[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]
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