Proposed Collection; 60-day Comment Request: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI), 52204-52206 [2013-20415]
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Federal Register / Vol. 78, No. 163 / Thursday, August 22, 2013 / Notices
remove potential ambiguities and
address several issues not included in
the original draft guidance. In response
to comments submitted to the public
docket, at stakeholder meetings, and in
calls from the public, FDA has provided
additional clarifying examples to assist
in complying with part 1140.
II. Significance of Guidance
FDA is issuing this guidance
document consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The guidance represents the
Agency’s current thinking on
‘‘Compliance with Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents.’’ It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
An electronic version of the guidance
document is available on the Internet at
https://www.regulations.gov and https://
www.fda.gov/TobaccoProducts/
GuidanceCompliance
RegulatoryInformation/default.htm.
Dated: August 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–20506 Filed 8–21–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-day Comment
Request: NIH NCI Central Institutional
Review Board (CIRB) Initiative (NCI)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI),
National Institutes of Health (NIH), will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: CAPT Michael
Montello, Pharm. D., MBA, Cancer
Therapy Evaluation Program,
Operations and Informatics Branch,
9609 Medical Center Drive, Rockville,
MD 20850 or call non-toll-free number
(240) 276–6080 or Email your request,
including your address to:
mike.montello@nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
SUMMARY:
PO 00000
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received within 60 days of the date of
this publication.
Proposed Collection: NIH NCI Central
Institutional Review Board (CIRB)
Initiative (NCI), 0925–0625, Revision,
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The National Cancer
Institute (NCI) Central Institutional
Review Board (CIRB) provides a
centralized approach to human subject
protection and provides a cost efficient
approach avoiding duplication of effort
at each institution. The CIRB provides
the services of a fully constituted IRB
and provides a comprehensive and
efficient mechanism to meet regulatory
requirements pertaining to human
subject protections including: Initial
reviews, continuing reviews, review of
amendments, and adverse events. The
Initiative consists of three central IRBs:
Adult CIRB—late phase emphasis,
Adult CIRB—early phase emphasis, and
Pediatric CIRB. CIRB membership
includes oncology physicians, surgeons,
nurses, patient advocates, ethicists,
statisticians, pharmacists, attorneys and
other health professionals. The benefits
of the CIRB Initiative reaches research
participants, investigators and research
staff, Institutional Review Boards (IRB),
and Institutions. Benefits include: Study
participants having dedicated review of
NCI-sponsored trials for participant
protections, access to more trials more
quickly and access to trials for rare
diseases, accrual to trials begin more
rapidly, ease of opening trials,
elimination of need to submit study
materials to local IRBs, and elimination
of the need for a full board review. The
benefits to the National Clinical Trials
Network and Experimental TherapyClinical Trials Network include a cost
efficient approach that avoids
duplication of efforts at each institution.
A variety of information collection tools
are needed to support NCI’s CIRB
activities which include: Worksheets,
forms and a survey that is provided to
all customers contacting the CIRB
helpdesk.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
2,199.
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Federal Register / Vol. 78, No. 163 / Thursday, August 22, 2013 / Notices
ESTIMATES OF ANNUAL BURDEN HOURS
Type of
respondents
CIRB Customer Satisfaction Survey ...............................
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Form name
Participants/
Board Members.
Participants .........
Participants .........
Request for 30 Day Web site Access Form ...................
Authorization Agreement and Division of Responsibilities between the NCI CIRB and Signatory Institution.
NCI CIRB Signatory Enrollment Form ............................
IRB Staff at Signatory Institution’s IRB ...........................
Investigator at Signatory Institution .................................
Research Staff at Signatory Institution ...........................
Investigator at Affiliate Institution with an IRB ................
Research Staff at Affiliate Institution with an IRB ...........
Investigator at Affiliate Institution without an IRB ...........
Research Staff at Affiliate Institution without an IRB ......
Institutional Contact for Signatory Institution ..................
IRB at Signatory Institution .............................................
Component Institution at Signatory Institution ................
IRB at Affiliate Institution .................................................
Affiliate Institution without an IRB ...................................
