E8-25346. Substances Prohibited From Use in Animal Food or Feed; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 25, 2008 (73 FR 22720). The document amended the agency's regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals to further strengthen existing safeguards against bovine spongiform encephalopathy (BSE). The document was inadvertently published with incorrect dollar amounts in two separate areas: The summary of economic impacts and the paperwork burden table. This document corrects those errors.

DATES:

Effective on April 27, 2009.

FOR FURTHER INFORMATION CONTACT:

Burt Pritchett, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6860, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

In the Federal Register of April 25, 2008, incorrect dollar amounts were published in the document with respect to: (1) The summary of economic impacts and (2) the paperwork burden table. Regarding the economic impact of the rule, a dollar figure of $58 million was cited as the estimated loss in annual surplus caused by import restrictions imposed on U.S. products by other countries; the correct figure is approximately $105 million. Regarding the paperwork burden table (Table 9), the estimated total operation and maintenance costs for annual recordkeeping was incorrectly cited as $157,080. The estimated cost per renderer should be $354.20, so the estimated total operation and maintenance costs for annual recordkeeping is actually $160,275.

Therefore, in FR Doc. 08-1180, appearing on page 22720 in the Federal Register of Friday, April 25, 2008, the following corrections are made to the SUPPLEMENTARY INFORMATION:

1. On page 22737, in the first column, in the last sentence preceding the first full paragraph, “Although we are unable to quantify the effects of this final rule on removing restrictions to foreign markets, the benefits are potentially large because the economy as a whole loses an annual surplus equal to about $58 million from the remaining restrictions.” is corrected to read:

“Although we are unable to quantify the effects of this final rule on removing restrictions to foreign markets, the benefits are potentially large because the economy as a whole loses an annual surplus equal to about $105 million from the remaining restrictions.”

2. On page 22753, table 9 is corrected to read:

Table 9.—Estimated Annual Recordkeeping Burden

21 CFR Section	No. of Recordkeepers	Annual Frequency per Recordkeeper	Total Annual Records	Hours per Recordkeeper	Total Hours	Operation and Maintenance Costs
589.2001(c)(2)(vi) and (c)(3)(i)	175	1	175	20	3,500	$61,985
589.2001(c)(2)(ii)	50	1	50	20	1,000	$17,710
589.2001(c)(3)(i)(A)	175	1	175	26	4,550	$80,580
Total					9,050	$160,275

3. On page 22753, in the third column, following table 9, the second complete sentence “Therefore, FDA estimates that the cost per renderer for compliance with the new requirement for establishing and maintaining written procedures will be $340 per renderer, hence the new figure of $17,000 as shown in Table 9 of this document.” is corrected to read:

“Therefore, FDA estimates that the cost per renderer for compliance with the new requirement for establishing and maintaining written procedures will be $354.20 per renderer (adjusted for inflation since the October 2005 proposed rule), hence the new figure of $17,710 as shown in Table 9 of this document.”

Dated: October 16, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.