79630 Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID SBIR Phase II 

Clinical Trial Implementation Cooperative 

Agreement (U44 Clinical Trial Required). 

Date: October 24, 2024. 

Time: 12:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F40A, 

Rockville, MD 20892 (Video Assisted 

Meeting). 

Contact Person: Robert C. Unfer, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3F40A, Rockville, MD 

20892, (240) 669–5035, robert.unfer@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: September 25, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–22377 Filed 9–27–24; 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 Investigational 

Agent Accountability Record Forms 

and International Investigator 

Statement in the Conduct of 

Investigational Trials for the Treatment 

of Cancer (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: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Charles Hall, Chief, 

Pharmaceutical Management Branch, 

Cancer Therapy Evaluation Program, 

Division of Cancer Diagnosis and 

Treatment, National Cancer Institute, 

9609 Medical Center Drive, Bethesda, 

Maryland 20892 or call non-toll-free 

number (240) 276–6575 or Email your 

request, including your address to: 

HallCh@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: This 

proposed information collection was 

previously published in the Federal 

Register on July 12, 2024 (89 FR 57157) 

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: Investigational 

Agent Accountability Record Forms and 

International Investigator Statement in 

the Conduct of Investigational Trials for 

the Treatment of Cancer (National 

Cancer Institute), 0925–0613, Expiration 

Date 1/31/2025, REVISION, National 

Cancer Institute (NCI), National 

Institutes of Health (NIH). 

Need and Use of Information 

Collection: The Food and Drug 

Administration (FDA) requires 

Investigational New Drug Application 

(IND) sponsors to maintain adequate 

records on the shipment and disposition 

of agents to investigators. The agent 

accountability effort for the National 

Cancer Institute/Division of Cancer 

Treatment and Diagnosis/Cancer 

Therapy Evaluation Program (NCI/ 

DCTD/CTEP) is managed by the 

Pharmaceutical Management Branch 

(PMB) at CTEP. The Investigational 

Agent Accountability Records (a.k.a. 

Drug Accountability Record Forms— 

DARF) are used to provide a 

standardized method of tracking agent 

disposition across all institutions 

participating in trials for which the NCI 

provides agents. Institutional auditors 

verify information on the agent 

accountability forms for compliance. In 

addition, PMB staff review 

Investigational Agent Accountability 

Record Forms against records 

maintained in PMB systems to ensure 

there is no inappropriate use or 

diversion of investigational agents. 

OMB approval is requested for 3 

years. Respondents’ only cost is their 

time. The total estimated annualized 

burden is 4,166 hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Form name Category of 

respondent 

Number of 

respondents 

Number of 

responses per 

respondent 

Average time 

per response 

(in hours) 

Total annual 

burden hours 

A1: Investigational Agent Accountability Record Form 

(DARF).

Individuals ........ 1,000 20 4/60 1,333 


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