[Federal Register Volume 84, Number 73 (Tuesday, April 16, 2019)]
[Notices]
[Pages 15621-15623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07468]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (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 information collection 
provisions of the Center for Veterinary Medicine (CVM) Guidance for 
Industry (GFI) #108 entitled ``Registering with CVM's Electronic 
Submission System.''

DATES: Submit either electronic or written comments on the collection 
of information by June 17, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 17, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 17, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you

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do not wish to be made available to the public, submit the comment as a 
written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-4839 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Guidance for Industry on 
Registering with the Center for Veterinary Medicine's Electronic 
Submission System.'' Received comments, those filed in a timely manner 
(see ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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.

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 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. 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 entitled ``Guidance for Industry (GFI) #108: 
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 Form.
    The reporting associated with new animal drug applications and 
related submissions is necessary to ensure that new animal drugs are in 
compliance with section 512(b)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(b)(1)). We use the information collected 
to review the data, labeling and manufacturing controls and procedures 
to evaluate the safety and effectiveness of the proposed new animal 
drug. The reporting associated with new animal drug applications is 
approved under OMB control number 0910-0032. Respondents use GFI #108

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and Form FDA 3538 to facilitate the electronic submission of such 
information. We use the information collected with Form FDA 3538 to 
register respondents to use the CVM ESS.
    Description of Respondents: The respondents are sponsors of new 
animal drug applications.
    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        Total hours
                                                                respondents     respondent       responses             response
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11.2............................  Form FDA 3538.............             179             1.3             233  .08 (5 minutes)...........              19
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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 using the CVM ESS and the number of electronic 
registration or change requests received between January 1, 2018, and 
November 30, 2018. Our estimated burden for the information collection 
reflects an overall increase of 16 hours and a corresponding increase 
of 195 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: April 10, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-07468 Filed 4-15-19; 8:45 am]
 BILLING CODE 4164-01-P