[Federal Register Volume 65, Number 35 (Tuesday, February 22, 2000)]
[Notices]
[Pages 8714-8715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-0505]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension for an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the recordkeeping requirements 
placed on handlers of ruminant protein to prevent the establishment and 
amplification of bovine spongiform encephalopathy in the United States 
by ensuring that ruminant animal feed does not contain animal protein 
derived from mammalian tissue.

DATES:  Submit written comments on the collection of information by 
April 24, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506 (c)(2)(A) of the PRA (44 U.S.C. 
3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in 
the Federal Register concerning each proposed collection of 
information, including each proposed extension of an existing 
collection of information, before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information listed below.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Substances Prohibited From Use in Animal Food or Feed; Animal 
Proteins Prohibited in Ruminant Feed--21 CFR Part 589 (OMB Control 
Number 0910-0339--Extension)

    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 recipents 
engaged in the manufacture, processing, 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

[[Page 8715]]

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 Burden1
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                                                      Annual
         21 CFR Section              Number of     frequency per   Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      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: February 14, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-4023 Filed 2-18-00; 8:45 am]
BILLING CODE 4160-01-F