1. U.S. Code
  2. title 42
  3. chapter 6A
  4. subchapter IX
  5. part A
  6. § 300b-2

Collapse to view only § 300b-2. Voluntary participation by individuals

§ 300b. Repealed. Pub. L. 97–35, title XXI, § 2193(b)(1), Aug. 13, 1981, 95 Stat. 827

CITE AS: 42 USC 300b

§ 300b–1. Research project grants and contracts

In carrying out section 241 of this title, the Secretary may make grants to public and 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 Cooley’s anemia.

(July 1, 1944, ch. 373, title XI, § 1102, as added Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90 Stat. 408.)

CITE AS: 42 USC 300b-1

§ 300b–2. 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.

(July 1, 1944, ch. 373, title XI, § 1103, as added Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90 Stat. 408.)

CITE AS: 42 USC 300b-2

§ 300b–3. 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
(July 1, 1944, ch. 373, title XI, § 1104, as added Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90 Stat. 408; amended Pub. L. 95–626, title II, § 205(c), Nov. 10, 1978, 92 Stat. 3584; Pub. L. 97–35, title XXI, § 2193(b)(2), (3), Aug. 13, 1981, 95 Stat. 827.)

CITE AS: 42 USC 300b-3

§ 300b–4. 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.

(July 1, 1944, ch. 373, title XI, § 1105, as added Pub. L. 94–278, title IV, § 403(a), Apr. 22, 1976, 90 Stat. 409.)

CITE AS: 42 USC 300b-4

§ 300b–5. Sickle cell disease and other heritable blood disorders research, surveillance, prevention, and treatment
(a) Grants
(1) In generalThe Secretary may award grants related to heritable blood disorders, including sickle cell disease, for one or more of the following purposes:
(A) To collect and maintain data on such diseases and conditions, including subtypes as applicable, and their associated health outcomes and complications, including for the purpose of—
(i) improving national incidence and prevalence data;
(ii) identifying health disparities, including the geographic distribution, related to such diseases and conditions;
(iii) assessing the utilization of therapies and strategies to prevent complications; and
(iv) evaluating the effects of genetic, environmental, behavioral, and other risk factors that may affect such individuals.
(B) To conduct public health activities with respect to such conditions, which may include—
(i) developing strategies to improve health outcomes and access to quality health care for the screening for, and treatment and management of, such diseases and conditions, including through public-private partnerships;
(ii) providing support to community-based organizations and State and local health departments in conducting education and training activities for patients, communities, and health care providers concerning such diseases and conditions;
(iii) supporting State health departments and regional laboratories, including through training, in testing to identify such diseases and conditions, including specific forms of sickle cell disease, in individuals of all ages; and
(iv) the identification and evaluation of best practices for treatment of such diseases and conditions, and prevention and management of their related complications.
(2) Population included
(3) Application
(4) Priority
(5) Eligible entity
(b) Demonstration program for the development and establishment of systemic mechanisms for the prevention and treatment of sickle cell disease
(1) Authority to conduct demonstration program
(A) In generalThe Administrator, through the Bureau of Primary Health Care and the Maternal and Child Health Bureau, shall continue efforts, including by awarding grants, to develop or establish mechanisms to improve the treatment of sickle cell disease, and to improve the prevention and treatment of complications of sickle cell disease, in populations with a high proportion of individuals with sickle cell disease, including through—
(i) the coordination of service delivery for individuals with sickle cell disease;
