I
105TH CONGRESS
1ST SESSION
H. R. 1451
To amend the Public Health Service Act with respect to research regarding
the health of children.
IN THE HOUSE OF REPRESENTATIVES
APRIL 24, 1997
Mr. MORAN of Virginia (for himself, Mr. PAYNE, Mr. SERRANO, Mr. WOLF,
Mrs. MORELLA, Mr. SCOTT, Mr. COYNE, Mr. UNDERWOOD, Mr. MILLER
of California, Mr. DELLUMS, Mr. MCDERMOTT, Mr. BENTSEN, Mr.
FAZIO of California, Ms. JACKSON-LEE of Texas, Mr. HALL of Ohio, Ms.
NORTON, Ms. MCKINNEY, Mr. BORSKI, Ms. RIVERS, Mr. THOMPSON,
Ms. LOFGREN, Mr. STRICKLAND, Mr. ACKERMAN, Mr. BOUCHER, Mrs.
MALONEY of New York, Mr. GREEN, and Mrs. THURMAN) introduced the
following bill; which was referred to the Committee on Commerce
A BILL
To amend the Public Health Service Act with respect to
research regarding the health of children.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Pediatric Research Ini-
tiative Act of 1997’’.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) The savings from biomedical and behavioral
research is significant due to the potential years of
productive life saved, and to improvements in the
quality of life for children and their families.
(2) The opportunities for biomedical advance-
ments are greater than ever, given the enormous
growth in knowledge and developments in genetics,
immunology and related therapies.
(3) Childhood cancer is the leading medical
cause of death in children ages 1 through adoles-
cence; the incidence of childhood cancer is increas-
ing; and a number of childhood cancers have not
yielded to research.
(4) The average age of onset of cancer in chil-
dren is 6 years; for adults, it is 67 years. The poten-
tial to save a lifetime of productive years by invest-
ing in pediatric research is not adequately reflected
in the current allocation of Federal research dollars.
(5) Unintentional injuries are the number one
killer of children ages 14 and under, and cost society
$13,800,000,000 annually. Investment in childhood
injury prevention can save billions of dollars as well
as save children and their families needless pain and
suffering.
(6) Biomedical, behavioral and injury preven-
tion research which focuses on the unique needs of
children receive far less funding than similar re-
search for any other demographic group, including
for men, seniors, women and minorities.
(7) Research indicates that children face signifi-
cant, long-term, and unique threats from environ-
mental pollution.
(8) The goal of the Pediatric Research Initia-
tive is to ensure that these opportunities to signifi-
cantly improve the identification, treatment, cure,
and, ultimately, prevention of diseases, disabilities,
and injuries that affect children are realized.
TITLE I—BIOMEDICAL AND
BEHAVIORAL RESEARCH
SEC. 101. INTERAGENCY PLAN FOR PEDIATRIC RESEARCH.
Part B of title IV of the Public Health Service Act
(42 U.S.C. 284 et seq.) is amended by adding at the end
the following section:
‘‘PEDIATRIC RESEARCH INITIATIVE
‘‘SEC. 409B. (a) IN GENERAL.—
‘‘(1) INTERAGENCY
PLAN.—The Director of
NIH, after consultation with the Administrator of
the Environmental Protection Agency, shall establish
a comprehensive plan for the conduct and support
by the national research institutes of pediatric re-
search, and shall periodically review and as appro-
priate make revisions in the plan. The Director of
NIH shall carry out this section in collaboration
with the Director of the National Institute of Child
Health and Human Development.
‘‘(2) CONSULTATIONS WITH INSTITUTE DIREC-
TORS.—In carrying out this section, the Director of
NIH shall consult with the directors of each of the
national research institutes.
‘‘(3) ADVISORY COUNCIL.—
‘‘(A) The Secretary shall establish an advi-
sory council to be known as the National Advi-
sory Council on Pediatric Research (in this
paragraph referred to as the ‘Advisory Coun-
cil’).
‘‘(B) The Advisory Council shall provide
advice to the Secretary and the Director of
NIH regarding the Plan. In carrying out the
preceding sentence, the advisory council shall
develop and submit to the Director proposals
regarding the contents of the Plan.
‘‘(C)(i) Subject to clause (ii), the Secretary
shall appoint to the Advisory Council, as voting
members, not more than 15 individuals. Such
individuals shall be appointed from among indi-
viduals who are not officers or employees of the
Federal Government.
