Submission for OMB Review; 30-Day Comment Request; CTEP Support Contracts Forms and Surveys, NCI, NIH, 12618-12621 [2017-04253]

Download as PDF 12618 Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices Dated: February 15, 2017. Karla Bailey, Project Clearance Liaison, National Cancer Institute, National Institutes of Health. [FR Doc. 2017–04255 Filed 3–3–17; 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 asabaliauskas 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 appications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel, PAR–14– 255: Multidisciplinary Studies of HIV and Viral Hepatitis Co-Infection. Date: March 28, 2017. Time: 10:00 a.m. to 11:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Kenneth A. Roebuck, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5106, MSC 7852, Bethesda, MD 20892, (301) 435– 1166, roebuckk@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Fellowships: Physiology and Pathobiology of Musculoskeletal, Oral and Skin Systems. Date: March 29, 2017. Time: 8:00 a.m. to 6:30 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Anshumali Chaudhari, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4124, MSC 7802, Bethesda, MD 20892, (301) 435– 1210, chaudhaa@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Small Business: Non-HIV Diagnostics, Food Safety, Sterilization/Disinfection and Bioremediation. Date: March 30–31, 2017. VerDate Sep<11>2014 19:24 Mar 03, 2017 Jkt 241001 Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Gagan Pandya, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Rm 3200, MSC 7808, Bethesda, MD 20892, 301–435–1167, pandyaga@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Small Business: Cancer Biotherapeutics Development. Date: March 30–31, 2017. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Courtyard by Marriott, 5520 Wisconsin Avenue, Chevy Chase, MD 20815. Contact Person: Nicholas J. Donato, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4040, Bethesda, MD 20817, 301–827–4810, nick.donato@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, RFA–GM– 17–004: Maximizing Investigators’ Research Award for Early Stage Investigators (R35). Date: March 30, 2017. Time: 8:00 a.m. to 6:30 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: David Balasundaram, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5189, MSC 7840, Bethesda, MD 20892, 301–435– 1022, balasundaramd@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: Cardiovascular Science. Date: March 30–31, 2017. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Kimm Hamann, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4118A, MSC 7814, Bethesda, MD 20892, 301–435– 5575, hamannkj@csr.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) Dated: February 28, 2017. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–04172 Filed 3–3–17; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary & Integrative Health; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The 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: National Center for Complementary and Integrative Health Special Emphasis Panel, NCCIH Training, Career Development, Fellowship, and Research Grant Review. Date: March 22, 2017. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Ashlee Tipton, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Center for Complementary and Integrative Health, 6707 Democracy Blvd., Suite 401, Bethesda, MD 20892, 301–451–3849, Ashlee.tipton@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.213, Research and Training in Complementary and Integrative Health, National Institutes of Health, HHS) Dated: February 28, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–04177 Filed 3–3–17; 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; CTEP Support Contracts Forms and Surveys, NCI, NIH AGENCY: National Institutes of Health, HHS. ACTION: E:\FR\FM\06MRN1.SGM Notice. 06MRN1 12619 Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices In compliance with 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 December 13, 2016, page 89955 (81 FR 89955) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. ADDRESSES: 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: Desk Officer for NIH. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Michael Montello, Pharm.D., Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, 9609 Medical Center Drive, Rockville, MD 20850 or call nontoll-free number (240–276–6080) or Email your request, including your address to: montellom@mail.nih.gov. Proposed Collection: CTEP Support Contracts Forms and Surveys, NCI, 0925-New, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) and the Division of Cancer Prevention (DCP) fund an extensive national program of cancer research, sponsoring clinical trials in cancer prevention, symptom management and treatment for qualified clinical investigators. As part of this effort, CTEP and DCP oversee two support programs, the NCI Central Institutional Review Board (CIRB) and the Cancer Trial Support Unit (CTSU). The purpose of the support programs is to increase efficiency and minimizing burden. The NCI CIRB provides trial oversight satisfying the requirements of 45 CFR part 45 and 21 CFR part 56 for review of NCI supported studies. The CTSU provides program and systems support for regulatory document collection, membership, data management and patient enrollment. The two programs use integrated systems and processes for managing participant information and documentation of regulatory review. To meet the responsibilities of each program, information is collected from the sites for purposes of membership, enrollment, opening of IRB approved studies, documenting IRB review, regulatory approval (for sites not using the CIRB), patient enrollment, and routing of case report forms. Several surveys are collected to assess satisfaction and provide feedback to guide improvements with processes and technology. Other Surveys have been developed to assess health professional’s interests in clinical trials. