83 FR 55902 - National Institute of Mental Health; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 217 (November 8, 2018)

Page Range		55902-55903
FR Document		2018-24480

Federal Register, Volume 83 Issue 217 (Thursday, November 8, 2018)

[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Pages 55902-55903]
From the Federal Register Online  [www.thefederalregister.org]
[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, 
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, 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]
 BILLING CODE 4140-01-P

55902 Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

310.305(c)(5) ........................................................................ 3 1 3 1 3
314.80(c)(1)(iii) ..................................................................... 5 1 5 1 5
314.80(c)(2) .......................................................................... 810 17.19 13,923.90 60 835,434
Reports of serious adverse drug events (21 U.S.C.
379aa((b) and (c)) ............................................................ 283 687.099 194,449 6 1,166,694

Total .............................................................................. ........................ ........................ ........................ ........................ 2,002,136
1 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.
2 The 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 Average
Number of Total annual Total
21 CFR section records per burden per
recordkeepers records hours
recordkeeper recordkeeping

310.305(g) ............................................................................ 25 1 25 16 400
314.80(j) ............................................................................... 352 1,870 658,240 16 10,531,840
Recordkeeping (21 U.S.C. 379aa(e)(1)) .............................. 300 885.6667 265,700 8 2,125,600

Total .............................................................................. ........................ ........................ ........................ ........................ 12,657,840
1 There are no capital costs or operating costs associated with this collection of information.
2 There are maintenance costs of approximately $22,000 annually.

Based on submissions received we provisions set forth in sections Place: National Institutes of Health,
have increased our burden estimate for 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Neuroscience Center, 6001 Executive
reporting under part 314.80(c)(2) and as amended. The grant applications and Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
recordkeeping under part 314.80(j). the discussions could disclose
Additionally, and as previously stated, confidential trade secrets or commercial Contact Person: Ipolia R. Ramadan, Ph.D.,
Scientific Review Officer, Office of
we are consolidating burden associated property such as patentable material, Extramural Policy and Review, Division of
with reporting and recordkeeping under and personal information concerning Extramural Research, National Institute on
section 760 of the FD&C Act. Based on individuals associated with the grant Drug Abuse, NIH, DHHS, 6001 Executive
our records, we received 194,449 total applications, the disclosure of which Boulevard, Room 4228, MSC 9550, Bethesda,
annual reports from approximately 283 would constitute a clearly unwarranted MD 20892, 301–827–5842, ramadanir@
respondents for nonprescription drugs invasion of personal privacy. mail.nih.gov.
marketed without an approved This notice is being published less than 15
Name of Committee: National Institute on days prior to the meeting due to the timing
application. We estimate each Drug Abuse Special Emphasis Panel; R13 limitations imposed by the review and
submission takes approximately 6 hours Conference Grant Review. funding cycle.
to prepare and submit. We estimate that Date: November 14, 2018. (Catalogue of Federal Domestic Assistance
there are 265,700 records per year Time: 12:00 p.m. to 3:30 p.m. Program Nos.: 93.279, Drug Abuse and
maintained by approximately 300 Agenda: To review and evaluate grant Addiction Research Programs, National
respondents, and that it takes 8 hours to applications. Institutes of Health, HHS)
maintain each record. Place: National Institutes of Health,
Dated: November 2, 2018.
Neuroscience Center, 6001 Executive
Dated: November 2, 2018. Natasha M. Copeland,
Boulevard, Rockville, MD 20852, (Telephone
Leslie Kux, Conference Call). Program Analyst, Office of Federal Advisory
Associate Commissioner for Policy. Contact Person: Ipolia R. Ramadan, Ph.D., Committee Policy.
[FR Doc. 2018–24442 Filed 11–7–18; 8:45 am] Scientific Review Officer, Office of [FR Doc. 2018–24470 Filed 11–7–18; 8:45 am]
BILLING CODE 4164–01–P Extramural Policy and Review, Division of BILLING CODE 4140–01–P
Extramural Research, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
DEPARTMENT OF HEALTH AND Boulevard, Room 4228, MSC 9550, Bethesda, DEPARTMENT OF HEALTH AND
HUMAN SERVICES MD 20892, 301–827–5842, ramadanir@ HUMAN SERVICES
mail.nih.gov.
National Institutes of Health This notice is being published less than 15 National Institutes of Health
days prior to the meeting due to the timing
National Institute on Drug Abuse; limitations imposed by the review and National Institute of Mental Health;
funding cycle.
daltland on DSKBBV9HB2PROD with NOTICES

