83 FR 14866 - Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 67 (April 6, 2018)

Page Range		14866-14867
FR Document		2018-07005

HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (Committee). 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 candidates to fill up to three positions on the Committee.

Federal Register, Volume 83 Issue 67 (Friday, April 6, 2018)

[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Notices]
[Pages 14866-14867]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-07005]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Nominations for Membership To Serve on 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 of qualified candidates to be 
considered for appointment as members of the Advisory Committee on 
Heritable Disorders in Newborns and Children (Committee). 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 
candidates to fill up to three positions on the Committee.

DATE: Written nominations for membership on the Committee must be 
received on or before April 30, 2018.

ADDRESSES: Nomination packages must be submitted electronically as 
email attachments to Alaina Harris, Genetic Services Branch, Maternal 
and Child Health Bureau (MCHB), HRSA, [email protected].

FOR FURTHER INFORMATION CONTACT: Alaina Harris. Address: MCHB, HRSA, 
5600 Fishers Lane, Room 18W66, Rockville, MD 20857; phone number: (301) 
443-0721; email: [email protected]. A copy of the Committee Charter and 
list of the current membership can be obtained by accessing the 
Committee website at www.hrsa.gov/advisory-committees/heritable-disorders.

SUPPLEMENTARY INFORMATION: The Committee was established in 2003 to 
advise the Secretary of HHS regarding newborn screening tests, 
technologies, policies, guidelines, and programs for

[[Page 14867]]

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 PHSA 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 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 are included in the RUSP and 
constitute part of the comprehensive guidelines supported by HRSA 
pursuant to section 2713 of the PHSA, 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 one (1) year from the Secretary's adoption of the 
condition for screening.
    Nominations: HRSA is requesting nominations to fill up to three (3) 
positions for voting members to serve on the Committee. The Secretary 
appoints committee members with the expertise needed to fulfill the 
duties of the Committee established under section 1111(b) of the PHSA, 
as amended by the Newborn Screening Saves Lives Reauthorization Act of 
2014 (Act; 42 U.S.C. 300b-10(b)). Areas of expertise include medical, 
technical, or scientific professionals with special expertise in the 
field of heritable disorders or in providing screening, counseling, 
testing, or specialty services for newborns and children with, or at 
risk for having, heritable disorders; and/or who have expertise in 
ethics (e.g., bioethics) and infectious diseases and who have worked 
and published material in the area of newborn screening; and/or are 
members of the public having special expertise about or concern with 
heritable disorders; and/or representatives from such federal agencies, 
public health constituencies, and medical professional societies. 
Interested applicants may self-nominate or be nominated by another 
individual or organization. Nominees must reside in the United States.
    Individuals selected for appointment to the Committee will be 
invited to serve for up to four (4) years. Members who are not federal 
officers or permanent federal employees are appointed as special 
government employees and receive a stipend and reimbursement for per 
diem and travel expenses incurred for attending Committee meetings and/
or conducting other business on behalf of the Committee, as authorized 
by section 5 U.S.C. 5703 for persons employed intermittently in 
government service. Members who are officers or employees of the United 
States Government shall not receive additional compensation for service 
on the Committee, but receive per diem and travel expenses incurred for 
attending Committee meetings and/or conducting other business on behalf 
of the Committee.
    The following information must be included in the package of 
materials submitted for each individual being nominated for 
consideration: (1) A statement that includes the name and affiliation 
of the nominee and a clear statement regarding the basis for the 
nomination, including the area(s) of expertise that may qualify a 
nominee for service on the Committee, as described above; (2) 
confirmation the nominee is willing to serve as a member of the 
Committee; (3) the nominee's contact information (include home address, 
work address, daytime telephone number, and an email address); and (4) 
a current copy of the nominee's curriculum vitae. Nomination packages 
may be submitted directly by the individual being nominated or by the 
person/organization recommending the candidate.
    HHS will endeavor to ensure that the membership of the Committee is 
fairly balanced in terms of points of view represented and that 
individuals from a broad representation of geographic areas, gender, 
ethnic and minority groups, as well as individuals with disabilities, 
are considered for membership. Appointments shall be made without 
discrimination on the basis of age, ethnicity, gender, sexual 
orientation, and cultural, religious, or socioeconomic status.
    Individuals who are selected to be considered for appointment will 
be required to provide detailed information regarding their financial 
holdings, consultancies, and research grants or contracts. Disclosure 
of this information is necessary in order to determine if the selected 
candidate is involved in any activity that may pose a potential 
conflict with the official duties to be performed as a member of the 
Committee.

    Authority: Section 1111 of the Public Health Service Act (PHSA), 
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.

    Dated: March 30, 2018.
Lori A. Roche,
Acting Deputy Director, Division of the Executive Secretariat.
[FR Doc. 2018-07005 Filed 4-5-18; 8:45 am]
 BILLING CODE 4165-15-P

