Proposed Collection; 60-Day Comment Request; CTEP Support Contracts Forms and Surveys (National Cancer Institute), 89955-89957 [2016-29767]

Download as PDF 89955 Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Karla Bailey, Office of Management Policy and Compliance, National Cancer Institute, 9609 Medical Center Drive, Bethesda, MD 20892–9760 or call non-toll-free number (240) 276– 5582 or Email your request, including your address to: karla.bailey@nih.gov. Formal requests for additional plans and instruments must be requested in writing. FOR FURTHER INFORMATION CONTACT: Section 3506(c)(2)(A) of the Paperwork SUPPLEMENTARY INFORMATION: National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This information collection activity is collecting qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration’s commitment to improving service delivery. This generic provides information about the National Cancer Institute’s customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. It also allows feedback to contribute directly to the improvement of program management. Feedback collected under this generic clearance provides useful information but it will not yield data that can be generalized to the overall population. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated burden hours are 8,917. Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimizes the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NCI), 0925–0642, Revision, ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of collection Number of responses per respondent Average burden per response (in hours) Total burden hours Surveys ............................................................................................................ In-Depth Interviews (IDIs) or Small Discussion Groups .................................. Focus Groups .................................................................................................. Website or Software Usability Tests ................................................................ 10,000 500 1,000 5,000 1 1 1 1 30/60 90/60 90/60 20/60 5,000 750 1,500 1,667 Total .......................................................................................................... 16,500 16,500 ........................ 8,917 Dated: December 7, 2016. Karla Bailey, Project Clearance Liaison, National Cancer Institute, National Institutes of Health. [FR Doc. 2016–29890 Filed 12–12–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health pmangrum on DSK3GDR082PROD with NOTICES Proposed Collection; 60-Day Comment Request; CTEP Support Contracts Forms and Surveys (National Cancer Institute) National Institutes of Health, Department of Health and Human Services. AGENCY: ACTION: Notice. In compliance with the requirement of the Paperwork SUMMARY: VerDate Sep<11>2014 15:08 Dec 12, 2016 Jkt 241001 Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Michael Montello, Pharm. D., Cancer Therapy Evaluation Program (CTEP), 9609 Medical Center Drive, MSC 9742, Rockville, MD 20850 or call non-toll-free number 240–276–6080 or Email your request, including your FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 address to: montellom@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimizes the burden of the collection of SUPPLEMENTARY INFORMATION: E:\FR\FM\13DEN1.SGM 13DEN1 89956 Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection Title: CTEP Support Contracts Forms and Surveys, 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 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 15,531. 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 45 and 21 CFR 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. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent pmangrum on DSK3GDR082PROD with NOTICES Form name CTSU IRB/Regulatory Approval Transmittal Form CTSU IRB Certification Form ............................... Withdrawal from Protocol Participation Form ....... Site Addition Form ................................................ CTSU Roster Update Form .................................. CTSU Request for Clinical Brochure .................... CTSU Supply Request Form ................................ Site Initiated Data Update Form ........................... Data Clarification Form ......................................... RTOG 0834 CTSU Data Transmittal Form .......... MC0845(8233) CTSU Data Transmittal ............... CTSU Generic Data Transmittal Form ................. TAILORx_PACCT1_Data Transmittal Form ......... Unsolicited Data Modification Form: Protocol: TAILORx/PACCT–1. CTSU Patient Enrollment Transmittal Form ......... CTSU Transfer Form ............................................ CTSU System Access Request Form .................. NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution. NCI CIRB Signatory Enrollment Form .................. CIRB Board Member Biographical Sketch Form CIRB Board Member Contact Information Form .. CIRB Board Member W–9 .................................... CIRB Board Member NDA ................................... CIRB Direct Deposit Form .................................... CIRB Member COI Screening Worksheet ............ CIRB COI Screening for CIRB meetings ............. CIRB IR Application .............................................. CIRB IR Application for Exempt Studies .............. CIRB Amendment Review Application ................. CIRB Ancillary Studies Application ....................... CIRB Continuing Review Application ................... Adult IR of Cooperative Group Protocol ............... Pediatric IR 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. Pharmacist’s Review of a Cooperative Group Study. CPC Pharmacist’s Review of Cooperative Group Study. Adult Expedited Amendment Review ................... VerDate Sep<11>2014 15:08 Dec 12, 2016 Jkt 241001 Health Health Health Health Health Health Health Health Health Health Health Health Health Health Number of responses per respondent Average burden per response (in hours) Total annual burden hours Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner 2,444 2,444 279 80 600 360 90 2 150 12 5 5 161 30 12 12 1 12 1 1 12 12 24 76 12 12 96 12 2/60 10/60 10/60 10/60 5/60 10/60 10/60 10/60 10/60 10/60 10/60 10/60 10/60 10/60 978 4,888 47 160 50 60 180 4 600 152 10 10 2,576 60 Health Care Practitioner Health Care Practitioner Health Care Practitioner Participants ................... 