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. 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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Pediatric Research Ini5 tiative Act of 1995’’.

6 SEC. 2. FINDINGS.

7 The Congress finds as follows:
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1 (1) The savings from biomedical and behavioral

2 research is significant due to the potential years of

3 productive life saved, and to improvements in the

4 quality of life for children and their families.

5 (2) The opportunities for biomedical advance6 ments are greater than ever, given the enormous

7 growth in knowledge and developments in genetics,

8 immunology and related therapies.

9 (3) Childhood cancer is the leading medical

10 cause of death in children ages 1 through adoles11 cence; the incidence of childhood cancer is increas12 ing; and a number of childhood cancers have not

13 yielded to research.

14 (4) The average age of onset of cancer in chil15 dren is 6 years; for adults, it is 67 years. The poten16 tial to save a lifetime of productive years by invest17 ing in pediatric research is not adequately reflected

18 in the current allocation of Federal research dollars.

19 (5) Unintentional injuries are the number one

20 killer of children ages 14 and under, and cost society

21 $13,800,000,000 annually. Investment in childhood

22 injury prevention can save billions of dollars as well

23 as save children and their families needless pain and

24 suffering.
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1 (6) Biomedical, behavioral and injury preven2 tion research which focuses on the unique needs of

3 children receive far less funding than similar re4 search for any other demographic group, including

5 for men, seniors, women and minorities.

6 (7) The goal of the Pediatric Research Initia7 tive is to ensure that these opportunities to signifi8 cantly improve the identification, treatment, cure,

9 and, ultimately, prevention of diseases, disabilities,

10 and injuries that affect children are realized.

11 TITLE I—BIOMEDICAL AND

12 BEHAVIORAL RESEARCH

13 SEC. 101. INTERAGENCY PLAN FOR PEDIATRIC RESEARCH.

14 Part B of title IV of the Public Health Service Act

15 (42 U.S.C. 284 et seq.) is amended by adding at the end

16 the following section:

17 ‘‘PEDIATRIC RESEARCH INITIATIVE

18 ‘‘SEC. 409B. (a) IN GENERAL.—

19 ‘‘(1) INTERAGENCY PLAN.—The Director of

20 NIH shall establish a comprehensive plan for the

21 conduct and support by the national research insti22 tutes of pediatric research, and shall periodically re23 view and as appropriate make revisions in the plan.

24 The Director of NIH shall carry out this section in

25 collaboration with the Director of the National Insti26 tute of Child Health and Human Development.
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1 ‘‘(2) CONSULTATIONS WITH INSTITUTE DIREC2 TORS.—In carrying out this section, the Director of

3 NIH shall consult with the directors of each of the

4 national research institutes.

5 ‘‘(3) ADVISORY COUNCIL.—

6 ‘‘(A) The Secretary shall establish an advi7 sory council to be known as the National Advi8 sory Council on Pediatric Research (in this

9 paragraph referred to as the ‘Advisory Coun10 cil’).

11 ‘‘(B) The Advisory Council shall provide

12 advice to the Secretary and the Director of

13 NIH regarding the Plan. In carrying out the

14 preceding sentence, the advisory council shall

15 develop and submit to the Director proposals

16 regarding the contents of the Plan.

17 ‘‘(C)(i) Subject to clause (ii), the Secretary

18 shall appoint to the Advisory Council, as voting

19 members, not more than 15 individuals. Such

20 individuals shall be appointed from among indi21 viduals who are not officers or employees of the

22 Federal Government.

23 ‘‘(ii) The Secretary shall ensure that, col24 lectively, the members of the Advisory Council

25 who are appointed under clause (i) have exper-
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1 tise in epidemiology, biomedical research, be2 havioral research, basic research, clinical re3 search (including the conduct of clinical trials),

4 and biomedical ethics. The individuals ap5 pointed under such clause shall include one

6 practicing pediatrician and one individual rep7 resenting the interests of pediatric patients and

8 the families of such patients.

