```

[110th Congress Public Law 85]
[From the U.S. Government Printing Office]

[DOCID: f:publ085.110]

[[Page 121 STAT. 823]]

Public Law 110-85
110th Congress

                                 An Act

 
 To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
the user-fee programs for prescription drugs and for medical devices, to 
 enhance the postmarket authorities of the Food and Drug Administration 
           with respect to the safety of drugs, and for other 
           purposes. <<NOTE: Sept. 27, 2007 -  [H.R. 3580]>> 

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

    This Act may be cited as the ``Food and Drug Administration 
Amendments Act of 2007''.
SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

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

         TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

Sec. 101. Short title; references in title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Fees relating to advisory review of prescription-drug 
           television advertising.
Sec. 105. Reauthorization; reporting requirements.
Sec. 106. Sunset dates.
Sec. 107. Effective date.
Sec. 108. Savings clause.
Sec. 109. Technical amendment; conforming amendment.

          TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007

Sec. 201. Short title; references in title; finding.

               Subtitle A--Fees Related to Medical Devices

Sec. 211. Definitions.
Sec. 212. Authority to assess and use device fees.
Sec. 213. Reauthorization; reporting requirements.
Sec. 214. Savings clause.
Sec. 215. Additional authorization of appropriations for postmarket 
           safety information.
Sec. 216. Effective date.
Sec. 217. Sunset clause.

     Subtitle B--Amendments Regarding Regulation of Medical Devices

Sec. 221. Extension of authority for third party review of premarket 
           notification.
Sec. 222. Registration.
Sec. 223. Filing of lists of drugs and devices manufactured, prepared, 
           propagated, and compounded by registrants; statements; 
           accompanying disclosures.
Sec. 224. Electronic registration and listing.
Sec. 225. Report by Government Accountability Office.
Sec. 226. Unique device identification system.
Sec. 227. Frequency of reporting for certain devices.

[[Page 121 STAT. 824]]

Sec. 228. Inspections by accredited persons.
Sec. 229. Study of nosocomial infections relating to medical devices.
Sec. 230. Report by the Food and Drug Administration regarding labeling 
           information on the relationship between the use of indoor 
           tanning devices and development of skin cancer or other skin 
           damage.

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

Sec. 301. Short title.
Sec. 302. Tracking pediatric device approvals.
Sec. 303. Modification to humanitarian device exemption.
Sec. 304. Encouraging pediatric medical device research.
Sec. 305. Demonstration grants for improving pediatric device 
           availability.
Sec. 306. Amendments to office of pediatric therapeutics and pediatric 
           advisory committee.
Sec. 307. Postmarket surveillance.

             TITLE IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007

Sec. 401. Short title.
Sec. 402. Reauthorization of Pediatric Research Equity Act.
Sec. 403. Establishment of internal committee.
Sec. 404. Government Accountability Office report.

         TITLE V--BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007

Sec. 501. Short title.
Sec. 502. Reauthorization of Best Pharmaceuticals for Children Act.
Sec. 503. Training of pediatric pharmacologists.

                    TITLE VI--REAGAN-UDALL FOUNDATION

Sec. 601. The Reagan-Udall Foundation for the Food and Drug 
           Administration.
Sec. 602. Office of the Chief Scientist.
Sec. 603. Critical path public-private partnerships.

                    TITLE VII--CONFLICTS OF INTEREST

Sec. 701. Conflicts of interest.

                  TITLE VIII--CLINICAL TRIAL DATABASES

Sec. 801. Expanded clinical trial registry data bank.

   TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS

             Subtitle A--Postmarket Studies and Surveillance

Sec. 901. Postmarket studies and clinical trials regarding human drugs; 
           risk evaluation and mitigation strategies.
Sec. 902. Enforcement.
Sec. 903. No effect on withdrawal or suspension of approval.
Sec. 904. Benefit-risk assessments.
Sec. 905. Active postmarket risk identification and analysis.
Sec. 906. Statement for inclusion in direct-to-consumer advertisements 
           of drugs.
Sec. 907. No effect on veterinary medicine.
Sec. 908. Authorization of appropriations.
Sec. 909. Effective date and applicability.

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

Sec. 911. Clinical trial guidance for antibiotic drugs.
Sec. 912. Prohibition against food to which drugs or biological products 
           have been added.
Sec. 913. Assuring pharmaceutical safety.
Sec. 914. Citizen petitions and petitions for stay of agency action.
Sec. 915. Postmarket drug safety information for patients and providers.
Sec. 916. Action package for approval.
Sec. 917. Risk communication.
Sec. 918. Referral to advisory committee.
Sec. 919. Response to the institute of medicine.
Sec. 920. Database for authorized generic drugs.
Sec. 921. Adverse drug reaction reports and postmarket safety.

                          TITLE X--FOOD SAFETY

Sec. 1001. Findings.

[[Page 121 STAT. 825]]

Sec. 1002. Ensuring the safety of pet food.
Sec. 1003. Ensuring efficient and effective communications during a 
           recall.
Sec. 1004. State and Federal Cooperation.
Sec. 1005. Reportable Food Registry.
Sec. 1006. Enhanced aquaculture and seafood inspection.
Sec. 1007. Consultation regarding genetically engineered seafood 
           products.
Sec. 1008. Sense of Congress.
Sec. 1009. Annual report to Congress.
Sec. 1010. Publication of annual reports.
Sec. 1011. Rule of construction.

                       TITLE XI--OTHER PROVISIONS

                         Subtitle A--In General

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

              Subtitle B--Antibiotic Access and Innovation

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

 TITLE I--PRESCRIPTION <<NOTE: Prescription Drug User Fee Amendments of 
2007.>> DRUG USER FEE AMENDMENTS OF 2007
SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING.

    (a) Short <<NOTE: 21 USC 301 note.>> Title.--This title may be cited 
as the ``Prescription Drug User Fee Amendments of 2007''.

    (b) References in Title.--Except as otherwise specified, amendments 
made by this title to a section or other provision of law are amendments 
to such section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).
    (c) Finding.--The <<NOTE: 21 USC 379g note.>> Congress finds that 
the fees authorized by the amendments made in this title will be 
dedicated toward expediting the drug development process and the process 
for the review of human drug applications, including postmarket drug 
safety activities, as set forth in the goals identified for purposes of 
part 2 of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act, in the letters from the Secretary of Health and Human 
Services to the Chairman of the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Chairman of the Committee on Energy 
and Commerce of the House of Representatives, as set forth in the 
Congressional Record.
SEC. 102. DEFINITIONS.

    Section 735 (21 U.S.C. 379g) is amended--
            (1) in the matter before paragraph (1), by striking ``For 
        purposes of this subchapter'' and inserting ``For purposes of 
        this part'';
            (2) in paragraph (1)--
                    (A) in subparagraph (A), by striking ``505(b)(1),'' 
                and inserting ``505(b), or'';
                    (B) by striking subparagraph (B);
                    (C) by redesignating subparagraph (C) as 
                subparagraph (B); and

[[Page 121 STAT. 826]]

                    (D) in the matter following subparagraph (B), as so 
                redesignated, by striking ``subparagraph (C)'' and 
                inserting ``subparagraph (B)'';
            (3) in paragraph (3)(C)--
                    (A) by striking ``505(j)(7)(A)'' and inserting 
                ``505(j)(7)(A) (not including the discontinued section 
                of such list)''; and
                    (B) by inserting before the period ``(not including 
                the discontinued section of such list)'';
            (4) in paragraph (4), by inserting before the period at the 
        end the following: ``(such as capsules, tablets, or lyophilized 
        products before reconstitution)'';
            (5) by amending paragraph (6)(F) to read as follows:
                    ``(F) Postmarket safety activities with respect to 
                drugs approved under human drug applications or 
                supplements, including the following activities:
                          ``(i) Collecting, developing, and reviewing 
                      safety information on approved drugs, including 
                      adverse event reports.
                          ``(ii) Developing and using improved adverse-
                      event data-collection systems, including 
                      information technology systems.
                          ``(iii) Developing and using improved 
                      analytical tools to assess potential safety 
                      problems, including access to external data bases.
                          ``(iv) Implementing and enforcing section 
                      505(o) (relating to postapproval studies and 
                      clinical trials and labeling changes) and section 
                      505(p) (relating to risk evaluation and mitigation 
                      strategies).
                          ``(v) Carrying out section 505(k)(5) (relating 
                      to adverse event reports and postmarket safety 
                      activities).'';
            (6) in paragraph (8)--
                    (A) by striking ``April of the preceding fiscal 
                year'' and inserting ``October of the preceding fiscal 
                year''; and
                    (B) by striking ``April 1997'' and inserting 
                ``October 1996'';
            (7) by redesignating paragraph (9) as paragraph (11); and
            (8) by inserting after paragraph (8) the following 
        paragraphs:
            ``(9) The term `person' includes an affiliate thereof.
            ``(10) The term `active', with respect to a commercial 
        investigational new drug application, means such an application 
        to which information was submitted during the relevant 
        period.''.
SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.

    (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``2003'' and inserting ``2008'';
            (2) in paragraph (1)--
                    (A) in subparagraph (D)--
                          (i) in the heading, by inserting ``or 
                      withdrawn before filing'' after ``refused for 
                      filing''; and
                          (ii) by inserting before the period at the end 
                      the following: ``or withdrawn without a waiver 
                      before filing'';

[[Page 121 STAT. 827]]

                    (B) by redesignating subparagraphs (E) and (F) as 
                subparagraphs (F) and (G), respectively; and
                    (C) by inserting after subparagraph (D) the 
                following:
                    ``(E) Fees for applications previously refused for 
                filing or withdrawn before filing.--A human drug 
                application or supplement that was submitted but was 
                refused for filing, or was withdrawn before being 
                accepted or refused for filing, shall be subject to the 
                full fee under subparagraph (A) upon being resubmitted 
                or filed over protest, unless the fee is waived or 
                reduced under subsection (d).''; and
            (3) in paragraph (2)--
                    (A) in subparagraph (A), by striking ``subparagraph 
                (B)'' and inserting ``subparagraphs (B) and (C)''; and
                    (B) by adding at the end the following:
                    ``(C) Special rules for positron emission tomography 
                drugs.--
                          ``(i) In general.--Except as provided in 
                      clause (ii), each person who is named as the 
                      applicant in an approved human drug application 
                      for a positron emission tomography drug shall be 
                      subject under subparagraph (A) to one-sixth of an 
                      annual establishment fee with respect to each such 
                      establishment identified in the application as 
                      producing positron emission tomography drugs under 
                      the approved application.
                          ``(ii) Exception from annual establishment 
                      fee.--Each person who is named as the applicant in 
                      an application described in clause (i) shall not 
                      be assessed an annual establishment fee for a 
                      fiscal year if the person certifies to the 
                      Secretary, at a time specified by the Secretary 
                      and using procedures specified by the Secretary, 
                      that--
                                    ``(I) the person is a not-for-profit 
                                medical center that has only 1 
                                establishment for the production of 
                                positron emission tomography drugs; and
                                    ``(II) at least 95 percent of the 
                                total number of doses of each positron 
                                emission tomography drug produced by 
                                such establishment during such fiscal 
                                year will be used within the medical 
                                center.
                          ``(iii) Definition.--For purposes of this 
                      subparagraph, the term `positron emission 
                      tomography drug' has the meaning given to the term 
                      `compounded positron emission tomography drug' in 
                      section 201(ii), except that paragraph (1)(B) of 
                      such section shall not apply.''.

    (b) Fee Revenue Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is 
amended to read as follows:
    ``(b) Fee Revenue Amounts.--
            ``(1) In general.--For each of the fiscal years 2008 through 
        2012, fees under subsection (a) shall, except as provided in 
        subsections (c), (d), (f), and (g), be established to generate a 
        total revenue amount under such subsection that is equal to the 
        sum of--
                    ``(A) $392,783,000; and

[[Page 121 STAT. 828]]

                    ``(B) an amount equal to the modified workload 
                adjustment factor for fiscal year 2007 (as determined 
                under paragraph (3)).
            ``(2) Types of fees.--Of the total revenue amount determined 
        for a fiscal year under paragraph (1)--
                    ``(A) one-third shall be derived from fees under 
                subsection (a)(1) (relating to human drug applications 
                and supplements);
                    ``(B) one-third shall be derived from fees under 
                subsection (a)(2) (relating to prescription drug 
                establishments); and
                    ``(C) one-third shall be derived from fees under 
                subsection (a)(3) (relating to prescription drug 
                products).
            ``(3) Modified workload adjustment factor for fiscal year 
        2007.--For purposes of paragraph (1)(B), the Secretary shall 
        determine the modified workload adjustment factor by determining 
        the dollar amount that results from applying the methodology 
        that was in effect under subsection (c)(2) for fiscal year 2007 
        to the amount $354,893,000, except that, with respect to the 
        portion of such determination that is based on the change in the 
        total number of commercial investigational new drug 
        applications, the Secretary shall count the number of such 
        applications that were active during the most recent 12-month 
        period for which data on such submissions is available.
            ``(4) Additional fee revenues for drug safety.--
                    ``(A) In general.--For <<NOTE: Applicability.>> each 
                of the fiscal years 2008 through 2012, paragraph (1)(A) 
                shall be applied by substituting the amount determined 
                under subparagraph (B) for `$392,783,000'.
                    ``(B) Amount determined.--For each of the fiscal 
                years 2008 through 2012, the amount determined under 
                this subparagraph is the sum of--
                          ``(i) $392,783,000; plus
                          ``(ii)(I) for fiscal year 2008, $25,000,000;
                          ``(II) for fiscal year 2009, $35,000,000;
                          ``(III) for fiscal year 2010, $45,000,000;
                          ``(IV) for fiscal year 2011, $55,000,000; and
                          ``(V) for fiscal year 2012, $65,000,000.''.

    (c) Adjustments to Fees.--
            (1) Inflation adjustment.--Section 736(c)(1) (21 U.S.C. 
        379h(c)(1)) is amended--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``The revenues established in subsection (b)'' 
                and inserting ``For fiscal year 2009 and subsequent 
                fiscal years, the revenues established in subsection 
                (b)'';
                    (B) in subparagraph (A), by striking ``or'' at the 
                end;
                    (C) in subparagraph (B), by striking the period at 
                the end and inserting ``, or'';
                    (D) by inserting after subparagraph (B) the 
                following:
                    ``(C) the average annual change in the cost, per 
                full-time equivalent position of the Food and Drug 
                Administration, of all personnel compensation and 
                benefits paid with respect to such positions for the 
                first 5 years of the preceding 6 fiscal years.''; and
                    (E) in the matter following subparagraph (C) (as 
                added by subparagraph (D)), by striking ``fiscal year 
                2003'' and inserting ``fiscal year 2008''.

[[Page 121 STAT. 829]]

            (2) Workload adjustment.--Section 736(c)(2) (21 U.S.C. 
