[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3047 Introduced in House (IH)]







107th CONGRESS
  1st Session
                                H. R. 3047

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
 Service Act with respect to pediatric studies of drugs, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 4, 2001

 Mr. Waxman (for himself, Mr. Brown of Ohio, Mr. Dingell, Mr. Deutsch, 
    Mr. Pallone, Mr. Green of Texas, Mr. Stupak, and Mr. Barrett of 
  Wisconsin) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
 Service Act with respect to pediatric studies of drugs, and for other 
                               purposes.

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

SECTION 1. SHORT TITLE.

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

SEC. 2. PEDIATRIC STUDIES OF DRUGS.

    (a) 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; COST-PLUS PAYMENTS.

    ``(a) Required Studies.--
            ``(1) In general.--In the case of a drug for which a market 
        application is pending or for which such an application has 
        been approved, or for which a research exemption has been 
        granted, if (pursuant to regulations promulgated by the 
        Secretary) the Secretary requires the sponsor or holder for the 
        drug (as the case may be) to conduct a pediatric study of the 
        drug, the Secretary may enter into a contract for payments in 
        accordance with subsection (d) regarding such study.
            ``(2) Market application; research exemption.--For purposes 
        of this section, the term `market application' means an 
        application under section 505 or under section 351 of the 
        Public Health Service Act, and the term `research exemption' 
        means an exemption under section 505(i).
            ``(3) Dispute resolution.--The Secretary shall develop and 
        publish in the Federal Register criteria describing the manner 
        in which the process of dispute resolution under section 562 
        will be applied with respect to paragraph (1). Such criteria 
        shall be so published not later than 180 days after the date of 
        the enactment of the Best Pharmaceuticals for Children Act. Any 
        process of dispute resolution regarding a requirement described 
        in subsection (a) that was commenced before the publication of 
        the criteria, including a process commenced before the date of 
        the enactment of such Act, may continue in accordance with the 
        applicable terms in effect before the publication of the 
        criteria.
    ``(b) Requested Studies.--
            ``(1) In general.--In the case of a drug that is included 
        on the list under paragraph (2), the Secretary may award 
        contracts for payments in accordance with subsection (d) for 
        the conduct of pediatric studies of the drug.
            ``(2) List of drugs.--The Secretary shall establish and 
        maintain a list of drugs--
                    ``(A) for which an approved market application is 
                in effect;
                    ``(B) for which there is no patent protection, and 
                for which no period of market exclusivity is in effect 
                under section 505 or section 527; and
                    ``(C) for which the Secretary has determined that 
                pediatric studies are needed to assess the safety and 
                effectiveness of the use of the drug in a pediatric 
                population.
        The initial list under this paragraph shall be established not 
        later than one year after the date of the enactment of the Best 
        Pharmaceuticals for Children Act. The reference in subparagraph 
        (B) to a period of market exclusivity in effect under section 
        505 includes such a period in effect pursuant to this section 
        as this section was in effect on the day before such date of 
        enactment.
            ``(3) Preference in awarding contracts.--In awarding a 
        contract under paragraph (1) regarding a drug, the Secretary 
        shall give preference to one or more of the holders for the 
        drug (in the event that Secretary has elected not to use the 
        authority under subsection (a) regarding the drug), to the 
        extent that one or more holders submit applications for the 
        contract.
            ``(4) Application for contract.--A contract may be made 
        under subsection (a) only if an application for the contract is 
        submitted to the Secretary and the application is in such form, 
        is made in such manner, and contains such agreements, 
        assurances, and information as the Secretary determines to be 
        necessary to carry out this subsection.
            ``(5) Competitive process.--Awards of contracts under 
        paragraph (1) shall be made through a competitive process, and 
        applications for such awards shall undergo technical and 
        scientific peer review. The Secretary may provide for the 
        assistance of the Director of the National Institutes of Health 
        in the administration of the requirements of the preceding 
        sentence.
    ``(c) Certain Study Procedures.--In providing for pediatric studies 
under subsection (a) or (b), the Secretary shall in writing (through 
publication in the Federal Register or otherwise) specify the criteria 
of the Secretary for the conduct of the studies, including with respect 
to protocols and including timeframes for completion of the studies and 
the submission to the Secretary of reports on the studies.
    ``(d) Payments.--A contract under subsection (a) or (b)--
            ``(1) shall provide for reimbursement by the Secretary of 
        the costs of conducting the pediatric studies involved, upon 
        the Secretary determining that the applicable conditions under 
