[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1735 Introduced in House (IH)]







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. Dellums, Mr. 
Pete Geren of Texas, Mr. Hastings of Florida, Mr. Peterson 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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pediatric Research Initiative 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 advancements 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 adolescence; the incidence of 
        childhood cancer is increasing; and a number of childhood 
        cancers have not yielded to research.
            (4) The average age of onset of cancer in children is 6 
        years; for adults, it is 67 years. The potential to save a 
        lifetime of productive years by investing 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 prevention research 
        which focuses on the unique needs of children receive far less 
        funding than similar research for any other demographic group, 
        including for men, seniors, women and minorities.
            (7) The goal of the Pediatric Research Initiative is to 
        ensure that these opportunities to significantly 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 institutes of pediatric research, and 
        shall periodically review 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 Institute of 
        Child Health and Human Development.
            ``(2) Consultations with institute directors.--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 advisory 
                council to be known as the National Advisory Council on 
                Pediatric Research (in this paragraph referred to as 
                the `Advisory Council').
                    ``(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 individuals who are not 
                officers or employees of the Federal Government.
                    ``(ii) The Secretary shall ensure that, 
                collectively, the members of the Advisory Council who 
                are appointed under clause (i) have expertise in 
                epidemiology, biomedical research, behavioral research, 
                basic research, clinical research (including the 
                conduct of clinical trials), and biomedical ethics. The 
                individuals appointed under such clause shall include 
                one practicing pediatrician and one individual 
                representing 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 
                        Institute of Child Health and Human 
                        Development.
                            ``(ii) The Directors of each of the 
                        national 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 member 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 
        conducted or supported by the national research institute, 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 Institutes of 
                Health.
                    ``(B) Priorities among such categories.
                    ``(C) The areas in which an insufficient number or 
                variety of projects have been conducted or supported by 
                such Institutes, and the areas in which the activities 
                of the national research institutes are overlapping.
                    ``(D) The process for coordinating research 
                activities among the national research institutes.
                    ``(E) Promising areas in which the National 
                Institutes of Health will conduct or support research.
                    ``(F) In the case of the research priorities 
                specified under subparagraph (B), mechanisms to 
                encourage public and private entities to initiate 
                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 regarding particular projects of 
        research within a category.
    ``(c) Certain Considerations.--In developing, reviewing, and 
revising the Plan, the Director of NIH shall consider the following 
with respect to children:
            ``(1) Epidemiological data, including the incidence 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 Director of NIH shall ensure 
that the Plan provides for an appropriate 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 pursuant to 
        solicitations by the national research institutes, and the 
        support of proposals developed independently of such 
        solicitations.
            ``(3) The support of proposals for projects whose principal 
        researchers will be individuals who have not previously served 
        as the principal researchers of projects supported by the 
        national research institutes.
            ``(4) Both biomedical research and behavioral research.
    ``(e) Dates Certain Regarding Applicability of Plan; Initial 
Review.--The initial Plan shall be developed 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 
subsequent 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 Appropriations (of the House of Representatives), and 
to the Committee on Labor and Human Resources and the Committee on 
Appropriations (of the Senate), a report describing 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 regarding this section as the Director determines to be 
appropriate.
    ``(g) Definitions.--For purposes of this section:
            ``(1) The term `pediatric research' means biomedical and 
        behavioral research regarding the health of children.
            ``(2) The term `Plan' means the plan established, 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 children 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 research; 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 Children.--
            ``(1) Increase regarding fiscal year 1998.--The Director of 
        NIH shall ensure that, for fiscal year 1998, the child-subject 
        percentage is significantly increased above such percentage for 
        fiscal year 1995.
            ``(2) Child-subject percentage.--For purposes of this 
        section, the term `child-health percentage', with respect to a 
        fiscal year, means the percentage 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 supported by the National 
                Institutes of Health; to
                    ``(B) the number of individuals (adults and 
                children) who, during the fiscal year, participated 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 PREVENTABLE DISEASES, 
              DISORDERS, AND INJURIES.

    ``(a) In General.--The Secretary shall carry out a program of 
research regarding preventable diseases, disabilities, 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 Secretary 
        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 members of the committee 
        shall be appointed from individuals 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 Federal employee may 
        serve as a member of the advisory committee under paragraph (1) 
        if the only Federal 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 determines 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 
                        prevention 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 provide 
                        training in the prevention of injuries in 
                        children.
                            ``(ii) Demonstration projects that develop 
                        curricula for such training for use in the 
                        training of health professionals who routinely 
                        provide care for children, including such 
                        professionals in the fields of public health, 
                        medicine, nursing, dentistry, and allied health 
                        (including emergency medical technicians).
                            ``(iii) Demonstration projects that develop 
                        curricula for such training for use in the 
                        training of parents, teachers, day-care 
                        personnel, and other individuals who routinely 
                        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 
                consolidating research activities among the agencies 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, reviewing, and 
revising the Plan, the Secretary shall consider the following with 
respect to children.
            ``(1) Epidemiological data, including the incidence and 
        prevalence of various causes of death or disability.
            ``(2) The severity of various diseases and injuries 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 Children.--With respect to 
parents, teachers, and other individuals who routinely supervise 
children, the Secretary shall ensure that the Plan provides for the 
development of model programs for educating such individuals on 
pediatric prevention activities.
    ``(h) Dates Certain Regarding Applicability of Plan; Initial 
Review.--The initial Plan shall be developed 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 
subsequent 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 regarding 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 Committee on Commerce and the 
Committee on Appropriations (of the House of Representatives), and to 
the Committee on Labor and Human Resources and the Committee 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 Department of Health 
        and Human Services, unless the context of usage indicates 
        otherwise.
            ``(2) The term `Fund' means the fund established in 
        subsection (i)(1).
            ``(3) The term `pediatric prevention activities' means 
        activities for the prevention of diseases, disabilities, and 
        injuries in children.
            ``(4) The term `pediatric prevention research' means 
        research described in subsection (a).
            ``(5) The term `Plan' means the plan established, 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 fiscal year 1998.''.

     TITLE III--DEVELOPMENT OF IMPROVED PHARMACEUTICALS 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 enactment of this 
section, and such application includes reports of pediatric studies 
described and requested in subsection (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 pediatric 
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 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 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 subsection 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 subsection 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 request 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 requirement 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 protocols and reported in 
accordance with the Secretary's requirements 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 submission 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 request, that such studies have been conducted in 
accordance with commonly accepted scientific principles and protocols, 
and that such studies have been reported in accordance 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 Secretary's discretion, 
pharmacokinetic studies may be considered 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 reports 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 exceed 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 determination 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