Discussion Paper: Distributed Manufacturing and Point-of-Care Manufacturing of Drugs; Request for Information and Comments, 62416-62417 [2022-22386]
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Federal Register / Vol. 87, No. 198 / Friday, October 14, 2022 / Notices
FDA anticipates that the 27 potential
respondents to this collection may need
to meet with CTP’s Office of Science to
discuss their investigational plans. This
number has been reduced based on the
average number of meeting requests
received over the past 3 years. To
request this meeting, applicants should
compile and submit information to FDA
for meeting approval. FDA estimates
that it will take approximately 270
hours to compile and request a meeting
with OS. We have revised the hours per
response to be consistent with the
meetings information collection for
originally regulated products (OMB
control number 0910–0731).
Based on the September 2020 order
vacating the health warning
requirements for cigars and pipe tobacco
(set forth in 21 CFR 1143.3 and 1143.5)
and remanding the Final Deeming
Rule’s warning requirements for cigars
and pipe tobacco, we have removed the
burden associated with this activity. We
have included 1 token hour of burden
associated with the requirements in part
1143 to acknowledge that the
requirement remains in the regulations.
We have adjusted our burden
estimate, which has resulted in a
decrease to the currently approved
burden. The total estimated burden for
this information collection is 1,285,021
reporting hours and 778 annual
responses. Our estimated burden for the
information collection reflects an
overall decrease of 2,779 hours and a
corresponding decrease of 262
responses. We attribute this adjustment
to updated information in the number of
meeting requests with CTP’s Office of
Science to discuss investigational plans,
the removal of burden for the cigar
warning plans, the removal of the smallscale manufacturer reporting, and have
therefore revised the estimated burden
and number of respondents to the
information collection.
Dated: October 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–22299 Filed 10–13–22; 8:45 am]
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BILLING CODE 4164–01–P
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17:22 Oct 13, 2022
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2316]
Discussion Paper: Distributed
Manufacturing and Point-of-Care
Manufacturing of Drugs; Request for
Information and Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for information
and comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing publication of a discussion
paper providing information for
stakeholders and soliciting public
comments on specific areas of emerging
and advanced manufacturing
technologies. The discussion paper
presents areas for consideration and
policy development identified by the
Center for Drug Evaluation and Research
(CDER) scientific and policy experts
associated with distributed
manufacturing (DM) and point-of-care
(POC) manufacturing for drugs,
including biological products regulated
by CDER and the Center for Biologics
Evaluation and Research (CBER). FDA
recognizes that regulatory policies and
programs may need to evolve to enable
the timely adoption of these
technologies. The discussion paper
includes a series of questions for each
technology to stimulate feedback from
the public.
DATES: Either electronic or written
comments and information on the
discussion paper must be submitted by
December 13, 2022.
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
December 13, 2022. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
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
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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–
2022–N–2316 for ‘‘Discussion Paper:
Distributed Manufacturing and Point-ofCare Manufacturing of Drugs; Request
for Information and 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, 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
E:\FR\FM\14OCN1.SGM
14OCN1
Federal Register / Vol. 87, No. 198 / Friday, October 14, 2022 / Notices
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.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4162,
Silver Spring, MD 20993, 240–402–
7930, Elizabeth.Giaquinto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
jspears on DSK121TN23PROD with NOTICES
I. Background
Advanced manufacturing is a general
term for an innovative pharmaceutical
manufacturing technology or approach
that has the potential to improve the
reliability and robustness of the
manufacturing process and supply
chain, and increase timely access to
quality medicines for the American
public. For the purposes of the
discussion paper, all references to drugs
include both human drugs and
biological products (including those
regulated by CBER), unless otherwise
specified. Advanced manufacturing can:
(1) integrate novel technological
approaches, (2) use established
techniques in an innovative way, or (3)
apply production methods in a new
domain. Advanced manufacturing can
potentially be used for new or existing
and large or small molecule drugs.
