---
kind: "section"
citation: "42 U.S.C. § 300b–10"
title: "42"
title_heading: "The Public Health and Welfare"
number: "300b–10"
heading: "Advisory Committee on Heritable Disorders in Newborns and Children"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/300b-10"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter IX — Genetic Diseases, Hemophilia Programs, and Sudden Infant Death Syndrome"
  - "Part A — Genetic Diseases"
---

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

- (a) **Establishment—** The [Secretary](/usc/42/201.md?p=c) shall establish an [advisory committee](/usc/42/17061.md?p=2) to be known as the “[Advisory Committee](/usc/42/17061.md?p=2) on Heritable Disorders in Newborns and Children” (referred to in this section as the “[Advisory Committee](/usc/42/17061.md?p=2)”).
- (b) **Duties—** The [Advisory Committee](/usc/42/17061.md?p=2) shall—
  - (1) provide advice and recommendations to the [Secretary](/usc/42/201.md?p=c) concerning grants and [projects](/usc/42/13641.md?p=2) awarded or funded under [section 300b–8 of this title](/usc/42/300b–8.md);
  - (2) provide technical information to the [Secretary](/usc/42/201.md?p=c) for the development of policies and priorities for the administration of grants under [section 300b–8 of this title](/usc/42/300b–8.md);
  - (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](/usc/42/17061.md?p=2) 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](/usc/42/201.md?p=f) attain the capacity to screen for the conditions described in [paragraph (3)](#b-3), and include in such consideration the results of grant funding under [section 300b–8 of this title](/usc/42/300b–8.md); and
  - (8) provide such recommendations, advice or information as may be necessary to enhance, expand or improve the ability of the [Secretary](/usc/42/201.md?p=c) 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](/usc/42/17061.md?p=19) in rapid diagnosis and appropriate [treatment](/usc/42/11851.md?p=11) in the short-term, and those that ascertain long-term case management outcomes and appropriate access to related [services](/usc/42/201.md?p=a);
    - (B) implementation, monitoring, and evaluation of newborn screening activities, including diagnosis, screening, follow-up, and [treatment](/usc/42/11851.md?p=11) 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](/usc/42/11851.md?p=11), including information on cost and incidence;
    - (E) conditions not included in the recommended uniform screening panel that are treatable with Food and [Drug](/usc/42/11851.md?p=4) Administration-approved products or other safe and effective [treatments](/usc/42/11851.md?p=11), as determined by scientific evidence and peer review;
    - (F) minimum standards and related policies and procedures used by [State](/usc/42/201.md?p=f) newborn screening [programs](/usc/42/274l–1.md?p=4), such as language and terminology used by [State](/usc/42/201.md?p=f) newborn screening [programs](/usc/42/274l–1.md?p=4) 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](/usc/42/201.md?p=f) newborn screening [programs](/usc/42/274l–1.md?p=4), including ensuring that tests and technologies used by each [State](/usc/42/201.md?p=f) meet established standards for detecting and reporting positive screening results;
    - (H) public and [provider](/usc/42/299b–21.md?p=8) awareness and education;
    - (I) the cost and effectiveness of newborn screening and medical evaluation systems and intervention [programs](/usc/42/274l–1.md?p=4) conducted by [State](/usc/42/201.md?p=f)-based [programs](/usc/42/274l–1.md?p=4);
    - (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—** The [Secretary](/usc/42/201.md?p=c) shall appoint not to exceed 15 members to the [Advisory Committee](/usc/42/17061.md?p=2). In appointing such members, the [Secretary](/usc/42/201.md?p=c) shall ensure that the total membership of the [Advisory Committee](/usc/42/17061.md?p=2) is an odd number.
  - (2) **Required members—** The [Secretary](/usc/42/201.md?p=c) shall appoint to the [Advisory Committee](/usc/42/17061.md?p=2) under [paragraph (1)](#c-1)—
    - (A) the [Administrator](/usc/42/4005.md?p=1) of the Health Resources and [Services](/usc/42/201.md?p=a) Administration;
