Notice2022-22386
Discussion Paper: Distributed Manufacturing and Point-of-Care Manufacturing of Drugs; Request for Information and Comments
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 198 (Friday, October 14, 2022)</title>
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[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Pages 62416-62417]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-22386]
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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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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]]
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#61240d081b00030415094f2608001014080f150e210705004f0909124f060e17"><span class="__cf_email__" data-cfemail="682d040112090a0d1c00462f0109191d01061c07280e0c094600001b460f071e">[email protected]</span></a>.
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
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