42 U.S.C. § 300b–10 — Advisory Committee on Heritable Disorders in Newborns and Children

(a) Establishment: The Secretary must set up the Advisory Committee on Heritable Disorders in Newborns and Children. (b) Duties: The Advisory Committee must: (1) advise the Secretary on grants and projects funded under section 300b–8; (2) give the Secretary technical information for setting policies and priorities for those grants; (3) make evidence-based, peer-reviewed recommendations about which heritable disorders — including conditions found as a side effect of the screening methods used — are serious enough that all newborns should be screened for them; (4) help people and organizations, on request, prepare nominations for the uniform screening panel; (5) prepare, at its own discretion, for reviewing nominations before they're formally submitted, including ones where the screening method works but other requirements aren't met yet; (6) build a model decision-making chart for expanding newborn screening — including looking at public-health impact and cost — and update the screening panel using that chart; (7) look for ways every state can screen for the conditions in (3), using results from section 300b–8 grants; and (8) give recommendations, advice, or information to help the Secretary reduce death and illness from heritable disorders, covering: (A) follow-up care, both fast diagnosis and treatment and long-term outcome tracking; (B) how well newborn screening — diagnosis, screening, follow-up, treatment — is being run; (C) screening technology; (D) testing for conditions with no existing treatment, including cost and how common they are; (E) conditions not on the panel that can be treated with FDA-approved or other proven treatments; (F) minimum standards, policies, and shared terminology across state newborn-screening programs; (G) quality control and oversight of state programs, making sure their tests meet standards; (H) public and provider awareness and education; (I) the cost and effectiveness of state screening and treatment systems; (J) what causes heritable disorders, their public-health impact, and risk factors; (K) coordinating data collection, shared lab definitions, and confirming positive test results; and (L) how quickly specimens are collected, shipped, and screened. (c) Membership: (1) In general — the Secretary appoints up to 15 members, and must make sure the total membership is an odd number. (2) Required members — the Secretary must include: (A) the Administrator of the Health Resources and Services Administration; (B) the Director of the CDC; (C) the Director of the NIH; (D) the Director of the Agency for Healthcare Research and Quality; (E) the Commissioner of the FDA; (F) medical, technical, or scientific experts on heritable disorders or on screening, counseling, testing, or specialty care for at-risk newborns and children; (G) experts in ethics and infectious disease who have worked and published on newborn screening; (H) members of the public with special expertise in or concern about heritable disorders; and (I) representatives from federal agencies, public health groups, and medical societies the Secretary decides are necessary. (d) Decision on recommendations: (1) In general — the Secretary must accept or reject each Committee recommendation within 120 days. If the Secretary can't decide in that time, the Secretary must tell the Committee and Congress why, along with a plan for handling the recommendation. (2) Determinations to be made public — the Secretary must publicly announce every decision to accept or reject a recommendation, along with the reasoning. (3) Deadline for review — for each condition nominated for the uniform screening panel, the Committee must review and vote on it within 9 months of sending it to the condition review workgroup. (e) Annual report: Starting 3 years after April 24, 2008, and every year after, the Committee must: (1) publish a report on peer-reviewed newborn screening guidelines, including follow-up and treatment, across the U.S.; (2) send that report to Congress, the Secretary, the Interagency Coordinating Committee (section 300b–13), and state health departments; and (3) share it as widely as practical, including on the internet clearinghouse (section 300b–11). (f) Meetings: The Committee must meet at least 4 times a year, or more often if the Designated Federal Officer, working with the Chair, decides to. (g) Continuation of operation of Committee: (1) In general — despite the usual advisory-committee expiration rule in section 1013 of title 5, this Committee keeps operating through the end of fiscal year 2019. (2) Continuation if not reauthorized — if the Committee's authorization isn't extended by the end of fiscal year 2019, it can still be treated, for the purposes of the advisory-committee law, as one created by the President or a federal officer.