9 ‘‘(D) The ex officio, nonvoting members of

10 the Advisory Council shall be the following:

11 ‘‘(i) The Director of the National In12 stitute of Child Health and Human Devel13 opment.

14 ‘‘(ii) The Directors of each of the na15 tional research institutes whose principal

16 responsibilities include the conduct and

17 support of pediatric research.

18 ‘‘(iii) The Commissioner of Food and

19 Drugs.

20 ‘‘(E) The Secretary shall designate a mem21 ber of the Advisory Council to serve as the

22 chair of the Council.

23 ‘‘(b) GENERAL REQUIREMENTS FOR PLAN.—

24 ‘‘(1) IDENTIFICATION OF RELEVANT

25 PROJECTS.—In developing, reviewing, and revising
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1 the Plan, the Director of NIH shall identify the

2 projects of pediatric research that are being con3 ducted or supported by the national research insti4 tute, and current proposals for such projects.

5 ‘‘(2) GENERAL REQUIREMENTS; CATEGORIES

6 OF RESEARCH.—The Director shall ensure that the

7 Plan specifies the following with respect to pediatric

8 research:

9 ‘‘(A) The categories of research that are to

10 be conducted and supported by the National In11 stitutes of Health.

12 ‘‘(B) Priorities among such categories.

13 ‘‘(C) The areas in which an insufficient

14 number or variety of projects have been con15 ducted or supported by such Institutes, and the

16 areas in which the activities of the national re17 search institutes are overlapping.

18 ‘‘(D) The process for coordinating research

19 activities among the national research insti20 tutes.

21 ‘‘(E) Promising areas in which the Na22 tional Institutes of Health will conduct or sup23 port research.

24 ‘‘(F) In the case of the research priorities

25 specified under subparagraph (B), mechanisms
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1 to encourage public and private entities to initi2 ate research independently of solicitations by

3 the National Institutes of Health for proposals.

4 ‘‘(G) Objectives for the research conducted

5 or supported under the Plan, the means for

6 achieving the objectives, and the date by which

7 the objectives are expected to be achieved.

8 ‘‘(3) PARTICULAR PROJECTS.—In carrying out

9 paragraph (2) with respect to a category of research,

10 the Director of NIH may establish requirements re11 garding particular projects of research within a cat12 egory.

13 ‘‘(c) CERTAIN CONSIDERATIONS.—In developing, re14 viewing, and revising the Plan, the Director of NIH shall

15 consider the following with respect to children:

16 ‘‘(1) Epidemiological data, including the inci17 dence and prevalence of various causes of death or

18 disability.

19 ‘‘(2) The severity of various diseases and the

20 impact of the diseases on functional capacity.

21 ‘‘(3) The potential for significant progress in

22 the diagnosis, treatment, prevention, and control of

23 various diseases, disorders, and disabilities.
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1 ‘‘(d) CERTAIN COMPONENTS OF PLAN.—The Direc2 tor of NIH shall ensure that the Plan provides for an ap3 propriate emphasis on the following:

4 ‘‘(1) Evaluations of the results of basic research

5 in order to develop and commence projects of clinical

6 research.

7 ‘‘(2) The support of proposals developed pursu8 ant to solicitations by the national research insti9 tutes, and the support of proposals developed inde10 pendently of such solicitations.

11 ‘‘(3) The support of proposals for projects

12 whose principal researchers will be individuals who

13 have not previously served as the principal research14 ers of projects supported by the national research in15 stitutes.

16 ‘‘(4) Both biomedical research and behavioral

17 research.

18 ‘‘(e) DATES CERTAIN REGARDING APPLICABILITY OF

19 PLAN; INITIAL REVIEW.—The initial Plan shall be devel20 oped and shall take effect not later than October 1, 1996.

21 The initial review of the Plan under subsection (a)(1) shall

22 be completed not later than October 1, 1998, and a review

23 shall be conducted not less than once during each subse24 quent two-year period.
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1 ‘‘(f) ANNUAL REPORT.—Not later than February 1

2 of each fiscal year, the Director of NIH shall submit to

3 the Committee on Commerce and the Committee on Ap4 propriations (of the House of Representatives), and to the

5 Committee on Labor and Human Resources and the Com6 mittee on Appropriations (of the Senate), a report describ7 ing the activities undertaken and expenditures made under

8 this section during the preceding fiscal year. The report

9 may contain such comments of the Director of NIH re10 garding this section as the Director determines to be ap11 propriate.

