Proposed Collection; 60-day Comment Request: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Proposed Collection; 60-day Comment Request: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)

SUMMARY:

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Written comments and/or suggestions from the public and affected agencies are invited on 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.

To Submit Comments and for Further Information:

To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: CAPT Michael Montello, Pharm. D., MBA, Cancer Therapy Evaluation Program, Operations and Informatics Branch, 9609 Medical Center Drive, Rockville, MD 20850 or call non-toll-free number (240) 276-6080 or Email your request, including your address to:

mike.montello@nih.gov.

Formal requests for additional plans and instruments must be requested in writing.

Comment Due Date:

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

Proposed Collection:

NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI), 0925-0625, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH).

Need and Use of Information Collection:

The National Cancer Institute (NCI) Central Institutional Review Board (CIRB) provides a centralized approach to human subject protection and provides a cost efficient approach avoiding duplication of effort at each institution. The CIRB provides the services of a fully constituted IRB and provides a comprehensive and efficient mechanism to meet regulatory requirements pertaining to human subject protections including: Initial reviews, continuing reviews, review of amendments, and adverse events. The Initiative consists of three central IRBs: Adult CIRB—late phase emphasis, Adult CIRB—early phase emphasis, and Pediatric CIRB. CIRB membership includes oncology physicians, surgeons, nurses, patient advocates, ethicists, statisticians, pharmacists, attorneys and other health professionals. The benefits of the CIRB Initiative reaches research participants, investigators and research staff, Institutional Review Boards (IRB), and Institutions. Benefits include: Study participants having dedicated review of NCI-sponsored trials for participant protections, access to more trials more quickly and access to trials for rare diseases, accrual to trials begin more rapidly, ease of opening trials, elimination of need to submit study materials to local IRBs, and elimination of the need for a full board review. The benefits to the National Clinical Trials Network and Experimental Therapy-Clinical Trials Network include a cost efficient approach that avoids duplication of efforts at each institution. A variety of information collection tools are needed to support NCI's CIRB activities which include: Worksheets, forms and a survey that is provided to all customers contacting the CIRB helpdesk.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,199.

Estimates of Annual Burden Hours

Form name

Type of

respondents

Number of

respondents

Frequency of

responses per respondent

Average

burden per

response

(in hours)

Total

annual burden hours

CIRB Customer Satisfaction Survey

Participants/Board Members

1500

1

10/60

250

Request for 30 Day Web site Access Form

Participants

25

1

10/60

4

Authorization Agreement and Division of Responsibilities between the NCI CIRB and Signatory Institution

Participants

340

1

30/60

170

NCI CIRB Signatory Enrollment Form

Participants

40

1

4

160

IRB Staff at Signatory Institution's IRB

Participants

25

1

10/60

4

Investigator at Signatory Institution

Participants

65

1

10/60

11

Research Staff at Signatory Institution

Participants

65

1

10/60

11

Investigator at Affiliate Institution with an IRB

Participants

25

1

10/60

4

Research Staff at Affiliate Institution with an IRB

Participants

25

1

10/60

4

Investigator at Affiliate Institution without an IRB

Participants

25

1

10/60

4

Research Staff at Affiliate Institution without an IRB

Participants

25

1

10/60

4

Institutional Contact for Signatory Institution

Participants

65

1

10/60

11

IRB at Signatory Institution

Participants

25

1

10/60

4

Component Institution at Signatory Institution

Participants

65

1

10/60

11

IRB at Affiliate Institution

Participants

25

1

10/60

4

Affiliate Institution without an IRB

Participants

25

1

10/60

4

Facilitated Review Acceptance Form

Participants

300

1

10/60

50

Study Review Responsibility Transfer Form

Participants

80

1

10/60

13

Annual Signatory Institution Worksheet About Local Context

Participants

120

1

20/60

40

Annual Principal Investigator Worksheet About Local Context

Participants

120

1

20/60

40

Study-Specific Worksheet About Local Context

Participants

220

1

20/60

73

Study Closure or Transfer of Study Review Responsibility Form

Participants

120

1

10/60

20

Potential Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form

Participants

120

1

15/60

30

Add or Remove Signatory and/or Component Institution Personnel

Participants

120

1

10/60

20

Add or Remove Affiliate Institution Personnel

Participants

120

1

10/60

20

Add or Remove Component Institution

Participants

120

1

10/60

20

Add or Remove Affiliate Institution

Participants

120

1

10/60

20

One Time Study Roll Over Worksheet

Participants

120

1

10/60

20

Change of Signatory Institution PI Form

Participants

120

1

10/60

20

CIRB Board Member Biographical Sketch Form

Board Members

25

1

15/60

6.25

CIRB Board Member Contact Information Form

Board Members

25

1

10/60

4

CIRB Board Member W-9

Board Members

25

1

15/60

6

CIRB Board Member Non-Disclosure Agreement (NDA)

Board Members

25

1

10/60

4

CIRB Direct Deposit Form

Board Members

25

1

15/60

6

NCI Adult/Pediatric CIRB Application for Treatment Studies

Participants

25

1

2

50

NCI Adult/Pediatric CIRB Application for Ancillary Studies

Participants

10

1

2

20

NCI Adult/Pediatric CIRB Application for Continuing Review

Participants

80

1

1

80

Summary of CIRB Application Revisions

Participants

20

1

30/60

10

Locally-Developed Material Submission Form

Participants

15

1

15/60

4

Application Request to Review Translated Documents

Participants

15

1

15/60

4

Adult Initial Review of Cooperative Group Protocol

Board Members

15

1

4

60

Pediatric Initial Review of Cooperative Group Protocol

Board Members

15

1

4

60

Adult Continuing Review of Cooperative Group Protocol

Board Members

130

1

1

130

Pediatric Continuing Review of Cooperative Group Protocol

Board Members

70

1

1

70

Adult Amendment of Cooperative Group Protocol

Board Members

10

1

2

20

Pediatric Amendment of Cooperative Group Protocol

Board Members

10

1

2

20

Adult Cooperative Group Response to CIRB Review

Participants

15

1

1

15

Pediatric Cooperative Group Response to CIRB Review

Participants

10

1

1

10

Adult Pharmacist's Review of a Cooperative Group Study

Board Members

10

1

2

20

Pediatric Pharmacist's Review of a Cooperative Group Study

Board Members

20

1

2

40

CIRB Statistical Reviewer Form

Board Members

30

1

30/60

15

Determination of Unanticipated Problem (UP) and/or Serious or Continuing Noncompliance (SCN)

Board Members

40

1

10/60

7

Adult Expedited Amendment Review

Board Members

350

1

30/60

175

Ped Expedited Amendment Review

Board Members

150

1

30/60

75

Adult Expedited Continuing Review

Board Members

120

1

30/60

60

Ped Expedited Continuing Review

Board Members

70

1

30/60

35

Adult Expedited Study Closure

Board Members

20

1

20/60

7

Ped Expedited Study Closure

Board Members

20

1

20/60

7

Adult Expedited Study Chair Response to Required Mod

Board Members

350

1

15/60

88

Ped Expedited Study Chair Response to Required Mod

Board Members

150

1

15/60

38

Reviewer Worksheet of Translated Documents

Board Members

15

1

15/60

4

Reviewer Advertisement Checklist

Board Members

10

1

20/60

3

Dated: August 15, 2013.

Vivian Horovitch-Kelley,

Program Analyst, National Institutes of Health.

[FR Doc. 2013-20415 Filed 8-21-13; 8:45 am]

BILLING CODE 4140-01-P