(ii) genetic counseling and testing;
(iii) bundling of technical services related to the prevention and treatment of sickle cell disease;
(iv) training of health professionals; and
(v) identifying and establishing other efforts related to the expansion and coordination of education, treatment, and continuity of care programs for individuals with sickle cell disease.
(B) Geographic diversity
(2) Additional requirementsAn eligible entity awarded a grant under this subsection shall use funds made available under the grant to carry out, in addition to the activities described in paragraph (1)(A), the following activities:
(A) To facilitate and coordinate the delivery of education, treatment, and continuity of care for individuals with sickle cell disease under—
(i) the entity’s collaborative agreement with a community-based sickle cell disease organization or a nonprofit entity that works with individuals who have sickle cell disease;
(ii) the sickle cell disease newborn screening program for the State in which the entity is located; and
(iii) the maternal and child health program under title V of the Social Security Act (42 U.S.C. 701 et seq.) for the State in which the entity is located.
(B) To train nursing and other health staff who provide care for individuals with sickle cell disease.
(C) To enter into a partnership with adult or pediatric hematologists in the region and other regional experts in sickle cell disease at tertiary and academic health centers and State and county health offices.
(D) To identify and secure resources for ensuring reimbursement under the medicaid program, State children’s health insurance program, and other health programs for the prevention and treatment of sickle cell disease.
(E) To provide or coordinate services for adolescents with sickle cell disease making the transition to adult health care.
(3) National coordinating center
(A) Establishment
(B) Activities describedThe National Coordinating Center shall—
(i) collect, coordinate, monitor, and distribute data, best practices, and findings regarding the activities funded under grants made to eligible entities under the demonstration program;
(ii) develop a model protocol for eligible entities with respect to the prevention and treatment of sickle cell disease;
(iii) develop educational materials regarding the prevention and treatment of sickle cell disease; and
(iv) prepare and submit to Congress a final report that includes recommendations regarding the effectiveness of the demonstration program conducted under this subsection and such direct outcome measures as—(I) the number and type of health care resources utilized (such as emergency room visits, hospital visits, length of stay, and physician visits for individuals with sickle cell disease); and(II) the number of individuals that were tested and subsequently received genetic counseling for the sickle cell trait.
(4) Application
(5) DefinitionsIn this subsection:
(A) Administrator
(B) Eligible entityThe term “eligible entity” means a Federally-qualified health center, a nonprofit hospital or clinic, or a university health center that provides primary health care, that—
(i) has a collaborative agreement with a community-based sickle cell disease organization or a nonprofit entity with experience in working with individuals who have sickle cell disease; and
(ii) demonstrates to the Administrator that either the Federally-qualified health center, the nonprofit hospital or clinic, the university health center, the organization or entity described in clause (i), or the experts described in paragraph (2)(C), has at least 5 years of experience in working with individuals who have sickle cell disease.
(C) Federally-qualified health center
(6) Authorization of appropriations
(July 1, 1944, ch. 373, title XI, § 1106, as added and amended Pub. L. 115–327, §§ 2, 3, Dec. 18, 2018, 132 Stat. 4468, 4469.)