‘‘(ii) The Secretary shall ensure that, col-
lectively, the members of the Advisory Council
who are appointed under clause (i) have exper-
tise in epidemiology, biomedical research, be-
havioral research, basic research, clinical re-
search (including the conduct of clinical trials),
and biomedical ethics. The individuals ap-
pointed under such clause shall include one
practicing pediatrician and one individual rep-
resenting the interests of pediatric patients and
the families of such patients.
‘‘(D) The ex officio, nonvoting members of
the Advisory Council shall be the following:
‘‘(i) The Director of the National In-
stitute of Child Health and Human Devel-
opment.
‘‘(ii) The Directors of each of the na-
tional research institutes whose principal
responsibilities include the conduct and
support of pediatric research.
‘‘(iii) The Commissioner of Food and
Drugs.
‘‘(E) The Secretary shall designate a mem-
ber of the Advisory Council to serve as the
chair of the Council.
‘‘(b) GENERAL REQUIREMENTS FOR PLAN.—
‘‘(1) 
IDENTIFICATION
OF
RELEVANT
PROJECTS.—In developing, reviewing, and revising
the Plan, the Director of NIH shall identify the
projects of pediatric research that are being con-
ducted or supported by the national research insti-
tute, and current proposals for such projects.
‘‘(2) GENERAL
REQUIREMENTS; CATEGORIES
OF RESEARCH.—The Director shall ensure that the
Plan specifies the following with respect to pediatric
research:
‘‘(A) The categories of research that are to
be conducted and supported by the National In-
stitutes of Health.
‘‘(B) Priorities among such categories.
‘‘(C) The areas in which an insufficient
number or variety of projects have been con-
ducted or supported by such Institutes, and the
areas in which the activities of the national re-
search institutes are overlapping.
‘‘(D) The process for coordinating research
activities among the national research insti-
tutes.
‘‘(E) Promising areas in which the Na-
tional Institutes of Health will conduct or sup-
port research.
‘‘(F) In the case of the research priorities
specified under subparagraph (B), mechanisms
to encourage public and private entities to initi-
ate research independently of solicitations by
the National Institutes of Health for proposals.
‘‘(G) Objectives for the research conducted
or supported under the Plan, the means for
achieving the objectives, and the date by which
the objectives are expected to be achieved.
‘‘(3) PARTICULAR PROJECTS.—In carrying out
paragraph (2) with respect to a category of research,
the Director of NIH may establish requirements re-
garding particular projects of research within a cat-
egory.
‘‘(c) CERTAIN CONSIDERATIONS.—In developing, re-
viewing, and revising the Plan, the Director of NIH shall
consider the following with respect to children:
‘‘(1) Epidemiological data, including the inci-
dence and prevalence of various causes of death or
disability, and including data on environmental fac-
tors.
‘‘(2) The severity of various diseases and the
impact of the diseases on functional capacity.
‘‘(3) The potential for significant progress in
the diagnosis, treatment, prevention, and control of
various diseases, disorders, and disabilities.
‘‘(d) CERTAIN COMPONENTS OF PLAN.—The Direc-
tor of NIH shall ensure that the Plan provides for an ap-
propriate emphasis on the following:
‘‘(1) Evaluations of the results of basic research
in order to develop and commence projects of clinical
research.
‘‘(2) The support of proposals developed pursu-
ant to solicitations by the national research insti-
tutes, and the support of proposals developed inde-
pendently of such solicitations.
‘‘(3) The support of proposals for projects
whose principal researchers will be individuals who
have not previously served as the principal research-
ers of projects supported by the national research in-
stitutes.
‘‘(4) Both biomedical research and behavioral
research.
‘‘(e) DATES CERTAIN REGARDING APPLICABILITY OF
PLAN; INITIAL REVIEW.—The initial Plan shall be devel-
oped and shall take effect not later than October 1, 1998.
The initial review of the Plan under subsection (a)(1) shall
be completed not later than October 1, 2000, and a review
shall be conducted not less than once during each subse-
quent two-year period.
‘‘(f) BIENNIAL REPORT.—Each biennial report sub-
mitted by the Director of NIH under section 403 shall
include provisions describing the activities undertaken and
expenditures made under this section and section 409C.
The report may contain such comments of the Director
of NIH regarding this section and section 409C as the
Director determines to be appropriate.
‘‘(g) DEFINITIONS.—For purposes of this section:
‘‘(1) The term ‘pediatric research’ means bio-
medical and behavioral research regarding the health
of children.
‘‘(2) The term ‘Plan’ means the plan estab-
lished, reviewed, and revised under subsection (a)(1).
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated $60,000,000 for fiscal year 1998,
$75,000,000 for fiscal year 1999, $100,000,000 for fiscal
year 2000, and such sums as may be necessary for fiscal
year 2001 and each subsequent fiscal year.’’.