Facilitated Review Acceptance Form .............................
Study Review Responsibility Transfer Form ...................
Annual Signatory Institution Worksheet About Local
Context.
Annual Principal Investigator Worksheet About Local
Context.
Study-Specific Worksheet About Local Context .............
Study Closure or Transfer of Study Review Responsibility Form.
Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form.
Add or Remove Signatory and/or Component Institution
Personnel.
Add or Remove Affiliate Institution Personnel ................
Add or Remove Component Institution ...........................
Add or Remove Affiliate Institution .................................
One Time Study Roll Over Worksheet ...........................
Change of Signatory Institution PI Form ........................
CIRB Board Member Biographical Sketch Form ............
CIRB Board Member Contact Information Form ............
CIRB Board Member W–9 ..............................................
CIRB Board Member Non-Disclosure Agreement (NDA)
CIRB Direct Deposit Form ..............................................
NCI Adult/Pediatric CIRB Application for Treatment
Studies.
NCI Adult/Pediatric CIRB Application for Ancillary Studies.
NCI Adult/Pediatric CIRB Application for Continuing Review.
Summary of CIRB Application Revisions .......................
Locally-Developed Material Submission Form ...............
Application Request to Review Translated Documents
Adult Initial Review of Cooperative Group Protocol .......
Pediatric Initial Review of Cooperative Group Protocol
Adult Continuing Review of Cooperative Group Protocol
Pediatric Continuing Review of Cooperative Group Protocol.
Adult Amendment of Cooperative Group Protocol .........
Pediatric Amendment of Cooperative Group Protocol ...
Adult Cooperative Group Response to CIRB Review ....
Pediatric Cooperative Group Response to CIRB Review.
Adult Pharmacist’s Review of a Cooperative Group
Study.
Pediatric Pharmacist’s Review of a Cooperative Group
Study.
CIRB Statistical Reviewer Form .....................................
Determination of Unanticipated Problem (UP) and/or
Serious or Continuing Noncompliance (SCN).
Adult Expedited Amendment Review .............................
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Number of
respondents
Frequency of
responses per
respondent
Average
burden per
response
(in hours)
Total
annual burden
hours
1500
1
10/60
250
25
340
1
1
10/60
30/60
4
170
........
........
........
........
........
........
........
........
........
........
........
........
.........
........
........
.........
40
25
65
65
25
25
25
25
65
25
65
25
25
300
80
120
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
4
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
20/60
160
4
11
11
4
4
4
4
11
4
11
4
4
50
13
40
Participants ........
120
1
20/60
40
Participants ........
Participants ........
220
120
1
1
20/60
10/60
73
20
Participants .........
120
1
15/60
30
Participants ........
120
1
10/60
20
Participants ........
Participants ........
Participants ........
Participants ........
Participants .........
Board Members ..
Board Members ..
Board Members ..
Board Members ..
Board Members ..
Participants ........
120
120
120
120
120
25
25
25
25
25
25
1
1
1
1
1
1
1
1
1
1
1
10/60
10/60
10/60
10/60
10/60
15/60
10/60
15/60
10/60
15/60
2
20
20
20
20
20
6.25
4
6
4
6
50
Participants .........
10
1
2
20
Participants .........
80
1
1
80
Participants .........
Participants ........
Participants .........
Board Members ..
Board Members ..
Board Members ..
Board Members ..
20
15
15
15
15
130
70
1
1
1
1
1
1
1
30/60
15/60
15/60
4
4
1
1
10
4
4
60
60
130
70
Board Members ..
Board Members ..
Participants .........
Participants ........
10
10
15
10
1
1
1
1
2
2
1
1
20
20
15
10
Board Members ..
10
1
2
20
Board Members ..
20
1
2
40
Board Members ..
Board Members ..
30
40
1
1
30/60
10/60
15
7
Board Members ..
350
1
30/60
175
Participants
Participants
Participants
Participants
Participants
Participants
Participants
Participants
Participants
Participants
Participants
Participants
Participants
Participants
Participants
Participants
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Federal Register / Vol. 78, No. 163 / Thursday, August 22, 2013 / Notices
ESTIMATES OF ANNUAL BURDEN HOURS—Continued
Type of
respondents
Form name
Ped Expedited Amendment Review ...............................