12 ‘‘(g) DEFINITIONS.—For purposes of this section:

13 ‘‘(1) The term ‘pediatric research’ means bio14 medical and behavioral research regarding the health

15 of children.

16 ‘‘(2) The term ‘Plan’ means the plan estab17 lished, reviewed, and revised under subsection (a)(1).

18 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the

19 purpose of carrying out this section, there are authorized

20 to be appropriated $60,000,000 for fiscal year 1996,

21 $75,000,000 for fiscal year 1997, $100,000,000 for fiscal

22 year 1998, and such sums as may be necessary for fiscal

23 year 1999 and each subsequent fiscal year.’’.
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1 SEC. 102. INCLUSION OF CHILDREN IN CLINICAL

2 RESEARCH.

3 Part H of title IV of the Public Health Service (42

4 U.S.C. 289 et seq.) is amended by inserting after section

5 492B the following section:

6 ‘‘INCLUSION OF CHILDREN IN CLINICAL RESEARCH

7 ‘‘SEC. 492C. (a) IN GENERAL.—The Director of NIH

8 shall establish guidelines regarding the inclusion of chil9 dren as subjects in projects of clinical research conducted

10 or supported by the National Institutes of Health.

11 ‘‘(b) CERTAIN CONSIDERATIONS.—In establishing

12 guidelines under subsection (a), the Director of NIH shall

13 consider—

14 ‘‘(1) the principles applied under section 492B

15 by the Director in including women and members of

16 minority groups as subjects in projects of clinical re17 search; and

18 ‘‘(2) the factors underlying the plan developed

19 under section 409B (relating to the conduct and

20 support of pediatric research).

21 ‘‘(c) INCREASE REGARDING INCLUSION OF CHIL22 DREN.—

23 ‘‘(1) INCREASE REGARDING FISCAL YEAR

24 1998.—The Director of NIH shall ensure that, for

25 fiscal year 1998, the child-subject percentage is sig-
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1 nificantly increased above such percentage for fiscal

2 year 1995.

3 ‘‘(2) CHILD-SUBJECT PERCENTAGE.—For pur4 poses of this section, the term ‘child-health percent5 age’, with respect to a fiscal year, means the per6 centage constituted by the ratio of—

7 ‘‘(A) the number of children who, during

8 the fiscal year, participated as subjects in

9 projects of clinical research conducted or sup10 ported by the National Institutes of Health; to

11 ‘‘(B) the number of individuals (adults and

12 children) who, during the fiscal year, partici13 pated as such subjects.’’.

14 TITLE II—PREVENTIVE HEALTH

15 RESEARCH

16 SEC. 201. INTERAGENCY PLAN FOR PEDIATRIC RESEARCH;

17 DISCRETIONARY FUND.

18 Title III of the Public Health Service Act (42 U.S.C.

19 241 et seq.) is amended by adding at the end the following

20 part:
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1 ‘‘PART O—PREVENTIVE HEALTH RESEARCH

2 REGARDING CHILDREN

3 ‘‘SEC. 399M. RESEARCH REGARDING CHILDREN AND PRE4 VENTABLE DISEASES, DISORDERS, AND INJU5 RIES.

6 ‘‘(a) IN GENERAL.—The Secretary shall carry out a

7 program of research regarding preventable diseases, dis8 abilities, and injuries in children, including research on the

9 causes of death in children. The Secretary may conduct

10 the research directly or through making grants to public

11 and nonprofit private entities.

