
[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]                         

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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.

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