Submission for OMB Review; 30-Day Comment Request: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI), 69426-69428 [2013-27556]
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69426
Federal Register / Vol. 78, No. 223 / Tuesday, November 19, 2013 / Notices
As the Exchanges mature and
enrollment in QHPs expands, we will
consider reporting the QRS at more
granular levels (that is, QHP metal
levels as defined in section 1302(d)(1) of
the Affordable Care Act). We will also
consider the development of a quality
rating system applicable to other
Exchange offerings, such as stand-alone
dental plans, catastrophic plans and
health care saving accounts.
VI. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements. However,
it does make reference to an information
collection activity. The aforementioned
Enrollee Satisfaction Survey is currently
seeking OMB approval via notice and
comment periods separate from this
proposed notice. The 60-day Federal
Register notice published on June 28,
2013. Additionally, in future
rulemaking, we will identify
information collection requirements
associated with the QRS and solicit
public comment at that time.
Dated: November 6, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2013–27649 Filed 11–14–13; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request: NIH NCI Central
Institutional Review Board (CIRB)
Initiative (NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
SUMMARY:
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.
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on August 22,
2013, Vol. 78, P. 52204 and allowed 60days for public comment. There were no
public comments received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Cancer Institute (NCI),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION: To obtain a
copy of the data collection plans and
instruments 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.
Proposed Collection: NIH NCI Central
Institutional Review Board (CIRB)
Initiative (NCI), 0925–0625, Expiration
Date 1/31/2014, Revision, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
ESTIMATES OF ANNUAL BURDEN HOURS
Type of respondents
CIRB Customer Satisfaction Survey ........................
TKELLEY on DSK3SPTVN1PROD with NOTICES
Form name
Number of
respondents
Participants/Board
Members.
Participants ................
Participants ................
Request for 30 Day Website 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 ....................
VerDate Mar<15>2010
17:21 Nov 18, 2013
Jkt 232001
PO 00000
Participants
Participants
Participants
Participants
Frm 00065
................
................
................
................
Fmt 4703
Sfmt 4703
Frequency of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
1,500
1
10/60
250
25
340
1
1
10/60
30/60
4
170
40
25
65
65
1
1
1
1
4
10/60
10/60
10/60
160
4
11
11
E:\FR\FM\19NON1.SGM
19NON1
69427
Federal Register / Vol. 78, No. 223 / Tuesday, November 19, 2013 / Notices
ESTIMATES OF ANNUAL BURDEN HOURS—Continued
TKELLEY on DSK3SPTVN1PROD with NOTICES
Form name
Type of respondents
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 ......................
Ped Expedited Amendment Review ........................
Adult Expedited Continuing Review ........................
Ped Expedited Continuing Review ..........................
Adult Expedited Study Closure ................................
VerDate Mar<15>2010
17:21 Nov 18, 2013
Jkt 232001
PO 00000
Participants
Participants
Participants
Participants
Participants
Participants
Participants
Participants
Participants
Participants
Participants
Participants
Number of
respondents
Frequency of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
................
................
................
................
................
................
................
................
................
................
................
................
25
25
25
25
65
25
65
25
25
300
80
120
1
1
1
1
1
1
1
1
1
1
1
1
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
10/60
20/60
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 .........
120
120
120
120
120
25
25
25
25
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
20
20
20
20
20
6.25
4
6
4
Board Members .........
Participants ................
25
25
1
1
15/60
2
6
50
Participants ................
10
1
2
20
Participants ................
80
1
1
80
Participants ................
Participants ................
Participants ................
20
15
15
1
1
1
30/60
15/60
15/60
10
4
4
Board Members .........
Board Members .........
15
15
1
1
4
4
60
60
Board Members .........
130
1
1
130
Board Members .........
70
1
1
70
Board Members .........
Board Members .........
10
10
1
1
2
2
20
20
Participants ................
15
1
1
15
Participants ................
10
1
1
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
350
150
120
70
20
1
1
1
1
1
30/60
30/60
30/60
30/60
20/60
175
75
60
35
7
Board
Board
Board
Board
Board
Members
Members
Members
Members
Members
Frm 00066
.........
.........
.........
.........
.........
Fmt 4703
Sfmt 4703
E:\FR\FM\19NON1.SGM
19NON1
69428
Federal Register / Vol. 78, No. 223 / Tuesday, November 19, 2013 / Notices
ESTIMATES OF ANNUAL BURDEN HOURS—Continued
Number of
respondents
Frequency of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
Form name
Type of respondents
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 ..........................
Board Members .........
Board Members .........
20
350
1
1
20/60
15/60
7
88
Board Members .........
150
1
15/60
38
Board Members .........
Board Members .........
15
10
1
1
15/60
20/60
4
3
Dated: November 7, 2013.
Vivian Horovitch-Kelley,
Program Analyst, National Institutes of
Health.