12 ‘‘(b) COLLABORATION WITH RELEVANT AGENCY

13 HEADS.—The Secretary shall carry out subsection (a) in

14 collaboration with the following:

15 ‘‘(1) The Director of the Centers for Disease

16 Control and Prevention.

17 ‘‘(2) The Director of the National Institute of

18 Child Health and Human Development.

19 ‘‘(3) The Director of the National Center for

20 Injury Prevention and Control.

21 ‘‘(4) The Director of the Maternal and Child

22 Health Bureau.

23 ‘‘(5) The Administrator for Health Care Policy

24 and Research.
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1 ‘‘(6) Such other Federal officials as the Sec2 retary determines to be appropriate.

3 ‘‘(c) ADVISORY COMMITTEE.—

4 ‘‘(1) IN GENERAL.—The Secretary shall provide

5 for a committee to provide advice to the Secretary

6 regarding pediatric prevention research. The mem7 bers of the committee shall be appointed from indi8 viduals who have expertise in pediatric prevention

9 activities and who, subject to paragraph (2), are not

10 officers or employees of the Federal Government.

11 ‘‘(2) USE OF EXISTING COMMITTEES.—A Fed12 eral employee may serve as a member of the advi13 sory committee under paragraph (1) if the only Fed14 eral duty of the employee is to serve on one or more

15 Federal advisory committees, and if the individual,

16 when first appointed to such a committee, was not

17 a Federal officer or employee.

18 ‘‘(d) INTERAGENCY PLAN.—The Secretary—

19 ‘‘(1) shall establish a comprehensive plan for

20 carrying out subsection (a) through the Centers for

21 Disease Control and Prevention and such other

22 agencies of the Department as the Secretary deter23 mines to be appropriate; and

24 ‘‘(2) shall periodically review and as appropriate

25 make revisions in the plan.
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1 ‘‘(e) GENERAL REQUIREMENTS FOR PLAN.—

2 ‘‘(1) PRELIMINARY EVALUATIONS.—

3 ‘‘(A) In developing, reviewing, and revising

4 the Plan, the Secretary shall—

5 ‘‘(i) identify and evaluate projects of

6 pediatric prevention research that are

7 being carried out through the agencies of

8 the Department, and proposals for such

9 projects; and

10 ‘‘(ii) to the extent practicable, identify

11 and evaluate the projects of pediatric pre12 vention research that are being carried out

13 through other public or private entities,

14 and proposals for such projects.

15 ‘‘(B) The projects identified and evaluated

16 by the Secretary under subparagraph (A) shall

17 include the following:

18 ‘‘(i) Demonstration projects that pro19 vide training in the prevention of injuries

20 in children.

21 ‘‘(ii) Demonstration projects that de22 velop curricula for such training for use in

23 the training of health professionals who

24 routinely provide care for children, includ25 ing such professionals in the fields of pub-
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1 lic health, medicine, nursing, dentistry, and

2 allied health (including emergency medical

3 technicians).

4 ‘‘(iii) Demonstration projects that de5 velop curricula for such training for use in

6 the training of parents, teachers, day-care

7 personnel, and other individuals who rou8 tinely supervise children.

9 ‘‘(2) GENERAL REQUIREMENTS; CATEGORIES

10 OF RESEARCH.—The Secretary shall ensure that the

11 Plan specifies the following with respect to pediatric

12 prevention research:

13 ‘‘(A) The categories of research that are to

14 be conducted and supported by the Department.

15 ‘‘(B) The allocation among such agencies

16 of responsibilities for the categories designated

17 under subparagraph (A).

18 ‘‘(C) Priorities among such categories.

19 ‘‘(D) Objectives for the research conducted

20 or supported under the Plan, the means for

21 achieving the objectives, and the date by which

22 the objectives are expected to be achieved.

23 ‘‘(E) The process for coordinating and con24 solidating research activities among the agen25 cies of the Department.
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1 ‘‘(3) PARTICULAR PROJECTS.—In carrying out

2 paragraph (2) with respect to a category of research,

3 the Secretary may establish requirements regarding

4 particular projects of research within a category.

5 ‘‘(f) CERTAIN CONSIDERATIONS.—In developing, re6 viewing, and revising the Plan, the Secretary shall con7 sider the following with respect to children.

