[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