FDA has recognized and embraced the
potential of advanced manufacturing for
many years. CDER established the
Emerging Technology Program in 2014
to work collaboratively with companies
to support the use of advanced
manufacturing. CDER has observed a
rapid emergence of advanced
VerDate Sep<11>2014
17:22 Oct 13, 2022
Jkt 259001
manufacturing technologies through the
Emerging Technology Program and
recognizes that regulatory policies and
programs may need to evolve to enable
the timely adoption of these
technologies. The National Academies
of Sciences, Engineering, and Medicine
issued a 2021 report entitled
‘‘Innovation in Pharmaceutical
Manufacturing on the Horizon:
Technical Challenges, Regulatory Issues,
and Recommendations’’, noting
potential innovations in integrated,
flexible, and distributed manufacturing.
These potential innovations include
modular approaches to streamline drug
development and production, and the
deployment and use of highly portable
manufacturing units. A range of drug
manufacturers have recently engaged
CDER through the Emerging Technology
Program specifically regarding the
development of portable and distributed
manufacturing platforms.
CBER established the CBER Advanced
Technologies Team in 2019 to promote
dialogue, education, and input between
CBER and prospective innovators and
developers of advanced manufacturing
technologies. Through these
interactions, CBER has observed interest
from manufacturers in the
implementation of novel manufacturing
approaches for CBER-regulated
products. CBER also recognizes the need
to consider developing a regulatory
framework to facilitate the adoption of
these emerging technologies. CBER
expects the development of advanced
manufacturing technologies associated
with DM and POC manufacturing for
products that it regulates.
The discussion paper (available on
FDA’s website at: CDER’s Framework
for Regulatory Advanced Manufacturing
Evaluation (FRAME) Initiative | FDA)
presents areas for consideration and
policy development identified by CDER
scientific and policy experts associated
with DM and POC manufacturing that
would be valuable as FDA considers
developing a regulatory framework that
contemplates these technologies for
CDER- and CBER-regulated drug and
biological products. For the purposes of
the discussion paper, CDER and CBER
define DM to be a decentralized
manufacturing strategy consisting of a
manufacturing platform of
manufacturing units deployed to
multiple locations; POC manufacturing
is defined as a subset of DM that uses
manufacturing units distributed to host
sites in proximity to patient care (e.g.,
healthcare facilities). Regulatory areas of
consideration include applicable
statutory provisions, regulations, and
guidance related to quality assessment
and inspections that could affect an
PO 00000
Frm 00059
Fmt 4703
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62417
applicant’s ability to comply with the
current regulatory framework or FDA’s
assessment of a marketing application.
II. Requested Information and
Comments
Interested persons are invited to
provide detailed comments to CDER and
CBER (see ADDRESSES) on all aspects
described in the discussion paper. The
discussion paper is available on FDA’s
website for the FRAME initiative at:
CDER’s Framework for Regulatory
Advanced Manufacturing Evaluation
(FRAME) Initiative | FDA. To facilitate
input, FDA has developed a series of
questions after each technology
described in the discussion paper. The
questions are not meant to be
exhaustive, and FDA is also interested
in any other pertinent information
stakeholders would like to share on this
topic. This feedback will help inform
the Agency’s policy development
regarding the technologies described in
the discussion paper. FDA encourages
stakeholders to provide the specific
rationale and basis for their comments,
including any available supporting data
and information.
Dated: October 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–22386 Filed 10–13–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0973]
Comparability Protocols for
Postapproval Changes to the
Chemistry, Manufacturing, and
Controls Information in a New Drug
Application, Abbreviated New Drug
Application, or Biologics License
Application; 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 final
guidance for industry entitled
‘‘Comparability Protocols for
Postapproval Changes to the Chemistry,
Manufacturing, and Controls
Information in an NDA, ANDA, or
BLA.’’ This final guidance is intended to
assist original applicants and holders of
approved new drug applications
(NDAs), abbreviated new drug
applications (ANDAs), and biologics
SUMMARY:
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]]>Agencies
[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Pages 62416-62417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22386]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2316]
Discussion Paper: Distributed Manufacturing and Point-of-Care
Manufacturing of Drugs; Request for Information and Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information and comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
publication of a discussion paper providing information for
stakeholders and soliciting public comments on specific areas of
emerging and advanced manufacturing technologies. The discussion paper
presents areas for consideration and policy development identified by
the Center for Drug Evaluation and Research (CDER) scientific and
policy experts associated with distributed manufacturing (DM) and
point-of-care (POC) manufacturing for drugs, including biological
products regulated by CDER and the Center for Biologics Evaluation and
Research (CBER). FDA recognizes that regulatory policies and programs
may need to evolve to enable the timely adoption of these technologies.
