Agency Information Collection Activities; Submission for Office and Management and Budget Review; Comment Request; 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, 22598 [2010-9901]

Download as PDF 22598 Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Notices Dated: April 23, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. 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 0910–0453. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: [FR Doc. 2010–9902 Filed 4–28–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0034] Agency Information Collection Activities; Submission for Office and Management and Budget Review; Comment Request; 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 AGENCY: 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. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Food and Drug Administration, HHS. ACTION: Notice. 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—(OMB Control Number 0910–0453)—Extension 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 June 1, 2010. 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: The Center for Veterinary Medicine (CVM) monitors the final disposition of investigational animals where such TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section/ Form No. 3487 Number of Respondents 511.1(b)(5) 1 There Annual Frequency per Response 40 Total Annual Responses 2 0.4 Hours per Response 16 Total Hours .08 1.3 are no capital or operating and maintenance costs associated with this collection of information. submissions received between January 1, 2008, and December 31, 2008. 2 Electronic mstockstill on DSKH9S0YB1PROD with NOTICES 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). Dated: April 23, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–9901 Filed 4–28–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0055] Agency Information Collection Activities; Submission for Office and Management and Budget Review; Comment Request; Guidance for Industry on How to Submit a Protocol Without Data in Electronic Format to the Center for Veterinary Medicine 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 VerDate Mar<15>2010 16:19 Apr 28, 2010 Jkt 220001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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 June 1, 2010. 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 0910–0524. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of Information E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 75, Number 82 (Thursday, April 29, 2010)]
[Notices]
[Page 22598]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9901]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0034]


Agency Information Collection Activities; Submission for Office 
and Management and Budget Review; Comment Request; 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

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 June 
1, 2010.

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 0910-0453. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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.

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.

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--(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:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Number of        Annual Frequency       Total Annual
         21 CFR Section/  Form No. 3487             Respondents         per Response         Responses \2\      Hours per  Response      Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
511.1(b)(5)                                                     40                  0.4                    16                   .08                  1.3
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital 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).

    Dated: April 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9901 Filed 4-28-10; 8:45 am]
BILLING CODE 4160-01-S
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