[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availability of a draft guidance entitled ``Interpretation of On-farm 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 The draft guidance is 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 The agency is requesting comments on this draft guidance.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ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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     Submit written comments on the draft guidance to the Dockets 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the full title of the draft guidance and the docket number found in 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INFORMATION section for information on electronic access to the draft 
guidance.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: 
[email protected].

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 This draft guidance 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