        subsection (c) are being or have been met; and
            ``(2) shall provide for an amount additional to such 
        reimbursement (payable once the reimbursement in full has been 
        made), which additional amount shall be equal to 100 percent of 
        the costs of conducting such pediatric studies.
    ``(e) Labeling Changes for Already-Marketed Drugs.--
            ``(1) Supplemental application; priority.--Not later than 
        180 days after receiving a report on pediatric studies under 
        this section, the Secretary shall determine whether a holder 
        for the drug involved should alter the labeling for the drug. 
        If the Secretary determines that a labeling change should be 
        made, the Secretary shall--
                    ``(A) promptly request the holder in writing to 
                submit to the Secretary a supplemental application for 
                purposes of making the labeling change;
                    ``(B) consider such application to be a priority 
                application, except that the Secretary may give greater 
                priority to such applications regarding fast track 
                products under section 506 (relating to the treatment 
                of serious or life-threatening conditions) as the 
                Secretary determines to be appropriate;
                    ``(C) apply to the application the performance 
                goals established by the Secretary for priority drugs; 
                and
                    ``(D) upon submission of the application, promptly 
                offer to enter into negotiations with the holder 
                regarding the labeling change, and promptly arrange for 
                the negotiations to take place.
            ``(2) Dispute resolution.--
                    ``(A) In general.--With respect to negotiations 
                under paragraph (1), if the Secretary and the holder 
                involved have not reached agreement on a labeling 
                change as of the expiration of the 45-day period 
                beginning on the date on which the negotiations 
                commenced, the Secretary, upon the request of the 
                holder, shall commence the process of dispute 
                resolution under section 562 regarding the labeling 
                change. In providing for the review under such section 
                of the matter by an advisory panel, the Secretary shall 
                ensure that the matter is reviewed by the Pediatric 
                Advisory Subcommittee of the Anti-Infective Drugs 
                Advisory Committee.
                    ``(B) Report from advisory panel.--Not later than 
                90 days after receiving a referral under subparagraph 
                (A), the subcommittee referred to in such subparagraph 
                shall--
                            ``(i) review the available information on 
                        the safety and effectiveness of the use of the 
                        drug in the pediatric population, including 
                        reports submitted under this section; and
                            ``(ii) make a recommendation to the 
                        Secretary regarding a labeling change.
            ``(3) Determination by secretary.--Not later than 30 days 
        after receiving a recommendation under paragraph (2)(B)(ii) 
        with respect to a drug, the Secretary shall make a 
        determination regarding a labeling change for the drug and 
        inform the holder involved in writing of the determination. 
        Upon the expiration of the 30-day period beginning on the date 
        on which the Secretary so informs the holder, the Secretary may 
        with respect to the labeling of the drug take such actions in 
        accordance with this Act as the Secretary determines to be 
        appropriate.
    ``(f) Definitions.--For purposes of this section:
            ``(1) The term `holder for a drug' means the holder of an 
        approved market application.
            ``(2) The term `market application' has the meaning given 
        such term in subsection (a)(2).
            ``(3) The term `pediatric studies' means at least one 
        clinical investigation (that, at the Secretary's discretion, 
        may include pharmacokinetic studies) in pediatric age groups in 
        which a drug is anticipated to be used.
            ``(4) The term `priority application' means a drug 
        application referred to in section 101(4) of the Food and Drug 
        Administration Modernization Act of 1997 (111 Stat. 2298).
            ``(5) The term `research exemption' has the meaning given 
        such term in subsection (a)(2).
            ``(6) The term `sponsor for a drug' means the sponsor of an 
        application for the drug under section 505(b)(1) or under 
        section 351 of the Public Health Service Act, or the sponsor of 
        a clinical investigation of the drug under an exemption under 
        section 505(i), as the case may be.
    ``(g) Funding.--
            ``(1) Authorization of appropriations.--For the purpose of 
        contracts under subsection (a) and (b), there are authorized to 
        be appropriated $200,000,000 for fiscal year 2002, and such 
        sums as may be necessary for each of the fiscal years 2003 
        through 2007.
            ``(2) Limitation.--The authority of the Secretary to enter 
        into contracts under subsection (a) or (b) is subject to the 
        extent of amounts provided in advance in an appropriations 
        Act.''.
    (b) Fees for Supplemental Applications.--Section 736(a)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(1)) is 
amended--
            (1) by striking subparagraph (F); and
            (2) by redesignating subparagraph (G) as subparagraph (F).

