Document ID: FDA-2018-D-0943-0008
Agency: fda
Document Type: Notice
Title: Elemental Impurities in Animal Drug Products—Questions and Answers;
Draft Guidance for Industry; Availability; Reopening of the Comment Period
Posted Date: 2018-08-15T04:00Z

[Federal Register Volume 83, Number 158 (Wednesday, August 15, 2018)]
[Notices]
[Pages 40524-40525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17525]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-0943]

Elemental Impurities in Animal Drug Products--Questions and 
Answers; Draft Guidance for Industry; Availability; Reopening of the 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is reopening 
the comment period for the notice of availability that published in the 
Federal Register on March 27, 2018. In that document, FDA requested 
comments on the draft guidance for industry (GFI) #255 entitled 
``Elemental Impurities in Animal Drug Products--Questions and 
Answers.'' The Agency is taking this action in response to requests for 
an extension to allow interested parties additional time to develop and 
submit comments.

DATES: FDA is reopening the comment period on the notice of 
availability published March 27, 2018 (83 FR 13134). Submit either 
electronic or written comments on the draft guidance by October 15, 
2018 to ensure that the Agency considers your comment on this draft 
guidance before it begins work on the final version of the guidance.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-2018-D-0943 for ``Elemental Impurities in Animal Drug Products--
Questions and Answers.'' 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

[[Page 40525]]

``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.
    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 draft 
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 draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Michael Brent, Center for Veterinary 
Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0647, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of March 27, 2018, FDA published a notice 
of availability with a 60-day comment period to request comments on 
draft GFI #255 entitled ``Elemental Impurities in Animal Drug 
Products--Questions and Answers.''
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the current thinking of FDA on 
``Elemental Impurities in Animal Drug Products--Questions and 
Answers'', providing recommendations to sponsors regarding the control 
of elemental impurities in animal drug products, including all dosage 
forms and routes of administration. 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. This guidance is not subject to Executive 
Order 12866.
    The Agency received two requests for an extension of the comment 
period for the draft guidance. The requestors indicated they needed 
more time to complete development of comments to submit in response to 
the draft guidance.
    FDA has considered the requests and is reopening the comment period 
for the draft guidance for 60 days, until October 15, 2018. The Agency 
believes that a 60-day reopening of the comment period allows adequate 
time for interested persons to submit comments to ensure that the 
Agency can consider the comments on this draft guidance before it 
begins work on the final version of the guidance.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or 
https://www.regulations.gov.

    Dated: August 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17525 Filed 8-14-18; 8:45 am]
 BILLING CODE 4164-01-P