        379h(c)(2)) is amended--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``Beginning with fiscal year 2004,'' and 
                inserting ``For fiscal year 2009 and subsequent fiscal 
                years,'';
                    (B) in subparagraph (A), in the first sentence--
                          (i) by striking ``human drug applications,'' 
                      and inserting ``human drug applications (adjusted 
                      for changes in review activities, as described in 
                      the notice that the Secretary is required to 
                      publish in the Federal Register under this 
                      subparagraph),'';
                          (ii) by striking ``commercial investigational 
                      new drug applications,''; and
                          (iii) by inserting before the period the 
                      following: ``, and the change in the total number 
                      of active commercial investigational new drug 
                      applications (adjusted for changes in review 
                      activities, as so described) during the most 
                      recent 12-month period for which data on such 
                      submissions is available'';
                    (C) in subparagraph (B), by adding at the end the 
                following: ``Any adjustment for changes in review 
                activities made in setting fees and revenue amounts for 
                fiscal year 2009 may not result in the total workload 
                adjustment being more than 2 percentage points higher 
                than it would have been in the absence of the adjustment 
                for changes in review activities.''; and
                    (D) by adding at the end the following:
                    ``(C) The <<NOTE: Contracts. Study.>> Secretary 
                shall contract with an independent accounting firm to 
                study the adjustment for changes in review activities 
                applied in setting fees and revenue amounts for fiscal 
                year 2009 and to make recommendations, if warranted, for 
                future changes in the methodology for calculating the 
                adjustment. <<NOTE: Effective date.>> After review of 
                the recommendations, the Secretary shall, if warranted, 
                make appropriate changes to the methodology, and the 
                changes shall be effective for each of the fiscal years 
                2010 through 2012. The Secretary shall not make any 
                adjustment for changes in review activities for any 
                fiscal year after 2009 unless such study has been 
                completed.''.
            (3) Rent and rent-related cost adjustment.--Section 736(c) 
        (21 U.S.C. 379h(c)) is amended--
                    (A) by redesignating paragraphs (3), (4), and (5) as 
                paragraphs (4), (5), and (6), respectively; and
                    (B) by inserting after paragraph (2) the following:
            ``(3) Rent and rent-related cost adjustment.--For fiscal 
        year 2010 and each subsequent fiscal year, the Secretary shall, 
        before making adjustments under paragraphs (1) and (2), decrease 
        the fee revenue amount established in subsection (b) if actual 
        costs paid for rent and rent-related expenses for the preceding 
        fiscal year are less than estimates made for such year in fiscal 
        year 2006. Any reduction made under this paragraph shall not 
        exceed the amount by which such costs fall below the estimates 
        made in fiscal year 2006 for such fiscal year, and shall not 
        exceed $11,721,000 for any fiscal year.''.
            (4) Final year adjustment.--Paragraph (4) of section 736(c) 
        (21 U.S.C. 379h(c)), as redesignated by paragraph (3)(A), is 
        amended to read as follows:

[[Page 121 STAT. 830]]

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

[[Page 121 STAT. 831]]

                                only if subclauses (I) and (II) of 
                                clause (i) apply to such fiscal year.
                                    ``(II) Relation to subparagraph 
                                (A).--The Secretary shall limit any 
                                decrease under this paragraph if such a 
                                limitation is necessary to provide for 
                                the 3 months of operating reserves 
                                described in subparagraph (A).''.
            (5) Limit.--Paragraph (5) of section 736(c) (21 U.S.C. 
        379h(c)), as redesignated by paragraph (3)(A), is amended by 
        striking ``2002'' and inserting ``2007''.

    (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 379h(d)) is 
amended--
            (1) in paragraph (1), in the matter preceding subparagraph 
        (A)--
                    (A) by inserting after ``The Secretary shall grant'' 
                the following: ``to a person who is named as the 
                applicant in a human drug application''; and
                    (B) by inserting ``to that person'' after ``one or 
                more fees assessed'';
            (2) by redesignating paragraphs (2) and (3) as paragraphs 
        (3) and (4), respectively;
            (3) by inserting after paragraph (1) the following:
            ``(2) Considerations.--In determining whether to grant a 
        waiver or reduction of a fee under paragraph (1), the Secretary 
        shall consider only the circumstances and assets of the 
        applicant involved and any affiliate of the applicant.''; and
            (4) in paragraph (4) (as redesignated by paragraph (2)), in 
        subparagraph (A), by inserting before the period the following: 
        ``, and that does not have a drug product that has been approved 
        under a human drug application and introduced or delivered for 
        introduction into interstate commerce''.

    (e) Crediting and Availability of Fees.--
            (1) Authorization of appropriations.--Section 736(g)(3) (21 
        U.S.C. 379h(g)(3)) is amended to read as follows:
            ``(3) Authorization of appropriations.--For each of the 
        fiscal years 2008 through 2012, there is authorized to be 
        appropriated for fees under this section an amount equal to the 
        total revenue amount determined under subsection (b) for the 
        fiscal year, as adjusted or otherwise affected under subsection 
        (c) and paragraph (4) of this subsection.''.
            (2) Offset.--Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is 
        amended to read as follows:
            ``(4) Offset.--If the sum of the cumulative amount of fees 
        collected under this section for the fiscal years 2008 through 
        2010 and the amount of fees estimated to be collected under this 
        section for fiscal year 2011 exceeds the cumulative amount 
        appropriated under paragraph (3) for the fiscal years 2008 
        through 2011, the excess shall be credited to the appropriation 
        account of the Food and Drug Administration as provided in 
        paragraph (1), and shall be subtracted from the amount of fees 
        that would otherwise be authorized to be collected under this 
        section pursuant to appropriation Acts for fiscal year 2012.''.

    (f) Exemption for Orphan Drugs.--Section 736 (21 U.S.C. 379h) is 
further amended by adding at the end the following:
    ``(k) Orphan Drugs.--

[[Page 121 STAT. 832]]

            ``(1) Exemption.--A drug designated under section 526 for a 
        rare disease or condition and approved under section 505 or 
        under section 351 of the Public Health Service Act shall be 
        exempt from product and establishment fees under this section, 
        if the drug meets all of the following conditions:
                    ``(A) The drug meets the public health requirements 
                contained in this Act as such requirements are applied 
                to requests for waivers for product and establishment 
                fees.
                    ``(B) The drug is owned or licensed and is marketed 
                by a company that had less than $50,000,000 in gross 
                worldwide revenue during the previous year.
            ``(2) Evidence of qualification.--An exemption under 
        paragraph (1) applies with respect to a drug only if the 
        applicant involved submits a certification that its gross annual 
        revenues did not exceed $50,000,000 for the preceding 12 months 
        before the exemption was requested.''.

    (g) Conforming Amendment.--Section 736(a) (21 U.S.C. 379h(a)) is 
amended in paragraphs (1)(A)(i), (1)(A)(ii), (2)(A), and (3)(A) by 
striking ``(c)(4)'' each place such term appears and inserting 
``(c)(5)''.
    (h) Technical Amendment.--
            (1) Amendment.--Section 736(g)(1) (21 U.S.C. 379h(g)(1)) is 
        amended by striking the first sentence and inserting the 
        following: ``Fees authorized under subsection (a) shall be 
        collected and available for obligation only to the extent and in 
        the amount provided in advance in appropriations Acts. Such fees 
        are authorized to remain available until expended.''.
            (2) Effective <<NOTE: 21 USC 379h note.>> date.--Paragraph 
        (1) shall take effect as if included in section 504 of the 
        Prescription Drug User Fee Amendments of 2002 (Public Law 107-
        188; 116 Stat. 687).
SEC. 104. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION-DRUG 
                        TELEVISION ADVERTISING.

    Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.) is 
amended by adding after section 736 the following:
``SEC. 736A. <<NOTE: 21 USC 379h-1.>> FEES RELATING TO ADVISORY 
                          REVIEW OF PRESCRIPTION-DRUG TELEVISION 
                          ADVERTISING.

    ``(a) Types of Direct-to-Consumer Television Advertisement Review 
Fees.--Beginning <<NOTE: Effective date.>> in fiscal year 2008, the 
Secretary shall assess and collect fees in accordance with this section 
as follows:
            ``(1) Advisory review fee.--
                    ``(A) In general.--With respect to a proposed 
                direct-to-consumer television advertisement (referred to 
                in this section as a `DTC advertisement'), each person 
                that on or after October 1, 2007, submits such an 
                advertisement for advisory review by the Secretary prior 
                to its initial public dissemination shall, except as 
                provided in subparagraph (B), be subject to a fee 
                established under subsection (c)(3).
                    ``(B) Exception for required submissions.--A DTC 
                advertisement that is required to be submitted to the 
                Secretary prior to initial public dissemination is not 
                subject to a fee under subparagraph (A) unless the 
                sponsor designates the submission as a submission for 
                advisory review.
                    ``(C) Notice to secretary of number of 
                advertisements.--Not later 
                than <<NOTE: Deadlines. Federal 
                Register, publication.>> June 1 of each fiscal

[[Page 121 STAT. 833]]

                year, the Secretary shall publish a notice in the 
                Federal Register requesting any person to notify the 
                Secretary within 30 days of the number of DTC 
                advertisements the person intends to submit for advisory 
                review in the next fiscal year. Notwithstanding the 
                preceding sentence, for fiscal year 2008, the Secretary 
                shall publish such a notice in the Federal Register not 
                later than 30 days after the date of the enactment of 
                the Food and Drug Administration Amendments Act of 2007.
                    ``(D) <<NOTE: Deadlines.>> Payment.--
                          ``(i) In general.--The fee required by 
                      subparagraph (A) (referred to in this section as 
                      `an advisory review fee') shall be due not later 
                      than October 1 of the fiscal year in which the DTC 
                      advertisement involved is intended to be submitted 
                      for advisory review, subject to subparagraph 
                      (F)(i). Notwithstanding the preceding sentence, 
                      the advisory review fee for any DTC advertisement 
                      that is intended to be submitted for advisory 
                      review during fiscal year 2008 shall be due not 
                      later than 120 days after the date of the 
                      enactment of the Food and Drug Administration 
                      Amendments of 2007 or an earlier date as specified 
                      by the Secretary.
                          ``(ii) Effect of submission.--Notification of 
                      the Secretary under subparagraph (C) of the number 
                      of DTC advertisements a person intends to submit 
                      for advisory review is a legally binding 
                      commitment by that person to pay the annual 
                      advisory review fee for that number of submissions 
                      on or before October 1 of the fiscal year in which 
                      the advertisement is intended to be submitted. 
                      Notwithstanding the preceding sentence, the 
                      commitment shall be a legally binding commitment 
                      by that person to pay the annual advisory review 
                      fee for that number of submissions for fiscal year 
                      2008 by the date specified in clause (i).
                          ``(iii) Notice regarding carryover 
                      submissions.--In making a notification under 
                      subparagraph (C), the person involved shall in 
                      addition notify the Secretary if under 
                      subparagraph (F)(i) the person intends to submit a 
                      DTC advertisement for which the advisory review 
                      fee has already been paid. If the person does not 
                      so notify the Secretary, each DTC advertisement 
                      submitted by the person for advisory review in the 
                      fiscal year involved shall be subject to the 
                      advisory review fee.
                    ``(E) Modification of advisory review fee.--
                          ``(i) Late <<NOTE: Applicability.>> payment.--
                      If a person has submitted a notification under 
                      subparagraph (C) with respect to a fiscal year and 
                      has not paid all advisory review fees due under 
                      subparagraph (D) not later than November 1 of such 
                      fiscal year (or, in the case of such a 
                      notification submitted with respect to fiscal year 
                      2008, not later than 150 days after the date of 
                      the enactment of the Food and Drug Administration 
                      Amendments Act of 2007 or an earlier date 
                      specified by the Secretary), the fees shall be 
                      regarded as late

[[Page 121 STAT. 834]]

                      and an increase in the amount of fees applies in 
                      accordance with this clause, notwithstanding any 
                      other provision of this 
                      section. <<NOTE: Deadline.>> For such person, all 
                      advisory review fees for such fiscal year shall be 
                      due and payable 20 days before any direct-to-
                      consumer advertisement is submitted to the 
                      Secretary for advisory review, and each such fee 
                      shall be equal to 150 percent of the fee that 
                      otherwise would have applied pursuant to 
                      subsection (c)(3).
                          ``(ii) Exceeding identified number of 
                      submissions.--If a person submits a number of DTC 
                      advertisements for advisory review in a fiscal 
                      year that exceeds the number identified by the 
                      person under subparagraph (C), an increase in the 
                      amount of fees applies under this clause for each 
                      submission in excess of such number, 
                      notwithstanding any other provision of this 
                      section. For <<NOTE: Deadline.>> each such DTC 
                      advertisement, the advisory review fee shall be 
                      due and payable 20 days before the advertisement 
                      is submitted to the Secretary, and the fee shall 
                      be equal to 150 percent of the fee that otherwise 
                      would have applied pursuant to subsection (c)(3).
                    ``(F) Limits.--
                          ``(i) Submissions.--For each advisory review 
                      fee paid by a person for a fiscal year, the person 
                      is entitled to acceptance for advisory review by 
                      the Secretary of one DTC advertisement and 
                      acceptance of one resubmission for advisory review 
                      of the same advertisement. The advertisement shall 
                      be submitted for review in the fiscal year for 
                      which the fee was assessed, except that a person 
                      may carry over not more than one paid advisory 
                      review submission to the next fiscal year. 
                      Resubmissions may be submitted without regard to 
                      the fiscal year of the initial advisory review 
                      submission.
                          ``(ii) No refunds.--Except as provided by 
                      subsections (d)(4) and (f), fees paid under this 
                      section shall not be refunded.
                          ``(iii) No waivers, exemptions, or 
                      reductions.--The Secretary shall not grant a 
                      waiver, exemption, or reduction of any fees due or 
                      payable under this section.
                          ``(iv) Right to advisory review not 
                      transferable.--The right to an advisory review 
                      under this paragraph is not transferable, except 
                      to a successor in interest.
            ``(2) Operating reserve fee.--
                    ``(A) In general.--Each person that on or after 
                October 1, 2007, is assessed an advisory review fee 
                under paragraph (1) shall be subject to fee established 
                under subsection (d)(2) (referred to in this section as 
                an `operating reserve fee') for the first fiscal year in 
                which an advisory review fee is assessed to such person. 
                The person is not subject to an operating reserve fee 
                for any other fiscal year.
                    ``(B) Payment.--Except <<NOTE: Deadlines.>> as 
                provided in subparagraph (C), the operating reserve fee 
                shall be due no later than--

[[Page 121 STAT. 835]]

                          ``(i) October 1 of the first fiscal year in 
                      which the person is required to pay an advisory 
                      review fee under paragraph (1); or
                          ``(ii) for fiscal year 2008, 120 days after 
                      the date of the enactment of the Food and Drug 
                      Administration Amendments Act of 2007 or an 
                      earlier date specified by the Secretary.
