65FR38292 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
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Posting-number: Volume 65, Issue 119, Page 38292
[Federal Register: June 20, 2000 (Volume 65, Number 119)]
[Notices]
[Page 38292]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jn00-80]
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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.
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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 (Sec. 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
Sec. 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 <SUP>1</SUP>
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Response Records Record
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589.2000(e)(1)(iv) 1,030 1 1,030 14 14,420
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\1\ There 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