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.
‘‘(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, 1996.
The initial review of the Plan under subsection (a)(1) shall
be completed not later than October 1, 1998, and a review
shall be conducted not less than once during each subse-
quent two-year period.
‘‘(f) ANNUAL REPORT.—Not later than February 1
of each fiscal year, the Director of NIH shall submit to
the Committee on Commerce and the Committee on Ap-
propriations (of the House of Representatives), and to the
Committee on Labor and Human Resources and the Com-
mittee on Appropriations (of the Senate), a report describ-
ing the activities undertaken and expenditures made under
this section during the preceding fiscal year. The report
may contain such comments of the Director of NIH re-
garding this section as the Director determines to be ap-
propriate.
‘‘(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 1996,
$75,000,000 for fiscal year 1997, $100,000,000 for fiscal
year 1998, and such sums as may be necessary for fiscal
year 1999 and each subsequent fiscal year.’’.
SEC. 
102. 
INCLUSION 
OF 
CHILDREN 
IN 
CLINICAL
RESEARCH.
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
1998.—The Director of NIH shall ensure that, for
fiscal year 1998, 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:
‘‘(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, 1996.
The initial review of the Plan under subsection (d)(2) shall
be completed not later than October 1, 1998, 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 1996,
$30,500,000 for fiscal year 1997, and $50,000,000 for fis-
cal year 1998.’’.
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:
‘‘PEDIATRIC STUDIES FOR NEW DRUG APPLICATIONS
‘‘SEC. 505A. (a) If an application submitted under
section 505(b)(1) is approved on or after the date of en-
actment of this section, and such application includes re-
ports of pediatric studies described and requested in sub-
section (c), and such studies are completed and the reports
thereof submitted in accordance with subsection (c)(2) or
completed and the reports thereof accepted in accordance
with subsection (c)(3), the Secretary may not make the
approval of an application submitted under section
505(b)(2) or section 505(j) which refers to the drug for
which the section 505(b)(1) approval is granted effective
prior to the expiration of 6 months from the earliest date
on which the approval of such application for the drug
under section 505(b)(2) or section 505(j), respectively,
could otherwise be made effective under the applicable
provisions of this chapter.
‘‘(b) If the Secretary makes a written request for pe-
diatric studies described in subsection (c) to the holder
of an approval under section 505(b)(1) for a drug, and
such studies are completed and the reports thereof submit-
ted in accordance with subsection (c)(2) or completed and
the reports thereof accepted in accordance with subsection
(c)(3), the Secretary may not make the approval of an
application submitted under section 505(b)(2) or section
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.’’.
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HR 1735 IH——2