(Sec. 4) Amends the Federal Food, Drug, and Cosmetic Act to set forth procedures for written requests for pediatric studies to holders of approved applications for drugs that have market exclusivity. Requires the Secretary to refer such drugs to the Foundation for Pediatric Research for pediatric studies if the need for more information continues and the holder refuses. Directs the Secretary to refer such drug onward to the Public Health Service list if the Foundation has insufficient funds to conduct the study.
(Sec. 6) Directs the Secretary to establish an Office of Pediatric Therapeutics within the Office of the Commissioner of Food and Drugs, which shall coordinate all FDA pediatric activities.
(Sec. 7) Amends the Federal Food, Drug, and Cosmetic Act to: (1) eliminate the user fee waiver for pediatric supplements to a human drug application; (2) provide priority status for pediatric supplements; (3) include neonates within age groups for pediatric studies; (4) provide for dissemination of pediatric supplement information; and (5) set forth requirements for the additional six-month exclusivity period for new or already-marketed pediatric drugs.
(Sec. 11) Requires only an abbreviated application for new drug approval for generic drugs with added pediatric information.
(Sec. 12) Establishes an adverse reaction toll-free number which must appear on the labels of drugs approved under new drug application procedures. Requires that adverse effects from drugs with pediatric market exclusivity be reported to and reviewed by the Office of Pediatric Therapeutics.
(Sec. 13) Amends Title IV of the Public Health Service Act to direct the Secretary to establish the Foundation for Pediatric Research to collect funds and award grants for research on drugs lacking exclusivity for which pediatric studies are needed. Requires that the result of such studies be submitted to the Director of NIH and the Commissioner.
(Sec. 14) Directs the Secretary to contract with the Institute of Medicine to review Federal regulations, reports, and support for research involving children, with particular attention to issues of compensation, informed consent, and risk/ benefits assessments in terms of research versus therapeutic treatment.
(Sec. 15) Requires the Comptroller General to report to Congress and the Secretary on the effectiveness of this Act in ensuring that all drugs used by children are tested and properly labeled. Requires such report to also include an assessment of: (1) this Act's economic impact; (2) the complexity of the pediatric drug studies; and (3) increased pediatric research ability.
(Sec. 16) Directs the Comptroller General to study and report on the representation of ethnic and racial minority children in such studies.
[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2887 Introduced in House (IH)]
107th CONGRESS
1st Session
H. R. 2887
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety
and efficacy of pharmaceuticals for children.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 13, 2001
Mr. Greenwood (for himself, Ms. Eshoo, Mr. Upton, Mr. Wynn, Mr. Buyer,
Mr. Rush, Mr. Brady of Pennsylvania, Ms. Roybal-Allard, and Ms.
Lofgren) 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 to improve the safety
and efficacy of pharmaceuticals for children.
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 ALREADY-MARKETED DRUGS.
Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a) is amended--
(1) by striking subsection (b); and
(2) in subsection (c)--
(A) by inserting after ``the Secretary'' the
following: ``determines that information relating to
the use of an approved drug in the pediatric population
may produce health benefits in that population and'';
and
(B) by striking ``concerning a drug identified in
the list described in subsection (b)''.
SEC. 3. RESEARCH FUND FOR THE STUDY OF DRUGS LACKING EXCLUSIVITY.
Part B of title IV of the Public Health Service Act (42 U.S.C. 284
et seq.) is amended--
(1) by redesignating the second section 409C, relating to
clinical research (42 U.S.C. 284k), as section 409G;
(2) by redesignating the second section 409D, relating to
enhancement awards (42 U.S.C. 284l), as section 409H; and
(3) by adding at the end the following:
``SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS LACKING
EXCLUSIVITY.