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 15,525. CTSU AND NCI CIRB FORMS AND CTSU, CIRB AND CTEP SURVEYS—ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent asabaliauskas on DSK3SPTVN1PROD with NOTICES Type of respondent CTSU IRB/Regulatory Approval Transmittal Form (Attachment A1). CTSU IRB Certification Form (Attachment A2). Withdrawal from Protocol Participation Form (Attachment A3). Site Addition Form (Attachment A4) ............. CTSU Roster Update Form (Attachment A5) CTSU Request for Clinical Brochure (Attachment A6). CTSU Supply Request Form (Attachment A7). Site Initiated Data Update Form (Attachment A8). Data Clarification Form (Attachment A9) ..... RTOG 0834 CTSU Data Transmittal Form (Attachment A10). MC0845(8233) CTSU Data Transmittal (Attachment A11). CTSU Generic Data Transmittal Form (Attachment A12). TAILORx—PACCT1—Data Transmittal Form (Attachment A13). Unsolicited Data Modification Form: Protocol: TAILORx/PACCT–1 (Attachment 14). CTSU Patient Enrollment Transmittal Form (Attachment A15). CTSU Transfer Form (Attachment A16) ....... CTSU System Access Request Form (Attachment A17). Health Care Practitioner ....... 2,444 12 2/60 978 Health Care Practitioner ....... 2,444 12 10/60 4,888 Health Care Practitioner ....... 279 1 10/60 47 Health Care Practitioner ....... Health Care Practitioner ....... Health Care Practitioner ....... 80 600 360 12 1 1 10/60 5/60 10/60 160 50 60 Health Care Practitioner ....... 90 12 10/60 180 Health Care Practitioner ....... 2 12 10/60 4 Health Care Practitioner ....... Health Care Practitioner ....... 150 12 24 76 10/60 10/60 600 152 Health Care Practitioner ....... 5 12 10/60 10 Health Care Practitioner ....... 5 12 10/60 10 Health Care Practitioner ....... 161 96 10/60 2576 Health Care Practitioner ....... 30 12 10/60 60 Health Care Practitioner ....... 12 12 10/60 24 Health Care Practitioner ....... Health Care Practitioner ....... 360 180 2 1 10/60 20/60 120 60 VerDate Sep<11>2014 19:24 Mar 03, 2017 Jkt 241001 PO 00000 Frm 00087 Fmt 4703 Number of respondents Average burden per response (in hours) Form name Sfmt 4703 E:\FR\FM\06MRN1.SGM 06MRN1 Total annual burden hours 12620 Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices CTSU AND NCI CIRB FORMS AND CTSU, CIRB AND CTEP SURVEYS—ESTIMATED ANNUALIZED BURDEN HOURS— Continued Number of responses per respondent asabaliauskas on DSK3SPTVN1PROD with NOTICES Type of respondent NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B1). NCI CIRB Signatory Enrollment Form (Attachment B2). CIRB Board Member Biographical Sketch Form (Attachment B3). CIRB Board Member Contact Information Form (Attachment B4). CIRB Board Member NDA (Attachment B6) CIRB Direct Deposit Form (Attachment B7) CIRB Member COI Screening Worksheet (Attachment B8). CIRB COI Screening for CIRB meetings (Attachment B9). CIRB IR Application (Attachment B10) ........ CIRB IR Application for Exempt Studies (Attachment B11). CIRB Amendment Review Application (Attachment B12). CIRB Ancillary Studies Application (Attachment B13). CIRB Continuing Review Application (Attachment B14). Adult IR of Cooperative Group Protocol (Attachment B15). Pediatric IR of Cooperative Group Protocol (Attachment B16). Adult Continuing Review of Cooperative Group Protocol (Attachment B17) Protocol. Pediatric Continuing Review of Cooperative Group Protocol (Attachment B18). Adult Amendment of Cooperative Group Protocol (Attachment B19). Pediatric Amendment of Cooperative Group Protocol (Attachment B20). Pharmacist’s Review of a Cooperative Group Study (Attachment B21). CPC Pharmacist’s Review of Cooperative Group Study (Attachment B22). Adult Expedited Amendment Review (Attachment B23). Pediatric Expedited Amendment Review (Attachment B24). Adult Expedited Continuing Review (Attachment B25). Pediatric Expedited Continuing Review (Attachment B26). Adult Cooperative Group Response to CIRB Review (Attachment B27). Pediatric Cooperative Group Response to CIRB Review (Attachment B28). Adult Expedited Study Chair Response to Required Mod (Attachment B29). Pediatric Expedited Study Chair Response to Required Mod (Attachment B30). Reviewer Worksheet—Determination of UP or SCN (Attachment B31). Reviewer Worksheet—CIRB Statistical Reviewer Form (Attachment B32). CIRB Application for Translated Documents (Attachment B33). Reviewer Worksheet of Translated Documents (Attachment B34). Reviewer Worksheet of Recruitment Material (Attachment B35). Participants ........................... 50 1 15/60 13 Participants ........................... 50 1 15/60 13 Board Member ...................... 25 1 15/60 6 Board Member ...................... 25 1 10/60 4 Board Member ...................... Board Member ...................... Board Members .................... 