II

106TH CONGRESS

2D SESSION S. 2879

To amend the Public Health Service Act to establish programs and activities

to address diabetes in children and youth, and for other purposes.

IN THE SENATE OF THE UNITED STATES

JULY 17, 2000

Ms. COLLINS (for herself, Mr. BREAUX, Mr. ABRAHAM, Mr. BUNNING, and

Mr. CRAIG) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Public Health Service Act to establish programs and activities to address diabetes in children and

youth, and for other purposes.

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 Diabetes Re5 search and Prevention Act’’.
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1 SEC. 2. PROGRAMS OF CENTERS FOR DISEASE CONTROL

2 AND PREVENTION.

3 Part B of title III of the Public Health Service Act

4 (42 U.S.C. 243 et seq.) is amended by inserting after sec5 tion 317G the following section:

6 ‘‘SEC. 317H. DIABETES IN CHILDREN AND YOUTH.

7 ‘‘(a) NATIONAL REGISTRY ON JUVENILE DIABE8 TES.—The Secretary, acting through the Director of the

9 Centers for Disease Control and Prevention, shall develop

10 a system to collect data on type 1 diabetes (or juvenile

11 diabetes), including information with respect to incidence

12 and prevalence, and shall establish a national registry for

13 such data.

14 ‘‘(b) ADVISORY COMMITTEE ON THE NATIONAL REG15 ISTRY ON JUVENILE DIABETES.—

16 ‘‘(1) ESTABLISHMENT.—There is established a

17 committee to be known as the Advisory Committee

18 on the National Registry on Juvenile Diabetes (re19 ferred to in this subsection as the ‘committee’).

20 ‘‘(2) MEMBERSHIP.—The committee shall be

21 composed of at least one member, to be appointed

22 by the Secretary, acting through the Director of the

23 Centers for Disease Control and Prevention, rep24 resenting each of the following:

25 ‘‘(A) Epidemiologists with experience in

26 data registries.
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1 ‘‘(B) Patients with type 1 diabetes (or ju2 venile diabetes), or family members of the pa3 tients.

4 ‘‘(C) Representatives from nonprofit orga5 nizations focused on diabetes research.

6 ‘‘(D) Clinicians who have worked with data

7 registries.

8 ‘‘(E) Statisticians.

9 ‘‘(F) Ethicists.

10 ‘‘(G) Attorneys.

11 ‘‘(H) Other individuals with an interest in

12 developing and maintaining the registry de13 scribed in subsection (a).

14 ‘‘(3) PERIOD OF APPOINTMENT; VACANCIES.—

15 Members shall be appointed for the life of the com16 mittee. Any vacancy in the committee shall not af17 fect the powers of the committee, but shall be filled

18 in the same manner as the original appointment.

19 ‘‘(4) DUTIES.—The committee shall study, and

20 make recommendations to the Secretary regarding,

21 the development and maintenance of the registry de22 scribed in subsection (a).

23 ‘‘(5) POWERS.—

24 ‘‘(A) HEARINGS.—The committee may

25 hold such hearings, sit and act at such times
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1 and places, take such testimony, and receive

2 such evidence as the committee considers advis3 able to carry out the objectives of this section.

4 ‘‘(B) INFORMATION FROM FEDERAL AGEN5 CIES.—The committee may secure directly from

6 any Federal department or agency such infor7 mation as the committee considers necessary to

8 carry out the provisions of this section. Upon

9 request of the committee, the head of such de10 partment or agency shall furnish such informa11 tion to the committee.

12 ‘‘(C) POSTAL SERVICES.—The committee

13 may use the United States mails in the same

14 manner and under the same conditions as other

15 departments and agencies of the Federal Gov16 ernment.

17 ‘‘(6) PERSONNEL.—

18 ‘‘(A) TRAVEL EXPENSES.—The members

19 of the committee shall not receive compensation

20 for the performance of services for the com21 mittee, but shall be allowed travel expenses, in22 cluding per diem in lieu of subsistence, at rates

23 authorized for employees of agencies under sub24 chapter I of chapter 57 of title 5, United States

25 Code, while away from their homes or regular
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1 places of business in the performance of serv2 ices for the committee. Notwithstanding section

3 1342 of title 31, United States Code, the Sec4 retary may accept the voluntary and uncompen5 sated services of members of the committee.