``(a) List of Drugs Lacking Exclusivity for Which Pediatric Studies
Are Needed.--
``(1) In general.--Not later than 1 year after the date of
enactment of this section, 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, prioritize, and
publish an annual list of approved drugs for which--
``(A)(i) there is an approved application under
section 505(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j));
``(ii) there is a submitted application that could
be approved under the criteria of section 505(j) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)); or
``(iii) there is no patent protection or market
exclusivity protection under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.); and
``(B) additional studies are needed to assess the
safety and effectiveness of the use of the drug in the
pediatric population.
``(2) Consideration of available information.--In
developing the list under paragraph (1), the Secretary shall
consider, for each drug on the list--
``(A) the availability of information concerning
the safe and effective use of the drug in the pediatric
population;
``(B) whether additional information is needed;
``(C) whether new pediatric studies concerning the
drug may produce health benefits in the pediatric
population; and
``(D) whether reformulation of the drug is
necessary;
``(b) Contracts for Pediatric Studies.--The Secretary shall award
contracts to entities that have the expertise to conduct pediatric
clinical trials (including qualified universities, hospitals,
laboratories, contract research organizations, federally funded
programs such as pediatric pharmacology research units, other public or
private institutions, or individuals) to enable the entities to conduct
pediatric studies concerning one or more drugs identified in the list
described in subsection (a).
``(c) Process for Contracts and Labeling Changes.--
``(1) Written request to holders of approved applications
for drugs lacking exclusivity.--
``(A) In general.--The Commissioner of Food and
Drugs, in consultation with the Director of National
Institutes of Health, may issue a written request
(which shall include a timeframe for negotiations for
an agreement) for pediatric studies concerning a drug
identified in the list described in 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 request shall be made in
accordance with section 505A of the Federal Food, Drug,
and Cosmetic Act.
``(B) Publication of request.--If the Commissioner
of Food and Drugs does not receive a response to a
written request issued under subparagraph (A) within 30
days of the date on which a request was issued, the
Secretary, acting through the Director of National
Institutes of Health and in consultation with the
Commissioner of Food and Drugs, shall publish a request
for contract proposals to conduct the pediatric studies
described in the written request.
``(C) Disqualification.--A holder that receives a
first right of refusal shall not be entitled to respond
to a request for contract proposals under subparagraph
(B).
``(D) Guidance.--Not later than 270 days after the
date of enactment of this section, the Commissioner of
Food and Drugs shall promulgate guidance to establish
the process for the submission of responses to written
requests under subparagraph (A).
``(2) Contracts.--A contract under this section may be
awarded only if a proposal for the contract 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.
``(3) Reporting of studies.--
``(A) Upon completion of a pediatric study in
accordance with a contract awarded under this section,
a report concerning the study shall be submitted to the
Director of National Institutes of Health and the
Commissioner of Food and Drugs. The report shall
include all data generated in connection with the
study.
``(B) Availability of reports.--Each report
submitted under subparagraph (A) shall be considered to
be in the public domain, and shall be assigned a docket
number by the Commissioner of Food and Drugs. An
interested person may submit written comments
concerning such pediatric studies to the Commissioner
of Food and Drugs, and the written comments shall
become part of the docket file with respect to each of
the drugs.
``(C) Action by commissioner.--The Commissioner of
Food and Drugs shall take appropriate action in
response to the reports submitted under subparagraph
(A) in accordance with paragraph (4).
``(4) Request for labeling changes.--During the 180-day
period after the date on which a report is submitted under
paragraph (3)(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; and
``(B) negotiate with the holders of approved
applications for the drug studied for any labeling
changes that the Commissioner of Food and Drugs
determines to be appropriate and requests the holders
to make; and
``(C)(i) place in the public docket file a copy of
the report and of any requested labeling changes; and
``(ii) publish in the Federal Register a summary of
the report and a copy of any requested labeling
changes.
