Federal Register / Vol. 63, No. 129 /Tuesday, July 7, 1998 / Notices 36707

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0265]

Guidance for Industry on Qualifying for

Pediatric Exclusivity; Availability;

Request for Submissions

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; request for submissions.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance for industry

entitled ‘‘Qualifying for Pediatric

Exclusivity Under Section 505A of the

Federal Food, Drug, and Cosmetic Act.’’

FDA is also requesting the submission

of proposed pediatric study requests.

This guidance is intended to assist

industry in interpreting newly enacted

provisions of the Food and Drug

Administration Modernization Act of

1997 (Modernization Act). This

guidance will remain in effect until

superseded by regulations or new

guidance.

DATES: Written comments may be

submitted on the guidance by October 5,

1998. General comments on agency

guidance documents are welcome at any

time. Sponsors of applications for

marketed drugs that appear in the

priority section of the ‘‘List of Approved

Drugs for Which Additional Pediatric

Information May Produce Health

Benefits in the Pediatric Population’’

(the list) (see Docket No. 98N–0056) (63

FR 27733) 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 below) on or before

August 31, 1998, for expedited

consideration.

ADDRESSES: Submit written requests for

single copies of ‘‘Qualifying for

Pediatric Exclusivity Under Section

505A of the Federal Food, Drug, and

Cosmetic Act’’ to the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, or the

Manufacturers Assistance and

Communications Staff (HFM–42),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist in

processing your requests. Submit

written comments on the guidance to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. See the Supplementary

Information section of this document

for electronic access to the draft

guidance.

FOR FURTHER INFORMATION CONTACT:

Khyati N. Roberts, Center for Drug

Evaluation and Research (HFD–6), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

6779, FAX 301–594–5493, e-mail

‘‘robertsk@cder.fda.gov’’, or David W.

Feigal, Center for Biologics Evaluation

and Research (HFM–6), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852, 301–827–0376,

FAX 301–827–0440, e-mail

‘‘feigal@cber.fda.gov’’.

SUPPLEMENTARY INFORMATION:

I. Description of the Guidance

FDA is announcing the availability of

a guidance for industry entitled

‘‘Qualifying for Pediatric Exclusivity

Under Section 505A of the Federal

Food, Drug, and Cosmetic Act.’’ Section

111 of the Modernization Act (Pub. L.

105–115), signed into law by President

Clinton on November 21, 1997, created

section 505A of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

355a). Section 505A of the act permits

certain applications to obtain an

additional 6 months of marketing

exclusivity if, in accordance with the

requirements of the statute, the sponsor

submits information relating to the use

of the drug in the pediatric population.

FDA plans to issue regulations through

notice-and-comment rulemaking to

implement the pediatric exclusivity

provisions of the Modernization Act.

The agency is publishing this

procedural guidance to explain how the

agency intends to implement section

505A of the act in the interim. The

guidance will be updated as

appropriate. This guidance will remain

in effect until superseded by regulations

or new guidance.

This guidance describes FDA’s

current thinking on how sponsors may

qualify for pediatric exclusivity under

section 505A of the act. The guidance

includes the following topics: (1)

Whether studies for certain drugs will

be requested under section 505A(a) or

(c), (2) the definition of pediatric

studies, (3) the content and format of an

FDA request for pediatric studies, (4)

how an applicant can obtain an FDA

written request, (5) the content of a

written agreement for the conduct of

pediatric studies, (6) the definition of

commonly accepted scientific

principles, (7) the filing of reports of

studies, (8) acceptance of studies by

FDA, (9) scope and nature of pediatric

exclusivity, (10) publication of

exclusivity determinations, and (11)

treatment of information submitted in

support of a request for pediatric

exclusivity.

This guidance document is being

implemented immediately without prior

public comment because the guidance is

needed to implement the Modernization

Act. However, the agency wishes to

solicit comment from the public, and it

is providing a 90-day comment period

and establishing a docket for the receipt

of comments. FDA will also consider

comments on pediatric exclusivity

submitted to Docket No. 98N–0056

(containing the ‘‘List of Approved Drugs

for Which Additional Pediatric

Information May Produce Health

Benefits in the Pediatric Population’’)

before July 7, 1998.

This guidance document represents

the agency’s current thinking on the

implementation of section 505A of the

act and pediatric exclusivity. It does not

create or confer any rights for or on any

person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of the

applicable statute, regulations, or both.

Submit written comments on the

guidance to the Dockets Management

Branch (address above). Two copies of

any comments are to be submitted,

except that individuals may submit one
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