61826 Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Notices

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 (NIH form 2564)

and Transfer Investigational Drug

Record (NIH form 2564–1). Type of

Information Collection Request:

Revision of a currently approved

collection, OMB No. 0925–0240,

Expiration Date 1/31/98. Need and Use

of Information Collection: Food and

Drug Administration (FDA) regulations

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 trails,

has the responsibility to assure the FDA

that investigators in its clinical trials

program are maintaining systems for

drug accountability. In order to fulfill

these requirements, a standard

Investigational Drug Accountability

Report Form (NIH 2564) was designed

to account for drug inventories and

usage by protocols. The Transfer

Investigational Drug Form (NIH 2564–1)

permits intra-institutional transfer of

drugs to other approved investigators for

other approved protocols. The data

obtained from the drug accountability

record will be used to keep track of the

dispensing of investigational anticancer

agents to patients. It is used by NCI

management to ensure that

investigational drug supplies are not

diverted for inappropriate protocol or

patient use. The information is also

compared to patient flow sheets

(protocol reporting forms) during site

visits conducted for each investigator

once every three years. All comparison

are done with the intention of ensuring

protocol, patient and drug compliance

for patient safety and protections.

Frequency of Response: Daily. Affected

Public: state or local governments,

businesses, or other for-profit, Federal

agencies or employees, non-profit

institutions, and small business or

organizations. Type of Respondents:

Investigators, pharmacist; nurses,

pharmacy technicians, data managers.

The annual reporting burden is as

follows: The annualized burden

estimate for record keeping is estimated

to require 3,650 hours for drug

accountability and 120 hours for drug

transfer. The annualized cost to the

respondents is estimated at $94,500.

The reporting burden is the average time

(4 minutes or 0.0666 hour) 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 0.0666 hour 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 36,500 items shipped by PMB and

the 1,200 items transfer approvals in

calendar year 1996. Cost estimates are

based upon burden hours at an average

cost of $25.00 per hour.

Drug Accountability Form:

No. Of Respondents—4560

No. Of responses per respondent—8

Average Burden per response—0.0666

Annual Burden hours—2430

Drug Transfer Form:

No. Of respondents—1200

No. Of responses per respondent—1

Average burden per response—0.0666

Annual Burden hours—80

Total Annualized Burden For Record

Keeping and Reporting: 2,510.

There are no Capital Costs, Operating

Costs, and/or Maintenance Cost 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 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.

Direct Comments To OMB

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, New

Executive Office Building, Room 10235,

Washington, D.C. 20503, Attention:

Desk Officer for NIH. To request

information on the proposed project or

to obtain a copy of the data collection

plans and instruments, contact Joseph

High, Head, Drug Management and

Authorization Section, Pharmaceutical

Management Branch, Cancer Therapy

Evaluation Program, Division Cancer

Therapy, Diagnosis, and Centers,

National Cancer Institute, Executive

Plaza North, Room 707, 9000 Rockville

Pike, Bethesda, MD 20892 or call nontoll-free number (301) 496–5725 or Email your request, including your

address to: JoeHigh@nih.gov.

COMMENTS DUE DATE: Comments

regarding this information collection are

best assured of having their full effect if

received on or before December 19,

1997.

Dated: November 12, 1997.

Nancie L. Bliss,

OMB Project Clearance Liaison.

[FR Doc. 97–30322 Filed 11–18–97; 8:45 am]

BILLING CODE 4140–07–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and

Human Development; Notice of

Meeting of the Board of Scientific

Counselors

Pursuant to Public Law 92–463,

notice is hereby given of the meeting of

the Board of Scientific Counselors,

National Institute of Child Health and

Human Development, December 5,

1997, in Building 31, Room 2A52.

This meeting will be open to the

public from 8:00 a.m. to 12 noon on

December 5 for the review of the

Intramural Research Program and

scientific presentations. Attendance by

the public will be limited to space

available.

In accordance with the provisions set

forth in section 552b(c)(6), Title 5,

U.S.C. and section 10(d) of Public Law

92–463, the meeting will be closed to

the public on December 5 from 1:00

p.m. to adjournment of the review,

discussion, and evaluation of individual

programs and projects conducted by the

National Institutes of Health, including

consideration of personnel

qualifications and performance, the

competence of individual investigators,

and similar items, the disclosure of

which would constitute a clearly

unwarranted invasion of personal

privacy. Ms. Catherine O’Connor, Senior

Biomedical Research Program Assistant,

NICHD, Building 31, Room 2A50,

National Institutes of Health, Bethesda,

Maryland, 20892–2425, 301–496–2133,

will provide a summary of the meeting,

a roster of Board members, and

substantive program information upon

request. Individuals who plan to attend
Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Notices 61827

the open session and need special

assistance, such as sign language

interpretation or other reasonable

accommodations, should contact Ms.

O’Connor in advance of the meeting.

Dated: November 12, 1997.

LaVeen Ponds,

Acting, Committee Management Officer, NIH.

[FR Doc. 97–30322 Filed 11–18–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

[AZ–050–08–1110–00; 6780; 1782]

Arizona: Availability of the Final

Lechuguilla-Mohawk Habitat

Management Plan (HMP), Yuma Field

Office

AGENCY: Bureau of Land Management,

Interior.