``(5) Dispute resolution.--If, not later than the end of
the 180-day period specified in paragraph (4), 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--
``(A) the Commissioner of Food and Drugs shall
immediately refer the request to the Pediatric Advisory
Subcommittee of the Anti-Infective Drugs Advisory
Committee; and
``(B) not later than 90 days after receiving the
referral, the Subcommittee shall--
``(i) review the available information on
the safe and effective use of the drug in the
pediatric population, including study reports
submitted under this section; and
``(ii) make a recommendation to the
Commissioner of Food and Drugs as to
appropriate labeling changes, if any.
``(6) FDA determination.--Not later than 30 days after
receiving a recommendation from the Subcommittee under
paragraph (5)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.
``(7) Failure to agree.--If a holder of an approved
application for a drug, within 30 days after receiving a
request to make a labeling change under paragraph (6), does not
agree to make a requested labeling change, the Commissioner may
deem the drug to be misbranded under the Federal Food, Drug,
and Cosmetic Act.
``(8) Recommendation for formulation changes.--If a
pediatric study completed under public contract indicates that
a formulation change is necessary and the Secretary agrees, the
Secretary shall send a nonbinding letter of recommendation
regarding that change to each holder of an approved application.
``(d) Authorization of Appropriations.--
``(1) In general.--There are authorized to be appropriated
to carry out this section--
``(A) $200,000,000 for fiscal year 2002; and
``(B) such sums as are necessary for each of the 5
succeeding fiscal years.
``(2) Availability.--Any amount appropriated under
paragraph (1) shall remain available to carry out this section
until expended.''.
SEC. 4. TIMELY LABELING CHANGES FOR DRUGS GRANTED EXCLUSIVITY; DRUG
FEES.
(a) Elimination of User Fee Waiver for Pediatric Supplements.--
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).
(b) Labeling Changes.--
(1) Definition of priority supplement.--Section 201 of the
Federal Food Drug, and Cosmetic Act (21 U.S.C. 321) is amended
by adding at the end the following:
``(kk) Priority supplement.--The term `priority supplement'
means a drug application referred to in section 101(4) of the
Food and Drug Administration Modernization Act of 1997 (111
Stat. 2298).''.
(2) Treatment as priority supplements.--Section 505A of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is
amended by adding at the end the following:
``(l) Labeling Supplements.--
``(1) Priority status for pediatric supplements.--Any
supplement to an application under section 505 proposing a
labeling change pursuant to a report on a pediatric study under
this section--
``(A) shall be considered to be a priority
supplement; and
``(B) shall be subject to the performance goals
established by the Commissioner for priority drugs.
``(2) Dispute resolution.--If the Commissioner determines
that an application with respect to which a pediatric study is
conducted under this section is approvable and that the only
open issue for final action on the application is the reaching
of an agreement between the sponsor of the application and the
Commissioner on appropriate changes to the labeling for the
drug that is the subject of the application--
``(A) not later than 180 days after the date of
submission of the application--
``(i) the Commissioner shall request that
the sponsor of the application make any
labeling change that the Commissioner
determines to be appropriate; and
``(ii) if the sponsor of the application
does not agree to make a labeling change
requested by the Commissioner by that date, the
Commissioner shall immediately refer the matter
to the Pediatric Advisory Subcommittee of the
Anti-Infective Drugs Advisory Committee;
``(B) not later than 90 days after receiving the
referral, the Pediatric Advisory Subcommittee of the
Anti-Infective Drugs Advisory Committee shall--
``(i) review the pediatric study reports;
and
``(ii) make a recommendation to the
Commissioner concerning appropriate labeling
changes, if any;
``(C) the Commissioner shall consider the
recommendations of the Pediatric Advisory Subcommittee
of the Anti-Infective Drugs 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; and
``(D) if the sponsor of the application, within 30
days after receiving a request under subparagraph (C),
does not agree to make a labeling change requested by
the Commissioner, the Commissioner may deem the drug
that is the subject of the application to be
misbranded.''.
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. NEONATES.
Section 505A(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a(g)) is amended by inserting ``(including neonates in
appropriate cases)'' after ``pediatric age groups''.
