3908 Federal Register / Vol. 63, No. 17 /Tuesday, January 27, 1998 / Notices

Submit written requests for single

copies of these draft GFI documents to

the Communications and Education

Team (HFV–12), Center for Veterinary

Medicine (CVM), Food and Drug

Administration, 7500 Standish Place,

Rockville, MD 20855. Send two selfaddressed adhesive labels to assist that

office in processing your requests.

Copies of these draft guidance

documents may be obtained on the

Internet from the CVM Home Page

(http://www.cvm.fda.gov).

FOR FURTHER INFORMATION CONTACT:

Regarding the GFI’s: William G.

Marnane, Center for Veterinary

Medicine (HFV–140), Food and

Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

0678. E-mail:

wmarnane@bangate.fda.gov.

Regarding VICH: Sharon R.

Thompson, Center for Veterinary

Medicine (HFV–3), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–

1798. E-mail:

sthompso@bangate.fda.gov.

SUPPLEMENTARY INFORMATION: In recent

years, many important initiatives have

been undertaken by regulatory

authorities, industry associations, and

individual sponsors to promote the

international harmonization of

regulatory requirements. FDA has

participated in efforts to enhance

harmonization and has expressed its

commitment to seeking scientifically

based harmonized technical procedures

for the development of pharmaceutical

products. One of the goals of

harmonization is to identify and reduce

the differences in technical

requirements for drug development

among regulatory agencies.

FDA has actively participated in the

ICH for several years to develop

harmonized technical requirements for

the registration of human

pharmaceutical products among the

European Union, Japan, and the United

States. The VICH is a parallel initiative

for veterinary pharmaceutical products.

The VICH is concerned with developing

harmonized technical requirements for

the registration of veterinary

pharmaceutical products in the

European Union, Japan, and the United

States, and includes input from both

regulatory and industry representatives.

The VICH meetings are held under the

auspices of the Office International des

E ́pizooties (OIE). During the initial

phase of the VICH, an OIE

representative chairs the VICH Steering

Committee. The VICH Steering

Committee is composed of member

representatives from the European

Commission; the European Medicines

Evaluation Agency; the European

Federation of Animal Health; the U.S.

Food and Drug Administration; the U.S.

Department of Agriculture; the Animal

Health Institute; the Japanese Veterinary

Pharmaceutical Association; and the

Japanese Ministry of Agriculture,

Forestry and Fisheries.

Four observers are eligible to

participate in the VICH Steering

Committee: One representative from the

Government of Australia/ New Zealand,

one representative from the industry in

Australia/ New Zealand, one

representative from MERCOSUR

(Argentina, Brazil, Uruguay and

Paraguay), and one representative from

Federacion Latino-Americana de la

Industria para la Salud Animal. The

VICH Secretariat, which coordinates the

preparation of documentation, is

provided by the Confe ́de ́ration

Mondiale de L’Industrie de la Sante ́

Animale (COMISA). A COMISA

representative also participates in the

VICH Steering Committee meetings.

At a meeting held on August 20 and

21, 1997, the VICH Steering Committee

agreed that the draft GFI documents

entitled ‘‘Validation of Analytical

Procedures: Definition and

Terminology’’ and ‘‘Validation of

Analytical Procedures: Methodology’’

should be made available for public

comment. These draft GFI documents

were prepared by the VICH Quality

Working Group and are based on the

ICH Guidelines (Q2A and Q2B) that

have already been adopted by FDA for

human pharmaceuticals. With one

exception, the deletion of the text ‘‘(e.g.

metered dose inhalers)’’ included in the

ICH guideline Q2B, Section 3, the

documents are identical.

The draft GFI document entitled,

‘‘Validation of Analytical Procedures:

Definition and Terminology,’’ discusses

the characteristics that should be

considered during the validation of the

analytical procedures included in an

application for registration of veterinary

medicinal products in the European

Union, Japan, and the United States.

