I
104TH CONGRESS
1ST SESSION
H. R. 1735
To amend the Public Health Service Act with respect to research regarding
the health of children.
IN THE HOUSE OF REPRESENTATIVES
MAY 25, 1995
Mr. MORAN (for himself, Mr. SERRANO, Mr. ACKERMAN, Mr. SCOTT, Mr.
COYNE, Mr. UNDERWOOD, Mr. MASCARA, Mr. MILLER of California, Mr.
RICHARDSON, Mr. ANDREWS, Mr. THORNTON, Mr. HILLIARD, Mr. DEL-
LUMS, Mr. PETE GEREN of Texas, Mr. HASTINGS of Florida, Mr. PETER-
SON of Florida, Ms. LOFGREN, Mrs. MALONEY, Mr. MCDERMOTT, Mr.
BENTSEN, Mr. FAZIO of California, Mr. WOLF, Mrs. MORELLA, Mr.
DAVIS, Mr. GEKAS, Mr. NETHERCUTT) 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 1995’’.
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) 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 shall establish a comprehensive plan for the
conduct and support by the national research insti-
tutes of pediatric research, and shall periodically re-
view and as appropriate make revisions in the plan.
The Director of NIH shall carry out this section in
collaboration with the Director of the National Insti-
tute 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