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").
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;
(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) develop a model decision-matrix for newborn screening expansion, including an evaluation of the potential public health impact of such expansion, and periodically update the recommended uniform screening panel, as appropriate, based on such decision-matrix;
(5) 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
(6) 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 rapid diagnosis 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;
(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; and
(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.
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.
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;
(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) of this section.
Not later than 180 days after the Advisory Committee issues a recommendation pursuant to this section, the Secretary shall adopt or reject such recommendation.
The Secretary shall adopt or reject any recommendation issued by the Advisory Committee that is pending on April 24, 2008, by not later than 180 days after April 24, 2008.
The Secretary shall publicize any determination on adopting or rejecting a recommendation of the Advisory Committee pursuant to this subsection, including the justification for the determination.
Not 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.
Notwithstanding section 14 of the Federal Advisory Committee Act (5 U.S.C. App.), the Advisory Committee shall continue to operate during the 5-year period beginning on April 24, 2008.
There are authorized to be appropriated to carry out this section, $1,000,000 for fiscal year 2009, $1,012,500 for fiscal year 2010, $1,025,000 for fiscal year 2011, $1,037,500 for fiscal year 2012, and $1,050,000 for fiscal year 2013.
(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.)
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Last modified: October 26, 2015