Document ID: FDA-2019-D-5664-0004
Agency: fda
Document Type: Notice
Title: Standardized Medicated Feed Assay Limits; Draft Guidance for Industry;
Availability; Extension of Comment Period
Posted Date: 2020-04-27T04:00Z

[Federal Register Volume 85, Number 81 (Monday, April 27, 2020)]
[Notices]
[Pages 23369-23370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08890]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5664]

Standardized Medicated Feed Assay Limits; Draft Guidance for 
Industry; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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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 February 27, 2020. In that notice, FDA requested 
comments on the draft guidance for industry (GFI) #264 entitled 
``Standardized Medicated Feed Assay Limits.'' 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 
February 27, 2020 (85 FR 11369). Submit either electronic or written 
comments on the draft guidance by June 26, 2020, to ensure that the 
Agency considers your comments on this draft guidance before it begins 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

[[Page 23370]]

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-2019-D-5664 for ``Standardized Medicated Feed Assay Limits.'' 
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 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: Katie Ciesienski, Center for 
Veterinary Medicine (HFV-141), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-0676, 
Katie.Ciesienski@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 27, 
2020, FDA published a notice announcing the availability of draft GFI 
#264 entitled ``Standardized Medicated Feed Assay Limits'' with a 60-
day comment period. This draft guidance recommends a standardized set 
of assay limits for medicated feeds. Standardized medicated feed assay 
limits allow predictability in the review process as the sponsor can 
determine early in the drug development process what assay limits they 
should expect to meet for medicated feeds used in Target Animal Safety, 
Effectiveness, Chemistry, Manufacturing, and Controls, Bioequivalence, 
and Human Food Safety residue chemistry studies. Assay limits are used 
pre-approval to ensure that medicated feeds in these studies contain 
the appropriate amount of drug, and post-approval for compliance and 
customer service purposes.
    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 60 days, until June 26, 2020. The 
Agency believes that a 60-day extension allows adequate time for 
interested persons to submit comments.

    Dated: April 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08890 Filed 4-24-20; 8:45 am]
BILLING CODE 4164-01-P