81 FR 83856 - Proposed Collection; 60-Day Comment Request; Cancer Trials Support Unit (National Cancer Institute)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 225 (November 22, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 225 (November 22, 2016)
| Page Range | 83856-83857 | |
| FR Document | 2016-28004 |
[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)] [Notices] [Pages 83856-83857] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28004] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; Cancer Trials Support Unit (National Cancer Institute) AGENCY: National Institutes of Health. 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 minimize 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: Cancer Trials Support Unit (CTSU) (NCI), 0925-0624, EXTENSION, 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. OMB approval for an extension to the existing approval is requested for one year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 25,204. Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Form name Type of respondent Number of responses per per response Total annual respondents respondent (in hours) burden hour -------------------------------------------------------------------------------------------------------------------------------------------------------- CTSU IRB/Regulatory Approval Transmittal Health Care Practitioner..................... 9,000 12 2/60 3,600 Form. CTSU IRB Certification Form.............. Health Care Practitioner..................... 8,500 12 10/60 17,000 CTSU Acknowledgement Form................ Health Care Practitioner..................... 500 12 5/60 500 Withdrawal from Protocol Participation Health Care Practitioner..................... 50 12 5/60 50 Form. [[Page 83857]] Site Addition............................ Health Care Practitioner..................... 25 12 5/60 25 CTSU Roster Update Form.................. Health Care Practitioner..................... 50 12 4/60 40 CTSU Radiation Therapy Facilities Health Care Practitioner..................... 20 12 30/60 120 Inventory Form. CTSU IBCSG Drug Accountability Form...... Health Care Practitioner..................... 11 12 10/60 22 CTSU IBCSG Transfer of Investigational Health Care Practitioner..................... 3 12 20/60 12 Agent Form. Site Initiated Data Update Form.......... Health Care Practitioner..................... 10 12 10/60 20 Data Clarification Form.................. Health Care Practitioner..................... 341 12 20/60 1,364 RTOG 0834 CTSU Data Transmittal Form..... Health Care Practitioner..................... 60 12 10/60 120 MC0845(8233) CTSU Data Transmittal....... Health Care Practitioner..................... 50 12 10/60 100 CTSU Generic Data Transmittal Form....... Health Care Practitioner..................... 500 12 10/60 1,000 CTSU Patient Enrollment Transmittal Form. Health Care Practitioner..................... 200 12 10/60 400 CTSU P2C Enrollment Transmittal Form..... Health Care Practitioner..................... 15 12 10/60 30 CTSU Transfer Form....................... Health Care Practitioner..................... 20 12 10/60 40 CTSU System Account Request Form......... Health Care Practitioner..................... 20 12 20/60 80 CTSU Request for Clinical Brochure....... Health Care Practitioner..................... 75 12 10/60 150 CTSU Supply Request Form................. Health Care Practitioner..................... 75 12 10/60 150 CTSU Web Site Customer Satisfaction Health Care Practitioner..................... 275 1 15/60 69 Survey. CTSU Helpdesk Customer Satisfaction Health Care Practitioner..................... 325 1 15/60 81 Survey. CTSU OPEN Survey......................... Health Care Practitioner..................... 60 1 15/60 15 PIO Customer Satisfaction Survey......... Health Care Practitioner..................... 100 1 5/60 8 Concept Clinical Trial Survey............ Health Care Practitioner..................... 500 1 5/60 42 Prospective Clinical Trial Survey........ Health Care Practitioner..................... 1,000 1 5/60 83 Low Accrual Clinical Trial Survey........ Health Care Practitioner..................... 1,000 1 5/60 83 --------------------------------------------------------------- Annualized Totals.................... ............................................. 22,785 237,560 .............. 25,204 -------------------------------------------------------------------------------------------------------------------------------------------------------- Dated: November 10, 2016. Karla Bailey, Project Clearance Liaison, National Cancer Institute, National Institutes of Health. [FR Doc. 2016-28004 Filed 11-21-16; 8:45 am] BILLING CODE 4140-01-P
![83856 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Estimated Average
Estimated Estimated
number of time per
Data collection activity Type of respondents number of total annual
responses per response
respondents burden hours
respondent (in hours)
APR ............................... Principal Investigator (MD or PhD) ..................... 20 1 2 40
IRLCW ........................... Principal Investigator (MD or PhD degree) or 250 1 2 500
Research Coordinator (RN, BA, MA degree)
or Regulatory Staff (BA degree).
CRLCW .......................... Principal Investigator (MD or PhD degree) or 250 1 1 250
Research Coordinator (RN, BA, MA degree)
or Regulatory Staff (BA degree).