25 25 12 1 1 1 10/60 15/60 30/60 4 6 6 Board Members .................... 72 1 15/60 18 Health Care Practitioner ....... Health Care Practitioner ....... 80 4 1 1 1 30/60 80 2 Health Care Practitioner ....... 400 1 15/60 100 Health Care Practitioner ....... 1 1 1 1 Health Care Practitioner ....... 400 1 30/60 200 Board Members .................... 65 1 180/60 195 Board Members .................... 15 1 180/60 45 Board Members .................... 275 1 1 275 Board Members .................... 130 1 1 130 Board Members .................... 40 1 120/60 80 Board Members .................... 25 1 120/60 50 Board Members .................... 10 1 120/60 20 Board Members .................... 20 1 120/60 40 Board Members .................... 348 1 30/60 174 Board Members .................... 140 1 30/60 70 Board Members .................... 140 1 30/60 70 Board Members .................... 36 1 30/60 18 Health Care Practitioner ....... 30 1 1 30 Health Care Practitioner ....... 5 1 1 5 Board Members .................... 40 1 15/60 10 Board Members .................... 40 1 15/60 10 Board Members .................... 360 1 10/60 61 Board Members .................... 100 1 1 100 Health Care Practitioner ....... 100 1 30/60 50 Board Members .................... 100 1 15/60 25 Board Members .................... 20 1 15/60 5 VerDate Sep<11>2014 19:24 Mar 03, 2017 Jkt 241001 PO 00000 Frm 00088 Fmt 4703 Number of respondents Average burden per response (in hours) Form name Sfmt 4703 E:\FR\FM\06MRN1.SGM 06MRN1 Total annual burden hours 12621 Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices CTSU AND NCI CIRB FORMS AND CTSU, CIRB AND CTEP SURVEYS—ESTIMATED ANNUALIZED BURDEN HOURS— Continued Average burden per response (in hours) Number of responses per respondent Form name Type of respondent Reviewer Worksheet Expedited Study Closure Review (Attachment B36). Reviewer Worksheet Expedited Review of Study Chair Response to CIRB-Required Modifications (Attachment B37). Reviewer Worksheet of Expedited IR (Attachment B38). Reviewer Worksheet—CPC—Determination of UP or SCN (Attachment B39). Annual Signatory Institution Worksheet About Local Context (Attachment B40). Annual Principal Investigator Worksheet About Local Context (Attachment B41). Study-Specific Worksheet About Local Context (Attachment B42). Study Closure or Transfer of Study Review Responsibility Form (Attachment B43). UP or SCN Reporting Form (Attachment B44). Change of SI PI Form (Attachment B45) ..... CTSU Website Customer Satisfaction Survey (Attachment C1). CTSU Help Desk Customer Satisfaction Survey (Attachment C2). CTSU OPEN Survey (Attachment C3) ......... CIRB Customer Satisfaction Survey (Attachment C4) Satisfaction Survey (Attachment C4). Follow-up Survey (Communication Audit) (Attachment C5). Website Focus Groups, Communication Project (Attachment C6 A–D). CIRB Board Member Annual Assessment Survey (Attachment C7). PIO Customer Satisfaction Survey (Attachment C8). Concept Clinical Trial Survey (Attachment C9). Prospective Clinical Trial Survey (Attachment C10). Low Accrual Clinical Trial Survey (Attachment C11). ETCTN PI Survey (Attachment 12) .............. ETCTN RS Survey (Attachment 13) ............ Board Members .................... 20 1 15/60 5 Board Members .................... 5 1 30/60 3 Board Members .................... 5 1 30/60 3 Board Members .................... 40 1 15/60 10 Health Care Practitioner ....... 400 1 40/60 267 Health Care Practitioner ....... 1800 1 20/60 600 Health Care Practitioner ....... 4800 1 20/60 1600 Health Care Practitioner ....... 1680 1 15/60 420 Health Care Practitioner ....... 360 1 20/60 120 Health Care Practitioner ....... Health Care Practitioner ....... 120 275 1 1 15/60 15/60 30 69 Health Care Practitioner ....... 325 1 15/60 81 Health Care Practitioner ....... Participants ........................... 60 600 1 1 15/60 15/60 15 150 Participants/Board Members 300 1 15/60 75 Participants/Board Members 18 1 1 18 Board Members .................... 60 1 20/60 20 Health Care Practitioner ....... 60 1 5/60 5 Health Care Practitioner ....... 500 1 5/60 42 Health Care Practitioner ....... 1000 1 1/60 17 Health Care Practitioner ....... 1000 1 1/60 17 Physician .............................. Health Care Practitioner ....... 75 175 1 1 15/60 15/60 19 44 Totals ..................................................... ............................................... 24,100 100,337 ........................ 15,525 Dated: February 15, 2017. Karla Bailey, PRA OMB Liaison, Office of Management Policy and Compliance, National Cancer Institute (NCI) National Institutes of Health (NIH). Number of respondents National Center for Complementary & Integrative Health; Notice of Closed Meeting 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. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and [FR Doc. 2017–04253 Filed 3–3–17; 8:45 am] Name of Committee: National Center for Complementary and Integrative Health Special Emphasis Panel, Exploratory Clinical Trials and Studies of Natural Products. Date: March 30, 2017. Time: 12:00 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health BILLING CODE 4140–01–P asabaliauskas on DSK3SPTVN1PROD with NOTICES Total annual burden hours VerDate Sep<11>2014 19:24 Mar 03, 2017 Jkt 241001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 E:\FR\FM\06MRN1.SGM 06MRN1

