 1996;
                                    ``(II) violates sections 552 or 
                                552a of title 5, United States Code, 
                                with regard to the privacy of 
                                individually-identifiable beneficiary 
                                health information; or
                                    ``(III) discloses individually 
                                identifiable health information when 
                                presenting drug safety signals and 
                                trends or when responding to inquiries 
                                regarding drug safety signals and 
                                trends.
                        Nothing in this clause prohibits lawful 
                        disclosure for other purposes.
                            ``(ii) Component of another organization.--
                        If a qualified entity is a component of another 
                        organization--
                                    ``(I) the qualified entity shall 
                                establish appropriate security measures 
                                to maintain the confidentiality and 
                                privacy of such data; and
                                    ``(II) the entity shall not make an 
                                unauthorized disclosure of such data to 
                                the other components of the 
                                organization in breach of such 
                                confidentiality and privacy 
                                requirement.
                            ``(iii) Termination or nonrenewal.--If a 
                        contract with a qualified entity under this 
                        subparagraph is terminated or not renewed, the 
                        following requirements shall apply:
                                    ``(I) Confidentiality and privacy 
                                protections.--The entity shall continue 
                                to comply with the confidentiality and 
                                privacy requirements under this 
                                paragraph with respect to all data 
                                disclosed to the entity.
                                    ``(II) Disposition of data.--The 
                                entity shall return any data disclosed 
                                to such entity under this subsection to 
                                which it would not otherwise have 
                                access or, if returning the data is not 
                                practicable, destroy the data.
                    ``(H) Competitive procedures.--The Secretary shall 
                use competitive procedures (as defined in section 4(5) 
                of the Federal Procurement Policy Act) to enter into 
                contracts under subparagraph (G).
                    ``(I) Review of contract in the event of a merger 
                or acquisition.--The Secretary shall review the 
                contract with a qualified entity under this paragraph 
                in the event of a merger or acquisition of the entity 
                in order to ensure that the requirements under this 
                paragraph will continue to be met.
                    ``(J) Coordination.--In carrying out this 
                paragraph, the Secretary shall provide for appropriate 
                communications to the public, scientific, public 
                health, and medical communities, and other key 
                stakeholders, and to the extent practicable shall 
                coordinate with the activities of private entities, 
                professional associations, or other entities that may 
                have sources of drug safety data.''.
    (b) Rule of Construction.--Nothing in this section or the amendment 
made by this section shall be construed to prohibit the lawful 
disclosure or use of data or information by an entity other than as 
described in paragraph (4)(B) or (4)(G) of section 505(k) of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection (a).
    (c) Report to Congress.--Not later than 4 years after the date of 
the enactment of this Act, the Secretary shall report to the Congress 
on the ways in which the Secretary has used the active postmarket risk 
identification and analysis system described in paragraphs (3) and (4) 
of section 505(k) of the Federal Food, Drug, and Cosmetic Act, as added 
by subsection (a), to identify specific drug safety signals and to 
better understand the outcomes associated with drugs marketed in the 
United States.
    (d) Authorization of Appropriations.--To carry out activities under 
the amendment made by this section for which funds are made available 
under section 736 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379h), there are authorized to be appropriated to carry out the 
amendment made by this section, in addition to such funds, $25,000,000 
for each of fiscal years 2008 through 2012.
    (e) GAO Report.--Not later than 18 months after the date of the 
enactment of this Act, the Comptroller General of the United States 
shall evaluate data privacy, confidentiality, and security issues 
relating to accessing, transmitting, and maintaining data for the 
active postmarket risk identification and analysis system described in 
paragraphs (3) and (4) of section 505(k) of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), and make recommendations to 
the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor and Pensions of the 
Senate, and any other congressional committees of relevant 
jurisdiction, regarding the need for any additional legislative or 
regulatory actions to ensure privacy, confidentiality, and security of 
this data or otherwise address privacy, confidentiality, and security 
issues to ensure the effective operation of such active postmarket 
identification and analysis system.

SEC. 906. STATEMENT FOR INCLUSION IN DIRECT-TO-CONSUMER ADVERTISEMENTS 
              OF DRUGS.

    (a) Published Direct-to-Consumer Advertisements.--Section 502(n) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352), as amended by 
section 901(d)(6), is further amended by inserting ``and in the case of 
published direct-to-consumer advertisements the following statement 
printed in conspicuous text: `You are encouraged to report negative 
side effects of prescription drugs to the FDA. Visit www.fda.gov/
medwatch, or call 1-800-FDA-1088.','' after ``section 701(a),''.
    (b) Study.--
            (1) In general.--In the case of direct-to-consumer 
        television advertisements, the Secretary of Health and Human 
        Services, in consultation with the Advisory Committee on Risk 
        Communication under section 567 of the Federal Food, Drug, and 
        Cosmetic Act (as added by section 917), shall, not later than 6 
        months after the date of the enactment of this Act, conduct a 
        study to determine if the statement in section 502(n) of such 
        Act (as added by subsection (a)) required with respect to 
        published direct-to-consumer advertisements is appropriate for 
        inclusion in such television advertisements.
            (2) Content.--As part of the study under paragraph (1), 
        such Secretary shall consider whether the information in the 
        statement described in paragraph (1) would detract from the 
        presentation of risk information in a direct-to-consumer 
        television advertisement. If such Secretary determines the 
        inclusion of such statement is appropriate in direct-to-
        consumer television advertisements, such Secretary shall issue 
        regulations requiring the implementation of such statement in 
        direct-to-consumer television advertisements, including 
        determining a reasonable length of time for displaying the 
        statement in such advertisements. The Secretary shall report to 
        the appropriate committees of Congress the findings of such 
        study and any plans to issue regulations under this paragraph.

SEC. 907. NO EFFECT ON VETERINARY MEDICINE.

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

SEC. 908. AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--For carrying out this subtitle and the amendments 
made by this subtitle, there is authorized to be appropriated 
$25,000,000 for each of fiscal years 2008 through 2012.
    (b) Relation to Other Funding.--The authorization of appropriations 
under subsection (a) is in addition to any other funds available for 
carrying out this subtitle and the amendments made by this subtitle.

SEC. 909. EFFECTIVE DATE AND APPLICABILITY.

    (a) Effective Date.--This subtitle takes effect 180 days after the 
date of the enactment of this Act.
    (b) Drugs Deemed to Have Risk Evaluation and Mitigation 
Strategies.--
            (1) In general.--A drug that was approved before the 
        effective date of this Act is, in accordance with paragraph 
        (2), deemed to have in effect an approved risk evaluation and 
        mitigation strategy under section 505-1 of the Federal Food, 
        Drug, and Cosmetic Act (as added by section 901) (referred to 
        in this section as the ``Act'') if there are in effect on the 
        effective date of this Act elements to assure safe use--
                    (A) required under section 314.520 or section 
                601.42 of title 21, Code of Federal Regulations; or
                    (B) otherwise agreed to by the applicant and the 
                Secretary for such drug.
            (2) Elements of strategy; enforcement.--The approved risk 
        evaluation and mitigation strategy in effect for a drug under 
        paragraph (1)--
                    (A) is deemed to consist of the timetable required 
                under section 505-1(d) and any additional elements 
                under subsections (e) and (f) of such section in effect 
                for such drug on the effective date of this Act; and
                    (B) is subject to enforcement by the Secretary to 
                the same extent as any other risk evaluation and 
                mitigation strategy under section 505-1 of the Act, 
                except that sections 303(f)(4) and 502(y) and (z) of 
                the Act (as added by section 902) shall not apply to 
                such strategy before the Secretary has completed review 
                of, and acted on, the first assessment of such strategy 
                under such section 505-1.
            (3) Submission.--Not later than 180 days after the 
        effective date of this Act, the holder of an approved 
        application for which a risk evaluation and mitigation strategy 
        is deemed to be in effect under paragraph (1) shall submit to 
        the Secretary a proposed risk evaluation and mitigation 
        strategy. Such proposed strategy is subject to section 505-1 of 
        the Act as if included in such application at the time of 
        submission of the application to the Secretary.

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

SEC. 911. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 510 the following:

``SEC. 511. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS.

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

SEC. 912. PROHIBITION AGAINST FOOD TO WHICH DRUGS OR BIOLOGICAL 
              PRODUCTS HAVE BEEN ADDED.

