Notices. Notice
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/register/2011/10/19/2011-27020A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4160-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0510] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget
(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by November 18, 2011. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, *Attn:* FDA Desk Officer, FAX: 202-395-7285, or e-mailed to *oira_submission@omb.eop.gov.* All comments should be identified with the OMB control number 0910-0627. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-7651, *juanmanuel.vilela@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Substances Prohibited From Use in Animal Food or Feed—21 CFR Part 589 (OMB Control Number 0910-0627)—(Extension) The final rule on bovine spongiform encephalopathy
(BSE)(73 FR 22720, April 25, 2008) prohibits the use of certain cattle origin materials in the food or feed of all animals to help prevent the spread of BSE in U.S. cattle. BSE is a progressive and fatal neurological disorder of cattle that results from an unconventional transmissible agent. BSE belongs to the family of diseases known as transmissible spongiform encephalopathies (TSEs). All TSEs affect the central nervous system of infected animals. These measures will further strengthen existing safeguards against BSE. In the **Federal Register** of July 28, 2011 (76 FR 45259), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received on the information collection. *Description of Recordkeeping for Respondents:* Rendering facilities, medicated feed manufacturers, livestock feeders. FDA estimates the burden of this collection of information as follows: Table 1—Estimated Annual Recordkeeping Burden 1 21 CFR Section Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeper Total hours Total operating & maintenance costs 589.2001 (c)(2)(vi) and (c)(3)(i) 175 1 175 20 3,500 $59,500 589.2001 (c)(2)(ii) 50 1 50 20 1,000 17,000 589.2001 (c)(3)(i)(A) 175 1 175 26 4,550 80,580 Total 9,050 157,080 1 There are no capital costs associated with this collection of information. The number of recordkeepers times the number of records per recordkeeper equals total annual records. Total annual records times average burden per recordkeeper equals total hours. *Description of Respondents for Reporting:* The final rule on BSE (73 FR 22720) included a provision that exempts cattle materials prohibited in animal feed (CMPAF) from designated countries from the prohibition on its use in animal feed (21 CFR 589.2001(b)(1)(vi)). A foreign country seeking this designation will submit a written request to FDA that includes a variety of information about the countries' BSE status (21 CFR 589.2001(f)). FDA estimates that 10 countries could submit a request to FDA to be exempted from CMPAF restrictions. FDA estimates the reporting burden for this information collection as follows: Table 2—Estimated One-Time and Recurring Reporting Burden 1 21 CFR Section Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 589.2001(b)(1) 2 10 1 10 80 800 589.2001(f) 10 1 10 26 260 1 There are no capital costs or operating costs associated with the collection of information. 2 One-time burden. Dated: October 14, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-27020 Filed 10-18-11; 8:45 am]
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- 21 CFR 589
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