[Federal Register Volume 83, Number 244 (Thursday, December 20, 2018)]
[Notices]
[Pages 65354-65356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27518]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Solicitation of Nominations for Organizational Representatives to 
the Advisory Committee on Heritable Disorders in Newborns and Children

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Request for nominations.

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SUMMARY: HRSA is seeking nominations from organizations to send a 
representative to be a liaison to the

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Advisory Committee on Heritable Disorders in Newborns and Children 
(Committee). Selections will be based on a review of the organization's 
subject area of expertise, mission, relevancy, and benefit provided 
relative to the Committee's purpose. The organizational representatives 
are non-voting liaisons. The Committee provides advice, 
recommendations, and technical information about aspects of heritable 
disorders and newborn and childhood screening to the Secretary of HHS. 
HRSA is seeking nominations of qualified organizations to fill up to 
three positions.
    Authority: Section 1111 of the Public Health Service (PHS) Act, as 
amended by the Newborn Screening Saves Lives Reauthorization Act of 
2014 (42 U.S.C. 300b-10). The Committee is governed by the Federal 
Advisory Committee Act (FACA), as amended (5 U.S.C. App.), and 41 CFR 
part 102-3, which set forth standards for the formation and use of 
advisory committees.

DATES: Written nominations for organization representatives on the 
Committee must be received on or before January 17, 2019.

ADDRESSES: Nomination packages must be submitted electronically as 
email attachments to Catharine Riley, Ph.D., MPH, Genetic Services 
Branch, Maternal and Child Health Bureau, HRSA, [email protected].

FOR FURTHER INFORMATION CONTACT: Designated Federal Official (DFO) 
Catharine Riley, Ph.D., MPH. Address: MCHB, HRSA 5600 Fishers Lane, 
Room 18-W-68, Rockville, MD 20857; phone number: 301-443-1291; email: 
[email protected]. A copy of the Committee Charter and list of the 
current membership can be obtained by accessing the Advisory Committee 
website at: www.hrsa.gov/advisory-committees/heritable-disorders.

SUPPLEMENTARY INFORMATION: The Committee is chartered under section 
1111 of the PHS Act, as amended by the Newborn Screening Saves Lives 
Reauthorization Act of 2014 (42 U.S.C. 300b-10). The Committee was 
established in 2003 to advise the Secretary of HHS regarding newborn 
screening tests, technologies, policies, guidelines, and programs for 
effectively reducing morbidity and mortality in newborns and children 
having or at risk for heritable disorders. In addition, the Committee 
provides advice and recommendations to the Secretary concerning the 
grants and projects authorized under section 1109 of the PHS Act and 
technical information to develop policies and priorities for grants, 
including those that will enhance the ability of the state and local 
health agencies to provide for newborn and child screening, counseling 
and health care services for newborns, and children having or at risk 
for heritable disorders. The Committee also is governed by the 
provisions of FACA, as amended (5 U.S.C. App. 2), and 41 CFR part 102-
3, which set forth standards for the formation and use of advisory 
committees.
    The Committee reviews and reports regularly on newborn and 
childhood screening practices for heritable disorders, recommends 
improvements in the national newborn and childhood heritable screening 
programs, and recommends conditions for inclusion in the Recommended 
Uniform Screening Panel (RUSP). The Committee's recommendations 
regarding additional conditions/inherited disorders for screening that 
have been adopted by the Secretary of HHS are included in the RUSP and 
constitute part of the comprehensive guidelines supported by HRSA 
pursuant to section 2713 of the PHS Act, codified at 42 U.S.C. 300gg-
13. Under this provision, non-grandfathered health plans and group and 
individual health insurance issuers are required to cover screenings 
included in the HRSA-supported comprehensive guidelines without 
charging a co-payment, co-insurance, or deductible for plan years 
(i.e., in the individual market, policy years) beginning on or after 
the date that is 1 year from the Secretary's adoption of the condition 
for screening.
    Nominations: The Committee may invite up to 15 organizations to 
designate individuals to serve as non-voting liaisons. Organizations 
should demonstrate wide-ranging newborn screening and heritable 
disorders interests. In addition, the organization's work should inform 
the activities of the Committee. Eligible organizations must represent 
national public health constituencies, medical professional societies, 
or organizations with large, broad constituencies and broad interest or 
involvement in newborn screening. Organizations which represent narrow 
interests (e.g., interest in a single disease or treatment) or smaller 
constituencies are not eligible. Organizational representatives attend 
Committee meetings to provide relevant expertise and perspectives to 
Committee members during their deliberations and discussions, but they 
do not vote and are not considered official members of the Committee.
    Applications must contain a cover letter and statement. The cover 
letter should include: Organization name and mission statement; contact 
information for the designated representative, including point of 
contact name, address, email, telephone number; and website of the 
organization. The statement should include: Perspective and expertise 
provided by the organization and its relevance to the Committee; a 
description of how the Committee's work affects and impacts the 
organization and its constituency; a list of organizational projects, 
programs, and products that are of relevance to the Committee's work; 
an affirmation of the organization's commitment to identify a 
representative with expertise who can attend Committee meetings in 
person and provide input to the Committee, at the discretion of the 
Chairperson; an affirmation of the organization's commitment to 
financially support (e.g., cover travel expenses) a representative to 
attend committee meetings held in Rockville, MD; an affirmation of the 
organization's commitment to ensure active contribution to and 
dissemination of Committee activities and recommendations to its 
constituencies; affirmation the designated representative is able to 
serve as the liaison; and an affirmation that the organization has no 
conflict of interest that would preclude informing the Committee in a 
fair and balanced manner. If there are potential conflicts of interest, 
please detail the information concerning any possible conflicts of 
interest relative to both the organization and the proposed 
organizational representative (e.g., current or anticipated employment, 
consultancies, research grants, or contracts), as well as how the 
organization proposes to address the potential conflict.
    Organizations are eligible to send a representative as long as the 
organization's subject area of expertise and mission is relevant to the 
Committee's purpose, objective, scope of activities and duties, and as 
long as the organization actively participates on Committee activities. 
Every three years, the Chair and DFO will re-assess the organization's 
mission, relevancy, and benefit as it relates to the Committee's 
purpose, objective, scope of activities, and duties. Every three years 
current organizations will be asked to reaffirm their commitment to 
send an organizational representative.
    The selection of eligible organizations is based on a review of the 
organization's subject area of expertise, mission, relevancy, and 
benefit as it relates to the Committee's purpose. The Committee 
Charter, legislation, and list of current voting membership may be 
obtained by accessing the Committee website at http://www.hrsa.gov/
advisory-committees/heritable-

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disorders. Final selection of organizational representatives will be 
made by the Committee Chair and HRSA.

Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-27518 Filed 12-19-18; 8:45 am]
 BILLING CODE 4165-15-P