8 ‘‘(1) Epidemiological data, including the inci9 dence and prevalence of various causes of death or

10 disability.

11 ‘‘(2) The severity of various diseases and inju12 ries and the impact of such diseases and injuries on

13 functional capacity.

14 ‘‘(3) The potential for significant progress in

15 the prevention of various diseases, disabilities, and

16 injuries.

17 ‘‘(g) MODEL PROGRAMS FOR SUPERVISORS OF CHIL18 DREN.—With respect to parents, teachers, and other indi19 viduals who routinely supervise children, the Secretary

20 shall ensure that the Plan provides for the development

21 of model programs for educating such individuals on pedi22 atric prevention activities.

23 ‘‘(h) DATES CERTAIN REGARDING APPLICABILITY OF

24 PLAN; INITIAL REVIEW.—The initial Plan shall be devel25 oped and shall take effect not later than October 1, 1996.
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1 The initial review of the Plan under subsection (d)(2) shall

2 be completed not later than October 1, 1998, and a review

3 shall be conducted not less than once during each subse4 quent two-year period.

5 ‘‘(i) DISCRETIONARY FUND.—

6 ‘‘(1) IN GENERAL.—There is established a fund

7 to be known as the Pediatric Prevention Research

8 Initiative Fund, consisting of such amounts as may

9 be appropriated under subsection (l) for the Fund.

10 ‘‘(2) USE OF FUND.—Amounts in the Fund are

11 available to the Secretary for such activities regard12 ing pediatric prevention research as are authorized

13 under this Act, including activities under the Plan.

14 ‘‘(j) ANNUAL REPORT.—Not later than February 1

15 of each fiscal year, the Secretary shall submit to the Com16 mittee on Commerce and the Committee on Appropria17 tions (of the House of Representatives), and to the Com18 mittee on Labor and Human Resources and the Commit19 tee on Appropriations (of the Senate), a report describing

20 the activities undertaken and expenditures made under

21 this section during the preceding fiscal year, including

22 with respect to the Fund. The report may contain such

23 comments of the Secretary regarding this section as the

24 Secretary determines to be appropriate.

25 ‘‘(k) DEFINITIONS.—For purposes of this section:
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1 ‘‘(1) The term ‘Department’ means the Depart2 ment of Health and Human Services, unless the con3 text of usage indicates otherwise.

4 ‘‘(2) The term ‘Fund’ means the fund estab5 lished in subsection (i)(1).

6 ‘‘(3) The term ‘pediatric prevention activities’

7 means activities for the prevention of diseases, dis8 abilities, and injuries in children.

9 ‘‘(4) The term ‘pediatric prevention research’

10 means research described in subsection (a).

11 ‘‘(5) The term ‘Plan’ means the plan estab12 lished, reviewed, and revised under subsection (d).

13 ‘‘(l) AUTHORIZATION OF APPROPRIATIONS.—For the

14 purpose of carrying out this section, there are authorized

15 to be appropriated $30,000,000 for fiscal year 1996,

16 $30,500,000 for fiscal year 1997, and $50,000,000 for fis17 cal year 1998.’’.

18 TITLE III—DEVELOPMENT OF

19 IMPROVED PHARMA20 CEUTICALS AND OTHER

21 THERAPEUTIC AGENTS

22 SEC. 301. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.

23 Chapter V of the Federal Food, Drug, and Cosmetic

24 Act (21 U.S.C. 501 et seq.) is amended by inserting after

25 section 505 the following section:
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1 ‘‘PEDIATRIC STUDIES FOR NEW DRUG APPLICATIONS

2 ‘‘SEC. 505A. (a) If an application submitted under

3 section 505(b)(1) is approved on or after the date of en4 actment of this section, and such application includes re5 ports of pediatric studies described and requested in sub6 section (c), and such studies are completed and the reports

7 thereof submitted in accordance with subsection (c)(2) or

8 completed and the reports thereof accepted in accordance

9 with subsection (c)(3), the Secretary may not make the

10 approval of an application submitted under section

11 505(b)(2) or section 505(j) which refers to the drug for

12 which the section 505(b)(1) approval is granted effective

13 prior to the expiration of 6 months from the earliest date

14 on which the approval of such application for the drug

15 under section 505(b)(2) or section 505(j), respectively,

16 could otherwise be made effective under the applicable

17 provisions of this chapter.