Agencies

[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Pages 12618-12621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04253]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; 30-Day Comment Request; CTEP Support
Contracts Forms and Surveys, NCI, NIH

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

[[Page 12619]]

In compliance with 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 December
13, 2016, page 89955 (81 FR 89955) and allowed 60 days for public
comment. No public comments were received. The purpose of this notice
is to allow an additional 30 days for public comment.

DATES: Comments regarding this information collection are best assured
of having their full effect if received within 30-days of the date of
this publication.

ADDRESSES: 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: Desk
Officer for NIH.

FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Michael Montello, Pharm.D., 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.
Proposed Collection: CTEP Support Contracts Forms and Surveys, NCI,
0925-New, National Cancer Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information Collection: The National Cancer
Institute (NCI) Cancer Therapy Evaluation Program (CTEP) and the
Division of Cancer Prevention (DCP) fund an extensive national program
of cancer research, sponsoring clinical trials in cancer prevention,
symptom management and treatment for qualified clinical investigators.
As part of this effort, CTEP and DCP oversee two support programs, the
NCI Central Institutional Review Board (CIRB) and the Cancer Trial
Support Unit (CTSU). The purpose of the support programs is to increase
efficiency and minimizing burden. The NCI CIRB provides trial oversight
satisfying the requirements of 45 CFR part 45 and 21 CFR part 56 for
review of NCI supported studies. The CTSU provides program and systems
support for regulatory document collection, membership, data management
and patient enrollment. The two programs use integrated systems and
processes for managing participant information and documentation of
regulatory review.
To meet the responsibilities of each program, information is
collected from the sites for purposes of membership, enrollment,
opening of IRB approved studies, documenting IRB review, regulatory
approval (for sites not using the CIRB), patient enrollment, and
routing of case report forms.
Several surveys are collected to assess satisfaction and provide
feedback to guide improvements with processes and technology. Other
Surveys have been developed to assess health professional's interests
in clinical trials.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 15,525.

