38292 Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Notices

Dated: June 14, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–15429 Filed 6–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–0505]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Substances Prohibited From Use in

Animal Food or Feed; Animal Protein

Prohibited in Ruminant Feed

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 20,

2000.

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, Attn: Wendy

Taylor, 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 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Title: Substances Prohibited From Use

in Animal Food or Feed; Animal

Proteins Prohibited in Ruminant Feed—

21 CFR Part 589—(OMB Control No.

0910–0339)—Extension

Description: This rule (§ 589.2000 (21

CFR 589.2000)) provides that protein

derived from mammalian tissue (with

some exceptions) for use in ruminant

feed is a food additive subject to section

409 of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 348).

Proteins derived from animal tissues

contained in such feed ingredients in

distribution cannot be readily identified

(i.e., species), by recipients engaged in

the manufacture, processing and

distribution, and use of animal feeds

and feed ingredients.

Thus, under the agency’s authority in

section 701(a) of the act (21 U.S.C.

371(a)), to issue regulations for the

efficient enforcement of the act, this rule

places three general requirements on

persons that manufacture, blend,

process, distribute, or use products that

contain or may contain protein derived

from mammalian tissues and feeds

made from such products. The first

requirement is for cautionary labeling of

these products with direct language

developed by FDA. This labeling

requirement is exempt from the scope of

the PRA because it is a ‘‘public

disclosure of information originally

supplied by the Federal Government for

the purpose of disclosure to the public’’

(5 CFR 1329.3(c)(2)).

The second requirement is for

establishments to maintain and make

available to FDA, records that are

sufficient to track any material that

contains protein derived from

mammalian tissues (as defined in

§ 589.2000(a)(1)), throughout the

material’s receipt, processing, and

distribution. Based on available

information, FDA believes that

maintenance of these records is a usual

and customary part of normal business

practices for these firms. Therefore, this

recordkeeping requirement creates no

additional paperwork burden.

The third requirement is that

individuals or firms that manufacture,

blend, process, or distribute both

mammalian and nonmammalian

materials must maintain written

procedures to prevent commingling and

cross-contamination. An estimate of the

burden resulting from this

recordkeeping requirement is provided

in table 1 of this document. The

estimate is based on the time required

to develop written procedures.

Respondents to this collection of

information are individuals or firms that

manufacture, blend, process distribute,

or use feed or feed ingredients that

contain or may contain protein that may

be derived from mammalian tissue.

FDA estimates the burden of this

collection of information as follows:

TABLE1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Response

Total Annual

Records

Hours per

Record Total Hours

589.2000(e)(1)(iv) 1,030 1 1,030 14 14,420

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

The estimated number of respondents,

persons that separate mammalian and

nonmammalian materials, is derived

from inspections of firms handling

animal protein intended for use in

animal feed. The estimate of the time

required for this recordkeeping

requirement is based on agency records

and communication with industry.

Dated: June 14, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–15430 Filed 6–19–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Biological Response Modifiers

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration