Federal Register / Vol. 87, No. 104 / Tuesday, May 31, 2022 / Notices 32427 

preparedness to respond to disasters in 

their communities. The MRC unit data 

collection has been refined to eliminate 

duplication and streamline data 

collection tools. 

ANNUALIZED BURDEN TABLE

Forms 

(if necessary) 

Type of 

respondents 

(if necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total 

burden hours 

Unit Profile ........................................ MRC Unit Leader ............................. 748 4 15/60 748 

Capability Assessment ...................... MRC Unit Leader ............................. 748 1 30/60 374 

Factors for Success .......................... MRC Unit Leader ............................. 748 1 30/60 374 

Unit Activity Reporting ...................... MRC Unit Leader ............................. 748 4 15/60 748 

Total ........................................... ........................................................... ........................ 10 ........................ 2,244 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2022–11546 Filed 5–27–22; 8:45 am] 

BILLING CODE 4150–47–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; Cancer Therapy Evaluation 

Program (CTEP) Branch and Support 

Contracts Forms and Surveys (NCI) 

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 proposed 

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, Cancer 

Therapy Evaluation Program—DCTD, 

National Cancer Institute, 9609 Medical 

Center Drive, Rockville, Maryland, 

20850 or call non-toll-free number (240) 

276–6080 or email your request, 

including your address to: montellom@

mail.nih.gov. 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 minimizes 

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 

Therapy Evaluation Program (CTEP) 

Branch and Support Contracts Forms 

and Surveys (NCI), 0925–0753, 

Expiration Date 05/31/2024, REVISION, 

National Cancer Institute (NCI), 

National Institutes of Health (NIH). 

Need and Use of Information 

Collection: This is a request for OMB to 

approve the revised information 

collection, Cancer Therapy Evaluation 

Program (CTEP) Support Contracts 

Forms and Survey. This revision 

removes one form (A17 CTSU System 

Access Request Form), adds one new 

form (A22 CLASS Course Setup Request 

Form), revises three forms (A18 CTSU 

Open Rave Request Form; B41 Annual 

Principal Investigator Worksheet about 

Local Context; B47 CIRB Waiver of 

Consent Request Supplemental Form), 

and includes an updated Privacy Impact 

Assessment. 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 subject’s research 

(45 CFR 46 and 21 CRF 50), and when 

CTEP acts as the Investigational New 

Drug (IND) holder (Food and Drug 

Administration (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 

151,769 hours. 


khammond on DSKJM1Z7X2PROD with NOTICES
32428 Federal Register / Vol. 87, No. 104 / Tuesday, May 31, 2022 / Notices 

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 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 (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 

CTSU CLASS Course Setup Form (Attachment 

A22).

Health Care Practitioner 10 2 20/60 7 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 104 / Tuesday, May 31, 2022 / Notices 32429 

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 

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 

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 ............................................................. ....................................... 167,545 235,510 ........................ 151,769 


khammond on DSKJM1Z7X2PROD with NOTICES
32430 Federal Register / Vol. 87, No. 104 / Tuesday, May 31, 2022 / Notices 

Dated: May 24, 2022. 

Diane Kreinbrink, 

Project Clearance Liaison, National Cancer 

Institute, National Institutes of Health. 

[FR Doc. 2022–11510 Filed 5–27–22; 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; Generic Clearance 

for Application Information for 

Fellowships, Internships, Training 

Programs, and Specialty Positions, 

National Cancer Institute (NCI) 

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: To 

obtain a copy of the data collection 

plans and instruments, submit 

comments in writing, or request more 

information on the proposed project, 

contact: Diane Kreinbrink, Office of 

Management Policy and Compliance, 

National Cancer Institute, 9609 Medical 

Center Drive, Rockville, Maryland 

20892 or call non-toll-free number (240) 

276–7283 or email your request, 

including your address to: 

diane.kreinbrink@nih.gov. Formal 

requests for additional plans and 

instruments must be requested in 

writing. 

SUPPLEMENTARY INFORMATION: This 

proposed information collection was 

previously published in the Federal 

Register on March 17, 2022 (Vol. 87, No. 

52, Page 15257) and allowed 60 days for 

public comment. No public comments 

were received. The purpose of this 

notice is to allow an additional 30 days 

for public comment. 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: Generic 

Clearance for Application Information 

from Fellows, Interns, and Trainees, 

0925–0761, Exp., Date 07/31/2022, 

EXTENSION, National Cancer Institute 

(NCI), National Institutes of Health 

(NIH). 

Need and Use of Information 

Collection: This generic information 

collection request is to support the 

science and research in a 

multidisciplinary environment at the 

National Cancer Institute (NCI), a part of 

the National Institutes of Health. 

Applicants may possess a variety of 

degrees including, but not limited to, 

high school, post-baccalaureate, 

graduate, postdoctoral, Registered 

Nurse, and Doctor of Medicine (MD). 

Potential applicants may apply for 

cancer-related positions by submitting 

applications, resumes, curriculum vitae 

(CV), reference letters, letters of intent 

and interest, and other related 

documentation directly to the Divisions, 

Offices, and Centers. This information is 

necessary to evaluate the eligibility, 

merits, and quality of potential 

candidates and will also assist in 

matching potential candidates to 

various training and internship 

programs, and specialty positions. The 

information is for internal use to make 

decisions about candidates invited to 

visit and attend NCI fellowships, 

internships, training opportunities, and 

apply for specialized staff and faculty 

positions. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden is 7,500 

hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

time per 

response 

(in hours) 

Total annual 

burden hours 

Individuals (Applicants) .................................................................................... 3,000 1 60/60 3,000

Individuals (Professional References) ............................................................. 9,000 1 30/60 4,500 

Totals ........................................................................................................ ........................ 12,000 ........................ 7,500 

Dated: May 24, 2022. 

Diane Kreinbrink, 

Project Clearance Liaison, National Cancer 

Institute, National Institutes of Health. 

[FR Doc. 2022–11506 Filed 5–27–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 


khammond on DSKJM1Z7X2PROD with NOTICES