[Federal Register Volume 63, Number 184 (Wednesday, September 23, 1998)]
[Notices]
[Pages 50918-50919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25357]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0727]
Draft ``Guidance for Industry: Interpretation of On-farm Feed
Manufacturing and Mixing Operations''; Availability; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Interpretation of On-farm
Feed Manufacturing and Mixing Operations.'' The draft guidance is
intended to clarify the applicability of certain sections of the Animal
Proteins Prohibited from Use in Animal Feed regulation to ruminant
feeders. The agency is requesting comments on this draft guidance.
DATES: Submit written comments by November 23, 1998.
ADDRESSES: Submit written requests for single copies of this draft
guidance to the Communications Staff (HFV-12), Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your requests.
Submit written comments on the draft guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with
the full title of the draft guidance and the docket number found in
brackets in the heading of this document. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the draft
guidance.
FOR FURTHER INFORMATION CONTACT: Gloria J. Dunnavan, Center for
Veterinary Medicine (HFV-230), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1726, E-mail:
gdunnava@bangate.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 589.2000 Animal proteins prohibited from use in animal
feed (21 CFR 589.2000) defines ``feed manufacturer'' to include ``on-
farm feed manufacturing and mixing operation.'' This draft guidance
makes it clear that an operation that mixes, but does not manufacture
feed onfarm is not considered a feed manufacturer by FDA. Rather such
mixing operations are ruminant feeders. While all ruminant feeders are
subject to the regulation, the regulation imposes significantly
different requirements on ruminant feeders that are also ``feed
manufacturers.'' For this reason, FDA finds it necessary to clarify the
phrase ``on-farm feed manufacturing and mixing operations.''
FDA believes that a ruminant producer who mixes total mixed
rations (TMR's), a complete mix of the cow's daily diet, for the
animals under the producer's control is not
[[Page 50919]]
``manufacturing and mixing.'' This draft guidance provides our
rationale for this interpretation.
The agency has adopted Good Guidance Practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This draft guidance is issued as a Level 1 guidance consistent
with GGP's. If finalized, this document will represent current FDA
thinking on on-farm feed manufacturing and mixing operations and their
responsibilities under Sec. 589.2000. The guidance 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.
II. Comments
Interested persons should submit written comments on or before
November 23, 1998, to the Dockets Management Branch (address above)
regarding this draft guidance. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments should
be identified with the docket number found in brackets in the heading
of this document. A copy of the draft guidance and received comments
are available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
using the World Wide Web (WWW). For WWW access, connect to CVM at
``http://www.fda.gov/cvm''.
Dated: September 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-25357 Filed 9-22-98; 8:45 am]
BILLING CODE 4160-01-F