6 ‘‘(B) DETAIL OF GOVERNMENT EMPLOY7 EES.—Any Federal Government employee may

8 be detailed to the committee without reimburse9 ment, and such detail shall be without interrup10 tion or loss of civil service status or privilege.

11 ‘‘(7) PERMANENT COMMITTEE.—Section 14 of

12 the Federal Advisory Committee Act (5 U.S.C.

13 App.) shall not apply to the committee.

14 ‘‘(c) TYPE 2 DIABETES IN YOUTH.—The Secretary,

15 acting through the Director of the Centers for Disease

16 Control and Prevention and in consultation with the Ad17 ministrator of the Health Resources and Services Admin18 istration, shall implement a national public health effort

19 to address type 2 diabetes in youth, including—

20 ‘‘(1) enhancing surveillance systems and ex21 panding research to better assess the prevalence of

22 type 2 diabetes in youth and determine the extent to

23 which type 2 diabetes is incorrectly diagnosed as

24 type 1 diabetes (or juvenile diabetes) among chil25 dren;
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1 ‘‘(2) assisting States in establishing coordinated

2 school health programs and physical activity and nu3 trition demonstration programs to control weight

4 and increase physical activity among youth; and

5 ‘‘(3) developing and improving laboratory meth6 ods to assist in diagnosis, treatment, and prevention

7 of diabetes including developing noninvasive ways to

8 monitor blood glucose to prevent hypoglycema and

9 improving glucometers that measure blood glucose.

10 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There

11 are authorized to be appropriated to carry out this section

12 such sums as may be necessary for each of fiscal years

13 2001 through 2005.’’.

14 SEC. 3. PROGRAMS OF NATIONAL INSTITUTES OF HEALTH.

15 Subpart 3 of part C of title IV of the Public Health

16 Service Act (42 U.S.C. 285c et seq.) is amended by insert17 ing after section 434 the following section:

18 ‘‘SEC. 434A. JUVENILE DIABETES.

19 ‘‘(a) LONG-TERM EPIDEMIOLOGY STUDIES.—

20 ‘‘(1) IN GENERAL.—The Director of the Insti21 tute shall conduct or support long-term epidemiology

22 studies in which individuals with type 1 diabetes (or

23 juvenile diabetes) are followed for 10 years or more.

24 Such studies shall, in order to provide a valuable re25 source for the purposes specified in paragraph (2),
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1 provide for complete characterization of disease

2 manifestations, description of the appropriate med3 ical history, elucidation of environmental factors, de4 lineation of complications, description of results of

5 usual medical treatment, and acquisition of a variety

6 of other potentially valuable information and sam7 ples (such as samples of blood).

8 ‘‘(2) PURPOSES.—The purposes referred to in

9 paragraph (1) with respect to type 1 diabetes (or ju10 venile diabetes) are the following:

11 ‘‘(A) Delineation of potential environ12 mental triggers thought to precipitate or cause

13 type 1 diabetes (or juvenile diabetes).

14 ‘‘(B) Delineation of clinical characteristics

15 or lab measures associated with complications

16 of the disease.

17 ‘‘(C) Specification of a potential study pop18 ulation to enter into clinical trials for preven19 tion and treatment, as well as genetic studies.

20 ‘‘(b) CLINICAL TRIAL INFRASTRUCTURE AND INNO21 VATIVE TREATMENTS FOR JUVENILE DIABETES.—The

22 Secretary, acting through the Director of the National In23 stitutes of Health, shall support regional clinical centers

24 for the cure of type 1 diabetes (or juvenile diabetes) and

25 shall through such centers provide for—
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1 ‘‘(1) a well-characterized population of children

2 appropriate for clinical trials;

3 ‘‘(2) well-trained clinical scientists able to con4 duct such trials;

5 ‘‘(3) appropriate clinical settings able to house

6 such trials; and

7 ‘‘(4) appropriate statistical capability, data,

8 safety, and other monitoring capacity.

9 ‘‘(c) DEVELOPMENT OF VACCINE.—The Secretary,

10 acting through the appropriate agencies of the Public

11 Health Service, shall provide for a national effort to de12 velop a vaccine for type 1 diabetes (or juvenile diabetes).

13 Such effort shall provide for a combination of increased

14 efforts in research and development of candidate vaccines,

15 coupled with appropriate ability to conduct large clinical

16 trials in children.

17 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There

18 are authorized to be appropriated to carry out this section

19 such sums as may be necessary for each of fiscal years

20 2001 through 2005.’’.

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