Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the Food and Drug Administration Electronic Submission Gateway, 6038-6039 [2010-2523]

Download as PDF 6038 Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Notices 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: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section/Form No. 3487 No. of Respondents 511.1(b)(5) 1 There Annual Frequency per Response 40 Total Annual Responses2 0.4 Hours per Response 16 Total Hours .08 1.3 are no capital costs or operating and maintenance costs associated with this collection of information. submissions received between January 1, 2008, and December 31, 2008. 2 Electronic 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: January 29, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2010–2527 Filed 2–4–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0057] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the Food and Drug Administration Electronic Submission Gateway srobinson on DSKHWCL6B1PROD with NOTICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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 VerDate Nov<24>2008 16:26 Feb 04, 2010 Jkt 220001 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 Center for Veterinary Medicine’s (CVM’s) ‘‘Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Gateway.’’ DATES: Submit written or electronic comments on the collection of information by April 6, 2010. ADDRESSES: Submit electronic comments on the collection of information to https:// 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. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3793. SUPPLEMENTARY 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 PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 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. E:\FR\FM\05FEN1.SGM 05FEN1 6039 Federal Register / Vol. 75, No. 24 / Friday, February 5, 2010 / Notices Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Submission Gateway—21 CFR 11.2 (OMB Control Number 0910–0454)— Extension) requirement for a paper copy. These types of documents are listed in public docket 97S–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 CVM accepts certain types of submissions electronically with no ‘‘Guidance for Industry: How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway’’ outlines general standards to be used for the submission of any information by e-mail. The likely respondents are sponsors for new animal drug applications. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section/FDA Form 3538 No. of Respondents 11.2 1 There Annual Frequency per Response 40 Total Annual Responses2 1.3 Hours per Response 52 Total Hours .08 4.2 are no capital costs or operating and maintenance costs associated with this collection of information. submissions received between July 1, 2005, and June 30, 2006. 2 Electronic The number of respondents in table 1 of this document is 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, (52 x hours per response (.08) =4.2 total hours). Dated: January 29, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Contact Person: Peter Kozel, PhD, Scientific Review Officer, NCCAM, 6707 Democracy Boulevard, Suite 401, Bethesda, MD 20892–5475, 301–496–8004, kozelp@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.213, Research and Training in Complementary and Alternative Medicine, National Institutes of Health, HHS) Dated: January 29, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–2523 Filed 2–4–10; 8:45 am] BILLING CODE 4160–01–S [FR Doc. 2010–2557 Filed 2–4–10; 8:45 am] Date: March 11, 2010. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Gaylord National Hotel & Convention Center, 201 Waterfront Street, National Harbor, MD 20745. Contact Person: John K. Hayes, PhD, Scientific Review Officer, 6707 Democracy Boulevard, Suite 959, Democracy Two, Bethesda, MD 20892, 301–451–3398, hayesj@mail.nih.gov. Dated: February 1, 2010 Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–2562 Filed 2–4–10; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health srobinson on DSKHWCL6B1PROD with NOTICES National Center for Complementary & Alternative Medicine; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Center for Complementary and Alternative Medicine Special Emphasis Panel Training. Date: March 1, 2010. Time: 8 a.m. to 5 p.m. VerDate Nov<24>2008 16:26 Feb 04, 2010 Jkt 220001 National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special; 2010/05 SBIR Review. PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: Neurodevices, Bioengineering and Biomodeling. Date: February 24, 2010. E:\FR\FM\05FEN1.SGM 05FEN1

Agencies

[Federal Register Volume 75, Number 24 (Friday, February 5, 2010)]
[Notices]
[Pages 6038-6039]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-2523]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0057]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry on How to Submit Information in 
Electronic Format to the Center for Veterinary Medicine Using the Food 
and Drug Administration Electronic Submission Gateway

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: 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 Center for Veterinary Medicine's (CVM's) ``Guidance for Industry on 
How to Submit Information in Electronic Format to the Center for 
Veterinary Medicine Using the FDA Electronic Gateway.''

DATES: Submit written or electronic comments on the collection of 
information by April 6, 2010.

ADDRESSES: Submit electronic comments on the collection of information 
to https://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.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

SUPPLEMENTARY 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.

[[Page 6039]]

Guidance for Industry on How to Submit Information in Electronic Format 
to the Center for Veterinary Medicine Using the FDA Electronic 
Submission Gateway--21 CFR 11.2 (OMB Control Number 0910-0454)--
Extension)

    CVM accepts certain types of submissions electronically with no 
requirement for a paper copy. These types of documents are listed in 
public docket 97S-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: How to Submit Information in 
Electronic Format to CVM Using the FDA Electronic Submission Gateway'' 
outlines general standards to be used for the submission of any 
information by e-mail.
    The likely respondents are sponsors for new animal drug 
applications.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
 21 CFR Section/         No. of        Annual Frequency     Total Annual        Hours per
  FDA Form 3538       Respondents        per Response       Responses\2\         Response         Total Hours
----------------------------------------------------------------------------------------------------------------
11.2                              40                1.3                 52                .08                4.2
----------------------------------------------------------------------------------------------------------------
\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 (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, 
(52 x hours per response (.08) =4.2 total hours).

    Dated: January 29, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-2523 Filed 2-4-10; 8:45 am]
BILLING CODE 4160-01-S
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