II

106TH CONGRESS

1ST SESSION S. 512

To amend the Public Health Service Act to provide for the expansion, intensification, and coordination of the activities of the Department of Health

and Human Services with respect to research on autism.

IN THE SENATE OF THE UNITED STATES

MARCH 2, 1999

Mr. GORTON (for himself, Mrs. FEINSTEIN, Mr. LAUTENBERG, Mr.

TORRICELLI, Mr. LIEBERMAN, and Mr. EDWARDS) 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 provide for

the expansion, intensification, and coordination of the

activities of the Department of Health and Human Services with respect to research on autism.

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 ‘‘Advancement in Pedi5 atric Autism Research Act’’.

6 SEC. 2. FINDINGS.

7 The Congress finds as follows:
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1 (1) Infantile autism and autism spectrum dis2 orders are biologically-based neurodevelopmental dis3 eases that cause severe impairments in language and

4 communication and generally manifest in young chil5 dren sometime during the first two years of life.

6 (2) Best estimates indicate that 1 in 500 chil7 dren born today will be diagnosed with an autism

8 spectrum disorder and that 400,000 Americans have

9 autism or an autism spectrum disorder.

10 (3) There is little information on the prevalence

11 of autism and other pervasive developmental disabil12 ities in the United States. There have never been

13 any national prevalence studies in the United States,

14 and the two studies that were conducted in the

15 1980s examined only selected areas of the country.

16 Recent studies in Canada, Europe, and Japan sug17 gest that the prevalence of classic autism alone may

18 be 300 percent to 400 percent higher than pre19 viously estimated.

20 (4) Three quarters of those with infantile au21 tism spend their adult lives in institutions or group

22 homes, and usually enter institutions by the age of

23 13.

24 (5) The cost of caring for individuals with au25 tism and autism spectrum disorder is great, and is
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1 estimated to be $13.3 billion per year solely for di2 rect costs.

3 (6) The rapid advancements in biomedical

4 science suggest that effective treatments and a cure

5 for autism are attainable if—

6 (A) there is appropriate coordination of the

7 efforts of the various agencies of the Federal

8 Government involved in biomedical research on

9 autism and autism spectrum disorders;

10 (B) there is an increased understanding of

11 autism and autism spectrum disorders by the

12 scientific and medical communities involved in

13 autism research and treatment; and

14 (C) sufficient funds are allocated to re15 search.

16 (7) The discovery of effective treatments and a

17 cure for autism will be greatly enhanced when sci18 entists and epidemiologists have an accurate under19 standing of the prevalence and incidence of autism.

20 (8) Recent research suggests that environ21 mental factors may contribute to autism. As a re22 sult, contributing causes of autism, if identified, may

23 be preventable.

24 (9) Finding the answers to the causes of autism

25 and related developmental disabilities may help re-
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1 searchers to understand other disorders, ranging

2 from learning problems, to hyperactivity, to commu3 nications deficits that affect millions of Americans.

4 (10) Specifically, more knowledge is needed

5 concerning—

6 (A) the underlying causes of autism and

7 autism spectrum disorders, how to treat the un8 derlying abnormality or abnormalities causing

9 the severe symptoms of autism, and how to pre10 vent these abnormalities from occurring in the

11 future;

12 (B) the epidemiology of, and the identifica13 tion of risk factors for, infantile autism and au14 tism spectrum disorders;

15 (C) the development of methods for early

16 medical diagnosis and functional assessment of

17 individuals with autism and autism spectrum

18 disorders, including identification and assess19 ment of the subtypes within the autism spec20 trum disorders, for the purpose of monitoring

21 the course of the disease and developing medi22 cally sound strategies for improving the out23 comes of such individuals;

24 (D) existing biomedical and diagnostic

25 data that are relevant to autism and autism
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1 spectrum disorders for dissemination to medical

2 personnel, particularly pediatricians, to aid in

3 the early diagnosis and treatment of this dis4 ease; and

5 (E) the costs incurred in educating and

6 caring for individuals with autism and autism

7 spectrum disorders.

