Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting, 46039 [2015-18953]

Download as PDF Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices manufacture, preparation, propagation, compounding, or processing of licensed biologic devices. CBER will send invoices for payment of the establishment registration fee to such establishments. Dated: July 28, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–18907 Filed 7–31–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration mstockstill on DSK4VPTVN1PROD with NOTICES 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, § 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 VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 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 PO 00000 Frm 00108 Fmt 4703 Sfmt 4703 46039 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: lvasquez@ hrsa.gov. 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: dsarkar@hrsa.gov.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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: HIV Molecular Biology. Date: August 7, 2015. E:\FR\FM\03AUN1.SGM 03AUN1

Agencies

[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Page 46039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: lvasquez@hrsa.gov.
    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: 
dsarkar@hrsa.gov.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