TITLE 42 - US CODE - SUBCHAPTER IX - GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT DEATH SYNDROME

Part A - Genetic Diseases

42 USC 300b - Repealed. Pub. L. 9735, title XXI, 2193(b)(1), Aug. 13, 1981, 95 Stat. 827

Section, act July 1, 1944, ch. 373, title XI, 1101, as added Apr. 22, 1976, Pub. L. 94–278, title IV, § 403(a), 90 Stat. 407; amended Nov. 10, 1978, Pub. L. 95–626, title II, § 205(b), (d)(2), (e), 92 Stat. 3583, 3584; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; Aug. 13, 1981, Pub. L. 97–35, title XXI, § 2193(a)(1)(B), 95 Stat. 826; Jan. 4, 1983, Pub. L. 97–414, § 8(o), 96 Stat. 2061, related to testing, counseling, information and education programs. A prior section 300b, act July 1, 1944, ch. 373, title XI, 1101, as added May 16, 1972, Pub. L. 92–294, § 3(c), 86 Stat. 137; amended Aug. 29, 1972, Pub. L. 92–414, § 4(2), 86 Stat. 652, authorized Secretary to make grants and enter contracts with public and nonprofit">nonprofit private entities with respect to establishment of voluntary sickle cell anemia screening and counseling programs and to develop and disseminate informational and educational materials relating to sickle cell anemia, prior to repeal by Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90 Stat. 407.

42 USC 300b1 - Research project grants and contracts

In carrying out section 241 of this title, the Secretary may make grants to public and nonprofit">nonprofit private entities, and may enter into contracts with public and private entities and individuals, for projects for

(1) basic or applied research leading to the understanding, diagnosis, treatment, and control of genetic diseases,

(2) planning, establishing, demonstrating, and developing special programs for the training of genetic counselors, social and behavioral scientists, and other health professionals,

(3) the development of programs to educate practicing physicians, other health professionals, and the public regarding the nature of genetic processes, the inheritance patterns of genetic diseases, and the means, methods, and facilities available to diagnose, control, counsel, and treat genetic diseases, and

(4) the development of counseling and testing programs and other programs for the diagnosis, control, and treatment of genetic diseases. In making grants and entering into contracts for projects described in clause (1) of the preceding sentence, the Secretary shall give priority to applications for such grants or contracts which are submitted for research on sickle cell anemia and for research on Cooleys anemia.

42 USC 300b2 - Voluntary participation by individuals

The participation by any individual in any program or portion thereof under this part shall be wholly voluntary and shall not be a prerequisite to eligibility for or receipt of any other service or assistance from, or to participation in, any other program.

42 USC 300b3 - Application; special consideration to prior sickle cell anemia grant recipients

(a) Manner of submission; contents
A grant or contract under this part may be made upon application submitted to the Secretary at such time, in such manner, and containing and accompanied by such information, as the Secretary may require, including assurances for an evaluation whether performed by the applicant or by the Secretary. Such grant or contract may be made available on less than a statewide or regional basis. Each applicant shall

(1) provide that the programs and activities for which assistance under this part is sought will be administered by or under the supervision of the applicant;

(2) provide for strict confidentiality of all test results, medical records, and other information regarding testing, diagnosis, counseling, or treatment of any person treated, except for

(A) such information as the patient (or his guardian) gives informed consent to be released, or

(B) statistical data compiled without reference to the identity of any such patient;

(3) provide for community representation where appropriate in the development and operation of voluntary genetic testing or counseling programs funded by a grant or contract under this part; and

(4) establish fiscal control and fund accounting procedures as may be necessary to assure proper disbursement of and accounting of Federal funds paid to the applicant under this part.

(b) Considerations for grants and contracts under section 300b–1 of this title
In making grants and entering into contracts for any fiscal year under section 241 of this title for projects described in section 300b–1 of this title the Secretary shall give special consideration to applications from entities that received grants from, or entered into contracts with, the Secretary for the preceding fiscal year for the conduct of comprehensive sickle cell centers or sickle cell screening and education clinics.

42 USC 300b4 - Public Health Service facilities

The Secretary shall establish a program within the Service to provide voluntary testing, diagnosis, counseling, and treatment of individuals respecting genetic diseases. Services under such program shall be made available through facilities of the Service to persons requesting such services, and the program shall provide appropriate publicity of the availability and voluntary nature of such services.