Adult Expedited Continuing Review ................................
Ped Expedited Continuing Review .................................
Adult Expedited Study Closure .......................................
Ped Expedited Study Closure .........................................
Adult Expedited Study Chair Response to Required
Mod.
Ped Expedited Study Chair Response to Required Mod
Reviewer Worksheet of Translated Documents .............
Reviewer Advertisement Checklist .................................
Dated: August 15, 2013.
Vivian Horovitch-Kelley,
Program Analyst, National Institutes of
Health.
[FR Doc. 2013–20415 Filed 8–21–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of
Closed Meetings
tkelley on DSK3SPTVN1PROD with NOTICES
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 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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Biophysics, Biochemistry and
Chemistry.
Date: September 18–19, 2013.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: John L Bowers, Ph.D.,
Scientific Review Officer, Center for
Board
Board
Board
Board
Board
Board
Members
Members
Members
Members
Members
Members
Number of
respondents
Frequency of
responses per
respondent
Average
burden per
response
(in hours)
Total
annual burden
hours
..
..
..
..
..
..
150
120
70
20
20
350
1
1
1
1
1
1
30/60
30/60
30/60
20/60
20/60
15/60
75
60
35
7
7
88
Board Members ..
Board Members ..
Board Members ..
150
15
10
1
1
1
15/60
15/60
20/60
38
4
3
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4170,
MSC 7806, Bethesda, MD 20892, (301) 435–
1725, bowersj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Program
Project: Immune Regulation by
Cannabinoids.
Date: September 23–24, 2013.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Scott Jakes, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4198,
MSC 7812, Bethesda, MD 20892, 301–495–
1506, jakesse@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: Assessment of the Town Hall
Meetings on Underage Drinking
Prevention—(OMB No. 0930–0288)—
Revision
[FR Doc. 2013–20422 Filed 8–21–13; 8:45 am]
The Substance Abuse and Mental
Health Services Administration/Center
for Substance Abuse Prevention
(SAMHSA/CSAP) is requesting a
revision from the Office of Management
and Budget (OMB) of the information
collection regarding the Assessment of
the Town Hall Meetings (THMs) on
Underage Drinking Prevention. The
current data collection has approval
under OMB No. 0930–0288, which
expires on November 30, 2013. The
assessment will continue to collect data
through two existing data collection
instruments: The Organizer Survey and
the Participant Form.
BILLING CODE 4140–01–P
Clarifications
Dated: August 16, 2013.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
Two questions were dropped from the
Organizer Survey, thus bringing the
total number of questions to 30.
Additionally, 10 questions have been
updated to provide clarification on the
intent of the questions. The following
table provides a summary of the
proposed question clarifications and the
questions that were deleted from the
Organizer Survey.
Current question/item
Clarification
Rationale for clarification
q5—Did you collaborate with other organizations to coordinate the THM event?
[No change to response options]
q5—Did any other community-based organization (e.g., business, school) collaborate
with your organization/coalition in hosting
this event?
Clarifies the point of question, which is community involvement beyond the host organization.
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]]>Agencies
[Federal Register Volume 78, Number 163 (Thursday, August 22, 2013)]
[Notices]
[Pages 52204-52206]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20415]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-day Comment Request: NIH NCI Central
Institutional Review Board (CIRB) Initiative (NCI)
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Cancer Institute
(NCI), National Institutes of Health (NIH), will publish periodic
summaries of proposed projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected
agencies are invited on one or more of the following points: (1)
Whether the proposed collection of information is necessary for the
proper performance of the function of the agency, including whether the
information will have practical utility; (2) The accuracy of the
agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) Ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) Ways to minimize the burden of the
collection of information on those who are to respond, including the
use of appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
To Submit Comments and for Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: CAPT
Michael Montello, Pharm. D., MBA, Cancer Therapy Evaluation Program,
Operations and Informatics Branch, 9609 Medical Center Drive,
Rockville, MD 20850 or call non-toll-free number (240) 276-6080 or
Email your request, including your address to: mike.montello@nih.gov.