                    ``(C) Late notice of submission.--If, in the first 
                fiscal year of a person's participation in the program 
                under this section, that person submits any DTC 
                advertisements for advisory review that are in excess of 
                the number identified by that person in response to the 
                Federal Register notice described in subsection 
                (a)(1)(C), that person shall pay an operating reserve 
                fee for each of those advisory reviews equal to the 
                advisory review fee for each submission established 
                under paragraph (1)(E)(ii). Fees required by this 
                subparagraph shall be in addition to any fees required 
                by subparagraph (A). <<NOTE: Deadline.>> Fees under this 
                subparagraph shall be due 20 days before any DTC 
                advertisement is submitted by such person to the 
                Secretary for advisory review.
                    ``(D) Late <<NOTE: Deadlines.>> payment.--
                          ``(i) In general.--Notwithstanding 
                      subparagraph (B), and subject to clause (ii), an 
                      operating reserve fee shall be regarded as late if 
                      the person required to pay the fee has not paid 
                      the complete operating reserve fee by--
                                    ``(I) for fiscal year 2008, 150 days 
                                after the date of the enactment of the 
                                Food and Drug Administration Amendments 
                                Act of 2007 or an earlier date specified 
                                by the Secretary; or
                                    ``(II) in any subsequent year, 
                                November 1.
                          ``(ii) Complete payment.--The complete 
                      operating reserve fee shall be due and payable 20 
                      days before any DTC advertisement is submitted by 
                      such person to the Secretary for advisory review.
                          ``(iii) Amount.--Notwithstanding any other 
                      provision of this section, an operating reserve 
                      fee that is regarded as late under this 
                      subparagraph shall be equal to 150 percent of the 
                      operating reserve fee that otherwise would have 
                      applied pursuant to subsection (d).

    ``(b) Advisory Review Fee Revenue Amounts.--Fees under subsection 
(a)(1) shall be established to generate revenue amounts of $6,250,000 
for each of fiscal years 2008 through 2012, as adjusted pursuant to 
subsections (c) and (g)(4).
    ``(c) Adjustments.--
            ``(1) Inflation <<NOTE: Effective date. Notice. Federal 
        Register, publication.>> adjustment.--Beginning with fiscal year 
        2009, the revenues established in subsection (b) shall be 
        adjusted by the Secretary by notice, published in the Federal 
        Register, for a fiscal year to reflect the greater of--
                    ``(A) the total percentage change that occurred in 
                the Consumer Price Index for all urban consumers (all 
                items; U.S. city average), for the 12-month period 
                ending June 30 preceding the fiscal year for which fees 
                are being established;
                    ``(B) the total percentage change for the previous 
                fiscal year in basic pay under the General Schedule in 
                accordance

[[Page 121 STAT. 836]]

                with section 5332 of title 5, United States Code, as 
                adjusted by any locality-based comparability payment 
                pursuant to section 5304 of such title for Federal 
                employees stationed in the District of Columbia; or
                    ``(C) the average annual change in the cost, per 
                full-time equivalent position of the Food and Drug 
                Administration, of all personnel compensation and 
                benefits paid with respect to such positions for the 
                first 5 fiscal years of the previous 6 fiscal years.
        The adjustment made each fiscal year by this subsection shall be 
        added on a compounded basis to the sum of all adjustments made 
        each fiscal year after fiscal year 2008 under this subsection.
            ``(2) Workload <<NOTE: Effective date.>> adjustment.--
        Beginning with fiscal year 2009, after the fee revenues 
        established in subsection (b) are adjusted for a fiscal year for 
        inflation in accordance with paragraph (1), the fee revenues 
        shall be adjusted further for such fiscal year to reflect 
        changes in the workload of the Secretary with respect to the 
        submission of DTC advertisements for advisory review prior to 
        initial dissemination. With respect to such adjustment:
                    ``(A) The adjustment shall be determined by the 
                Secretary based upon the number of DTC advertisements 
                identified pursuant to subsection (a)(1)(C) for the 
                upcoming fiscal year, excluding allowable previously 
                paid carry over submissions. The adjustment shall be 
                determined by multiplying the number of such 
                advertisements projected for that fiscal year that 
                exceeds 150 by $27,600 (adjusted each year beginning 
                with fiscal year 2009 for inflation in accordance with 
                paragraph (1)). <<NOTE: Federal 
                Register, publication.>> The Secretary shall publish in 
                the Federal Register the fee revenues and fees resulting 
                from the adjustment and the supporting methodologies.
                    ``(B) Under no circumstances shall the adjustment 
                result in fee revenues for a fiscal year that are less 
                than the fee revenues established for the prior fiscal 
                year.
            ``(3) Annual fee setting for advisory review.--
                    ``(A) In <<NOTE: Deadlines.>> general.--Not later 
                than August 1 of each fiscal year (or, with respect to 
                fiscal year 2008, not later than 90 days after the date 
                of the enactment of the Food and Drug Administration 
                Amendments Act of 2007), the Secretary shall establish 
                for the next fiscal year the DTC advertisement advisory 
                review fee under subsection (a)(1), based on the revenue 
                amounts established under subsection (b), the 
                adjustments provided under paragraphs (1) and (2), and 
                the number of DTC advertisements identified pursuant to 
                subsection (a)(1)(C), excluding allowable previously-
                paid carry over submissions. The annual advisory review 
                fee shall be established by dividing the fee revenue for 
                a fiscal year (as adjusted pursuant to this subsection) 
                by the number of DTC advertisements so identified, 
                excluding allowable previously-paid carry over 
                submissions under subsection (a)(1)(F)(i).
                    ``(B) Fiscal year 2008 fee limit.--Notwithstanding 
                subsection (b) and the adjustments pursuant to this 
                subsection, the fee established under subparagraph (A) 
                for

[[Page 121 STAT. 837]]

                fiscal year 2008 may not be more than $83,000 per 
                submission for advisory review.
                    ``(C) Annual fee limit.--Notwithstanding subsection 
                (b) and the adjustments pursuant to this subsection, the 
                fee established under subparagraph (A) for a fiscal year 
                after fiscal year 2008 may not be more than 50 percent 
                more than the fee established for the prior fiscal year.
                    ``(D) Limit.--The total amount of fees obligated for 
                a fiscal year may not exceed the total costs for such 
                fiscal year for the resources allocated for the process 
                for the advisory review of prescription drug 
                advertising.

    ``(d) Operating Reserves.--
            ``(1) In general.--The Secretary shall establish in the Food 
        and Drug Administration salaries and expenses appropriation 
        account without fiscal year limitation a Direct-to-Consumer 
        Advisory Review Operating Reserve, of at least $6,250,000 in 
        fiscal year 2008, to continue the program under this section in 
        the event the fees collected in any subsequent fiscal year 
        pursuant to subsection (a)(1) do not generate the fee revenue 
        amount established for that fiscal year.
            ``(2) Fee setting.--The Secretary shall establish the 
        operating reserve fee under subsection (a)(2)(A) for each person 
        required to pay the fee by multiplying the number of DTC 
        advertisements identified by that person pursuant to subsection 
        (a)(1)(C) by the advisory review fee established pursuant to 
        subsection (c)(3) for that fiscal year, except that in no case 
        shall the operating reserve fee assessed be less than the 
        operating reserve fee assessed if the person had first 
        participated in the program under this section in fiscal year 
        2008.
            ``(3) Use of operating reserve.--The Secretary may use funds 
        from the reserves only to the extent necessary in any fiscal 
        year to make up the difference between the fee revenue amount 
        established for that fiscal year under subsections (b) and (c) 
        and the amount of fees actually collected for that fiscal year 
        pursuant to subsection (a)(1), or to pay costs of ending the 
        program under this section if it is terminated pursuant to 
        subsection (f) or not reauthorized beyond fiscal year 2012.
            ``(4) Refund <<NOTE: Deadline.>> of operating reserves.--
        Within 120 days after the end of fiscal year 2012, or if the 
        program under this section ends early pursuant to subsection 
        (f), the Secretary, after setting aside sufficient operating 
        reserve amounts to terminate the program under this section, 
        shall refund all amounts remaining in the operating reserve on a 
        pro rata basis to each person that paid an operating reserve fee 
        assessment. In no event shall the refund to any person exceed 
        the total amount of operating reserve fees paid by such person 
        pursuant to subsection (a)(2).

    ``(e) Effect of Failure To Pay Fees.--Notwithstanding any other 
requirement, a submission for advisory review of a DTC advertisement 
submitted by a person subject to fees under subsection (a) shall be 
considered incomplete and shall not be accepted for review by the 
Secretary until all fees owed by such person under this section have 
been paid.
    ``(f) Effect of Inadequate Funding of Program.--
            ``(1) Initial <<NOTE: Effective date.>> funding.--If on 
        November 1, 2007, or 120 days after the date of the enactment of 
        the Food and Drug Administration Amendments Act of 2007, 
        whichever is later,

[[Page 121 STAT. 838]]

        the Secretary has not received at least $11,250,000 in advisory 
        review fees and operating reserve fees combined, the program 
        under this section shall not commence and all collected fees 
        shall be refunded.
            ``(2) Later <<NOTE: Effective date. Notification.>> fiscal 
        years.--Beginning in fiscal year 2009, if, on November 1 of the 
        fiscal year, the combination of the operating reserves, annual 
        fee revenues from that fiscal year, and unobligated fee revenues 
        from prior fiscal years falls below $9,000,000, adjusted for 
        inflation (as described in subsection (c)(1)), the program under 
        this section shall terminate, and the Secretary shall notify all 
        participants, retain any money from the unused advisory review 
        fees and the operating reserves needed to terminate the program, 
        and refund the remainder of the unused fees and operating 
        reserves. To the extent required to terminate the program, the 
        Secretary shall first use unobligated advisory review fee 
        revenues from prior fiscal years, then the operating reserves, 
        and finally, unused advisory review fees from the relevant 
        fiscal year.

    ``(g) Crediting and Availability of Fees.--
            ``(1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to the 
        extent and in the amount provided in advance in appropriations 
        Acts. Such fees are authorized to remain available until 
        expended. Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salaries and expenses with such fiscal 
        year limitation. The sums transferred shall be available solely 
        for the process for the advisory review of prescription drug 
        advertising.
            ``(2) Collections and appropriation acts.--
                    ``(A) In general.--The fees authorized by this 
                section--
                          ``(i) shall be retained in each fiscal year in 
                      an amount not to exceed the amount specified in 
                      appropriation Acts, or otherwise made available 
                      for obligation for such fiscal year; and
                          ``(ii) shall be available for obligation only 
                      if the amounts appropriated as budget authority 
                      for such fiscal year are sufficient to support a 
                      number of full-time equivalent review employees 
                      that is not fewer than the number of such 
                      employees supported in fiscal year 2007.
                    ``(B) Review employees.--For purposes of 
                subparagraph (A)(ii), the term `full-time equivalent 
                review employees' means the total combined number of 
                full-time equivalent employees in--
                          ``(i) the Center for Drug Evaluation and 
                      Research, Division of Drug Marketing, Advertising, 
                      and Communications, Food and Drug Administration; 
                      and
                          ``(ii) the Center for Biologics Evaluation and 
                      Research, Advertising and Promotional Labeling 
                      Branch, Food and Drug Administration.
            ``(3) Authorization of appropriations.--For each of the 
        fiscal years 2008 through 2012, there is authorized to be 
        appropriated for fees under this section an amount equal to the 
        total revenue amount determined under subsection (b) for the

[[Page 121 STAT. 839]]

        fiscal year, as adjusted pursuant to subsection (c) and 
        paragraph (4) of this subsection, plus amounts collected for the 
        reserve fund under subsection (d).
            ``(4) Offset.--Any amount of fees collected for a fiscal 
        year under this section that exceeds the amount of fees 
        specified in appropriation Acts for such fiscal year shall be 
        credited to the appropriation account of the Food and Drug 
        Administration as provided in paragraph (1), and shall be 
        subtracted from the amount of fees that would otherwise be 
        collected under this section pursuant to appropriation Acts for 
        a subsequent fiscal year.

    ``(h) Definitions.--For purposes of this section:
            ``(1) The term `advisory review' means reviewing and 
        providing advisory comments on DTC advertisements regarding 
        compliance of a proposed advertisement with the requirements of 
        this Act prior to its initial public dissemination.
            ``(2) The term `advisory review fee' has the meaning 
        indicated for such term in subsection (a)(1)(D).
            ``(3) The term `carry over submission' means a submission 
        for an advisory review for which a fee was paid in one fiscal 
        year that is submitted for review in the following fiscal year.
            ``(4) The term `direct-to-consumer television advertisement' 
        means an advertisement for a prescription drug product (as 
        defined in section 735(3)) intended to be displayed on any 
        television channel for less than 3 minutes.
            ``(5) The term `DTC advertisement' has the meaning indicated 
        for such term in subsection (a)(1)(A).
            ``(6) The term `operating reserve fee' has the meaning 
        indicated for such term in subsection (a)(2)(A).
            ``(7) The term `person' includes an individual, partnership, 
        corporation, and association, and any affiliate thereof or 
        successor in interest.
            ``(8) The term `process for the advisory review of 
        prescription drug advertising' means the activities necessary to 
        review and provide advisory comments on DTC advertisements prior 
        to public dissemination and, to the extent the Secretary has 
        additional staff resources available under the program under 
        this section that are not necessary for the advisory review of 
        DTC advertisements, the activities necessary to review and 
        provide advisory comments on other proposed advertisements and 
        promotional material prior to public dissemination.
            ``(9) The term `resources allocated for the process for the 
        advisory review of prescription drug advertising' means the 
        expenses incurred in connection with the process for the 
        advisory review of prescription drug advertising for--
                    ``(A) officers and employees of the Food and Drug 
                Administration, contractors of the Food and Drug 
                Administration, advisory committees, and costs related 
                to such officers, employees, and committees, and to 
                contracts with such contractors;
                    ``(B) management of information, and the 
                acquisition, maintenance, and repair of computer 
                resources;
                    ``(C) leasing, maintenance, renovation, and repair 
                of facilities and acquisition, maintenance, and repair 
                of fixtures, furniture, scientific equipment, and other 
                necessary materials and supplies;

[[Page 121 STAT. 840]]

                    ``(D) collection of fees under this section and 
                accounting for resources allocated for the advisory 
                review of prescription drug advertising; and
                    ``(E) terminating the program under this section 
                pursuant to subsection (f)(2) if that becomes necessary.
            ``(10) The term `resubmission' means a subsequent submission 
        for advisory review of a direct-to-consumer television 
        advertisement that has been revised in response to the 
        Secretary's comments on an original submission. A resubmission 
        may not introduce significant new concepts or creative themes 
        into the television advertisement.
            ``(11) The term `submission for advisory review' means an 
        original submission of a direct-to-consumer television 
        advertisement for which the sponsor voluntarily requests 
        advisory comments before the advertisement is publicly 
        disseminated.''.
SEC. 105. REAUTHORIZATION; REPORTING REQUIREMENTS.

    Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.), as 
amended by section 104, is further amended by inserting after section 
736A the following:
``SEC. 736B. <<NOTE: 21 USC 379h-2.>> REAUTHORIZATION; REPORTING 
                          REQUIREMENTS.