Total ........................ .............................................................................. 520 520 ........................ 790
Dated: November 16, 2016. Cancer Therapy Evaluation Program Need and Use of Information
Lawrence A. Tabak, (CTEP), 9609 Medical Center Drive, Collection: The Cancer Therapy
Deputy Director, National Institutes of Health. MSC 9742, Rockville, MD 20850 or call Evaluation Program (CTEP) establishes
[FR Doc. 2016–28140 Filed 11–21–16; 8:45 am] non-toll-free number 240–276–6080 or and supports programs to facilitate the
BILLING CODE 4140–01–P
Email your request, including your participation of qualified investigators
address to: montellom@mail.nih.gov. on CTEP-supported studies, and to
Formal requests for additional plans and institute programs that minimize
DEPARTMENT OF HEALTH AND instruments must be requested in redundancy among grant and contract
HUMAN SERVICES writing. holders, thereby reducing overall cost of
maintaining a robust treatment trials
National Institutes of Health SUPPLEMENTARY INFORMATION: Section program. Currently guided by the efforts
3506(c)(2)(A) of the Paperwork of the Clinical Trials Working Group
Proposed Collection; 60-Day Comment Reduction Act of 1995 requires: Written (CTWG) and the Institute of Medicine
Request; Cancer Trials Support Unit comments and/or suggestions from the (IOM) recommendations to revitalize the
(National Cancer Institute) public and affected agencies are invited Cooperative Group program, CTEP has
to address one or more of the following funded the Cancer Trials Support Unit
AGENCY: National Institutes of Health. points: (1) Whether the proposed (CTSU). The CTSU collects
ACTION: Notice. collection of information is necessary standardized forms to process site
for the proper performance of the regulatory information, changes to
SUMMARY: In compliance with the function of the agency, including
requirement of the Paperwork membership, patient enrollment data,
whether the information will have and routing information for case report
Reduction Act of 1995 to provide practical utility; (2) The accuracy of the
opportunity for public comment on forms. In addition, CTSU collects
agency’s estimate of the burden of the annual surveys of customer satisfaction
proposed data collection projects, the proposed collection of information,
National Cancer Institute (NCI) will for clinical site staff using the CTSU
including the validity of the Help Desk, the CTSU Web site, and the
publish periodic summaries of propose methodology and assumptions used; (3)
projects to be submitted to the Office of Protocol and Information Office (PIO).
Ways to enhance the quality, utility, and An ongoing user satisfaction survey is in
Management and Budget (OMB) for clarity of the information to be
review and approval. place for the Oncology Patient
collected; and (4) Ways to minimize the Enrollment Network (OPEN). User
DATES: Comments regarding this burden of the collection of information satisfaction surveys are compiled as part
information collection are best assured on those who are to respond, including of the project quality assurance
of having their full effect if received the use of appropriate automated, activities and are used to direct
within 60 days of the date of this electronic, mechanical, or other improvements to processes and
publication. technological collection techniques or technology.
FOR FURTHER INFORMATION CONTACT: To other forms of information technology. OMB approval for an extension to the
obtain a copy of the data collection Proposed Collection Title: Cancer existing approval is requested for one
plans and instruments, submit Trials Support Unit (CTSU) (NCI), year. There are no costs to respondents
comments in writing, or request more 0925–0624, EXTENSION, National other than their time. The total
information on the proposed project, Cancer Institute (NCI), National estimated annualized burden hours are
contact: Michael Montello, Pharm. D., Institutes of Health (NIH). 25,204.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total annual
sradovich on DSK3GMQ082PROD with NOTICES
Form name Type of respondent responses per
respondents response burden hour
respondent (in hours)
CTSU IRB/Regulatory Approval Transmittal Health Care Practitioner ..... 9,000 12 2/60 3,600
Form.
CTSU IRB Certification Form ......................... Health Care Practitioner ..... 8,500 12 10/60 17,000
CTSU Acknowledgement Form ...................... Health Care Practitioner ..... 500 12 5/60 500
Withdrawal from Protocol Participation Form Health Care Practitioner ..... 50 12 5/60 50
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![Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices 83857
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden per Total annual
Form name Type of respondent responses per
respondents response burden hour
respondent (in hours)
Site Addition .................................................... Health Care Practitioner ..... 25 12 5/60 25
CTSU Roster Update Form ............................ Health Care Practitioner ..... 50 12 4/60 40
CTSU Radiation Therapy Facilities Inventory Health Care Practitioner ..... 20 12 30/60 120
Form.
CTSU IBCSG Drug Accountability Form ........ Health Care Practitioner ..... 11 12 10/60 22
CTSU IBCSG Transfer of Investigational Health Care Practitioner ..... 3 12 20/60 12
Agent Form.