SEC. 3. SAVINGS PROVISION; INTERACTION OF VARIOUS MARKET-EXCLUSIVITY 
              PROVISIONS.

    (a) Savings Provision.--The amendment made by section 2(a) does not 
apply with respect to pediatric studies of drugs that, before the date 
of the enactment of this Act, were requested by the Secretary of Health 
and Human Services under section 505A of the Federal Food, Drug, and 
Cosmetic Act, as in effect on the day before such date of enactment, or 
were required by the Secretary within the meaning of subsection (i) of 
such section as so in effect. Such section 505A as so in effect 
continues to apply to the pediatric studies described in the preceding 
sentence.
    (b) Market-Exclusivity Interactions.--
            (1) In general.--Paragraph (2) applies in the case of a 
        period of market exclusivity that is in effect pursuant to 
        subsection (a). References in paragraph (2) to section 505A of 
        the Federal Food, Drug, and Cosmetic Act are references to such 
        section as in effect on the day before the date of the 
        enactment of this Act.
            (2) Overlap of provisions.--If a 180-day period under 
        section 505(j)(5)(B)(iv) of the Federal Food, Drug, and 
        Cosmetic Act overlaps with a 6-month extension under section 
        505A of such Act, so that the applicant for approval of a drug 
        under section 505(j) of such Act 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--
                    (A) if the 180-day period would, but for this 
                subsection, expire after the 6-month extension, by the 
                number of days of the overlap; or
                    (B) if the 180-day period would, but for this 
                subsection, expire during the 6-month extension, by 6 
                months.
            (3) Effect of subsection.--Under no circumstances shall 
        application of this subsection result in an applicant for 
        approval of a drug under section 505(j) of the Federal Food, 
        Drug, and Cosmetic Act being enabled to commercially market the 
        drug to the exclusion of a subsequent applicant for approval of 
        a drug under section 505(j) of such Act for more than 180 days.

SEC. 4. FOUNDATION FOR PEDIATRIC RESEARCH.

    Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) 
is amended by adding at the end the following part:

              ``PART J--FOUNDATION FOR PEDIATRIC RESEARCH

``SEC. 499A. ESTABLISHMENT AND DUTIES OF FOUNDATION.

