Document ID: FDA-2018-D-4533-0614
Agency: fda
Document Type: Notice
Title: Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance
for Industry; Availability; Reopening of Comment Period
Posted Date: 2020-02-20T05:00Z

[Federal Register Volume 85, Number 34 (Thursday, February 20, 2020)]
[Notices]
[Pages 9783-9784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03312]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4533]

Compounding Animal Drugs From Bulk Drug Substances; Draft 
Guidance for Industry; Availability; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period for the notice of availability that 
published in the Federal Register on November 20, 2019. In that notice, 
FDA requested comments on the draft guidance for industry (GFI) #256 
entitled ``Compounding Animal Drugs from Bulk Drug Substances.'' FDA is 
reopening the comment period to update comments and to receive any new 
information.

DATES: FDA is reopening the comment period on the document published 
November 20, 2019 (84 FR 64085). Submit either electronic or written 
comments on the draft guidance by June 17, 2020, to ensure that the 
Agency considers your comments on this draft guidance before it begins 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-2018-D-4533 for ``Compounding Animal Drugs From Bulk Drug 
Substances.'' 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.

[[Page 9784]]

     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.

FOR FURTHER INFORMATION CONTACT: Eric Nelson, Division of Compliance 
(HFV-230), Center for Veterinary Medicine, Food and Drug 
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-7001, 
cvmcompliance@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 20, 
2019, FDA published a notice announcing the availability of draft GFI 
#256 entitled ``Compounding Animal Drugs From Bulk Drug Substances'' 
with a 90-day comment period. We requested comments on the draft 
guidance with respect to animal drug compounding from bulk drug 
substances under certain circumstances when no other medically 
appropriate treatment option exists.
    Interested persons were originally given until February 18, 2020, 
to comment on the draft guidance.
    The Agency has received several requests to allow interested 
persons additional time to comment. The requests conveyed concern that 
the current 90-day comment period does not allow sufficient time to 
develop a comprehensive response.
    FDA has considered the requests and is reopening the comment period 
for the notice of availability for 120 days, until June 17, 2020. The 
Agency believes that a 120-day reopening allows adequate time for 
interested persons to submit comments.

    Dated: February 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03312 Filed 2-19-20; 8:45 am]
 BILLING CODE 4164-01-P