Document ID: FDA-2013-N-0519-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; 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
Posted Date: 2016-10-04T04:00Z

[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Page 68434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23897]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0519]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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.

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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 
November 3, 2016.

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 emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0454. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

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 Information in Electronic Format 
to the Center for Veterinary Medicine Using the Food and Drug 
Administration Electronic Submission Gateway--21 CFR 11.2 OMB Control 
Number 0910-0454--Extension

    We accept 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. Our ability to 
receive and process information submitted electronically is limited by 
our current information technology capabilities and the requirements of 
the Electronic Records; Electronic Signatures final regulation. Our 
guidance entitled ``Guidance for Industry #108: 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 electronic information to CVM using the FDA 
Electronic Submission Gateway (ESG). The likely respondents are 
sponsors for new animal drug applications.
    In the Federal Register of April 8, 2016 (81 FR 20647), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment; however, it did 
not pertain to the information collection.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                           Number of
            21 CFR Section               FDA Form No.      Number of     responses per   Total annual     Average  burden per  response     Total hours
                                                          respondents     respondent       responses
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11.2..................................            3538              29             1.3              38  .08.............................             3.0
                                                                                                        (5 minutes).....................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimates on our experience with the submission of 
electronic information to us using the FDA ESG and the number of 
electronic registration or change requests received between January 1, 
2014, and December 31, 2014.

    Dated: September 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23897 Filed 10-3-16; 8:45 am]
 BILLING CODE 4164-01-P