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

Federal Register, Volume 83 Issue 35 (Wednesday, February 21, 2018)

Federal Register Volume 83, Number 35 (Wednesday, February 21, 2018)

Notices

Pages 7483-7487

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2018-03471

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

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

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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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

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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., Shanda Finnigan, MPH, RN, CCRC, or Jacquelyn Goldberg, JD, 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: CTEP Support Contract Forms and Surveys 0925-0753 Expiration Date 06/30/2020 ICR Type: Revision, 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 implements programs to register clinical site investigators and clinical site staff, and to oversee the conduct of research at the clinical sites. CTEP and DCP also oversee two support programs, the NCI Central Institutional Review Board (CIRB) and the Cancer Trial Support Unit (CTSU). The combined systems and processes for initiating and managing clinical trials is termed the Clinical Oncology Research Enterprise (CORE) and represents an integrated set of information systems and processes which support investigator registration, trial oversight, patient enrollment, and clinical data collection. The information collected is required to ensure compliance with applicable federal regulations governing the conduct of human subjects research (45 CFR 46 and 21 CRF 50), and when CTEP acts as the Investigational New Drug (IND) holder, FDA regulations pertaining to the sponsor of clinical trials and the selection of qualified investigators under 21 CRF 312.53). Information is also collected through surveys to assess satisfaction, provide feedback to guide improvements with processes and technology, and assess health professional's interests in clinical trials.

To increase efficiencies, reduce administrative burden and cost, CTEP has requested consolidation of their current OMB submission. Consolidation is justified because although the various branches and contracts are responsible for distinct services, the processes that support the NCI and participating clinical sites efforts are intertwined. This revision of the previous submission includes changes to the NCI CIRB and CTSU form collections and integrates the Clinical Trials Monitoring Branch (CTMB) and Pharmaceutical Management Branch (PMB) form collections related to site audit and clinical investigator and key clinical site staff registration.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 68,855.

Estimated Annualized Burden Hours

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Number of Average burden

Form name Type of respondent Number of responses per per response Total annual

respondents respondent (in hours) burden hours

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CTSU IRB/Regulatory Approval Transmittal Form Health Care Practitioner............... 2,444 12 2/60 978

(Attachment A01).

CTSU IRB Certification Form (Attachment A02)... Health Care Practitioner............... 2,444 12 10/60 4,888

Withdrawal from Protocol Participation Form Health Care Practitioner............... 279 1 10/60 47

(Attachment A03).

Site Addition Form (Attachment A04)............ Health Care Practitioner............... 80 12 10/60 160

CTSU Roster Update Form (Attachment A05)....... Health Care Practitioner............... 600 1 5/60 50

CTSU Request for Clinical Brochure (Attachment Health Care Practitioner............... 360 1 10/60 60

A06).

CTSU Supply Request Form (Attachment A07)...... Health Care Practitioner............... 90 12 10/60 180

Site Initiated Data Update Form (Attachment Health Care Practitioner............... 2 12 10/60 4

A08).

Data Clarification Form (Attachment A09)....... Health Care Practitioner............... 150 24 10/60 600

RTOG 0834 CTSU Data Transmittal Form Health Care Practitioner............... 12 76 10/60 152

(Attachment A10).

CTSU Generic Data Transmittal Form (Attachment Health Care Practitioner............... 5 12 10/60 10

A12).

CTSU Patient Enrollment Transmittal Form Health Care Practitioner............... 12 12 10/60 24

(Attachment A15).

CTSU Transfer Form (Attachment A16)............ Health Care Practitioner............... 360 2 10/60 120

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CTSU System Access Request Form (Attachment Health Care Practitioner............... 180 1 20/60 60

A17).

CTSU OPEN Rave Request Form (Attachment A18)... Health Care Practitioner............... 30 21 10/60 105

CTSU LPO Form Creation (Attachment A19)........ Health Care Practitioner............... 5 2 120/60 20

CTSU Site Form Creation and PDF (Attachment Health Care Practitioner............... 400 10 30/60 2,000

A20).

CTSU PDF Signature Form (Attachment A21)....... Health Care Practitioner............... 400 10 10/60 667

NCI CIRB AA & DOR between the NCI CIRB and Participants........................... 50 1 15/60 13

Signatory Institution (Attachment B01).

NCI CIRB Signatory Enrollment Form (Attachment Participants........................... 50 1 15/60 13

B02).

CIRB Board Member Application (Attachment B03). Board Member........................... 100 1 30/60 50

CIRB Member COI Screening Worksheet (Attachment Board Members.......................... 100 1 15/60 25

B08).

CIRB COI Screening for CIRB meetings Board Members.......................... 72 1 15/60 18

(Attachment B09).

CIRB IR Application (Attachment B10)........... Health Care Practitioner............... 80 1 60/60 80

CIRB IR Application for Exempt Studies Health Care Practitioner............... 4 1 30/60 2

(Attachment B11).

CIRB Amendment Review Application (Attachment Health Care Practitioner............... 400 1 15/60 100

B12).

CIRB Ancillary Studies Application (Attachment Health Care Practitioner............... 1 1 60/60 1

B13).

CIRB Continuing Review Application (Attachment Health Care Practitioner............... 400 1 15/60 100

B14).

Adult IR of Cooperative Group Protocol Board Members.......................... 65 1 180/60 195

(Attachment B15).

Pediatric IR of Cooperative Group Protocol Board Members.......................... 15 1 180/60 45

(Attachment B16).