    (a) Prohibition.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331), as amended by section 901(d), is amended 
by adding at the end the following:
    ``(ll) The introduction or delivery for introduction into 
interstate commerce of any food to which has been added a drug approved 
under section 505, a biological product licensed under section 351 of 
the Public Health Service Act, or a drug or a biological product for 
which substantial clinical investigations have been instituted and for 
which the existence of such investigations has been made public, 
unless--
            ``(1) such drug or such biological product was marketed in 
        food before any approval of the drug under section 505, before 
        licensure of the biological product under such section 351, and 
        before any substantial clinical investigations involving the 
        drug or the biological product have been instituted;
            ``(2) the Secretary, in the Secretary's discretion, has 
        issued a regulation, after notice and comment, approving the 
        use of such drug or such biological product in the food;
            ``(3) the use of the drug or the biological product in the 
        food is to enhance the safety of the food to which the drug or 
        the biological product is added or applied and not to have 
        independent biological or therapeutic effects on humans, and 
        the use is in conformity with--
                    ``(A) a regulation issued under section 409 
                prescribing conditions of safe use in food;
                    ``(B) a regulation listing or affirming conditions 
                under which the use of the drug or the biological 
                product in food is generally recognized as safe;
                    ``(C) the conditions of use identified in a 
                notification to the Secretary of a claim of exemption 
                from the premarket approval requirements for food 
                additives based on the notifier's determination that 
                the use of the drug or the biological product in food 
                is generally recognized as safe, provided that the 
                Secretary has not questioned the general recognition of 
                safety determination in a letter to the notifier;
                    ``(D) a food contact substance notification that is 
                effective under section 409(h); or
                    ``(E) such drug or biological product had been 
                marketed for smoking cessation prior to the date of the 
                enactment of the Food and Drug Administration 
                Amendments Act of 2007; or
            ``(4) the drug is a new animal drug whose use is not unsafe 
        under section 512.''.
    (b) Conforming Changes.--The Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.) is amended--
            (1) in section 304(a)(1), by striking ``section 404 or 
        505'' and inserting ``section 301(ll), 404, or 505''; and
            (2) in section 801(a), by striking ``is adulterated, 
        misbranded, or in violation of section 505,'' and inserting 
        ``is adulterated, misbranded, or in violation of section 505, 
        or prohibited from introduction or delivery for introduction 
        into interstate commerce under section 301(ll),''.

SEC. 913. ASSURING PHARMACEUTICAL SAFETY.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.), as amended in section 403, is amended by inserting after 
section 505C the following:

``SEC. 505D. PHARMACEUTICAL SECURITY.

    ``(a) In General.--The Secretary shall develop standards and 
identify and validate effective technologies for the purpose of 
securing the drug supply chain against counterfeit, diverted, 
subpotent, substandard, adulterated, misbranded, or expired drugs.
    ``(b) Standards Development.--
            ``(1) In general.--The Secretary shall, in consultation 
        with the agencies specified in paragraph (4), manufacturers, 
        distributors, pharmacies, and other supply chain stakeholders, 
        prioritize and develop standards for the identification, 
        validation, authentication, and tracking and tracing of 
        prescription drugs.
            ``(2) Standardized numeral identifier.--Not later than 30 
        months after the date of the enactment of the Food and Drug 
        Administration Amendments Act of 2007, the Secretary shall 
        develop a standardized numerical identifier (which, to the 
        extent practicable, shall be harmonized with international 
        consensus standards for such an identifier) to be applied to a 
        prescription drug at the point of manufacturing and repackaging 
        (in which case the numerical identifier shall be linked to the 
        numerical identifier applied at the point of manufacturing) at 
        the package or pallet level, sufficient to facilitate the 
        identification, validation, authentication, and tracking and 
        tracing of the prescription drug.
            ``(3) Promising technologies.--The standards developed 
        under this subsection shall address promising technologies, 
        which may include--
                    ``(A) radio frequency identification technology;
                    ``(B) nanotechnology;
                    ``(C) encryption technologies; and
                    ``(D) other track-and-trace or authentication 
                technologies.
            ``(4) Interagency collaboration.--In carrying out this 
        subsection, the Secretary shall consult with Federal health and 
        security agencies, including--
                    ``(A) the Department of Justice;
                    ``(B) the Department of Homeland Security;
                    ``(C) the Department of Commerce; and
                    ``(D) other appropriate Federal and State agencies.
    ``(c) Inspection and Enforcement.--
            ``(1) In general.--The Secretary shall expand and enhance 
        the resources and facilities of agency components of the Food 
        and Drug Administration involved with regulatory and criminal 
        enforcement of this Act to secure the drug supply chain against 
        counterfeit, diverted, subpotent, substandard, adulterated, 
        misbranded, or expired drugs including biological products and 
        active pharmaceutical ingredients from domestic and foreign 
        sources.
            ``(2) Activities.--The Secretary shall undertake enhanced 
        and joint enforcement activities with other Federal and State 
        agencies, and establish regional capacities for the validation 
        of prescription drugs and the inspection of the prescription 
        drug supply chain.
    ``(d) Definition.--In this section, the term `prescription drug' 
means a drug subject to section 503(b)(1).''.

SEC. 914. CITIZEN PETITIONS AND PETITIONS FOR STAY OF AGENCY ACTION.

