[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)]
[Notices]
[Pages 42124-42125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17858]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1558]


Food and Drug Administration's Evaluation of Approaches To 
Demonstrate Effectiveness of Heartworm Preventatives for Dogs; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments; 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 request for comments that appeared 
in the Federal Register of May 24, 2018. In the request for comments, 
FDA requested comments on the design of studies intended to generate 
data to support substantial evidence of effectiveness for 
investigational new animal drugs intended for the prevention of 
heartworm disease in dogs. The Agency is taking this action in response 
to requests for an extension to allow interested persons additional 
time to submit comments.

DATES: FDA is extending the comment period on the request for comments 
published May 24, 2018 (83 FR 24122). Submit either electronic or 
written comments by November 20, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 20, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 20, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <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-2018-N-1558 for ``FDA's Evaluation of Approaches to Demonstrate 
Effectiveness of Heartworm Preventatives for Dogs.'' Received comments, 
those filed in a timely manner (see ADDRESSES), 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.
    <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 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

[[Page 42125]]

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: 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#d7a4a3b2a1b2b9f9b1bbb2bea4b4bfb2a597b1b3b6f9bfbfa4f9b0b8a1"><span class="__cf_email__" data-cfemail="b0c3c4d5c6d5de9ed6dcd5d9c3d3d8d5c2f0d6d4d19ed8d8c39ed7dfc6">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 24, 2018, FDA 
published a request for comments with a 90-day comment period to 
request comments on the design of studies intended to generate data to 
support substantial evidence of effectiveness for investigational new 
animal drugs intended for the prevention of heartworm disease in dogs. 
Comments received will inform FDA's current thinking regarding the 
design of studies intended to generate data to support substantial 
evidence of effectiveness for investigational new animal drugs intended 
for the prevention of heartworm disease in dogs.
    The Agency has received a request for a 90-day extension of the 
comment period for the request for comments. The request conveyed 
concern that the current 90-day comment period does not allow 
sufficient time to develop a meaningful or thoughtful response to the 
request for comments.
    FDA has considered the request and is extending the comment period 
for the request for comments for 90 days, until November 20, 2018. The 
Agency believes that a 90-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
further action on these important issues.

    Dated: August 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17858 Filed 8-17-18; 8:45 am]
 BILLING CODE 4164-01-P


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