Center For Scientific Review; Notice of Closed Meetings, 64920-64921 [2016-22666]
Download as PDF
64920
Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices
III. Listing of New Entries
In table 2, FDA provides the listing of
new entries and consensus standards
added as modifications to the list of
recognized standards under Recognition
List Number: 045.
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Title of standard 1
Recognition No.
Reference No. and date
A. General I (Quality Systems/Risk Management) (QS/RM)
5–110 ..............................................
5–111 ..............................................
5–112 ..............................................
Packaged-Products for Parcel Delivery System Shipment 70 kg (150
lb) or Less.
Packaged-Products for Less-Than-Truckload (LTL) Shipment .............
Unitized Loads of Same Product ...........................................................
ISTA 3A 2008.
ISTA 3B 2012.
ISTA 3E 2009.
B. In Vitro Diagnostics (IVD)
7–265 ..............................................
7–266 ..............................................
Liquid Chromatography-Mass Spectrometry Methods; Approved
Guideline.
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures.
C62–A: 2014.
EP19 Second Edition: 2015.
C. Ophthalmic
10–101 ............................................
10–102 ............................................
1 All
Ophthalmic optics—Contact lenses and contact lens care products—
Cytotoxicity testing of contact lenses in combination with lens care
solution to evaluate lens/solution interactions.
American National Standard for Ophthalmics—Light Hazard Protection for Ophthalmic Instruments.
ANSI Z80.36—2016.
standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards
FDA maintains the Agency’s current
list of FDA Recognized Consensus
Standards in a searchable database that
may be accessed directly at FDA’s
Internet site at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. FDA
will incorporate the modifications and
revisions described in this notice into
the database and, upon publication in
the Federal Register, this recognition of
consensus standards will be effective.
FDA will announce additional
modifications and revisions to the list of
recognized consensus standards, as
needed, in the Federal Register once a
year, or more often if necessary.
Beginning with Recognition List 033,
FDA no longer announces minor
revisions to the list of recognized
consensus standards such as technical
contact person, devices affected,
processes affected, Code of Federal
Regulations citations, and product
codes.
mstockstill on DSK3G9T082PROD with NOTICES
ISO 18189 First edition 2016–06–
01.
information: (1) Title of the standard, (2)
any reference number and date, (3)
name and address of the national or
international standards development
organization, (4) a proposed list of
devices for which a declaration of
conformity to this standard should
routinely apply, and (5) a brief
identification of the testing or
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
VI. Electronic Access
You may obtain a copy of ‘‘Guidance
on the Recognition and Use of
Consensus Standards’’ by using the
Internet. The Center for Devices and
Radiological Health (CDRH) maintains a
site on the Internet for easy access to
information including text, graphics,
and files that you may download to a
personal computer with access to the
Internet. Updated on a regular basis, the
CDRH home page, https://www.fda.gov/
MedicalDevices, includes a link to
standards-related documents including
V. Recommendation of Standards for
the guidance and the current list of
Recognition by FDA
recognized standards. After publication
in the Federal Register, this notice
Any person may recommend
announcing ‘‘Modification to the List of
consensus standards as candidates for
Recognized Standards, Recognition List
recognition under section 514 of the
Number: 045’’ will be available at https://
FD&C Act by submitting such
www.fda.gov/MedicalDevices/
recommendations, with reasons for the
DeviceRegulationandGuidance/
recommendation, to standards@
cdrh.fda.gov. To be properly considered, Standards/ucm123792.htm. You may
access ‘‘Guidance on the Recognition
such recommendations should contain,
and Use of Consensus Standards,’’ and
at a minimum, the following
VerDate Sep<11>2014
18:19 Sep 20, 2016
Jkt 238001
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
the searchable database for ‘‘FDA
Recognized Consensus Standards’’ at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards.
Dated: September 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–22710 Filed 9–20–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of
Closed Meetings
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 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.
E:\FR\FM\21SEN1.SGM
21SEN1
mstockstill on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Prokaryotic
Gene Expression.
Date: October 5, 2016.
Time: 9:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Richard A. Currie, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1108,
MSC 7890, Bethesda, MD 20892, (301) 435–
1219, currieri@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.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Musculoskeletal Rehabilitation Sciences
Study Section.
Date: October 17, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Westin BWI, 1110 Old Elkridge
Landing Road, Linthicum, MD 21090.
Contact Person: Maria Nurminskaya, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, Bethesda, MD 20892, (301) 435–1222,
nurminskayam@csr.nih.gov.
Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group;
Virology—B Study Section.
Date: October 17–18, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Alexandria Old
Town, 1456 Duke St, Alexandria, VA 22314.
Contact Person: John C. Pugh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1206,
MSC 7808, Bethesda, MD 20892, (301) 435–
2398, pughjohn@csr.nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Mechanisms of
Sensory, Perceptual, and Cognitive Processes
Study Section.