8 (11) In 1998, the National Institutes of Health

9 announced a program of research on autism and au10 tism spectrum disorders. A sufficient level of fund11 ing should be made available for carrying out the

12 program.

13 SEC. 3. EXPANSION, INTENSIFICATION, AND COORDINA14 TION OF ACTIVITIES OF NATIONAL INSTI15 TUTES OF HEALTH WITH RESPECT TO RE16 SEARCH ON AUTISM.

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

18 (42 U.S.C. 284 et seq.) is amended by adding at the end

19 the following section:

20 ‘‘AUTISM

21 ‘‘SEC. 409C. (a) IN GENERAL.—

22 ‘‘(1) EXPANSION OF ACTIVITIES.—The Director

23 of NIH (in this section referred to as the ‘Director’)

24 shall expand, intensify, and coordinate the activities

25 of the National Institutes of Health with respect to

26 research on autism.
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1 ‘‘(2) ADMINISTRATION OF PROGRAM; COLLABO2 RATION AMONG AGENCIES.—The Director shall carry

3 out this section acting through the Director of the

4 National Institute of Mental Health and in collabo5 ration with any other agencies that the Director de6 termines appropriate.

7 ‘‘(b) CENTERS OF EXCELLENCE.—

8 ‘‘(1) IN GENERAL.—The Director shall under

9 subsection (a)(1) make awards of grants and con10 tracts to public or nonprofit private entities to pay

11 all or part of the cost of planning, establishing, im12 proving, and providing basic operating support for

13 centers of excellence regarding research on autism.

14 ‘‘(2) RESEARCH.—Each center under para15 graph (1) shall conduct basic and clinical research

16 into the cause, diagnosis, early detection, prevention,

17 control, and treatment of autism, including research

18 in the fields of developmental neurobiology, genetics,

19 and psychopharmacology.

20 ‘‘(3) SERVICES FOR PATIENTS.—A center under

21 paragraph (1) may expend amounts provided under

22 such paragraph to carry out a program to make in23 dividuals aware of opportunities to participate as

24 subjects in research conducted by the centers. The

25 program may provide fees to such subjects. The pro-
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1 gram may, in accordance with such criteria as the

2 Director may establish, provide to such subjects

3 health care, referrals for health and other services,

4 and such incidental services as will facilitate the par5 ticipation of individuals as such subjects.

6 ‘‘(4) COORDINATION OF CENTERS; REPORTS.—

7 The Director shall, as appropriate, provide for the

8 coordination of information among centers under

9 paragraph (1) and ensure regular communication

10 between such centers, and may require the periodic

11 preparation of reports on the activities of the centers

12 and the submission of the reports to the Director.

13 ‘‘(5) ORGANIZATION OF CENTERS.—Each cen14 ter under paragraph (1) shall use the facilities of a

15 single institution, or be formed from a consortium of

16 cooperating institutions, meeting such requirements

17 as may be prescribed by the Director.

18 ‘‘(6) NUMBER OF CENTERS; DURATION OF SUP19 PORT.—The Director shall, subject to the extent of

20 amounts made available in appropriations Acts, pro21 vide for the establishment of not less than five cen22 ters under paragraph (1). Support of such a center

23 may be for a period not exceeding 5 years. Such pe24 riod may be extended for one or more additional pe25 riods not exceeding 5 years if the operations of such
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1 center have been reviewed by an appropriate tech2 nical and scientific peer review group established by

3 the Director and if such group has recommended to

4 the Director that such period should be extended.

5 ‘‘(c) FACILITATION OF RESEARCH.—The Director

6 shall under subsection (a)(1) provide for a program under

7 which samples of tissues and genetic materials that are

8 of use in research on autism are donated, collected, pre9 served, and made available for such research. The pro10 gram shall be carried out in accordance with accepted sci11 entific and medical standards for the donation, collection,

12 and preservation of such samples.