    (a) In General.--Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355), as amended by section 901(a), is amended 
by adding at the end the following:
    ``(q) Petitions and Civil Actions Regarding Approval of Certain 
Applications.--
            ``(1) In general.--
                    ``(A) Determination.--The Secretary shall not delay 
                approval of a pending application submitted under 
                subsection (b)(2) or (j) because of any request to take 
                any form of action relating to the application, either 
                before or during consideration of the request, unless--
                            ``(i) the request is in writing and is a 
                        petition submitted to the Secretary pursuant to 
                        section 10.30 or 10.35 of title 21, Code of 
                        Federal Regulations (or any successor 
                        regulations); and
                            ``(ii) the Secretary determines, upon 
                        reviewing the petition, that a delay is 
                        necessary to protect the public health.
                    ``(B) Notification.--If the Secretary determines 
                under subparagraph (A) that a delay is necessary with 
                respect to an application, the Secretary shall provide 
                to the applicant, not later than 30 days after making 
                such determination, the following information:
                            ``(i) Notification of the fact that a 
                        determination under subparagraph (A) has been 
                        made.
                            ``(ii) If applicable, any clarification or 
                        additional data that the applicant should 
                        submit to the docket on the petition to allow 
                        the Secretary to review the petition promptly.
                            ``(iii) A brief summary of the specific 
                        substantive issues raised in the petition which 
                        form the basis of the determination.
                    ``(C) Format.--The information described in 
                subparagraph (B) shall be conveyed via either, at the 
                discretion of the Secretary--
                            ``(i) a document; or
                            ``(ii) a meeting with the applicant 
                        involved.
                    ``(D) Public disclosure.--Any information conveyed 
                by the Secretary under subparagraph (C) shall be 
                considered part of the application and shall be subject 
                to the disclosure requirements applicable to 
                information in such application.
                    ``(E) Denial based on intent to delay.--If the 
                Secretary determines that a petition or a supplement to 
                the petition was submitted with the primary purpose of 
                delaying the approval of an application and the 
                petition does not on its face raise valid scientific or 
                regulatory issues, the Secretary may deny the petition 
                at any point based on such determination. The Secretary 
                may issue guidance to describe the factors that will be 
                used to determine under this subparagraph whether a 
                petition is submitted with the primary purpose of 
                delaying the approval of an application.
                    ``(F) Final agency action.--The Secretary shall 
                take final agency action on a petition not later than 
                180 days after the date on which the petition is 
                submitted. The Secretary shall not extend such period 
                for any reason, including--
                            ``(i) any determination made under 
                        subparagraph (A);
                            ``(ii) the submission of comments relating 
                        to the petition or supplemental information 
                        supplied by the petitioner; or
                            ``(iii) the consent of the petitioner.
                    ``(G) Extension of 30-month period.--If the filing 
                of an application resulted in first-applicant status 
                under subsection (j)(5)(D)(i)(IV) and approval of the 
                application was delayed because of a petition, the 30-
                month period under such subsection is deemed to be 
                extended by a period of time equal to the period 
                beginning on the date on which the Secretary received 
                the petition and ending on the date of final agency 
                action on the petition (inclusive of such beginning and 
                ending dates), without regard to whether the Secretary 
                grants, in whole or in part, or denies, in whole or in 
                part, the petition.
                    ``(H) Certification.--The Secretary shall not 
                consider a petition for review unless the party 
                submitting such petition does so in written form and 
                the subject document is signed and contains the 
                following certification: `I certify that, to my best 
                knowledge and belief: (a) this petition includes all 
                information and views upon which the petition relies; 
                (b) this petition includes representative data and/or 
                information known to the petitioner which are 
                unfavorable to the petition; and (c) I have taken 
                reasonable steps to ensure that any representative data 
                and/or information which are unfavorable to the 
                petition were disclosed to me. I further certify that 
                the information upon which I have based the action 
                requested herein first became known to the party on 
                whose behalf this petition is submitted on or about the 
                following date: __________. If I received or expect to 
                receive payments, including cash and other forms of 
                consideration, to file this information or its 
                contents, I received or expect to receive those 
                payments from the following persons or organizations: 
                _____________. I verify under penalty of perjury that 
                the foregoing is true and correct as of the date of the 
                submission of this petition.', with the date on which 
                such information first became known to such party and 
                the names of such persons or organizations inserted in 
                the first and second blank space, respectively.
                    ``(I) Verification.--The Secretary shall not accept 
                for review any supplemental information or comments on 
                a petition unless the party submitting such information 
                or comments does so in written form and the subject 
                document is signed and contains the following 
                verification: `I certify that, to my best knowledge and 
                belief: (a) I have not intentionally delayed submission 
                of this document or its contents; and (b) the 
                information upon which I have based the action 
                requested herein first became known to me on or about 
                __________. If I received or expect to receive 
                payments, including cash and other forms of 
                consideration, to file this information or its 
                contents, I received or expect to receive those 
                payments from the following persons or organizations: 
                _____. I verify under penalty of perjury that the 
                foregoing is true and correct as of the date of the 
                submission of this petition.', with the date on which 
                such information first became known to the party and 
                the names of such persons or organizations inserted in 
                the first and second blank space, respectively.
            ``(2) Exhaustion of administrative remedies.--
                    ``(A) Final agency action within 180 days.--The 
                Secretary shall be considered to have taken final 
                agency action on a petition if--
                            ``(i) during the 180-day period referred to 
                        in paragraph (1)(F), the Secretary makes a 
                        final decision within the meaning of section 
                        10.45(d) of title 21, Code of Federal 
                        Regulations (or any successor regulation); or
                            ``(ii) such period expires without the 
                        Secretary having made such a final decision.
                    ``(B) Dismissal of certain civil actions.--If a 
                civil action is filed against the Secretary with 
                respect to any issue raised in the petition before the 
                Secretary has taken final agency action on the petition 
                within the meaning of subparagraph (A), the court shall 
                dismiss without prejudice the action for failure to 
                exhaust administrative remedies.
                    ``(C) Administrative record.--For purposes of 
                judicial review related to the approval of an 
                application for which a petition under paragraph (1) 
                was submitted, the administrative record regarding any 
                issue raised by the petition shall include--
                            ``(i) the petition filed under paragraph 
                        (1) and any supplements and comments thereto;
                            ``(ii) the Secretary's response to such 
                        petition, if issued; and
                            ``(iii) other information, as designated by 
                        the Secretary, related to the Secretary's 
                        determinations regarding the issues raised in 
                        such petition, as long as the information was 
                        considered by the agency no later than the date 
                        of final agency action as defined under 
                        subparagraph (2)(A), and regardless of whether 
                        the Secretary responded to the petition at or 
                        before the approval of the application at issue 
                        in the petition.
            ``(3) Annual report on delays in approvals per petitions.--
        The Secretary shall annually submit to the Congress a report 
        that specifies--
                    ``(A) the number of applications that were approved 
                during the preceding 12-month period;
                    ``(B) the number of such applications whose 
                effective dates were delayed by petitions referred to 
                in paragraph (1) during such period;
                    ``(C) the number of days by which such applications 
                were so delayed; and
                    ``(D) the number of such petitions that were 
                submitted during such period.
            ``(4) Exceptions.--This subsection does not apply to--
                    ``(A) a petition that relates solely to the timing 
                of the approval of an application pursuant to 
                subsection (j)(5)(B)(iv); or
                    ``(B) a petition that is made by the sponsor of an 
                application and that seeks only to have the Secretary 
                take or refrain from taking any form of action with 
                respect to that application.
            ``(5) Definitions.--
                    ``(A) Application.--For purposes of this 
                subsection, the term `application' means an application 
                submitted under subsection (b)(2) or (j).
                    ``(B) Petition.--For purposes of this subsection, 
                other than paragraph (1)(A)(i), the term `petition' 
                means a request described in paragraph (1)(A)(i).''.
    (b) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Secretary of Health and Human Services shall submit a 
report to the Congress on ways to encourage the early submission of 
petitions under section 505(q), as added by subsection (a).

SEC. 915. POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND 
              PROVIDERS.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355), as amended by section 914(a), is amended by adding at the end the 
following:
    ``(r) Postmarket Drug Safety Information for Patients and 
Providers.--
            ``(1) Establishment.--Not later than 1 year after the date 
        of the enactment of the Food and Drug Administration Amendments 
        Act of 2007, the Secretary shall improve the transparency of 
        information about drugs and allow patients and health care 
        providers better access to information about drugs by 
        developing and maintaining an Internet Web site that--
                    ``(A) provides links to drug safety information 
                listed in paragraph (2) for prescription drugs that are 
                approved under this section or licensed under section 
                351 of the Public Health Service Act; and
                    ``(B) improves communication of drug safety 
                information to patients and providers.
            ``(2) Internet web site.--The Secretary shall carry out 
        paragraph (1) by--
                    ``(A) developing and maintaining an accessible, 
                consolidated Internet Web site with easily searchable 
                drug safety information, including the information 
                found on United States Government Internet Web sites, 
                such as the United States National Library of 
                Medicine's Daily Med and Medline Plus Web sites, in 
                addition to other such Web sites maintained by the 
                Secretary;
                    ``(B) ensuring that the information provided on the 
                Internet Web site is comprehensive and includes, when 
                available and appropriate--
                            ``(i) patient labeling and patient 
                        packaging inserts;
                            ``(ii) a link to a list of each drug, 
                        whether approved under this section or licensed 
                        under such section 351, for which a Medication 
                        Guide, as provided for under part 208 of title 
                        21, Code of Federal Regulations (or any 
                        successor regulations), is required;
                            ``(iii) a link to the registry and results 
                        data bank provided for under subsections (i) 
                        and (j) of section 402 of the Public Health 
                        Service Act;
                            ``(iv) the most recent safety information 
                        and alerts issued by the Food and Drug 
                        Administration for drugs approved by the 
                        Secretary under this section, such as product 
                        recalls, warning letters, and import alerts;
                            ``(v) publicly available information about 
                        implemented RiskMAPs and risk evaluation and 
                        mitigation strategies under subsection (o);
                            ``(vi) guidance documents and regulations 
                        related to drug safety; and
                            ``(vii) other material determined 
                        appropriate by the Secretary;
                    ``(C) providing access to summaries of the assessed 
                and aggregated data collected from the active 
                surveillance infrastructure under subsection (k)(3) to 
                provide information of known and serious side-effects 
                for drugs approved under this section or licensed under 
                such section 351;
                    ``(D) preparing, by 18 months after approval of a 
                drug or after use of the drug by 10,000 individuals, 
                whichever is later, a summary analysis of the adverse 
                drug reaction reports received for the drug, including 
                identification of any new risks not previously 
                identified, potential new risks, or known risks 
                reported in unusual number;
                    ``(E) enabling patients, providers, and drug 
                sponsors to submit adverse event reports through the 
                Internet Web site;
                    ``(F) providing educational materials for patients 
                and providers about the appropriate means of disposing 
                of expired, damaged, or unusable medications; and
                    ``(G) supporting initiatives that the Secretary 
                determines to be useful to fulfill the purposes of the 
                Internet Web site.
            ``(3) Posting of drug labeling.--The Secretary shall post 
        on the Internet Web site established under paragraph (1) the 
        approved professional labeling and any required patient 
        labeling of a drug approved under this section or licensed 
        under such section 351 not later than 21 days after the date 
        the drug is approved or licensed, including in a supplemental 
        application with respect to a labeling change.
            ``(4) Private sector resources.--To ensure development of 
        the Internet Web site by the date described in paragraph (1), 
        the Secretary may, on a temporary or permanent basis, implement 
        systems or products developed by private entities.
            ``(5) Authority for contracts.--The Secretary may enter 
        into contracts with public and private entities to fulfill the 
        requirements of this subsection.
            ``(6) Review.--The Advisory Committee on Risk Communication 
        under section 567 shall, on a regular basis, perform a 
        comprehensive review and evaluation of the types of risk 
        communication information provided on the Internet Web site 
        established under paragraph (1) and, through other means, shall 
        identify, clarify, and define the purposes and types of 
        information available to facilitate the efficient flow of 
        information to patients and providers, and shall recommend ways 
        for the Food and Drug Administration to work with outside 
        entities to help facilitate the dispensing of risk 
        communication information to patients and providers.''.

