§ 300b–8 — Improved Newborn And Child Screening For Heritable Disorders

(a) From amounts appropriated under section 300b–16 of this title, the Secretary, acting through the Administrator of the Health Resources and Services Administration (referred to in this section as the “Administrator”) and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in Newborns and Children (referred to in this section as the “Advisory Committee”), shall award grants to eligible entities to enable such entities— (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) In 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) An application for a grant under this section shall not be approved by the Secretary unless the application contains assurances that the eligible entity has adopted and implemented, is in the process of adopting and implementing, or will use amounts received under such grant to adopt and implement the guidelines and recommendations of the Advisory Committee that are adopted by the Secretary and in effect at the time the grant is awarded or renewed under this section, which shall include the screening of each newborn for the heritable disorders recommended by the Advisory Committee and adopted by the Secretary. (d) The Secretary shall take all necessary steps to coordinate programs funded with grants received under this section and to coordinate with existing newborn screening activities. (e) 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. (f) 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. (g) 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. (1) An application for a grant under 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 received by the State after the publication described in paragraph (1) shall be addressed in the application for a grant under this section. (i) The Secretary shall provide to entities receiving grants under subsection (a) such technical assistance as may be necessary to ensure the quality of programs conducted under this section.