13 ‘‘(d) PUBLIC INPUT.—The Director shall under sub14 section (a)(1) provide for means through which the public

15 can obtain information on the existing and planned pro16 grams and activities of the National Institutes of Health

17 with respect to autism and through which the Director can

18 receive comments from the public regarding such pro19 grams and activities.

20 ‘‘(e) FUNDING.—For the purpose of carrying out this

21 section, there are authorized to be appropriated

22 $33,000,000 for fiscal year 2000, and such sums as may

23 be necessary for each of the fiscal years 2001 through

24 2004. Such authorizations of appropriations are in addi-
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1 tion to any other authorization of appropriations that is

2 available for such purpose.’’.

3 SEC. 4. DEVELOPMENTAL DISABILITIES SURVEILLANCE

4 AND RESEARCH PROGRAMS.

5 (a) NATIONAL AUTISM AND PERVASIVE DEVELOP6 MENTAL DISABILITIES SURVEILLANCE PROGRAM.—The

7 Secretary of Health and Human Services (in this Act re8 ferred to as the ‘‘Secretary’’), acting through the Director

9 of the Centers for Disease Control and Prevention, may

10 make awards of grants and cooperative agreements for the

11 collection, analysis, and reporting of data on autism and

12 pervasive developmental disabilities. An entity may receive

13 such an award only if the entity is a public or nonprofit

14 private entity (including health departments of States and

15 political subdivisions of States, and including universities

16 and other educational entities). In making such awards,

17 the Secretary may provide direct technical assistance in

18 lieu of cash.

19 (b) CENTERS OF EXCELLENCE IN AUTISM AND PER20 VASIVE DEVELOPMENTAL DISABILITIES EPIDEMIOL21 OGY.—

22 (1) IN GENERAL.—The Secretary, acting

23 through the Director of the Centers for Disease

24 Control and Prevention, shall (subject to the extent

25 of amounts made available in appropriations Acts)
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1 establish not less than 3, and not more than 5, re2 gional centers of excellence in autism and pervasive

3 developmental disabilities epidemiology for the pur4 pose of collecting and analyzing information on the

5 number, incidence, correlates, and causes of autism

6 and related developmental disabilities.

7 (2) RECIPIENTS OF AWARDS FOR ESTABLISH8 MENT OF CENTERS.—Centers under paragraph (1)

9 shall be established and operated through the award10 ing of grants or cooperative agreements to public or

11 nonprofit private entities that conduct research, in12 cluding health departments of States and political

13 subdivisions of States, and including universities and

14 other educational entities.

15 (3) CERTAIN REQUIREMENTS.—An award for a

16 center under paragraph (1) may be made only if the

17 entity involved submits to the Secretary an applica18 tion containing such agreements and information as

19 the Secretary may require, including an agreement

20 that the center involved will operate in accordance

21 with the following:

22 (A) The center will collect, analyze, and re23 port autism and pervasive developmental dis24 abilities data according to guidelines prescribed

25 by the Director, after consultation with relevant
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1 State and local public health officials, private

2 sector developmental disability researchers, and

3 advocates for those with developmental disabil4 ities.

5 (B) The center will assist with the develop6 ment and coordination of State autism and per7 vasive developmental disabilities surveillance ef8 forts within a region.

9 (C) The center will provide education,

10 training, and clinical skills improvement for

11 health professionals aimed at better under12 standing and treatment of autism and related

13 developmental disabilities.

14 (D) The center will identify eligible cases

15 and controls through its surveillance systems

16 and conduct research into factors which may

17 cause autism and related developmental disabil18 ities. Each program will develop or extend an

19 area of special research expertise (including ge20 netics, environmental exposure to contaminants,

21 immunology, and other relevant research spe22 cialty areas).

23 (c) CLEARINGHOUSE.—The Secretary, acting

24 through the Director of the Centers for Disease Control

25 and Prevention, shall carry out the following:
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1 (1) The Secretary shall establish a clearing2 house within the Centers for Disease Control and

3 Prevention for the collection and storage of data

4 generated from the monitoring programs created by

5 this Act. Through the clearinghouse, such Centers

6 shall serve as the coordinating agency for autism

7 and pervasive developmental disabilities surveillance

8 activities. The functions of such a clearinghouse

9 shall include facilitating the coordination of research

10 and policy development relating to the epidemiology

11 of autism and other pervasive developmental disabil12 ities.

