03-25042. Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 (BSE) in the United States by ensuring that ruminant animal feed does not contain animal protein derived from mammalian tissue.

DATES:

Submit written or electronic comments on the collection of information by December 2, 2003.

ADDRESSES:

Submit electronic comments on the collection of information to http://www.fda.gov/​dockets/​ecomments. Submit written comments on the collection of information to the Division of Dockets Management (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 Management Programs (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 set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (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

Epidemiological evidence gathered in the United Kingdom suggests that BSE, a progressively degenerative central nervous system disease, is spread to ruminant animals by feeding protein derived from ruminants infected with BSE. While BSE has yet to be diagnosed in the United States, measures were necessary to prevent the establishment and amplification of this fatal disease in this country. Effective August 4, 1997, FDA amended its regulations in part 589 (21 CFR part 589) to create new § 589.2000 to regulate handlers of certain animal protein intended for use in ruminant feed. The regulation was designed to ensure that ruminant feed does not contain protein derived from mammalian tissue. It requires that firms that manufacture, blend, process or distribute both mammalian and nonmammalian materials intended for use in ruminant feed maintain written procedures to prevent commingling and cross-contamination of these materials.

Respondents to this collection of information are individuals or firms that manufacture, blend, process or 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:

Table 1.—Estimated Annual Recordkeeping Burden¹

21 CFR Section	No. of Recordkeepers	Annual Frequency of Recordkeeping	Total Annual Records	Hours per Record	Total Hours
589.2000(e)(1)(iv)	400	1	400	14	5,600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimated number of recordkeepers, i.e., 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 communication with industry.

Dated: September 25, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.