This document pertaining to ‘‘Definition

and Terminology’’ is not intended to

cover testing requirements or

procedures, rather it is intended to serve

as a collection of terms and definitions.

These common definitions such as

‘‘analytical procedures,’’ ‘‘specificity,’’

‘‘precision,’’ ‘‘accuracy,’’ etc., are meant

to bridge the differences that often exist

among various compendia and

requirements of the European Union,

Japan, and the United States. The draft

GFI document entitled, ‘‘Validation of

Analytical Procedures: Methodology,’’

discusses common analytical

procedures and provides guidance and

recommendations on how to consider

various validation characteristics for

each analytical procedure. It also

indicates the data that should be

included in an application for

registration. Comments about these draft

GFI documents will be considered by

the FDA and the VICH Quality Working

Group. Ultimately, FDA intends to

adopt the VICH Steering Committee’s

final guidelines and publish them as

future GFI documents.

If finalized, these documents will

represent current FDA thinking on

characteristics for consideration during

the validation of the analytical

procedures included as part of

applications. The draft GFI documents

will not create or confer any rights for

or on any person and will not operate

to bind FDA or the public. Alternate

approaches may be used if they satisfy

the requirements of applicable statutes,

regulations, or both.

Interested persons may, on or before

March 30, 1998, submit to the Dockets

Management Branch (address above)

written comments on the draft guidance

document. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document and with the

full title of the guidance document. The

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday. After

review of these comments, FDA will

implement the guidance document with

any appropriate changes. Thereafter,

interested persons may submit written

comment on the guidance document

directly to the CVM Communications

and Education Team (address above).

Dated: January 20, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–1848 Filed 1–26–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Information Collection To Be

Submitted to the Office of Management

and Budget (OMB) for Approval Under

the Paperwork Reduction Act

ACTION: Notice.

SUMMARY: The collection of information

described below will be submitted to

OMB for approval under the provisions
Federal Register / Vol. 63, No. 17 /Tuesday, January 27, 1998 / Notices 3909

of the Paperwork Reduction Act of 1995.

Copies of specific information collection

requirements, related forms and

explanatory material may be obtained

by contacting the Service Information

Collection Clearance officer at the

address and/or phone numbers listed

below.

DATES: Comments must be submitted on

or before March 30, 1998.

ADDRESSES: Comments and suggestions

on specific requirements should be sent

to the Service Information Collection

Clearance Officer, U.S. Fish and

Wildlife Service, MS 222 ARLSQ, 1849

C Street, NW, Washington, DC 20240.

FOR FURTHER INFORMATION CONTACT:

Stephen R. Vehrs, Refuge Program

Specialist, Division of Refuges, 703/

358–2397.

SUPPLEMENTARY INFORMATION: The

Service proposes to submit the

following information collection

clearance requirements to OMB for

review and approval under the

Paperwork Reduction Act of 1995, Pub.

L. 104–13. Comments are invited on: (1)

Whether the collection of information is

necessary for the proper performance of

the functions of the agency, including

whether the information will have

practical utility; (2) the accuracy of the

agency’s estimate of burden, 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 through the

use of appropriate automated,

electronic, mechanical, or other

technological collection techniques or

other forms of information technology.

The issuance of a Permit by the Fish

and Wildlife Service for access to units

of the National Wildlife Refuge System

Administration Act (16 U.S.C. 668dd–

668ee et seq.) as amended; the Refuge

Recreation Act (16 U.S.C. 460K–3); the

National Wildlife Refuge System

Improvement Act of 1997 (Pub. L. 105–

57); and as implemented by regulations

in 50 CFR 25–38.

The information requested prior to

issuing the Permit is required to obtain

a benefit, and will assist the Service in

administering System programs in

accordance with the above statutory

authorities. The Improvement Act

requires that a wildlife dependent

recreational use or any other uses of a

refuge that, in the sound professional

judgment of the Director, will not

materially interfere with or detract from

the fulfillment of the mission of the

System or the purposes for which the

refuge was established. The information

is needed by the Service to make this

determination before a permit can be

issued.