    ``(a) In General.--The Secretary, acting through the Director of 
NIH and in consultation with the Commissioner of Food and Drugs, shall 
establish a nonprofit corporation to be known as the Foundation for 
Pediatric Research (hereafter in this section referred to as the 
`Foundation'). The Foundation shall not be an agency or instrumentality 
of the United States Government.
    ``(b) Purpose of Foundation.--The purpose of the Foundation shall 
be to support the conduct of research on drugs listed by the Secretary 
pursuant to section 505A(b)(2) of the Federal Food, Drug, and Cosmetic 
Act.
    ``(c) Certain Activities of Foundation.--
            ``(1) In general.--In carrying out subsection (b), the 
        Foundation may solicit and accept gifts, grants, and other 
        donations, establish accounts, and invest and expend funds in 
        support of a program to encourage donations for the conduct of 
        studies of drugs referred to in subsection (b).
            ``(2) Fees.--The Foundation may assess fees for the 
        provision of professional, administrative and management 
        services by the Foundation in amounts determined reasonable and 
        appropriate by the Executive Director.
            ``(3) Authority of foundation.--The Foundation shall be the 
        sole entity responsible for carrying out the activities 
        described in this subsection.
    ``(d) Board of Directors.--
            ``(1) Composition.--
                    ``(A) The Foundation shall have a Board of 
                Directors (hereafter referred to in this section 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) The ex officio members of the Board shall 
                be--
                            ``(i) the Chairman and ranking minority 
                        member of the Subcommittee on Health (Committee 
                        on Energy and Commerce) or their designees, in 
                        the case of the House of Representatives;
                            ``(ii) the Chairman and ranking minority 
                        member of the Committee on Health, Education, 
                        Labor and Pensions or their designees, in the 
                        case of the Senate;
                            ``(iii) the Director of NIH; and
                            ``(iv) the Commissioner of Food and Drugs.
                    ``(C) The ex officio members of the Board under 
                subparagraph (B) shall appoint to the Board 11 
                individuals from among a list of candidates to be 
                provided by the National Academy of Science. Of such 
                appointed members--
                            ``(i) 5 shall be representative of the 
                        experts in pediatric medicine and research 
                        field;
                            ``(ii) 1 shall be a biomedical ethicist; 
                        and
                            ``(iii) 5 shall be representatives of the 
                        general public, which may include 
                        representatives of affected industries.
                    ``(D)(i) Not later than 30 days after the date of 
                the enactment of the Best Pharmaceuticals for Children 
                Act, the Director of NIH shall convene a meeting of the 
                ex officio members of the Board to--
                            ``(I) incorporate the Foundation and 
                        establish the general policies of the 
                        Foundation for carrying out the purposes of 
                        subsection (b), including the establishment of 
                        the bylaws of the Foundation; and
                            ``(II) appoint the members of the Board in 
                        accordance with subparagraph (C).
                    ``(ii) Upon the appointment of the members of the 
                Board under clause (i)(II), the terms of service of the 
                ex officio members of the Board as members of the Board 
                shall terminate.
                    ``(E) The agreement of not less than three-fifths 
                of the members of the ex officio members of the Board 
shall be required for the appointment of each member to the initial 
Board.
                    ``(F) No employee of the National Institutes of 
                Health shall be appointed as a member of the Board.
                    ``(G) The Board may, through amendments to the 
                bylaws of the Foundation, provide that the number of 
                members of the Board shall be greater than the number 
                specified in subparagraph (C).
            ``(2) Chair.--
                    ``(A) The ex officio members of the Board under 
                paragraph (1)(B) shall designate an individual to serve 
                as the initial Chair of the Board.
                    ``(B) Upon the termination of the term of service 
                of the initial Chair of the Board, the appointed 
                members of the Board shall elect a member of the Board 
                to serve as the Chair of the Board.
            ``(3) Terms and vacancies.--
                    ``(A) The term of office of each member of the 
                Board appointed under paragraph (1)(C) shall be 5 
                years, except that the terms of offices for the initial 
                appointed members of the Board shall expire as 
                determined by the ex officio members and the Chair.
                    ``(B) Any vacancy in the membership of the Board 
                shall be filled in the manner in which the original 
                position was made and shall not affect the power of the 
                remaining members to execute the duties of the Board.
                    ``(C) If a member of the Board does not serve the 
                full term applicable under subparagraph (A), the 
                individual appointed to fill the resulting vacancy 
                shall be appointed for the remainder of the term of the 
                predecessor of the individual.
                    ``(D) 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.
            ``(5) Meetings and quorum.--A majority of the members of 
        the Board shall constitute a quorum for purposes of conducting 
