In-Home Disposal Systems for Opioid Analgesics; Request for Information; Reopening of the Comment Period, 65397-65398 [2023-20516]
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Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / 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, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
VerDate Sep<11>2014
16:40 Sep 21, 2023
Jkt 259001
FOR FURTHER INFORMATION CONTACT:
Jessica Dunn, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4214,
Silver Spring, MD 20993–0002, 240–
402–8985; or Anne Taylor, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, 240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Alternative Tools: Assessing Drug
Manufacturing Facilities Identified in
Pending Applications.’’ This draft
guidance provides information to
applicants on how FDA intends to use
alternative tools to assess manufacturing
facilities identified in an NDA, an
ANDA, a BLA, or a supplement to any
of these types of applications. As part of
the negotiations relating to the
reauthorization of BsUFA and PDUFA,
FDA agreed to issue guidance on the use
of alternative tools to assess
manufacturing facilities named in
pending applications and to incorporate
best practices from the use of such tools
during the COVID–19 pandemic. This
draft guidance, within the context of
approval and licensure decisions by
FDA, describes the use of alternative
tools to assess manufacturing facilities
identified in an NDA, an ANDA, or a
BLA to establish that these facilities
meet the applicable requirements,
including under section 501(a)(2)(B) of
the FD&C Act (21 U.S.C. 351(a)(2)(B))
and either section 505 of the FD&C Act
(21 U.S.C. 355) or section 351 of the
PHS Act (42 U.S.C. 262).
During the pandemic, FDA expanded
its use of alternative tools to evaluate
drug manufacturing facilities to support
regulatory decision making when
facility inspections were not feasible.
Given the success of these innovative
approaches, FDA intends to continue
risk-based use of these alternative tools
and to apply certain virtual
technological capabilities within a
specific inspectional context defined
within this draft guidance. When used
in advance or in lieu of preapproval
inspections (PAIs) and prelicense
inspections (PLIs) or to support PAIs
and PLIs, the appropriate use of these
approaches will help FDA maintain
operational flexibility to support timely
facility evaluations and application
decisions.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
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65397
represent the current thinking of FDA
on ‘‘Alternative Tools: Assessing Drug
Manufacturing Facilities Identified in
Pending Applications.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR parts 210 and
211 pertaining to current good
manufacturing practice requirements
and electronic records and signatures
have been approved under OMB control
numbers 0910–0139 and 0910–0303,
respectively. The collections of
information in 21 CFR part 314
pertaining to the submission of NDAs
and ANDAs have been approved under
OMB control number 0910–0001. The
collections of information in 21 CFR
part 601 pertaining to BLAs have been
approved under OMB control number
0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: September 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–20590 Filed 9–21–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0917]
In-Home Disposal Systems for Opioid
Analgesics; Request for Information;
Reopening of the Comment Period
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\22SEN1.SGM
22SEN1
65398
Federal Register / Vol. 88, No. 183 / Friday, September 22, 2023 / Notices
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA, Agency, or we) is
reopening the comment period for the
notice entitled ‘‘In-Home Disposal
Systems for Opioid Analgesics; Request
for Information’’ published in the
Federal Register of April 4, 2023. FDA
is reopening the comment period to
allow interested persons additional time
to develop and submit comments.
DATES: FDA is reopening the comment
period on the notice published April 4,
2023 (88 FR 19959). Either electronic or
written comments must be submitted by
November 6, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
November 6, 2023. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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
VerDate Sep<11>2014
16:40 Sep 21, 2023
Jkt 259001
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–
2023–N–0917 for ‘‘In-Home Disposal
Systems for Opioid Analgesics; Request
for Information.’’ 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, 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-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, 240–402–7500.
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
In the
Federal Register of April 4, 2023 (88 FR
19959), FDA published a notice
requesting information and comments
that will assist the Agency in assessing
whether in-home disposal products can
be expected to meet the public health
goal of mitigating the risk of nonmedical
use or overdose if the Agency were to
require drug manufacturers to make inhome disposal products available to
patients under a risk evaluation and
mitigation strategy. The Agency
requested information and comments on
the issues that were discussed at the
public workshop convened by the
National Academies of Sciences,
Engineering, and Medicine’s Forum on
Drug Discovery, Development, and
Translation entitled ‘‘Defining and
Evaluating In-Home Disposal Systems
for Opioid Analgesics’’ on June 26 and
27, 2023. Interested persons were
originally given until August 28, 2023,
to submit comments on in-home
disposal systems for opioid analgesics.
FDA is reopening the public docket to
allow interested persons additional time
to submit comments. We note that there
is a listening session on October 5, 2023,
with federally recognized American
Indian and Alaska Native tribes on the
safe disposal of opioid analgesics. The
Agency believes that reopening the
comment period for an additional 45
days will allow adequate time for
interested persons to submit comments
without significantly delaying Agency
decision-making on these important
issues. FDA is reopening the comment
period for 45 days, until November 6,
2023.
SUPPLEMENTARY INFORMATION:
Dated: September 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–20516 Filed 9–21–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
AGENCY:
E:\FR\FM\22SEN1.SGM
22SEN1
Agencies
[Federal Register Volume 88, Number 183 (Friday, September 22, 2023)]
[Notices]
[Pages 65397-65398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20516]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0917]
In-Home Disposal Systems for Opioid Analgesics; Request for
Information; Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
[[Page 65398]]
ACTION: Notice; reopening of the comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
reopening the comment period for the notice entitled ``In-Home Disposal
Systems for Opioid Analgesics; Request for Information'' published in
the Federal Register of April 4, 2023. FDA is reopening the comment
period to allow interested persons additional time to develop and
submit comments.
DATES: FDA is reopening the comment period on the notice published
April 4, 2023 (88 FR 19959). Either electronic or written comments must
be submitted by November 6, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 6, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-2023-N-0917 for ``In-Home Disposal Systems for Opioid Analgesics;
Request for Information.'' 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, 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: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of April 4, 2023 (88
FR 19959), FDA published a notice requesting information and comments
that will assist the Agency in assessing whether in-home disposal
products can be expected to meet the public health goal of mitigating
the risk of nonmedical use or overdose if the Agency were to require
drug manufacturers to make in-home disposal products available to
patients under a risk evaluation and mitigation strategy. The Agency
requested information and comments on the issues that were discussed at
the public workshop convened by the National Academies of Sciences,
Engineering, and Medicine's Forum on Drug Discovery, Development, and
Translation entitled ``Defining and Evaluating In-Home Disposal Systems
for Opioid Analgesics'' on June 26 and 27, 2023. Interested persons
were originally given until August 28, 2023, to submit comments on in-
home disposal systems for opioid analgesics.
FDA is reopening the public docket to allow interested persons
additional time to submit comments. We note that there is a listening
session on October 5, 2023, with federally recognized American Indian
and Alaska Native tribes on the safe disposal of opioid analgesics. The
Agency believes that reopening the comment period for an additional 45
days will allow adequate time for interested persons to submit comments
without significantly delaying Agency decision-making on these
important issues. FDA is reopening the comment period for 45 days,
until November 6, 2023.
Dated: September 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20516 Filed 9-21-23; 8:45 am]
BILLING CODE 4164-01-P