Federal Register / Vol. 63, No. 110 /Tuesday, June 9, 1998 / Notices 31505

releasable, and (2) enforcement actions

which are releasable.

Three respondents were not clear

whether approved product labeling was

still required to accompany promotional

materials, and one respondent proposed

an alternative method of submitting

labeling. The agency presently requests

that sponsors submit two copies of the

approved product labeling for each

referenced drug product. This has been

clarified on the form. Alternative

methods of submitting approved

product labeling may be considered at a

later time.

Three respondents proposed that the

agency provide the revised Form FDA

2253 in electronic form, and accept

some promotional materials via

electronic means. The agency currently

provides many forms on the Internet

using the World Wide Web (WWW) at

‘‘http://www.fda.gov/opacom/

morechoices/fdaforms/fdaforms.html’’

and intends to add the revised Form

FDA 2253 shortly after it is an approved

form. As for the submission of

promotional materials by electronic

means, DDMAC is currently reviewing a

pilot project where proposed

promotional materials are submitted for

review via CD–ROM and in hard copy.

If successful, DDMAC plans to continue

the pilot project and refine the means of

submitting promotional materials by

electronic means.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Form No. of

Respondents

Total Annual

Responses

Hours per

Response

Total Estimated

Hours

FDA 2253 612 12,379 2 24,758

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

In fiscal year 1995, CDER received

10,879 submissions of advertising and

promotional labeling under Form FDA

2253 from an estimated 512

manufacturers. In the same period of

time, CBER received 1, 034 submissions

from 57 manufacturers that could have

made use of revised Form FDA 2253.

Prior to October 7, 1997, the submission

of advertising and promotional labeling

to CBER using Form FDA 2567 was a

voluntary procedure. Under

§ 601.12(f)(4) (62 FR 39890),

manufacturers of licensed biological

products are required to submit

specimens of advertising and

promotional labeling to FDA in

accordance with § 314.81(b)(3)(i), FDA

estimates that under the new regulation

CBER will receive over 1,500

submissions from approximately 100

manufacturers that may use the revised

Form FDA 2253. Thus, FDA estimates

that there may be 12,379 submissions of

advertising and promotional labeling to

FDA under revised Form FDA 2253.

Based on contacts with industry

representatives, FDA estimates that 2

hours would be required for an industry

regulatory affairs specialist to fill out the

proposed form, collate the

documentation, and send the

submission to CDER or CBER.

Manufacturers of biological products

may use the revised Form FDA 2253 or

may continue to use Form FDA 2567 for

the submission of advertisements and

promotional labeling to CBER.

Dated: June 2, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15192 Filed 6–8–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0503]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by July 9,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attention: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance.

New Animal Drug Application (NADA),

Form FDA 356 V, 21 CFR Part 514—

(OMB Control Number 0910–0032—

Reinstatement)

Under the Federal Food, Drug, and

Cosmetic Act (the act), FDA has the

responsibility for the approval of new

animal drugs that are safe and effective.

Section 512(b) of the act (21 U.S.C.

360b(b)), requires that a sponsor submit

and receive approval of a NADA before

interstate marketing is allowed. The

regulations implementing statutory

requirements for NADA approval have

been codified under 21 CFR part 514.

NADA applicants generally use a single

form, FDA 356 V. The NADA must

contain, among other things, safety and

effectiveness data for the drug, labeling,

a list of components, manufacturing and

controls information, and complete

information on any methods used to

determine residues of drug chemicals in

edible tissues. While the NADA is

pending, an amended application may

be submitted for proposed changes.

After a NADA has been approved, a

supplemental application must be

submitted for certain proposed changes,

including changes beyond the variations

provided for in the NADA and other

labeling changes. An amended

application and a supplemental

application may omit statements

concerning which no change is

proposed. This information is reviewed

by FDA scientific personnel to ensure

that the intended use of an animal drug,

whether as a pharmaceutical dosage

form, in drinking water, or in medicated

feed is safe and effective. The

respondents are pharmaceutical firms

that produce veterinary products and

commercial feed mills.

FDA estimates the burden for this

collection of information as follows:
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