Center for Scientific Review; Notice of Closed Meeting, 46039-46040 [2015-18875]
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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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
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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
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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
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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.
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46040
Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Shiv A. Prasad, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5220,
MSC 7852, Bethesda, MD 20892, 301–443–
5779, prasads@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS).
Dated: July 28, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–18875 Filed 7–31–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
mstockstill on DSK4VPTVN1PROD with NOTICES
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 meetings.
The meetings 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
Science Moving TowArds Research
Translation and Therapy (SMARTT),
Coordinating Center—Program Extension.
Date: August 25, 2015.
Time: 3:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7185, Bethesda, MD
20892, (Telephone Conference Call).
Contact Person: Kristen Page, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7185, Bethesda, MD 20892, 301–435–0725,
kristen.page@nih.gov.
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Name of Committee: National Heart, Lung,
and Blood Institute, Special Emphasis Panel,
Science Moving TowArds Research
Translation and Therapy (SMARTT),
Biologics Production Facility (PF), Program
Extension.
Date: August 25, 2015.
Time: 3:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7185, Bethesda, MD
20892, (Telephone Conference Call).
Contact Person: Kristen Page, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7185, Bethesda, MD 20892, 301–435–0725,
kristen.page@nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute, Special Emphasis Panel,
Science Moving TowArds Research
Translation and Therapy (SMARTT), NonBiological Production Facility (PF), Program
Extension.
Date: August 25, 2015.
Time: 4:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7185, Bethesda, MD
20892, (Telephone Conference Call).
Contact Person: Kristen Page, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7185, Bethesda, MD 20892, 301–435–0725,
kristen.page@nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute, Special Emphasis Panel,
Science Moving TowArds Research
Translation and Therapy (SMARTT),
Pharmacology and Toxicology, Program
Extension.
Date: August 25, 2015.
Time: 4:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7185, Bethesda, MD
20892, (Telephone Conference Call).
Contact Person: Kristen Page, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7185, Bethesda, MD 20892, 301–435–0725,
kristen.page@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: July 28, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–18874 Filed 7–31–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of HHS-Certified
Laboratories and Instrumented Initial
Testing Facilities Which Meet Minimum
Standards To Engage in Urine Drug
Testing for Federal Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) notifies federal
agencies of the laboratories and
Instrumented Initial Testing Facilities
(IITF) currently certified to meet the
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines). The
Mandatory Guidelines were first
published in the Federal Register on
April 11, 1988 (53 FR 11970), and
subsequently revised in the Federal
Register on June 9, 1994 (59 FR 29908);
September 30, 1997 (62 FR 51118);
April 13, 2004 (69 FR 19644); November
25, 2008 (73 FR 71858); December 10,
2008 (73 FR 75122); and on April 30,
2010 (75 FR 22809).
A notice listing all currently HHScertified laboratories and IITFs is
published in the Federal Register
during the first week of each month. If
any laboratory or IITF certification is
suspended or revoked, the laboratory or
IITF will be omitted from subsequent
lists until such time as it is restored to
full certification under the Mandatory
Guidelines.
If any laboratory or IITF has
withdrawn from the HHS National
Laboratory Certification Program (NLCP)
during the past month, it will be listed
at the end and will be omitted from the
monthly listing thereafter.
This notice is also available on the
Internet at https://www.samhsa.gov/
workplace.
FOR FURTHER INFORMATION CONTACT:
Giselle Hersh, Division of Workplace
Programs, SAMHSA/CSAP, Room 7–
1051, One Choke Cherry Road,
Rockville, Maryland 20857; 240–276–
2600 (voice), 240–276–2610 (fax).
SUPPLEMENTARY INFORMATION: The
Mandatory Guidelines were initially
developed in accordance with Executive
Order 12564 and section 503 of Public
Law 100–71. The ‘‘Mandatory
Guidelines for Federal Workplace Drug
Testing Programs,’’ as amended in the
revisions listed above, requires strict
standards that laboratories and IITFs
must meet in order to conduct drug and
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46039-46040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18875]
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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.
[[Page 46040]]
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Shiv A. Prasad, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5220, MSC 7852, Bethesda, MD
20892, 301-443-5779, prasads@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS).
Dated: July 28, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-18875 Filed 7-31-15; 8:45 am]
BILLING CODE 4140-01-P
