Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How to Use E-mail to Submit Information to the Center for Veterinary Medicine, 7044-7045 [E7-2470]

Download as PDF 7044 Federal Register / Vol. 72, No. 30 / Wednesday, February 14, 2007 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Responses Total Hours Total Operating & Maintenance Costs 42 CFR 493.17 60 15 900 1 hr 900 hr $45,000 Total 60 15 900 1 hr 900 hr $45,000 1 There are no capital costs associated with this collection of information. The number of respondents is approximately 60. On average, each respondent will request categorizations (independent of a 510(k) or PMA) 15 times per year. The cost, not including personnel, is estimated at $50. Thisincludes the cost of copying and mailing copies of package inserts and a cover letter, which includes a statement of the reason for the request and reference to the original 510(k) numbers, including regulation numbers and product codes. Dated: February 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–2468 Filed 2–13–07; 8:45 am] Dated: February 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–2469 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 [Docket No. 2006N–0203] Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; User Fee Cover Sheet; Form FDA 3397 AGENCY: Food and Drug Administration, HHS. ycherry on PROD1PC64 with PRELIMS ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘User Fee Cover Sheet; Form FDA 3397’’ 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. SUPPLEMENTARY INFORMATION: In the Federal Register of August 29, 2006 (71 FR 51195), the agency announced that VerDate Aug<31>2005 17:27 Feb 13, 2007 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, 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 0910–0297. 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. Jkt 211001 [Docket No. 2006N–0432] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How to Use E-mail to Submit Information 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 March 16, 2007. ADDRESSES: To ensure that comments on the information collection are received, PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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. 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 Information to the Center for Veterinary Medicine—21 CFR 11.2 (OMB Control Number 0910– 0454)—Extension The Center for Veterinary Medicine (CVM) accepts certain types of submissions electronically with no requirement for a paper copy. These types of documents are listed in public docket 1992S–0251 as required by 21 CFR 11.2. CVM’s ability to receive and process information submitted electronically is limited by its current information technology capabilities and the requirements of the Electronic Records; Electronic Signatures final regulation. CVM’s guidance entitled ‘‘Guidance for Industry #108: How to Submit Information in Electronic Format by E-Mail’’ outlines general standards to be used for the submission of any information by e-mail. In the Federal Register of November 8, 2006 (71 FR 65533), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. The likely respondents for this collection of information are sponsors for new animal drug applications. FDA estimates the burden for this collection of information as follows: E:\FR\FM\14FEN1.SGM 14FEN1 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

Agencies

[Federal Register Volume 72, Number 30 (Wednesday, February 14, 2007)]
[Notices]
[Pages 7044-7045]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2470]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0432]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on How to Use E-mail to Submit Information 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 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 Information to the 
Center for Veterinary Medicine--21 CFR 11.2 (OMB Control Number 0910-
0454)--Extension

    The Center for Veterinary Medicine (CVM) accepts certain types of 
submissions electronically with no requirement for a paper copy. These 
types of documents are listed in public docket 1992S-0251 as required 
by 21 CFR 11.2. CVM's ability to receive and process information 
submitted electronically is limited by its current information 
technology capabilities and the requirements of the Electronic Records; 
Electronic Signatures final regulation. CVM's guidance entitled 
``Guidance for Industry 108: How to Submit Information in 
Electronic Format by E-Mail'' outlines general standards to be used for 
the submission of any information by e-mail.
    In the Federal Register of November 8, 2006 (71 FR 65533), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    The likely respondents for this collection of information are 
sponsors for new animal drug applications.
    FDA estimates the burden for this collection of information as 
follows:

[[Page 7045]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response       Responses\2\         Response         Total Hours
----------------------------------------------------------------------------------------------------------------
11.2                              25               5.62                140                .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]
BILLING CODE 4160-01-S
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