Substances Prohibited From Use in Animal Food or Feed; Correction

Federal Register: October 23, 2008 (Volume 73, Number 206)

Rules and Regulations

Page 63072-63073

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr23oc08-6

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Part 589

Docket No. FDA-2002-N-0031

(formerly Docket No. 2002N-0273)

RIN 0910-AF46

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.

Page 63073

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: burt.pritchett@fda.hhs.gov.

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

Operation and 21 CFR Section

No. of

Annual Frequency

Total Annual

Hours per

Total Hours

Maintenance

Recordkeepers per Recordkeeper

Records

Recordkeeper

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.

FR Doc. E8-25346 Filed 10-22-08; 8:45 am

BILLING CODE 4160-01-S