The discussion paper includes a series of questions for each technology
to stimulate feedback from the public.
DATES: Either electronic or written comments and information on the
discussion paper must be submitted by December 13, 2022.
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 December 13, 2022. 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-2022-N-2316 for ``Discussion Paper: Distributed Manufacturing and
Point-of-Care Manufacturing of Drugs; Request for Information and
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, 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
[[Page 62417]]
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: Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm. 4162, Silver Spring, MD 20993, 240-
402-7930, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Advanced manufacturing is a general term for an innovative
pharmaceutical manufacturing technology or approach that has the
potential to improve the reliability and robustness of the
manufacturing process and supply chain, and increase timely access to
quality medicines for the American public. For the purposes of the
discussion paper, all references to drugs include both human drugs and
biological products (including those regulated by CBER), unless
otherwise specified. Advanced manufacturing can: (1) integrate novel
technological approaches, (2) use established techniques in an
innovative way, or (3) apply production methods in a new domain.
Advanced manufacturing can potentially be used for new or existing and
large or small molecule drugs.
FDA has recognized and embraced the potential of advanced
manufacturing for many years. CDER established the Emerging Technology
Program in 2014 to work collaboratively with companies to support the
use of advanced manufacturing. CDER has observed a rapid emergence of
advanced manufacturing technologies through the Emerging Technology
Program and recognizes that regulatory policies and programs may need
to evolve to enable the timely adoption of these technologies. The
National Academies of Sciences, Engineering, and Medicine issued a 2021
report entitled ``Innovation in Pharmaceutical Manufacturing on the
Horizon: Technical Challenges, Regulatory Issues, and
Recommendations'', noting potential innovations in integrated,
flexible, and distributed manufacturing. These potential innovations
include modular approaches to streamline drug development and
production, and the deployment and use of highly portable manufacturing
units. A range of drug manufacturers have recently engaged CDER through
the Emerging Technology Program specifically regarding the development
of portable and distributed manufacturing platforms.
CBER established the CBER Advanced Technologies Team in 2019 to
promote dialogue, education, and input between CBER and prospective
innovators and developers of advanced manufacturing technologies.
Through these interactions, CBER has observed interest from
manufacturers in the implementation of novel manufacturing approaches
for CBER-regulated products. CBER also recognizes the need to consider
developing a regulatory framework to facilitate the adoption of these
emerging technologies. CBER expects the development of advanced
manufacturing technologies associated with DM and POC manufacturing for
products that it regulates.
The discussion paper (available on FDA's website at: CDER's
Framework for Regulatory Advanced Manufacturing Evaluation (FRAME)
Initiative [verbar] FDA) presents areas for consideration and policy
development identified by CDER scientific and policy experts associated
with DM and POC manufacturing that would be valuable as FDA considers
developing a regulatory framework that contemplates these technologies
for CDER- and CBER-regulated drug and biological products. For the
purposes of the discussion paper, CDER and CBER define DM to be a
decentralized manufacturing strategy consisting of a manufacturing
platform of manufacturing units deployed to multiple locations; POC
manufacturing is defined as a subset of DM that uses manufacturing
units distributed to host sites in proximity to patient care (e.g.,
healthcare facilities). Regulatory areas of consideration include
applicable statutory provisions, regulations, and guidance related to
quality assessment and inspections that could affect an applicant's
ability to comply with the current regulatory framework or FDA's
assessment of a marketing application.
II. Requested Information and Comments
Interested persons are invited to provide detailed comments to CDER
and CBER (see ADDRESSES) on all aspects described in the discussion
paper. The discussion paper is available on FDA's website for the FRAME
initiative at: CDER's Framework for Regulatory Advanced Manufacturing
Evaluation (FRAME) Initiative [verbar] FDA. To facilitate input, FDA
has developed a series of questions after each technology described in
the discussion paper. The questions are not meant to be exhaustive, and
FDA is also interested in any other pertinent information stakeholders
would like to share on this topic. This feedback will help inform the
Agency's policy development regarding the technologies described in the
discussion paper. FDA encourages stakeholders to provide the specific
rationale and basis for their comments, including any available
supporting data and information.
Dated: October 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22386 Filed 10-13-22; 8:45 am]
BILLING CODE 4164-01-P