SEC. 916. ACTION PACKAGE FOR APPROVAL.

    Section 505(l) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(l)) is amended by--
            (1) redesignating paragraphs (1), (2), (3), (4), and (5) as 
        subparagraphs (A), (B), (C), (D), and (E), respectively;
            (2) striking ``(l) Safety and'' and inserting ``(l)(1) 
        Safety and''; and
            (3) adding at the end the following:
    ``(2) Action Package for Approval.--
            ``(A) Action package.--The Secretary shall publish the 
        action package for approval of an application under subsection 
        (b) or section 351 of the Public Health Service Act on the 
        Internet Web site of the Food and Drug Administration--
                    ``(i) not later than 30 days after the date of 
                approval of such application for a drug no active 
                ingredient (including any ester or salt of the active 
                ingredient) of which has been approved in any other 
                application under this section or section 351 of the 
                Public Health Service Act; and
                    ``(ii) not later than 30 days after the third 
                request for such action package for approval received 
                under section 552 of title 5, United States Code, for 
                any other drug.
            ``(B) Immediate publication of summary review.--
        Notwithstanding subparagraph (A), the Secretary shall publish, 
        on the Internet Web site of the Food and Drug Administration, 
        the materials described in subparagraph (C)(iv) not later than 
        48 hours after the date of approval of the drug, except where 
        such materials require redaction by the Secretary.
            ``(C) Contents.--An action package for approval of an 
        application under subparagraph (A) shall be dated and shall 
        include the following:
                    ``(i) Documents generated by the Food and Drug 
                Administration related to review of the application.
                    ``(ii) Documents pertaining to the format and 
                content of the application generated during drug 
                development.
                    ``(iii) Labeling submitted by the applicant.
                    ``(iv) A summary review that documents conclusions 
                from all reviewing disciplines about the drug, noting 
                any critical issues and disagreements with the 
                applicant and within the review team and how they were 
                resolved, recommendations for action, and an 
                explanation of any nonconcurrence with review 
                conclusions.
                    ``(v) The Division Director and Office Director's 
                decision document which includes--
                            ``(I) a brief statement of concurrence with 
                        the summary review;
                            ``(II) a separate review or addendum to the 
                        review if disagreeing with the summary review; 
                        and
                            ``(III) a separate review or addendum to 
                        the review to add further analysis.
                    ``(vi) Identification by name of each officer or 
                employee of the Food and Drug Administration who--
                            ``(I) participated in the decision to 
                        approve the application; and
                            ``(II) consents to have his or her name 
                        included in the package.
            ``(D) Review.--A scientific review of an application is 
        considered the work of the reviewer and shall not be altered by 
        management or the reviewer once final.
            ``(E) Confidential information.--This paragraph does not 
        authorize the disclosure of any trade secret, confidential 
        commercial or financial information, or other matter listed in 
        section 552(b) of title 5, United States Code.''.

SEC. 917. RISK COMMUNICATION.

    Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb et seq.), as amended by section 603, is amended 
by adding at the end the following:

``SEC. 567. RISK COMMUNICATION.

    ``(a) Advisory Committee on Risk Communication.--
            ``(1) In general.--The Secretary shall establish an 
        advisory committee to be known as the `Advisory Committee on 
        Risk Communication' (referred to in this section as the 
        `Committee').
            ``(2) Duties of committee.--The Committee shall advise the 
        Commissioner on methods to effectively communicate risks 
        associated with the products regulated by the Food and Drug 
        Administration.
            ``(3) Members.--The Secretary shall ensure that the 
        Committee is composed of experts on risk communication, experts 
        on the risks described in subsection (b), and representatives 
        of patient, consumer, and health professional organizations.
            ``(4) Permanence of committee.--Section 14 of the Federal 
        Advisory Committee Act shall not apply to the Committee 
        established under this subsection.
    ``(b) Partnerships for Risk Communication.--
            ``(1) In general.--The Secretary shall partner with 
        professional medical societies, medical schools, academic 
        medical centers, and other stakeholders to develop robust and 
        multi-faceted systems for communication to health care 
        providers about emerging postmarket drug risks.
            ``(2) Partnerships.--The systems developed under paragraph 
        (1) shall--
                    ``(A) account for the diversity among physicians in 
                terms of practice, willingness to adopt technology, and 
                medical specialty; and
                    ``(B) include the use of existing communication 
                channels, including electronic communications, in place 
                at the Food and Drug Administration.''.

SEC. 918. REFERRAL TO ADVISORY COMMITTEE.

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

SEC. 919. RESPONSE TO THE INSTITUTE OF MEDICINE.

    (a) In General.--Not later than 1 year after the date of the 
enactment of this title, the Secretary shall issue a report responding 
to the 2006 report of the Institute of Medicine entitled ``The Future 
of Drug Safety--Promoting and Protecting the Health of the Public''.
    (b) Content of Report.--The report issued by the Secretary under 
subsection (a) shall include--
            (1) an update on the implementation by the Food and Drug 
        Administration of its plan to respond to the Institute of 
        Medicine report described under such subsection; and
            (2) an assessment of how the Food and Drug Administration 
        has implemented--
                    (A) the recommendations described in such Institute 
                of Medicine report; and
                    (B) the requirement under section 505-1(c)(2) of 
                the Federal Food, Drug, and Cosmetic Act (as added by 
                this title), that the appropriate office responsible 
                for reviewing a drug and the office responsible for 
                postapproval safety with respect to the drug work 
                together to assess, implement, and ensure compliance 
                with the requirements of such section 505-1.

SEC. 920. DATABASE FOR AUTHORIZED GENERIC DRUGS.

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

SEC. 921. ADVERSE DRUG REACTION REPORTS AND POSTMARKET SAFETY.

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

                          TITLE X--FOOD SAFETY

SEC. 1001. FINDINGS.

    Congress finds that--
            (1) the safety and integrity of the United States food 
        supply are vital to public health, to public confidence in the 
        food supply, and to the success of the food sector of the 
        Nation's economy;
            (2) illnesses and deaths of individuals and companion 
        animals caused by contaminated food--
                    (A) have contributed to a loss of public confidence 
                in food safety; and
                    (B) have caused significant economic losses to 
                manufacturers and producers not responsible for 
                contaminated food items;
            (3) the task of preserving the safety of the food supply of 
        the United States faces tremendous pressures with regard to--
                    (A) emerging pathogens and other contaminants and 
                the ability to detect all forms of contamination;
                    (B) an increasing volume of imported food from a 
                wide variety of countries; and
                    (C) a shortage of adequate resources for monitoring 
                and inspection;
            (4) according to the Economic Research Service of the 
        Department of Agriculture, the United States is increasing the 
        amount of food that it imports such that--
                    (A) from 2003 to 2007, the value of food imports 
                has increased from $45,600,000,000 to $64,000,000,000; 
                and
                    (B) imported food accounts for 13 percent of the 
                average American diet including 31 percent of fruits, 
                juices, and nuts, 9.5 percent of red meat, and 78.6 
                percent of fish and shellfish; and
            (5) the number of full-time equivalent Food and Drug 
        Administration employees conducting inspections has decreased 
        from 2003 to 2007.