18 ‘‘(b) If the Secretary makes a written request for pe19 diatric studies described in subsection (c) to the holder

20 of an approval under section 505(b)(1) for a drug, and

21 such studies are completed and the reports thereof submit22 ted in accordance with subsection (c)(2) or completed and

23 the reports thereof accepted in accordance with subsection

24 (c)(3), the Secretary may not make the approval of an

25 application submitted under section 505(b)(2) or section
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1 505(j) which refers to the drug subject to the section

2 505(b)(1) approval effective prior to the expiration of 6

3 months from the earliest date on which an approval of

4 such application under section 505(b)(2) or section 505(j),

5 respectively, could otherwise be made effective under the

6 applicable provisions of this chapter. Nothing in this sub7 section shall affect the ability of the Secretary to make

8 effective a section 505(b)(2) or section 505(j) approval for

9 a subject drug if such approval is proper under such sub10 section and is made effective prior to the submission of

11 the reports of pediatric studies described in subsection (c).

12 ‘‘(c)(1) The Secretary may, pursuant to a written re13 quest for studies after consultation with the sponsor of

14 an application or holder of an approval for a drug under

15 section 505(b)(1), agree with the sponsor or holder for the

16 conduct of pediatric studies for such drug.

17 ‘‘(2) If the sponsor or holder and the Secretary agree

18 upon written protocols for such studies, the studies re19 quirement of subsection (a) or (b) is satisfied upon the

20 completion of the studies in accordance with the protocols

21 and the submission of the reports thereof to the Secretary.

22 Within 60 days after the submission of the report of the

23 studies, the Secretary shall determine if such studies were

24 or were not conducted in accordance with the written pro-
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1 tocols and reported in accordance with the Secretary’s re2 quirements for filing and so notify the sponsor or holder.

3 ‘‘(3) If the sponsor or holder and the Secretary have

4 not agreed in writing on the protocols for the studies, the

5 studies requirement of subsection (a) or (b) is satisfied

6 when such studies have been completed and the reports

7 accepted by the Secretary. Within 90 days after the sub8 mission of the reports of the studies, the Secretary shall

9 accept or reject such reports and so notify the sponsor

10 or holder. The Secretary’s only responsibility in accepting

11 or rejecting the reports shall be to determine, within 90

12 days, that the studies fairly respond to the written re13 quest, that such studies have been conducted in accord14 ance with commonly accepted scientific principles and pro15 tocols, and that such studies have been reported in accord16 ance with the Secretary’s requirements for filing.

17 ‘‘(4) As used in this section, ‘pediatric studies’ or

18 ‘studies’ means at least 1 human clinical investigation in

19 a population of adolescent age or younger. At the Sec20 retary’s discretion, pharmacokinetic studies may be con21 sidered as clinical investigations.

22 ‘‘(d) If the Secretary determines that an approval of

23 an application under section 505(b)(2) or section 505(j)

24 for a drug may be made effective after submission of re25 ports of pediatric studies under this section but before the
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1 Secretary has determined whether the requirements of

2 subsection (c) have been satisfied, the Secretary may delay

3 the effective date of any approval under section 505(b)(2)

4 or section 505(j), respectively, until the determination

5 under subsection (c) is made, but such delay shall not ex6 ceed 90 days. In the event that the requirements of this

7 section are satisfied, the 6-month period referred to in

8 subsection (a) or (b) shall be deemed to have begun on

9 the date an approval of an application under section

10 505(b)(2) or section 505(j), respectively, would have been

11 permitted absent action under this subsection.

12 ‘‘(e) The Secretary shall publish notice of any deter13 mination that the requirements of subsection (c)(2) or

14 (c)(3) have been met and that approvals for the drug will

15 be subject to deferred effective dates under this section.’’.

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