[Federal Register Volume 79, Number 153 (Friday, August 8, 2014)]
[Notices]
[Pages 46444-46445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18737]
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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: September 11, 2014, 9:30 a.m. to 4:30 p.m.
September 12, 2014, 9:00 a.m. to 3:00 p.m.
Place: Webinar and In-Person, National Institute of Health, Natcher
Conference Center (Building 45), 9000 Rockville Pike, Bethesda, MD
20892.
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 at https://www.blsmeetings.net/ACHDNCSeptember2014/. The registration deadline is
Thursday, August 28, 2014, 11:59 p.m. Eastern Time. If there are
technical problems gaining access to the Web site, please contact
Anthony Rodell, Director of Client Relations, at
[email protected].
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 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) Presentations from the
Newborn Screening Translational Research Network and the Region 4
Genetics Collaborative on long-term follow up activities as they relate
to newborn screening; (2) an update on the Mucopolysaccharidosis 1
(MPS-1) condition review; (3) presentations and discussion on national
activities addressing timeliness of newborn screening; (4) a
presentation on the Region 4 Stork (R4S) database that facilitates the
clinical validation of cutoff target ranges for metabolic disorders by
tandem mass spectrometry; (5) a presentation of the National Committee
on Vital and Health Statistics' recommendations regarding the adoption
of electronic standards for public health information exchanges; (6) a
presentation on the Clinical Laboratory Improvement Amendments (CLIA)
Program and Health Insurance Portability and Accountability Act (HIPAA)
Privacy Rule--Patients' Access to Test Reports; and (7) updates from
the Laboratory Standards and Procedures, Follow-up and Treatment, and
Education and Training subcommittees. Tentatively, the Committee is
expected to review and/or vote on recommendations to the Secretary
regarding educational activities that emphasize succinylacetone as the
best marker for Tyrosinemia Type I screening, a condition on the
Recommended Uniform Screening Panel (RUSP). This tentative vote does
not involve any proposed addition of a condition to the RUSP.
Agenda items are subject to change as necessary or appropriate. The
agenda, webinar information, Committee Roster,
[[Page 46445]]
Charter, presentations, and other meeting materials are 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 September 11, 2014. Advance registration is required to present
oral comments and/or submit written comments at https://www.blsmeetings.net/ACHDNCSeptember2014/. The registration deadline is
Thursday, August 28, 2014, 11:59 p.m. Eastern Time. Written comments
must be received by the deadline in order to be included in the
September 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 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].
For More Information Contact: 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.
Dated: August 1, 2014.
Jackie Painter,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2014-18737 Filed 8-7-14; 8:45 am]
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