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42 U.S.C. § 284gExpansion, intensification, and coordination of activities of National Institutes of Health with respect to research on autism spectrum disorder

submitted 82 years ago by Pub. L. 106-310 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 1,025 words · no verdicts yet

in plain englishAI-generated · not legal advice

The NIH Director must expand, coordinate, and broaden research into autism spectrum disorder, covering causes, detection, treatment, and caregiver support. The Director must fund at least seven "centers of excellence" for up to five years each, doing basic and clinical research. The Director must also run a tissue-donation program for research and a way for the public to give input, and must submit a yearly budget estimate through fiscal year 2029.

(a) In general. (1) The Director of NIH, working with relevant federal agencies as needed, must — as money is appropriated — expand, intensify, and coordinate NIH's research on autism spectrum disorder, in fields like pathology, genetics, neurobiology, and psychiatry, and on interventions that improve outcomes. (2) That research must investigate causes (including possible environmental ones), diagnosis, early detection, prevention, treatment, and support across a person's whole life, including for co-occurring conditions; it must also look at support for caregivers, and reflect the full range of people with autism spectrum disorder, including their safety and well-being needs. The Director may combine program activities where that improves efficiency, and must carry out this section through the Director of the National Institute of Mental Health, working with other agencies as appropriate. (b) Centers of excellence. (1) The Director must award grants and contracts to public or nonprofit entities to plan, set up, improve, and operate centers of excellence for autism spectrum disorder research. (2) Each center must do basic and clinical research into causes, diagnosis, detection, prevention, and treatment across the lifespan, in fields like developmental neurobiology, genetics, genomics, and psychology. (3) A center may run a program telling people about opportunities to join research studies, and — under criteria the Director sets — provide referrals to services and cover required patient-care costs. The Director will weigh whether a center can show real access to clinical services, including for people from diverse racial, ethnic, geographic, or language backgrounds, when deciding on grants. (4) Each center must use one institution or a group of cooperating institutions meeting the Director's rules. (5) The Director must set up at least seven centers, each supported for up to 5 years, extendable in additional 5-year blocks if a scientific peer-review group recommends it. (c) Facilitation of research. The Director must run a program that collects, preserves, and makes available tissue and genetic material samples useful for autism spectrum disorder research, following accepted scientific and medical standards for handling such samples. (d) Public input. (1) The Director must give the public a way to learn about NIH's autism spectrum disorder programs and to send comments about them. (2) The Director may guide centers on how to engage people with autism spectrum disorder and their families, guardians, and advocates in the centers' work. (e) Budget estimate. For each fiscal year from 2026 through 2029, the Director must send a yearly budget estimate for NIH's autism spectrum disorder initiatives directly to the President, to be passed on to Congress — based on the strategic plan under section 280i–2(b)(5) and its later updates, after the Secretary and the Interagency Autism Coordinating Committee get a chance to comment (though their comments can't change the estimate).
the actual law source: uscode.house.gov ↗public domain
(a) In general
(1) Expansion of activities

The Director of NIH (in this section referred to as the “Director”), in consultation with relevant Federal departments and agencies, as appropriate, shall—

(A)

subject to the availability of appropriations, expand, intensify, and coordinate the activities of the National Institutes of Health with respect to research on autism spectrum disorder, including basic and clinical research

(i)

in fields, such as pathology, developmental neurobiology, genetics, epigenetics, pharmacology, nutrition, immunology, neuroimmunology, neurobehavioral development, endocrinology, gastroenterology, toxicology, psychiatry, psychology, developmental behavioral pediatrics, audiology, and gerontology; and

(ii)

on interventions to maximize outcomes for individuals with autism spectrum disorder; and

(B)

ensure that research referred to in subparagraph (A)—

(i)

investigates the causes (including possible environmental causes), diagnosis or ruling out, early and ongoing detection, prevention, services and supports across the lifespan, intervention, and treatment of autism spectrum disorder and co-occurring conditions, including dissemination and implementation of clinical care, supports, interventions, and treatments;

(ii)

examines supports for caregivers; and

(iii)

reflects the entire population of individuals with autism spectrum disorder, including those individuals with co-occurring conditions and the full range of needs for supports and services, including such supports and services to ensure the safety, and promote the well-being, of such individuals.

(2) Consolidation

The Director may consolidate program activities under this section if such consolidation would improve program efficiencies and outcomes.

(3) Administration of program; collaboration among agencies

The Director shall carry out this section acting through the Director of the National Institute of Mental Health and in collaboration with any other agencies that the Director determines appropriate.

(b) Centers of excellence
(1) In general

The Director shall under subsection (a)(1) make awards of grants and contracts to public or nonprofit private entities to pay all or part of the cost of planning, establishing, improving, and providing basic operating support for centers of excellence regarding research on autism spectrum disorder.