SEC. 1002. ENSURING THE SAFETY OF PET FOOD.

    (a) Processing and Ingredient Standards.--Not later than 2 years 
after the date of the enactment of this Act, the Secretary of Health 
and Human Services (referred to in this title as the ``Secretary''), in 
consultation with the Association of American Feed Control Officials 
and other relevant stakeholder groups, including veterinary medical 
associations, animal health organizations, and pet food manufacturers, 
shall by regulation establish--
            (1) ingredient standards and definitions with respect to 
        pet food;
            (2) processing standards for pet food; and
            (3) updated standards for the labeling of pet food that 
        include nutritional and ingredient information.
    (b) Early Warning Surveillance Systems and Notification During Pet 
Food Recalls.--Not later than 1 year after the date of the enactment of 
this Act, the Secretary shall establish an early warning and 
surveillance system to identify adulteration of the pet food supply and 
outbreaks of illness associated with pet food. In establishing such 
system, the Secretary shall--
            (1) consider using surveillance and monitoring mechanisms 
        similar to, or in coordination with, those used to monitor 
        human or animal health, such as the Foodborne Diseases Active 
        Surveillance Network (FoodNet) and PulseNet of the Centers for 
        Disease Control and Prevention, the Food Emergency Response 
        Network of the Food and Drug Administration and the Department 
        of Agriculture, and the National Animal Health Laboratory 
        Network of the Department of Agriculture;
            (2) consult with relevant professional associations and 
        private sector veterinary hospitals;
            (3) work with the National Companion Animal Surveillance 
        Program, the Health Alert Network, or other notification 
        networks as appropriate to inform veterinarians and relevant 
        stakeholders during any recall of pet food; and
            (4) use such information and conduct such other activities 
        as the Secretary deems appropriate.

SEC. 1003. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS DURING A 
              RECALL.

    The Secretary shall, during an ongoing recall of human or pet food 
regulated by the Secretary--
            (1) work with companies, relevant professional 
        associations, and other organizations to collect and aggregate 
        information pertaining to the recall;
            (2) use existing networks of communication, including 
        electronic forms of information dissemination, to enhance the 
        quality and speed of communication with the public; and
            (3) post information regarding recalled human and pet foods 
        on the Internet Web site of the Food and Drug Administration in 
        a single location, which shall include a searchable database of 
        recalled human foods and a searchable database of recalled pet 
        foods, that is easily accessed and understood by the public.

SEC. 1004. STATE AND FEDERAL COOPERATION.

    (a) In General.--The Secretary shall work with the States in 
undertaking activities and programs that assist in improving the safety 
of food, including fresh and processed produce, so that State food 
safety programs and activities conducted by the Secretary function in a 
coordinated and cost-effective manner. With the assistance provided 
under subsection (b), the Secretary shall encourage States to--
            (1) establish, continue, or strengthen State food safety 
        programs, especially with respect to the regulation of retail 
        commercial food establishments; and
            (2) establish procedures and requirements for ensuring that 
        processed produce under the jurisdiction of State food safety 
        programs is not unsafe for human consumption.
    (b) Assistance.--The Secretary may provide to a State, for 
planning, developing, and implementing such a food safety program--
            (1) advisory assistance;
            (2) technical assistance, training, and laboratory 
        assistance (including necessary materials and equipment); and
            (3) financial and other assistance.
    (c) Service Agreements.--The Secretary may, under an agreement 
entered into with a Federal, State, or local agency, use, on a 
reimbursable basis or otherwise, the personnel, services, and 
facilities of the agency to carry out the responsibilities of the 
agency under this section. An agreement entered into with a State 
agency under this subsection may provide for training of State 
employees.

SEC. 1005. REPORTABLE FOOD REGISTRY.

    (a) Findings.--Congress makes the following findings:
            (1) In 1994, Congress passed the Dietary Supplement Health 
        and Education Act of 1994 (Public Law 103-417) to provide the 
        Food and Drug Administration the legal framework which is 
        intended to ensure that dietary supplements are safe and 
        properly labeled foods.
            (2) In 2006, Congress passed the Dietary Supplement and 
        Nonprescription Drug Consumer Protection Act (Public Law 109-
        462) to establish a mandatory reporting system of serious 
        adverse events for nonprescription drugs and dietary 
        supplements sold and consumed in the United States.
            (3) The adverse event reporting system created under the 
        Dietary Supplement and Nonprescription Drug Consumer Protection 
        Act is intended to serve as an early warning system for 
        potential public health issues associated with the use of these 
        products.
            (4) A reliable mechanism to track patterns of adulteration 
        in food would support efforts by the Food and Drug 
        Administration to target limited inspection resources to 
        protect the public health.
    (b) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the 
following:

``SEC. 417. REPORTABLE FOOD REGISTRY.