ACTION: Notice of availability of the final

Lechuguilla-Mohawk Habitat

Management Plan (HMP) and

environmental assessment, Yuma Field

Office.

SUMMARY: The Lechuguilla-Mohawk

Habitat Management Plan covers

wildlife habitat improvement projects

and monitoring on approximately

930,000 acres of public land and

military-withdrawn public land in

southwestern Arizona. The plan will be

implemented in cooperation with

Arizona Game and Fish Department

under the Sikes Act. Most of the land

included in the plan is part of the Barry

M. Goldwater Air Force Range which is

administered by the Luke Air Force

Base in Glendale, Arizona. The western

portion of the Goldwater Range is used

primarily by the Marine Corps Air

Station, Yuma for training.

Objectives of the plan include

maintenance and enhancement of

habitat for Sonoran pronghorn, desert

tortoise, flat-tailed horned lizard, mule

deer, desert bighorn sheep, upland

game, nongame, and other sensitive

wildlife habitat. It is projected that the

plan objectives will be achieved within

20 years.

ADDRESSES: A limited number of copies

of the Plan and Environmental

Assessment are available upon request

to: Field Manager, Bureau of Land

Management, 2555 East Gila Ridge

Road, Yuma, Arizona 85365. There are

also copies available for review at the

above location.

FOR FURTHER INFORMATION CONTACT:

Wildlife Biologist Susanna Henry,

Bureau of Land Management, 2555 East

Gila Ridge Road, Yuma, Arizona 85365,

telephone (520) 317–3211.

Dated: November 10, 1997.

Curtis Gunn,

Program Manager, Resources, Lands, and

Minerals/Acting Field Manager.

[FR Doc. 97–30299 Filed 11–18–97; 8:45 am]

BILLING CODE 4310–32–M

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

[NV–040–1020–001]

Mojave-Southern Great Basin

Resource Advisory Council—Notice of

Meeting, Locations and Times

AGENCY: Bureau of Land Management,

Interior.

ACTION: Resource Advisory Council

Meeting Locations and Times.

SUMMARY: In accordance with the

Federal Land Policy and Management

Act and the Federal Advisory

Committee Act of 1972 (FACA), 5

U.S.C., the Department of the Interior,

Bureau of Land Management (BLM),

council meeting of the Mojave-Southern

Great Basin Resource Advisory Council

(RAC) will be held as indicated below.

The agenda includes a public comment

period, and discussion of public land

issues.

The Resource Advisory Council

develops recommendations for BLM

regarding the preparation, amendment,

and implementation of land use plans

for the public lands and resources

within the jurisdiction of the council.

For the Mojave-Great Basin RAC this

jurisdiction is Clark, Esmeralda, Lincoln

and Nye counties in Nevada. Except for

the purposes of long-range planning and

the establishment of resource

management priorities, the RAC shall

not provide advice on the allocation and

expenditure of Federal funds, or on

personnel issues.

The RAC may develop

recommendation for implementation of

ecosystem management concepts,

principles and programs, and assist the

BLM to establish landscape goals and

objectives.

All meetings are open to the public.

The public may present written

comments to the council. Public

comments should be limited to issues

for which the RAC may make

recommendations within its area of

jurisdiction. Depending of the number

of persons wishing to comment, and

time available, the time for individual

oral comments may be limited.

Individuals who plan to attend and

need further information about the

meetings, or need special assistance

such as sign language interpretation or

other reasonable accommodations,

should contact Michael Dwyer at the

Las Vegas District Office, 4765 Vegas

Dr., Las Vegas, NV 89108, telephone,

(702) 647–5000.

DATES: Date is December 8, 1997, from

1:00 p.m. to approximately 4 p.m. and

will reconvene on December 9, 1997

and meet from 8 a.m. to 4:40 p.m. The

public comment period will begin at 2

p.m. on December 8, 1997 at 2:00 p.m.

ADDRESSES: The council will meet at the

Las Vegas District Office, 4765 West

Vegas Drive, Las Vegas, NV.

FOR FURTHER INFORMATION CONTACT:

Dan Netcher, District Minerals

Specialist, Ely, telephone: (702) 289–

1872.

Dated: November 10, 1997.

Gene A. Kolkman,

Ely District Manager.

[FR Doc. 97–30300 Filed 11–18–97; 8:45 am]

BILLING CODE 4310–HC–M

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

[ES–960–1420–00] ES–49231, Group 34,

Illinois

Notice of Filing of Plat of Survey;

Illinois

The plat of the survey of the

Kaskaskia Lock and Dam acquisition

boundary, Township 6 South, Range 8

West, Third Principal Meridian, Illinois,

will be officially filed in Eastern States,

Springfield, Virginia at 7:30 a.m., on

December 22, 1997.

The survey was requested by the U.S.

Army Corps of Engineers.

All inquiries or protests concerning

the technical aspects of the survey must

be sent to the Chief Cadastral Surveyor,

Eastern States, Bureau of Land

Management, 7450 Boston Boulevard,

Springfield, Virginia 22153, prior to

7:30 a.m., December 22, 1997.

Copies of the plat will be made

available upon request and prepayment

of the reproduction fee of $2.75 per

copy.

Dated: November 7, 1997.

Stephen G. Kopach,

Chief Cadastral Surveyor.

[FR Doc. 97–30298 Filed 11–18–97; 8:45 am]

BILLING CODE 4310–GJ–M