CITE AS: 42 USC 300b-5

§ 300b–6. 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 private entities (including grants and contracts for demonstration projects).
(July 1, 1944, ch. 373, title XI, § 1107, as added Pub. L. 95–626, title II, § 205(d)(1), Nov. 10, 1978, 92 Stat. 3584; amended Pub. L. 97–35, title XXI, § 2193(b)(5), Aug. 13, 1981, 95 Stat. 827.)

CITE AS: 42 USC 300b-6

§ 300b–7. Tourette Syndrome
(a) In general
(b) Certain activities
Activities under subsection (a) 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
(July 1, 1944, ch. 373, title XI, § 1108, as added Pub. L. 106–310, div. A, title XXIII, § 2301, Oct. 17, 2000, 114 Stat. 1157.)

CITE AS: 42 USC 300b-7

§ 300b–8. Improved newborn and child screening for heritable disorders
(a) Authorization of grant programFrom amounts appropriated under section 300b–16 of this title
(1) 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;
(2) to assist in providing health care professionals and newborn screening laboratory personnel with education in newborn screening, counseling, and training in—
(A) relevant and new technologies in newborn screening and congenital, genetic, and metabolic disorders;
(B) the importance of the timeliness of collection, delivery, receipt, and screening of specimens; and
(C) sharing of medical and diagnostic information with providers and families;
(3) to develop and deliver educational programs (at appropriate literacy levels) about newborn screening counseling, testing, follow-up, treatment, and specialty services to parents, families, and patient advocacy and support groups;
(4) to establish, maintain, and operate a system to assess and coordinate followup and treatment relating to congenital, genetic, and metabolic disorders; and
(5) to improve the timeliness of—
(A) the collection, delivery, receipt, and screening of specimens; and
(B) the diagnosis of heritable disorders in newborns.
(b) Eligible entityIn this section, the term “eligible entity” means—
(1) a State or a political subdivision of a State;
(2) a consortium of 2 or more States or political subdivisions of States;
(3) a territory;
(4) a health facility or program operated by or pursuant to a contract with or grant from the Indian Health Service; or
(5) any other entity with appropriate expertise in newborn screening, as determined by the Secretary.
(c) Approval factors
(d) Coordination
(e) LimitationAn 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.
(f) Voluntary participation
(g) Supplement not supplant
(h) Publication
(1) In general
(2) Comments
(i) Technical assistance
(July 1, 1944, ch. 373, title XI, § 1109, as added Pub. L. 106–310, div. A, title XXVI, § 2601, Oct. 17, 2000, 114 Stat. 1164; amended Pub. L. 110–204, § 2, Apr. 24, 2008, 122 Stat. 705; Pub. L. 110–237, § 1(a)(1), May 27, 2008, 122 Stat. 1556; Pub. L. 113–240, § 2, Dec. 18, 2014, 128 Stat. 2851.)

CITE AS: 42 USC 300b-8

§ 300b–9. Evaluating the effectiveness of newborn and child screening and followup programs
(a) In general
(b) Demonstration programsA 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, treatment, counseling, testing, followup, or specialty services for newborns and children at risk for heritable disorders in reducing the morbidity and mortality associated with such disorders, including, as appropriate, through the assessment of health and development outcomes for such children through adolescence;
(2) the effectiveness of screening, treatment, counseling, testing, followup, or specialty services in accurately and reliably diagnosing heritable disorders in newborns and children in a timely manner;
(3) the availability of screening, counseling, testing or specialty services for newborns and children at risk for heritable disorders;
(4) methods that may be identified to improve quality in the diagnosis, treatment, and disease management of heritable disorders based on gaps in services or care; or
(5) methods or best practices by which the eligible entities described in section 300b–8 of this title can achieve in a timely manner—
(A) collection, delivery, receipt, and screening of newborn screening specimens; and
(B) diagnosis of heritable disorders in newborns.
(c) Eligible entities
(July 1, 1944, ch. 373, title XI, § 1110, as added Pub. L. 106–310, div. A, title XXVI, § 2601, Oct. 17, 2000, 114 Stat. 1165; amended Pub. L. 110–204, § 3, Apr. 24, 2008, 122 Stat. 706; Pub. L. 110–237, § 1(a)(2), May 27, 2008, 122 Stat. 1556; Pub. L. 113–240, § 3, Dec. 18, 2014, 128 Stat. 2852.)