    ``(a) Definitions.--In this section:
            ``(1) Responsible party.--The term `responsible party', 
        with respect to an article of food, means a person that submits 
        the registration under section 415(a) for a food facility that 
        is required to register under section 415(a), at which such 
        article of food is manufactured, processed, packed, or held.
            ``(2) Reportable food.--The term `reportable food' means an 
        article of food (other than infant formula) for which there is 
        a reasonable probability that the use of, or exposure to, such 
        article of food will cause serious adverse health consequences 
        or death to humans or animals.
    ``(b) Establishment.--
            ``(1) In general.--Not later than 1 year after the date of 
        the enactment of this section, the Secretary shall establish 
        within the Food and Drug Administration a Reportable Food 
        Registry to which instances of reportable food may be submitted 
        by the Food and Drug Administration after receipt of reports 
        under subsection (d), via an electronic portal, from--
                    ``(A) Federal, State, and local public health 
                officials; or
                    ``(B) responsible parties.
            ``(2) Review by secretary.--The Secretary shall promptly 
        review and assess the information submitted under paragraph (1) 
        for the purposes of identifying reportable food, submitting 
        entries to the Reportable Food Registry, acting under 
        subsection (c), and exercising other existing food safety 
        authorities under this Act to protect the public health.
    ``(c) Issuance of an Alert by the Secretary.--
            ``(1) In general.--The Secretary shall issue, or cause to 
        be issued, an alert or a notification with respect to a 
        reportable food using information from the Reportable Food 
        Registry as the Secretary deems necessary to protect the public 
        health.
            ``(2) Effect.--Paragraph (1) shall not affect the authority 
        of the Secretary to issue an alert or a notification under any 
        other provision of this Act.
    ``(d) Reporting and Notification.--
            ``(1) In general.--Except as provided in paragraph (2), as 
        soon as practicable, but in no case later than 24 hours after a 
        responsible party determines that an article of food is a 
        reportable food, the responsible party shall--
                    ``(A) submit a report to the Food and Drug 
                Administration through the electronic portal 
                established under subsection (b) that includes the data 
                elements described in subsection (e) (except the 
                elements described in paragraphs (8), (9), and (10) of 
                such subsection); and
                    ``(B) investigate the cause of the adulteration if 
                the adulteration of the article of food may have 
                originated with the responsible party.
            ``(2) No report required.--A responsible party is not 
        required to submit a report under paragraph (1) if--
                    ``(A) the adulteration originated with the 
                responsible party;
                    ``(B) the responsible party detected the 
                adulteration prior to any transfer to another person of 
                such article of food; and
                    ``(C) the responsible party--
                            ``(i) corrected such adulteration; or
                            ``(ii) destroyed or caused the destruction 
                        of such article of food.
            ``(3) Reports by public health officials.--A Federal, 
        State, or local public health official may submit a report 
        about a reportable food to the Food and Drug Administration 
        through the electronic portal established under subsection (b) 
        that includes the data elements described in subsection (e) 
        that the official is able to provide.
            ``(4) Report number.--The Secretary shall ensure that, upon 
        submission of a report under paragraph (1) or (3), a unique 
        number is issued through the electronic portal established 
        under subsection (b) to the person submitting such report, by 
        which the Secretary is able to link reports about the 
        reportable food submitted and amended under this subsection and 
        identify the supply chain for such reportable food.
            ``(5) Review.--The Secretary shall promptly review a report 
        submitted under paragraph (1) or (3).
            ``(6) Response to report submitted by a responsible 
        party.--After consultation with the responsible party that 
        submitted a report under paragraph (1), the Secretary may 
        require such responsible party to perform, as soon as 
        practicable, but in no case later than a time specified by the 
        Secretary, 1 or more of the following:
                    ``(A) Amend the report submitted by the responsible 
                party under paragraph (1) to include the data element 
                described in subsection (e)(9).
                    ``(B) Provide a notification--
                            ``(i) to the immediate previous source of 
                        the article of food, if the Secretary deems 
                        necessary;
                            ``(ii) to the immediate subsequent 
                        recipient of the article of food, if the 
                        Secretary deems necessary; and
                            ``(iii) that includes--
                                    ``(I) the data elements described 
                                in subsection (e) that the Secretary 
                                deems necessary;
                                    ``(II) the actions described under 
                                paragraph (7) that the recipient of the 
                                notification shall perform, as required 
                                by the Secretary; and
                                    ``(III) any other information that 
                                the Secretary may require.
            ``(7) Subsequent reports and notifications.--Except as 
        provided in paragraph (8), the Secretary may require a 
        responsible party to perform, as soon as practicable, but in no 
        case later than a time specified by the Secretary, after the 
        responsible party receives a notification under subparagraph 
        (C) or paragraph (6)(B), 1 or more of the following:
                    ``(A) Submit a report to the Food and Drug 
                Administration through the electronic portal 
                established under subsection (b) that includes those 
                data elements described in subsection (e) and other 
                information that the Secretary deems necessary.
                    ``(B) Investigate the cause of the adulteration if 
                the adulteration of the article of food may have 
                originated with the responsible party.
                    ``(C) Provide a notification--
                            ``(i) to the immediate previous source of 
                        the article of food, if the Secretary deems 
                        necessary;
                            ``(ii) to the immediate subsequent 
                        recipient of the article of food, if the 
                        Secretary deems necessary; and
                            ``(iii) that includes--
                                    ``(I) the data elements described 
                                in subsection (e) that the Secretary 
                                deems necessary;
                                    ``(II) the actions described under 
                                this paragraph that the recipient of 
                                the notification shall perform, as 
                                required by the Secretary; and
                                    ``(III) any other information that 
                                the Secretary may require.
            ``(8) Amended report.--If a responsible party receives a 
        notification under paragraph (6)(B) or paragraph (7)(C) with 
        respect to an article of food after the responsible party has 
        submitted a report to the Food and Drug Administration under 
        paragraph (1) with respect to such article of food--
                    ``(A) the responsible party is not required to 
                submit an additional report or make a notification 
                under paragraph (7); and
                    ``(B) the responsible party shall amend the report 
                submitted by the responsible party under paragraph (1) 
                to include the data elements described in paragraph 
                (9), and, with respect to both such notification and 
                such report, paragraph (11) of subsection (e).
    ``(e) Data Elements.--The data elements described in this 
subsection are the following:
            ``(1) The registration numbers of the responsible party 
        under section 415(a)(3).
            ``(2) The date on which an article of food was determined 
        to be a reportable food.
            ``(3) A description of the article of food including the 
        quantity or amount.
            ``(4) The extent and nature of the adulteration.
            ``(5) If the adulteration of the article of food may have 
        originated with the responsible party, the results of the 
        investigation required under paragraph (1)(B) or (7)(B) of 
        subsection (d), as applicable and when known.
            ``(6) The disposition of the article of food, when known.
            ``(7) Product information typically found on packaging 
        including product codes, use-by dates, and names of 
        manufacturers, packers, or distributors sufficient to identify 
        the article of food.
            ``(8) Contact information for the responsible party.
            ``(9) The contact information for parties directly linked 
        in the supply chain and notified under paragraph (6)(B) or 
        (7)(C) of subsection (d), as applicable.
            ``(10) The information required by the Secretary to be 
        included in a notification provided by the responsible party 
        involved under paragraph (6)(B) or (7)(C) of subsection (d) or 
        required in a report under subsection (d)(7)(A).
            ``(11) The unique number described in subsection (d)(4).
    ``(f) Coordination of Federal, State, and Local Efforts.--
            ``(1) Department of agriculture.--In implementing this 
        section, the Secretary shall--
                    ``(A) share information and coordinate regulatory 
                efforts with the Department of Agriculture; and
                    ``(B) if the Secretary receives a report submitted 
                about a food within the jurisdiction of the Department 
                of Agriculture, promptly provide such report to the 
                Department of Agriculture.
            ``(2) States and localities.--In implementing this section, 
        the Secretary shall work with the State and local public health 
        officials to share information and coordinate regulatory 
        efforts, in order to--
                    ``(A) help to ensure coverage of the safety of the 
                food supply chain, including those food establishments 
                regulated by the States and localities that are not 
                required to register under section 415; and
                    ``(B) reduce duplicative regulatory efforts.
    ``(g) Maintenance and Inspection of Records.--The responsible party 
shall maintain records related to each report received, notification 
made, and report submitted to the Food and Drug Administration under 
this section for 2 years. A responsible party shall, at the request of 
the Secretary, permit inspection of such records as provided for 
section 414.
    ``(h) Request for Information.--Except as provided by section 
415(a)(4), section 552 of title 5, United States Code, shall apply to 
any request for information regarding a record in the Reportable Food 
Registry.
    ``(i) Safety Report.--A report or notification under subsection (d) 
shall be considered to be a safety report under section 756 and may be 
accompanied by a statement, which shall be part of any report released 
for public disclosure, that denies that the report or the notification 
constitutes an admission that the product involved caused or 
contributed to a death, serious injury, or serious illness.
    ``(j) Admission.--A report or notification under this section shall 
not be considered an admission that the article of food involved is 
adulterated or caused or contributed to a death, serious injury, or 
serious illness.
    ``(k) Homeland Security Notification.--If, after receiving a report 
under subsection (d), the Secretary believes such food may have been 
deliberately adulterated, the Secretary shall immediately notify the 
Secretary of Homeland Security. The Secretary shall make relevant 
information from the Reportable Food Registry available to the 
Secretary of Homeland Security.''.
    (c) Definition.--Section 201(ff) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(ff)) is amended by striking ``section 
201(g)'' and inserting ``sections 201(g) and 417''.
    (d) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331), as amended by section 912, is further 
amended--
            (1) in subsection (e), by--
                    (A) striking ``414,'' and inserting ``414, 
                417(g),''; and
                    (B) striking ``414(b)'' and inserting ``414(b), 
                417''; and
            (2) by adding at the end the following:
    ``(mm) The failure to submit a report or provide a notification 
required under section 417(d).
    ``(nn) The falsification of a report or notification required under 
section 417(d).''.
    (e) Effective Date.--The requirements of section 417(d) of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall 
become effective 1 year after the date of the enactment of this Act.
    (f) Guidance.--Not later than 9 months after the date of the 
enactment of this Act, the Secretary shall issue a guidance to industry 
about submitting reports to the electronic portal established under 
section 417 of the Federal Food, Drug, and Cosmetic Act (as added by 
this section) and providing notifications to other persons in the 
supply chain of an article of food under such section 417.
    (g) Effect.--Nothing in this title, or an amendment made by this 
title, shall be construed to alter the jurisdiction between the 
Secretaries of Agriculture and of Health and Human Services, under 
applicable statutes and regulations.

SEC. 1006. ENHANCED AQUACULTURE AND SEAFOOD INSPECTION.

    (a) Findings.--Congress finds the following:
            (1) In 2007, there has been an overwhelming increase in the 
        volume of aquaculture and seafood that has been found to 
        contain substances that are not approved for use in food in the 
        United States.
            (2) As of May 2007, inspection programs are not able to 
        satisfactorily accomplish the goals of ensuring the food safety 
        of the United States.
            (3) To protect the health and safety of consumers in the 
        United States, the ability of the Secretary to perform 
        inspection functions must be enhanced.
    (b) Heightened Inspections.--The Secretary is authorized to 
enhance, as necessary, the inspection regime of the Food and Drug 
Administration for aquaculture and seafood, consistent with obligations 
of the United States under international agreements and United States 
law.
    (c) Report to Congress.--Not later than 180 days after the date of 
the enactment of this Act, the Secretary shall submit to Congress a 
report that--
            (1) describes the specifics of the aquaculture and seafood 
        inspection program;
            (2) describes the feasibility of developing a traceability 
        system for all catfish and seafood products, both domestic and 
        imported, for the purpose of identifying the processing plant 
        of origin of such products; and
            (3) provides for an assessment of the risks associated with 
        particular contaminants and banned substances.
    (d) Partnerships With States.--Upon the request by any State, the 
Secretary may enter into partnership agreements, as soon as practicable 
after the request is made, to implement inspection programs to Federal 
standards regarding the importation of aquaculture and seafood.