SEC. 7. SUNSET.
Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a) is amended by striking subsection (j) and inserting the
following:
``(j) Sunset.--A drug may not receive any 6-month period under
subsection (a) or (c) unless--
``(1) on or before October 1, 2007, the Secretary makes a
written request for pediatric studies of the drug;
``(2) on or before October 1, 2007, an approvable
application for the drug is submitted under section 505(b)(1);
and
``(3) all requirements of this section are met.''.
SEC. 8. DISSEMINATION OF PEDIATRIC INFORMATION.
Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a) (as amended by section 4(b)(2)) is amended by adding at the end
the following:
``(m) Dissemination of Pediatric Information.--
``(1) In general.--Not later than 180 days after the date
of submission of a report on a pediatric study under this
section, the Commissioner shall make available to the public a
summary of the medical and clinical pharmacology reviews of
pediatric studies conducted for the supplement, including by
publication in the Federal Register.
``(2) Effect of subsection.--Nothing in this subsection
alters or amends in any way section 552 of title 5 or section
1905 of title 18, United States Code.''.
SEC. 9. CLARIFICATION OF INTERACTION OF MARKET EXCLUSIVITY UNDER
SECTION 505A OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
AND MARKET EXCLUSIVITY AWARDED TO AN APPLICANT FOR
APPROVAL OF A DRUG UNDER SECTION 505(J) OF THAT ACT.
Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a) (as amended by section 8) is amended by adding at the end the
following:
``(n) 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).--
``(1) In general.--If a 180-day period under section
505(j)(5)(B)(iv) overlaps with a 6-month extension 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--
``(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.
``(2) Effect of subsection.--Under no circumstances shall
application of this section result in an applicant for approval
of a drug under section 505(j) being enabled to commercially
market the drug to the exclusion of a subsequent applicant for
approval of a drug under section 505(j) for more than 180
days.''.
SEC. 10. 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 409I(a)(1)(A)(iii).
``(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. 11. 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.
SEC. 12. TECHNICAL AND CONFORMING AMENDMENTS.
Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a) (as amended by sections 2(1), 4(b)(2), 8, and 9) is amended--
(1)(A) by striking ``(j)(4)(D)(ii)'' each place it appears
and inserting ``(j)(5)(D)(ii)'';
(B) by striking ``(j)(4)(D)'' each place it appears and
inserting ``(j)(5)(D)''; and
(C) by striking ``505(j)(4)(D)'' each place it appears and
inserting ``505(j)(5)(D)'';
(2) by redesignating subsections (a), (g), (h), (i), (j),
(k), (l), (m), and (n) as subsections (b), (a), (g), (h), (m),
(l), (i), (j), and (k), respectively;
(3) by moving the subsections so as to appear in
alphabetical order;
(4) in paragraphs (1), (2), and (3) of subsection (d),
subsection (e), and subsection (m) (as redesignated by
paragraph (1)), by striking ``subsection (a) or (c)'' and
inserting ``subsection (b) or (c)''; and
(5) in subsection (g) (as redesignated by paragraph (1)),
by striking ``subsection (a) or (b)'' and inserting
``subsection (b) or (c)''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Subcommittee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 24 - 5.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by the Yeas and Nays: 41 - 6.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 107-277.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 107-277.
Placed on the Union Calendar, Calendar No. 167.
Mr. Tauzin moved to suspend the rules and pass the bill, as amended.
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Considered under suspension of the rules. (consideration: CR H8094-8107)
DEBATE - The House proceeded with forty minutes of debate on H.R. 2887.
At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
Considered as unfinished business. (consideration: CR H8216)
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 338 - 86 (Roll no. 444).(text: CR 11/13/2001 H8094-8098)
Roll Call #444 (House)On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 338 - 86 (Roll no. 444). (text: CR 11/13/2001 H8094-8098)
Roll Call #444 (House)Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 228.