(2) Research

Each center under paragraph (1) shall conduct basic and clinical research into autism spectrum disorder. Such research should include investigations into the causes, diagnosis, early and ongoing detection, prevention, and treatment of autism spectrum disorder across the lifespan. The centers, as a group, shall conduct research in fields such as developmental neurobiology, genetics, genomics, psychopharmacology, developmental psychology, behavioral psychology, clinical psychology, and gerontology.

(3) Services for patients
(A) In general

A center under paragraph (1) may expend amounts provided under such paragraph to carry out a program to make individuals aware of opportunities to participate as subjects in research conducted by the centers.

(B) Referrals and costs

A program under subparagraph (A) may, in accordance with such criteria as the Director may establish, provide to the subjects described in such subparagraph, referrals for health and other services, and such patient care costs as are required for research.

(C) Availability and access

The extent to which a center can demonstrate availability and access to clinical services shall be considered by the Director in decisions about awarding grants to applicants which meet the scientific criteria for funding under this section.

(D) Reducing disparities

The Director may consider, as appropriate, the extent to which a center can demonstrate availability and access to clinical services for youth and adults from diverse racial, ethnic, geographic, or linguistic backgrounds in decisions about awarding grants to applicants which meet the scientific criteria for funding under this section.

(4) Organization of centers

Each center under paragraph (1) shall use the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be prescribed by the Director.

(5) Number of centers; duration of support
(A) In general

The Director shall provide for the establishment of not less than seven centers under paragraph (1).

(B) Duration

Support for a center established under paragraph (1) may be provided under this section for a period not to exceed 5 years. Such period may be extended for one or more additional periods not exceeding 5 years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.

(c) Facilitation of research

The Director shall under subsection (a)(1) provide for a program under which samples of tissues and genetic materials that are of use in research on autism spectrum disorder are donated, collected, preserved, and made available for such research. The program shall be carried out in accordance with accepted scientific and medical standards for the donation, collection, and preservation of such samples.

(d) Public input
(1) In general

The Director shall under subsection (a)(1) provide for means through which the public can obtain information on the existing and planned programs and activities of the National Institutes of Health with respect to autism spectrum disorder and through which the Director can receive comments from the public regarding such programs and activities.

(2) Guidance

The Director may provide guidance to centers under subsection (b)(1) on strategies, activities, and opportunities to promote engagement with, and solicit input from, individuals with autism spectrum disorder and their family members, guardians, advocates or authorized representatives, providers, or other appropriate individuals to inform the activities of the center. Such strategies, activities, and opportunities should consider including, as appropriate, individuals, family members, and caregivers of individuals with autism spectrum disorder who represent the entire population of individuals with autism spectrum disorder, including those individuals with co-occurring conditions and the full range of needs for supports and services, including such supports and services to ensure the safety, and promote the well-being, of such individuals, to inform the activities of the center.

(e) Budget estimate

For each of fiscal years 2026 through 2029, the Director shall prepare and submit, directly to the President for review and transmittal to Congress, an annual budget estimate for the initiatives of the National Institutes of Health pursuant to the strategic plan developed under section 280i–2(b)(5) of this title and updated under section 280i–2(b)(6)(B) of this title, after reasonable opportunity for comment (but without change) by the Secretary and the Interagency Autism Coordinating Committee established under section 280i–2 of this title.

Source credit: (July 1, 1944, ch. 373, title IV, § 409C, as added Pub. L. 106–310, div. A, title I, § 101, Oct. 17, 2000, 114 Stat. 1105; amended Pub. L. 109–416, §§ 2(a), 4(b), Dec. 19, 2006, 120 Stat. 2821, 2830; Pub. L. 109–482, title I, §§ 103(b)(9), 104(b)(1)(D), Jan. 15, 2007, 120 Stat. 3687, 3693; Pub. L. 116–60, § 2, Sept. 30, 2019, 133 Stat. 1110; Pub. L. 118–180, § 2, Dec. 23, 2024, 138 Stat. 2614.)

history & why it existsrecord from the source credit
  • 1944Enacted · Pub. L. 106-310 · 114 Stat. 1105
  • 2006Amended · Pub. L. 109-416 · 120 Stat. 2821, 2830
  • 2007Amended · Pub. L. 109-482 · 120 Stat. 3687, 3693
  • 2019Amended · Pub. L. 116-60 · 133 Stat. 1110
  • 2024Amended · Pub. L. 118-180 · 138 Stat. 2614

A history note hasn’t been published yet. The record shows enactment by Pub. L. 106-310 on 1944-07-01.

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