Submission for OMB Review; 30-Day Comment Request: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI), 69426-69428 [2013-27556]

Download as PDF 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