9524 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 

Bethesda, MD 20892, (301) 402–4128, 

mark.vosvick@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: February 9, 2021. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–03019 Filed 2–12–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-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 

Paperwork Reduction Act of 1995, the 

National Institutes of Health (NIH) has 

submitted to the Office of Management 

and Budget (OMB) a request for review 

and approval of the information 

collection listed below. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 30 days of the date of this 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: 

Michael Montello, Pharm. D., Cancer 

Therapy Evaluation Program (CTEP), 

9609 Medical Center Drive, MSC 9742, 

Rockville, MD 20850 or call non-tollfree number 240–276–6080 or Email 

your request, including your address to: 

montellom@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: This 

proposed information collection was 

previously published in the Federal 

Register on October 8, 2020, page 63565 

(Vol. 85, No. 196, FR 63565) and 

allowed 60 days for public comment. No 

public comments were received. The 

National Cancer Institute (NCI), 

National Institutes of Health, may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after October 1, 1995, unless it displays 

a currently valid OMB control number. 

In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. 

Proposed Collection Title: CTEP 

Support Contract Forms and Surveys 

(NCI), OMB #0925–0753 Expiration Date 

07/31/2021, 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). 

Survey collections assess satisfaction 

and provide feedback to guide 

improvements with processes and 

technology. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

151,792. 

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 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 

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

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 10/60 30 

CTSU OPEN Rave Request Form (Attachment 

A18).

Health Care Practitioner 30 21 10/60 105 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 9525 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Form name Type of 

respondent 

Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Total 

annual 

burden 

hours 

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

CTSU Site Form Creation (Attachment A20) ....... Health Care Practitioner 400 10 30/60 2,000 

CTSU Electronic 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 

Adult 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 15/60 1,200 


khammond on DSKJM1Z7X2PROD with NOTICES
9526 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Form name Type of 

respondent 

Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Total 

annual 

burden 

hours 

Study Closure or Transfer of Study Review Responsibility (Attachment B43).Health Care Practitioner 1,680 1 15/60 420 

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).

Health Care Practitioner 35 1 20/60 12 

CIRB Waiver of Consent Request Supplemental 

Form (Attachment B47).

Health Care Practitioner 20 1 15/60 5 

Review Worksheet CIRB Review for Inclusion of 

Incarcerated Participants (Attachment B48).

Board Members ............ 20 1 60/60 20 

Notification of Incarcerated Participant Form 

(B49).

Health Care Practitioner 20 1 20/60 7 

CTSU OPEN Survey (Attachment C03) ............... Health Care Practitioner 10 1 15/60 3 

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 

Audit Scheduling Form (Attachment D01) ............ Health Care Practitioner 152 5 21/60 266 

Preliminary Audit Finding Form (Attachment D02) Health Care Practitioner 152 5 10/60 127 

Audit Maintenance Form (Attachment D03) ......... Health Care Practitioner 152 5 9/60 114 

Final Audit finding Report Form (Attachment 

D04).

Health Care Practitioner 75 11 1,098/60 15,098 

Follow-up Form (Attachment D05) ....................... Health Care Practitioner 75 7 27/60 236 

Roster Maintenance Form (Attachment D06) ...... Health Care Practitioner 5 1 18/60 2 

Final Report and CAPA Request Form (Attachment D07).Health Care Practitioner 12 9 1,800/60 3,240 

NCI/DCTD/CTEP FDA Form 1572 for Annual 

Submission (Attachment E01).

Physician ...................... 26,500 1 15/60 6,625 

NCI/DCTD/CTE Biosketch (Attachment E02) ...... Physician; Health Care 

Practitioner.

48,000 1 120/60 96,000 

NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03).Physician; Health Care 

Practitioner.

48,000 1 15/60 12,000 

NCI/DCTD/CTEP Agent Shipment Form (ASF) 

(Attachment E04).

Physician ...................... 24,000 1 10/60 4,000 

Totals ............................................................. ....................................... 167,715 235,670 ........................ 151,792 

Dated: February 1, 2021. 

Diane Kreinbrink, 

Project Clearance Liaison, National Cancer 

Institute, National Institutes of Health. 

[FR Doc. 2021–03046 Filed 2–12–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Notice of Meeting 

Pursuant to Public Law 92–463, 

notice is hereby given that the 

Substance Abuse and Mental Health 

Services Administration’s (SAMHSA) 

Center for Substance Abuse Prevention’s 

(CSAP) Drug Testing Advisory Board 

(DTAB) will convene via web 

conference on March 2nd, 2021, from 

10:00 a.m. EST to 4:30 p.m. EST, and 

March 3rd, 2021, from 10:00 a.m. EST 

to 4:30 p.m. EST. 

The board will meet in open-session 

March 2nd, 2021, from 10:00 a.m. EST 

to 2:00 p.m. EST to discuss the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs with 

updates from the Department of 

Transportation, the Nuclear Regulatory 

Commission, and the Department of 

Defense. Other discussion topics 

include an update on marijuana studies 

and efforts as well as the Employee 

Assistance Program (EAP) Toolkit. The 

board will meet in closed-session on 

March 2nd, 2021, from 2:15 p.m. EST to 

4:30 p.m. EST, and March 3rd, 2021, 

from 10:00 a.m. EST to 4:30 p.m. EST, 

to discuss confidential issues 

surrounding the proposed Mandatory 

Guidelines for Federal Workplace Drug 

Testing Programs (hair), the Federal 

Drug-Free Workplace Programs and 

emerging issues, updates on the 

revisions of the Urine and Oral Fluid 

Mandatory Guidelines and the 

Biomarker Table, preliminary and 

unpublished studies from the Johns 

Hopkins University Behavioral 

Pharmacology Research Unit (BPRU), 

and cannabidiol (CBD) information from 

FDA. Therefore, the March 2nd, 2021, 

from 2:15 p.m. EST to 4:30 p.m. EST, 

and the March 3rd, 2021, from 10:00 

a.m. EST to 4:30 p.m. EST, meetings are 

closed to the public, as determined by 

the Assistant Secretary for Mental 

Health and Substance Use, SAMHSA, in 

accordance with 5 U.S.C. 552b(c)(4) and 


khammond on DSKJM1Z7X2PROD with NOTICES