    ``(a) Performance Report.--Beginning with fiscal year 2008, not 
later than 120 days after the end of each fiscal year for which fees are 
collected under this part, the Secretary shall prepare and submit to the 
Committee on Energy and Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pensions of the Senate a 
report concerning the progress of the Food and Drug Administration in 
achieving the goals identified in the letters described in section 
101(c) of the Food and Drug Administration Amendments Act of 2007 during 
such fiscal year and the future plans of the Food and Drug 
Administration for meeting the goals. The report for a fiscal year shall 
include information on all previous cohorts for which the Secretary has 
not given a complete response on all human drug applications and 
supplements in the cohort.
    ``(b) Fiscal Report.--Beginning with fiscal year 2008, not later 
than 120 days after the end of each fiscal year for which fees are 
collected under this part, the Secretary shall prepare and submit to the 
Committee on Energy and Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pensions of the Senate a 
report on the implementation of the authority for such fees during such 
fiscal year and the use, by the Food and Drug Administration, of the 
fees collected for such fiscal year.
    ``(c) Public <<NOTE: Website.>> Availability.--The Secretary shall 
make the reports required under subsections (a) and (b) available to the 
public on the Internet Web site of the Food and Drug Administration.

    ``(d) Reauthorization.--
            ``(1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals, and plans for 
        meeting the goals, for the process for the review of human drug 
        applications for the first 5 fiscal years after fiscal year 
        2012, and for the reauthorization of this part for such fiscal 
        years, the Secretary shall consult with--
                    ``(A) the Committee on Energy and Commerce of the 
                House of Representatives;

[[Page 121 STAT. 841]]

                    ``(B) the Committee on Health, Education, Labor, and 
                Pensions of the Senate;
                    ``(C) scientific and academic experts;
                    ``(D) health care professionals;
                    ``(E) representatives of patient and consumer 
                advocacy groups; and
                    ``(F) the regulated industry.
            ``(2) Prior public input.--Prior to beginning negotiations 
        with the regulated industry on the reauthorization of this part, 
        the Secretary shall--
                    ``(A) <<NOTE: Federal 
                Register, publication.>> publish a notice in the Federal 
                Register requesting public input on the reauthorization;
                    ``(B) hold a public meeting at which the public may 
                present its views on the reauthorization, including 
                specific suggestions for changes to the goals referred 
                to in subsection (a);
                    ``(C) provide a period of 30 days after the public 
                meeting to obtain written comments from the public 
                suggesting changes to this part; and
                    ``(D) <<NOTE: Website.>> publish the comments on the 
                Food and Drug Administration's Internet Web site.
            ``(3) Periodic consultation.--Not less frequently than once 
        every month during negotiations with the regulated industry, the 
        Secretary shall hold discussions with representatives of patient 
        and consumer advocacy groups to continue discussions of their 
        views on the reauthorization and their suggestions for changes 
        to this part as expressed under paragraph (2).
            ``(4) Public review of recommendations.--After negotiations 
        with the regulated industry, the Secretary shall--
                    ``(A) present the recommendations developed under 
                paragraph (1) to the Congressional committees specified 
                in such paragraph;
                    ``(B) <<NOTE: Federal 
                Register, publication.>> publish such recommendations in 
                the Federal Register;
                    ``(C) provide for a period of 30 days for the public 
                to provide written comments on such recommendations;
                    ``(D) hold a meeting at which the public may present 
                its views on such recommendations; and
                    ``(E) after consideration of such public views and 
                comments, revise such recommendations as necessary.
            ``(5) Transmittal of <<NOTE: Deadline.>> recommendations.--
        Not later than January 15, 2012, the Secretary shall transmit to 
        the Congress the revised recommendations under paragraph (4), a 
        summary of the views and comments received under such paragraph, 
        and any changes made to the recommendations in response to such 
        views and comments.
            ``(6) Minutes of negotiation meetings.--
                    ``(A) Public <<NOTE: Website.>> availability.--
                Before presenting the recommendations developed under 
                paragraphs (1) through (5) to the Congress, the 
                Secretary shall make publicly available, on the public 
                Web site of the Food and Drug Administration, minutes of 
                all negotiation meetings conducted under this subsection 
                between the Food and Drug Administration and the 
                regulated industry.
                    ``(B) Content.--The minutes described under 
                subparagraph (A) shall summarize any substantive 
                proposal made

[[Page 121 STAT. 842]]

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

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

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

    The amendments made by this title shall take effect on October 1, 
2007, or the date of the enactment of this Act, whichever is later, 
except that fees under part 2 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act shall be assessed for all human 
drug applications received on or after October 1, 2007, regardless of 
the date of the enactment of this Act.
SEC. 108. <<NOTE: 21 USC 379g note.>> SAVINGS CLAUSE.

    Notwithstanding section 509 of the Prescription Drug User Fee 
Amendments of 2002 (21 U.S.C. 379g note), and notwithstanding the 
amendments made by this title, part 2 of subchapter C of chapter VII of 
the Federal Food, Drug, and Cosmetic Act, as in effect on the day before 
the date of the enactment of this title, shall continue to be in effect 
with respect to human drug applications and supplements (as defined in 
such part as of such day) that on or after October 1, 2002, but before 
October 1, 2007, were accepted by the Food and Drug Administration for 
filing with respect to assessing and collecting any fee required by such 
part for a fiscal year prior to fiscal year 2008.
SEC. 109. TECHNICAL AMENDMENT; CONFORMING AMENDMENT.

    (a) Section 739 (21 U.S.C. 379j-11) is amended in the matter 
preceding paragraph (1) by striking ``subchapter'' and inserting 
``part''.
    (b) Paragraph (11) of section 739 (21 U.S.C. 379j-11) is amended by 
striking ``735(9)'' and inserting ``735(11)''.

    TITLE II--MEDICAL <<NOTE: Medical Device User Fee Amendments of 
2007.>> DEVICE USER FEE AMENDMENTS OF 2007
SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING.

    (a) Short <<NOTE: 21 USC 301 note.>> Title.--This title may be cited 
as the ``Medical Device User Fee Amendments of 2007''.

    (b) References in Title.--Except as otherwise specified, amendments 
made by this title to a section or other provision of law are amendments 
to such section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).
    (c) Finding.--The <<NOTE: 21 USC 379i note.>> Congress finds that 
the fees authorized under the amendments made by this title will be 
dedicated toward expediting the process for the review of device 
applications and for assuring the safety and effectiveness of devices, 
as set forth in the goals identified for purposes of part 3 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act 
in the letters from the Secretary of Health and Human Services to the 
Chairman of the Committee on Health, Education, Labor, and Pensions of 
the Senate and the Chairman of the Committee on Energy

[[Page 121 STAT. 843]]

and Commerce of the House of Representatives, as set forth in the 
Congressional Record.

               Subtitle A--Fees Related to Medical Devices

SEC. 211. DEFINITIONS.

    Section <<NOTE: 21 USC 379i.>> 737 is amended--
            (1) in the matter preceding paragraph (1), by striking ``For 
        purposes of this subchapter'' and inserting ``For purposes of 
        this part'';
            (2) by redesignating paragraphs (5), (6), (7), and (8) as 
        paragraphs (8), (9), (10), and (12), respectively;
            (3) by inserting after paragraph (4) the following:
            ``(5) The term `30-day notice' means a notice under section 
        515(d)(6) that is limited to a request to make modifications to 
        manufacturing procedures or methods of manufacture affecting the 
        safety and effectiveness of the device.
            ``(6) The term `request for classification information' 
        means a request made under section 513(g) for information 
        respecting the class in which a device has been classified or 
        the requirements applicable to a device.
            ``(7) The term `annual fee', for periodic reporting 
        concerning a class III device, means the annual fee associated 
        with periodic reports required by a premarket application 
        approval order.'';
            (4) in paragraph (10), as so redesignated--
                    (A) by striking ``April of the preceding fiscal 
                year'' and inserting ``October of the preceding fiscal 
                year''; and
                    (B) by striking ``April 2002'' and inserting 
                ``October 2001'';
            (5) by inserting after paragraph (10), as so amended, the 
        following:
            ``(11) The term `person' includes an affiliate thereof.''; 
        and
            (6) by inserting after paragraph (12), as so redesignated, 
        the following:
            ``(13) The term `establishment subject to a registration 
        fee' means an establishment that is required to register with 
        the Secretary under section 510 and is one of the following 
        types of establishments:
                    ``(A) Manufacturer.--An establishment that makes by 
                any means any article that is a device, including an 
                establishment that sterilizes or otherwise makes such 
                article for or on behalf of a specification developer or 
                any other person.
                    ``(B) Single-use device reprocessor.--An 
                establishment that, within the meaning of section 
                201(ll)(2)(A), performs additional processing and 
                manufacturing operations on a single-use device that has 
                previously been used on a patient.
                    ``(C) Specification developer.--An establishment 
                that develops specifications for a device that is 
                distributed under the establishment's name but which 
                performs no manufacturing, including an establishment 
                that, in addition to developing specifications, also 
                arranges for the manufacturing of devices labeled with 
                another establishment's name by a contract 
                manufacturer.''.

[[Page 121 STAT. 844]]

SEC. 212. AUTHORITY TO ASSESS AND USE DEVICE FEES.

    (a) Types of Fees.--
            (1) In general.--Section 738(a) (21 U.S.C. 379j(a)) is 
        amended--
                    (A) in paragraph (1), by striking ``Beginning on the 
                date of the enactment of the Medical Device User Fee and 
                Modernization Act of 2002'' and inserting ``Beginning in 
                fiscal year 2008''; and
                    (B) by amending the designation and heading of 
                paragraph (2) to read as follows:
            ``(2) Premarket application, premarket report, supplement, 
        and submission fee, and annual fee for periodic reporting 
        concerning a class iii device.--''.
            (2) Fee amounts.--Section 738(a)(2)(A) (21 U.S.C. 
        379j(a)(2)(A)) is amended--
                    (A) in clause (iii), by striking ``a fee equal to 
                the fee that applies'' and inserting ``a fee equal to 75 
                percent of the fee that applies'';
                    (B) in clause (iv), by striking ``21.5 percent'' and 
                inserting ``15 percent'';
                    (C) in clause (v), by striking ``7.2 percent'' and 
                inserting ``7 percent'';
                    (D) by redesignating clauses (vi) and (vii) as 
                clauses (vii) and (viii), respectively;
                    (E) by inserting after clause (v) the following:
                          ``(vi) For a 30-day notice, a fee equal to 1.6 
                      percent of the fee that applies under clause 
                      (i).'';
                    (F) in clause (viii), as so redesignated--
                          (i) by striking ``1.42 percent'' and inserting 
                      ``1.84 percent''; and
                          (ii) by striking ``, subject to any adjustment 
                      under subsection (e)(2)(C)(ii)''; and
                    (G) by inserting after such clause (viii) the 
                following:
                          ``(ix) For a request for classification 
                      information, a fee equal to 1.35 percent of the 
                      fee that applies under clause (i).
                          ``(x) For periodic reporting concerning a 
                      class III device, an annual fee equal to 3.5 
                      percent of the fee that applies under clause 
                      (i).''.
            (3) Payment.--Section 738(a)(2)(C) (21 U.S.C. 379j(a)(2)(C)) 
        is amended to read as follows:
                    ``(C) Payment.--The fee required by subparagraph (A) 
                shall be due upon submission of the premarket 
                application, premarket report, supplement, premarket 
                notification submission, 30-day notice, request for 
                classification information, or periodic reporting 
                concerning a class III device. Applicants submitting 
                portions of applications pursuant to section 515(c)(4) 
                shall pay such fees upon submission of the first portion 
                of such applications.''.
            (4) Refunds.--Section 738(a)(2)(D) (21 U.S.C. 379j(a)(2)(D)) 
        is amended--
                    (A) in clause (iii), by striking the last two 
                sentences; and
                    (B) by adding after clause (iii) the following:
                          ``(iv) Modular applications withdrawn before 
                      first action.--The Secretary shall refund 75 
                      percent of the application fee paid for an 
                      application submitted

[[Page 121 STAT. 845]]

                      under section 515(c)(4) that is withdrawn before a 
                      second portion is submitted and before a first 
                      action on the first portion.
                          ``(v) Later withdrawn modular applications.--
                      If an application submitted under section 
                      515(c)(4) is withdrawn after a second or 
                      subsequent portion is submitted but before any 
                      first action, the Secretary may return a portion 
                      of the fee. The amount of refund, if any, shall be 
                      based on the level of effort already expended on 
                      the review of the portions submitted.
                          ``(vi) Sole discretion to refund.--The 
                      Secretary shall have sole discretion to refund a 
                      fee or portion of the fee under clause (iii) or 
                      (v). A determination by the Secretary concerning a 
                      refund under clause (iii) or (v) shall not be 
                      reviewable.''.
            (5) Annual establishment registration fee.--Section 738(a) 
        (21 U.S.C. 379j(a)) is amended by adding after paragraph (2) the 
        following:
            ``(3) Annual establishment registration fee.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), each establishment subject to a 
                registration fee shall be subject to a fee for each 
                initial or annual registration under section 510 
                beginning with its registration for fiscal year 2008.
                    ``(B) Exception.--No fee shall be required under 
                subparagraph (A) for an establishment operated by a 
                State or Federal governmental entity or an Indian tribe 
                (as defined in the Indian Self Determination and 
                Educational Assistance Act), unless a device 
                manufactured by the establishment is to be distributed 
                commercially.
                    ``(C) Payment.--The fee required under subparagraph 
                (A) shall be due once each fiscal year, upon the initial 
                registration of the establishment or upon the annual 
                registration under section 510.''.

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

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

    (c) Annual Fee Setting.--
            (1) In general.--Section 738(c) (21 U.S.C. 379j(c)(1)) is 
        amended--
                    (A) in the subsection heading, by striking ``Annual 
                Fee Setting'' and inserting ``Annual Fee Setting''; and
                    (B) in paragraph (1), by striking the last sentence.

[[Page 121 STAT. 846]]

            (2) Adjustment of annual establishment fee.--Section 738(c) 
        (21 U.S.C. 379j(c)), as amended by paragraph (1), is further 
        amended--
                    (A) by redesignating paragraphs (2) and (3) as 
                paragraphs (3) and (4), respectively;
                    (B) by inserting after paragraph (1) the following:
            ``(2) Adjustment.--
                    ``(A) In general.--When setting fees for fiscal year 
                2010, the Secretary may increase the fee under 
                subsection (a)(3)(A) (applicable to establishments 
                subject to registration) only if the Secretary estimates 
                that the number of establishments submitting fees for 
                fiscal year 2009 is fewer than 12,250. The percentage 
                increase shall be the percentage by which the estimate 
                of establishments submitting fees in fiscal year 2009 is 
                fewer than 12,750, but in no case may the percentage 
                increase be more than 8.5 percent over that specified in 
                subsection (b) for fiscal year 2010. If the Secretary 
                makes any adjustment to the fee under subsection 
                (a)(3)(A) for fiscal year 2010, then such fee for fiscal 
                years 2011 and 2012 shall be adjusted so that such fee 
                for fiscal year 2011 is equal to the adjusted fee for 
                fiscal year 2010 increased by 8.5 percent, and such fee 
                for fiscal year 2012 is equal to the adjusted fee for 
                fiscal year 2011 increased by 8.5 percent.
