81 FR 89955 - Proposed Collection; 60-Day Comment Request; CTEP Support Contracts Forms and Surveys (National Cancer Institute)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 239 (December 13, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 239 (December 13, 2016)
| Page Range | 89955-89957 | |
| FR Document | 2016-29767 |
[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)] [Notices] [Pages 89955-89957] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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
![Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices 89955
proposed data collection projects, the Reduction Act of 1995 requires: Written National Cancer Institute (NCI),
National Cancer Institute (NCI) will comments and/or suggestions from the National Institutes of Health (NIH).
publish periodic summaries of propose public and affected agencies are invited Need and Use of Information
projects to be submitted to the Office of to address one or more of the following Collection: This information collection
Management and Budget (OMB) for points: (1) Whether the proposed activity is collecting qualitative
review and approval. collection of information is necessary customer and stakeholder feedback in
DATES: Comments regarding this for the proper performance of the an efficient, timely manner, in
information collection are best assured function of the agency, including accordance with the Administration’s
of having their full effect if received whether the information will have commitment to improving service
within 60 days of the date of this practical utility; (2) The accuracy of the delivery. This generic provides
publication. agency’s estimate of the burden of the information about the National Cancer
proposed collection of information, Institute’s customer or stakeholder
FOR FURTHER INFORMATION CONTACT: To perceptions, experiences and
obtain a copy of the data collection including the validity of the
methodology and assumptions used; (3) expectations, provide an early warning
plans and instruments, submit of issues with service, or focus attention
comments in writing, or request more Ways to enhance the quality, utility, and
on areas where communication, training
information on the proposed project, clarity of the information to be
or changes in operations might improve
contact: Karla Bailey, Office of collected; and (4) Ways to minimizes
delivery of products or services. It also
Management Policy and Compliance, the burden of the collection of
allows feedback to contribute directly to
National Cancer Institute, 9609 Medical information on those who are to
the improvement of program
Center Drive, Bethesda, MD 20892–9760 respond, including the use of
management. Feedback collected under
or call non-toll-free number (240) 276– appropriate automated, electronic, this generic clearance provides useful
5582 or Email your request, including mechanical, or other technological information but it will not yield data
your address to: karla.bailey@nih.gov. collection techniques or other forms of that can be generalized to the overall
Formal requests for additional plans and information technology. population.
instruments must be requested in Proposed Collection Title: Generic OMB approval is requested for 3
writing. Clearance for the Collection of years. There are no costs to respondents
SUPPLEMENTARY INFORMATION: Section Qualitative Feedback on Agency Service other than their time. The total
3506(c)(2)(A) of the Paperwork Delivery (NCI), 0925–0642, Revision, estimated burden hours are 8,917.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of collection responses per
respondents response hours
respondent (in hours)
Surveys ............................................................................................................ 10,000 1 30/60 5,000
In-Depth Interviews (IDIs) or Small Discussion Groups .................................. 500 1 90/60 750
Focus Groups .................................................................................................. 1,000 1 90/60 1,500
Website or Software Usability Tests ................................................................ 5,000 1 20/60 1,667
Total .......................................................................................................... 16,500 16,500 ........................ 8,917
Dated: December 7, 2016. Reduction Act of 1995 to provide address to: montellom@mail.nih.gov.
Karla Bailey, opportunity for public comment on Formal requests for additional plans and
Project Clearance Liaison, National Cancer proposed data collection projects, the instruments must be requested in
Institute, National Institutes of Health. National Cancer Institute (NCI) will writing.
[FR Doc. 2016–29890 Filed 12–12–16; 8:45 am] publish periodic summaries of propose
projects to be submitted to the Office of SUPPLEMENTARY INFORMATION: Section
BILLING CODE 4140–01–P
Management and Budget (OMB) for 3506(c)(2)(A) of the Paperwork
review and approval. Reduction Act of 1995 requires: Written
DEPARTMENT OF HEALTH AND comments and/or suggestions from the
DATES: Comments regarding this
HUMAN SERVICES public and affected agencies are invited
information collection are best assured to address one or more of the following
of having their full effect if received points: (1) Whether the proposed
National Institutes of Health within 60 days of the date of this collection of information is necessary
Proposed Collection; 60-Day Comment publication. for the proper performance of the
Request; CTEP Support Contracts FOR FURTHER INFORMATION CONTACT: To function of the agency, including
Forms and Surveys (National Cancer obtain a copy of the data collection whether the information will have
Institute) plans and instruments, submit practical utility; (2) The accuracy of the
pmangrum on DSK3GDR082PROD with NOTICES
comments in writing, or request more agency’s estimate of the burden of the
AGENCY: National Institutes of Health, information on the proposed project, proposed collection of information,
Department of Health and Human contact: Michael Montello, Pharm. D., including the validity of the
Services. Cancer Therapy Evaluation Program methodology and assumptions used; (3)
ACTION: Notice. (CTEP), 9609 Medical Center Drive, Ways to enhance the quality, utility, and
MSC 9742, Rockville, MD 20850 or call clarity of the information to be
SUMMARY: In compliance with the non-toll-free number 240–276–6080 or collected; and (4) Ways to minimizes
requirement of the Paperwork Email your request, including your the burden of the collection of
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![Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices 89957
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Type of Number of burden Total annual
Form name responses per
respondent respondents per response burden hours
respondent (in hours)
Pediatric Expedited Amendment Review ............. Board Members ............ 140 1 30/60 70
Adult Expedited Continuing Review ..................... Board Members ............ 140 1 30/60 70
Pediatric Expedited Continuing Review ............... Board Members ............ 36 1 30/60 18
Adult Cooperative Group Response to CIRB Re- Health Care Practitioner 30 1 60/60 30
view.
