Extension of Effective Date of NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research, 91183 [2016-30398]
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Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices
each year, 5 of which FDA expects to be
HDEs. This estimate is based on the
average of FDA’s receipt of new PMA
applications. The Agency estimates that
10 of the estimated 40 original PMA
submissions will fail to provide the
required pediatric use information and
their sponsors will therefore be required
to submit PMA amendments. The
Agency also expects to receive
approximately 700 supplements that
will include the pediatric use
Furthermore, because supplements may
include readily available information on
pediatric populations by referencing a
previous submission, FDA estimates the
average time to obtain and submit the
required information in a supplement to
be 2 hours. FDA estimates that the total
estimated burden is 1,760 hours.
FDA estimates the burden of this
collection of information as follows:
information required by section 515A(a)
of the FD&C Act and part 814 (21 CFR
part 814).
All that is required is to gather,
organize, and submit information that is
readily available, using any approach
that meets the requirements of section
515A(a) of the FD&C Act and part 814.
We believe that because the applicant is
required to organize and submit only
readily available information, no more
than 8 hours will be required to comply.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
Activity/21 CFR section
Pediatric
Pediatric
Pediatric
Pediatric
in
in
in
in
Total annual
responses
Average
burden per
response
Total hours
an original PMA or PDP—814.20(b)(13)
a PMA amendment—814.37(b)(2) ..........
a PMA supplement—814.39(c)(2) ...........
an HDE—814.104(b)(6) ...........................
30
10
700
5
1
1
1
1
30
10
700
5
8
8
2
8
240
80
1,400
40
Total ........................................................................................
......................
........................
......................
......................
1,760
1 There
information
information
information
information
Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Dated: December 12, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016–30243 Filed 12–15–16; 8:45 am]
[FR Doc. 2016–30398 Filed 12–15–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Meeting
mstockstill on DSK3G9T082PROD with NOTICES
Extension of Effective Date of NIH
Policy on the Use of a Single
Institutional Review Board for MultiSite Research
The National Institutes of Health
(NIH) is extending the effective date of
the NIH Policy on the Use of a Single
Institutional Review Board for MultiSite Research from May 25, 2017, to
September 25, 2017. A copy of the NIH
Policy was published in the Federal
Register on June 21, 2016 (81 FR 40325).
See https://www.gpo.gov/fdsys/pkg/FR2016-06-21/pdf/2016-14513.pdf.
Guidance and Frequently Asked
Questions to assist in the
implementation of the policy will soon
be available at https://osp.od.nih.gov/
office-clinical-research-and-bioethicspolicy/clinical-research-policy/modelsirb-review.
For further information contact the
NIH Office of Science Policy,
Telephone: 301–496–9838, Email:
SingleIRBPolicy@mail.nih.gov.
VerDate Sep<11>2014
18:42 Dec 15, 2016
Jkt 241001
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Council on Alcohol
Abuse and Alcoholism.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the 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
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
PO 00000
Frm 00069
Fmt 4703
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constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council on Alcohol Abuse and Alcoholism.
Date: February 9, 2017.
Closed: 9:00 a.m. to 9:30 a.m.
Agenda: BSC Report: Evaluation of the
NIAAA Intramural Program.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 5635 Fishers Lane, Terrace
Conference Rooms, Bethesda, MD 20892.
Closed: 9:40 a.m. to 10:50 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 5635 Fishers Lane, Terrace
Conference Rooms, Bethesda, MD 20892.
Open: 11:00 a.m. to 3:15 p.m.
Agenda: Presentations and other business
of the Council.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 5635 Fishers Lane, Terrace
Conference Rooms, Bethesda, MD 20892.
Contact Person: Abraham P. Bautista,
Ph.D., Executive Secretary, National Institute
on Alcohol Abuse and Alcoholism, National
Institutes of Health, 5635 Fishers Lane, Room
2085, Rockville, MD 20852, 301–443–9737
bautista@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.niaaa.nih.gov/AboutNIAAA/
AdvisoryCouncil/Pages/default.aspx, where
an agenda and any additional information for
the meeting will be posted when available.
E:\FR\FM\16DEN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)]
[Notices]
[Page 91183]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30398]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Extension of Effective Date of NIH Policy on the Use of a Single
Institutional Review Board for Multi-Site Research
The National Institutes of Health (NIH) is extending the effective
date of the NIH Policy on the Use of a Single Institutional Review
Board for Multi-Site Research from May 25, 2017, to September 25, 2017.
A copy of the NIH Policy was published in the Federal Register on June
21, 2016 (81 FR 40325). See https://www.gpo.gov/fdsys/pkg/FR-2016-06-21/pdf/2016-14513.pdf. Guidance and Frequently Asked Questions to
assist in the implementation of the policy will soon be available at
https://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/models-irb-review.
For further information contact the NIH Office of Science Policy,
Telephone: 301-496-9838, Email: SingleIRBPolicy@mail.nih.gov.
Dated: December 12, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-30398 Filed 12-15-16; 8:45 am]
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