                    ``(B) Publication.--For <<NOTE: Federal 
                Register, publication.>> any adjustment made under 
                subparagraph (A), the Secretary shall publish in the 
                Federal Register the Secretary's determination to make 
                the adjustment and the rationale for the 
                determination.''; and
                    (C) in paragraph (4), as redesignated by this 
                paragraph, in subparagraph (A)--
                          (i) by striking ``For fiscal years 2006 and 
                      2007, the Secretary'' and inserting ``The 
                      Secretary''; and
                          (ii) by striking ``for the first month of 
                      fiscal year 2008'' and inserting ``for the first 
                      month of the next fiscal year''.

    (d) Small Businesses; Fee Waiver and Fee Reduction Regarding 
Premarket Approval.--
            (1) In general.--Section 738(d)(1) (21 U.S.C. 379j(d)(1)) is 
        amended--
                    (A) by striking ``, partners, and parent firms''; 
                and
                    (B) by striking ``clauses (i) through (vi) of 
                subsection (a)(2)(A)'' and inserting ``clauses (i) 
                through (v) and clauses (vii), (ix), and (x) of 
                subsection (a)(2)(A)''.
            (2) Rules relating to premarket approval fees.--
                    (A) Definition.--Section 738(d)(2)(A) (21 U.S.C. 
                379j(d)(2)(A)) is amended by striking ``, partners, and 
                parent firms''.
                    (B) Evidence of qualification.--Section 738(d)(2)(B) 
                (21 U.S.C. 379j(d)(2)(B)) is amended--
                          (i) by striking ``(B) Evidence of 
                      qualification.--An applicant'' and inserting the 
                      following:
                    ``(B) Evidence of qualification.--
                          ``(i) In general.--An applicant'';
                          (ii) by striking ``The applicant shall support 
                      its claim'' and inserting the following:

[[Page 121 STAT. 847]]

                          ``(ii) Firms submitting tax returns to the 
                      united states internal revenue service.--The 
                      applicant shall support its claim'';
                          (iii) by striking ``, partners, and parent 
                      firms'' each place it appears;
                          (iv) by striking the last sentence and 
                      inserting ``If no tax forms are submitted for any 
                      affiliate, the applicant shall certify that the 
                      applicant has no affiliates.''; and
                          (v) by adding at the end the following:
                          ``(iii) Firms not submitting tax returns to 
                      the united <<NOTE: Certification. Federal 
                      Register, publication.>> states internal revenue 
                      service.--In the case of an applicant that has not 
                      previously submitted a Federal income tax return, 
                      the applicant and each of its affiliates shall 
                      demonstrate that it meets the definition under 
                      subparagraph (A) by submission of a signed 
                      certification, in such form as the Secretary may 
                      direct through a notice published in the Federal 
                      Register, that the applicant or affiliate meets 
                      the criteria for a small business and a 
                      certification, in English, from the national 
                      taxing authority of the country in which the 
                      applicant or, if applicable, affiliate is 
                      headquartered. The certification from such taxing 
                      authority shall bear the official seal of such 
                      taxing authority and shall provide the applicant's 
                      or affiliate's gross receipts or sales for the 
                      most recent year in both the local currency of 
                      such country and in United States dollars, the 
                      exchange rate used in converting such local 
                      currency to dollars, and the dates during which 
                      these receipts or sales were collected. The 
                      applicant shall also submit a statement signed by 
                      the head of the applicant's firm or by its chief 
                      financial officer that the applicant has submitted 
                      certifications for all of its affiliates, or that 
                      the applicant has no affiliates.''.
            (3) Reduced fees.--Section 738(d)(2)(C) (21 U.S.C. 
        379j(d)(2)(C)) is amended to read as follows:
                    ``(C) Reduced fees.--Where the Secretary finds that 
                the applicant involved meets the definition under 
                subparagraph (A), the fees established under subsection 
                (c)(1) may be paid at a reduced rate of--
                          ``(i) 25 percent of the fee established under 
                      such subsection for a premarket application, a 
                      premarket report, a supplement, or periodic 
                      reporting concerning a class III device; and
                          ``(ii) 50 percent of the fee established under 
                      such subsection for a 30-day notice or a request 
                      for classification information.''.

    (e) Small Businesses; Fee Reduction Regarding Premarket Notification 
Submissions.--
            (1) In general.--Section 738(e)(1) (21 U.S.C. 379j(e)(1)) is 
        amended--
                    (A) by striking ``2004'' and inserting ``2008''; and
                    (B) by striking ``(a)(2)(A)(vii)'' and inserting 
                ``(a)(2)(A)(viii)''.
            (2) Rules relating to premarket notification submissions.--

[[Page 121 STAT. 848]]

                    (A) Definition.--Section 738(e)(2)(A) (21 U.S.C. 
                379j(e)(2)(A)) is amended by striking ``, partners, and 
                parent firms''.
                    (B) Evidence of qualification.--Section 738(e)(2)(B) 
                (21 U.S.C. 379j(e)(2)(B)) is amended--
                          (i) by striking ``(B) Evidence of 
                      qualification.--An applicant'' and inserting the 
                      following:
                    ``(B) Evidence of qualification.--
                          ``(i) In general.--An applicant'';
                          (ii) by striking ``The applicant shall support 
                      its claim'' and inserting the following:
                          ``(ii) Firms submitting tax returns to the 
                      united states internal revenue service.--The 
                      applicant shall support its claim'';
                          (iii) by striking ``, partners, and parent 
                      firms'' each place it appears;
                          (iv) by striking the last sentence and 
                      inserting ``If no tax forms are submitted for any 
                      affiliate, the applicant shall certify that the 
                      applicant has no affiliates.''; and
                          (v) by adding at the end the following:
                          ``(iii) Firms not submitting tax returns to 
                      the united <<NOTE: Certification. Federal 
                      Register, publication.>> states internal revenue 
                      service.--In the case of an applicant that has not 
                      previously submitted a Federal income tax return, 
                      the applicant and each of its affiliates shall 
                      demonstrate that it meets the definition under 
                      subparagraph (A) by submission of a signed 
                      certification, in such form as the Secretary may 
                      direct through a notice published in the Federal 
                      Register, that the applicant or affiliate meets 
                      the criteria for a small business and a 
                      certification, in English, from the national 
                      taxing authority of the country in which the 
                      applicant or, if applicable, affiliate is 
                      headquartered. The certification from such taxing 
                      authority shall bear the official seal of such 
                      taxing authority and shall provide the applicant's 
                      or affiliate's gross receipts or sales for the 
                      most recent year in both the local currency of 
                      such country and in United States dollars, the 
                      exchange rate used in converting such local 
                      currency to dollars, and the dates during which 
                      these receipts or sales were collected. The 
                      applicant shall also submit a statement signed by 
                      the head of the applicant's firm or by its chief 
                      financial officer that the applicant has submitted 
                      certifications for all of its affiliates, or that 
                      the applicant has no affiliates.''.
            (3) Reduced fees.--Section 738(e)(2)(C) (21 U.S.C. 
        379j(e)(2)(C)) is amended to read as follows:
                    ``(C) Reduced fees.--For fiscal year 2008 and each 
                subsequent fiscal year, where the Secretary finds that 
                the applicant involved meets the definition under 
                subparagraph (A), the fee for a premarket notification 
                submission may be paid at 50 percent of the fee that 
                applies under subsection (a)(2)(A)(viii), and as 
                established under subsection (c)(1).''.

    (f) Effect of Failure To Pay Fees.--Section 738(f) (21 U.S.C. 
379j(f)) is amended to read as follows:

[[Page 121 STAT. 849]]

    ``(f) Effect of Failure To Pay Fees.--
            ``(1) No acceptance of submissions.--A premarket 
        application, premarket report, supplement, premarket 
        notification submission, 30-day notice, request for 
        classification information, or periodic reporting concerning a 
        class III device submitted by a person subject to fees under 
        subsections (a)(2) and (a)(3) shall be considered incomplete and 
        shall not be accepted by the Secretary until all fees owed by 
        such person have been paid.
            ``(2) No registration.--Registration information submitted 
        under section 510 by an establishment subject to a registration 
        fee shall be considered incomplete and shall not be accepted by 
        the Secretary until the registration fee under subsection (a)(3) 
        owed for the establishment has been paid. Until the fee is paid 
        and the registration is complete, the establishment is deemed to 
        have failed to register in accordance with section 510.''.

    (g) Conditions.--Section 738(g) (21 U.S.C. 379j(g)) is amended--
            (1) by striking paragraph (1) and inserting the following:
            ``(1) Performance goals; termination of program.--With 
        respect to the amount that, under the salaries and expenses 
        account of the Food and Drug Administration, is appropriated for 
        a fiscal year for devices and radiological products, fees may 
        not be assessed under subsection (a) for the fiscal year, and 
        the Secretary is not expected to meet any performance goals 
        identified for the fiscal year, if--
                    ``(A) the amount so appropriated for the fiscal 
                year, excluding the amount of fees appropriated for the 
                fiscal year, is more than 1 percent less than 
                $205,720,000 multiplied by the adjustment factor 
                applicable to such fiscal year; or
                    ``(B) fees were not assessed under subsection (a) 
                for the previous fiscal year.''; and
            (2) by amending paragraph (2) to read as follows:
            ``(2) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal year because 
        of paragraph (1) and if at a later date in such fiscal year the 
        Secretary may assess such fees, the Secretary may assess and 
        collect such fees, without any modification in the rate for 
        premarket applications, supplements, premarket reports, 
        premarket notification submissions, 30-day notices, requests for 
        classification information, periodic reporting concerning a 
        class III device, and establishment registrations at any time in 
        such fiscal year, notwithstanding the provisions of subsection 
        (a) relating to the date fees are to be paid.''.

    (h) Crediting and Availability of Fees.--
            (1) Authorization of appropriations.--Section 738(h)(3) (21 
        U.S.C. 379j(h)(3)) is amended to read as follows:
            ``(3) Authorizations of appropriations.--There are 
        authorized to be appropriated for fees under this section--
                    ``(A) $48,431,000 for fiscal year 2008;
                    ``(B) $52,547,000 for fiscal year 2009;
                    ``(C) $57,014,000 for fiscal year 2010;
                    ``(D) $61,860,000 for fiscal year 2011; and
                    ``(E) $67,118,000 for fiscal year 2012.''.

[[Page 121 STAT. 850]]

            (2) Offset.--Section 738(h)(4) (21 U.S.C. 379j(h)(3)) is 
        amended to read as follows:
            ``(4) Offset.--If the cumulative amount of fees collected 
        during fiscal years 2008, 2009, and 2010, added to the amount 
        estimated to be collected for fiscal year 2011, which estimate 
        shall be based upon the amount of fees received by the Secretary 
        through June 30, 2011, exceeds the amount of fees specified in 
        aggregate in paragraph (3) for these four fiscal years, the 
        aggregate amount in excess shall be credited to the 
        appropriation account of the Food and Drug Administration as 
        provided in paragraph (1), and shall be subtracted from the 
        amount of fees that would otherwise be authorized to be 
        collected under this section pursuant to appropriation Acts for 
        fiscal year 2012.''.
SEC. 213. REAUTHORIZATION; REPORTING REQUIREMENTS.

    Part 3 of subchapter C of chapter VII is amended by inserting after 
section 738 the following:
``SEC. 738A. <<NOTE: 21 USC 379j-1.>> REAUTHORIZATION; REPORTING 
                          REQUIREMENTS.

    ``(a) Reports.--
            ``(1) Performance report.--For fiscal years 2008 through 
        2012, not later than 120 days after the end of each fiscal year 
        during which fees are collected under this part, the Secretary 
        shall prepare and submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, a report 
        concerning the progress of the Food and Drug Administration in 
        achieving the goals identified in the letters described in 
        section 201(c) of the Food and Drug Administration Amendments 
        Act of 2007 during such fiscal year and the future plans of the 
        Food and Drug Administration for meeting the goals. The report 
        for a fiscal year shall include information on all previous 
        cohorts for which the Secretary has not given a complete 
        response on all device premarket applications and reports, 
        supplements, and premarket notifications in the cohort.
            ``(2) Fiscal report.--For fiscal years 2008 through 2012, 
        not later than 120 days after the end of each fiscal year during 
        which fees are collected under this part, the Secretary shall 
        prepare and submit to the Committee on Health, Education, Labor, 
        and Pensions of the Senate and the Committee on Energy and 
        Commerce of the House of Representatives, a report on the 
        implementation of the authority for such fees during such fiscal 
        year and the use, by the Food and Drug Administration, of the 
        fees collected during such fiscal year for which the report is 
        made.
            ``(3) Public <<NOTE: Website.>> availability.--The Secretary 
        shall make the reports required under paragraphs (1) and (2) 
        available to the public on the Internet Web site of the Food and 
        Drug Administration.

    ``(b) Reauthorization.--
            ``(1) Consultation.--In developing recommendations to 
        present to Congress with respect to the goals, and plans for 
        meeting the goals, for the process for the review of device 
        applications for the first 5 fiscal years after fiscal year 
        2012, and for the reauthorization of this part for such fiscal 
        years, the Secretary shall consult with--

[[Page 121 STAT. 851]]

                    ``(A) the Committee on Energy and Commerce of the 
                House of Representatives;
                    ``(B) the Committee on Health, Education, Labor, and 
                Pensions of the Senate;
                    ``(C) scientific and academic experts;
                    ``(D) health care professionals;
                    ``(E) representatives of patient and consumer 
                advocacy groups; and
                    ``(F) the regulated industry.
            ``(2) Prior public input.--Prior to beginning negotiations 
        with the regulated industry on the reauthorization of this part, 
        the Secretary shall--
                    ``(A) <<NOTE: Federal 
                Register, publication.>> publish a notice in the Federal 
                Register requesting public input on the reauthorization;
                    ``(B) hold a public meeting at which the public may 
                present its views on the reauthorization, including 
                specific suggestions for changes to the goals referred 
                to in subsection (a)(1);
                    ``(C) provide a period of 30 days after the public 
                meeting to obtain written comments from the public 
                suggesting changes to this part; and
                    ``(D) <<NOTE: Website.>> publish the comments on the 
                Food and Drug Administration's Internet Web site.
            ``(3) Periodic consultation.--Not less frequently than once 
        every month during negotiations with the regulated industry, the 
        Secretary shall hold discussions with representatives of patient 
        and consumer advocacy groups to continue discussions of their 
        views on the reauthorization and their suggestions for changes 
        to this part as expressed under paragraph (2).
            ``(4) Public review of recommendations.--After negotiations 
        with the regulated industry, the Secretary shall--
                    ``(A) present the recommendations developed under 
                paragraph (1) to the Congressional committees specified 
                in such paragraph;
                    ``(B) <<NOTE: Federal 
                Register, publication.>> publish such recommendations in 
                the Federal Register;
                    ``(C) provide for a period of 30 days for the public 
                to provide written comments on such recommendations;
                    ``(D) hold a meeting at which the public may present 
                its views on such recommendations; and
                    ``(E) after consideration of such public views and 
                comments, revise such recommendations as necessary.