CITE AS: 42 USC 300b-9

§ 300b–10. Advisory Committee on Heritable Disorders in Newborns and Children
(a) Establishment
(b) DutiesThe 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;
(3) make systematic evidence-based and peer-reviewed recommendations that include the heritable disorders that have the potential to significantly impact public health for which all newborns should be screened, including secondary conditions that may be identified as a result of the laboratory methods used for screening;
(4) provide technical assistance, as appropriate, to individuals and organizations regarding the submission of nominations to the uniform screening panel, including prior to the submission of such nominations;
(5) take appropriate steps, at its discretion, to prepare for the review of nominations prior to their submission, including for conditions for which a screening method has been validated but other nomination criteria are not yet met, in order to facilitate timely action by the Advisory Committee once such submission has been received by the Committee;
(6) develop a model decision-matrix for newborn screening expansion, including an evaluation of the potential public health impact, including the cost of such expansion, and periodically update the recommended uniform screening panel, as appropriate, based on such decision-matrix;
(7) consider ways to ensure that all States attain the capacity to screen for the conditions described in paragraph (3), and include in such consideration the results of grant funding under section 300b–8 of this title; and
(8) 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, which may include recommendations, advice, or information dealing with—
(A) follow-up activities, including those necessary to achieve best practices in rapid diagnosis and appropriate treatment in the short-term, and those that ascertain long-term case management outcomes and appropriate access to related services;
(B) implementation, monitoring, and evaluation of newborn screening activities, including diagnosis, screening, follow-up, and treatment activities;
(C) diagnostic and other technology used in screening;
(D) the availability and reporting of testing for conditions for which there is no existing treatment, including information on cost and incidence;
(E) conditions not included in the recommended uniform screening panel that are treatable with Food and Drug Administration-approved products or other safe and effective treatments, as determined by scientific evidence and peer review;
(F) minimum standards and related policies and procedures used by State newborn screening programs, such as language and terminology used by State newborn screening programs to include standardization of case definitions and names of disorders for which newborn screening tests are performed;
(G) quality assurance, oversight, and evaluation of State newborn screening programs, including ensuring that tests and technologies used by each State meet established standards for detecting and reporting positive screening results;
(H) public and provider awareness and education;
(I) the cost and effectiveness of newborn screening and medical evaluation systems and intervention programs conducted by State-based programs;
(J) identification of the causes of, public health impacts of, and risk factors for heritable disorders;
(K) coordination of surveillance activities, including standardized data collection and reporting, harmonization of laboratory definitions for heritable disorders and testing results, and confirmatory testing and verification of positive results, in order to assess and enhance monitoring of newborn diseases; and
(L) the timeliness of collection, delivery, receipt, and screening of specimens to be tested for heritable disorders in newborns in order to ensure rapid diagnosis and followup.
(c) Membership
(1) In general
(2) Required membersThe 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;
(C) the Director of the National Institutes of Health;
(D) the Director of the Agency for Healthcare Research and Quality;
(E) the Commissioner of the Food and Drug Administration;
(F) 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;
(G) individuals with expertise in ethics and infectious diseases who have worked and published material in the area of newborn screening;
(H) members of the public having special expertise about or concern with heritable disorders; and
(I) 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).
(d) Decision on recommendations
(1) In general
(2) Determinations to be made public
(3) Deadline for review
(e) Annual reportNot later than 3 years after April 24, 2008, and each fiscal year thereafter, the Advisory Committee shall—
(1) publish a report on peer-reviewed newborn screening guidelines, including follow-up and treatment, in the United States;
(2) submit such report to the appropriate committees of Congress, the Secretary, the Interagency Coordinating Committee established under section 300b–13 of this title, and the State departments of health; and
(3) disseminate such report on as wide a basis as practicable, including through posting on the internet clearinghouse established under section 300b–11 of this title.
(f) Meetings
(g) Continuation of operation of Committee
(1) In general
(2) Continuation if not reauthorized
(July 1, 1944, ch. 373, title XI, § 1111, as added Pub. L. 106–310, div. A, title XXVI, § 2601, Oct. 17, 2000, 114 Stat. 1166; amended Pub. L. 110–204, § 4, Apr. 24, 2008, 122 Stat. 706; Pub. L. 110–237, § 1(a)(3), (b)(2), May 27, 2008, 122 Stat. 1556, 1557; Pub. L. 113–240, § 4, Dec. 18, 2014, 128 Stat. 2853; Pub. L. 117–286, § 4(a)(244), Dec. 27, 2022, 136 Stat. 4332.)

