National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting, 7841-7842 [2017-01252]
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7841
Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices
current good manufacturing practices
for medical devices regulation (21 CFR
part 820) may be relevant to a PMA
review and may be submitted as part of
an application. In individual instances,
records may be required as conditions of
approval to ensure the device’s
continuing safety and effectiveness.
In the Federal Register of October 19,
2016 (81 FR 72063), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/21 CFR or FD&C Act section
Research conducted outside the United States (814.15(b))
PMA application (814.20) ....................................................
PMA amendments and resubmitted PMAs (814.37(a)–(c)
and (e)) .............................................................................
PMA supplements (814.39(a)) .............................................
Special PMA supplement—changes being affected
(814.39(d)) ........................................................................
30-day notice (814.39(f)) .....................................................
Postapproval requirements (814.82(a)(9)) ...........................
Periodic reports (814.84(b)) .................................................
Agreement meeting (520(g)(7)) ...........................................
Expedited review request (515(d)(5) of the FD&C Act) ......
Determination Meeting (513(1)(3)(D) of the FD&C Act) ......
Panel meeting (515(c)(3) of the FD&C Act) ........................
Day 100 meeting (515(d)(3) of the FD&C Act) ...................
Total .....................................................................................
1 There
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25
35
1
1
25
35
2
668
50
23,380
1,222
695
1
1
1,222
695
167
60
204,074
41,700
88
1,710
340
695
1
6
1
9
19
1
1
1
1
1
1
1
1
1
88
1,710
340
695
1
6
1
9
19
6
16
135
10
50
10
50
30
10
528
27,360
45,900
6,950
50
60
50
270
190
........................
........................
........................
........................
350,562
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity/21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
responses
Average
burden per
response
Total hours
Maintenance of records (814.82(a)(5) and (a)(6)) ...............
422
1
422
17
7,174
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
would constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2017–01188 Filed 1–19–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK3G9T082PROD with NOTICES
National Institute on Drug Abuse;
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 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
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Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; Virtual
Reality Tools to Enhance Evidence-Based
Treatment of Substance Use Disorders (5583).
Date: February 1, 2017.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Gerald L. McLaughlin,
Ph.D., Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, NIH, DHHS, 6001
Executive Blvd., Room 4238, MSC 9550,
Bethesda, MD 20892–9550, 301–827–5819,
gm145a@nih.gov.
(Catalogue of Federal Domestic Assistance
Program No.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
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Dated: January 13, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–01253 Filed 1–19–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; 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
E:\FR\FM\23JAN1.SGM
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7842
Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; P41 BTRC Review
(2017/05).
Date: March 16, 2017.
Time: 08:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, Suite 920, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Dennis Hlasta, Ph.D.,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707
Democracy Blvd., Bethesda, MD 20892, (301)
451–4794, dennis.hlasta@nih.gov.
Dated: January 12, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–01252 Filed 1–19–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
mstockstill on DSK3G9T082PROD 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 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; SBIB
Clinical Pediatric and Fetal Applications.
Date: February 15, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Songtao Liu, M.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5108,
Bethesda, MD 20817, 301–435–3578,
songtao.liu@nih.gov.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
VerDate Sep<11>2014
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Oral, Dental and Craniofacial Sciences Study
Section.
Date: February 16–17, 2017.
Time: 7:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree by Hilton Los Angeles
Westside Hotel, 6161 W. Centinela Avenue,
Culver City, CA 90230.
Contact Person: Yi-Hsin Liu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4214,
MSC 7814, Bethesda, MD 20892, 301–435–
1781, liuyh@csr.nih.gov.
Name of Committee: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group; Macromolecular Structure
and Function A Study Section.
Date: February 16–17, 2017.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Pier 2620 Hotel, 2620 Jones Street,
San Francisco, CA 94133.
Contact Person: Nitsa Rosenzweig, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4152,
MSC 7760, Bethesda, MD 20892, (301) 404–
7419, rosenzweign@csr.nih.gov.
Name of Committee: Immunology
Integrated Review Group; Innate Immunity
and Inflammation Study Section.
Date: February 16–17, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Ritz-Carlton, Pentagon City,
1250 South Hayes St., Arlington, VA 22202.
Contact Person: Tina McIntyre, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4202,
MSC 7812, Bethesda, MD 20892, 301–594–
6375, mcintyrt@csr.nih.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group; Cellular,
Molecular and Integrative Reproduction
Study Section.
Date: February 16–17, 2017.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westgate Hotel, 1055 Second
Avenue, San Diego, CA 92101.
Contact Person: Gary Hunnicutt, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6164,
MSC 7892, Bethesda, MD 20892, 301–435–
0229, hunnicuttgr@csr.nih.gov.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Myocardial Ischemia and Metabolism
Study Section.
Date: February 16–17, 2017.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Fairmont Washington, DC, 2401
M Street NW., Washington, DC 20037.
Contact Person: Kimm Hamann, Ph.D.,
Scientific Review Officer, Center for
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Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118A,
MSC 7814, Bethesda, MD 20892, 301–435–
5575, hamannkj@csr.nih.gov.
Name of Committee: Genes, Genomes, and
Genetics Integrated Review Group; Genetic
Variation and Evolution Study Section.
Date: February 16–17, 2017.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance M Street Hotel, 1143
New Hampshire Avenue NW., Washington,
DC 20037.
Contact Person: Ronald Adkins, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2206,
MSC 7890, Bethesda, MD 20892, 301–435–
4511, ronald.adkins@nih.gov.
Name of Committee: Emerging
Technologies and Training Neurosciences
Integrated Review Group; Molecular
Neurogenetics Study Section.
Date: February 16–17, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Mary G Schueler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5214,
MSC 7846, Bethesda, MD 20892, 301–915–
6301, marygs@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group, Diseases and Pathophysiology of the
Visual System Study Section.
Date: February 16–17, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bahia Resort Hotel, 998 West
Mission Bay Drive, San Diego, CA 92109.
Contact Person: Nataliya Gordiyenko,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5202,
MSC 7846, Bethesda, MD 20892,
301.435.1265, gordiyenkon@csr.nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Child Psychopathology and
Developmental Disabilities Study Section.
Date: February 16–17, 2017.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz-Carlton Hotel, 1700 Tysons
Boulevard, McLean, VA 22102.
Contact Person: Jane A DoussardRoosevelt, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 3184, MSC 7848, Bethesda, MD 20892,
(301) 435–4445, doussarj@csr.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group,
Community Influences on Health Behavior
Study Section.
Date: February 16–17, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
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]]>Agencies
[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Notices]
[Pages 7841-7842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01252]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering;
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
[[Page 7842]]
individuals associated with the grant applications, the disclosure of
which would constitute a clearly unwarranted invasion of personal
privacy.
Name of Committee: National Institute of Biomedical Imaging and
Bioengineering Special Emphasis Panel; P41 BTRC Review (2017/05).
Date: March 16, 2017.
Time: 08:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Two Democracy Plaza, Suite
920, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Dennis Hlasta, Ph.D., Scientific Review Officer,
National Institute of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707 Democracy Blvd., Bethesda, MD
20892, (301) 451-4794, dennis.hlasta@nih.gov.
Dated: January 12, 2016.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-01252 Filed 1-19-17; 8:45 am]
BILLING CODE 4140-01-P
