31506 Federal Register / Vol. 63, No. 110 /Tuesday, June 9, 1998 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Form No. 21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Form FDA 356 V 514.1 and 514.6 190 6.76 1,824 211.6 271,694

514.8 and 514.9 30 8,520

514.11 1 1,824

Total burden hours 282,038

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimate of the burden hours

required for reporting are based on fiscal

year 1996 data. The burden estimate

includes original NADA’s, supplemental

NADA‘s, and amendments to

unapproved applications.

Dated: June 2, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15271 Filed 6–8–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Request for Nominations for Members

on Public Advisory Committees;

Veterinary Medicine Advisory

Committee

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

nominations for members to serve on

the Veterinary Medicine Advisory

Committee (the Committee) in FDA’s

Center for Veterinary Medicine.

FDA has a special interest in ensuring

that women, minority groups, and the

physically challenged are adequately

represented on advisory committees

and, therefore, extends particular

encouragement to nominations for

appropriately qualified candidates from

these groups.

DATES: No cutoff date is established for

receipt of nominations.

ADDRESSES: All nominations for

membership should be submitted to

Jacquelyn L. Pace (address below).

FOR FURTHER INFORMATION CONTACT:

Jacquelyn L. Pace, Center for Veterinary

Medicine (HFV–200), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–6650.

SUPPLEMENTARY INFORMATION: FDA is

requesting nominations for members to

serve on the Committee. The function of

the Committee is to review and evaluate

available data concerning safety and

effectiveness of marketed and

investigational new animal drugs, feeds,

and devices for use in the treatment and

prevention of animal disease and

increased animal production.

Criteria for Members

Persons nominated for membership

on the Committee shall have adequately

diversified experience that is

appropriate to the work of the

Committee in such fields as companion

animal medicine, food animal medicine,

avian medicine, microbiology,

biometrics, toxicology, pathology,

pharmacology, animal science, public

health/epidemiology, minor species/

minor use veterinary medicine, and

chemistry. The specialized training and

experience necessary to qualify the

nominee as an expert suitable for

appointment is subject to review, but

may include experience in medical

practice, teaching, and/or research

relevant to the field of activity of the

Committee. The term of office is 4 years.

As of November 1, 1998, the

Committee will have three vacancies in

the areas of animal science, veterinary

toxicology, and veterinary microbiology.

However, membership nominations are

not limited to these three areas.

Nomination Procedures

Any interested person may nominate

one or more qualified persons for

membership on the Committee.

Nominations shall state that the

nominee is willing to serve as a member

of the Committee and appears to have

no conflict of interest that would

preclude committee membership. A

current copy of the nominee’s

curriculum vitae should be included.

Potential candidates will be asked by

FDA to provide detailed information

concerning such matters as

employment, financial holdings,

consultancies, and research grants or

contracts in order to permit evaluation

of possible sources of conflict of

interest.

This notice is issued under the

Federal Advisory Committee Act (5

U.S.C. app. 2) and 21 CFR part 14,

relating to advisory committees.

Dated: May 29, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–15195 Filed 6–8–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0374]

International Conference on

Harmonisation; Draft Guidance on

Specifications: Test Procedures and

Acceptance Criteria for

Biotechnological/Biological Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

draft guidance entitled ‘‘Q6B

Specifications: Test Procedures and

Acceptance Criteria for

Biotechnological/Biological Products.’’

The draft guidance was prepared under

the auspices of the International

Conference on Harmonisation of

Technical Requirements for Registration

of Pharmaceuticals for Human Use

(ICH). The draft guidance provides

guidance on general principles for the

selection of test procedures and the

setting and justification of acceptance

criteria for biotechnological and

biological products. The draft guidance

is intended to assist in the

establishment of a uniform set of

international specifications for

biotechnological and biological

products to support new marketing

applications.

DATES: Written comments by July 24,

1998.

ADDRESSES: Submit written comments

on the draft guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Copies of the draft guidance are

available from the Drug Information

Branch (HFD–210), Center for Drug