[Federal Register Volume 84, Number 199 (Tuesday, October 15, 2019)]
[Notices]
[Pages 55160-55161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4839]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Registering With the Center for Veterinary Medicine's Electronic 
Submission System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 14, 2019.

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 [email protected]. 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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

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 Registering With the Center for Veterinary 
Medicine's Electronic Submission System--21 CFR 11.2

OMB Control Number 0910-0454--Extension

    FDA's ``Electronic Records; Electronic Signatures'' regulation (21 
CFR part 11) requires that we identify in the Electronic Submission 
Docket (Docket No. FDA-1992-S-0039) the types of documents or parts of 
documents acceptable for official electronic submission. FDA's Center 
for Veterinary Medicine (CVM) has placed notifications in that docket 
identifying documents acceptable for electronic submission to the 
Center, 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 FDA's 
``Electronic Records; Electronic Signatures'' regulation.
    The FDA Electronic Submissions Gateway (ESG) is an Agency-wide 
solution for accepting electronic regulatory submissions. The FDA ESG 
enables the secure submission of premarket and postmarket regulatory 
information for review. The FDA ESG is the central transmission point 
for sending information electronically to FDA. Within that context, the 
FDA ESG is a conduit along which submissions travel to reach the proper 
FDA Center or Office. The CVM's Electronic Submission System (ESS) is a 
Center-wide solution for accepting electronic regulatory submissions. 
The CVM ESS is used to accept electronic submissions for animal and 
veterinary products.
    Our Guidance for Industry (GFI) #108 entitled ``Registering with 
the Center for Veterinary Medicine's Electronic Submission System'' 
outlines general standards to be used for the submission of any 
electronic information to CVM using the FDA ESG, including how to 
register with the CVM ESS using Form FDA 3538, ``Electronic Submission 
System Participant Management.'' Registering with the CVM ESS allows 
respondents to send electronic regulatory submissions to the Office of 
New Animal Drug Evaluation, the Office of Surveillance and Compliance's 
Division of Animal Feeds and Division of Surveillance, and the Office 
of Minor Use and Minor Species Animal Drug Development.
    Respondents use GFI #108 and Form FDA 3538 to facilitate the 
electronic submission of regulatory information. We use the information 
collected with Form FDA 3538 to register respondents to use the CVM 
ESS.
    Description of Respondents: The respondents are submitters of 
regulatory information to CVM.
    In the Federal Register of April 16, 2019 (84 FR 15621), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 55161]]



                                                     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..................  Form FDA 3538..................             193             1.3             251  0.08 (5 minutes)...............              20
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the 60-day notice published April 16, 2019, we based our 
estimate of 179 respondents per year on our experience with the 
submission of electronic information using the CVM ESS and the number 
of electronic registration or change requests received between January 
1, 2018, and November 30, 2018. We are now adjusting our estimate to 
193 respondents per year to better reflect the data for the time period 
January 1 to December 31, 2018. Using these new figures, our estimated 
burden for the information collection reflects an overall increase from 
the previous OMB approval of 17 hours and a corresponding increase of 
213 responses. We attribute this adjustment to the reauthorizations of 
both the Animal Drug User Fee Act and the Animal Generic Drug User Fee 
Act, which require sponsors to submit information electronically to the 
CVM's Office of New Animal Drug Evaluation. Because of this 
requirement, sponsors are now registering to use the CVM ESS in greater 
numbers than in previous years.

    Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22371 Filed 10-11-19; 8:45 am]
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