Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Notices 78053 

amended, notice is hereby given of the 

following meeting. 

The meeting 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 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR–22– 

233: Time-Sensitive Opportunities for Health 

Research. 

Date: December 8, 2023. 

Time: 11:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Wenjuan Wang, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institute of 

Health, 6701 Rockledge Drive, Room 3154, 

Bethesda, MD 20892, (301) 480–8667, 

wangw22@mail.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: November 8, 2023. 

Patricia B. Hansberger, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–25072 Filed 11–13–23; 8:45 am] 

BILLING CODE 4140–01–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 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: Cancer 

Therapy Evaluation Program (CTEP) 

Branch and Support Contracts Forms 

and Surveys (NCI), 0925–0753, 

Expiration Date 03/31/2026, 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. It includes 

modifications to OMB-approved forms 

for the CTSU and CIRB and the addition 

of new forms for the CTSU, CIRB, and 

CTEP. The National Cancer Institute 

(NCI) 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 are termed the 

Clinical Oncology Research Enterprise 

(CORE) and represent an integrated set 

of information systems and processes 

that 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 (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 

162,831 hours. 

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 2444 12 2/60 978 

CTSU IRB Certification Form (Attachment A02) .. Health Care Practitioner 2444 12 10/60 4888 


khammond on DSKJM1Z7X2PROD with NOTICES
78054 Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / 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 

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 30 2 5/60 5 

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 and PDF (Attachment 

A20).

Health Care Practitioner 400 10 30/60 2000 

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

CTSU CLASS Course Setup Request Form (Attachment A22).Health Care Practitioner 10 2 20/60 7 

CTSU LPO Approval of Early Closure Form (Attachment A23).Health Care Practitioner 2444 6 20/60 4888 

International DTL Signing (Attachment 24) .......... Health Care Practitioner 29 1 10/60 5 

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) Protocol.

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. 88, No. 218 / Tuesday, November 14, 2023 / Notices 78055 

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 1800 1 20/60 600 

Study-Specific Worksheet About Local Context 

(Attachment B42).

Health Care Practitioner 4800 1 15/60 1200 

Study Closure or Transfer of Study Review Responsibility (Attachment B43).Health Care Practitioner 1680 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 (Attachment B49).Health Care Practitioner 20 1 20/60 7 

Final Video Submission Posting Form (Attachment B50).Health Care Practitioner 80 1 15/60 20 

Unanticipated Problem or Serious or Continuing 

Noncompliance Application (Attachment B52).

Health Care Practitioner 20 1 30/60 10 

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 

Audit Scheduling Form (Attachment D01) ............ Health Care Practitioner 229 5 21/60 401 

Preliminary Audit Finding Form (Attachment D02) Health Care Practitioner 229 5 10/60 191 

Audit Maintenance Form (Attachment D03) ......... Health Care Practitioner 158 5 9/60 119 

Final Audit finding Report Form (Attachment 

D04).

Health Care Practitioner 110 11 1098/60 22143 

Follow-up Form (Attachment D05) ....................... Health Care Practitioner 44 7 27/60 139 

Roster Maintenance Form (Attachment D06) ...... Health Care Practitioner 7 1 18/60 2 

Final Report and CAPA Request Form (Attachment D07).Health Care Practitioner 3 9 1800/60 810 

NCI/DCTD/CTEP FDA Form 1572 for Annual 

Submission (Attachment E01).

Physician ...................... 26,500 1 15/60 6625 

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

Practioner.

48,000 1 120/60 96000 

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

Practioner.

48,000 1 15/60 12000 

NCI/DCTD/CTEP Agent Shipment Form (ASF) 

(Attachment E04).

Physician ...................... 24,000 1 10/60 4000 

NINT Registration Form? ...................................... Health Care Practitioner, Other.1,000 1 60/60 1000 

ISS Form ............................................................... Physician ...................... 2,100 1 15/60 525 

Basic Study Information Form (Attachment TBD) Health Care Practioner 140 1 20/60 47 

Totals ............................................................. ....................................... 173,463 253,510 ........................ 162,831 


khammond on DSKJM1Z7X2PROD with NOTICES
78056 Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Notices 

Dated: November 8, 2023. 

Diane Kreinbrink, 

Project Clearance Liaison, National Cancer 

Institute, National Institutes of Health. 

[FR Doc. 2023–25022 Filed 11–13–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

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 purpose of this 

meeting is to evaluate requests for 

preclinical development resources for 

potential new therapeutics for the 

treatment of cancer. The outcome of the 

evaluation will provide information to 

internal NCI committees that will 

decide whether NCI should support 

requests and make available contract 

resources for development of the 

potential therapeutic to improve the 

treatment of various forms of cancer. 