42 USC 300b5 - Repealed. Pub. L. 9735, title XXI, 2193(b)(4), Aug. 13, 1981, 95 Stat. 827

Section, act July 1, 1944, ch. 373, title XI, 1106, as added Apr. 22, 1976, Pub. L. 94–278, title IV, § 403(a), 90 Stat. 409, related to an annual report to President and Congress on administration of this part. A prior section 300b–5, act July 1, 1944, ch. 373, title XI, 1106, as added May 16, 1972, Pub. L. 92–294, § 3(c), 86 Stat. 139; amended Aug. 29, 1972, Pub. L. 92–414, § 4(3), 86 Stat. 652, related to an annual report to President and Congress on administration of this part, prior to repeal by Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90 Stat. 407.

42 USC 300b6 - Applied technology

The Secretary, acting through an identifiable administrative unit, shall

(1) conduct epidemiological assessments and surveillance of genetic diseases to define the scope and extent of such diseases and the need for programs for the diagnosis, treatment, and control of such diseases, screening for such diseases, and the counseling of persons with such diseases;

(2) on the basis of the assessments and surveillance described in paragraph (1), develop for use by the States programs which combine in an effective manner diagnosis, treatment, and control of such diseases, screening for such diseases, and counseling of persons with such diseases; and

(3) on the basis of the assessments and surveillance described in paragraph (1), provide technical assistance to States to implement the programs developed under paragraph (2) and train appropriate personnel for such programs.

In carrying out this section, the Secretary may, from funds allotted for use under section 702 (a) of this title, make grants to or contracts with public or nonprofit">nonprofit private entities (including grants and contracts for demonstration projects).

42 USC 300b7 - Tourette Syndrome

(a) In general
The Secretary shall develop and implement outreach programs to educate the public, health care providers, educators and community based organizations about the etiology, symptoms, diagnosis and treatment of Tourette Syndrome, with a particular emphasis on children with Tourette Syndrome. Such programs may be carried out by the Secretary directly and through awards of grants or contracts to public or nonprofit">nonprofit private entities.

(b) Certain activities
Activities under subsection (a) of this section shall include

(1) the production and translation of educational materials, including public service announcements;

(2) the development of training material for health care providers, educators and community based organizations; and

(3) outreach efforts directed at the misdiagnosis and underdiagnosis of Tourette Syndrome in children and in minority groups.

(c) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.

42 USC 300b8 - Improved newborn and child screening for heritable disorders

(a) In general
The Secretary shall award grants to eligible entities to enhance, improve or expand the ability of State and local public health agencies to provide screening, counseling or health care services to newborns and children having or at risk for heritable disorders.

(b) Use of funds
Amounts provided under a grant awarded under subsection (a) of this section shall be used to

(1) establish, expand, or improve systems or programs to provide screening, counseling, testing or specialty services for newborns and children at risk for heritable disorders;

(2) establish, expand, or improve programs or services to reduce mortality or morbidity from heritable disorders;

(3) establish, expand, or improve systems or programs to provide information and counseling on available therapies for newborns and children with heritable disorders;

(4) improve the access of medically underserved populations to screening, counseling, testing and specialty services for newborns and children having or at risk for heritable disorders; or

(5) conduct such other activities as may be necessary to enable newborns and children having or at risk for heritable disorders to receive screening, counseling, testing or specialty services, regardless of income, race, color, religion, sex, national origin, age, or disability.

(1) be a State or political subdivision of a State, or a consortium of two or more States or political subdivisions of States; and

(2) prepare and submit to the Secretary an application that includes

(A) a plan to use amounts awarded under the grant to meet specific health status goals and objectives relative to heritable disorders, including attention to needs of medically underserved populations;

(B) a plan for the collection of outcome data or other methods of evaluating the degree to which amounts awarded under this grant will be used to achieve the goals and objectives identified under subparagraph (A);

(D) an assurance that amounts awarded under the grant will be used only to implement the approved plan for the State;

(E) an assurance that the provision of services under the plan is coordinated with services provided under programs implemented in the State under title V, XVIII, XIX, XX, or XXI of the Social Security Act [42 U.S.C. 701 et seq., 1395 et seq., 1396 et seq. 1397 et seq., 1397aa et seq.] (subject to Federal regulations applicable to such programs) so that the coverage of services under such titles is not substantially diminished by the use of granted funds; and

(F) such other information determined by the Secretary to be necessary.

