[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Pages 18864-18865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07321]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


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: Advisory Committee on Heritable Disorders in Newborns and 
Children.
    Dates and Times: May 9, 2016, 9:00 a.m. to 5:00 p.m. (Meeting time 
is tentative.) May 10, 2016, 9:00 a.m. to 3:00 p.m. (Meeting time is 
tentative.)
    Place: Webcast and In-Person, Fishers Lane Conference Center, 
Terrace Level, 5635 Fishers Lane, Rockville, MD 20852.
    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 webcast. Whether attending in-person or via 
webcast, 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, April 29, 2016, 11:59 p.m. Eastern Time.
    Purpose: The Advisory Committee on Heritable Disorders in Newborns 
and Children (Committee), as authorized by Public Health Service Act, 
title XI, section 1111 (42 U.S.C. 300b-10), as amended by the Newborn 
Screening Saves Lives Reauthorization Act of 2014 (Pub. L. 113-240), 
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/heritable 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 and 
group and individual health insurance issuers are required to cover 
evidence-informed care and screenings included in the HRSA-supported 
comprehensive guidelines without charging a co-payment, co-insurance, 
or deductible for plan years (in the individual market, policy years) 
beginning on or after the date that is 1 year from the Secretary's 
adoption of the condition for screening.
    Agenda: The Committee will hear presentations and discussions on 
topics including newborn screening long-term follow-up, the Newborn 
Sequencing in Genomic Medicine and Public Health projects, screening 
for lysosomal storage disorders, and prenatal education regarding 
newborn screening bloodspots. The Committee will also review draft 
reports from the Pilot Study and Cost Analysis workgroups and hear 
updates from the Committee's subcommittees on Laboratory Standards and 
Procedures, Follow-up and Treatment, and Education and Training 
Tentatively, the Committee is expected to review and/or vote on whether 
or not the nominated condition Guanidinoacetate Methyltransferase

[[Page 18865]]

Deficiency should be referred for a full evidence-based review. This 
vote does not involve a proposed addition of a condition to the 
Recommended Uniform Screening Panel. The meeting agenda will be 
available two (2) days prior to the meeting on the Committee's Web 
site: 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 for public comments is of Friday April 29, 2016, 11:59 p.m. 
(Eastern Time). Written comments must be received by the deadline of 
Friday April 29, 2016, 11:59 p.m. (Eastern Time) in order to be 
included in the May 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. Individuals who plan to attend and need special assistance, 
such as sign language interpretation or other reasonable 
accommodations, should notify the contact person listed below at least 
10 days prior to the meeting. For additional information or questions 
on public comments, please contact Alaina Harris, Maternal and Child 
Health Bureau, Health Resources and Services Administration; phone: 
(301) 443-0721; or email: [email protected].
    Contact Person: Anyone interested in obtaining other relevant 
information should contact Alaina Harris, Maternal and Child Health 
Bureau, Health Resources and Services Administration, Room 18W66, 5600 
Fishers Lane, Rockville, Maryland 20857; phone: (301) 443-0721; or 
email: [email protected].
    More information on the Advisory Committee is available at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.

Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-07321 Filed 3-31-16; 8:45 am]
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