Food and Drug Administration, HHS.
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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements for the information collection activity “How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter In Electronic Format to the Center for Veterinary Medicine.”
Submit written or electronic comments on the collection of information by April 6, 2010.
Submit electronic comments on the collection of information to http://www.regulations.gov. 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.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3793.End Further Info End Preamble Start Supplemental 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.Start Printed Page 6038
Guidance for Industry on How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter in Electronic Format to the Center for Veterinary Medicine—21 CFR 514.117(b)(2) and 21 CFR 511.1(b)(5); (OMB Control Number 0910-0453)—Extension
The Center for Veterinary Medicine (CVM) monitors the final disposition of investigational animals where such animals do not enter the human food chain immediately at the completion of an investigational study. CVM's monitoring of the final disposition of investigational food animals is intended to ensure that unsafe residues of new animal drugs do not get into the food supply. CVM issues a slaughter authorization letter to investigational new animal drug (INAD) sponsors that sets the terms under which investigational animals may be slaughtered (21 CFR 511.1(b)(5)). Also in the letter, CVM requests that sponsors submit a notice of final disposition of investigational animals (NFDA) not intended for immediate slaughter. NFDAs have historically been submitted to CVM on paper. CVM's guidance entitled “How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter in Electronic Format to CVM,” provides sponsors with an option to submit an NFDA as an e-mail attachment to CVM via the Internet.
The likely respondents are INAD sponsors.
FDA estimates the burden of this collection of information as follows:
|21 CFR Section/Form No. 3487||No. of Respondents||Annual Frequency per Response||Total Annual Responses2||Hours per Response||Total Hours|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
|2 Electronic submissions received between January 1, 2008, and December 31, 2008.|
The number of respondents in table 1 of this document are the number of sponsors registered to make electronic submissions (40). The number of total annual responses is based on a review of the actual number of such submissions made between January 1, 2008, and December 31, 2008. Thus, FDA estimates the total reporting burden at 1.3 hours (16 x .08 = 1.3 total hours).Start Signature
Dated: January 29, 2010.
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-2527 Filed 2-4-10; 8:45 am]
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