            ``(5) Transmittal <<NOTE: Deadline.>> of recommendations.--
        Not later than January 15, 2012, the Secretary shall transmit to 
        Congress the revised recommendations under paragraph (4), a 
        summary of the views and comments received under such paragraph, 
        and any changes made to the recommendations in response to such 
        views and comments.
            ``(6) Minutes of negotiation meetings.--
                    ``(A) Public <<NOTE: Website.>> availability.--
                Before presenting the recommendations developed under 
                paragraphs (1) through (5) to the Congress, the 
                Secretary shall make publicly available, on the public 
                Web site of the Food and Drug Administration, minutes of 
                all negotiation meetings conducted under this subsection 
                between the Food and Drug Administration and the 
                regulated industry.

[[Page 121 STAT. 852]]

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

    Notwithstanding section 107 of the Medical Device User Fee and 
Modernization Act of 2002 (Public Law 107-250), and notwithstanding the 
amendments made by this subtitle, part 3 of subchapter C of chapter VII 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as 
in effect on the day before the date of the enactment of this subtitle, 
shall continue to be in effect with respect to premarket applications, 
premarket reports, premarket notification submissions, and supplements 
(as defined in such part as of such day) that on or after October 1, 
2002, but before October 1, 2007, were accepted by the Food and Drug 
Administration for filing with respect to assessing and collecting any 
fee required by such part for a fiscal year prior to fiscal year 2008.
SEC. 215. ADDITIONAL AUTHORIZATION OF APPROPRIATIONS FOR 
                        POSTMARKET SAFETY INFORMATION.

    For the purpose of collecting, developing, reviewing, and evaluating 
postmarket safety information on medical devices, there are authorized 
to be appropriated to the Food and Drug Administration, in addition to 
the amounts authorized by other provisions of law for such purpose--
            (1) $7,100,000 for fiscal year 2008;
            (2) $7,455,000 for fiscal year 2009;
            (3) $7,827,750 for fiscal year 2010;
            (4) $8,219,138 for fiscal year 2011; and
            (5) $8,630,094 for fiscal year 2012.
SEC. 216. <<NOTE: 21 USC 379i note.>> EFFECTIVE DATE.

    The amendments made by this subtitle shall take effect on October 1, 
2007, or the date of the enactment of this Act, whichever is later, 
except that fees under part 3 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act shall be assessed for all premarket 
applications, premarket reports, supplements, 30-day notices, and 
premarket notification submissions received on or after October 1, 2007, 
regardless of the date of the enactment of this Act.
SEC. 217. <<NOTE: 21 USC 379i note.>> SUNSET CLAUSE.

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

     Subtitle B--Amendments Regarding Regulation of Medical Devices

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

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

[[Page 121 STAT. 853]]

SEC. 222. REGISTRATION.

    (a) Annual Registration of Producers of Drugs and Devices.--Section 
510(b) (21 U.S.C. 360(b)) is amended--
            (1) by striking ``(b) On or before'' and inserting ``(b)(1) 
        On or before'';
            (2) by striking ``or a device or devices''; and
            (3) by adding at the end the following:

    ``(2) During the period beginning on October 1 and ending on 
December 31 of each year, every person who owns or operates any 
establishment in any State engaged in the manufacture, preparation, 
propagation, compounding, or processing of a device or devices shall 
register with the Secretary his name, places of business, and all such 
establishments.''.
    (b) Registration of Foreign Establishments.--Section 510(i)(1) (21 
U.S.C. 360(i)(1)) is amended by striking ``On or before December 31'' 
and all that follows and inserting the following: ``Any establishment 
within any foreign country engaged in the manufacture, preparation, 
propagation, compounding, or processing of a drug or device that is 
imported or offered for import into the United States shall, through 
electronic means in accordance with the criteria of the Secretary--
            ``(A) upon first engaging in any such activity, immediately 
        register with the Secretary the name and place of business of 
        the establishment, the name of the United States agent for the 
        establishment, the name of each importer of such drug or device 
        in the United States that is known to the establishment, and the 
        name of each person who imports or offers for import such drug 
        or device to the United States for purposes of importation; and
            ``(B) each establishment subject to the requirements of 
        subparagraph (A) shall thereafter--
                    ``(i) with respect to drugs, register with the 
                Secretary on or before December 31 of each year; and
                    ``(ii) with respect to devices, register with the 
                Secretary during the period beginning on October 1 and 
                ending on December 31 of each year.''.
SEC. 223. <<NOTE: Reports. Deadlines.>> FILING OF LISTS OF DRUGS 
                        AND DEVICES MANUFACTURED, PREPARED, 
                        PROPAGATED, AND COMPOUNDED BY REGISTRANTS; 
                        STATEMENTS; ACCOMPANYING DISCLOSURES.

    Section 510(j)(2) (21 U.S.C. 360(j)(2)) is amended, in the matter 
preceding subparagraph (A), by striking ``Each person'' and all that 
follows through ``the following information:'' and inserting ``Each 
person who registers with the Secretary under this section shall report 
to the Secretary, with regard to drugs once during the month of June of 
each year and once during the month of December of each year, and with 
regard to devices once each year during the period beginning on October 
1 and ending on December 31, the following information:''.
SEC. 224. ELECTRONIC REGISTRATION AND LISTING.

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

[[Page 121 STAT. 854]]

SEC. 225. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE.

    (a) In General.--The <<NOTE: Study.>> Comptroller General of the 
United States shall conduct a study on the appropriate use of the 
process under section 510(k) of the Federal Food, Drug, and Cosmetic Act 
as part of the device classification process to determine whether a new 
device is as safe and effective as a classified device.

    (b) Consideration.--In determining the effectiveness of the 
premarket notification and classification authority under section 510(k) 
and subsections (f) and (i) of section 513 of the Federal Food, Drug, 
and Cosmetic Act, the study under subsection (a) shall consider the 
Secretary of Health and Human Services's evaluation of the respective 
intended uses and technologies of such devices, including the 
effectiveness of such Secretary's comparative assessment of 
technological characteristics such as device materials, principles of 
operations, and power sources.
    (c) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Comptroller General shall complete the study under 
subsection (a) and submit to the Congress a report on the results of 
such study.
SEC. 226. UNIQUE DEVICE IDENTIFICATION SYSTEM.

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

                  ``Unique Device Identification System

    ``(f) The <<NOTE: Regulations.>> Secretary shall promulgate 
regulations establishing a unique device identification system for 
medical devices requiring the label of devices to bear a unique 
identifier, unless the Secretary requires an alternative placement or 
provides an exception for a particular device or type of device. The 
unique identifier shall adequately identify the device through 
distribution and use, and may include information on the lot or serial 
number.''.

    (b) Conforming Amendment.--Section 303 (21 U.S.C. 333) is amended--
            (1) by redesignating the subsection that follows subsection 
        (e) as subsection (f); and
            (2) in paragraph (1)(B)(ii) of subsection (f), as so 
        redesignated, by striking ``519(f)'' and inserting ``519(g)''.
SEC. 227. FREQUENCY OF REPORTING FOR CERTAIN DEVICES.

    Subparagraph (B) of section 519(a)(1) (21 U.S.C. 360i(a)(1)) is 
amended by striking ``were to recur;'' and inserting the following: 
``were to recur, which report under this subparagraph--
                          ``(i) shall be submitted in accordance with 
                      part 803 of title 21, Code of Federal Regulations 
                      (or successor regulations), unless the Secretary 
                      grants an exemption or variance from, or an 
                      alternative to, a requirement under such 
                      regulations pursuant to section 803.19 of such 
                      part, if the device involved is--
                                    ``(I) a class III device;
                                    ``(II) a class II device that is 
                                permanently implantable, is life 
                                supporting, or is life sustaining; or
                                    ``(III) <<NOTE: Federal 
                                Register, publication.>> a type of 
                                device which the Secretary has, by 
                                notice published in the Federal Register 
                                or letter to the person who is the 
                                manufacturer

[[Page 121 STAT. 855]]

                                or importer of the device, indicated 
                                should be subject to such part 803 in 
                                order to protect the public health;
                          ``(ii) shall, if the device is not subject to 
                      clause (i), be submitted in accordance with 
                      criteria established by the Secretary for reports 
                      made pursuant to this clause, which criteria shall 
                      require the reports to be in summary form and made 
                      on a quarterly basis; or
                          ``(iii) shall, if the device is imported into 
                      the United States and for which part 803 of title 
                      21, Code of Federal Regulations (or successor 
                      regulations) requires an importer to submit a 
                      report to the manufacturer, be submitted by the 
                      importer to the manufacturer in accordance with 
                      part 803 of title 21, Code of Federal Regulations 
                      (or successor regulations)''.
SEC. 228. INSPECTIONS BY ACCREDITED PERSONS.

    Section 704(g) (21 U.S.C. 374(g)) is amended--
            (1) in paragraph (1), by striking ``Not later than one year 
        after the date of the enactment of this subsection, the 
        Secretary'' and inserting ``The Secretary'';
            (2) in paragraph (2), by--
                    (A) striking ``Not later than 180 days after the 
                date of enactment of this subsection, the Secretary'' 
                and inserting ``The Secretary''; and
                    (B) striking the fifth sentence;
            (3) in paragraph (3), by adding at the end the following:
            ``(F) <<NOTE: Notification. Deadline.>> Such person shall 
        notify the Secretary of any withdrawal, suspension, restriction, 
        or expiration of certificate of conformance with the quality 
        systems standard referred to in paragraph (7) for any device 
        establishment that such person inspects under this subsection 
        not later than 30 days after such withdrawal, suspension, 
        restriction, or expiration.
            ``(G) Such person may conduct audits to establish 
        conformance with the quality systems standard referred to in 
        paragraph (7).'';
            (4) by amending paragraph (6) to read as follows:

    ``(6)(A) Subject to subparagraphs (B) and (C), a device 
establishment is eligible for inspection by persons accredited under 
paragraph (2) if the following conditions are met:
            ``(i) The Secretary classified the results of the most 
        recent inspection of the establishment as `no action indicated' 
        or `voluntary action indicated'.
            ``(ii) With respect to inspections of the establishment to 
        be conducted by an accredited person, the owner or operator of 
        the establishment submits to the Secretary a notice that--
                    ``(I) provides the date of the last inspection of 
                the establishment by the Secretary and the 
                classification of that inspection;
                    ``(II) states the intention of the owner or operator 
                to use an accredited person to conduct inspections of 
                the establishment;
                    ``(III) identifies the particular accredited person 
                the owner or operator intends to select to conduct such 
                inspections; and

[[Page 121 STAT. 856]]

                    ``(IV) includes a certification that, with respect 
                to the devices that are manufactured, prepared, 
                propagated, compounded, or processed in the 
                establishment--
                          ``(aa) at least 1 of such devices is marketed 
                      in the United States; and
                          ``(bb) at least 1 of such devices is marketed, 
                      or is intended to be marketed, in 1 or more 
                      foreign countries, 1 of which countries certifies, 
                      accredits, or otherwise recognizes the person 
                      accredited under paragraph (2) and identified 
                      under subclause (III) as a person authorized to 
                      conduct inspections of device establishments.

    ``(B)(i) <<NOTE: Deadline.>> Except with respect to the requirement 
of subparagraph (A)(i), a device establishment is deemed to have 
clearance to participate in the program and to use the accredited person 
identified in the notice under subparagraph (A)(ii) for inspections of 
the establishment unless the Secretary, not later than 30 days after 
receiving such notice, issues a response that--
            ``(I) denies clearance to participate as provided under 
        subparagraph (C); or
            ``(II) makes a request under clause (ii).

    ``(ii) The Secretary may request from the owner or operator of a 
device establishment in response to the notice under subparagraph 
(A)(ii) with respect to the establishment, or from the particular 
accredited person identified in such notice--
            ``(I) compliance data for the establishment in accordance 
        with clause (iii)(I); or
            ``(II) information concerning the relationship between the 
        owner or operator of the establishment and the accredited person 
        identified in such notice in accordance with clause (iii)(II).

The <<NOTE: Deadline.>> owner or operator of the establishment, or such 
accredited person, as the case may be, shall respond to such a request 
not later than 60 days after receiving such request.

    ``(iii)(I) The compliance data to be submitted by the owner or 
operator of a device establishment in response to a request under clause 
(ii)(I) are data describing whether the quality controls of the 
establishment have been sufficient for ensuring consistent compliance 
with current good manufacturing practice within the meaning of section 
501(h) and with other applicable provisions of this Act. Such data shall 
include complete reports of inspectional findings regarding good 
manufacturing practice or other quality control audits that, during the 
preceding 2-year period, were conducted at the establishment by persons 
other than the owner or operator of the establishment, together with all 
other compliance data the Secretary deems necessary. Data under the 
preceding sentence shall demonstrate to the Secretary whether the 
establishment has facilitated consistent compliance by promptly 
correcting any compliance problems identified in such inspections.
    ``(II) A request to an accredited person under clause (ii)(II) may 
not seek any information that is not required to be maintained by such 
person in records under subsection (f)(1).
    ``(iv) <<NOTE: Deadline.>> A device establishment is deemed to have 
clearance to participate in the program and to use the accredited person 
identified in the notice under subparagraph (A)(ii) for inspections of 
the establishment unless the Secretary, not later than 60 days after 
receiving the information requested under clause (ii), issues

[[Page 121 STAT. 857]]

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

    ``(C)(i) The Secretary may deny clearance to a device establishment 
if the Secretary has evidence that the certification under subparagraph 
(A)(ii)(IV) is untrue and the Secretary provides to the owner or 
operator of the establishment a statement summarizing such evidence.
    ``(ii) The Secretary may deny clearance to a device establishment if 
the Secretary determines that the establishment has failed to 
demonstrate consistent compliance for purposes of subparagraph 
(B)(iii)(I) and the Secretary provides to the owner or operator of the 
establishment a statement of the reasons for such determination.
    ``(iii)(I) The Secretary may reject the selection of the accredited 
person identified in the notice under subparagraph (A)(ii) if the 
Secretary provides to the owner or operator of the establishment a 
statement of the reasons for such rejection. Reasons for the rejection 
may include that the establishment or the accredited person, as the case 
may be, has failed to fully respond to the request, or that the 
Secretary has concerns regarding the relationship between the 
establishment and such accredited person.
    ``(II) <<NOTE: Notification.>> If the Secretary rejects the 
selection of an accredited person by the owner or operator of a device 
establishment, the owner or operator may make an additional selection of 
an accredited person by submitting to the Secretary a notice that 
identifies the additional selection. <<NOTE: Applicability.>> Clauses 
(i) and (ii) of subparagraph (B), and subclause (I) of this clause, 
apply to the selection of an accredited person through a notice under 
the preceding sentence in the same manner and to the same extent as such 
provisions apply to a selection of an accredited person through a notice 
under subparagraph (A)(ii).

