Document ID: FDA-2022-D-2899-0005
Agency: fda
Document Type: Notice
Title: 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of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Draft Guidance for Industry; Availability;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
Posted Date: 2023-01-20T05:00Z

[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Notices]
[Pages 3743-3744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Draft Guidance for Industry; Availability; Extension of Comment Period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draft guidance for industry that appeared in the Federal Register of 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 In that notice, FDA requested comments on draft 
guidance for industry (GFI) #276 entitled ``Effectiveness of 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comment on this draft guidance before it begins work on the final 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:
     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-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 https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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, 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, 
[email protected].

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