Formal requests for additional plans and instruments must be requested
in writing.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Proposed Collection: NIH NCI Central Institutional Review Board
(CIRB) Initiative (NCI), 0925-0625, Revision, National Cancer Institute
(NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The National Cancer
Institute (NCI) Central Institutional Review Board (CIRB) provides a
centralized approach to human subject protection and provides a cost
efficient approach avoiding duplication of effort at each institution.
The CIRB provides the services of a fully constituted IRB and provides
a comprehensive and efficient mechanism to meet regulatory requirements
pertaining to human subject protections including: Initial reviews,
continuing reviews, review of amendments, and adverse events. The
Initiative consists of three central IRBs: Adult CIRB--late phase
emphasis, Adult CIRB--early phase emphasis, and Pediatric CIRB. CIRB
membership includes oncology physicians, surgeons, nurses, patient
advocates, ethicists, statisticians, pharmacists, attorneys and other
health professionals. The benefits of the CIRB Initiative reaches
research participants, investigators and research staff, Institutional
Review Boards (IRB), and Institutions. Benefits include: Study
participants having dedicated review of NCI-sponsored trials for
participant protections, access to more trials more quickly and access
to trials for rare diseases, accrual to trials begin more rapidly, ease
of opening trials, elimination of need to submit study materials to
local IRBs, and elimination of the need for a full board review. The
benefits to the National Clinical Trials Network and Experimental
Therapy-Clinical Trials Network include a cost efficient approach that
avoids duplication of efforts at each institution. A variety of
information collection tools are needed to support NCI's CIRB
activities which include: Worksheets, forms and a survey that is
provided to all customers contacting the CIRB helpdesk.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 2,199.
[[Page 52205]]
Estimates of Annual Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Frequency of Average burden
Form name Type of respondents Number of responses per per response Total annual
respondents respondent (in hours) burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
CIRB Customer Satisfaction Survey.............. Participants/Board Members............. 1500 1 10/60 250
Request for 30 Day Web site Access Form........ Participants........................... 25 1 10/60 4
Authorization Agreement and Division of Participants........................... 340 1 30/60 170
Responsibilities between the NCI CIRB and
Signatory Institution.
NCI CIRB Signatory Enrollment Form............. Participants........................... 40 1 4 160
IRB Staff at Signatory Institution's IRB....... Participants........................... 25 1 10/60 4
Investigator at Signatory Institution.......... Participants........................... 65 1 10/60 11
Research Staff at Signatory Institution........ Participants........................... 65 1 10/60 11
Investigator at Affiliate Institution with an Participants........................... 25 1 10/60 4
IRB.
Research Staff at Affiliate Institution with an Participants........................... 25 1 10/60 4
IRB.
Investigator at Affiliate Institution without Participants........................... 25 1 10/60 4
an IRB.
Research Staff at Affiliate Institution without Participants........................... 25 1 10/60 4
an IRB.
Institutional Contact for Signatory Institution Participants........................... 65 1 10/60 11
IRB at Signatory Institution................... Participants........................... 25 1 10/60 4
Component Institution at Signatory Institution. Participants........................... 65 1 10/60 11
IRB at Affiliate Institution................... Participants........................... 25 1 10/60 4
Affiliate Institution without an IRB........... Participants........................... 25 1 10/60 4
Facilitated Review Acceptance Form............. Participants........................... 300 1 10/60 50
Study Review Responsibility Transfer Form...... Participants........................... 80 1 10/60 13
Annual Signatory Institution Worksheet About Participants........................... 120 1 20/60 40
Local Context.
Annual Principal Investigator Worksheet About Participants........................... 120 1 20/60 40
Local Context.
Study-Specific Worksheet About Local Context... Participants........................... 220 1 20/60 73
Study Closure or Transfer of Study Review Participants........................... 120 1 10/60 20
Responsibility Form.