(d) Limitation
An eligible entity may not use amounts received under this section to

(1) provide cash payments to or on behalf of affected individuals;

(2) provide inpatient services;

(3) purchase land or make capital improvements to property; or

(4) provide for proprietary research or training.

(e) Voluntary participation
The participation by any individual in any program or portion thereof established or operated with funds received under this section shall be wholly voluntary and shall not be a prerequisite to eligibility for or receipt of any other service or assistance from, or to participation in, another Federal or State program.

(f) Supplement not supplant
Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities of the type described in this section.

(g) Publication

(1) In general
An application submitted under subsection (c)(2) of this section shall be made public by the State in such a manner as to facilitate comment from any person, including through hearings and other methods used to facilitate comments from the public.

(2) Comments
Comments received by the State after the publication described in paragraph (1) shall be addressed in the application submitted under subsection (c)(2) of this section.

(h) Technical assistance
The Secretary shall provide to entities receiving grants under subsection (a) of this section such technical assistance as may be necessary to ensure the quality of programs conducted under this section.

(i) Authorization of appropriations
There are authorized to be appropriated to carry out this section such sums as may be necessary for each of the fiscal years 2001 through 2005.

42 USC 300b9 - Evaluating the effectiveness of newborn and child screening programs

(a) In general
The Secretary shall award grants to eligible entities to provide for the conduct of demonstration programs to evaluate the effectiveness of screening, counseling or health care services in reducing the morbidity and mortality caused by heritable disorders in newborns and children.

(b) Demonstration programs
A demonstration program conducted under a grant under this section shall be designed to evaluate and assess, within the jurisdiction of the entity receiving such grant

(1) the effectiveness of screening, counseling, testing or specialty services for newborns and children at risk for heritable disorders in reducing the morbidity and mortality associated with such disorders;

(2) the effectiveness of screening, counseling, testing or specialty services in accurately and reliably diagnosing heritable disorders in newborns and children; or

(3) the availability of screening, counseling, testing or specialty services for newborns and children at risk for heritable disorders.

(c) Eligible entities
To be eligible to receive a grant under subsection (a) of this section an entity shall be a State or political subdivision of a State, or a consortium of two or more States or political subdivisions of States.

42 USC 300b10 - Advisory Committee on Heritable Disorders in Newborns and Children

(a) Establishment
The Secretary shall establish an advisory committee to be known as the Advisory Committee on Heritable Disorders in Newborns and Children (referred to in this section as the Advisory Committee).

(b) Duties
The Advisory Committee shall

(1) provide advice and recommendations to the Secretary concerning grants and projects awarded or funded under section 300b–8 of this title;

(2) provide technical information to the Secretary for the development of policies and priorities for the administration of grants under section 300b–8 of this title; and

(3) provide such recommendations, advice or information as may be necessary to enhance, expand or improve the ability of the Secretary to reduce the mortality or morbidity from heritable disorders.

(1) In general
The Secretary shall appoint not to exceed 15 members to the Advisory Committee. In appointing such members, the Secretary shall ensure that the total membership of the Advisory Committee is an odd number.

(2) Required members
The Secretary shall appoint to the Advisory Committee under paragraph (1)

(A) the Administrator of the Health Resources and Services Administration;

(B) the Director of the Centers for Disease Control and Prevention;

(D) the Director of the Agency for Healthcare Research and Quality;

(E) medical, technical, or scientific professionals with special expertise in heritable disorders, or in providing screening, counseling, testing or specialty services for newborns and children at risk for heritable disorders;

(F) members of the public having special expertise about or concern with heritable disorders; and

(G) representatives from such Federal agencies, public health constituencies, and medical professional societies as determined to be necessary by the Secretary, to fulfill the duties of the Advisory Committee, as established under subsection (b) of this section.

