Notice2023-08545
Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches; Public Workshop; Request for Comments
Primary source
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Published
April 24, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we), in cosponsorship with the Duke-Margolis Center for Health Policy, is announcing a public workshop entitled "Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches." This workshop will address innovative manufacturing technologies for drug and biological products and will include a discussion of potential best practices, case studies from previous submissions, potential barriers to adoption, corresponding regulatory strategies, and the Advanced Manufacturing Technologies Designation Program.
Full Text
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<title>Federal Register, Volume 88 Issue 78 (Monday, April 24, 2023)</title>
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[Federal Register Volume 88, Number 78 (Monday, April 24, 2023)]
[Notices]
[Pages 24807-24808]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-08545]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1259]
Advancing the Utilization and Supporting the Implementation of
Innovative Manufacturing Approaches; Public Workshop; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we), in
cosponsorship with the Duke-Margolis Center for Health Policy, is
announcing a public workshop entitled ``Advancing the Utilization and
Supporting the Implementation of Innovative Manufacturing Approaches.''
This workshop will address innovative manufacturing technologies for
drug and biological products and will include a discussion of potential
best practices, case studies from previous submissions, potential
barriers to adoption, corresponding regulatory strategies, and the
Advanced Manufacturing Technologies Designation Program.
DATES: The public workshop will be held on June 8, 2023, from 9 a.m. to
4:30 p.m. Eastern Time. Either electronic or written comments on this
public workshop must be submitted by July 8, 2023. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public workshop will be held at the National Press Club,
529 14th Street NW, Washington, DC 20045.
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 on July 8, 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:
<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-2023-N-1259 for ``Advancing the Utilization and Supporting the
Implementation of Innovative Manufacturing Approaches.'' 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 24808]]
<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: Luke Durocher, Duke-Margolis Center
for Health Policy, 1201 Pennsylvania Ave., Suite 500, Washington, DC
20004, 202-621-2800, <a href="/cdn-cgi/l/email-protection#bcd1ddcedbd3d0d5cfd9cad9d2c8cffcd8c9d7d992d9d8c9"><span class="__cf_email__" data-cfemail="34595546535b585d475142515a40477450415f511a515041">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
There is significant interest in the use, implementation, and
advancement of innovative drug manufacturing approaches and
technologies. In accordance with commitments described in the
Prescription Drug User Fee Act (PDUFA) VII commitment letter ``PDUFA
Reauthorization Performance Goals and Procedures Fiscal Years 2023
through 2027,'' \1\ FDA agreed to conduct a public workshop by the end
of fiscal year 2023 on the use of innovative manufacturing technologies
for products regulated by the Center for Drug Evaluation and Research
(CDER) or the Center for Biologics Evaluation and Research (CBER).
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\1\ See section I.N.5, ``Advancing Utilization and
Implementation of Innovative Manufacturing'' at <a href="https://www.fda.gov/media/151712/download">https://www.fda.gov/media/151712/download</a>.
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Additionally, section 506L of the Federal Food, Drug, and Cosmetic
Act (FD&C Act, 21 U.S.C. 356l), as added by section 3213 of the Food
and Drug Omnibus Reform Act of 2022 (FDORA), authorizes the Advanced
Manufacturing Technologies Designation Program and requires FDA to
publish a Federal Register notice announcing a public meeting to
solicit industry and public feedback regarding this program.
FDA is holding a public workshop entitled ``Advancing the
Utilization and Supporting the Implementation of Innovative
Manufacturing'' to fulfill both the PDUFA VII commitment and the FD&C
Act requirement described above. The purpose of the public workshop is
to discuss potential best practices for drug applications that include
innovative manufacturing technologies, sponsor-presented case studies
from previous submissions involving innovative technology, potential
barriers to the adoption of innovative manufacturing technologies,
corresponding regulatory strategies, ways in which FDA will support the
use of innovative manufacturing technologies and approaches for drug
and biological products, and the Advanced Manufacturing Technologies
Designation Program.
II. Topics for Discussion at the Public Workshop
The public workshop will include the following topics for
discussion:
<bullet> Best practices and lessons learned from the CDER Emerging
Technology Team and the CBER Advanced Technology Team programs from
both industry and regulatory perspectives.
<bullet> Case studies from previous innovative technology
submissions presented by industry sponsors.
<bullet> Potential barriers (e.g., technical, regulatory) to the
adoption of innovative manufacturing technologies.
<bullet> Regulatory strategies for the adoption of innovative
manufacturing technologies, including submission strategies for the
implementation of certain innovative technologies across multiple
commercial products or multiple manufacturing sites.
<bullet> Science- and risk-based approaches for developing and
accessing innovative technologies across platform products and sites to
streamline adoption.
<bullet> Input and recommendations from stakeholders regarding
initiation and implementation of the Advanced Manufacturing
Technologies Designation Program, including the process and information
needed to request a designation, the evaluation of designation
requests, and the review of applications that involve use of designated
advanced manufacturing technologies.\2\
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\2\ In the context of this program, application refers to an
application submitted under section 505 of the FD&C Act (21 U.S.C.
355), or section 351 of the Public Health Service Act (42 U.S.C.
262).
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III. Participating in the Public Workshop
Registration: Persons interested in attending this public workshop
must register online at <a href="https://duke.is/8zckq">https://duke.is/8zckq</a> by 9 a.m. Eastern Time,
June 8, 2023. Please provide complete contact information for each
attendee, including name, title, affiliation, address, email, and
telephone.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by 9 a.m. Eastern Time, June 8, 2023. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation when they have been accepted.
If you need special accommodations due to a disability, please
contact Luke Durocher, Duke-Margolis Center for Health Policy, 202-621-
2800, <a href="/cdn-cgi/l/email-protection#b2dfd3c0d5dddedbc1d7c4d7dcc6c1f2d6c7d9d79cd7d6c7"><span class="__cf_email__" data-cfemail="bed3dfccd9d1d2d7cddbc8dbd0cacdfedacbd5db90dbdacb">[email protected]</span></a>, no later than 5 p.m. Eastern Time, May
25, 2023.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. Refer to registration information online at <a href="https://duke.is/8zckq">https://duke.is/8zckq</a>.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may be viewed at the Dockets Management Staff.
Dated: April 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08545 Filed 4-21-23; 8:45 am]
BILLING CODE 4164-01-P
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