82 FR 7841 - National Institute on Drug Abuse; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 13 (January 23, 2017)

Page Range		7841-7841
FR Document		2017-01253

Federal Register, Volume 82 Issue 13 (Monday, January 23, 2017)

[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Notices]
[Page 7841]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].

(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

Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 7841

current good manufacturing practices records may be required as conditions of comment on the proposed collection of
for medical devices regulation (21 CFR approval to ensure the device’s information. No comments were
part 820) may be relevant to a PMA continuing safety and effectiveness. received.
review and may be submitted as part of In the Federal Register of October 19,
FDA estimates the burden of this
an application. In individual instances, 2016 (81 FR 72063), FDA published a
collection of information as follows:
60-day notice requesting public
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR or FD&C Act section responses per burden per Total hours
respondents responses
respondent response

Research conducted outside the United States (814.15(b)) 25 1 25 2 50
PMA application (814.20) .................................................... 35 1 35 668 23,380
PMA amendments and resubmitted PMAs (814.37(a)–(c)
and (e)) ............................................................................. 1,222 1 1,222 167 204,074
PMA supplements (814.39(a)) ............................................. 695 1 695 60 41,700
Special PMA supplement—changes being affected
(814.39(d)) ........................................................................ 88 1 88 6 528
30-day notice (814.39(f)) ..................................................... 1,710 1 1,710 16 27,360
Postapproval requirements (814.82(a)(9)) ........................... 340 1 340 135 45,900
Periodic reports (814.84(b)) ................................................. 695 1 695 10 6,950
Agreement meeting (520(g)(7)) ........................................... 1 1 1 50 50
Expedited review request (515(d)(5) of the FD&C Act) ...... 6 1 6 10 60
Determination Meeting (513(1)(3)(D) of the FD&C Act) ...... 1 1 1 50 50
Panel meeting (515(c)(3) of the FD&C Act) ........................ 9 1 9 30 270
Day 100 meeting (515(d)(3) of the FD&C Act) ................... 19 1 19 10 190

Total ..................................................................................... ........................ ........................ ........................ ........................ 350,562
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section records per burden per Total hours
recordkeepers responses
recordkeeper response

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. would constitute a clearly unwarranted Dated: January 13, 2017.
Leslie Kux, invasion of personal privacy. Natasha M. Copeland,
Associate Commissioner for Policy. Name of Committee: National Institute on Program Analyst, Office of Federal Advisory
[FR Doc. 2017–01188 Filed 1–19–17; 8:45 am] Committee Policy.
Drug Abuse Special Emphasis Panel; Virtual
BILLING CODE 4164–01–P Reality Tools to Enhance Evidence-Based [FR Doc. 2017–01253 Filed 1–19–17; 8:45 am]
Treatment of Substance Use Disorders (5583). BILLING CODE 4140–01–P
Date: February 1, 2017.
DEPARTMENT OF HEALTH AND Time: 8:00 a.m. to 4:00 p.m.
HUMAN SERVICES Agenda: To review and evaluate contract DEPARTMENT OF HEALTH AND
proposals. HUMAN SERVICES
National Institutes of Health Place: National Institutes of Health,
National Institutes of Health
National Institute on Drug Abuse; Neuroscience Center, 6001 Executive
Notice of Closed Meeting Boulevard, Rockville, MD 20852 (Telephone National Institute of Biomedical
Conference Call). Imaging and Bioengineering; Notice of
Pursuant to section 10(d) of the Contact Person: Gerald L. McLaughlin, Closed Meeting
Federal Advisory Committee Act, as Ph.D., Scientific Review Officer, Office of
amended (5 U.S.C. App), notice is Extramural Policy and Review, National Pursuant to section 10(d) of the
hereby given of the following meeting. Institute on Drug Abuse, NIH, DHHS, 6001 Federal Advisory Committee Act, as
The meeting will be closed to the Executive Blvd., Room 4238, MSC 9550, amended (5 U.S.C. App.), notice is
public in accordance with the Bethesda, MD 20892–9550, 301–827–5819, hereby given of the following meeting.
provisions set forth in sections gm145a@nih.gov. The meeting will be closed to the
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., public in accordance with the
mstockstill on DSK3G9T082PROD with NOTICES

(Catalogue of Federal Domestic Assistance
as amended. The contract proposals and Program No.: 93.279, Drug Abuse and provisions set forth in sections
the discussions could disclose Addiction Research Programs, National 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
confidential trade secrets or commercial Institutes of Health, HHS) as amended. The grant applications and
property such as patentable material, the discussions could disclose
and personal information concerning confidential trade secrets or commercial
individuals associated with the contract property such as patentable material,
proposals, the disclosure of which and personal information concerning

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Document Modified: 2017-01-20 01:29:40

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		February 1, 2017.
FR Citation		82 FR 7841

82 FR 7841 - National Institute on Drug Abuse; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 13 (January 23, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health