Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Reopening of Comment Period, 9783-9784 [2020-03312]
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Federal Register / Vol. 85, No. 34 / Thursday, February 20, 2020 / Notices
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Dated: February 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03424 Filed 2–19–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–4533]
Compounding Animal Drugs From
Bulk Drug Substances; Draft Guidance
for Industry; Availability; Reopening of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; reopening
of comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
reopening the comment period for the
notice of availability that published in
the Federal Register on November 20,
2019. In that notice, FDA requested
comments on the draft guidance for
industry (GFI) #256 entitled
‘‘Compounding Animal Drugs from Bulk
Drug Substances.’’ FDA is reopening the
comment period to update comments
and to receive any new information.
DATES: FDA is reopening the comment
period on the document published
November 20, 2019 (84 FR 64085).
SUMMARY:
PO 00000
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9783
Submit either electronic or written
comments on the draft guidance by June
17, 2020, to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the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–
2018–D–4533 for ‘‘Compounding
Animal Drugs From Bulk Drug
Substances.’’ 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.
E:\FR\FM\20FEN1.SGM
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lotter on DSKBCFDHB2PROD with NOTICES
9784
Federal Register / Vol. 85, No. 34 / Thursday, February 20, 2020 / Notices
• 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-201509-18/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: Eric
Nelson, Division of Compliance (HFV–
230), Center for Veterinary Medicine,
Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240–
402–7001, cvmcompliance@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of November 20, 2019,
FDA published a notice announcing the
availability of draft GFI #256 entitled
‘‘Compounding Animal Drugs From
Bulk Drug Substances’’ with a 90-day
comment period. We requested
comments on the draft guidance with
respect to animal drug compounding
from bulk drug substances under certain
circumstances when no other medically
appropriate treatment option exists.
Interested persons were originally
given until February 18, 2020, to
comment on the draft guidance.
VerDate Sep<11>2014
19:48 Feb 19, 2020
Jkt 250001
The Agency has received several
requests to allow interested persons
additional time to comment. The
requests conveyed concern that the
current 90-day comment period does
not allow sufficient time to develop a
comprehensive response.
FDA has considered the requests and
is reopening the comment period for the
notice of availability for 120 days, until
June 17, 2020. The Agency believes that
a 120-day reopening allows adequate
time for interested persons to submit
comments.
Dated: February 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–03312 Filed 2–19–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–5607]
Nonclinical Safety Evaluation of the
Immunotoxic Potential of Drugs and
Biologics; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance entitled ‘‘Nonclinical Safety
Evaluation of the Immunotoxic Potential
of Drugs and Biologics.’’ This guidance
expands upon, consolidates, and
supplements the recommendations on
nonclinical immune system assessments
provided across multiple guidance
documents, most notably the
International Conference on
Harmonization (ICH) guidance for
industry ‘‘S8 Immunotoxicity Studies
for Human Pharmaceuticals.’’ The
topics covered include various aspects
of immune suppression, modulation,
and stimulation. This guidance replaces
the withdrawn guidance entitled
‘‘Immunotoxicology Evaluation of
Investigational New Drugs.’’
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by April 20, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
DATES:
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
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–D–5607 for ‘‘Nonclinical Safety
Evaluation of the Immunotoxic Potential
of Drugs and Biologics.’’ 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.
• 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
E:\FR\FM\20FEN1.SGM
20FEN1
]]>Agencies
[Federal Register Volume 85, Number 34 (Thursday, February 20, 2020)]
[Notices]
[Pages 9783-9784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03312]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-4533]
Compounding Animal Drugs From Bulk Drug Substances; Draft
Guidance for Industry; Availability; Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; reopening of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening the comment period for the notice of availability that
published in the Federal Register on November 20, 2019. In that notice,
FDA requested comments on the draft guidance for industry (GFI) #256
entitled ``Compounding Animal Drugs from Bulk Drug Substances.'' FDA is
reopening the comment period to update comments and to receive any new
information.
DATES: FDA is reopening the comment period on the document published
November 20, 2019 (84 FR 64085). Submit either electronic or written
comments on the draft guidance by June 17, 2020, to ensure that the
Agency considers your comments 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-2018-D-4533 for ``Compounding Animal Drugs From Bulk Drug
Substances.'' 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.
[[Page 9784]]
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.
FOR FURTHER INFORMATION CONTACT: Eric Nelson, Division of Compliance
(HFV-230), Center for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-7001,
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of November 20,
2019, FDA published a notice announcing the availability of draft GFI
#256 entitled ``Compounding Animal Drugs From Bulk Drug Substances''
with a 90-day comment period. We requested comments on the draft
guidance with respect to animal drug compounding from bulk drug
substances under certain circumstances when no other medically
appropriate treatment option exists.
Interested persons were originally given until February 18, 2020,
to comment on the draft guidance.
The Agency has received several requests to allow interested
persons additional time to comment. The requests conveyed concern that
the current 90-day comment period does not allow sufficient time to
develop a comprehensive response.
FDA has considered the requests and is reopening the comment period
for the notice of availability for 120 days, until June 17, 2020. The
Agency believes that a 120-day reopening allows adequate time for
interested persons to submit comments.
Dated: February 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03312 Filed 2-19-20; 8:45 am]
BILLING CODE 4164-01-P