        the business of the Board.
            ``(6) Certain bylaws.--
                    ``(A) In establishing bylaws under this subsection, 
                the Board shall ensure that the following are provided 
                for:
                            ``(i) Policies for the selection of the 
                        officers, employees, agents, and contractors of 
                        the Foundation.
                            ``(ii) 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. Policies with respect 
                        to ethical standards shall ensure that 
                        officers, employees and agents of the 
                        Foundation (including members of the Board) 
                        avoid encumbrances that would result in a 
                        conflict of interest, including a financial 
                        conflict of interest or a divided allegiance. 
                        Such policies shall include requirements for 
                        the provision of information concerning any 
                        ownership or controlling interest in entities 
                        related to the activities of the Foundation by 
                        such officers, employees and agents and their 
                        spouses and relatives.
                            ``(iii) Policies for the conduct of the 
                        general operations of the Foundation.
                            ``(iv) Policies for writing, editing, 
                        printing, publishing, and vending of books and 
                        other materials.
                    ``(B) In establishing bylaws under this subsection, 
                the Board shall ensure that such bylaws (and activities 
                carried out under the bylaws) do not--
                            ``(i) reflect unfavorably upon the ability 
                        of the Foundation to carry out its 
                        responsibilities or official duties in a fair 
                        and objective manner; or
                            ``(ii) compromise, or appear to compromise, 
                        the integrity of any governmental agency or 
                        program, or any officer or employee involved in 
                        such program.
    ``(e) Incorporation.--The initial members of the Board shall serve 
as incorporators and shall take whatever actions necessary to 
incorporate the Foundation.
    ``(f) Nonprofit Status.--The Foundation shall be considered to be a 
corporation under section 501(c) of the Internal Revenue Code of 1986, 
and shall be subject to the provisions of such section.
    ``(g) Executive Director.--
            ``(1) In general.--The Foundation shall have an Executive 
        Director who shall be appointed by the Board and 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 rate of compensation of the 
        Executive Director shall be fixed by the Board.
    ``(h) Powers.--In carrying out subsection (b), the Foundation may--
            ``(1) operate under the direction of its Board;
            ``(2) adopt, alter, and use a corporate seal, which shall 
        be judicially noticed;
            ``(3) provide for 1 or more officers, employees, and 
        agents, as may be necessary, define their duties, and require 
        surety bonds or make other provisions against losses occasioned 
        by acts of such persons;
            ``(4) hire, promote, compensate, and discharge officers and 
        employees of the Foundation, and define the duties of the 
        officers and employees;
            ``(5) with the consent of any executive department or 
        independent agency, use the information, services, staff, and 
        facilities of such in carrying out this section;
            ``(6) sue and be sued in its corporate name, and complain 
        and defend in courts of competent jurisdiction;
            ``(7) 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 part;
            ``(8) establish a process for the selection of candidates 
        for positions under subsection (c);
            ``(9) enter into contracts with public and private 
        organizations for the writing, editing, printing, and 
        publishing of books and other material;
            ``(10) take such action as may be necessary to obtain 
        patents and licenses for devices and procedures developed by 
        the Foundation and its employees;
            ``(11) solicit, accept, hold, administer, invest, and spend 
        any gift, devise, or bequest of real or personal property made 
        to the Foundation;
            ``(12) enter into such other contracts, leases, cooperative 
        agreements, and other transactions as the Executive Director 
        considers appropriate to conduct the activities of the 
        Foundation;
            ``(13) appoint other groups of advisors as may be 
        determined necessary from time to time to carry out the 
        functions of the Foundation;
            ``(14) enter into such other contracts, leases, cooperative 
        agreements, and other transactions as the Executive Director 
        considers appropriate to conduct the activities of the 
        Foundation; and
            ``(15) 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 part.
    ``(i) Administrative Control.--No participant in the program 
established under this part shall exercise any administrative control 
over any Federal employee.
    ``(j) General Provisions.--
            ``(1) Foundation integrity.--The members of the Board shall 
        be accountable for the integrity of the operations of the 
        Foundation and shall ensure such integrity through the 
        development and enforcement of criteria and procedures relating 
        to standards of conduct (including those developed under 
        subsection (d)(6)(A)(ii)), financial disclosure statements, 
        conflict of interest rules, recusal and waiver rules, audits 
        and other matter determined appropriate by the Board.
            ``(2) Financial conflicts of interest.--Any individual who 
        is an officer, employee, or member of the Board of the 
        Foundation may not (in accordance with policies and 
        requirements developed under subsection (d)(6)(A)(ii)) 
