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

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2018-03471

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** February 21, 2018
- **Citation:** 83 FR 7483

## Text

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.

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., 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:
ctsuconstact@westat.com.
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

Form name
Type of respondent

Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total annual
burden hours

CTSU IRB/Regulatory Approval Transmittal Form (Attachment A01)
Health Care Practitioner
2,444
12
2/60
978

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

Withdrawal from Protocol Participation Form (Attachment A03)
Health Care Practitioner
279
1
10/60
47

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 A06)
Health Care Practitioner
360
1
10/60
60

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

Site Initiated Data Update Form (Attachment A08)
Health Care Practitioner
2
12
10/60
4

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

RTOG 0834 CTSU Data Transmittal Form (Attachment A10)
Health Care Practitioner
12
76
10/60
152

CTSU Generic Data Transmittal Form (Attachment A12)
Health Care Practitioner
5
12
10/60
10

CTSU Patient Enrollment Transmittal Form (Attachment A15)
Health Care Practitioner
12
12
10/60
24

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

CTSU System Access Request Form (Attachment A17)
Health Care Practitioner
180
1
20/60
60

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 A20)
Health Care Practitioner
400
10
30/60
2,000

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

NCI CIRB AA & DOR between the NCI CIRB and Signatory Institution (Attachment B01)
Participants
50
1
15/60
13

NCI CIRB Signatory Enrollment Form (Attachment B02)
Participants
50
1
15/60
13

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

CIRB Member COI Screening Worksheet (Attachment B08)
Board Members
100
1
15/60
25

CIRB COI Screening for CIRB meetings (Attachment B09)
Board Members
72
1
15/60
18

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

CIRB IR Application for Exempt Studies (Attachment B11)
Health Care Practitioner
4
1
30/60
2

CIRB Amendment Review Application (Attachment B12)
Health Care Practitioner
400
1
15/60
100

CIRB Ancillary Studies Application (Attachment B13)
Health Care Practitioner
1
1
60/60
1

CIRB Continuing Review Application (Attachment B14)
Health Care Practitioner
400
1
15/60
100

Adult IR of Cooperative Group Protocol (Attachment B15)
Board Members
65
1
180/60
195

Pediatric IR of Cooperative Group Protocol (Attachment B16)
Board Members
15
1
180/60
45

NCI Adult/Pediatric Continuing Review of Cooperative Group Protocol (Attachment B17)
Board Members
275
1
60/60
275

Adult Amendment of Cooperative Group Protocol (Attachment B19)
Board Members
40
1
120/60
80

Pediatric Amendment of Cooperative Group Protocol (Attachment B20)
Board Members
25
1
120/60
50

Pharmacist's Review of a Cooperative Group Study (Attachment B21)
Board Members
50
1
120/60
100

Adult Expedited Amendment Review (Attachment B23)
Board Members
348
1
30/60
174

Pediatric Expedited Amendment Review (Attachment B24)
Board Members
140
1
30/60
70

Adult Expedited Continuing Review (Attachment B25)
Board Members
140
1
30/60
70

Pediatric Expedited Continuing Review (Attachment B26)
Board Members
36
1
30/60
18

Adult Cooperative Group Response to CIRB Review (Attachment B27)
Health Care Practitioner
30
1
60/60
30

Pediatric Cooperative Group Response to CIRB Review (Attachment B28)
Health Care Practitioner
5
1
60/60
5

Adult Expedited Study Chair Response to Required Modifications(Attachment B29)
Board Members
40
1
30/60
20

Reviewer Worksheet- Determination of UP or SCN (Attachment B31)
Board Members
400
1
10/60
67

Reviewer Worksheet -CIRB Statistical Reviewer Form (Attachment B32)
Board Members
100
1
15/60
25

CIRB Application for Translated Documents (Attachment B33)
Health Care Practitioner
100
1
30/60
50

Reviewer Worksheet of Translated Documents (Attachment B34)
Board Members
100
1
15/60
25

Reviewer Worksheet of Recruitment Material (Attachment B35)
Board Members
20
1
15/60
5

Reviewer Worksheet Expedited Study Closure Review (Attachment B36)
Board Members
20
1
15/60
5

Reviewer Worksheet of Expedited IR (Attachment B38)
Board Members
5
1
30/60
3

Annual Signatory Institution Worksheet About Local Context (Attachment B40)
Health Care Practitioner
400
1
40/60
267

Annual Principal Investigator Worksheet About Local Context (Attachment B41)
Health Care Practitioner
1,800
1
20/60
600

Study-Specific Worksheet About Local Context (Attachment B42)
Health Care Practitioner
4,800
1
20/60
1,600

Study Closure or Transfer of Study Review Responsibility(Attachment B43)
Health Care Practitioner
1,680
1
20/60
560

Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form (Attachment (B44)
Health Care Practitioner
360
1
20/60
120

Change of Signatory Institution PI Form (Attachment B45)
Health Care Practitioner
120
1
20/60
40

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 C04)
Participants
600
1
15/60
150

Follow-up Survey (Communication Audit) (Attachment C05)
Participants/Board Members
300
1
15/60
75

CIRB Board Member Annual Assessment Survey (Attachment C07)
Board Members
60
1
15/60
15

PIO Customer Satisfaction Survey (Attachment C08)
Health Care Practitioner
60
1
5/60
5

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

Prospective Clinical Trial Survey (Attachment C10)
Health Care Practitioner
1,000
1
1/60
17

Low Accrual Clinical Trial Survey (Attachment C11)
Health Care Practitioner
1,000
1
1/60
17

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

Preliminary Audit Findings Form (Attachment D02)
Auditor
152
5
10/60
127

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

Final Audit Finding Report Form (Attachment D04)
Group/CTMS Users
75
11
1,098/60
15,098

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 D07)
CTMS Users
12
9
1,800/60
3,240

NCI/DCTD/CTEP FDA Form 1572 for Annual Submission(Attachment E01)
Physician
23,000
1
8/60
3,067

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

NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03)
Physician; Health Care Practitioner
33,000
1
5/60
2,750

NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04)
Physician
23,000
1
7/60
2,683

Totals

136,487
207,989

68,855

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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2018-03471. Public record. Not legal advice.