12 360 180 50 12 2 1 1 10/60 10/60 20/60 15/60 24 120 60 13 Participants ................... Board Member .............. Board Member .............. Board Member .............. Board Member .............. Board Member .............. Board Members ............ Board Members ............ Health Care Practitioner Health Care Practitioner Health Care Practitioner Health Care Practitioner Health Care Practitioner Board Members ............ Board Members ............ Board Members ............ 50 25 25 25 25 25 12 72 80 4 400 1 400 65 15 275 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 15/60 15/60 10/60 15/60 10/60 15/60 30/60 15/60 60/60 30/60 15/60 60/60 30/60 180/60 180/60 60/60 13 6 4 6 4 6 6 18 80 2 100 1 200 195 45 275 Board Members ............ 130 1 60/60 130 Board Members ............ Board Members ............ 40 25 1 1 120/60 120/60 80 50 Board Members ............ 10 1 120/60 20 Board Members ............ 20 1 120/60 40 Board Members ............ 348 1 30/60 174 PO 00000 Care Care Care Care Care Care Care Care Care Care Care Care Care Care Number of respondents Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\13DEN1.SGM 13DEN1 89957 Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of responses per respondent Type of respondent Pediatric Expedited Amendment Review ............. Adult Expedited Continuing Review ..................... Pediatric Expedited Continuing Review ............... Adult Cooperative Group Response to CIRB Review. Pediatric Cooperative Group Response to CIRB Review. Adult Expedited Study Chair Response to Required Mod. Pediatric Expedited Study Chair Response to Required Mod. Reviewer Worksheet—Determination of UP or SCN. Reviewer Worksheet—CIRB Statistical Reviewer Form. CIRB Application for Translated Documents ........ Reviewer Worksheet of Translated Documents ... Reviewer Worksheet of Recruitment Material ...... Reviewer Worksheet Expedited Study Closure Review. Reviewer Worksheet Expedited Review of Study Chair Response to CIRB—Required Modifications. Reviewer Worksheet of Expedited IR .................. Reviewer Worksheet—CPC—Determination of UP or SCN. 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. UP or SCN Reporting Form ................................. Change of SI PI Form .......................................... CTSU Web site Customer Satisfaction Survey .... CTSU Help Desk Customer Satisfaction Survey CTSU OPEN Survey ............................................ CIRB Customer Satisfaction Survey .................... Follow-up Survey (Communication Audit) ............ Board Members ............ Board Members ............ Board Members ............ Health Care Practitioner 140 140 36 30 1 1 1 1 30/60 30/60 30/60 60/60 70 70 18 30 Health Care Practitioner 5 1 60/60 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 60/60 100 Health Care Practitioner Board Members ............ Board Members ............ Board Members ............ 100 100 20 20 1 1 1 1 30/60 15/60 15/60 15/60 50 25 5 5 Board Members ............ 5 1 30/60 3 Board Members ............ Board Members ............ 5 40 1 1 30/60 15/60 3 10 Health Care Practitioner 400 1 40/60 267 Health Care Practitioner 1,800 1 20/60 600 Health Care Practitioner Health Care Practitioner 4,800 1,680 1 1 20/60 15/60 1,600 420 360 120 275 325 60 600 300 1 1 1 1 1 1 1 20/60 15/60 15/60 15/60 15/60 15/60 15/60 120 30 69 81 15 150 75 18 1 60/60 18 CIRB Board Member Annual Assessment Survey PIO Customer Satisfaction Survey ....................... Concept Clinical Trial Survey ............................... Prospective Clinical Trial Survey .......................... Low Accrual Clinical Trial Survey ......................... ETCTN PI Survey ................................................. ETCTN RS Survey ............................................... Health Care Practitioner Health Care Practitioner Health Care Practitioner Health Care Practitioner Health Care Practitioner Participants ................... Participants/Board Members. Participants/Board Members. Board Members ............ Health Care Practitioner Health Care Practitioner Health Care Practitioner Health Care Practitioner Physician ...................... Health Care Practitioner 60 60 500 1,000 1,000 75 175 1 1 1 1 1 1 1 20/60 5/60 5/60 1/60 1/60 15/60 15/60 20 5 42 17 17 19 44 Totals ............................................................. ....................................... 24,125 100,362 ........................ 15,531 Web site Focus Groups, Communication Project Number of respondents Average burden per response (in hours) Form name pmangrum on DSK3GDR082PROD with NOTICES Dated: December 1, 2016. Karla Bailey, Project Clearance Liaison, National Cancer Institute, National Institutes of Health. DEPARTMENT OF HOMELAND SECURITY ACTION: Office of the Secretary SUMMARY: [FR Doc. 2016–29767 Filed 12–12–16; 8:45 am] [Docket No. DHS–2016–0088] Total annual burden hours BILLING CODE 4140–01–P Privacy Act of 1974; Department of Homeland Security/U.S. Customs and Border Protection-007 Border Crossing Information (BCI) System of Records Department of Homeland Security, Privacy Office. AGENCY: VerDate Sep<11>2014 15:08 Dec 12, 2016 Jkt 241001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 Notice of Privacy Act System of Records. In accordance with the Privacy Act of 1974, the Department of Homeland Security proposes to update and reissue a current Department of Homeland Security system of records titled, ‘‘Department of Homeland Security (DHS)/U.S. Customs and Border Protection (CBP)-007 Border Crossing Information (BCI) System of Records.’’ This system of records allows E:\FR\FM\13DEN1.SGM 13DEN1

