[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34595-34596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15568]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Documenting Electronic Data Files and Statistical Analysis 
Programs; Draft Guidance for Industry; Availability; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is extending 
the comment period for the notice of availability that published in the 
Federal Register on May 21, 2018. In that document, FDA requested 
comments on the draft revised guidance for industry (GFI) #197 entitled 
``Documenting Electronic Data Files and Statistical Analysis 
Programs.'' The Agency is taking this action in response to a request 
for an extension to allow interested persons additional time to submit 
comments.

DATES: FDA is extending the comment period on the document published 
May 21, 2018 (83 FR 23468). Submit either electronic or written 
comments on the draft revised guidance by October 18, 2018, to ensure 
that the Agency considers your comment on this draft guidance before it 
begins work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance 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.
     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

[[Page 34596]]

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: 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: In the Federal Register of May 21, 2018, FDA 
published a notice announcing the availability of draft revised GFI 
#197 entitled ``Documenting Electronic Data Files and Statistical 
Analysis Programs'' with a 60-day comment period. We requested comments 
about informing sponsors of recommendations for 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 and to simplify submission preparation by 
providing a recommended documentation framework.
    The Agency has received a request for a 90-day extension of the 
comment period. The request conveyed concern that the current 60-day 
comment period does not allow sufficient time to develop a 
comprehensive response.
    FDA has considered the request and is extending the comment period 
for the notice of availability for 90 days, until October 18, 2018. The 
Agency believes that a 90-day extension allows adequate time for 
interested persons to submit comments.

    Dated: July 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15568 Filed 7-19-18; 8:45 am]
 BILLING CODE 4164-01-P