[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Notices]
[Page 47857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19654]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Secretary's 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. 2), notice is 
hereby given of the following meeting:

    Name: Secretary's Advisory Committee on Heritable Disorders in 
Newborns and Children.
    Dates and Times: September 13, 2012, 8:30 a.m. to 6:00 p.m., 
September 14, 2012, 8:30 a.m. to 2:30 p.m.
    Place: Hubert H. Humphrey Building, 200 Independence Avenue SW., 
Room 800, Washington, DC 20201.
    Status: The meeting is open to the public, but seating will be 
limited by the space available. Security at the Humphrey building 
has requested that the public register for the meeting by September 
11, 2012. See http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders for a link to register for the meeting. Please 
have a government I.D. for the meeting. For directions to the 
meeting, please visit http://www.hhs.gov/about/hhhmap.html.
    Purpose: The Secretary's Advisory Committee on Heritable 
Disorders in Newborns and Children (SACHDNC), as authorized by 
Public Law 106-310, which added section 1111 of the Public Health 
Service Act, codified at 42 U.S.C. 300b-10, was established by 
Congress to advise the Secretary of the Department of Health and 
Human Services with 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 SACHDNC'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 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 screening. The SACHDNC also provides advice and 
recommendations concerning grants and projects authorized under 
section 1109 of the Public Health Service Act (42 U.S.C. 300b-8).
    Agenda: The meeting will include: (1) Updates on newborn 
screening case definitions and newborn screening quality indicators; 
(2) updates from the Nomination and Prioritization Workgroup and the 
Condition Review Workgroup regarding the final condition review 
matrix, Adrenoleukodystrophy, and Pompe Disease; (3) presentations 
on the National Institutes for Health's Ethical, Legal, and Social 
Implications Research Program, HRSA-funded prenatal family history 
project, and the Institute of Medicine meeting summary on assessing 
the economics of genomic medicine; (4) reports on the continued work 
of the Advisory Committee's subcommittees on Laboratory Standards 
and Procedures, Follow-up and Treatment, and Education and Training; 
(5) workgroup reports on the second screen study, and carrier 
screening; and (6) CDC's Morbidity and Mortality Weekly Report on 
laboratory practices for genetic testing and newborn screening. 
Tentatively, the SACHDNC is expected to review and/or vote on the 
following items, none of which currently involve votes to add 
conditions to the RUSP: (1) Adrenoleukodystrophy--Nomination and 
Prioritization Report; (2) Condition Review Matrix; (3) Second 
Screen Study from CDC; and (4) the Morbidity and Mortality Weekly 
Report on Good Laboratory Practices for Biochemical Genetic Testing 
and Newborn Screening for Inherited Metabolic Disorder.
    Proposed agenda items are subject to change as priorities 
dictate. The agenda, Committee Roster, Charter, presentations, and 
meeting materials are located at the homepage of the Advisory 
Committee's Web site at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.
    Public Comments: Members of the public can submit written 
comments and/or present oral comments during the public comment 
periods 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. Written comments should be emailed or 
received by Thursday, September 6, 2012 to Debi Sarkar, Maternal and 
Child Health Bureau, Health Resources and Services Administration, 
Parklawn Building, 5600 Fishers Lane, Room 18A-19, Rockville, 
Maryland 20857; email: [email protected]. Comments may also be faxed 
to 301-480-1312. Those individuals who want to make oral comments 
are required to notify Debi Sarkar via email or regular mail by 5 
p.m. Eastern Daylight Time, Thursday, September 6, 2012. 
Notification is required in order to present oral comments, Oral 
comments will be heard on September 13, 2012. All written and oral 
comments should contain the name, address, telephone number, 
professional or business affiliation of the author, and topic of 
comment. Presentations of oral comments may be limited depending on 
the number of presenters. Individuals who are associated with groups 
having similar interests are requested to combine their comments and 
present them through a single representative. No audiovisual 
presentations are permitted, to ensure that all individuals who 
provided notification to make oral comments have an opportunity to 
present their comments.
    Contact Person: Anyone interested in obtaining other relevant 
information or attendees that will require special accommodations 
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]. More information on the 
Advisory Committee is available at http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.

    Dated: August 6, 2012.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2012-19654 Filed 8-9-12; 8:45 am]
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