[Federal Register Volume 85, Number 220 (Friday, November 13, 2020)]
[Notices]
[Pages 72671-72672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25131]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0052]


Documenting Electronic Data Files and Statistical Analysis 
Programs; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry (GFI) #197 entitled 
``Documenting Electronic Data Files and Statistical Analysis 
Programs.'' This guidance is intended to inform sponsors of 
recommendations for documenting electronic data files and statistical 
analyses submitted to the Center for Veterinary Medicine (CVM) to 
support new animal drug applications.

DATES: The announcement of the guidance is published in the Federal 
Register on November 13, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

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 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-2009-D-0052 for ``Documenting Electronic Data Files and Statistical 
Analysis Programs.'' Received comments 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, 240-
402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Virginia Recta, Center for Veterinary 
Medicine (HFV-160), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0840, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of GFI #197 entitled 
``Documenting Electronic Data Files and Statistical Analysis 
Programs.'' In the Federal Register of May 21, 2018 (83 FR 23468), FDA 
published the notice of availability for a draft guidance entitled 
``Documenting Electronic Data Files and Statistical Analysis 
Programs,'' giving interested persons until July 20, 2018, to comment 
on the draft guidance. On July 20, 2018, FDA published a notice of 
availability announcing the extension of the comment period to October 
18, 2018 (83 FR 34595). FDA received numerous comments on the draft 
guidance and these comments were considered as the guidance was 
finalized. The guidance announced in this notice finalizes the draft 
guidance dated May 2018.
    This guidance is intended to inform sponsors of recommendations for

[[Page 72672]]

documenting electronic data files and statistical analyses submitted to 
CVM to support new animal drug applications. These recommendations are 
intended to reduce the number of revisions that may be required for CVM 
to effectively review data submissions. They are also intended to 
simplify submission preparation for sponsors by providing a suggested 
documentation framework, including a sample structure on how to 
describe and organize the information regarding the electronic data 
files and statistical analysis programs.
    This Level I guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on ``Documenting Electronic Data Files and 
Statistical Analysis Programs.'' It does not establish any rights for 
any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required.
    However, this guidance refers to previously approved collections of 
information. These collections of information are subject to review by 
OMB under the PRA (44 U.S.C. 3501-3521). The collections of information 
in 21 CFR part 514 have been approved under OMB control number 0910-
0032.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry or https://www.regulations.gov.

    Dated: November 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25131 Filed 11-12-20; 8:45 am]
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