SEC. 102. INCLUSION OF CHILDREN IN CLINICAL RE-
SEARCH.
Part H of title IV of the Public Health Service (42
U.S.C. 289 et seq.) is amended by inserting after section
492B the following section:
‘‘INCLUSION OF CHILDREN IN CLINICAL RESEARCH
‘‘SEC. 492C. (a) IN GENERAL.—The Director of NIH
shall establish guidelines regarding the inclusion of chil-
dren as subjects in projects of clinical research conducted
or supported by the National Institutes of Health.
‘‘(b) CERTAIN CONSIDERATIONS.—In establishing
guidelines under subsection (a), the Director of NIH shall
consider—
‘‘(1) the principles applied under section 492B
by the Director in including women and members of
minority groups as subjects in projects of clinical re-
search; and
‘‘(2) the factors underlying the plan developed
under section 409B (relating to the conduct and
support of pediatric research).
‘‘(c) INCREASE REGARDING INCLUSION
OF CHIL-
DREN.—
‘‘(1) 
INCREASE
REGARDING
FISCAL
YEAR
2000.—The Director of NIH shall ensure that, for
fiscal year 2000, the child-subject percentage is sig-
nificantly increased above such percentage for fiscal
year 1995.
‘‘(2) CHILD-SUBJECT PERCENTAGE.—For pur-
poses of this section, the term ‘child-health percent-
age’, with respect to a fiscal year, means the per-
centage constituted by the ratio of—
‘‘(A) the number of children who, during
the fiscal year, participated as subjects in
projects of clinical research conducted or sup-
ported by the National Institutes of Health; to
‘‘(B) the number of individuals (adults and
children) who, during the fiscal year, partici-
pated as such subjects.’’.
TITLE II—PREVENTIVE HEALTH
RESEARCH
SEC. 201. INTERAGENCY PLAN FOR PEDIATRIC RESEARCH;
DISCRETIONARY FUND.
Title III of the Public Health Service Act (42 U.S.C.
241 et seq.) is amended by adding at the end the following
part:
‘‘PART O—PREVENTIVE HEALTH RESEARCH
REGARDING CHILDREN
‘‘SEC. 399M. RESEARCH REGARDING CHILDREN AND PRE-
VENTABLE DISEASES, DISORDERS, AND INJU-
RIES.
‘‘(a) IN GENERAL.—The Secretary shall carry out a
program of research regarding preventable diseases, dis-
abilities, and injuries in children, including research on the
causes of death in children. The Secretary may conduct
the research directly or through making grants to public
and nonprofit private entities.
‘‘(b) COLLABORATION WITH RELEVANT AGENCY
HEADS.—The Secretary shall carry out subsection (a) in
collaboration with the following:
‘‘(1) The Director of the Centers for Disease
Control and Prevention.
‘‘(2) The Director of the National Institute of
Child Health and Human Development.
‘‘(3) The Director of the National Center for
Injury Prevention and Control.
‘‘(4) The Director of the Maternal and Child
Health Bureau.
‘‘(5) The Administrator for Health Care Policy
and Research.
‘‘(6) Such other Federal officials as the Sec-
retary determines to be appropriate.
‘‘(c) ADVISORY COMMITTEE.—
‘‘(1) IN GENERAL.—The Secretary shall provide
for a committee to provide advice to the Secretary
regarding pediatric prevention research. The mem-
bers of the committee shall be appointed from indi-
viduals who have expertise in pediatric prevention
activities and who, subject to paragraph (2), are not
officers or employees of the Federal Government.
‘‘(2) USE OF EXISTING COMMITTEES.—A Fed-
eral employee may serve as a member of the advi-
sory committee under paragraph (1) if the only Fed-
eral duty of the employee is to serve on one or more
Federal advisory committees, and if the individual,
when first appointed to such a committee, was not
a Federal officer or employee.
‘‘(d) INTERAGENCY PLAN.—The Secretary—
‘‘(1) shall establish a comprehensive plan for
carrying out subsection (a) through the Centers for
Disease Control and Prevention and such other
agencies of the Department as the Secretary deter-
mines to be appropriate; and
‘‘(2) shall periodically review and as appropriate
make revisions in the plan.
‘‘(e) GENERAL REQUIREMENTS FOR PLAN.—
‘‘(1) PRELIMINARY EVALUATIONS.—
‘‘(A) In developing, reviewing, and revising
the Plan, the Secretary shall—
‘‘(i) identify and evaluate projects of
pediatric prevention research that are
being carried out through the agencies of
the Department, and proposals for such
projects; and
‘‘(ii) to the extent practicable, identify
and evaluate the projects of pediatric pre-
vention research that are being carried out
through other public or private entities,
and proposals for such projects.