[FR Doc. 2013–27556 Filed 11–18–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request: Cancer Trials
Support Unit (CTSU) (NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on August 30,
2013, Vol. 78, p. 53763 and allowed 60days for public comment. There have
been no public comments. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Cancer Institute (NCI),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
SUMMARY:
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Michael Montello, Cancer
Therapy Evaluation Program, Division
of Cancer Treatment and Diagnosis,
9609 Medical Center Drive, Rockville,
MD 20850 or call non-toll-free number
240–276–6080 or Email your request,
including your address to: montellom@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Proposed Collection: Cancer Trials
Support Unit (CTSU) (NCI), 0925–0624,
Expiration Date 12/31/2013, REVISION,
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The Cancer Therapy
Evaluation Program (CTEP) establishes
and supports programs to facilitate the
participation of qualified investigators
on CTEP-supported studies, and to
institute programs that minimize
redundancy among grant and contract
holders, thereby reducing overall cost of
maintaining a robust treatment trials
program. Currently guided by the efforts
of the Clinical Trials Working Group
(CTWG) and the Institute of Medicine
(IOM) recommendations to revitalize the
Cooperative Group program, CTEP has
funded the Cancer Trials Support Unit
(CTSU). The CTSU collects
standardized forms to process site
regulatory information, changes to
membership, patient enrollment data,
and routing information for case report
forms. In addition, CTSU collects
annual surveys of customer satisfaction
for clinical site staff using the CTSU
Help Desk, the CTSU Web site, and the
Protocol and Information Office (PIO).
An ongoing user satisfaction survey is in
place for the Oncology Patient
Enrollment Network (OPEN). User
satisfaction surveys are compiled as part
of the project quality assurance
activities and are used to direct
improvements to processes and
technology. Additionally, there are three
surveys that collect information about
health professional’s interests in clinical
trial, potential issues with opening and
accruing to a clinical trial and reasons
for low accrual.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
25,205.
ESTIMATED ANNUALIZED BURDEN HOURS
TKELLEY on DSK3SPTVN1PROD with NOTICES
Form name
CTSU IRB/Regulatory Approval Transmittal Form
CTSU IRB Certification Form ...............................
CTSU Acknowledgement ......................................
Withdrawal from Protocol Participation Form .......
Site Addition ..........................................................
CTSU Roster Update Form ..................................
CTSU Radiation Therapy Facilities Inventory
Form.
VerDate Mar<15>2010
17:21 Nov 18, 2013
Number of
respondents
Type of respondent
Jkt 232001
Health
Health
Health
Health
Health
Health
Health
PO 00000
Care
Care
Care
Care
Care
Care
Care
Frm 00067
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
9,000
8,500
500
50
25
50
20
E:\FR\FM\19NON1.SGM
12
12
12
12
12
12
12
19NON1
Average
burden per
response
(in hours)
2/60
10/60
5/60
5/60
5/60
4/60
30/60
Total annual
burden hour
3,600
17,000
500
50
25
40
120
]]>Agencies
[Federal Register Volume 78, Number 223 (Tuesday, November 19, 2013)]
[Notices]
[Pages 69426-69428]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27556]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request: NIH NCI
Central Institutional Review Board (CIRB) Initiative (NCI)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH), has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on August 22, 2013, Vol. 78, P. 52204 and allowed 60-days for
public comment. There were no public comments received. The purpose of
this notice is to allow an additional 30 days for public comment. The
National Cancer Institute (NCI), National Institutes of Health, may not
conduct or sponsor, and the respondent is not required to respond to,
an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
FOR FURTHER INFORMATION: To obtain a copy of the data collection plans
and instruments 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.
Proposed Collection: NIH NCI Central Institutional Review Board
(CIRB) Initiative (NCI), 0925-0625, Expiration Date 1/31/2014,
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.
Estimates of Annual Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Number of Frequency of burden per Total annual
Form name Type of respondents respondents responses per response (in burden hours
respondent hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
CIRB Customer Satisfaction Survey........... Participants/Board Members................ 1,500 1 10/60 250
Request for 30 Day Website 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
[[Page 69427]]
Investigator at Affiliate Institution with Participants.............................. 25 1 10/60 4
an IRB.
Research Staff at Affiliate Institution with Participants.............................. 25 1 10/60 4
an IRB.
Investigator at Affiliate Institution Participants.............................. 25 1 10/60 4
without an IRB.
Research Staff at Affiliate Institution Participants.............................. 25 1 10/60 4
without an IRB.
Institutional Contact for Signatory Participants.............................. 65 1 10/60 11
Institution.
IRB at Signatory Institution................ Participants.............................. 25 1 10/60 4
Component Institution at Signatory Participants.............................. 65 1 10/60 11
Institution.
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 Participants.............................. 120 1 20/60 40
About 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 Participants.............................. 120 1 15/60 30
or Continuing Noncompliance Reporting Form.
Add or Remove Signatory and/or Component Participants.............................. 120 1 10/60 20
Institution Personnel.
Add or Remove Affiliate Institution Participants.............................. 120 1 10/60 20
Personnel.
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 Board Members............................. 15 1 4 60
Group 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 Board Members............................. 10 1 2 20
Protocol.
Pediatric Amendment of Cooperative Group Board Members............................. 10 1 2 20
Protocol.
Adult Cooperative Group Response to CIRB Participants.............................. 15 1 1 15
Review.
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 Board Members............................. 20 1 2 40
Cooperative Group Study.
CIRB Statistical Reviewer Form.............. Board Members............................. 30 1 30/60 15
Determination of Unanticipated Problem (UP) Board Members............................. 40 1 10/60 7
and/or Serious or Continuing Noncompliance
(SCN).
Adult Expedited Amendment Review............ Board Members............................. 350 1 30/60 175
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
[[Page 69428]]
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 Board Members............................. 150 1 15/60 38
Required Mod.
Reviewer Worksheet of Translated Documents.. Board Members............................. 15 1 15/60 4
Reviewer Advertisement Checklist............ Board Members............................. 10 1 20/60 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: November 7, 2013.
Vivian Horovitch-Kelley,
Program Analyst, National Institutes of Health.
[FR Doc. 2013-27556 Filed 11-18-13; 8:45 am]
BILLING CODE 4140-01-P