Notice of Closed Meetings Notice of Closed Meetings
Name of Committee: National Institute on
Pursuant to section 10(d) of the Drug Abuse Special Emphasis Panel; Multi- Pursuant to section 10(d) of the
Federal Advisory Committee Act, as site Clinical Trials. Federal Advisory Committee Act, as
amended, notice is hereby given of the Date: November 16, 2018. amended, notice is hereby given of the
following meetings. Time: 12:00 p.m. to 3:00 p.m. following meetings.
The meetings will be closed to the Agenda: To review and evaluate grant The meetings will be closed to the
public in accordance with the applications. public in accordance with the

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Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices 55903

provisions set forth in sections Bethesda, MD 20892–9606, 301–443–2742, materials are at http://ntp.niehs.nih.gov/
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., nick.gaiano@nih.gov. go/165.
as amended. The grant applications and This notice is being published less than 15 Webcast: The URL for viewing the
the discussions could disclose days prior to the meeting due to the timing meeting webcast will be provided to
confidential trade secrets or commercial limitations imposed by the review and
funding cycle.
registrants.
property such as patentable material,
and personal information concerning (Catalogue of Federal Domestic Assistance FOR FURTHER INFORMATION CONTACT: Dr.
Program No. 93.242, Mental Health Research Mary Wolfe, Designated Federal Official
individuals associated with the grant
Grants, National Institutes of Health, HHS) for the BSC, Office of Liaison, Policy
applications, the disclosure of which
would constitute a clearly unwarranted Dated: November 5, 2018. and Review, Division of NTP, NIEHS,
invasion of personal privacy. Melanie J. Pantoja, P.O. Box 12233, K2–03, Research
Program Analyst, Office of Federal Advisory Triangle Park, NC 27709. Phone: 984–
Name of Committee: National Institute of 287–3209, Fax: 301–451–5759, email:
Mental Health Special Emphasis Panel; Committee Policy.
Silvio O. Conte Centers for Basic [FR Doc. 2018–24480 Filed 11–7–18; 8:45 am] wolfe@niehs.nih.gov. Hand Deliver/
Neuroscience or Translational Mental Health BILLING CODE 4140–01–P
Courier address: 530 Davis Drive, Room
Research (P50). K2130, Morrisville, NC 27560.
Date: November 14, 2018. SUPPLEMENTARY INFORMATION: The BSC
Time: 8:00 a.m. to 5:00 p.m. DEPARTMENT OF HEALTH AND will provide input to the NTP on
Agenda: To review and evaluate grant HUMAN SERVICES programmatic activities and issues. The
applications.
Place: Bethesda North Marriott Hotel &
agenda on December 11 will recognize
National Institutes of Health NTP’s 40th anniversary with the theme
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852. ‘‘Celebrate the Past, and Embrace the
National Toxicology Program Board of
Contact Person: Rebecca Steiner Garcia, Future,’’ and on December 12, several
Scientific Counselors; Announcement
Ph.D., Scientific Review Officer, Division of talks will focus on translation as a
of Meeting; Request for Comments
Extramural Activities, National Institute of scientific framework. Please see the
Mental Health, NIH Neuroscience Center, AGENCY: National Institutes of Health, preliminary agenda for information
6001 Executive Blvd., Room 6149, MSC 9608, HHS. about the specific presentations. The
Bethesda, MD 20892–9608, 301–443–4525, preliminary agenda, roster of BSC
steinerr@mail.nih.gov.
ACTION: Notice.
members, background materials, public
This notice is being published less than 15 SUMMARY: This notice announces the comments, and any additional
days prior to the meeting due to the timing next meeting of the National Toxicology information, when available, will be
limitations imposed by the review and Program (NTP) Board of Scientific
funding cycle.
posted on the BSC meeting website
Counselors (BSC). The BSC, a federally (http://ntp.niehs.nih.gov/go/165) or may
Name of Committee: National Institute of chartered, external advisory group