The permit is required for any person

entering a national wildlife refuge,

unless otherwise provided under the

provisions of 50 CFR, subchapter C. The

permittee must abide by all the terms

and conditions set forth in the permit.

Information collected in submitting

an application for a permit, prior to

issuing a permit, may be used to

evaluate and conclude the eligibility of,

or merely document, permit applicants.

The Service will require the use of

permits as a condition in new and

revised regulations pursuant to the

Refuge Improvement Act.

The Service will provide Special Use

Permit forms as requested by interested

citizens. The required written forms

and/or verbal application information

will be sued by the Service to ensure

that the applicant is eligible to receive

a Permit.

Title: United States Department of the

Interior, Fish and Wildlife Service,

Special Use Permit.

Bureau form number: 3–1383.

Frequency of collection: On occasion.

Description of respondents:

Individuals or households; State, local,

or Tribal governments; businesses or

other for profit and not-for-profit

institutions.

Number of respondents: 10,000.

Estimated completion time: The

reporting burden for FWS Form 3–1383

(Special Use Permit) is estimated to be

30 minutes.

Burden estimate: 5,000 hours.

Dated: January 15, 1998.

Carolyn A. Bohan,

Acting Assistant Director for Refuges and

Wildlife.

[FR Doc. 98–1862 Filed 1–26–98; 8:45 am]

BILLING CODE 4310–55–M

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 application.

The following applicant has applied

for a permit 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–697830

Applicant: Assistant Regional

Director, Ecological Services, Region 3,

U.S. Fish and Wildlife Service, Fort

Snelling, Minnesota.

The applicant requests to renew and

amend his current permit to take the

following species for scientific purposes

and the enhancement of propagation or

survival of the species in the wild in

accordance with listing, recovery

outlines, recovery plans, and/or other

Service work for those species:

Mammals

bat, gray (Myotis grisescens)

bat, Indiana (Myotis sodalis)

bat, Ozark big-eared (Plecotus

townsendii ingens)

wolf (Canis lupus)

Birds

eagle, bald (Haliaeetus leucocephalus)

falcon, peregrine (Falco peregrinus)

plover, piping (Charadrius melodus)

tern, least tern (Sterna antillarum)

warbler, Kirtland’s (wood) (Dendroica

kirtlandii)

Reptiles

snake, copperbelly water (northern

population) (Nerodia erythrogaster

neglecta)

Fish

cavefish, Ozark (Amblyopsis rosae)

darter, Niangua (Etheostoma nianguae)

madtom, Scioto (Noturus trautmani)

madtom, Neosho (Noturus placidus)

sturgeon, pallid (Scaphirhynchus albus)

Clams

clubshell (Pleurobema clava)

fanshell [Cyprogenia stegaria

(=irrorata)]

mussel, ring pink (=golf stick pearly)

(Obovaria retusa)

mussel, winged mapleleaf (Quadrula

fragosa)

pearlymussel, cracking [Hemistena

(=Lastena) lata]

pearlymussel, Curtis’ [Epioblasma

(=Dysnomia) florentina curtisi]

pearlymussel, Higgins’ eye (Lampsilis

higginsi)

pearlymussel, orange-foot pimple back

(Plethobasus cooperianus)

pearlymussel, pink mucket [Lampsilis

(=abrupta) orbiculata]

pearlymussel, purple cat’s paw pearly

mussel [Epioblasma (=Dysnomia)

obliquata obliquata (=sulcata

sulcata)]

pearlymussel, tubercled-blossom

[Epioblasma (=Dysnomia) torulosa

torulosa]

pearlymussel, turgid-blossom

[Epioblasma (=Dysnomia) turgidula]

pearlymussel, white cat’s paw

[Epioblasma (=Dysnomia) obliquata

perobliqua]

pearlymussel, white wartyback

(Plethobasus cicatricosus)