[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4290-4291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01351]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Discretionary Advisory Committee on Heritable Disorders in
Newborns and Children; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463, codified at 5 U.S.C. App.), notice is
hereby given of the following meeting:
Name: Discretionary Advisory Committee on Heritable Disorders in
Newborns and Children.
Dates and Times: February 12, 2015, 8:30 a.m. to 5:00 p.m.;
February 13, 2015, 9:00 a.m. to 4:00 p.m.
Place: Webinar and In-Person, National Institutes of Health, 5635
Fishers Lane, Rockville, Maryland 20857.
Status: The meeting will be open to the public with attendance
limited to space availability. Participants also have the option of
viewing the meeting via webinar. Whether attending in-person or via
webinar, all participants must register for the meeting. The
registration link will be made available at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/. The registration
deadline is Friday, January 30, 2015, 11:59 p.m. Eastern Time.
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 about 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. In addition, 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) and
constitute 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 1 year from the
Secretary's adoption of the condition for screening.
Agenda: The meeting will include: (1) A final report on the
Mucopolysaccharidosis 1 (MPS 1) Condition Nomination for inclusion on
the Recommended Uniform Screening Panel (RUSP), (2) a final report on
the Laboratory Procedures and Standards Subcommittee's Timely Newborn
Screening Project, (3) a presentation from the U.S. Preventive Services
Task Force on the transfer of newborn screening topics (sickle cell
disease, phenylketonuira, congenital hypothyroidism) to the Committee,
(4) update on the condition review of Adrenoleukodystrophy (ALD), (5)
update from the Pilot Study Workgroup and discussion on the different
mechanisms and challenges for implementing pilot studies, (6)
presentation on analyzing costs when implementing screening for a new
condition, (7) presentation by the Newborn Screening Translational
Research Network Long-term Follow-up Project, and (8) 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 Secretary the addition of MPS 1 to the RUSP. Tentatively, the
Committee is expected to review and/or vote on the final
recommendations on timely newborn screening. Agenda items are subject
to change as necessary or appropriate. The agenda, webinar information,
Committee Roster, Charter, presentations, and other meeting materials
will be located on the Advisory Committee's Web site at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.
Public Comments: Members of the public may present oral comments
and/or submit written comments. Comments are part of the official
Committee record. The public comment period is tentatively scheduled
for both days of the meeting. Advance registration is required to
present oral comments and/or submit written comments. Registration
information will be on the Committee Web site at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders. The registration
deadline is Friday, January 30, 2015, 11:59 p.m. Eastern Time. Written
comments must be received by the deadline in order to be included in
the February meeting briefing book. 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
comments. 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
[[Page 4291]]
representative. No audiovisual presentations are permitted. For
additional information or questions on public comments, please contact
Lisa Vasquez, Maternal and Child Health Bureau, Health Resources and
Services Administration; email: [email protected].
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; email:
[email protected].
More information on the Advisory Committee is available at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.
Jackie Painter,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2015-01351 Filed 1-26-15; 8:45 am]
BILLING CODE 4165-15-P