36708 Federal Register / Vol. 63, No. 129 /Tuesday, July 7, 1998 / Notices

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. The guidance and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

II. Request for Proposed Pediatric

Study Requests

Sponsors of applications for marketed

drugs that appear in the priority section

of the list (see Docket No. 98N–0056) for

which any exclusivity or patent period

expires on or before March 31, 1999,

should submit proposed pediatric study

requests to the appropriate new drug

review division with a facsimile copy to

Khyati N. Roberts (address above) on or

before August 17, 1998, for expedited

consideration. These sponsors should

label their proposals ‘‘Proposed

Pediatric Study Request—Expiration on

or Before March 31, 1999.’’ FDA will

endeavor to issue Written Requests on

or before October 15, 1998, for adequate

proposals or as soon thereafter as

possible. FDA will ask sponsors of

proposals that are submitted before

August 31, 1998, and that are not

adequate to resubmit their proposal. The

resubmitted proposal will be processed

based on the date of resubmission.

Other proposed pediatric study requests

may also be submitted during this

period, but they will be processed in the

order described in the guidance. As

FDA gains experience with this process,

it may provide additional guidance

regarding the timing of a proposed

pediatric study request.

III. Paperwork Reduction Act of 1995

This notice contains no new

collections of information. The

information requested for proposed

pediatric studies is already covered by

the collection of information on IND

regulations (21 CFR part 312) submitted

to OMB for review and clearance. In

accordance with the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520), OMB approved the information

collection and assigned OMB control

number 0910–0014. The approval

expires on December 31, 1999.

IV. Electronic Access

Copies of this guidance for industry

are available on the Internet at ‘‘http://

www.fda.gov/cder/guidance/

index.htm’’ and at ‘http://www.fda.gov/

cber/guidelines.htm’’.

Dated: June 24, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–17876 Filed 7–6–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Endangered and Threatened Species

Permit Applications

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of receipt of applications.

The following applicants have

applied for permits to conduct certain

activities with endangered species. This

notice is provided pursuant to section

10(c) of the Endangered Species Act of

1973, as amended (16 U.S.C. 1531, et

seq.).

PRT–844263

Applicant: Dr. Brenda Molano-Flores, Illinois

Natural History Survey/Midewin National

Tallgrass Prairie, Wilmington, Illinois.

The applicant requests a permit to

take (collect infructescence, flowers,

and leaf tissue samples) endangered

Leafy Prairie Clover (Dalea foliosa)

plants located in the Midewin National

Tallgrass Prairie (Federal jurisdiction).

Activities are proposed for scientific

research aimed at survival and

enhancement of the species in the wild.

PRT–842503

Applicant: Robert Mies and Kimberly

Williams, The Organization for Bat

Conservation, Williamston, Michigan.

The applicant requests an amendment

to permit number PRT–842503 to take

(capture, handle, band) endangered

Indiana Bat (Myotis sodalis) at locations

within the States of Region 3 (Illinois,

Indiana, Iowa, Michigan, Minnesota,

Missouri, Ohio, and Wisconsin) where

they occur. Activities are proposed for

scientific research aimed at survival and

enhancement of the species in the wild.

Written data or comments should be

submitted to the Regional Director, U.S.

Fish and Wildlife Service, Ecological

Services Operations, 1 Federal Drive,

Fort Snelling, Minnesota 55111–4056,

and must be received within 30 days of

the date of this publication.

Documents and other information

submitted with these applications are

available for review by any party who

submits a written request for a copy of

such documents to the following office

within 30 days of the date of publication

of this notice: U.S. Fish and Wildlife

Service, Ecological Services Operations,

1 Federal Drive, Fort Snelling,

Minnesota 55111–4056. Telephone:

(612/713–5332); FAX: (612/713–5292).

Dated: June 25, 1998.

Matthias A. Kerschbaum,

Acting Assistant Regional Director, IL, IN,

MO (Ecological Services), Region 3, Fort

Snelling, Minnesota.

[FR Doc. 98–17860 Filed 7–6–98; 8:45 am]

BILLING CODE 4310–55–P

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

[WO–310–1310–01–24–1A]

Extension of Currently Approved

Information Collection; OMB Approval

Number 1004–0034

AGENCY: Bureau of Land Management,

Interior.

ACTION: Notice and request for

comments.

SUMMARY: In accordance with the

Paperwork Reduction Act of 1995, the

Bureau of Land Management (BLM) is

announcing its intention to request

extension of approval for the collection

of information from those persons who

wish to transfer interest in oil and gas

or geothermal leases by assignment of

record title, or transfer operating rights

(sublease) in oil and gas or geothermal

leases under the terms of the mineral

leasing laws.

DATES: Comments on the proposed

information collection must be received

by September 8, 1998, to be considered.

ADDRESSES: Comments may be mailed

to: Regulatory Management Team (420),

Bureau of Land Management, 1849 C

Street NW, Room 401 LS Bldg.,

Washington, D.C. 20240.

Comments may be sent via Internet to:

!WO140attmail.com. Please include

‘‘Attn: 1004–0034’’ and your name and

return address in your Internet message.

Comments may be hand delivered to

the Bureau of Land Management

Administrative Record, Room 401 L

Street, NW, Washington, D.C.

Comments will be available for public

review at the L Street address during

regular business hours (7:45 A.M. to

4:15 P.M., Monday through Friday).

FOR FURTHER INFORMATION CONTACT:

Barbara Gamble, Fluids Minerals Group,

(202) 452–0340.

SUPPLEMENTARY INFORMATION: In

accordance with 5 CFR 1320.12(a), the

BLM is required to provide 60-day

notice in the Federal Register

concerning a collection of information

contained in published current rules to

solicit comments on (a) whether the

proposed collection of information is