Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting, 47857 [2012-19654]
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47857
Federal Register / Vol. 77, No. 155 / Friday, August 10, 2012 / Notices
Instrument: A summary of the progress on the following
activities
Number of
respondents
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
Organizational Information ...................................................
33
1
33
2
66
Total ..............................................................................
33
1
33
........................
1,452
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by
email to OIRA_submission@omb.eop.
gov or by fax to 202–395–5806. Please
direct all correspondence to the
‘‘attention of the desk officer for HRSA.’’
Dated: August 6, 2012.
Wendy Ponton,
Director, Office of Management.
[FR Doc. 2012–19653 Filed 8–9–12; 8:45 am]
BILLING CODE 4165–15–P
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
mstockstill on DSK4VPTVN1PROD with NOTICES
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 https://
www.hrsa.gov/advisorycommittees/mchb
advisory/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
https://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
VerDate Mar<15>2010
18:02 Aug 09, 2012
Jkt 226001
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, HRSAfunded 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 https://www.hrsa.gov/advisory
committees/mchbadvisory/heritable
disorders.
Public Comments: Members of the public
can submit written comments and/or present
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
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: dsarkar@hrsa.gov.
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: dsarkar@
hrsa.gov. More information on the Advisory
Committee is available at https://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]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
E:\FR\FM\10AUN1.SGM
10AUN1
Agencies
[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Notices]
[Page 47857]
From the Federal Register Online via the Government Printing 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 https://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 https://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 https://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: dsarkar@hrsa.gov. 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: dsarkar@hrsa.gov. More information on the
Advisory Committee is available at https://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]
BILLING CODE 4165-15-P