NCI Adult/Pediatric Continuing Review of Board Members.......................... 275 1 60/60 275

Cooperative Group Protocol (Attachment B17).

Adult Amendment of Cooperative Group Protocol Board Members.......................... 40 1 120/60 80

(Attachment B19).

Pediatric Amendment of Cooperative Group Board Members.......................... 25 1 120/60 50

Protocol (Attachment B20).

Pharmacist's Review of a Cooperative Group Board Members.......................... 50 1 120/60 100

Study (Attachment B21).

Adult Expedited Amendment Review (Attachment Board Members.......................... 348 1 30/60 174

B23).

Pediatric Expedited Amendment Review Board Members.......................... 140 1 30/60 70

(Attachment B24).

Adult Expedited Continuing Review (Attachment Board Members.......................... 140 1 30/60 70

B25).

Pediatric Expedited Continuing Review Board Members.......................... 36 1 30/60 18

(Attachment B26).

Adult Cooperative Group Response to CIRB Review Health Care Practitioner............... 30 1 60/60 30

(Attachment B27).

Pediatric Cooperative Group Response to CIRB Health Care Practitioner............... 5 1 60/60 5

Review (Attachment B28).

Adult Expedited Study Chair Response to Board Members.......................... 40 1 30/60 20

Required Modifications(Attachment B29).

Reviewer Worksheet- Determination of UP or SCN Board Members.......................... 400 1 10/60 67

(Attachment B31).

Reviewer Worksheet -CIRB Statistical Reviewer Board Members.......................... 100 1 15/60 25

Form (Attachment B32).

CIRB Application for Translated Documents Health Care Practitioner............... 100 1 30/60 50

(Attachment B33).

Reviewer Worksheet of Translated Documents Board Members.......................... 100 1 15/60 25

(Attachment B34).

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Reviewer Worksheet of Recruitment Material Board Members.......................... 20 1 15/60 5

(Attachment B35).

Reviewer Worksheet Expedited Study Closure Board Members.......................... 20 1 15/60 5

Review (Attachment B36).

Reviewer Worksheet of Expedited IR (Attachment Board Members.......................... 5 1 30/60 3

B38).

Annual Signatory Institution Worksheet About Health Care Practitioner............... 400 1 40/60 267

Local Context (Attachment B40).

Annual Principal Investigator Worksheet About Health Care Practitioner............... 1,800 1 20/60 600

Local Context (Attachment B41).

Study-Specific Worksheet About Local Context Health Care Practitioner............... 4,800 1 20/60 1,600

(Attachment B42).

Study Closure or Transfer of Study Review Health Care Practitioner............... 1,680 1 20/60 560

Responsibility(Attachment B43).

Unanticipated Problem or Serious or Continuing Health Care Practitioner............... 360 1 20/60 120

Noncompliance Reporting Form (Attachment (B44).

Change of Signatory Institution PI Form Health Care Practitioner............... 120 1 20/60 40

(Attachment B45).

Request Waiver of Assent Form (Attachment B46). ....................................... 60 1 20/60 20

CTSU OPEN Survey (Attachment C03).............. Health Care Practitioner............... 60 1 15/60 15

CIRB Customer Satisfaction Survey (Attachment Participants........................... 600 1 15/60 150

C04).

Follow-up Survey (Communication Audit) Participants/Board Members............. 300 1 15/60 75

(Attachment C05).

CIRB Board Member Annual Assessment Survey Board Members.......................... 60 1 15/60 15

(Attachment C07).

PIO Customer Satisfaction Survey (Attachment Health Care Practitioner............... 60 1 5/60 5

C08).

Concept Clinical Trial Survey (Attachment C09). Health Care Practitioner............... 500 1 5/60 42

Prospective Clinical Trial Survey (Attachment Health Care Practitioner............... 1,000 1 1/60 17

C10).

Low Accrual Clinical Trial Survey (Attachment Health Care Practitioner............... 1,000 1 1/60 17

C11).

Audit Scheduling Form (Attachment D01)......... Group/CTMS Users....................... 152 5 21/60 266

Preliminary Audit Findings Form (Attachment Auditor................................ 152 5 10/60 127

D02).

Audit Maintenance Form (Attachment D03)........ Group/CTMS Users....................... 152 5 9/60 114

Final Audit Finding Report Form (Attachment Group/CTMS Users....................... 75 11 1,098/60 15,098

D04).

Follow-up Form (Attachment D05)................ Group/CTMS Users....................... 75 7 27/60 236

Roster Maintenance Form (Attachment D06)....... CTMS Users............................. 5 1 18/60 2

Final Report and CAPA Request Form (Attachment CTMS Users............................. 12 9 1,800/60 3,240

D07).

NCI/DCTD/CTEP FDA Form 1572 for Annual Physician.............................. 23,000 1 8/60 3,067

Submission(Attachment E01).

NCI/DCTD/CTE Biosketch (Attachment E02)........ Physician; Health Care Practitioner.... 33,000 1 47/60 25,850

NCI/DCTD/CTEP Financial Disclosure Form Physician; Health Care Practitioner.... 33,000 1 5/60 2,750

(Attachment E03).

NCI/DCTD/CTEP Agent Shipment Form (ASF) Physician.............................. 23,000 1 7/60 2,683

(Attachment E04).

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Totals..................................... ....................................... 136,487 207,989 .............. 68,855

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Dated: January 23, 2018.

Karla Bailey,

Project Clearance Liaison, National Cancer Institute, National Institutes of Health.

FR Doc. 2018-03471 Filed 2-20-18; 8:45 am

BILLING CODE 4140-01-P