§300b–10 — Title 42 The Public Health and Welfare | U.S. Code

Summary

Creates an advisory committee called the Advisory Committee on Heritable Disorders in Newborns and Children to give advice to the Secretary of Health and Human Services. The committee must advise on grants, policies, and priorities for newborn screening. It must use evidence and peer review to recommend which inherited disorders all newborns should be screened for, including related conditions found by screening tests. The committee must help people and organizations with nominations for the recommended screening panel, prepare for reviews before nominations arrive, build a decision tool that looks at public health impact and cost for expanding screening, and work to help all States gain the ability to screen for recommended conditions. It must also give guidance to reduce illness and death from heritable disorders, covering follow-up and long-term care, program monitoring and evaluation, testing technology and reporting, conditions without treatments, treatable conditions not on the panel, standards and quality assurance, public and provider education, cost and effectiveness, causes and risk factors, data and surveillance coordination, and timely specimen handling. The Secretary must appoint no more than 15 members, and the total must be an odd number. Members include the heads of HRSA, CDC, NIH, AHRQ, and FDA, plus doctors and lab experts, ethics and infectious disease experts who have published on newborn screening, members of the public with relevant interest, and other needed representatives. The Secretary must accept or reject a committee recommendation within 120 days and must publicly explain the decision. For each nominated condition, the committee must review and vote within 9 months after sending it to the review workgroup. The committee must publish a report on peer-reviewed newborn screening guidelines within 3 years after April 24, 2008 and every fiscal year after that, send it to Congress and health agencies, and share it widely. The committee must meet at least 4 times each year. The committee was allowed to continue through the end of fiscal year 2019; if it was not extended by statute by then, it may be treated, for purposes of chapter 10 of title 5, as an advisory committee established by the President or an officer under section 1008(a) of title 5.

Title 42, §300b–10

The Public Health and Welfare — Source: USLM XML via OLRC

(a)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)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)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)(1)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)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).

(d)(1)Not later than 120 days after the Advisory Committee issues a recommendation pursuant to this section, the Secretary shall adopt or reject such recommendation. If the Secretary is unable to make a determination to adopt or reject such recommendation within such 120-day period, the Secretary shall notify the Advisory Committee and the appropriate committees of Congress of such determination together with an explanation for why the Secretary was unable to comply within such 120-day period, as well as a plan of action for consideration of such pending recommendation.

(2)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.

(3)For each condition nominated to be added to the recommended uniform screening panel in accordance with the requirements of this section, the Advisory Committee shall review and vote on the nominated condition within 9 months of the date on which the Advisory Committee referred the nominated condition to the condition review workgroup.

(e)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.

(f)The Advisory Committee shall meet at least 4 times each calendar year, or at the discretion of the Designated Federal Officer in consultation with the Chair.

(g)(1)Notwithstanding section 1013 of title 5, the Advisory Committee shall continue to operate through the end of fiscal year 2019.

(2)If at the end of fiscal year 2019 the duration of the Advisory Committee has not been extended by statute, the Advisory Committee may be deemed, for purposes of chapter 10 of title 5, an advisory committed 11 So in original. Probably should be “committee”. established by the President or an officer of the Federal Government under section 1008(a) of title 5.

