Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; How to Use E-mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter, 7045-7046 [E7-2485]

Download as PDF 7045 Federal Register / Vol. 72, No. 30 / Wednesday, February 14, 2007 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section Annual Frequency per Response 11.2 25 Total Annual Responses2 5.62 Hours per Response 140 Total Hours .08 11.2 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Electronic submissions received between July 1, 2005, and June 30, 2006. The number of respondents in table 1 of this document is the number of sponsors registered to make electronic submissions (25). The number of total annual responses is based on a review of the actual number of such submissions made between July 1, 2005, and June 30, 3006. (140 x hours per response (.08) = 11.2 total hours.) Dated: February 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–2470 Filed 2–13–07; 8:45 am] a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0331. The approval expires on January 31, 2010. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. Dated: February 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–2480 Filed 2–13–07; 8:45 am] BILLING CODE 4160–01–S BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. 2006N–0277] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Labeling; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION: In the Federal Register of December 1, 2006 (71 FR 69569), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, SUPPLEMENTARY INFORMATION: ycherry on PROD1PC64 with PRELIMS Food and Drug Administration, HHS. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Food Labeling; Notification Procedures for Statements on Dietary Supplements’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. 17:27 Feb 13, 2007 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; How to Use E-mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter AGENCY: Notice. VerDate Aug<31>2005 [Docket No. 2006N–0433] Jkt 211001 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 March 16, 2007. 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: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA–250), Food PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. 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: Guidance for Industry on How to Use E-mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter—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 the 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 this letter, CVM requests that sponsors submit a notice of final disposition of investigational animals not intended for immediate slaughter (NFDA). NFDAs have historically been submitted to CVM on paper. CVM’s guidance on ‘‘How to Use E-mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter’’ provides sponsors with the option to submit an NFDA as an e-mail attachment to CVM via the Internet. In the Federal Register of November 9, 2006 (71 FR 65827), FDA published a 60-day notice soliciting public comment on the proposed collection of information requirements. In response to that notice, no comments were received. The likely respondents for this collection are are INAD sponsors. FDA estimates the burden of this collection of information as follows: E:\FR\FM\14FEN1.SGM 14FEN1 7046 Federal Register / Vol. 72, No. 30 / Wednesday, February 14, 2007 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section / Form No. 511.1(b)(5)/ Form FDA 3487 Annual Frequency per Response 25 Total Annual Responses2 1.44 Hours per Response 36 .08 Total Hours 2.88 1There are no capital costs or operating and maintenance costs associated with this collection of information. 2Electronic submissions received between July 1, 2005, and June 30, 2006. The number of respondents in Table 1 are the number of sponsors registered to make electronic submissions (25). The number of total annual responses is based on a review of the actual number of such submissions made between July 1, 2005, and June 30, 2006. (36 x hours per response (.08) = 2.88 total hours). 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: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. 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: ADDRESSES: Dated: February 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–2485 Filed 2–13–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Export of Medical Devices-Foreign Letters of Approval (OMB Control Number 0910–0264)—Extension Section 801(e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381(e)(2)) provides for the exportation of an unapproved device under certain circumstances if the exportation is not contrary to the public health and safety and it has the approval of the foreign country to which it is intended for export. Requesters communicate (either directly or through a business associate in the foreign country) with a representative of the foreign government to which they seek exportation, and written authorization must be obtained from the appropriate office within the foreign government approving the importation of the medical device. An alternative to obtaining written authorization from the foreign [Docket No. 2006N–0380] Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices-Foreign Letters of Approval 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 March 16, 2007. government is to accept a notarized certification from a responsible company official in the United States that the product is not in conflict with the foreign country’s laws. This certification must include a statement acknowledging that the responsible company official making the certification is subject to the provisions of 18 U.S.C. 1001. This statutory provision makes it a criminal offense to knowingly and willingly make a false or fraudulent statement, or make or use a false document, in any manner within the jurisdiction of a department or agency of the United States. FDA uses the written authorization from the foreign country or the certification from a responsible company official in the United States to determine whether the foreign country has any objection to the importation of the device into their country. In the Federal Register of September 22, 2006 (71 FR 55487), FDA published a 60-day notice soliciting public comments on the proposed information collection provisions for this requirement. In response to this notice, no comments were received. The agency is also correcting an error. The operating and maintenance cost, which was inadvertently omitted in the burden table for the 60-day notice, has been added as a column to the burden table for this notice. The respondents to this collection of information are companies that seek to export medical devices. FDA estimates the reporting burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section 801(e)2 ycherry on PROD1PC64 with PRELIMS 1There Annual Frequency Per Response No. of Respondents 25 Total Annual Responses 1 Hours per Response Total Hours Total Operating & Maintenance Costs 2.5 62.5 $6,250 25 are no capital costs associated with this collection of information. These estimates are based on the experience of FDA’s medical device program personnel. There are no capital costs associated with this collection of information. In addition, the respondent’s costs of submission of a VerDate Aug<31>2005 17:27 Feb 13, 2007 Jkt 211001 request to the foreign country for approval to import into that country, and subsequent submission of such approval to FDA, vary and are considered operating and maintenance costs. On average, it appears that it can PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 cost a requester approximately $125 per page of translation. From review of our records, it appears that foreign approval letters average two pages. Therefore, the ‘‘other’’ estimated cost to requestors for processing a foreign approval letter is E:\FR\FM\14FEN1.SGM 14FEN1

Agencies

[Federal Register Volume 72, Number 30 (Wednesday, February 14, 2007)]
[Notices]
[Pages 7045-7046]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2485]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0433]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; How to Use E-mail to 
Submit a Notice of Final Disposition of Animals Not Intended for 
Immediate Slaughter

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 March 
16, 2007.

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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 Use E-mail to Submit a Notice of Final 
Disposition of Animals Not Intended for Immediate Slaughter--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 the 
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 this letter, CVM 
requests that sponsors submit a notice of final disposition of 
investigational animals not intended for immediate slaughter (NFDA). 
NFDAs have historically been submitted to CVM on paper. CVM's guidance 
on ``How to Use E-mail to Submit a Notice of Final Disposition of 
Animals Not Intended for Immediate Slaughter'' provides sponsors with 
the option to submit an NFDA as an e-mail attachment to CVM via the 
Internet.
    In the Federal Register of November 9, 2006 (71 FR 65827), FDA 
published a 60-day notice soliciting public comment on the proposed 
collection of information requirements. In response to that notice, no 
comments were received.
    The likely respondents for this collection are are INAD sponsors.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 7046]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
 21 CFR Section /      No. of       Annual Frequency     Total Annual
     Form No.        Respondents      per Response       Responses\2\     Hours per Response      Total Hours
----------------------------------------------------------------------------------------------------------------
511.1(b)(5)/ Form              25               1.44                 36                   .08               2.88
 FDA 3487
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\Electronic submissions received between July 1, 2005, and June 30, 2006.

    The number of respondents in Table 1 are the number of sponsors 
registered to make electronic submissions (25). The number of total 
annual responses is based on a review of the actual number of such 
submissions made between July 1, 2005, and June 30, 2006. (36 x hours 
per response (.08) = 2.88 total hours).

    Dated: February 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2485 Filed 2-13-07; 8:45 am]
BILLING CODE 4160-01-S
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