Site Initiated Data Update Form ..................... Health Care Practitioner ..... 10 12 10/60 20
Data Clarification Form ................................... Health Care Practitioner ..... 341 12 20/60 1,364
RTOG 0834 CTSU Data Transmittal Form .... Health Care Practitioner ..... 60 12 10/60 120
MC0845(8233) CTSU Data Transmittal ......... Health Care Practitioner ..... 50 12 10/60 100
CTSU Generic Data Transmittal Form ........... Health Care Practitioner ..... 500 12 10/60 1,000
CTSU Patient Enrollment Transmittal Form ... Health Care Practitioner ..... 200 12 10/60 400
CTSU P2C Enrollment Transmittal Form ....... Health Care Practitioner ..... 15 12 10/60 30
CTSU Transfer Form ...................................... Health Care Practitioner ..... 20 12 10/60 40
CTSU System Account Request Form ........... Health Care Practitioner ..... 20 12 20/60 80
CTSU Request for Clinical Brochure .............. Health Care Practitioner ..... 75 12 10/60 150
CTSU Supply Request Form .......................... Health Care Practitioner ..... 75 12 10/60 150
CTSU Web Site Customer Satisfaction Sur- Health Care Practitioner ..... 275 1 15/60 69
vey.
CTSU Helpdesk Customer Satisfaction Sur- Health Care Practitioner ..... 325 1 15/60 81
vey.
CTSU OPEN Survey ....................................... Health Care Practitioner ..... 60 1 15/60 15
PIO Customer Satisfaction Survey ................. Health Care Practitioner ..... 100 1 5/60 8
Concept Clinical Trial Survey ......................... Health Care Practitioner ..... 500 1 5/60 42
Prospective Clinical Trial Survey .................... Health Care Practitioner ..... 1,000 1 5/60 83
Low Accrual Clinical Trial Survey ................... Health Care Practitioner ..... 1,000 1 5/60 83
Annualized Totals .................................... ............................................. 22,785 237,560 ........................ 25,204
Dated: November 10, 2016. The meeting will be closed to the Executive Blvd., Bethesda, MD 20892–9670,
Karla Bailey, public in accordance with the 301–496–8693, jordanc@nidcd.nih.gov.
Project Clearance Liaison, National Cancer provisions set forth in sections Any interested person may file written
Institute, National Institutes of Health. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., comments with the committee by forwarding
as amended. The grant applications the statement to the Contact Person listed on
[FR Doc. 2016–28004 Filed 11–21–16; 8:45 am]
and/or contract proposals and the this notice. The statement should include the
BILLING CODE 4140–01–P
discussions could disclose confidential name, address, telephone number and when
applicable, the business or professional
trade secrets or commercial property
affiliation of the interested person.
DEPARTMENT OF HEALTH AND such as patentable material, and In the interest of security, NIH has
HUMAN SERVICES personal information concerning instituted stringent procedures for entrance
individuals associated with the grant onto the NIH campus. All visitor vehicles,
National Institutes of Health applications and/or contract proposals, including taxicabs, hotel, and airport shuttles
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Notice of Meeting government-issued photo ID, driver’s license,
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Pursuant to section 10(d) of the Council. Information is also available on the
Federal Advisory Committee Act, as Date: January 27, 2017. Institute’s/Center’s home page: http://
amended (5 U.S.C. App.), notice is Closed: 8:30 a.m. to 9:40 a.m. www.nidcd.nih.gov/about/Pages/Advisory-
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Drive, Bethesda, MD 20892. Program Nos. 93.173, Biological Research
The meeting will be open to the Open: 9:40 a.m. to 2:00 p.m. Related to Deafness and Communicative
public as indicated below, with
sradovich on DSK3GMQ082PROD with NOTICES
Agenda: Staff reports on divisional, Disorders, National Institutes of Health, HHS)
attendance limited to space available. programmatic, and special activities.
Individuals who plan to attend and Dated: November 16, 2016.
Place: National Institutes of Health,
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language interpretation or other Drive, Bethesda, MD 20892. Program Analyst, Office of Federal Advisory
reasonable accommodations, should Contact Person: Craig A. Jordan, Ph.D., Committee Policy.
notify the Contact Person listed below Director, Division of Extramural Activities, [FR Doc. 2016–27998 Filed 11–21–16; 8:45 am]
in advance of the meeting. NIDCD, NIH, Room 8345, MSC 9670, 6001 BILLING CODE 4140–01–P
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Document Created: 2018-02-14 08:29:06
Document Modified: 2018-02-14 08:29:06
| 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 83856 |
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