14866 Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices

Secretary on the methods of obtaining, ACCV members are appointed as composition of the Committee.
compiling, publishing, and using Special Government Employees. As Appointment to the ACCV shall be
credible data related to the frequency such, they are covered by the federal made without discrimination on basis of
and severity of adverse reactions ethics rules, including the criminal age, race, ethnicity, gender, sexual
associated with childhood vaccines; conflict of interest statutes governing orientation, disability, and cultural,
consulting on the development or executive branch employees. For religious, or socioeconomic status. HHS
revision of Vaccine Information example, an ACCV member may be encourages nominations of qualified
Statements; and recommending to the prohibited from discussions about candidates from all groups and
Director of the National Vaccine making changes to the Vaccine Injury locations.
Program research related to vaccine Table and Vaccine Information Dated: March 30, 2018.
injuries which should be conducted to Statements for the Hepatitis B vaccine if
Lori A. Roche,
carry out the VICP. he/she or his/her spouse owns stock
The ACCV consists of nine voting valued above a certain amount in Acting Deputy, Division of the Executive
members appointed by the Secretary as Secretariat.
companies that manufacturer this
follows: (1) Three health professionals, [FR Doc. 2018–07007 Filed 4–5–18; 8:45 am]
vaccine, affecting their own pecuniary
who are not employees of the United interests—including interests imputed BILLING CODE 4165–15–P
States Government, and who have to them. To evaluate possible conflicts
expertise in the health care of children, of interest, potential candidates will be
the epidemiology, etiology, and asked to fill out the U.S. Office of DEPARTMENT OF HEALTH AND
prevention of childhood diseases, and Government Ethics (OGE) Confidential HUMAN SERVICES
the adverse reactions associated with Financial Disclosure Report, OGE Form Solicitation of Nominations for
vaccines, of whom at least two shall be 450, to provide detailed information Membership To Serve on the Advisory
pediatricians; (2) three members from concerning financial interests,
Committee on Heritable Disorders in
the general public, of whom at least two consultancies, research grants, and/or
Newborns and Children
shall be legal representatives (parents or contracts that might be affected by
guardians) of children who have recommendations made by the ACCV. AGENCY: Health Resources and Services
suffered a vaccine-related injury or Interested persons may nominate one Administration (HRSA), Department of
death; and (3) three attorneys, of whom or more qualified persons for Health and Human Services (HHS).
at least one shall be an attorney whose membership on the ACCV. Nominations ACTION: Request for nominations.
specialty includes representation of shall state that the nominee is willing to
persons who have suffered a vaccine- serve as a member of the ACCV. SUMMARY: HRSA is seeking nominations
related injury or death, and of whom Nominees will be invited to serve a 3- of qualified candidates to be considered
one shall be an attorney whose specialty year term beginning the date of for appointment as members of the
includes representation of vaccine appointment. A nomination package Advisory Committee on Heritable
manufacturers. In addition, the Director should be submitted as hard copy or Disorders in Newborns and Children
of the National Institutes of Health, the email communication and should (Committee). The Committee provides
Assistant Secretary for Health, the include the following information for advice, recommendations, and technical
Director of the Centers for Disease each nominee: (1) A letter of nomination information about aspects of heritable
Control and Prevention, and the stating the name, affiliation, and contact disorders and newborn and childhood
Commissioner of the Food and Drug information for the nominee, the basis screening to the Secretary of HHS.
Administration (or the designees of such for the nomination (i.e., what specific HRSA is seeking nominations of
officials) serve as nonvoting ex officio attributes, perspectives, and/or skills qualified candidates to fill up to three
members. does the individual possess that would positions on the Committee.
HHS will consider nominations of all benefit the workings of the ACCV) and DATE: Written nominations for
qualified individuals with a view to the nominee’s field(s) of expertise; (2) a membership on the Committee must be
ensure that the ACCV includes the areas biographical sketch of the nominee and received on or before April 30, 2018.
of subject matter expertise noted above. a copy of his/her curriculum vitae; and ADDRESSES: Nomination packages must
As indicated above, at least two of the (3) the name, address, daytime be submitted electronically as email
three ACCV members of the general telephone number, and email address at
attachments to Alaina Harris, Genetic
public must be legal representatives which the nominator can be contacted.
Services Branch, Maternal and Child
(parents or guardians) of children who Nomination packages will be collected
Health Bureau (MCHB), HRSA,
have suffered a vaccine-related injury or and retained to create a pool of possible
death. Because those members must be AHarris@hrsa.gov.
future ACCV voting members. When a
the legal representatives of children vacancy occurs, nomination packages FOR FURTHER INFORMATION CONTACT:
who have suffered a vaccine-related from the appropriate category will be Alaina Harris. Address: MCHB, HRSA,
injury or death, to be considered for reviewed and nominees may be 5600 Fishers Lane, Room 18W66,
appointment to the ACCV in that contacted at that time. Rockville, MD 20857; phone number:
category there must have been a finding HHS strives to ensure that the (301) 443–0721; email: AHarris@
(i.e., a decision) by the U.S. Court of membership of the ACCV is balanced in hrsa.gov. A copy of the Committee
Federal Claims or a civil court that a terms of points of view presented and Charter and list of the current
VICP-covered vaccine caused, or was the committee’s function. Every effort is membership can be obtained by
presumed to have caused, the made to ensure that the views of accessing the Committee website at
daltland on DSKBBV9HB2PROD with NOTICES

represented child’s injury or death. women, all ethnic and racial groups, www.hrsa.gov/advisory-committees/
Additionally, based on a and people with disabilities are heritable-disorders.
recommendation made by the ACCV, represented on HHS Federal Advisory SUPPLEMENTARY INFORMATION: The
the Secretary will consider having a Committees and, therefore, HHS Committee was established in 2003 to
health professional with expertise in encourages nominations of qualified advise the Secretary of HHS regarding
obstetrics as one of the members of the candidates from these groups. HHS also newborn screening tests, technologies,
general public. encourages geographic diversity in the policies, guidelines, and programs for

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Document Created: 2018-11-01 09:15:20
Document Modified: 2018-11-01 09:15:20

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Request for nominations.
Dates		Written nominations for membership on the Committee must be received on or before April 30, 2018.
FR Citation		83 FR 14866