Pediatric Cooperative Group Response to CIRB Health Care Practitioner 5 1 60/60 5
Review.
Adult Expedited Study Chair Response to Re- Board Members ............ 40 1 15/60 10
quired Mod.
Pediatric Expedited Study Chair Response to Board Members ............ 40 1 15/60 10
Required Mod.
Reviewer Worksheet—Determination of UP or Board Members ............ 360 1 10/60 61
SCN.
Reviewer Worksheet—CIRB Statistical Reviewer Board Members ............ 100 1 60/60 100
Form.
CIRB Application for Translated Documents ........ Health Care Practitioner 100 1 30/60 50
Reviewer Worksheet of Translated Documents ... Board Members ............ 100 1 15/60 25
Reviewer Worksheet of Recruitment Material ...... Board Members ............ 20 1 15/60 5
Reviewer Worksheet Expedited Study Closure Board Members ............ 20 1 15/60 5
Review.
Reviewer Worksheet Expedited Review of Study Board Members ............ 5 1 30/60 3
Chair Response to CIRB—Required Modifica-
tions.
Reviewer Worksheet of Expedited IR .................. Board Members ............ 5 1 30/60 3
Reviewer Worksheet—CPC—Determination of Board Members ............ 40 1 15/60 10
UP or SCN.
Annual Signatory Institution Worksheet About Health Care Practitioner 400 1 40/60 267
Local Context.
Annual Principal Investigator Worksheet About Health Care Practitioner 1,800 1 20/60 600
Local Context.
Study-Specific Worksheet About Local Context ... Health Care Practitioner 4,800 1 20/60 1,600
Study Closure or Transfer of Study Review Re- Health Care Practitioner 1,680 1 15/60 420
sponsibility Form.
UP or SCN Reporting Form ................................. Health Care Practitioner 360 1 20/60 120
Change of SI PI Form .......................................... Health Care Practitioner 120 1 15/60 30
CTSU Web site Customer Satisfaction Survey .... Health Care Practitioner 275 1 15/60 69
CTSU Help Desk Customer Satisfaction Survey Health Care Practitioner 325 1 15/60 81
CTSU OPEN Survey ............................................ Health Care Practitioner 60 1 15/60 15
CIRB Customer Satisfaction Survey .................... Participants ................... 600 1 15/60 150
Follow-up Survey (Communication Audit) ............ Participants/Board 300 1 15/60 75
Members.
Web site Focus Groups, Communication Project Participants/Board 18 1 60/60 18
Members.
CIRB Board Member Annual Assessment Survey Board Members ............ 60 1 20/60 20
PIO Customer Satisfaction Survey ....................... Health Care Practitioner 60 1 5/60 5
Concept Clinical Trial Survey ............................... Health Care Practitioner 500 1 5/60 42
Prospective Clinical Trial Survey .......................... Health Care Practitioner 1,000 1 1/60 17
Low Accrual Clinical Trial Survey ......................... Health Care Practitioner 1,000 1 1/60 17
ETCTN PI Survey ................................................. Physician ...................... 75 1 15/60 19
ETCTN RS Survey ............................................... Health Care Practitioner 175 1 15/60 44
Totals ............................................................. ....................................... 24,125 100,362 ........................ 15,531
Dated: December 1, 2016. DEPARTMENT OF HOMELAND ACTION:Notice of Privacy Act System of
Karla Bailey, SECURITY Records.
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health. Office of the Secretary SUMMARY: In accordance with the
[FR Doc. 2016–29767 Filed 12–12–16; 8:45 am]
Privacy Act of 1974, the Department of
[Docket No. DHS–2016–0088]
pmangrum on DSK3GDR082PROD with NOTICES
Homeland Security proposes to update
BILLING CODE 4140–01–P
Privacy Act of 1974; Department of and reissue a current Department of
Homeland Security/U.S. Customs and Homeland Security system of records
Border Protection-007 Border Crossing titled, ‘‘Department of Homeland
Information (BCI) System of Records Security (DHS)/U.S. Customs and
Border Protection (CBP)-007 Border
AGENCY: Department of Homeland Crossing Information (BCI) System of
Security, Privacy Office. Records.’’ This system of records allows
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Document Created: 2016-12-13 02:44:32
Document Modified: 2016-12-13 02:44:32
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| 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- | |
| FR Citation | 81 FR 89955 |
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