Agencies

[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Notices]
[Pages 89955-89957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29767]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Proposed Collection; 60-Day Comment Request; CTEP Support
Contracts Forms and Surveys (National Cancer Institute)

AGENCY: National Institutes of Health, Department of Health and Human
Services.

ACTION: Notice.

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

SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Cancer Institute (NCI) will publish
periodic summaries of propose projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.

DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Michael
Montello, Pharm. D., Cancer Therapy Evaluation Program (CTEP), 9609
Medical Center Drive, MSC 9742, 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.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written comments and/or suggestions
from the public and affected agencies are invited to address one or
more of the following points: (1) Whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) Ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) Ways
to minimizes the burden of the collection of

[[Page 89956]]

information on those who are to respond, including the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology.
Proposed Collection Title: CTEP Support Contracts Forms and
Surveys, 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 45 and 21 CFR 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 15,531.

Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Type of Number of Number of burden per Total annual
Form name respondent respondents responses per response (in burden hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
CTSU IRB/Regulatory Approval Health Care 2,444 12 2/60 978
Transmittal Form. Practitioner.
CTSU IRB Certification Form... Health Care 2,444 12 10/60 4,888
Practitioner.
Withdrawal from Protocol Health Care 279 1 10/60 47
Participation Form. Practitioner.
Site Addition Form............ Health Care 80 12 10/60 160
Practitioner.
CTSU Roster Update Form....... Health Care 600 1 5/60 50
Practitioner.
CTSU Request for Clinical Health Care 360 1 10/60 60
Brochure. Practitioner.
CTSU Supply Request Form...... Health Care 90 12 10/60 180
Practitioner.
Site Initiated Data Update Health Care 2 12 10/60 4
Form. Practitioner.
Data Clarification Form....... Health Care 150 24 10/60 600
Practitioner.
RTOG 0834 CTSU Data Health Care 12 76 10/60 152
Transmittal Form. Practitioner.
MC0845(8233) CTSU Data Health Care 5 12 10/60 10
Transmittal. Practitioner.
CTSU Generic Data Transmittal Health Care 5 12 10/60 10
Form. Practitioner.
TAILORx_PACCT1_Data Health Care 161 96 10/60 2,576
Transmittal Form. Practitioner.
Unsolicited Data Modification Health Care 30 12 10/60 60
Form: Protocol: TAILORx/PACCT- Practitioner.
1.
CTSU Patient Enrollment Health Care 12 12 10/60 24
Transmittal Form. Practitioner.
CTSU Transfer Form............ Health Care 360 2 10/60 120
Practitioner.
CTSU System Access Request Health Care 180 1 20/60 60
Form. Practitioner.
NCI CIRB AA & DOR between the Participants.... 50 1 15/60 13
NCI CIRB and Signatory
Institution.
NCI CIRB Signatory Enrollment Participants.... 50 1 15/60 13
Form.
CIRB Board Member Biographical Board Member.... 25 1 15/60 6
Sketch Form.
CIRB Board Member Contact Board Member.... 25 1 10/60 4
Information Form.
CIRB Board Member W-9......... Board Member.... 25 1 15/60 6
CIRB Board Member NDA......... Board Member.... 25 1 10/60 4
CIRB Direct Deposit Form...... Board Member.... 25 1 15/60 6
CIRB Member COI Screening Board Members... 12 1 30/60 6
Worksheet.
CIRB COI Screening for CIRB Board Members... 72 1 15/60 18
meetings.
CIRB IR Application........... Health Care 80 1 60/60 80
Practitioner.
CIRB IR Application for Exempt Health Care 4 1 30/60 2
Studies. Practitioner.
CIRB Amendment Review Health Care 400 1 15/60 100
Application. Practitioner.
CIRB Ancillary Studies Health Care 1 1 60/60 1
Application. Practitioner.
CIRB Continuing Review Health Care 400 1 30/60 200
Application. Practitioner.
Adult IR of Cooperative Group Board Members... 65 1 180/60 195
Protocol.
Pediatric IR of Cooperative Board Members... 15 1 180/60 45
Group Protocol.
Adult Continuing Review of Board Members... 275 1 60/60 275
Cooperative Group Protocol.
Pediatric Continuing Review of Board Members... 130 1 60/60 130
Cooperative Group Protocol.
Adult Amendment of Cooperative Board Members... 40 1 120/60 80
Group Protocol.
Pediatric Amendment of Board Members... 25 1 120/60 50
Cooperative Group Protocol.
Pharmacist's Review of a Board Members... 10 1 120/60 20
Cooperative Group Study.
CPC Pharmacist's Review of Board Members... 20 1 120/60 40
Cooperative Group Study.
Adult Expedited Amendment Board Members... 348 1 30/60 174
Review.