CITE AS: 42 USC 300b-10

§ 300b–11. Clearinghouse of newborn screening information
(a) In generalThe Secretary, acting through the Administrator of the Health Resources and Services Administration (referred to in this part as the “Administrator”), in consultation with the Director of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health, shall establish and maintain a central clearinghouse of current educational and family support and services information, materials, resources, research, and data on newborn screening to—
(1) enable parents and family members of newborns, health professionals, industry representatives, and other members of the public to increase their awareness, knowledge, and understanding of newborn screening;
(2) increase awareness, knowledge, and understanding of newborn diseases and screening services for expectant individuals and families;
(3) maintain current information on quality indicators to measure performance of newborn screening, such as false-positive rates and other quality indicators as determined by the Advisory Committee under section 300b–10 of this title;
(4) maintain current information on the number of conditions for which screening is conducted in each State; and
(5) disseminate available evidence-based guidelines related to diagnosis, counseling, and treatment with respect to conditions detected by newborn screening.
(b) Internet availabilityThe Secretary, acting through the Administrator, shall ensure that the clearinghouse described under subsection (a)—
(1) is available on the Internet;
(2) includes an interactive forum;
(3) is updated on a regular basis, but not less than quarterly; and
(4) provides—
(A) links to Government-sponsored, non-profit, and other Internet websites of laboratories that have demonstrated expertise in newborn screening that supply research-based information on newborn screening tests currently available throughout the United States;
(B) information about newborn conditions and screening services available in each State from laboratories certified under subpart 2 of part F of subchapter II, including information about supplemental screening that is available but not required, in the State where the infant is born;
(C) current research on both treatable and not-yet treatable conditions for which newborn screening tests are available;
(D) the availability of Federal funding for newborn and child screening for heritable disorders including grants authorized under the Newborn Screening Saves Lives Reauthorization Act of 2014; and
(E) other relevant information as determined appropriate by the Secretary.
(c) Nonduplication
(July 1, 1944, ch. 373, title XI, § 1112, as added Pub. L. 110–204, § 5, Apr. 24, 2008, 122 Stat. 708; amended Pub. L. 110–237, § 1(a)(4), May 27, 2008, 122 Stat. 1557; Pub. L. 113–240, § 5, Dec. 18, 2014, 128 Stat. 2854.)

CITE AS: 42 USC 300b-11

§ 300b–12. Laboratory quality and surveillance
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in Newborns and Children established under section 300b–10 of this title, shall provide for—
(1) quality assurance for laboratories involved in screening newborns and children for heritable disorders, including quality assurance for newborn-screening tests, timeliness for processing such tests, performance evaluation services, and technical assistance and technology transfer to newborn screening laboratories to ensure analytic validity and utility of screening tests; and
(2) appropriate quality control and other performance test materials to evaluate the performance of new screening tools.
(b) Surveillance activities
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in Newborns and Children established under section 300b–10 of this title, may provide, as appropriate, for the coordination of surveillance activities, including—
(1) through standardized data collection and reporting, as well as the use of electronic health records; and
(2) by promoting data sharing regarding newborn screening with State-based birth defects and developmental disabilities monitoring programs.
(July 1, 1944, ch. 373, title XI, § 1113, as added Pub. L. 110–204, § 6, Apr. 24, 2008, 122 Stat. 710; amended Pub. L. 110–237, § 1(a)(5), May 27, 2008, 122 Stat. 1557; Pub. L. 113–240, § 6, Dec. 18, 2014, 128 Stat. 2854.)

CITE AS: 42 USC 300b-12

§ 300b–13. Interagency Coordinating Committee on Newborn and Child Screening
(a) Purpose
It is the purpose of this section to—
(1) assess existing activities and infrastructure, including activities on birth defects and developmental disabilities authorized under section 247b–4 of this title, in order to make recommendations for programs to collect, analyze, and make available data on the heritable disorders recommended by the Advisory Committee on Heritable Disorders in Newborns and Children under section 300b–10 of this title, including data on the incidence and prevalence of, as well as poor health outcomes resulting from, such disorders; and
(2) make recommendations for the establishment of regional centers for the conduct of applied epidemiological research on effective interventions to promote the prevention of poor health outcomes resulting from such disorders as well as providing information and education to the public on such effective interventions.
(b) Establishment
(c) Composition
(d) Activities
The Interagency Coordinating Committee shall—
(1) report to the Secretary and the appropriate committees of Congress on its recommendations related to the purpose described in subsection (a); and
(2) carry out other activities determined appropriate by the Secretary.
(July 1, 1944, ch. 373, title XI, § 1114, as added Pub. L. 110–204, § 6, Apr. 24, 2008, 122 Stat. 710; amended Pub. L. 110–237, § 1(a)(6), May 27, 2008, 122 Stat. 1557; Pub. L. 113–240, § 7, Dec. 18, 2014, 128 Stat. 2855.)

