National Institute on Drug Abuse; Notice of Closed Meetings, 55902 [2018-24470]
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55902
Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of
respondents
21 CFR section
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
310.305(c)(5) ........................................................................
314.80(c)(1)(iii) .....................................................................
314.80(c)(2) ..........................................................................
Reports of serious adverse drug events (21 U.S.C.
379aa((b) and (c)) ............................................................
3
5
810
1
1
17.19
3
5
13,923.90
1
1
60
3
5
835,434
283
687.099
194,449
6
1,166,694
Total ..............................................................................
........................
........................
........................
........................
2,002,136
1 The
2 The
reporting burden for § 310.305(c)(1), (2), and (3), and § 314.80(c)(1)(i) and (ii) is covered under OMB control number 0910–0645.
capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of
recordkeepers
21 CFR section
Average
burden per
recordkeeping
Total annual
records
Total
hours
310.305(g) ............................................................................
314.80(j) ...............................................................................
Recordkeeping (21 U.S.C. 379aa(e)(1)) ..............................
25
352
300
1
1,870
885.6667
25
658,240
265,700
16
16
8
400
10,531,840
2,125,600
Total ..............................................................................
........................
........................
........................
........................
12,657,840
1 There
2 There
are no capital costs or operating costs associated with this collection of information.
are maintenance costs of approximately $22,000 annually.
Based on submissions received we
have increased our burden estimate for
reporting under part 314.80(c)(2) and
recordkeeping under part 314.80(j).
Additionally, and as previously stated,
we are consolidating burden associated
with reporting and recordkeeping under
section 760 of the FD&C Act. Based on
our records, we received 194,449 total
annual reports from approximately 283
respondents for nonprescription drugs
marketed without an approved
application. We estimate each
submission takes approximately 6 hours
to prepare and submit. We estimate that
there are 265,700 records per year
maintained by approximately 300
respondents, and that it takes 8 hours to
maintain each record.
Dated: November 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24442 Filed 11–7–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
daltland on DSKBBV9HB2PROD with NOTICES
Number of
records per
recordkeeper
National Institute on Drug Abuse;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
VerDate Sep<11>2014
16:51 Nov 07, 2018
Jkt 247001
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: National Institute on
Drug Abuse Special Emphasis Panel; R13
Conference Grant Review.
Date: November 14, 2018.
Time: 12:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Ipolia R. Ramadan, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, Division of
Extramural Research, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Boulevard, Room 4228, MSC 9550, Bethesda,
MD 20892, 301–827–5842, ramadanir@
mail.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: National Institute on
Drug Abuse Special Emphasis Panel; Multisite Clinical Trials.
Date: November 16, 2018.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
PO 00000
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Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Ipolia R. Ramadan, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, Division of
Extramural Research, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Boulevard, Room 4228, MSC 9550, Bethesda,
MD 20892, 301–827–5842, ramadanir@
mail.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.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: November 2, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–24470 Filed 11–7–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
E:\FR\FM\08NON1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Page 55902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24470]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, 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: National Institute on Drug Abuse Special
Emphasis Panel; R13 Conference Grant Review.
Date: November 14, 2018.
Time: 12:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Ipolia R. Ramadan, Ph.D., Scientific Review
Officer, Office of Extramural Policy and Review, Division of
Extramural Research, National Institute on Drug Abuse, NIH, DHHS,
6001 Executive Boulevard, Room 4228, MSC 9550, Bethesda, MD 20892,
301-827-5842, [email protected].
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: National Institute on Drug Abuse Special
Emphasis Panel; Multi-site Clinical Trials.
Date: November 16, 2018.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852 (Telephone Conference
Call).
Contact Person: Ipolia R. Ramadan, Ph.D., Scientific Review
Officer, Office of Extramural Policy and Review, Division of
Extramural Research, National Institute on Drug Abuse, NIH, DHHS,
6001 Executive Boulevard, Room 4228, MSC 9550, Bethesda, MD 20892,
301-827-5842, [email protected].
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.: 93.279, Drug
Abuse and Addiction Research Programs, National Institutes of
Health, HHS)
Dated: November 2, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-24470 Filed 11-7-18; 8:45 am]
BILLING CODE 4140-01-P
