[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Notices]
[Pages 40071-40072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17258]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2281]


Incorporating Alternative Approaches in Clinical Investigations 
for New Animal Drugs; Public Meeting; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
extending the comment period for the notice of public meeting entitled 
``Incorporating Alternative Approaches in Clinical Investigations for 
New Animal Drugs; Public Meeting; Request for Comments'' that appeared 
in the Federal Register of July 9, 2019. In the notice of public 
meeting, FDA requested comments on the use of complex adaptive and 
other novel investigation designs, data from foreign countries, real 
world evidence, and biomarkers and surrogate endpoints in animal drug 
development and regulatory decision making. 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 of public 
meeting published July 9, 2019 (84 FR 32749). Submit either electronic 
or written comments by September 16, 2019.

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 September 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 16, 2019. 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:
     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-2019-N-2281 for ``Incorporating Alternative Approaches in Clinical 
Investigations for New Animal Drugs; Public Meeting; Request for 
Comments.'' 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.
     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

[[Page 40072]]

``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.

FOR FURTHER INFORMATION CONTACT: Susan Storey, Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl. (HFV-131), 
Rockville, MD, 20855, 240-402-0578, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of July 9, 2019 (84 
FR 32749), FDA published a notice of public meeting and request for 
comment with a 30-day comment period to request comments on the use of 
complex adaptive and other novel investigation designs, data from 
foreign countries, real world evidence, and biomarkers and surrogate 
endpoints in animal drug development and regulatory decision making. 
Comments are intended to support FDA guidance development as required 
under section 305 of the Animal Drug and Animal Generic Drug User Fee 
Amendments of 2018 (Pub. L. 115-234). Section 305 directs FDA to 
develop guidance to address several alternative approaches in clinical 
investigations for new animal drugs.
    The Agency has received a request for a 30-day extension of the 
comment period for the notice of meeting. The request conveyed concern 
that the current 30-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to alternative 
approaches in clinical investigations for new animal drugs.
    FDA has considered the request and is extending the comment period 
for the notice of public meeting for 30 days, until September 16, 2019. 
The Agency believes that a 30-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
the development of guidance on these important issues.

    Dated: August 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17258 Filed 8-12-19; 8:45 am]
 BILLING CODE 4164-01-P