    ``(iv) In the case of a device establishment that is denied 
clearance under clause (i) or (ii) or with respect to which the 
selection of the accredited person is rejected under clause (iii), the 
Secretary shall designate a person to review the statement of reasons, 
or statement summarizing such evidence, as the case may be, of the 
Secretary under such clause if, during the 30-day period beginning on 
the date on which the owner or operator of the establishment receives 
such statement, the owner or operator requests the review. 
The <<NOTE: Deadline.>> review shall commence not later than 30 days 
after the owner or operator requests the review, unless the Secretary 
and the owner or operator otherwise agree.'';
            (5) in paragraph (7)--
                    (A) in subparagraph (A), by striking ``(A) Persons'' 
                and all that follows through the end and inserting the 
                following: ``(A) <<NOTE: Records.>> Persons accredited 
                under paragraph (2) to conduct inspections shall record 
                in writing their inspection observations and shall 
                present the observations to the device establishment's 
                designated representative and describe each observation. 
                Additionally, <<NOTE: Reports.>> such accredited person 
                shall prepare an inspection report in a form and manner 
                designated by the Secretary to conduct inspections, 
                taking into consideration the goals of international 
                harmonization of quality systems standards. Any official 
                classification of the inspection shall be determined by 
                the Secretary.''; and
                    (B) by adding at the end the following:

[[Page 121 STAT. 858]]

    ``(F) <<NOTE: Audits.>> For the purpose of setting risk-based 
inspectional priorities, the Secretary shall accept voluntary 
submissions of reports of audits assessing conformance with appropriate 
quality systems standards set by the International Organization for 
Standardization (ISO) and identified by the Secretary in public notice. 
If the owner or operator of an establishment elects to submit audit 
reports under this subparagraph, the owner or operator shall submit all 
such audit reports with respect to the establishment during the 
preceding 2-year periods.''; and
            (6) in paragraph (10)(C)(iii), by striking ``based'' and 
        inserting ``base''.
SEC. 229. STUDY OF NOSOCOMIAL INFECTIONS RELATING TO MEDICAL 
                        DEVICES.

    (a) In General.--The Comptroller General of the United States shall 
conduct a study on--
            (1) the number of nosocomial infections attributable to new 
        and reused medical devices; and
            (2) the causes of such nosocomial infections, including the 
        following:
                    (A) Reprocessed single-use devices.
                    (B) Handling of sterilized medical devices.
                    (C) In-hospital sterilization of medical devices.
                    (D) Health care professionals' practices for patient 
                examination and treatment.
                    (E) Hospital-based policies and procedures for 
                infection control and prevention.
                    (F) Hospital-based practices for handling of medical 
                waste.
                    (G) Other causes.

    (b) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Comptroller General shall complete the study under 
subsection (a) and submit to the Congress a report on the results of 
such study.
    (c) Definition.--In this section, the term ``nosocomial infection'' 
means an infection that is acquired while an individual is a patient at 
a hospital and was neither present nor incubating in the patient prior 
to receiving services in the hospital.
SEC. 230. REPORT BY THE FOOD AND DRUG ADMINISTRATION REGARDING 
                        LABELING INFORMATION ON THE RELATIONSHIP 
                        BETWEEN THE USE OF INDOOR TANNING DEVICES 
                        AND DEVELOPMENT OF SKIN CANCER OR OTHER 
                        SKIN DAMAGE.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary''), acting through the 
Commissioner of Food and Drugs, shall determine--
            (1) whether the labeling requirements for indoor tanning 
        devices, including the positioning requirements, provide 
        sufficient information to consumers regarding the risks that the 
        use of such devices pose for the development of irreversible 
        damage to the eyes and skin, including skin cancer; and
            (2)(A) whether modifying the warning label required on 
        tanning beds to read, ``Ultraviolet radiation can cause skin 
        cancer'', or any other additional warning, would communicate the 
        risks of indoor tanning more effectively; or
            (B) whether there is no warning that would be capable of 
        adequately communicating such risks.

[[Page 121 STAT. 859]]

    (b) Consumer Testing.--In making the determinations under subsection 
(a), the Secretary shall conduct appropriate consumer testing to 
determine consumer understanding of label warnings.
    (c) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Secretary shall submit to the Congress a report that 
provides the determinations under subsection (a). In addition, the 
Secretary shall include in the report the measures being implemented by 
the Secretary to significantly reduce the risks associated with indoor 
tanning devices.

    TITLE III--PEDIATRIC <<NOTE: Pediatric Medical Device Safety and 
Improvement Act of 2007.>> MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 
2007
SEC. 301. <<NOTE: 21 USC 301 note.>> SHORT TITLE.

    This title may be cited as the ``Pediatric Medical Device Safety and 
Improvement Act of 2007''.
SEC. 302. TRACKING PEDIATRIC DEVICE APPROVALS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.) is amended by inserting after section 515 the following:
``SEC. 515A. <<NOTE: 21 USC 360e-1.>> PEDIATRIC USES OF DEVICES.

    ``(a) New Devices.--
            ``(1) In general.--A person that submits to the Secretary an 
        application under section 520(m), or an application (or 
        supplement to an application) or a product development protocol 
        under section 515, shall include in the application or protocol 
        the information described in paragraph (2).
            ``(2) Required information.--The application or protocol 
        described in paragraph (1) shall include, with respect to the 
        device for which approval is sought and if readily available--
                    ``(A) a description of any pediatric subpopulations 
                that suffer from the disease or condition that the 
                device is intended to treat, diagnose, or cure; and
                    ``(B) the number of affected pediatric patients.
            ``(3) Annual report.--Not later than 18 months after the 
        date of the enactment of this section, and annually thereafter, 
        the Secretary shall submit to the Committee on Health, 
        Education, Labor, and Pensions of the Senate and the Committee 
        on Energy and Commerce of the House of Representatives a report 
        that includes--
                    ``(A) the number of devices approved in the year 
                preceding the year in which the report is submitted, for 
                which there is a pediatric subpopulation that suffers 
                from the disease or condition that the device is 
                intended to treat, diagnose, or cure;
                    ``(B) the number of devices approved in the year 
                preceding the year in which the report is submitted, 
                labeled for use in pediatric patients;
                    ``(C) the number of pediatric devices approved in 
                the year preceding the year in which the report is 
                submitted, exempted from a fee pursuant to section 
                738(a)(2)(B)(v); and

[[Page 121 STAT. 860]]

                    ``(D) the review time for each device described in 
                subparagraphs (A), (B), and (C).

    ``(b) Determination of Pediatric Effectiveness Based on Similar 
Course of Disease or Condition or Similar Effect of Device on Adults.--
            ``(1) In general.--If the course of the disease or condition 
        and the effects of the device are sufficiently similar in adults 
        and pediatric patients, the Secretary may conclude that adult 
        data may be used to support a determination of a reasonable 
        assurance of effectiveness in pediatric populations, as 
        appropriate.
            ``(2) Extrapolation between subpopulations.--A study may not 
        be needed in each pediatric subpopulation if data from one 
        subpopulation can be extrapolated to another subpopulation.

    ``(c) Pediatric Subpopulation.--For purposes of this section, the 
term `pediatric subpopulation' has the meaning given the term in section 
520(m)(6)(E)(ii).''.
SEC. 303. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION.

    (a) In General.--Section 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)) is amended--
            (1) in paragraph (3), by striking ``No'' and inserting 
        ``Except as provided in paragraph (6), no'';
            (2) in paragraph (5)--
                    (A) by inserting ``, if the Secretary has reason to 
                believe that the requirements of paragraph (6) are no 
                longer met,'' after ``public health''; and
                    (B) by adding at the end the following: ``If the 
                person granted an exemption under paragraph (2) fails to 
                demonstrate continued compliance with the requirements 
                of this subsection, the Secretary may suspend or 
                withdraw the exemption from the effectiveness 
                requirements of sections 514 and 515 for a humanitarian 
                device only after providing notice and an opportunity 
                for an informal hearing.''; and
            (3) by striking paragraph (6) and inserting after paragraph 
        (5) the following new paragraphs:

    ``(6)(A) Except as provided in subparagraph (D), the prohibition in 
paragraph (3) shall not apply with respect to a person granted an 
exemption under paragraph (2) if each of the following conditions apply:
            ``(i)(I) The device with respect to which the exemption is 
        granted is intended for the treatment or diagnosis of a disease 
        or condition that occurs in pediatric patients or in a pediatric 
        subpopulation, and such device is labeled for use in pediatric 
        patients or in a pediatric subpopulation in which the disease or 
        condition occurs.
            ``(II) The device was not previously approved under this 
        subsection for the pediatric patients or the pediatric 
        subpopulation described in subclause (I) prior to the date of 
        the enactment of the Pediatric Medical Device Safety and 
        Improvement Act of 2007.
            ``(ii) During any calendar year, the number of such devices 
        distributed during that year does not exceed the annual 
        distribution number specified by the Secretary when the 
        Secretary grants such exemption. The annual distribution number 
        shall

[[Page 121 STAT. 861]]

        be based on the number of individuals affected by the disease or 
        condition that such device is intended to treat, diagnose, or 
        cure, and of that number, the number of individuals likely to 
        use the device, and the number of devices reasonably necessary 
        to treat such individuals. In no case shall the annual 
        distribution number exceed the number identified in paragraph 
        (2)(A).
            ``(iii) <<NOTE: Notification.>> Such person immediately 
        notifies the Secretary if the number of such devices distributed 
        during any calendar year exceeds the annual distribution number 
        referred to in clause (ii).
            ``(iv) <<NOTE: Deadline.>> The request for such exemption is 
        submitted on or before October 1, 2012.

    ``(B) The Secretary may inspect the records relating to the number 
of devices distributed during any calendar year of a person granted an 
exemption under paragraph (2) for which the prohibition in paragraph (3) 
does not apply.
    ``(C) A person may petition the Secretary to modify the annual 
distribution number specified by the Secretary under subparagraph 
(A)(ii) with respect to a device if additional information on the number 
of individuals affected by the disease or condition arises, and the 
Secretary may modify such number but in no case shall the annual 
distribution number exceed the number identified in paragraph (2)(A).
    ``(D) <<NOTE: Applicability.>> If a person notifies the Secretary, 
or the Secretary determines through an inspection under subparagraph 
(B), that the number of devices distributed during any calendar year 
exceeds the annual distribution number, as required under subparagraph 
(A)(iii), and modified under subparagraph (C), if applicable, then the 
prohibition in paragraph (3) shall apply with respect to such person for 
such device for any sales of such device after such notification.

    ``(E)(i) In this subsection, the term `pediatric patients' means 
patients who are 21 years of age or younger at the time of the diagnosis 
or treatment.
    ``(ii) In this subsection, the term `pediatric subpopulation' means 
1 of the following populations:
            ``(I) Neonates.
            ``(II) Infants.
            ``(III) Children.
            ``(IV) Adolescents.

    ``(7) The Secretary shall refer any report of an adverse event 
regarding a device for which the prohibition under paragraph (3) does 
not apply pursuant to paragraph (6)(A) that the Secretary receives to 
the Office of Pediatric Therapeutics, established under section 6 of the 
Best Pharmaceuticals for Children Act (Public Law 107-109). In 
considering the report, the Director of the Office of Pediatric 
Therapeutics, in consultation with experts in the Center for Devices and 
Radiological Health, shall provide for periodic review of the report by 
the Pediatric Advisory Committee, including obtaining any 
recommendations of such committee regarding whether the Secretary should 
take action under this Act in response to the report.
    ``(8) <<NOTE: Annual review.>> The Secretary, acting through the 
Office of Pediatric Therapeutics and the Center for Devices and 
Radiological Health, shall provide for an annual review by the Pediatric 
Advisory Committee

[[Page 121 STAT. 862]]

of all devices described in paragraph (6) to ensure that the exemption 
under paragraph (2) remains appropriate for the pediatric populations 
for which it is granted.''.

    (b) Report.--Not later than January 1, 2012, the Comptroller General 
of the United States shall submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives a report on the impact of 
allowing persons granted an exemption under section 520(m)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) with respect 
to a device to profit from such device pursuant to section 520(m)(6) of 
such Act (21 U.S.C. 360j(m)(6)) (as amended by subsection (a)), 
including--
            (1) an assessment of whether such section 520(m)(6) (as 
        amended by subsection (a)) has increased the availability of 
        pediatric devices for conditions that occur in small numbers of 
        children, including any increase or decrease in the number of--
                    (A) exemptions granted under such section 520(m)(2) 
                for pediatric devices; and
                    (B) applications approved under section 515 of such 
                Act (21 U.S.C. 360e) for devices intended to treat, 
                diagnose, or cure conditions that occur in pediatric 
                patients or for devices labeled for use in a pediatric 
                population;
            (2) the conditions or diseases the pediatric devices were 
        intended to treat or diagnose and the estimated size of the 
        pediatric patient population for each condition or disease;
            (3) the costs of purchasing pediatric devices, based on a 
        representative sampling of children's hospitals;
            (4) the extent to which the costs of such devices are 
        covered by health insurance;
            (5) the impact, if any, of allowing profit on access to such 
        devices for patients;
            (6) the profits made by manufacturers for each device that 
        receives an exemption;
            (7) an estimate of the extent of the use of the pediatric 
        devices by both adults and pediatric populations for a condition 
        or disease other than the condition or disease on the label of 
        such devices;
            (8) recommendations of the Comptroller General of the United 
        States regarding the effectiveness of such section 520(m)(6) (as 
        amended by subsection (a)) and whether any modifications to such 
        section 520(m)(6) (as amended by subsection (a)) should be made;
            (9) existing obstacles to pediatric device development; and
            (10) an evaluation of the demonstration grants described in 
        section 305, which shall include an evaluation of the number of 
        pediatric medical devices--
                    (A) that have been or are being studied in children; 
                and
                    (B) that have been submitted to the Food and Drug 
                Administration for approval, clearance, or review under 
                such section 520(m) (as amended by this Act) and any 
                regulatory actions taken.

    (c) Guidance.--Not <<NOTE: Deadline. 21 USC 360j note.>> later than 
180 days after the date of the enactment of this Act, the Commissioner 
of Food and Drugs shall issue guidance for institutional review 
committees on how to evaluate requests for approval for devices for 
which a humanitarian

[[Page 121 STAT. 863]]

device exemption under section 520(m)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted.
SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH.

    (a) Contact Point for Available Funding.--Section 402(b) of the 
Public Health Service Act (42 U.S.C. 282(b)) is amended--
            (1) in paragraph (21), by striking ``and'' after the 
        semicolon at the end;
            (2) in paragraph (22), by striking the period at the end and 
        inserting ``; and''; and
            (3) by inserting after paragraph (22) the following:
            ``(23) shall designate a contact point or office to help 
        innovators and physicians identify sources of funding available 
        for pediatric medical device development.''.

