National Institute of Mental Health; Notice of Closed Meetings, 55902-55903 [2018-24480]
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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
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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.
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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]
BILLING CODE 4140–01–P
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
08NON1
Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
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 of
Mental Health Special Emphasis Panel;
Silvio O. Conte Centers for Basic
Neuroscience or Translational Mental Health
Research (P50).
Date: November 14, 2018.
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: Rebecca Steiner Garcia,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH Neuroscience Center,
6001 Executive Blvd., Room 6149, MSC 9608,
Bethesda, MD 20892–9608, 301–443–4525,
steinerr@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 of
Mental Health Special Emphasis Panel; First
in Human and Early Stage Clinical Trials of
Novel Investigational Drugs or Devices for
Psychiatric Disorders.
Date: November 14, 2018.
Time: 1:00 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: Vinod Charles, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH Neuroscience Center,
6001 Executive Blvd., Room 6151, MSC 9606,
Bethesda, MD 20892–9606, 301–443–1606,
charlesvi@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 of
Mental Health Special Emphasis Panel;
NRSA Institutional Research Grant Training
Review.
Date: November 16, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications
Place: Washington Plaza Hotel, 10 Thomas
Circle NW, Washington, DC 20005.
Contact Person: Nicholas Gaiano, Ph.D.,
Review Branch Chief, Division of Extramural
Activities, National Institute of Mental
Health, NIH Neuroscience Center/Room
6150/MSC 9606, 6001 Executive Boulevard,
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Bethesda, MD 20892–9606, 301–443–2742,
nick.gaiano@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 No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: November 5, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–24480 Filed 11–7–18; 8:45 am]
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materials are at https://ntp.niehs.nih.gov/
go/165.
Webcast: The URL for viewing the
meeting webcast will be provided to
registrants.
Dr.
Mary Wolfe, Designated Federal Official
for the BSC, Office of Liaison, Policy
and Review, Division of NTP, NIEHS,
P.O. Box 12233, K2–03, Research
Triangle Park, NC 27709. Phone: 984–
287–3209, Fax: 301–451–5759, email:
wolfe@niehs.nih.gov. Hand Deliver/
Courier address: 530 Davis Drive, Room
K2130, Morrisville, NC 27560.
FOR FURTHER INFORMATION CONTACT:
The BSC
will provide input to the NTP on
programmatic activities and issues. The
agenda on December 11 will recognize
NTP’s 40th anniversary with the theme
‘‘Celebrate the Past, and Embrace the
Future,’’ and on December 12, several
talks will focus on translation as a
scientific framework. Please see the
preliminary agenda for information
about the specific presentations. The
preliminary agenda, roster of BSC
members, background materials, public
comments, and any additional
information, when available, will be
posted on the BSC meeting website
(https://ntp.niehs.nih.gov/go/165) or may
be requested in hardcopy from the
Designated Federal Official for the BSC.
Following the meeting, summary
minutes will be prepared and made
available on the BSC meeting website.
Meeting Attendance Registration: The
meeting is open to the public with time
set aside for oral public comment; inperson attendance at the NIEHS is
limited by the space available (∼100
attendees). Registration for in-person
attendance is on a first-come, firstserved basis, and registrants will be
assigned a number in their confirmation
email. After the first 100 registrants,
persons will be placed on a wait list and
notified should an opening become
available. Registration to attend the
meeting in-in person or view the
webcast is by December 12, 2018 at
https://ntp.niehs.nih.gov/go/165.
Registration is required to view the
webcast; the URL for the webcast will be
provided in the email confirming
registration. Visitor and security
information for those attending inperson is available at niehs.nih.gov/
about/visiting/index.cfm. Individuals
with disabilities who need
accommodation to participate in this
event should contact Ms. Robbin Guy at
phone: (984) 287–3136 or email: guyr2@
niehs.nih.gov. TTY users should contact
the Federal TTY Relay Service at 800–
877–8339. Requests should be made at
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Toxicology Program Board of
Scientific Counselors; Announcement
of Meeting; Request for Comments
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This notice announces the
next meeting of the National Toxicology
Program (NTP) Board of Scientific
Counselors (BSC). The BSC, a federally
chartered, external advisory group
composed of scientists from the public
and private sectors, will review and
provide advice on programmatic
activities. The meeting is open to the
public and registration is requested for
both attendance and oral comment and
required to access the webcast.
Information about the meeting and
registration are available at https://
ntp.niehs.nih.gov/go/165.
DATES:
Meeting: Scheduled for December 11,
2018 at 8:30 a.m. to adjournment on
December 12, 2018 at approximately
5:00 p.m. Eastern Standard Time (EST).
Written Public Comment
Submissions: Deadline is December 3,
2018.
Registration for Oral Comments:
Deadline is December 3, 2018.
Registration to Attend Meeting Inperson or to View Webcast: Deadline is
December 12, 2018.
Registration to view the meeting via
the webcast is required.
ADDRESSES:
Meeting Location: Rodbell
Auditorium, Rall Building, National
Institute of Environmental Health
Sciences (NIEHS), 111 T.W. Alexander
Drive, Research Triangle Park, NC
27709.
Meeting web page: The preliminary
agenda, registration, and other meeting
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Pages 55902-55903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24480]
-----------------------------------------------------------------------
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
[[Page 55903]]
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 of Mental Health Special
Emphasis Panel; Silvio O. Conte Centers for Basic Neuroscience or
Translational Mental Health Research (P50).
Date: November 14, 2018.
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: Rebecca Steiner Garcia, Ph.D., Scientific Review
Officer, Division of Extramural Activities, National Institute of
Mental Health, NIH Neuroscience Center, 6001 Executive Blvd., Room
6149, MSC 9608, Bethesda, MD 20892-9608, 301-443-4525,
[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 of Mental Health Special
Emphasis Panel; First in Human and Early Stage Clinical Trials of
Novel Investigational Drugs or Devices for Psychiatric Disorders.
Date: November 14, 2018.
Time: 1:00 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: Vinod Charles, Ph.D., Scientific Review Officer,
Division of Extramural Activities, National Institute of Mental
Health, NIH Neuroscience Center, 6001 Executive Blvd., Room 6151,
MSC 9606, Bethesda, MD 20892-9606, 301-443-1606,
[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 of Mental Health Special
Emphasis Panel; NRSA Institutional Research Grant Training Review.
Date: November 16, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications
Place: Washington Plaza Hotel, 10 Thomas Circle NW, Washington,
DC 20005.
Contact Person: Nicholas Gaiano, Ph.D., Review Branch Chief,
Division of Extramural Activities, National Institute of Mental
Health, NIH Neuroscience Center/Room 6150/MSC 9606, 6001 Executive
Boulevard, Bethesda, MD 20892-9606, 301-443-2742,
[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 No. 93.242, Mental
Health Research Grants, National Institutes of Health, HHS)
Dated: November 5, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-24480 Filed 11-7-18; 8:45 am]
BILLING CODE 4140-01-P
