Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices 785 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; Investigational 

Agent Accountability Record Forms 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/or 

suggestions regarding the item(s) 

contained in this notice, especially 

regarding the estimated public burden 

and associated response time, should be 

directed to the: Office of Management 

and Budget, Office of Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. 

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 nontoll-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 October 25, 2018 (83 FR 

53885) and allowed 60 days for public 

comment. One public comment was 

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 in 

the Conduct of Investigational Trials for 

the Treatment of Cancer, 0925–0613, 

Expiration Date 3/31/2019, REVISION, 

National Cancer Institute (NCI), 

National Institutes of Health (NIH). 

Need and Use of Information 

Collection: The U.S. Food and Drug 

Administration (FDA) holds the 

National Cancer Institute (NCI), Division 

of Cancer Treatment and Diagnosis/ 

Cancer Therapy Evaluation Program 

(NCI/DCTD/CTEP) and the Division of 

Cancer Prevention (DCP) responsible, as 

a sponsor of investigational drug trials, 

to assure the FDA that systems for 

accountability are being maintained by 

investigators in its clinical trials 

program. Data obtained from the 

Investigational Agent Accountability 

Record Forms (aka. Drug Accountability 

Record Forms—DARF) are used to track 

the dispensing of investigational 

anticancer agents from receipt from the 

NCI to dispensing or administration to 

patients. Requirements for the tracking 

of investigational agents under an 

Investigational New Drug Application 

are outlined in Title 21 Code of Federal 

Regulations (CRF) part 312. NCI and/or 

its auditors use this information to 

ensure compliance with federal 

regulations and NCI policies. 

Previously, the investigator registration 

forms and process were part of this 

submission. These forms were more 

appropriately submitted and approved 

under the CTEP Branch and Support 

Contracts Forms and Surveys in July 

2018 (OMB No. 0925–0753; Expiration 

Date 7/31/2021). Thus, the investigator 

registration forms are no longer 

included in this request. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden are 3,033 

hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Category of respondent Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

time per 

response 

(in hours) 

Total annual 

burden hours 

Individuals (DARF) ........................................................................................... 2,133 16 4/60 2,275 

Individuals (DARF-Oral) ................................................................................... 711 16 4/60 758 

Total .......................................................................................................... 2,844 45,504 ........................ 3,033 

Patricia M. Busche, 

Project Clearance Liaison, National Cancer 

Institute, National Institutes of Health. 

[FR Doc. 2019–00447 Filed 1–30–19; 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 Meeting 

Pursuant to section 10(d) 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. 


amozie on DSK3GDR082PROD with NOTICES1
786 Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices 

Name of Committee: Genes, Genomes, and 

Genetics Integrated Review Group; Molecular 

Genetics A Study Section. 

Date: February 7–8, 2019. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Shinako Takada, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, 301–402–9448, shinako.takada@

nih.gov. 

This meeting notice is being published less 

than 15 days in advance of the meeting due 

to the partial Government shutdown of 

December 2018. 

(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: January 25, 2019. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2019–00328 Filed 1–30–19; 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 Meeting 

Pursuant to section 10(d) 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: Center for Scientific 

Review Special Emphasis Panel; Molecular 

and Cellular Endocrinology Study Section. 

Date: February 7, 2019. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: San Diego Marriott Mission Valley, 

8757 Rio San Diego Drive, San Diego, CA 

92108. 

Contact Person: Elaine Sierra-Rivera, Ph.D., 

Scientific Review Officer, EMNR IRG, Center 

for Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6182, 

MSC 7892, Bethesda, MD 20892, 301 435– 

2514, riverase@csr.nih.gov. 

This meeting notice is being published less 

than 15 days in advance of the meeting due 

to the partial Government shutdown of 

December 2018. 

(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: January 24, 2019. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2019–00363 Filed 1–30–19; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 10(d) 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 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Fellowships in 

Diabetes, Endocrinology and Metabolic 

Diseases. 

Date: February 12–13, 2019. 

Time: 8:00 a.m. to 12:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Thomas A. Tatham, Ph.D., 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 7021, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, (301) 594–3993, 

tathamt@mail.nih.gov. 

This meeting notice is being published less 

than 15 days in advance of the meeting due 

to the partial Government shutdown of 

December 2018. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: January 25, 2019. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2019–00349 Filed 1–30–19; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Meeting 

Pursuant to section 10(d) 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 Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Statistical Analysis in Late Phase Clinical 

Trial Design. 

Date: February 15, 2019. 

Time: 8:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Sheraton Baltimore Washington 

Airport Hotel, 1100 Old Elkridge Landing 

Road, Linthicum Heights, MD 21090. 

Contact Person: David A. Wilson, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, National Heart, Lung, and Blood 

Institute, National Institutes of Health, 6701 

Rockledge Drive, Room 7204, Bethesda, MD 

20892, 301–827–7953, wilsond@

nhlbi.nih.gov. 

This meeting notice is being published less 

than 15 days in advance of the meeting due 

to the partial Government Shutdown of 

December 2018. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 


amozie on DSK3GDR082PROD with NOTICES1