13 (2) The Secretary, acting through the Centers

14 for Disease Control and Prevention, shall coordinate

15 the Federal response to requests for assistance from

16 State health department officials regarding potential

17 or alleged autism or developmental disability clus18 ters.

19 (d) DEFINITION.—In this Act, the term ‘‘State’’

20 means each of the several States, the District of Columbia,

21 the Commonwealth of Puerto Rico, American Samoa,

22 Guam, the Commonwealth of the Northern Mariana Is23 lands, the Virgin Islands, and the Trust Territory of the

24 Pacific Islands.
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1 (e) AUTHORIZATION OF APPROPRIATIONS.—To carry

2 out this section, there is authorized to be appropriated

3 $7,500,000 for each of the fiscal years 2000 through

4 2004.

5 SEC. 5. INFORMATION AND EDUCATION.

6 (a) IN GENERAL.—The Secretary shall establish and

7 implement a program to provide information and edu8 cation on autism to health professionals and the general

9 public, including information and education on advances

10 in the diagnosis and treatment of autism and training and

11 continuing education through programs for scientists, phy12 sicians, and other health professionals who provide care

13 for patients with autism.

14 (b) STIPENDS.—The Secretary may use amounts

15 made available under this section to provide stipends for

16 health professionals who are enrolled in training programs

17 under this section.

18 (c) AUTHORIZATION OF APPROPRIATIONS.—To carry

19 out this section, there is authorized to be appropriated

20 $6,000,000 for each of the fiscal years 2000 through

21 2004.

22 SEC. 6. INTER-AGENCY AUTISM COORDINATING COMMIT23 TEE.

24 (a) ESTABLISHMENT.—The Secretary shall establish

25 a committee to be known as the ‘‘Autism Coordinating
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1 Committee’’ (in this section referred to as the ‘‘Commit2 tee’’) to coordinate all efforts within the Department of

3 Health and Human Services concerning autism, including

4 activities carried out through the National Institutes of

5 Health and the Centers for Disease Control and Preven6 tion under this Act (and the amendment made by this

7 Act).

8 (b) MEMBERSHIP.—

9 (1) IN GENERAL.—The Committee shall be

10 composed of the Directors of such national research

11 institutes, of the Centers for Disease Control and

12 Prevention, and of such other agencies and such

13 other officials as the Secretary determines appro14 priate.

15 (2) ADDITIONAL MEMBERS.—If determined ap16 propriate by the Secretary, the Secretary may ap17 point to the Committee—

18 (A) parents or legal guardians of individ19 uals with autism or other pervasive develop20 mental disorders; and

21 (B) representatives of other governmental

22 agencies that serve children with autism such

23 as the Department of Education.
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1 (c) ADMINISTRATIVE SUPPORT; TERMS OF SERVICE;

2 OTHER PROVISIONS.—The following shall apply with re3 spect to the Committee:

4 (1) The Committee shall receive necessary and

5 appropriate administrative support from the Depart6 ment of Health and Human Services.

7 (2) Members of the Committee appointed under

8 subsection (b)(2)(A) shall serve for a term of 3

9 years, and may serve for an unlimited number of

10 terms if reappointed.

11 (3) The Committee shall meet not less than 2

12 times per year.

13 (4) Members of the Committee shall not receive

14 additional compensation for their service. Such

15 members may receive reimbursement for appropriate

16 and additional expenses that are incurred through

17 service on the Committee which would not have in18 curred had they not been a member of the Commit19 tee.

20 SEC. 7. REPORT TO CONGRESS.

21 Not later than January 1, 2000, and each January

22 1 thereafter, the Secretary shall prepare and submit to

23 the appropriate committees of Congress, a report concern-
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1 ing the implementation of this Act and the amendments

2 made by this Act.

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