Potential Unanticipated Problem or Serious or Participants........................... 120 1 15/60 30
Continuing Noncompliance Reporting Form.
Add or Remove Signatory and/or Component Participants........................... 120 1 10/60 20
Institution Personnel.
Add or Remove Affiliate Institution Personnel.. Participants........................... 120 1 10/60 20
Add or Remove Component Institution............ Participants........................... 120 1 10/60 20
Add or Remove Affiliate Institution............ Participants........................... 120 1 10/60 20
One Time Study Roll Over Worksheet............. Participants........................... 120 1 10/60 20
Change of Signatory Institution PI Form........ Participants........................... 120 1 10/60 20
CIRB Board Member Biographical Sketch Form..... Board Members.......................... 25 1 15/60 6.25
CIRB Board Member Contact Information Form..... Board Members.......................... 25 1 10/60 4
CIRB Board Member W-9.......................... Board Members.......................... 25 1 15/60 6
CIRB Board Member Non-Disclosure Agreement Board Members.......................... 25 1 10/60 4
(NDA).
CIRB Direct Deposit Form....................... Board Members.......................... 25 1 15/60 6
NCI Adult/Pediatric CIRB Application for Participants........................... 25 1 2 50
Treatment Studies.
NCI Adult/Pediatric CIRB Application for Participants........................... 10 1 2 20
Ancillary Studies.
NCI Adult/Pediatric CIRB Application for Participants........................... 80 1 1 80
Continuing Review.
Summary of CIRB Application Revisions.......... Participants........................... 20 1 30/60 10
Locally-Developed Material Submission Form..... Participants........................... 15 1 15/60 4
Application Request to Review Translated Participants........................... 15 1 15/60 4
Documents.
Adult Initial Review of Cooperative Group Board Members.......................... 15 1 4 60
Protocol.
Pediatric Initial Review of Cooperative Group Board Members.......................... 15 1 4 60
Protocol.
Adult Continuing Review of Cooperative Group Board Members.......................... 130 1 1 130
Protocol.
Pediatric Continuing Review of Cooperative Board Members.......................... 70 1 1 70
Group Protocol.
Adult Amendment of Cooperative Group Protocol.. Board Members.......................... 10 1 2 20
Pediatric Amendment of Cooperative Group Board Members.......................... 10 1 2 20
Protocol.
Adult Cooperative Group Response to CIRB Review Participants........................... 15 1 1 15
Pediatric Cooperative Group Response to CIRB Participants........................... 10 1 1 10
Review.
Adult Pharmacist's Review of a Cooperative Board Members.......................... 10 1 2 20
Group Study.
Pediatric Pharmacist's Review of a Cooperative Board Members.......................... 20 1 2 40
Group Study.
CIRB Statistical Reviewer Form................. Board Members.......................... 30 1 30/60 15
Determination of Unanticipated Problem (UP) and/ Board Members.......................... 40 1 10/60 7
or Serious or Continuing Noncompliance (SCN).
Adult Expedited Amendment Review............... Board Members.......................... 350 1 30/60 175
[[Page 52206]]
Ped Expedited Amendment Review................. Board Members.......................... 150 1 30/60 75
Adult Expedited Continuing Review.............. Board Members.......................... 120 1 30/60 60
Ped Expedited Continuing Review................ Board Members.......................... 70 1 30/60 35
Adult Expedited Study Closure.................. Board Members.......................... 20 1 20/60 7
Ped Expedited Study Closure.................... Board Members.......................... 20 1 20/60 7
Adult Expedited Study Chair Response to Board Members.......................... 350 1 15/60 88
Required Mod.
Ped Expedited Study Chair Response to Required Board Members.......................... 150 1 15/60 38
Mod.
Reviewer Worksheet of Translated Documents..... Board Members.......................... 15 1 15/60 4
Reviewer Advertisement Checklist............... Board Members.......................... 10 1 20/60 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: August 15, 2013.
Vivian Horovitch-Kelley,
Program Analyst, National Institutes of Health.
[FR Doc. 2013-20415 Filed 8-21-13; 8:45 am]
BILLING CODE 4140-01-P