        personally or substantially participate in the consideration or 
        determination by the Foundation of any matter that would 
        directly or predictably affect any financial interest of the 
        individual or a relative (as such term is defined in section 
        109(16) of the Ethics in Government Act of 1978) of the 
        individual, of any business organization or other entity, or of 
        which the individual is an officer or employee, or is 
        negotiating for employment, or in which the individual has any 
        other financial interest.
            ``(3) Audits; availability of records.--The Foundation 
        shall--
                    ``(A) provide for annual audits of the financial 
                condition of the Foundation; and
                    ``(B) make such audits, and all other records, 
                documents, and other papers of the Foundation, 
                available to the Secretary and the Comptroller General 
                of the United States for examination or audit.
            ``(4) Reports.--
                    ``(A) Not later than 5 months following the end of 
                each fiscal year, the Foundation shall publish a report 
                describing the activities of the Foundation during the 
                preceding fiscal year. Each such report shall include 
                for the fiscal year involved a comprehensive statement 
                of the operations, activities, financial condition, and 
                accomplishments of the Foundation.
                    ``(B) With respect to the financial condition of 
                the Foundation, each report under subparagraph (A) 
                shall include the source, and a description of, all 
                gifts or grants to the Foundation of real or personal 
                property, and the source and amount of all gifts or 
                grants to the Foundation of money. Each such report 
                shall include a specification of any restrictions on 
                the purposes for which gifts or grants to the 
                Foundation may be used.
                    ``(C) The Foundation shall make copies of each 
                report submitted under subparagraph (A) available for 
                public inspection, and shall upon request provide a 
                copy of the report to any individual for a charge not 
                exceeding the cost of providing the copy.
                    ``(D) The Board shall annually hold a public 
                meeting to summarize the activities of the Foundation 
                and distribute written reports concerning such 
                activities and the scientific results derived from such 
                activities.
            ``(5) Service of federal employees.--Federal employees may 
        serve on committees advisory to the Foundation and otherwise 
        cooperate with and assist the Foundation in carrying out its 
        function, so long as the employees do not direct or control 
        Foundation activities.
            ``(6) Relationship with existing entities.--The Foundation 
        may, pursuant to appropriate agreements, merge with, acquire, 
        or use the resources of existing nonprofit private corporations 
        with missions similar to the purposes of the Foundation.
            ``(7) Intellectual property rights.--The Board shall adopt 
        written standards with respect to the ownership of any 
        intellectual property rights derived from the collaborative 
        efforts of the Foundation prior to the commencement of such 
        efforts.
            ``(8) National institutes of health amendments of 1990.--
        The activities conducted in support of the National Institutes 
        of Health Amendments of 1990 (Public Law 101-613), and the 
        amendments made by such Act, shall not be nullified by the 
        enactment of this section.
            ``(9) Limitation of activities.--The Foundation shall exist 
        solely as an entity to work in collaboration with the research 
        programs of the National Institutes of Health. The Foundation 
        may not undertake activities (such as the operation of 
        independent laboratories or competing for Federal research 
        funds) that are independent of those of the National Institutes 
        of Health research programs.
            ``(10) Transfer of funds.--The Foundation may transfer 
        funds to the National Institutes of Health. Any funds 
        transferred under this paragraph shall be subject to all 
        Federal limitations relating to federally-funded research.
    ``(k) Duties of the Director.--
            ``(1) Applicability of certain standards to non-federal 
        employees.--In the case of any individual who is not an 
        employee of the Federal Government and who serves in 
        association with the National Institutes of Health, with 
        respect to financial assistance received from the Foundation, 
        the Foundation may not provide the assistance of, or otherwise 
        permit the work at the National Institutes of Health to begin 
        until a memorandum of understanding between the individual and 
        the Director of NIH, or the designee of such Director, has been 
        executed specifying that the individual shall be subject to 
        such ethical and procedural standards of conduct relating to 
        duties performed at the National Institutes of Health, as the 
        Director of NIH determines is appropriate.
            ``(2) Support services.--The Director of NIH may provide 
        facilities, utilities and support services to the Foundation if 
        it is determined by the Director to be advantageous to the 
        research programs of the National Institutes of Health.
    ``(l) Funding.--
            ``(1) Authorization of appropriations.--For the purpose of 
        carrying out this part, there are authorized to be appropriated 
        such sums as may be necessary for fiscal year 2002 and each 
        subsequent fiscal year.
            ``(2) Limitation regarding other funds.--Amounts 
        appropriated under any provision of law other than paragraph 
        (1) may not be expended to establish or operate the 
        Foundation.''.

