Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting, 46039 [2015-18953]
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Leslie Kux,
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[FR Doc. 2015–18907 Filed 7–31–15; 8:45 am]
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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
https://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 https://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]
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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 https://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 https://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