Mental Health Special Emphasis Panel; First
be requested in hardcopy from the
in Human and Early Stage Clinical Trials of
composed of scientists from the public Designated Federal Official for the BSC.
Novel Investigational Drugs or Devices for and private sectors, will review and Following the meeting, summary
Psychiatric Disorders. provide advice on programmatic minutes will be prepared and made
Date: November 14, 2018. activities. The meeting is open to the available on the BSC meeting website.
Time: 1:00 p.m. to 3:00 p.m. public and registration is requested for Meeting Attendance Registration: The
Agenda: To review and evaluate grant both attendance and oral comment and meeting is open to the public with time
applications. required to access the webcast. set aside for oral public comment; in-
Place: National Institutes of Health Information about the meeting and
Neuroscience Center, 6001 Executive person attendance at the NIEHS is
registration are available at http:// limited by the space available (∼100
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
ntp.niehs.nih.gov/go/165. attendees). Registration for in-person
Contact Person: Vinod Charles, Ph.D., DATES: attendance is on a first-come, first-
Scientific Review Officer, Division of Meeting: Scheduled for December 11, served basis, and registrants will be
Extramural Activities, National Institute of 2018 at 8:30 a.m. to adjournment on assigned a number in their confirmation
Mental Health, NIH Neuroscience Center, December 12, 2018 at approximately email. After the first 100 registrants,
6001 Executive Blvd., Room 6151, MSC 9606, 5:00 p.m. Eastern Standard Time (EST). persons will be placed on a wait list and
Bethesda, MD 20892–9606, 301–443–1606, Written Public Comment notified should an opening become
charlesvi@mail.nih.gov.
Submissions: Deadline is December 3, available. Registration to attend the
This notice is being published less than 15 2018. meeting in-in person or view the
days prior to the meeting due to the timing
Registration for Oral Comments: webcast is by December 12, 2018 at
limitations imposed by the review and
funding cycle. Deadline is December 3, 2018. http://ntp.niehs.nih.gov/go/165.
Registration to Attend Meeting In- Registration is required to view the
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
person or to View Webcast: Deadline is webcast; the URL for the webcast will be
NRSA Institutional Research Grant Training December 12, 2018. provided in the email confirming
Review. Registration to view the meeting via registration. Visitor and security
Date: November 16, 2018. the webcast is required. information for those attending in-
Time: 8:00 a.m. to 5:00 p.m. ADDRESSES: person is available at niehs.nih.gov/
Agenda: To review and evaluate grant Meeting Location: Rodbell about/visiting/index.cfm. Individuals
daltland on DSKBBV9HB2PROD with NOTICES

applications Auditorium, Rall Building, National with disabilities who need
Place: Washington Plaza Hotel, 10 Thomas
Institute of Environmental Health accommodation to participate in this
Circle NW, Washington, DC 20005.
Contact Person: Nicholas Gaiano, Ph.D., Sciences (NIEHS), 111 T.W. Alexander event should contact Ms. Robbin Guy at
Review Branch Chief, Division of Extramural Drive, Research Triangle Park, NC phone: (984) 287–3136 or email: guyr2@
Activities, National Institute of Mental 27709. niehs.nih.gov. TTY users should contact
Health, NIH Neuroscience Center/Room Meeting web page: The preliminary the Federal TTY Relay Service at 800–
6150/MSC 9606, 6001 Executive Boulevard, agenda, registration, and other meeting 877–8339. Requests should be made at

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Document Created: 2018-11-08 06:23:31
Document Modified: 2018-11-08 06:23:31

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		November 14, 2018.
FR Citation		83 FR 55902

83 FR 55902 - National Institute of Mental Health; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 217 (November 8, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health