[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]
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