    - (B) the [Director](/usc/42/11851.md?p=5) of the Centers for Disease Control and Prevention;
    - (C) the [Director](/usc/42/11851.md?p=5) of the National Institutes of Health;
    - (D) the [Director](/usc/42/11851.md?p=5) of the [Agency](/usc/42/8262.md?p=1) for Healthcare Research and Quality;
    - (E) the Commissioner of the Food and [Drug](/usc/42/11851.md?p=4) Administration;
    - (F) medical, technical, or scientific professionals with special expertise in heritable disorders, or in providing screening, counseling, testing or specialty [services](/usc/42/201.md?p=a) 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](/usc/42/8262.md?p=1), public health constituencies, and medical professional societies as determined to be necessary by the [Secretary](/usc/42/201.md?p=c), to fulfill the duties of the [Advisory Committee](/usc/42/17061.md?p=2), as established under [subsection (b)](#b).
- (d) **Decision on recommendations—**
  - (1) **In general—** Not later than 120 days after the [Advisory Committee](/usc/42/17061.md?p=2) issues a recommendation pursuant to this section, the [Secretary](/usc/42/201.md?p=c) shall adopt or reject such recommendation. If the [Secretary](/usc/42/201.md?p=c) is unable to make a determination to adopt or reject such recommendation within such 120-day period, the [Secretary](/usc/42/201.md?p=c) shall notify the [Advisory Committee](/usc/42/17061.md?p=2) and the appropriate committees of Congress of such determination together with an explanation for why the [Secretary](/usc/42/201.md?p=c) was unable to comply within such 120-day period, as well as a plan of action for consideration of such pending recommendation.
  - (2) **Determinations to be made public—** The [Secretary](/usc/42/201.md?p=c) shall publicize any determination on adopting or rejecting a recommendation of the [Advisory Committee](/usc/42/17061.md?p=2) pursuant to this subsection, including the justification for the determination.
  - (3) **Deadline for review—** For each condition nominated to be added to the recommended uniform screening panel in accordance with the requirements of this section, the [Advisory Committee](/usc/42/17061.md?p=2) shall review and vote on the nominated condition within 9 months of the date on which the [Advisory Committee](/usc/42/17061.md?p=2) referred the nominated condition to the condition review workgroup.
- (e) **Annual report—** Not later than 3 years after April 24, 2008, and each fiscal year thereafter, the [Advisory Committee](/usc/42/17061.md?p=2) shall—
  - (1) publish a report on peer-reviewed newborn screening guidelines, including follow-up and [treatment](/usc/42/11851.md?p=11), in the United States;
  - (2) submit such report to the appropriate committees of Congress, the [Secretary](/usc/42/201.md?p=c), the Interagency Coordinating Committee established under [section 300b–13 of this title](/usc/42/300b–13.md), 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](/usc/42/300b–11.md).
- (f) **Meetings—** The [Advisory Committee](/usc/42/17061.md?p=2) shall meet at least 4 times each calendar year, or at the discretion of the Designated Federal Officer in consultation with the Chair.
- (g) **Continuation of operation of Committee—**
  - (1) **In general—** Notwithstanding [section 1013 of title 5](/usc/5/1013.md), the [Advisory Committee](/usc/42/17061.md?p=2) shall continue to operate through the end of fiscal year 2019.
  - (2) **Continuation if not reauthorized—** If at the end of fiscal year 2019 the duration of the [Advisory Committee](/usc/42/17061.md?p=2) has not been extended by statute, the [Advisory Committee](/usc/42/17061.md?p=2) may be deemed, for purposes of [chapter 10](/usc/5/chptI/ch10.md) of title 5, an advisory committed[^1] established by the President or an officer of the Federal Government under [section 1008(a) of title 5](/usc/5/1008.md?p=a).

## Footnotes

[^1]: So in original. Probably should be “committee”.

## Source credit

(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.)

## Notes

### 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 Committees

Advisory 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.