National Institute on Drug Abuse; Notice of Closed Meeting, 7841 [2017-01253]
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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]
BILLING CODE 4164–01–P
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
VerDate Sep<11>2014
19:02 Jan 19, 2017
Jkt 241001
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)
PO 00000
Frm 00059
Fmt 4703
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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]
BILLING CODE 4140–01–P
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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[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Notices]
[Page 7841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01253]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
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 would
constitute a clearly unwarranted invasion of personal privacy.
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)
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]
BILLING CODE 4140-01-P