CTSU and NCI CIRB Forms and CTSU, CIRB and CTEP Surveys--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of Number of responses per per response Total annual
respondent respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
CTSU IRB/Regulatory Approval Health Care 2,444 12 2/60 978
Transmittal Form (Attachment Practitioner.
A1).
CTSU IRB Certification Form Health Care 2,444 12 10/60 4,888
(Attachment A2). Practitioner.
Withdrawal from Protocol Health Care 279 1 10/60 47
Participation Form Practitioner.
(Attachment A3).
Site Addition Form (Attachment Health Care 80 12 10/60 160
A4). Practitioner.
CTSU Roster Update Form Health Care 600 1 5/60 50
(Attachment A5). Practitioner.
CTSU Request for Clinical Health Care 360 1 10/60 60
Brochure (Attachment A6). Practitioner.
CTSU Supply Request Form Health Care 90 12 10/60 180
(Attachment A7). Practitioner.
Site Initiated Data Update Health Care 2 12 10/60 4
Form (Attachment A8). Practitioner.
Data Clarification Form Health Care 150 24 10/60 600
(Attachment A9). Practitioner.
RTOG 0834 CTSU Data Health Care 12 76 10/60 152
Transmittal Form (Attachment Practitioner.
A10).
MC0845(8233) CTSU Data Health Care 5 12 10/60 10
Transmittal (Attachment A11). Practitioner.
CTSU Generic Data Transmittal Health Care 5 12 10/60 10
Form (Attachment A12). Practitioner.
TAILORx--PACCT1--Data Health Care 161 96 10/60 2576
Transmittal Form (Attachment Practitioner.
A13).
Unsolicited Data Modification Health Care 30 12 10/60 60
Form: Protocol: TAILORx/PACCT- Practitioner.
1 (Attachment 14).
CTSU Patient Enrollment Health Care 12 12 10/60 24
Transmittal Form (Attachment Practitioner.
A15).
CTSU Transfer Form (Attachment Health Care 360 2 10/60 120
A16). Practitioner.
CTSU System Access Request Health Care 180 1 20/60 60
Form (Attachment A17). Practitioner.

[[Page 12620]]

NCI CIRB AA & DOR between the Participants.... 50 1 15/60 13
NCI CIRB and Signatory
Institution (Attachment B1).
NCI CIRB Signatory Enrollment Participants.... 50 1 15/60 13
Form (Attachment B2).
CIRB Board Member Biographical Board Member.... 25 1 15/60 6
Sketch Form (Attachment B3).
CIRB Board Member Contact Board Member.... 25 1 10/60 4
Information Form (Attachment
B4).
CIRB Board Member NDA Board Member.... 25 1 10/60 4
(Attachment B6).
CIRB Direct Deposit Form Board Member.... 25 1 15/60 6
(Attachment B7).
CIRB Member COI Screening Board Members... 12 1 30/60 6
Worksheet (Attachment B8).
CIRB COI Screening for CIRB Board Members... 72 1 15/60 18
meetings (Attachment B9).
CIRB IR Application Health Care 80 1 1 80
(Attachment B10). Practitioner.
CIRB IR Application for Exempt Health Care 4 1 30/60 2
Studies (Attachment B11). Practitioner.
CIRB Amendment Review Health Care 400 1 15/60 100
Application (Attachment B12). Practitioner.
CIRB Ancillary Studies Health Care 1 1 1 1
Application (Attachment B13). Practitioner.
CIRB Continuing Review Health Care 400 1 30/60 200
Application (Attachment B14). Practitioner.
Adult IR of Cooperative Group Board Members... 65 1 180/60 195
Protocol (Attachment B15).
Pediatric IR of Cooperative Board Members... 15 1 180/60 45
Group Protocol (Attachment
B16).
Adult Continuing Review of Board Members... 275 1 1 275
Cooperative Group Protocol
(Attachment B17) Protocol.
Pediatric Continuing Review of Board Members... 130 1 1 130
Cooperative Group Protocol
(Attachment B18).
Adult Amendment of Cooperative Board Members... 40 1 120/60 80
Group Protocol (Attachment
B19).
Pediatric Amendment of Board Members... 25 1 120/60 50
Cooperative Group Protocol
(Attachment B20).
Pharmacist's Review of a Board Members... 10 1 120/60 20
Cooperative Group Study
(Attachment B21).
CPC Pharmacist's Review of Board Members... 20 1 120/60 40
Cooperative Group Study
(Attachment B22).
Adult Expedited Amendment Board Members... 348 1 30/60 174
Review (Attachment B23).
Pediatric Expedited Amendment Board Members... 140 1 30/60 70
Review (Attachment B24).
Adult Expedited Continuing Board Members... 140 1 30/60 70
Review (Attachment B25).
Pediatric Expedited Continuing Board Members... 36 1 30/60 18
Review (Attachment B26).
Adult Cooperative Group Health Care 30 1 1 30
Response to CIRB Review Practitioner.
(Attachment B27).
Pediatric Cooperative Group Health Care 5 1 1 5
Response to CIRB Review Practitioner.
(Attachment B28).
Adult Expedited Study Chair Board Members... 40 1 15/60 10
Response to Required Mod
(Attachment B29).
Pediatric Expedited Study Board Members... 40 1 15/60 10
Chair Response to Required
Mod (Attachment B30).
Reviewer Worksheet-- Board Members... 360 1 10/60 61
Determination of UP or SCN
(Attachment B31).
Reviewer Worksheet--CIRB Board Members... 100 1 1 100
Statistical Reviewer Form
(Attachment B32).
CIRB Application for Health Care 100 1 30/60 50
Translated Documents Practitioner.
(Attachment B33).
Reviewer Worksheet of Board Members... 100 1 15/60 25
Translated Documents
(Attachment B34).
Reviewer Worksheet of Board Members... 20 1 15/60 5
Recruitment Material
(Attachment B35).