    (b) Plan for Pediatric Medical Device Research.--
            (1) In <<NOTE: Deadline.>> general.--Not later than 180 days 
        after the date of the enactment of this Act, the Secretary of 
        Health and Human Services, acting through the Commissioner of 
        Food and Drugs, the Director of the National Institutes of 
        Health, and the Director of the Agency for Healthcare Research 
        and Quality, shall submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives a plan for 
        expanding pediatric medical device research and development. In 
        developing such plan, the Secretary of Health and Human Services 
        shall consult with individuals and organizations with 
        appropriate expertise in pediatric medical devices.
            (2) Contents.--The plan under paragraph (1) shall include--
                    (A) the current status of federally funded pediatric 
                medical device research;
                    (B) any gaps in such research, which may include a 
                survey of pediatric medical providers regarding unmet 
                pediatric medical device needs, as needed; and
                    (C) a research agenda for improving pediatric 
                medical device development and Food and Drug 
                Administration clearance or approval of pediatric 
                medical devices, and for evaluating the short- and long-
                term safety and effectiveness of pediatric medical 
                devices.
SEC. 305. <<NOTE: 42 USC 282 note.>> DEMONSTRATION GRANTS FOR 
                        IMPROVING PEDIATRIC DEVICE AVAILABILITY.

    (a) In <<NOTE: Deadline.>> General.--
            (1) Request for proposals.--Not later than 90 days after the 
        date of the enactment of this Act, the Secretary of Health and 
        Human Services shall issue a request for proposals for 1 or more 
        grants or contracts to nonprofit consortia for demonstration 
        projects to promote pediatric device development.
            (2) Determination on grants or contracts.--Not later than 
        180 days after the date the Secretary of Health and Human 
        Services issues a request for proposals under paragraph (1), the 
        Secretary shall make a determination on the grants or contracts 
        under this section.

    (b) Application.--A nonprofit consortium that desires to receive a 
grant or contract under this section shall submit an application to the 
Secretary of Health and Human Services at such time, in such manner, and 
containing such information as the Secretary may require.

[[Page 121 STAT. 864]]

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

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

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

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

[[Page 121 STAT. 865]]

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

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

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

    ``(b) Surveillance Approval.--

[[Page 121 STAT. 866]]

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

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

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

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

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

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

[[Page 121 STAT. 867]]

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

[[Page 121 STAT. 868]]

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

[[Page 121 STAT. 869]]

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

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

[[Page 121 STAT. 870]]

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

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

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

[[Page 121 STAT. 871]]

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

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

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

[[Page 121 STAT. 872]]

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

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

[[Page 121 STAT. 873]]

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

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

[[Page 121 STAT. 874]]

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

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

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

[[Page 121 STAT. 875]]

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

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

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

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

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

[[Page 121 STAT. 876]]

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

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

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

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

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

[[Page 121 STAT. 877]]

        include a timeframe for completing such studies), the applicant 
        agrees to the request, such studies are completed using 
        appropriate formulations for each age group for which the study 
        is requested within any such timeframe, and the reports thereof 
        are submitted and accepted in accordance with subsection 
        (d)(3)--
                    ``(A)(i)(I) the period referred to in subsection 
                (c)(3)(E)(ii) of section 505, and in subsection 
                (j)(5)(F)(ii) of such section, is deemed to be five 
                years and six months rather than five years, and the 
                references in subsections (c)(3)(E)(ii) and 
                (j)(5)(F)(ii) of such section to four years, to forty-
                eight months, and to seven and one-half years are deemed 
                to be four and one-half years, fifty-four months, and 
                eight years, respectively; or
                    ``(II) the period referred to in clauses (iii) and 
                (iv) of subsection (c)(3)(E) of such section, and in 
                clauses (iii) and (iv) of subsection (j)(5)(F) of such 
                section, is deemed to be three years and six months 
                rather than three years; and
                    ``(ii) if the drug is designated under section 526 
                for a rare disease or condition, the period referred to 
                in section 527(a) is deemed to be seven years and six 
                months rather than seven years; and
                    ``(B)(i) if the drug is the subject of--
                          ``(I) a listed patent for which a 
                      certification has been submitted under subsection 
                      (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 
                      and for which pediatric studies were submitted 
                      prior to the expiration of the patent (including 
                      any patent extensions); or
                          ``(II) a listed patent for which a 
                      certification has been submitted under subsections 
                      (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 
                      505,
                the period during which an application may not be 
                approved under section 505(c)(3) or section 505(j)(5)(B) 
                shall be extended by a period of six months after the 
                date the patent expires (including any patent 
                extensions); or
                    ``(ii) if the drug is the subject of a listed patent 
                for which a certification has been submitted under 
                subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
                section 505, and in the patent infringement litigation 
                resulting from the certification the court determines 
                that the patent is valid and would be infringed, the 
                period during which an application may not be approved 
                under section 505(c)(3) or section 505(j)(5)(B) shall be 
                extended by a period of six months after the date the 
                patent expires (including any patent extensions).
            ``(2) Exception.--The Secretary shall not extend the period 
        referred to in paragraph (1)(A) or (1)(B) if the determination 
        made under subsection (d)(3) is made later than 9 months prior 
        to the expiration of such period.

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

[[Page 121 STAT. 878]]

        505(b)(1) for pediatric studies (which shall include a timeframe 
        for completing such studies), the holder agrees to the request, 
        such studies are completed using appropriate formulations for 
        each age group for which the study is requested within any such 
        timeframe, and the reports thereof are submitted and accepted in 
        accordance with subsection (d)(3)--
                    ``(A)(i)(I) the period referred to in subsection 
                (c)(3)(E)(ii) of section 505, and in subsection 
                (j)(5)(F)(ii) of such section, is deemed to be five 
                years and six months rather than five years, and the 
                references in subsections (c)(3)(E)(ii) and 
                (j)(5)(F)(ii) of such section to four years, to forty-
                eight months, and to seven and one-half years are deemed 
                to be four and one-half years, fifty-four months, and 
                eight years, respectively; or
                    ``(II) the period referred to in clauses (iii) and 
                (iv) of subsection (c)(3)(D) of such section, and in 
                clauses (iii) and (iv) of subsection (j)(5)(F) of such 
                section, is deemed to be three years and six months 
                rather than three years; and
                    ``(ii) if the drug is designated under section 526 
                for a rare disease or condition, the period referred to 
                in section 527(a) is deemed to be seven years and six 
                months rather than seven years; and
                    ``(B)(i) if the drug is the subject of--
                          ``(I) a listed patent for which a 
                      certification has been submitted under subsection 
                      (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 
                      and for which pediatric studies were submitted 
                      prior to the expiration of the patent (including 
                      any patent extensions); or
                          ``(II) a listed patent for which a 
                      certification has been submitted under subsection 
                      (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 
                      505,
                the period during which an application may not be 
                approved under section 505(c)(3) or section 
                505(j)(5)(B)(ii) shall be extended by a period of six 
                months after the date the patent expires (including any 
                patent extensions); or
                    ``(ii) if the drug is the subject of a listed patent 
                for which a certification has been submitted under 
                subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
                section 505, and in the patent infringement litigation 
                resulting from the certification the court determines 
                that the patent is valid and would be infringed, the 
                period during which an application may not be approved 
                under section 505(c)(3) or section 505(j)(5)(B) shall be 
                extended by a period of six months after the date the 
                patent expires (including any patent extensions).
            ``(2) Exception.--The <<NOTE: Deadline.>> Secretary shall 
        not extend the period referred to in paragraph (1)(A) or (1)(B) 
        if the determination made under subsection (d)(3) is made later 
        than 9 months prior to the expiration of such period.

    ``(d) Conduct of Pediatric Studies.--
            ``(1) Request for studies.--
                    ``(A) In general.--The Secretary may, after 
                consultation with the sponsor of an application for an 
                investigational new drug under section 505(i), the 
                sponsor of an application for a new drug under section 
                505(b)(1), or the

[[Page 121 STAT. 879]]

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

[[Page 121 STAT. 880]]

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

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

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

[[Page 121 STAT. 881]]

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

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

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

[[Page 121 STAT. 882]]

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

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

[[Page 121 STAT. 883]]

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

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

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

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

[[Page 121 STAT. 884]]

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

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

[[Page 121 STAT. 885]]

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

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

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

[[Page 121 STAT. 886]]

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

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

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

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

[[Page 121 STAT. 887]]

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

[[Page 121 STAT. 888]]

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

[[Page 121 STAT. 889]]

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

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

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

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

[[Page 121 STAT. 890]]

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

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

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

                    TITLE VI--REAGAN-UDALL FOUNDATION

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

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

[[Page 121 STAT. 891]]

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

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

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

[[Page 121 STAT. 892]]

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

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

[[Page 121 STAT. 893]]

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

[[Page 121 STAT. 894]]

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

[[Page 121 STAT. 895]]

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

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

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

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

[[Page 121 STAT. 896]]

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

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

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

[[Page 121 STAT. 897]]

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

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

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

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

[[Page 121 STAT. 898]]

SEC. 602. OFFICE OF THE CHIEF SCIENTIST.

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

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

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

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

[[Page 121 STAT. 899]]

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

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

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

[[Page 121 STAT. 900]]

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

                    TITLE VII--CONFLICTS OF INTEREST

SEC. 701. CONFLICTS OF INTEREST.

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

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

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

[[Page 121 STAT. 901]]

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

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

[[Page 121 STAT. 902]]

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

[[Page 121 STAT. 903]]

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

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

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

[[Page 121 STAT. 904]]

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

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

                  TITLE VIII--CLINICAL TRIAL DATABASES

SEC. 801. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.

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

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

[[Page 121 STAT. 905]]

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

[[Page 121 STAT. 906]]

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

[[Page 121 STAT. 907]]

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

[[Page 121 STAT. 908]]

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

[[Page 121 STAT. 909]]

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

[[Page 121 STAT. 910]]

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

[[Page 121 STAT. 911]]

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

[[Page 121 STAT. 912]]

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

[[Page 121 STAT. 913]]

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

[[Page 121 STAT. 914]]

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

[[Page 121 STAT. 915]]

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

[[Page 121 STAT. 916]]

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

[[Page 121 STAT. 917]]

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

[[Page 121 STAT. 918]]

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

[[Page 121 STAT. 919]]

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

[[Page 121 STAT. 920]]

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

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

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

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

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

[[Page 121 STAT. 921]]

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

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

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

[[Page 121 STAT. 922]]

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

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

   TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS

             Subtitle A--Postmarket Studies and Surveillance

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

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

[[Page 121 STAT. 923]]

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

[[Page 121 STAT. 924]]

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

[[Page 121 STAT. 925]]

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

[[Page 121 STAT. 926]]

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

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

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

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

[[Page 121 STAT. 927]]

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

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

[[Page 121 STAT. 928]]

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

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

[[Page 121 STAT. 929]]

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

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

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

[[Page 121 STAT. 930]]

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

[[Page 121 STAT. 931]]

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

[[Page 121 STAT. 932]]

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

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

[[Page 121 STAT. 933]]

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

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

[[Page 121 STAT. 934]]

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

[[Page 121 STAT. 935]]

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

[[Page 121 STAT. 936]]

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

[[Page 121 STAT. 937]]

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

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

[[Page 121 STAT. 938]]

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

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

[[Page 121 STAT. 939]]

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

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

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

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

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

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

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

[[Page 121 STAT. 940]]

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

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

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

[[Page 121 STAT. 941]]

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

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

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

[[Page 121 STAT. 942]]

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

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

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

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

[[Page 121 STAT. 943]]

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

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

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

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

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

[[Page 121 STAT. 944]]

SEC. 904. <<NOTE: Deadline. Reports.>> BENEFIT-RISK ASSESSMENTS.

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

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

[[Page 121 STAT. 945]]

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

[[Page 121 STAT. 946]]

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

[[Page 121 STAT. 947]]

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

[[Page 121 STAT. 948]]

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

[[Page 121 STAT. 949]]

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

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

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

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

[[Page 121 STAT. 950]]

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

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

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

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

[[Page 121 STAT. 951]]

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

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

SEC. 911. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS.

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

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

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

[[Page 121 STAT. 952]]

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

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

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

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

    ``(b) Standards Development.--

[[Page 121 STAT. 953]]

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

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

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

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

[[Page 121 STAT. 954]]

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

[[Page 121 STAT. 955]]

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

[[Page 121 STAT. 956]]

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

[[Page 121 STAT. 957]]

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

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

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

[[Page 121 STAT. 958]]

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

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

[[Page 121 STAT. 959]]

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

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

[[Page 121 STAT. 960]]

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

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

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

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

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

[[Page 121 STAT. 961]]

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

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

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

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

[[Page 121 STAT. 962]]

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

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

                          TITLE X--FOOD SAFETY

SEC. 1001. <<NOTE: 21 USC 2101.>> FINDINGS.

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

[[Page 121 STAT. 963]]

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

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

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

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

[[Page 121 STAT. 964]]

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

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

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

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

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

[[Page 121 STAT. 965]]

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

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

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

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

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

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

[[Page 121 STAT. 966]]

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

[[Page 121 STAT. 967]]

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

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

[[Page 121 STAT. 968]]

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

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

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

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

[[Page 121 STAT. 969]]

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

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

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

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

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

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

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

[[Page 121 STAT. 970]]

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

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

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

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

[[Page 121 STAT. 971]]

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

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

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

                       TITLE XI--OTHER PROVISIONS

                         Subtitle A--In General

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

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

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

[[Page 121 STAT. 972]]

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

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

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

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

[[Page 121 STAT. 973]]

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

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

[[Page 121 STAT. 974]]

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

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

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

[[Page 121 STAT. 975]]

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

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

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

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

              Subtitle B--Antibiotic Access and Innovation

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

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

[[Page 121 STAT. 976]]

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

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

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

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

[[Page 121 STAT. 977]]

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

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

[[Page 121 STAT. 978]]

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

    Approved September 27, 2007.

LEGISLATIVE HISTORY--H.R. 3580:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 153 (2007):
            Sept. 19, considered and passed House.
            Sept. 20, considered and passed Senate.

                                  <all>
```