Notes & Related Subsidiaries

Editorial Notes

Amendments

2022—Subsec. (g)(1). Pub. L. 117–286, § 4(a)(244)(A), substituted “section 1013 of title 5,” for “section 14 of the Federal Advisory Committee Act,”. Subsec. (g)(2). Pub. L. 117–286, § 4(a)(244)(B), substituted “chapter 10 of title 5, an advisory committed established by the President or an officer of the Federal Government under section 1008(a) of title 5.” for “the Federal Advisory Committee Act, an advisory committee established by the President or an officer of the Federal Government under section 9(a) of such Act.” 2014—Subsec. (b)(4), (5). Pub. L. 113–240, § 4(1)(B), added pars. (4) and (5). Former pars. (4) and (5) redesignated (6) and (7), respectively. Subsec. (b)(6). Pub. L. 113–240, § 4(1)(A), (C), redesignated par. (4) as (6) and inserted “, including the cost” after “public health impact”. Former par. (6) redesignated (8). Subsec. (b)(7). Pub. L. 113–240, § 4(1)(A), redesignated par. (5) as (7). Subsec. (b)(8). Pub. L. 113–240, § 4(1)(A), redesignated par. (6) as (8). Subsec. (b)(8)(A). Pub. L. 113–240, § 4(1)(D)(i), substituted “achieve best practices in rapid diagnosis and appropriate treatment” for “achieve rapid diagnosis”. Subsec. (b)(8)(D). Pub. L. 113–240, § 4(1)(D)(ii), inserted “, including information on cost and incidence” before semicolon at end. Subsec. (b)(8)(L). Pub. L. 113–240, § 4(1)(D)(iii)–(v), added subpar. (L). Subsec. (d)(1). Pub. L. 113–240, § 4(2)(A), substituted “120 days” for “180 days” and inserted at end “If the Secretary is unable to make a determination to adopt or reject such recommendation within such 120-day period, the Secretary shall notify the Advisory Committee and the appropriate committees of Congress of such determination together with an explanation for why the Secretary was unable to comply within such 120-day period, as well as a plan of action for consideration of such pending recommendation.” Subsec. (d)(2). Pub. L. 113–240, § 4(2)(B), (C), redesignated par. (3) as (2) and struck out former par. (2). Prior to amendment, text of par. (2) read as follows: “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.” Subsec. (d)(3). Pub. L. 113–240, § 4(2)(D), added par. (3). Former par. (3) redesignated (2). Subsec. (f). Pub. L. 113–240, § 4(4), added subsec. (f). Former subsec. (f) redesignated (g). Subsec. (g). Pub. L. 113–240, § 4(3), (5), redesignated subsec. (f) as (g) and amended it generally. Prior to amendment, text read as follows: “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.” Subsec. (h). Pub. L. 113–240, § 4(3), (6), redesignated subsec. (g) as (h) and struck it out. Prior to amendment, text read as follows: “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.” 2008—Subsec. (b)(3) to (5). Pub. L. 110–204, § 4(1)(B), (C), added pars. (3) to (5). Former par. (3) redesignated (6). Subsec. (b)(6). Pub. L. 110–204, § 4(1)(A), (D), redesignated par. (3) as (6), substituted “, which may include recommendations, advice, or information dealing with—” for period at end, and added subpars. (A) to (K). Subsec. (c)(2)(E) to (I). Pub. L. 110–204, § 4(2), as amended by Pub. L. 110–237, § 1(b)(2), added subpars. (E) and (G) and redesignated former subpars. (E), (F), and (G) as (F), (H), and (I), respectively. Subsec. (d). Pub. L. 110–204, § 4(3), added subsec. (d). Subsec. (d)(2). Pub. L. 110–237, § 1(a)(3)(A), made technical amendment to reference in original act which appears in text as the first reference to

April 24, 2008. Subsecs. (e), (f). Pub. L. 110–237, § 1(a)(3)(B), (C), made technical amendment to references in original act which appear in text as references to

April 24, 2008. Pub. L. 110–204, § 4(3), added subsecs. (e) and (f). Subsec. (g). Pub. L. 110–237, § 1(a)(3)(D), substituted “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.” for “2008, $1,012,500 for fiscal year 2009, $1,025,000 for fiscal year 2010, $1,037,500 for fiscal year 2011, and $1,050,000 for fiscal year 2012.” Pub. L. 110–204, § 4(3), added subsec. (g).

Statutory Notes and Related Subsidiaries

Termination of Advisory CommitteesAdvisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by the Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees. Pub. L. 93–641, § 6, Jan. 4, 1975, 88 Stat. 2275, set out as a note under section 217a of this title, provided that an advisory committee established pursuant to the Public Health Service Act shall terminate at such time as may be specifically prescribed by an Act of Congress enacted after Jan. 4, 1975.

§300b–10 Advisory Committee on Heritable Disorders in Newborns and Children