Part B - Sudden Infant Death Syndrome

42 USC 300c11 - Repealed. Pub. L. 9735, title XXI, 2193(b)(1), Aug. 13, 1981, 95 Stat. 827

Section, act July 1, 1944, ch. 373, title XI, 1121, as added Apr. 22, 1974, Pub. L. 93–270, § 3(a), 88 Stat. 91; amended Apr. 22, 1976, Pub. L. 94–278, title IV, § 403(b)(1), 90 Stat. 409; S. Res. 4, Feb. 4, 1977; Aug. 1, 1977, Pub. L. 95–83, title III, § 306(a), 91 Stat. 389; Dec. 19, 1977, Pub. L. 95–215, § 8(a), 91 Stat. 1507; Nov. 8, 1978, Pub. L. 95–613, § 2, 92 Stat. 3094; Dec. 12, 1979, Pub. L. 96–142, title II, § 202, 93 Stat. 1070; H. Res. 549, Mar. 25, 1980; Aug. 13, 1981, Pub. L. 97–35, title XXI, § 2193(a)(1)(C), 95 Stat. 827, related to sudden infant death syndrome counseling, information, educational, and statistical programs.

42 USC 300c12 - Sudden infant death syndrome research

From the sums appropriated to the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the Secretary shall assure that there are applied to research of the type described in subparagraphs (A) and (B) of subsection (b)(1)1 of this section such amounts each year as will be adequate, given the leads and findings then available from such research, in order to make maximum feasible progress toward identification of infants at risk of sudden infant death syndrome and prevention of sudden infant death syndrome.

[1] See References in Text note below.

Part C - Hemophilia Programs

42 USC 300c21 - Repealed. Pub. L. 9735, title XXI, 2193(b)(1), Aug. 13, 1981, 95 Stat. 827

Section, act July 1, 1944, ch. 373, title XI, 1131, as added July 29, 1975, Pub. L. 94–63, title VI, § 606, 89 Stat. 350; amended Aug. 1, 1977, Pub. L. 95–83, title III, § 306(b), 91 Stat. 389; Nov. 10, 1978, Pub. L. 95–626, title II, § 206(a), 92 Stat. 3584; Aug. 13, 1981, Pub. L. 97–35, title XXI, § 2193(a)(1)(D), 95 Stat. 827, related to comprehensive hemophilia diagnostic and treatment centers.

42 USC 300c22 - Blood-separation centers

(a) Grants and contracts with public and nonprofit">nonprofit private entities for projects to develop and expand existing facilities; definitions
The Secretary may make grants to and enter into contracts with public and nonprofit">nonprofit private entities for projects to develop and expand, within existing facilities, blood-separation centers to separate and make available for distribution blood components to providers of blood services and manufacturers of blood fractions. For purposes of this section

(1) the term blood components means those constituents of whole blood which are used for therapy and which are obtained by physical separation processes which result in licensed products such as red blood cells, platelets, white blood cells, AHF-rich plasma, fresh-frozen plasma, cryoprecipitate, and single unit plasma for infusion; and

(2) the term blood fractions means those constituents of plasma which are used for therapy and which are obtained by licensed fractionation processes presently used in manufacturing which result in licensed products such as normal serum albumin, plasma, protein fraction, prothrombin complex, fibrinogen, AHF concentrate, immune serum globulin, and hyperimmune globulins.

(b) Grants for alleviation of insufficient supplies of blood fractions
In the event the Secretary finds that there is an insufficient supply of blood fractions available to meet the needs for treatment of persons suffering from hemophilia, and that public and other nonprofit">nonprofit private centers already engaged in the production of blood fractions could alleviate such insufficiency with assistance under this subsection, he may make grants not to exceed $500,000 to such centers for the purposes of alleviating the insufficiency.

(c) Approval of application as prerequisite for grant or contract; form, manner of submission, and contents of application
No grant or contract may be made under subsection (a) or (b) of this section unless an application therefor has been submitted to and approved by the Secretary. Such an application shall be in such form, submitted in such manner, and contain such information as the Secretary shall by regulation prescribe.

(d) Nonapplicability of statutory provisions to contracts
Contracts may be entered into under subsection (a) of this section without regard to section 3324 (a) and (b) of title 31 and section 5 of title 41.

(e) Authorization of appropriations
For the purpose of making payments under grants and contracts under subsections (a) and (b) of this section, there are authorized to be appropriated $4,000,000 for fiscal year 1976, $5,000,000 for the fiscal year ending September 30, 1977, $3,450,000 for the fiscal year ending September 30, 1978, $2,500,000 for the fiscal year ending September 30, 1979, $3,000,000 for the fiscal year ending September 30, 1980, and $3,500,000 for the fiscal year ending September 30, 1981.