[Federal Register Volume 78, Number 84 (Wednesday, May 1, 2013)]
[Notices]
[Pages 25447-25448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10241]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Establishment of the Discretionary Advisory Committee on
Heritable Disorders in Newborns and Children and Notice of Meeting
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice of establishment of the Discretionary Advisory Committee
on Heritable Disorders in Newborns and Children and Notice of Meeting.
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Authority: The Committee is governed by Public Health Service
Act (PHS), 42 U.S.C. 217a: Advisory councils or committees as well
as provisions of Public Law 92-463, as amended, (5 U.S.C. App. 2),
which sets forth standards for the formation and use of advisory
committees.
SUMMARY: The U.S. Department of Health and Human Services announces the
establishment of the Discretionary Advisory Committee on Heritable
Disorders in Newborns and Children. This notice also announces the
Committee's first meeting.
FOR FURTHER INFORMATION CONTACT: Debi Sarkar, Health Resources and
Services Administration, Maternal and Child Health Bureau; Telephone:
301-443-1080; Email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background and Authority
Under the Public Health Service Act (PHS), 42 U.S.C. 217a, the
Secretary of Health and Human Services directed that the Discretionary
Advisory Committee on Heritable Disorders in Newborns and Children
(DACHDNC) shall be established within the Department of Health and
Human Services (HHS). To comply with the authorizing directive and
guidelines under the Federal Advisory Committee Act (FACA), a charter
was filed with the Committee Management Secretariat in the General
Services Administration (GSA), the appropriate committees in the Senate
and U.S. House of Representatives, and the Library of Congress to
establish the Committee as a discretionary federal advisory committee.
The purpose of the Discretionary Advisory Committee on Heritable
Disorders in Newborns and Children (DACHDNC) is to advise the Secretary
of Health and Human Services about aspects of newborn and childhood
screening and technical information for the development of policies and
priorities 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 DACHDNC will review and report regularly on
newborn and childhood screening practices, recommend improvements for
newborn and childhood screening programs, as well as fulfill the list
of requirements stated in the original authorizing legislation.
II. Structure
The Committee consists of fifteen (15) voting members, including
the Chair. The members of the Committee were appointed by the
Secretary. Membership is composed of the Chair, Special Government
Employees (SGEs) and federal ex-officio members. Federal ex-officio
members include the Administrator of the Health Resources and Services
Administration; the Directors of the Centers for Disease Control and
Prevention; the National Institutes of Health; the Agency for
Healthcare Research and Quality; and the Commissioner of the Food and
Drug Administration--or their designees. The Chair and other members
are (a) medical, technical, public health 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 at risk for heritable disorders; (b) experts in
ethics and heritable disorders who have worked and published material
in the area of public health and genetic conditions; and (c) members
from the public sector who have expertise, either professional or
personal, about or concerning heritable disorders in order to achieve a
fairly balanced membership.
The DACHDNC also includes nonvoting liaisons or representatives
from Federal Agencies, public health constituencies, advocacy
organizations and medical professional societies, as determined to be
necessary by the Chair and/or the Designated Federal Official, to
fulfill the duties of the DACHDNC. In addition, the DACHDNC is
encouraged to work closely with other relevant HHS entities that focus
on reviewing scientific evidence and making recommendations on clinical
preventive services.
III. First Meeting of the DACHDNC
Dates and Times: May 16, 2013, 10:00 a.m. to 2:00 p.m.
May 17, 2013, 10:00 a.m. to 2:00 p.m.
Place: Virtual via Webinar.
Status: The meeting is open to the public. For more information on
registration and webinar details, please visit the Committee's Web
site: http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.
Purpose: The Discretionary Advisory Committee on Heritable
Disorders in Newborns and Children (Committee), as authorized by Public
Health Service Act (PHS), 42 U.S.C. 217a: Advisory councils or
committees, was established to advise the Secretary of the Department
of Health and Human Services regarding the development of newborn
screening activities, technologies, policies, guidelines, and programs
for effectively reducing morbidity and mortality in newborns and
children having, or at risk for, heritable disorders. The Committee's
recommendations regarding additional conditions/inherited disorders for
screening that have been adopted by the Secretary are included in the
Recommended Uniform Screening Panel (RUSP) that constitutes part of the
comprehensive guidelines supported by the Health Resources and Services
Administration. Pursuant to section 2713 of the Public Health Service
Act, codified at 42 U.S.C. 300gg-13, non-grandfathered health plans 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., policy years) beginning on or after
the date that is one year from the Secretary's adoption of the
condition for screening.
Agenda: The meeting will include: (1) A final report on the Pompe
Condition Nomination for inclusion in the RUSP, and (2) updates on
priority projects from the Committee's subcommittees on Laboratory
Standards and Procedures, Follow-up and Treatment, and Education and
Training.
The Committee is expected to vote on whether or not to recommend to
the
[[Page 25448]]
Secretary the addition of Pompe Disease to the Recommended Uniform
Screening Panel (RUSP).
Certain proposed agenda items may be subject to change as necessary
or appropriate. The agenda, webinar information, Committee Roster,
Charter, presentations, and meeting materials are located on the
Committee's Web site at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.
Public Comments: Members of the public can submit written comments
and/or register to present oral comments during the public comment
period of the meeting. All comments, whether oral or written, are part
of the official Committee record and will be available for public
inspection and copying. Advance registration is required to present
oral comments or submit written comments. Individuals who wish to make
public comments are required to email Lisa Vasquez ([email protected])
by Tuesday, May 7, 2013. The public comment period is scheduled for the
morning of May 17, 2013.
Written comments should identify the individual's name, address,
email, telephone number, professional or business affiliation, type of
expertise (i.e., parent, researcher, clinician, public health, etc.),
and the topic/subject matter of comment. To ensure that all individuals
who have registered to make oral comments can be accommodated, the
allocated time may be limited. Individuals who are associated with
groups or have similar interests may be requested to combine their
comments and present them through a single representative. No
audiovisual presentations are permitted.
Contact Person: Anyone interested in obtaining other relevant
information should contact Debi Sarkar, Maternal and Child Health
Bureau, Health Resources and Services Administration, Room 18A-19,
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857;
telephone: (301) 443-1080; email: [email protected]. The logistical
challenges of coordinating this meeting hindered an earlier publication
of this meeting notice.
More information on the Committee is available at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.
Dated: April 25, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013-10241 Filed 4-30-13; 8:45 am]
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