SEC. 5. OFFICE OF PEDIATRIC THERAPEUTICS.

    (a) Establishment.--The Secretary of Health and Human Services 
shall establish an Office of Pediatric Therapeutics within the Office 
of the Commissioner of Food and Drugs.
    (b) Duties.--The Office of Pediatric Therapeutics shall be 
responsible for oversight and coordination of all activities of the 
Food and Drug Administration that may have any effect on a pediatric 
population or the practice of pediatrics or may in any other way 
involve pediatric issues.
    (c) Staff.--The staff of the Office of Pediatric Therapeutics shall 
include--
            (1) employees of the Department of Health and Human 
        Services who, as of the date of enactment of this Act, exercise 
        responsibilities relating to pediatric therapeutics;
            (2) 1 or more additional individuals with expertise 
        concerning ethical issues presented by the conduct of clinical 
        research in the pediatric population; and
            (3) 1 or more additional individuals with expertise in 
        pediatrics who shall consult and collaborate with all 
        components of the Food and Drug Administration concerning 
        activities described in subsection (b).

SEC. 6. STUDY CONCERNING RESEARCH INVOLVING CHILDREN.

    (a) Contract With Institute of Medicine.--The Secretary of Health 
and Human Services shall enter into a contract with the Institute of 
Medicine for--
            (1) the conduct, in accordance with subsection (b), of a 
        review of--
                    (A) Federal regulations in effect on the date of 
                the enactment of this Act relating to research 
                involving children;
                    (B) federally-prepared or supported reports 
                relating to research involving children; and
                    (C) federally-supported evidence-based research 
                involving children; and
            (2) the submission to the appropriate committees of 
        Congress, by not later than 2 years after the date of enactment 
        of this Act, of a report concerning the review conducted under 
        paragraph (1) that includes recommendations on best practices 
        relating to research involving children.
    (b) Areas of Review.--In conducting the review under subsection 
(a)(1), the Institute of Medicine shall consider the following:
            (1) The written and oral process of obtaining and defining 
        ``assent'', ``permission'' and ``informed consent'' with 
        respect to child clinical research participants and the 
        parents, guardians, and the individuals who may serve as the 
        legally authorized representatives of such children (as defined 
        in subpart A of part 46 of title 45, Code of Regulations).
            (2) The expectations and comprehension of child research 
        participants and the parents, guardians, or legally authorized 
        representatives of such children, for the direct benefits and 
        risks of the child's research involvement, particularly in 
        terms of research versus therapeutic treatment.
            (3) The definition of ``minimal risk'' with respect to a 
        healthy child or a child with an illness.
            (4) The appropriateness of the regulations applicable to 
        children of differing ages and maturity levels, including 
        regulations relating to legal status.
            (5) Whether payment (financial or otherwise) may be 
        provided to a child or his or her parent, guardian, or legally 
        authorized representative for the participation of the child in 
        research, and if so, the amount and type of payment that may be 
        made.
            (6) Compliance with the regulations referred to in 
        subsection (a)(1)(A), the monitoring of such compliance 
        (including the role of institutional review boards), and the 
        enforcement actions taken for violations of such regulations.
            (7) The unique roles and responsibilities of institutional 
        review boards in reviewing research involving children, 
        including composition of membership on institutional review 
        boards.
    (c) Requirements of Expertise.--The Institute of Medicine shall 
conduct the review under subsection (a)(1) and make recommendations 
under subsection (a)(2) in conjunction with experts in pediatric 
medicine, pediatric research, and the ethical conduct of research 
involving children.
                                 <all>