13332 Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices

center networks in the implementation

of comprehensive pharmacy services.

The estimated burden is as follows:

Form name Number of

respondents

Responses

per

respondent

Hours per

response

Total

burden

hours

Baseline ........................................................................................................................... 1400 1 .33 462

Encounter data ................................................................................................................ 1400 4 .16 933

Pharmacy Survey ............................................................................................................ 14 3 1 42

Total .......................................................................................................................... 1414 .................... .................... 1437

Send comments to Susan G. Queen,

Ph.D., HRSA Reports Clearance Officer,

Room 14–22, Parklawn Building, 5600

Fishers Lane, Rockville, MD 20857.

Written comments should be received

within 60 days of this notice.

Dated: February 27, 2001.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 01–5224 Filed 3–2–01; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Submission for OMB Review;

Comment Request; Drug

Accountability Record

SUMMARY: Under the provisions of

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

Reduction Act of 1995, the National

Cancer Institute (NCI), 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. This proposed information

collection was previously published in

the Federal Register on December 14,

2000, pages 78175–78176, 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 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.

Proposed Collection

Title: Drug Accountability Record.

Type of Information Collection Request:

Revision. (OMB No. 0925–0240, expires

3/31/2001). Need and use of

Information Collection: The regulations

of the Food and Drug Administration

(FDA) require investigators to establish

a record of the receipt, use, and

disposition of all investigational agents.

The National Cancer Institute (NCI), as

a sponsor of investigational drug trials,

has the responsibility for assuring to the

FDA that systems for drug

accountability are being maintained by

investigators in its clinical trials

program. In order to fulfill these

requirements, we have developed two

standardized forms. One, the

investigational Drug Accountability

Report Form (NIH 2564) designed to

account for drug inventories and usage

by protocol and the other, Transfer

Investigational Drug Form (NIH–2564–

1) that permits intra-institutional

transfer of agents to NCI approved

protocols for use by the investigator or

other NCI registered investigators on

approved protocols. The data obtained

from the drug accountability record is

used to track the dispensing of

investigational anticancer drugs from

receipt from NCI to dispensing or

administration to patients. NCI uses the

accountability data to ensure that

investigational drug supplies are not

diverted for inappropriate protocol or

patient use. The drug accountability

information is used to validate patient

protocol reporting forms during site

audits conducted at each of the

Cooperative Groups. The intent is to

ensure the investigational agents are

used according to protocol guidelines

and to ensure the patient’s safety and

protection. Frequency of response:

Daily. Affected public: State or local

governments, businesses or other forprofit, Federal agencies or employees,

non-profit institutions, and small

business or organizations. Types of

Respondents: Investigators and their

designees, pharmacists, nurses,

pharmacy technicians, data managers.

The annual reporting burden is divided

into two major areas. These are the

audits of Drug Accountability Forms by

Government and its contractors and the

use of the forms by clinical research

sites. The burden is as follows: The

annualized respondents’ burden for

record keeping is estimated to require

2,436 hours for drug accountability and

80 hours for drug transfer. The reporting

burden is the average time (4 minutes or

0.0668 hours) required to complete the

transfer investigational drug form

multiplied by the number of forms

completed annually. The record keeping

burden represents an average time

required for multiple entries (4 minutes

or 0.0668 hours per entry) on the drug

accountability form, the average number

of forms maintained by each record

keeper and the number of record

keepers. These estimates are based on

the items shipped by the PMB and the

number of transfer approvals in the

calendar year 1999.

Type of respondents Est. number of

respondents

Est. number of

responses/

respondents

Avg. burden

hours per

response

Avg. burden

hours

Est. total annual burden

hours

requested

Drug transfer, form ............................................................... 1,200 1 0.0668 80 80

Drug, accountability, form .................................................... 4,560 8 0.0668 2,436 2,436

Total .......................................................................... 5,760 ........................ ........................ ........................ 2,516

Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices 13333

There are no Capital Costs to report.

There are no Operating or Maintenance

Costs to report.

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

are invited on one or more of the

following points: (1) Whether the

proposed collection of information is

necessary for the proposed performance

of the functions of the agency, including

whether the information shall 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.

Direct Comments to OMB

Written comment 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, New

Executive office Building, Room 10235,

Washington, DC 20503, Attention: Desk

Officer for NIH. To request more

information on the proposed project or

to obtain a copy of the data collection

plans and instruments, contact Carl

Huntley, Head Drug Management and

Authorization Section, Pharmaceutical

Management Branch, Cancer Therapy

Evaluation Program, Division of Cancer

Therapy and Diagnosis, National Cancer

Institute, Executive Plaza North, Room

7112, 9000 Rockville Pike, Bethesda,

Maryland 20892. Or call non-toll-free

number 301–496–5725 or e-mail your

request, include your address to

HuntleyC@ctep.nci.nih.gov.

Comments Due Date

Comments regarding this information

collection are best assured of having

their full effect if received on or before

April 14, 2001.

Dated: February 26, 2001.

Reesa Nichols,

NCI Project Clearance Liaison.

[FR Doc. 01–5174 Filed 3–2–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of General Medical

Sciences; Notice of Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), 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

General Medical Sciences Initial Review

Group, Biomedical Research and Research

Training Review Subcommittee A.

Date: March 14, 2001.

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

Agenda: To review and evaluate grant

applications.

Place: Holiday Inn Chevy Chase, 5520

Wisconsin Avenue, Chevy Chase, MD 20815.

Contact Person: Carole H. Latker, Scientific

Review Administrator, Office of Scientific

Review, National Institute of General Medical

Sciences, National Institutes of Health,

Natcher Building, Room 1AS–13, Bethesda,

MD 20892, (301) 594–2848,

latkerc@nigms.nih.gov.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.375, Minority Biomedical

Research Support; 93.821, Cell Biology and

Biophysics Research; 93.859, Pharmacology,

Physiology, and Biological Chemistry

Research; 93.862, Genetics and

Developmental Biology Research; 93.88,

Minority Access to Research Careers; 93.96,

Special Minority Initiatives, National

Institutes of Health, HHS).

Dated: February 20, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–5172 Filed 3–2–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Environmental

Health Sciences; Notice of Closed

Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), 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 contract proposals and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the contract

proposals, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

Environmental Health Sciences Special

Emphasis Panel, National Center for

Toxicogenomics (NCT) Microarray Resource.

Date: March 14, 2001.

Time: 11 a.m. to 1 p.m.

Agenda: To review and evaluate contract

proposals.

Place: NC Biotechnology Center, 15 T.W.

Alexander Drive, Post Office Box 13547,

Research Triangle Park, NC 27709.

Contact Person: Linda K. Bass, Scientific

Review Administrator, Nat’l Institute of

Environmental Health Sciences, P.O. Box

12233, MD EC–24, Research Triangle Park,

NC 27709, (919) 541–1307.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.113, Biological Response to

Environmental Health Hazards; 93.114,

Applied Toxicological Research and Testing;

93.115, Biometry and Risk Estimation—

Health Risks from Environmental Exposures;

93.142, NIEHS Hazardous Waste Worker

Health and Safety Training; 93.143, NIEHS

Superfund Hazardous Substances—Basic

Research and Education; 93.894, Resources

and Manpower Development in the

Environmental Health Sciences, National

Institutes of Health, HHS)

Dated: February 23, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–5173 Filed 3–2–01; 8:45 am]

BILLING CODE 4140–01–M