Notice2023-01031
Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Draft Guidance for Industry; Availability; Extension of Comment Period
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Published
January 20, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice announcing the availability of a draft guidance for industry that appeared in the Federal Register of November 30, 2022. In that notice, FDA requested comments on draft guidance for industry (GFI) #276 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Full Text
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<title>Federal Register, Volume 88 Issue 13 (Friday, January 20, 2023)</title>
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[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Notices]
[Pages 3743-3744]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-01031]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-2899]
Effectiveness of Anthelmintics: Specific Recommendations for
Products Proposed for the Prevention of Heartworm Disease in Dogs;
Draft Guidance for Industry; Availability; Extension of Comment Period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 the Agency) is
extending the comment period for the notice announcing the availability
of a
[[Page 3744]]
draft guidance for industry that appeared in the Federal Register of
November 30, 2022. In that notice, FDA requested comments on draft
guidance for industry (GFI) #276 entitled ``Effectiveness of
Anthelmintics: Specific Recommendations for Products Proposed for the
Prevention of Heartworm Disease in Dogs.'' 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 notice published
November 30, 2022 (87 FR 73560). Submit either electronic or written
comments by May 1, 2023, 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2022-D-2899 for ``Effectiveness of Anthelmintics: Specific
Recommendations for Products Proposed for the Prevention of Heartworm
Disease in Dogs.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Steven Fleischer, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-0809,
<a href="/cdn-cgi/l/email-protection#0c5f78697a6962224a6069657f6f64697e4c6a686d2264647f226b637a"><span class="__cf_email__" data-cfemail="d380a7b6a5b6bdfd95bfb6baa0b0bbb6a193b5b7b2fdbbbba0fdb4bca5">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of November 30,
2022, FDA published a notice announcing the availability of a draft
guidance for industry entitled ``Effectiveness of Anthelmintics:
Specific Recommendations for Products Proposed for the Prevention of
Heartworm Disease in Dogs,'' and requesting comments on the proposed
GFI.
Interested persons were originally given until January 30, 2023, to
comment on the document. The Agency has received a request for an
extension of the comment period. The request stated that an additional
90 days would allow interested parties to thoroughly consider the
request for input. FDA has considered the request and is extending the
comment period for the request for comments for 90 days, until May 1,
2023. The Agency believes that a 90-day extension allows adequate time
for interested persons to submit comments.
Dated: January 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01031 Filed 1-19-23; 8:45 am]
BILLING CODE 4164-01-P
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