CITE AS: 42 USC 300b-13

§ 300b–14. National contingency plan for newborn screening
(a) In general
(b) Contents
The contingency plan developed under subsection (a) shall include a plan for—
(1) the collection and transport of specimens;
(2) the shipment of specimens to State newborn screening laboratories;
(3) the processing of specimens;
(4) the reporting of screening results to physicians and families;
(5) the diagnostic confirmation of positive screening results;
(6) ensuring the availability of treatment and management resources;
(7) educating families about newborn screening; and
(8) carrying out other activities determined appropriate by the Secretary.
(July 1, 1944, ch. 373, title XI, § 1115, as added Pub. L. 110–204, § 7, Apr. 24, 2008, 122 Stat. 711; amended Pub. L. 113–240, § 8, Dec. 18, 2014, 128 Stat. 2855.)

CITE AS: 42 USC 300b-14

§ 300b–15. Hunter Kelly Research Program
(a) Newborn screening activities
(1) In general
The Secretary, in conjunction with the Director of the National Institutes of Health and taking into consideration the recommendations of the Advisory Committee, may continue carrying out, coordinating, and expanding research in newborn screening (to be known as “Hunter Kelly Newborn Screening Research Program”) including—
(A) identifying, developing, and testing the most promising new screening technologies, in order to improve already existing screening tests, increase the specificity of newborn screening, and expand the number of conditions for which screening tests are available;
(B) experimental treatments and disease management strategies for additional newborn conditions, and other genetic, metabolic, hormonal, or functional conditions that can be detected through newborn screening for which treatment is not yet available;
(C) providing research findings and data for newborn conditions under review by the Advisory Committee on Heritable Disorders in Newborns and Children to be added to the recommended uniform screening panel;
(D) conducting pilot studies on conditions recommended by the Advisory Committee on Heritable Disorders in Newborns and Children to ensure that screenings are ready for nationwide implementation; and
(E) other activities that would improve newborn screening, as identified by the Director.
(2) Additional newborn condition
(b) Funding
(c) Reports
(d) Nonduplication
(e) Peer review
(July 1, 1944, ch. 373, title XI, § 1116, as added Pub. L. 110–204, § 7, Apr. 24, 2008, 122 Stat. 711; amended Pub. L. 110–237, § 1(a)(7), May 27, 2008, 122 Stat. 1557; Pub. L. 113–240, § 9, Dec. 18, 2014, 128 Stat. 2855.)

CITE AS: 42 USC 300b-15

§ 300b–16. Authorization of appropriations for newborn screening programs and activities
There are authorized to be appropriated—
(1) to carry out sections 300b–8, 300b–9, 300b–10, and 300b–11 of this title, $11,900,000 for each of fiscal years 2015 through 2019; and
(2) to carry out section 300b–12 of this title, $8,000,000 for each of fiscal years 2015 through 2019.
(July 1, 1944, ch. 373, title XI, § 1117, as added Pub. L. 113–240, § 10, Dec. 18, 2014, 128 Stat. 2856.)

CITE AS: 42 USC 300b-16

§ 300b–17. Report by Secretary
(1) In generalThe Secretary of Health and Human Services shall—
(A) not later than 1 year after December 18, 2014, submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on activities related to—
(i) newborn screening; and
(ii) screening children who have or are at risk for heritable disorders; and
(B) not less than every 2 years, submit to such committees an updated version of such report.
(2) ContentsThe report submitted under this section shall contain a description of—
(A) the ongoing activities under sections 300b–8, 300b–9, and 300b–11 through 300b–14 of this title; and
(B) the amounts expended on such activities.
(Pub. L. 113–240, § 11(b), Dec. 18, 2014, 128 Stat. 2856.)

CITE AS: 42 USC 300b-17