[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Answers; Draft Guidance for Industry; Availability; Reopening of the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comments on the draft guidance for industry (GFI) #255 entitled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electronic or written comments on the draft guidance by October 15,
2018 to ensure that the Agency considers your comment on this draft
guidance before it begins work on the final version of the guidance.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]
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