SEC. 1007. CONSULTATION REGARDING GENETICALLY ENGINEERED SEAFOOD 
              PRODUCTS.

    The Commissioner of Food and Drugs shall consult with the Assistant 
Administrator of the National Marine Fisheries Service of the National 
Oceanic and Atmospheric Administration to produce a report on any 
environmental risks associated with genetically engineered seafood 
products, including the impact on wild fish stocks.

SEC. 1008. SENSE OF CONGRESS.

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

SEC. 1009. ANNUAL REPORT TO CONGRESS.

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

SEC. 1010. PUBLICATION OF ANNUAL REPORTS.

    (a) In General.--The Commissioner of Food and Drugs shall annually 
submit to Congress and publish on the Internet Web site of the Food and 
Drug Administration, a report concerning the results of the 
Administration's pesticide residue monitoring program, that includes--
            (1) information and analysis similar to that contained in 
        the report entitled ``Food and Drug Administration Pesticide 
        Program Residue Monitoring 2003'' as released in June of 2005;
            (2) based on an analysis of previous samples, an 
        identification of products or countries (for imports) that 
        require special attention and additional study based on a 
        comparison with equivalent products manufactured, distributed, 
        or sold in the United States (including details on the plans 
        for such additional studies), including in the initial report 
        (and subsequent reports as determined necessary) the results 
        and analysis of the Ginseng Dietary Supplements Special Survey 
        as described on page 13 of the report entitled ``Food and Drug 
        Administration Pesticide Program Residue Monitoring 2003'';
            (3) information on the relative number of interstate and 
        imported shipments of each tested commodity that were sampled, 
        including recommendations on whether sampling is statistically 
        significant, provides confidence intervals or other related 
        statistical information, and whether the number of samples 
        should be increased and the details of any plans to provide for 
        such increase; and
            (4) a description of whether certain commodities are being 
        improperly imported as another commodity, including a 
        description of additional steps that are being planned to 
        prevent such smuggling.
    (b) Initial Reports.--Annual reports under subsection (a) for 
fiscal years 2004 through 2006 may be combined into a single report, by 
not later than June 1, 2008, for purposes of publication under 
subsection (a). Thereafter such reports shall be completed by June 1 of 
each year for the data collected for the year that was 2-years prior to 
the year in which the report is published.
    (c) Memorandum of Understanding.--The Commissioner of Food and 
Drugs, the Administrator of the Food Safety and Inspection Service, the 
Department of Commerce, and the head of the Agricultural Marketing 
Service shall enter into a memorandum of understanding to permit 
inclusion of data in the reports under subsection (a) relating to 
testing carried out by the Food Safety and Inspection Service and the 
Agricultural Marketing Service on meat, poultry, eggs, and certain raw 
agricultural products, respectively.

SEC. 1011. RULE OF CONSTRUCTION.

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

                       TITLE XI--OTHER PROVISIONS

                         Subtitle A--In General

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

    Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 371 et seq.), as amended by section 701, is further 
amended by adding at the end the following:

``SEC. 713. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC ARTICLES 
              PUBLISHED BY FDA EMPLOYEES.

    ``(a) Definition.--In this section, the term `article' means a 
paper, poster, abstract, book, book chapter, or other published 
writing.
    ``(b) Policies.--The Secretary, through the Commissioner of Food 
and Drugs, shall establish and make publicly available clear written 
policies to implement this section and govern the timely submission, 
review, clearance, and disclaimer requirements for articles.
    ``(c) Timing of Submission for Review.--If an officer or employee, 
including a Staff Fellow and a contractor who performs staff work, of 
the Food and Drug Administration is directed by the policies 
established under subsection (b) to submit an article to the supervisor 
of such officer or employee, or to some other official of the Food and 
Drug Administration, for review and clearance before such officer or 
employee may seek to publish or present such an article at a 
conference, such officer or employee shall submit such article for such 
review and clearance not less than 30 days before submitting the 
article for publication or presentation.
    ``(d) Timing for Review and Clearance.--The supervisor or other 
reviewing official shall review such article and provide written 
clearance, or written clearance on the condition of specified changes 
being made, to such officer or employee not later than 30 days after 
such officer or employee submitted such article for review.
    ``(e) Non-Timely Review.--If, 31 days after such submission under 
subsection (c), the supervisor or other reviewing official has not 
cleared or has not reviewed such article and provided written 
clearance, such officer or employee may consider such article not to 
have been cleared and may submit the article for publication or 
presentation with an appropriate disclaimer as specified in the 
policies established under subsection (b).
    ``(f) Effect.--Nothing in this section shall be construed as 
affecting any restrictions on such publication or presentation provided 
by other provisions of law.''.

SEC. 1102. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL 
              DISEASES.

    Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by adding at the end the 
following:

``SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL 
              DISEASES.

    ``(a)  Definitions.--In this section:
            ``(1) Priority review.--The term `priority review', with 
        respect to a human drug application as defined in section 
        735(1), means review and action by the Secretary on such 
        application not later than 6 months after receipt by the 
        Secretary of such application, as described in the Manual of 
        Policies and Procedures of the Food and Drug Administration and 
        goals identified in the letters described in section 101(c) of 
        the Food and Drug Administration Amendments Act of 2007.
            ``(2) Priority review voucher.--The term `priority review 
        voucher' means a voucher issued by the Secretary to the sponsor 
        of a tropical disease product application that entitles the 
        holder of such voucher to priority review of a single human 
        drug application submitted under section 505(b)(1) or section 
        351 of the Public Health Service Act after the date of approval 
        of the tropical disease product application.
            ``(3) Tropical disease.--The term `tropical disease' means 
        any of the following:
                    ``(A) Tuberculosis.
                    ``(B) Malaria.
                    ``(C) Blinding trachoma.
                    ``(D) Buruli Ulcer.
                    ``(E) Cholera.
                    ``(F) Dengue/dengue haemorrhagic fever.
                    ``(G) Dracunculiasis (guinea-worm disease).
                    ``(H) Fascioliasis.
                    ``(I) Human African trypanosomiasis.
                    ``(J) Leishmaniasis.
                    ``(K) Leprosy.
                    ``(L) Lymphatic filariasis.
                    ``(M) Onchocerciasis.
                    ``(N) Schistosomiasis.
                    ``(O) Soil transmitted helmithiasis.
                    ``(P) Yaws.
                    ``(Q) Any other infectious disease for which there 
                is no significant market in developed nations and that 
                disproportionately affects poor and marginalized 
                populations, designated by regulation by the Secretary.
            ``(4) Tropical disease product application.--The term 
        `tropical disease product application' means an application 
        that--
                    ``(A) is a human drug application as defined in 
                section 735(1)--
                            ``(i) for prevention or treatment of a 
                        tropical disease; and
                            ``(ii) the Secretary deems eligible for 
                        priority review;
                    ``(B) is approved after the date of the enactment 
                of the Food and Drug Administration Amendments Act of 
                2007, by the Secretary for use in the prevention, 
                detection, or treatment of a tropical disease; and
                    ``(C) is for a human drug, no active ingredient 
                (including any ester or salt of the active ingredient) 
                of which has been approved in any other application 
                under section 505(b)(1) or section 351 of the Public 
                Health Service Act.
    ``(b) Priority Review Voucher.--
            ``(1) In general.--The Secretary shall award a priority 
        review voucher to the sponsor of a tropical disease product 
        application upon approval by the Secretary of such tropical 
        disease product application.
            ``(2) Transferability.--The sponsor of a tropical disease 
        product that receives a priority review voucher under this 
        section may transfer (including by sale) the entitlement to 
        such voucher to a sponsor of a human drug for which an 
        application under section 505(b)(1) or section 351 of the 
        Public Health Service Act will be submitted after the date of 
        the approval of the tropical disease product application.
            ``(3) Limitation.--
                    ``(A) No award for prior approved application.--A 
                sponsor of a tropical disease product may not receive a 
                priority review voucher under this section if the 
                tropical disease product application was submitted to 
                the Secretary prior to the date of the enactment of 
                this section.
                    ``(B) One-year waiting period.--The Secretary shall 
                issue a priority review voucher to the sponsor of a 
                tropical disease product no earlier than the date that 
                is 1 year after the date of the enactment of the Food 
                and Drug Administration Amendments Act of 2007.
            ``(4) Notification.--The sponsor of a human drug 
        application shall notify the Secretary not later than 365 days 
        prior to submission of the human drug application that is the 
        subject of a priority review voucher of an intent to submit the 
        human drug application, including the date on which the sponsor 
        intends to submit the application. Such notification shall be a 
        legally binding commitment to pay for the user fee to be 
        assessed in accordance with this section.
    ``(c) Priority Review User Fee.--
            ``(1) In general.--The Secretary shall establish a user fee 
        program under which a sponsor of a human drug application that 
        is the subject of a priority review voucher shall pay to the 
        Secretary a fee determined under paragraph (2). Such fee shall 
        be in addition to any fee required to be submitted by the 
        sponsor under chapter VII.
            ``(2) Fee amount.--The amount of the priority review user 
        fee shall be determined each fiscal year by the Secretary and 
        based on the average cost incurred by the agency in the review 
        of a human drug application subject to priority review in the 
        previous fiscal year.
            ``(3) Annual fee setting.--The Secretary shall establish, 
        before the beginning of each fiscal year beginning after 
        September 30, 2007, for that fiscal year, the amount of the 
        priority review user fee.
            ``(4) Payment.--
                    ``(A) In general.--The priority review user fee 
                required by this subsection shall be due upon the 
                submission of a human drug application under section 
                505(b)(1) or section 351 of the Public Health Services 
                Act for which the priority review voucher is used.
                    ``(B) Complete application.--An application 
                described under subparagraph (A) for which the sponsor 
                requests the use of a priority review voucher shall be 
                considered incomplete if the fee required by this 
                subsection and all other applicable user fees are not 
                paid in accordance with the Secretary's procedures for 
                paying such fees.
                    ``(C) No waivers, exemptions, reductions, or 
                refunds.--The Secretary may not grant a waiver, 
                exemption, reduction, or refund of any fees due and 
                payable under this section.
            ``(5) Offsetting collections.--Fees collected pursuant to 
        this subsection for any fiscal year--
                    ``(A) shall be deposited and credited as offsetting 
                collections to the account providing appropriations to 
                the Food and Drug Administration; and
                    ``(B) shall not be collected for any fiscal year 
                except to the extent provided in advance in 
                appropriation Acts.''.