The research proposals and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the 

proposed research projects, the 

disclosure of which would constitute a 

clearly unwarranted invasion of 

personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; OCT2023 

Cycle 45 NExT SEP Committee Meeting. 

Date: December 12, 2023. 

Time: 10:00 a.m. to 2:00 p.m. 

Agenda: To evaluate the NCI Experimental 

Therapeutics Program Portfolio. 

Place: National Institutes of Health, 9000 

Rockville Pike, Building 31, Room 3A44, 

Bethesda, Maryland 20892 (Virtual Meeting). 

Contact Persons: Barbara Mroczkowski, 

Ph.D., Executive Secretary, Discovery 

Experimental Therapeutics Program, 

National Cancer Institute, NIH, 31 Center 

Drive, Room 3A44, Bethesda, Maryland 

20892, 301–496–4291, mroczkoskib@

mail.nih.gov. 

Toby Hecht, Ph.D., Executive Secretary, 

Development Experimental Therapeutics 

Program, National Cancer Institute, NIH, 

9609 Medical Center Drive, Room 3W110, 

Rockville, Maryland 20850, 240–276–5683, 

toby.hecht2@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: November 8, 2023. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–25069 Filed 11–13–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2010–1066] 

Recreational Boating Safety Projects, 

Programs, and Activities Funded 

Under Provisions of the Infrastructure 

Investment and Jobs Act; Fiscal Year 

2023 

ACTION: Notice. 

SUMMARY: The Coast Guard is publishing 

this notice to satisfy a requirement of 

the Infrastructure Investment and Jobs 

Act that requires a detailed accounting 

of the projects, programs, and activities 

funded under the national recreational 

boating safety program provision of the 

Act be published annually in the 

Federal Register. This notice specifies 

the funding amounts the Coast Guard 

has committed, obligated, or expended 

during fiscal year 2023, as of September 

30, 2023. 

FOR FURTHER INFORMATION CONTACT: For 

questions on this notice please contact 

Mr. Jeff Decker, U.S. Coast Guard, 

Regulations Development Manager, 

(202) 372–1507 or mailto: RBSInfo@

uscg.mil. 

SUPPLEMENTARY INFORMATION: 

Background and Purpose 

Since 1998, Congress has passed a 

series of laws providing funding for 

projects, programs, and activities 

funded under the national recreational 

boating safety program, which is 

administered by the U.S. Coast Guard. 

On November 15, 2021, the 

Infrastructure Investment and Jobs Act 

(Pub. L. 117–58, Sec. 28001) set aside 

funding for Coast Guard administration, 

which for fiscal year 2023 was $13.835 

million. Of that, not less than $2.1 

million shall be made available to 

ensure compliance with chapter 43 of 

title 46, U.S. Code, and not more than 

$1.5 million is available to conduct by 

grant or contract a survey of levels of 

recreational boating participation and 

related matters in the United States. 

These funds are available to the 

Secretary from the Sport Fish 

Restoration and Boating Trust Fund 

(Trust Fund) established under 26 

U.S.C. 9504(a) for payment of Coast 

Guard expenses for personnel and 

activities directly related to 

coordinating and carrying out the 

national recreational boating safety 

program. Amounts made available 

under this subsection remain available 

during the two succeeding fiscal years. 

Any amount that is unexpended or 

unobligated at the end of the three-year 

period during which it is available shall 

be withdrawn by the Secretary and 

allocated to the States in addition to any 

other amounts available for allocation in 

the fiscal year in which they are 

withdrawn or the following fiscal year. 

Use of these funds requires 

compliance with standard Federal 

contracting rules with associated lead 

and processing times resulting in a lag 

time between available funds and 

spending. The total amount of funding 

transferred to the Coast Guard from the 

Trust Fund, and committed, obligated, 

and/or expended during fiscal year 2023 

for each project is shown below. 

Specific Accounting of Funds 

The total amount of funding 

transferred to the Coast Guard from the 

Sport Fish Restoration and Boating 

Trust Fund and committed, obligated, 

and/or expended during fiscal year 2023 

for each project is shown in the chart 

below. 

Project Description Cost 

46 U.S.C. 43 Compliance: Inspection Program/Boat 

Testing Program.

Provided for continuance of the national recreational boat compliance 

inspection program, which began in January 2001.

$2,484,350 

46 U.S.C. 43 Compliance: Staff Salaries ..................... Provided for 3 personnel to oversee manufacturer compliance with 46

U.S.C. 43 requirements.

558,743 

46 U.S.C. 43 Compliance: Staff Travel ........................ Provided for travel by employees of the Boating Safety Division to

oversee manufacturer compliance with 46 U.S.C. 43 requirements.

66,009 


khammond on DSKJM1Z7X2PROD with NOTICES