[[Page 12621]]

Reviewer Worksheet Expedited Board Members... 20 1 15/60 5
Study Closure Review
(Attachment B36).
Reviewer Worksheet Expedited Board Members... 5 1 30/60 3
Review of Study Chair
Response to CIRB-Required
Modifications (Attachment
B37).
Reviewer Worksheet of Board Members... 5 1 30/60 3
Expedited IR (Attachment B38).
Reviewer Worksheet--CPC-- Board Members... 40 1 15/60 10
Determination of UP or SCN
(Attachment B39).
Annual Signatory Institution Health Care 400 1 40/60 267
Worksheet About Local Context Practitioner.
(Attachment B40).
Annual Principal Investigator Health Care 1800 1 20/60 600
Worksheet About Local Context Practitioner.
(Attachment B41).
Study-Specific Worksheet About Health Care 4800 1 20/60 1600
Local Context (Attachment Practitioner.
B42).
Study Closure or Transfer of Health Care 1680 1 15/60 420
Study Review Responsibility Practitioner.
Form (Attachment B43).
UP or SCN Reporting Form Health Care 360 1 20/60 120
(Attachment B44). Practitioner.
Change of SI PI Form Health Care 120 1 15/60 30
(Attachment B45). Practitioner.
CTSU Website Customer Health Care 275 1 15/60 69
Satisfaction Survey Practitioner.
(Attachment C1).
CTSU Help Desk Customer Health Care 325 1 15/60 81
Satisfaction Survey Practitioner.
(Attachment C2).
CTSU OPEN Survey (Attachment Health Care 60 1 15/60 15
C3). Practitioner.
CIRB Customer Satisfaction Participants.... 600 1 15/60 150
Survey (Attachment C4)
Satisfaction Survey
(Attachment C4).
Follow-up Survey Participants/ 300 1 15/60 75
(Communication Audit) Board Members.
(Attachment C5).
Website Focus Groups, Participants/ 18 1 1 18
Communication Project Board Members.
(Attachment C6 A-D).
CIRB Board Member Annual Board Members... 60 1 20/60 20
Assessment Survey (Attachment
C7).
PIO Customer Satisfaction Health Care 60 1 5/60 5
Survey (Attachment C8). Practitioner.
Concept Clinical Trial Survey Health Care 500 1 5/60 42
(Attachment C9). Practitioner.
Prospective Clinical Trial Health Care 1000 1 1/60 17
Survey (Attachment C10). Practitioner.
Low Accrual Clinical Trial Health Care 1000 1 1/60 17
Survey (Attachment C11). Practitioner.
ETCTN PI Survey (Attachment Physician....... 75 1 15/60 19
12).
ETCTN RS Survey (Attachment Health Care 175 1 15/60 44
13). Practitioner.
---------------------------------------------------------------
Totals.................... ................ 24,100 100,337 .............. 15,525
----------------------------------------------------------------------------------------------------------------

Dated: February 15, 2017.
Karla Bailey,
PRA OMB Liaison, Office of Management Policy and Compliance, National
Cancer Institute (NCI) National Institutes of Health (NIH).
[FR Doc. 2017-04253 Filed 3-3-17; 8:45 am]
BILLING CODE 4140-01-P

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