Date: October 17–18, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Plaza Hotel, 10 Thomas
Circle NW., Washington, DC 20005.
Contact Person: Kirk Thompson, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5184,
MSC 7844, Bethesda, MD 20892, 301–435–
1242, kgt@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Vaccine
Related Immune Activation and
Immunoregulation.
Date: October 18, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
VerDate Sep<11>2014
18:19 Sep 20, 2016
Jkt 238001
64921
Place: Doubletree Hotel Bethesda,
(Formerly Holiday Inn Select), 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Liying Guo, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4016F,
Bethesda, MD 20892, 301–435–0908, lguo@
mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–16–
114: Spermatogenic Stem Cell Culture
Systems to Preserve and Restore
Reproductive Capacity in Males.
Date: October 19, 2016.
Time: 2:00 p.m. to 6:00 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: Clara M. Cheng, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6170,
MSC 7892, Bethesda, MD 20892, 301–435–
1041, chengc@csr.nih.gov.
(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)
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Robert S. Balaban, Ph.D.,
Scientific Director, National Heart, Lung, and
Blood Institute, National Institutes of Health,
Building 10, 10 Center Drive, CRC, 4th Floor,
Room 1581, Bethesda, MD 20892, 301–496–
2116, balabanr@nhlbi.nih.gov.
Information is also available on the
Institute’s/Center’s home page:
www.nhlbi.nih.gov/meetings/index.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(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: September 15, 2016.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–22666 Filed 9–20–16; 8:45 am]
Center for Scientific Review; Notice of
Closed Meetings
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; 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 a meeting of the Board
of Scientific Counselors, NHLBI. The
meeting will be closed to the public as
indicated below in accordance with the
provisions set forth in section
552b(c)(6), title 5 U.S.C., as amended for
the review, discussion, and evaluation
of individual intramural programs and
projects conducted by the NATIONAL
HEART, LUNG, AND BLOOD
INSTITUTE, including consideration of
personnel qualifications and
performance, and the competence of
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Board of Scientific
Counselors, NHLBI.
Date: October 25, 2016.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Dated: September 15, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–22667 Filed 9–20–16; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
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 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: Oncology 1-Basic
Translational Integrated Review Group;
Tumor Microenvironment Study Section.
Date: October 13–14, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Angela Y. Ng, MBA, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6200,
MSC 7804, Bethesda, MD 20892, 301–435–
1715, ngan@mail.nih.gov.
E:\FR\FM\21SEN1.SGM
21SEN1
Agencies
[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Notices]
[Pages 64920-64921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22666]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
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 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.
[[Page 64921]]
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Prokaryotic Gene Expression.
Date: October 5, 2016.
Time: 9:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Richard A. Currie, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1108, MSC 7890, Bethesda, MD
20892, (301) 435-1219, currieri@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.
Name of Committee: Musculoskeletal, Oral and Skin Sciences
Integrated Review Group; Musculoskeletal Rehabilitation Sciences
Study Section.
Date: October 17, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Westin BWI, 1110 Old Elkridge Landing Road, Linthicum, MD
21090.
Contact Person: Maria Nurminskaya, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, Bethesda, MD 20892, (301) 435-1222,
nurminskayam@csr.nih.gov.
Name of Committee: Infectious Diseases and Microbiology
Integrated Review Group; Virology--B Study Section.
Date: October 17-18, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn Alexandria Old Town, 1456 Duke St,
Alexandria, VA 22314.
Contact Person: John C. Pugh, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 1206, MSC 7808, Bethesda, MD 20892, (301) 435-
2398, pughjohn@csr.nih.gov.
Name of Committee: Integrative, Functional and Cognitive
Neuroscience Integrated Review Group; Mechanisms of Sensory,
Perceptual, and Cognitive Processes Study Section.
Date: October 17-18, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Washington Plaza Hotel, 10 Thomas Circle NW., Washington,
DC 20005.
Contact Person: Kirk Thompson, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5184, MSC 7844, Bethesda, MD 20892, 301-435-
1242, kgt@mail.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Vaccine Related Immune Activation and Immunoregulation.
Date: October 18, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Doubletree Hotel Bethesda, (Formerly Holiday Inn Select),
8120 Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Liying Guo, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4016F, Bethesda, MD 20892, 301-435-0908,
lguo@mail.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR-16-114: Spermatogenic Stem Cell Culture Systems to
Preserve and Restore Reproductive Capacity in Males.
Date: October 19, 2016.
Time: 2:00 p.m. to 6:00 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: Clara M. Cheng, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6170, MSC 7892, Bethesda, MD
20892, 301-435-1041, chengc@csr.nih.gov.
(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: September 15, 2016.
Carolyn Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-22666 Filed 9-20-16; 8:45 am]
BILLING CODE 4140-01-P