[[Page 89957]]

Pediatric Expedited Amendment Board Members... 140 1 30/60 70
Review.
Adult Expedited Continuing Board Members... 140 1 30/60 70
Review.
Pediatric Expedited Continuing Board Members... 36 1 30/60 18
Review.
Adult Cooperative Group Health Care 30 1 60/60 30
Response to CIRB Review. Practitioner.
Pediatric Cooperative Group Health Care 5 1 60/60 5
Response to CIRB Review. Practitioner.
Adult Expedited Study Chair Board Members... 40 1 15/60 10
Response to Required Mod.
Pediatric Expedited Study Board Members... 40 1 15/60 10
Chair Response to Required
Mod.
Reviewer Worksheet-- Board Members... 360 1 10/60 61
Determination of UP or SCN.
Reviewer Worksheet--CIRB Board Members... 100 1 60/60 100
Statistical Reviewer Form.
CIRB Application for Health Care 100 1 30/60 50
Translated Documents. Practitioner.
Reviewer Worksheet of Board Members... 100 1 15/60 25
Translated Documents.
Reviewer Worksheet of Board Members... 20 1 15/60 5
Recruitment Material.
Reviewer Worksheet Expedited Board Members... 20 1 15/60 5
Study Closure Review.
Reviewer Worksheet Expedited Board Members... 5 1 30/60 3
Review of Study Chair
Response to CIRB--Required
Modifications.
Reviewer Worksheet of Board Members... 5 1 30/60 3
Expedited IR.
Reviewer Worksheet--CPC-- Board Members... 40 1 15/60 10
Determination of UP or SCN.
Annual Signatory Institution Health Care 400 1 40/60 267
Worksheet About Local Context. Practitioner.
Annual Principal Investigator Health Care 1,800 1 20/60 600
Worksheet About Local Context. Practitioner.
Study-Specific Worksheet About Health Care 4,800 1 20/60 1,600
Local Context. Practitioner.
Study Closure or Transfer of Health Care 1,680 1 15/60 420
Study Review Responsibility Practitioner.
Form.
UP or SCN Reporting Form...... Health Care 360 1 20/60 120
Practitioner.
Change of SI PI Form.......... Health Care 120 1 15/60 30
Practitioner.
CTSU Web site Customer Health Care 275 1 15/60 69
Satisfaction Survey. Practitioner.
CTSU Help Desk Customer Health Care 325 1 15/60 81
Satisfaction Survey. Practitioner.
CTSU OPEN Survey.............. Health Care 60 1 15/60 15
Practitioner.
CIRB Customer Satisfaction Participants.... 600 1 15/60 150
Survey.
Follow-up Survey Participants/ 300 1 15/60 75
(Communication Audit). Board Members.
Web site Focus Groups, Participants/ 18 1 60/60 18
Communication Project. Board Members.
CIRB Board Member Annual Board Members... 60 1 20/60 20
Assessment Survey.
PIO Customer Satisfaction Health Care 60 1 5/60 5
Survey. Practitioner.
Concept Clinical Trial Survey. Health Care 500 1 5/60 42
Practitioner.
Prospective Clinical Trial Health Care 1,000 1 1/60 17
Survey. Practitioner.
Low Accrual Clinical Trial Health Care 1,000 1 1/60 17
Survey. Practitioner.
ETCTN PI Survey............... Physician....... 75 1 15/60 19
ETCTN RS Survey............... Health Care 175 1 15/60 44
Practitioner.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Totals.................... ................ 24,125 100,362 .............. 15,531
----------------------------------------------------------------------------------------------------------------

Dated: December 1, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2016-29767 Filed 12-12-16; 8:45 am]
BILLING CODE 4140-01-P

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