80_FR_46187 80 FR 46039 - Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting

80 FR 46039 - Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 80, Issue 148 (August 3, 2015)

Page Range46039-46039
FR Document2015-18953

Federal Register, Volume 80 Issue 148 (Monday, August 3, 2015) 
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Page 46039]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18953]


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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: August 27, 2015, 9 a.m. to 5 p.m.
    August 28, 2015, 10 a.m. to 1 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. Please 
register at https://www.blsmeetings.net/ACHDNCAugust2015. The 
registration deadline is Friday, August 14, 2015, 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, Sec.  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 one year from the Secretary's 
adoption of the condition for screening.
    Agenda: The meeting will include: (1) A final evidence review 
report on the Adrenoleukodystrophy (ALD) condition nomination for 
inclusion in the RUSP; (2) a presentation by the Newborn Screening 
Technical Assistance and Evaluation Program (NewSTEPs) on their 
activities and the NewSTEPs data repository, a centralized and secure 
database designed for state newborn screening programs to explore data 
to meet program needs; (3) updates on the implementation of screening 
for Severe Combined Immunodeficiency, Critical Congenital Heart 
Disease, and Pompe Disease; and (4) updates from workgroups focused on 
cost analysis in newborn screening, newborn screening timeliness, and 
pilot studies for evidence-based reviews of conditions. Following the 
final evidence review report on ALD, the Committee also is expected to 
vote on whether or not to recommend to the Secretary the addition of 
ALD to the RUSP. 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. Please register 
at https://www.blsmeetings.net/ACHDNCAugust2015. The registration 
deadline is Friday, August 14, 2015, 11:59 p.m. Eastern Time. Written 
comments must be received by the deadline in order to be included in 
the August 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].
    Contact Person: Anyone interested in obtaining other relevant 
information should contact Debi Sarkar, Maternal and Child Health 
Bureau, Health Resources and Services Administration, Room 18W68, 
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,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-18953 Filed 7-31-15; 8:45 am]
BILLING CODE 4165-15-P

Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 46039 manufacture, preparation, propagation, included in the Recommended Uniform comments should identify the compounding, or processing of licensed Screening Panel (RUSP) and constitute individual’s name, address, email, biologic devices. CBER will send part of the comprehensive guidelines telephone number, professional or invoices for payment of the supported by the Health Resources and business affiliation, type of expertise establishment registration fee to such Services Administration. Pursuant to (i.e., parent, researcher, clinician, public establishments. section 2713 of the Public Health health, etc.), and the topic/subject Dated: July 28, 2015. Service Act, codified at 42 U.S.C. matter of comments. To ensure that all 300gg–13, non-grandfathered health individuals who have registered to make Leslie Kux, plans and group and individual health oral comments can be accommodated, Associate Commissioner for Policy. insurance issuers are required to cover the allocated time may be limited. [FR Doc. 2015–18907 Filed 7–31–15; 8:45 am] evidence-informed care and screenings Individuals who are associated with BILLING CODE 4164–01–P included in the HRSA-supported groups or have similar interests may be comprehensive guidelines without requested to combine their comments charging a co-payment, co-insurance, or and present them through a single DEPARTMENT OF HEALTH AND deductible for plan years (in the representative. No audiovisual HUMAN SERVICES individual market, policy years) presentations are permitted. For beginning on or after the date that is one additional information or questions on Health Resources and Services year from the Secretary’s adoption of the public comments, please contact Lisa Administration condition for screening. Vasquez, Maternal and Child Health Advisory Committee on Heritable Agenda: The meeting will include: (1) Bureau, Health Resources and Services Disorders in Newborns and Children; A final evidence review report on the Administration; email: lvasquez@ Notice of Meeting Adrenoleukodystrophy (ALD) condition hrsa.gov. nomination for inclusion in the RUSP; Contact Person: Anyone interested in In accordance with section 10(a)(2) of (2) a presentation by the Newborn obtaining other relevant information the Federal Advisory Committee Act Screening Technical Assistance and should contact Debi Sarkar, Maternal (Pub. L. 92–463, codified at 5 U.S.C. Evaluation Program (NewSTEPs) on and Child Health Bureau, Health App.), notice is hereby given of the their activities and the NewSTEPs data Resources and Services Administration, following meeting: repository, a centralized and secure Room 18W68, Parklawn Building, 5600 Name: Advisory Committee on database designed for state newborn Fishers Lane, Rockville, Maryland Heritable Disorders in Newborns and screening programs to explore data to 20857; email: dsarkar@hrsa.gov.More Children meet program needs; (3) updates on the information on the Advisory Committee Dates and Times: August 27, 2015, 9 implementation of screening for Severe is available at http://www.hrsa.gov/ a.m. to 5 p.m. Combined Immunodeficiency, Critical advisorycommittees/mchbadvisory/ August 28, 2015, 10 a.m. to 1 p.m. Congenital Heart Disease, and Pompe heritabledisorders. Place: Webinar and In-Person, Disease; and (4) updates from National Institutes of Health, 5635 workgroups focused on cost analysis in Jackie Painter, Fishers Lane, Rockville, Maryland newborn screening, newborn screening Director, Division of the Executive Secretariat. 20857 timeliness, and pilot studies for [FR Doc. 2015–18953 Filed 7–31–15; 8:45 am] Status: The meeting will be open to evidence-based reviews of conditions. BILLING CODE 4165–15–P the public with attendance limited to Following the final evidence review space availability. Participants also have report on ALD, the Committee also is the option of viewing the meeting via expected to vote on whether or not to DEPARTMENT OF HEALTH AND webinar. Whether attending in-person recommend to the Secretary the HUMAN SERVICES or via webinar, all participants must addition of ALD to the RUSP. Agenda register for the meeting. Please register items are subject to change as necessary National Institutes of Health at https://www.blsmeetings.net/ or appropriate. The agenda, webinar ACHDNCAugust2015. The registration Center for Scientific Review; Notice of information, Committee Roster, Charter, Closed Meeting deadline is Friday, August 14, 2015, presentations, and other meeting 11:59 p.m. Eastern Time. materials will be located on the Pursuant to section 10(d) of the Purpose: The Advisory Committee on Advisory Committee’s Web site at Federal Advisory Committee Act, as Heritable Disorders in Newborns and http://www.hrsa.gov/ amended (5 U.S.C. App.), notice is Children (Committee), as authorized by advisorycommittees/mchbadvisory/ hereby given of the following meeting. Public Health Service Act, Title XI, heritabledisorders. The meeting will be closed to the § 1111 (42 U.S.C. 300b-10), as amended Public Comments: Members of the public in accordance with the by the Newborn Screening Saves Lives public may present oral comments and/ provisions set forth in sections Reauthorization Act of 2014 (Pub. L. or submit written comments. Comments 552b(c)(4) and 552b(c)(6), title 5 U.S.C., 113–240), was established to advise the are part of the official Committee record. as amended. The grant applications and Secretary of the Department of Health The public comment period is the discussions could disclose and Human Services about the tentatively scheduled for both days of confidential trade secrets or commercial development of newborn screening the meeting. Advance registration is property such as patentable material, activities, technologies, policies, required to present oral comments and/ and personal information concerning mstockstill on DSK4VPTVN1PROD with NOTICES guidelines, and programs for effectively or submit written comments. Please individuals associated with the grant reducing morbidity and mortality in register at https://www.blsmeetings.net/ applications, the disclosure of which newborns and children having, or at risk ACHDNCAugust2015. The registration would constitute a clearly unwarranted for, heritable disorders. In addition, the deadline is Friday, August 14, 2015, invasion of personal privacy. Committee’s recommendations 11:59 p.m. Eastern Time. Written Name of Committee: Center for Scientific regarding additional conditions/ comments must be received by the Review Special Emphasis Panel; Member heritable disorders for screening that deadline in order to be included in the Conflict: HIV Molecular Biology. have been adopted by the Secretary are August meeting briefing book. Written Date: August 7, 2015. VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 PO 00000 Frm 00108 Fmt 4703 Sfmt 4703 E:\FR\FM\03AUN1.SGM 03AUN1


Document Created: 2018-02-23 10:51:19
Document Modified: 2018-02-23 10:51:19
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation80 FR 46039 
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