SEC. 1103. IMPROVING GENETIC TEST SAFETY AND QUALITY.

    (a) Report.--If the Secretary's Advisory Committee on Genetics, 
Health, and Society does not complete and submit the Regulatory 
Oversight of Genetic/Genomic Testing Report & Action Recommendations to 
the Secretary of Health and Human Services (referred to in this section 
as the ``Secretary'') by July of 2008, the Secretary shall enter into a 
contract with the Institute of Medicine to conduct a study to assess 
the overall safety and quality of genetic tests and prepare a report 
that includes recommendations to improve Federal oversight and 
regulation of genetic tests. Such study shall take into consideration 
relevant reports by the Secretary's Advisory Committee on Genetics, 
Health, and Society and other groups and shall be completed not later 
than 1 year after the date on which the Secretary entered into such 
contract.
    (b) Rule of Construction.--Nothing in this section shall be 
construed as requiring Federal efforts with respect to regulatory 
oversight of genetic tests to cease or be limited or delayed pending 
completion of the report by the Secretary's Advisory Committee on 
Genetics, Health, and Society or the Institute of Medicine.

SEC. 1104. NIH TECHNICAL AMENDMENTS.

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

SEC. 1105. SEVERABILITY CLAUSE.

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

              Subtitle B--Antibiotic Access and Innovation

SEC. 1111. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE CONCENTRATIONS OF 
              ANTIMICROBIALS.

    (a) Definition.--In this section, the term ``clinically susceptible 
concentrations'' means specific values which characterize bacteria as 
clinically susceptible, intermediate, or resistant to the drug (or 
drugs) tested.
    (b) Identification.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary''), through the 
Commissioner of Food and Drugs, shall identify (where such information 
is reasonably available) and periodically update clinically susceptible 
concentrations.
    (c) Public Availability.--The Secretary, through the Commissioner 
of Food and Drugs, shall make such clinically susceptible 
concentrations publicly available, such as by posting on the Internet, 
not later than 30 days after the date of identification and any update 
under this section.
    (d) Effect.--Nothing in this section shall be construed to 
restrict, in any manner, the prescribing of antibiotics by physicians, 
or to limit the practice of medicine, including for diseases such as 
Lyme and tick-borne diseases.

SEC. 1112. ORPHAN ANTIBIOTIC DRUGS.

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

SEC. 1113. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355), as amended by section 920, is further amended by adding at the 
end the following:
    ``(u) Certain Drugs Containing Single Enantiomers.--
            ``(1) In general.--For purposes of subsections 
        (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is submitted 
        under subsection (b) for a non-racemic drug containing as an 
        active ingredient (including any ester or salt of the active 
        ingredient) a single enantiomer that is contained in a racemic 
        drug approved in another application under subsection (b), the 
        applicant may, in the application for such non-racemic drug, 
        elect to have the single enantiomer not be considered the same 
        active ingredient as that contained in the approved racemic 
        drug, if--
                    ``(A)(i) the single enantiomer has not been 
                previously approved except in the approved racemic 
                drug; and
                    ``(ii) the application submitted under subsection 
                (b) for such non-racemic drug--
                            ``(I) includes full reports of new clinical 
                        investigations (other than bioavailability 
                        studies)--
                                    ``(aa) necessary for the approval 
                                of the application under subsections 
                                (c) and (d); and
                                    ``(bb) conducted or sponsored by 
                                the applicant; and
                            ``(II) does not rely on any investigations 
                        that are part of an application submitted under 
                        subsection (b) for approval of the approved 
                        racemic drug; and
                    ``(B) the application submitted under subsection 
                (b) for such non-racemic drug is not submitted for 
                approval of a condition of use--
                            ``(i) in a therapeutic category in which 
                        the approved racemic drug has been approved; or
                            ``(ii) for which any other enantiomer of 
                        the racemic drug has been approved.
            ``(2) Limitation.--
                    ``(A) No approval in certain therapeutic 
                categories.--Until the date that is 10 years after the 
                date of approval of a non-racemic drug described in 
                paragraph (1) and with respect to which the applicant 
                has made the election provided for by such paragraph, 
                the Secretary shall not approve such non-racemic drug 
                for any condition of use in the therapeutic category in 
                which the racemic drug has been approved.
                    ``(B) Labeling.--If applicable, the labeling of a 
                non-racemic drug described in paragraph (1) and with 
                respect to which the applicant has made the election 
                provided for by such paragraph shall include a 
                statement that the non-racemic drug is not approved, 
                and has not been shown to be safe and effective, for 
                any condition of use of the racemic drug.
            ``(3) Definition.--
                    ``(A) In general.--For purposes of this subsection, 
                the term `therapeutic category' means a therapeutic 
                category identified in the list developed by the United 
                States Pharmacopeia pursuant to section 1860D-
                4(b)(3)(C)(ii) of the Social Security Act and as in 
                effect on the date of the enactment of this subsection.
                    ``(B) Publication by secretary.--The Secretary 
                shall publish the list described in subparagraph (A) 
                and may amend such list by regulation.
            ``(4) Availability.--The election referred to in paragraph 
        (1) may be made only in an application that is submitted to the 
        Secretary after the date of the enactment of this subsection 
        and before October 1, 2012.''.

SEC. 1114. REPORT.

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

            Passed the House of Representatives September 19, 2007.

            Attest:

                                                                 Clerk.
110th CONGRESS

  1st Session

                               H. R. 3580

_______________________________________________________________________

                                 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.