[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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