‘‘(B) The projects identified and evaluated
by the Secretary under subparagraph (A) shall
include the following:
‘‘(i) Demonstration projects that pro-
vide training in the prevention of injuries
in children.
‘‘(ii) Demonstration projects that de-
velop curricula for such training for use in
the training of health professionals who
routinely provide care for children, includ-
ing such professionals in the fields of pub-
lic health, medicine, nursing, dentistry, and
allied health (including emergency medical
technicians).
‘‘(iii) Demonstration projects that de-
velop curricula for such training for use in
the training of parents, teachers, day-care
personnel, and other individuals who rou-
tinely supervise children.
‘‘(2) GENERAL
REQUIREMENTS; CATEGORIES
OF RESEARCH.—The Secretary shall ensure that the
Plan specifies the following with respect to pediatric
prevention research:
‘‘(A) The categories of research that are to
be conducted and supported by the Department.
‘‘(B) The allocation among such agencies
of responsibilities for the categories designated
under subparagraph (A).
‘‘(C) Priorities among such categories.
‘‘(D) Objectives for the research conducted
or supported under the Plan, the means for
achieving the objectives, and the date by which
the objectives are expected to be achieved.
‘‘(E) The process for coordinating and con-
solidating research activities among the agen-
cies of the Department.
‘‘(3) PARTICULAR PROJECTS.—In carrying out
paragraph (2) with respect to a category of research,
the Secretary may establish requirements regarding
particular projects of research within a category.
‘‘(f) CERTAIN CONSIDERATIONS.—In developing, re-
viewing, and revising the Plan, the Secretary shall con-
sider the following with respect to children.
‘‘(1) Epidemiological data, including the inci-
dence and prevalence of various causes of death or
disability.
‘‘(2) The severity of various diseases and inju-
ries and the impact of such diseases and injuries on
functional capacity.
‘‘(3) The potential for significant progress in
the prevention of various diseases, disabilities, and
injuries.
‘‘(g) MODEL PROGRAMS FOR SUPERVISORS OF CHIL-
DREN.—With respect to parents, teachers, and other indi-
viduals who routinely supervise children, the Secretary
shall ensure that the Plan provides for the development
of model programs for educating such individuals on pedi-
atric prevention activities.
‘‘(h) DATES CERTAIN REGARDING APPLICABILITY OF
PLAN; INITIAL REVIEW.—The initial Plan shall be devel-
oped and shall take effect not later than October 1, 1998.
The initial review of the Plan under subsection (d)(2) shall
be completed not later than October 1, 2000, and a review
shall be conducted not less than once during each subse-
quent two-year period.
‘‘(i) DISCRETIONARY FUND.—
‘‘(1) IN GENERAL.—There is established a fund
to be known as the Pediatric Prevention Research
Initiative Fund, consisting of such amounts as may
be appropriated under subsection (l) for the Fund.
‘‘(2) USE OF FUND.—Amounts in the Fund are
available to the Secretary for such activities regard-
ing pediatric prevention research as are authorized
under this Act, including activities under the Plan.
‘‘(j) ANNUAL REPORT.—Not later than February 1
of each fiscal year, the Secretary shall submit to the Com-
mittee on Commerce and the Committee on Appropria-
tions (of the House of Representatives), and to the Com-
mittee on Labor and Human Resources and the Commit-
tee on Appropriations (of the Senate), a report describing
the activities undertaken and expenditures made under
this section during the preceding fiscal year, including
with respect to the Fund. The report may contain such
comments of the Secretary regarding this section as the
Secretary determines to be appropriate.
‘‘(k) DEFINITIONS.—For purposes of this section:
‘‘(1) The term ‘Department’ means the Depart-
ment of Health and Human Services, unless the con-
text of usage indicates otherwise.
‘‘(2) The term ‘Fund’ means the fund estab-
lished in subsection (i)(1).
‘‘(3) The term ‘pediatric prevention activities’
means activities for the prevention of diseases, dis-
abilities, and injuries in children.
‘‘(4) The term ‘pediatric prevention research’
means research described in subsection (a).
‘‘(5) The term ‘Plan’ means the plan estab-
lished, reviewed, and revised under subsection (d).
‘‘(l) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated $30,000,000 for fiscal year 1998,
$30,500,000 for fiscal year 1999, and $50,000,000 for fis-
cal year 2000.’’.
TITLE 
III—DEVELOPMENT 
OF
IMPROVED 
PHARMA-
CEUTICALS 
AND 
OTHER
THERAPEUTIC AGENTS
SEC. 301. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.
Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 501 et seq.) is amended by inserting after
section 505 the following section:
505(j) which refers to the drug subject to the section
505(b)(1) approval effective prior to the expiration of 6
months from the earliest date on which an approval of
such application under section 505(b)(2) or section 505(j),
respectively, could otherwise be made effective under the
applicable provisions of this chapter. Nothing in this sub-
section shall affect the ability of the Secretary to make
effective a section 505(b)(2) or section 505(j) approval for
a subject drug if such approval is proper under such sub-
section and is made effective prior to the submission of
the reports of pediatric studies described in subsection (c).
‘‘(c)(1) The Secretary may, pursuant to a written re-
quest for studies after consultation with the sponsor of
an application or holder of an approval for a drug under
section 505(b)(1), agree with the sponsor or holder for the
conduct of pediatric studies for such drug.
‘‘(2) If the sponsor or holder and the Secretary agree
upon written protocols for such studies, the studies re-
quirement of subsection (a) or (b) is satisfied upon the
completion of the studies in accordance with the protocols
and the submission of the reports thereof to the Secretary.
Within 60 days after the submission of the report of the
studies, the Secretary shall determine if such studies were
or were not conducted in accordance with the written pro-
tocols and reported in accordance with the Secretary’s re-
quirements for filing and so notify the sponsor or holder.
‘‘(3) If the sponsor or holder and the Secretary have
not agreed in writing on the protocols for the studies, the
studies requirement of subsection (a) or (b) is satisfied
when such studies have been completed and the reports
accepted by the Secretary. Within 90 days after the sub-
mission 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 90
days, that the studies fairly respond to the written re-
quest, that such studies have been conducted in accord-
ance with commonly accepted scientific principles and pro-
tocols, and that such studies have been reported in accord-
ance with the Secretary’s requirements for filing.
‘‘(4) As used in this section, ‘pediatric studies’ or
‘studies’ means at least 1 human clinical investigation in
a population of adolescent age or younger. At the Sec-
retary’s discretion, pharmacokinetic studies may be con-
sidered as clinical investigations.
‘‘(d) If the Secretary determines that an approval of
an application under section 505(b)(2) or section 505(j)
for a drug may be made effective after submission of re-
ports of pediatric studies under this section but before the
Secretary has determined whether the requirements of
subsection (c) have been satisfied, the Secretary may delay
the effective date of any approval under section 505(b)(2)
or section 505(j), respectively, until the determination
under subsection (c) is made, but such delay shall not ex-
ceed 90 days. In the event that the requirements of this
section are satisfied, the 6-month period referred to in
subsection (a) or (b) shall be deemed to have begun on
the date an approval of an application under section
505(b)(2) or section 505(j), respectively, would have been
permitted absent action under this subsection.
‘‘(e) The Secretary shall publish notice of any deter-
mination that the requirements of subsection (c)(2) or
(c)(3) have been met and that approvals for the drug will
be subject to deferred effective dates under this section.’’.
TITLE IV—RESEARCH ON
ENVIRONMENTAL RISKS
SEC. 401. ESTABLISHMENT OF INTERAGENCY PEDIATRIC
PROGRAM.
Part B of title IV of the Public Health Service Act,
as amended by section 101 of this Act, is amended by add-
ing at the end the following section:
‘‘INTERAGENCY PEDIATRIC RESEARCH REGARDING
ENVIRONMENTAL RISKS
‘‘SEC. 409C. (a) IN GENERAL.—The Director of NIH
shall carry out a program for the conduct and support
of research with respect to factors in the environment that
affect the health of children differently than the factors
affect adults.
‘‘(b) INTERAGENCY COOPERATION.—
‘‘(1) AGENCIES OF NIH.—The program under
subsection (a) shall be carried out by the Director
of NIH in collaboration with the Director of the Na-
tional Institute of Child Health and Human Devel-
opment and the Director of the National Institute of
Environmental Health Sciences.
‘‘(2) ENVIRONMENTAL
PROTECTION
AGENCY;
CENTERS
FOR
DISEASE
CONTROL
AND
PREVEN-
TION.—In planning the program under subsection
(a), the Director of NIH shall consult with the Ad-
ministrator of the Environmental Protection Agency
and the Director of the Centers for Disease Control
and Prevention, including consultations regarding
priorities in research under the program. The Direc-
tor of NIH shall ensure that the results of projects
of research conducted or supported under the pro-
gram are reported to such agency heads.
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated such sums as may be necessary for
each of the fiscal years 1998 through 2002.’’.
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