[Federal Register Volume 88, Number 78 (Monday, April 24, 2023)]
[Notices]
[Pages 24807-24808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08545]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.regulations.gov 
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:
     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-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 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 24808]]

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: Luke Durocher, Duke-Margolis Center 
for Health Policy, 1201 Pennsylvania Ave., Suite 500, Washington, DC 
20004, 202-621-2800, [email protected].

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).
---------------------------------------------------------------------------

    \1\ See section I.N.5, ``Advancing Utilization and 
Implementation of Innovative Manufacturing'' at https://www.fda.gov/media/151712/download.
---------------------------------------------------------------------------

    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:
     Best practices and lessons learned from the CDER Emerging 
Technology Team and the CBER Advanced Technology Team programs from 
both industry and regulatory perspectives.
     Case studies from previous innovative technology 
submissions presented by industry sponsors.
     Potential barriers (e.g., technical, regulatory) to the 
adoption of innovative manufacturing technologies.
     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.
     Science- and risk-based approaches for developing and 
accessing innovative technologies across platform products and sites to 
streamline adoption.
     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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

III. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop 
must register online at https://duke.is/8zckq 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, [email protected], 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 https://duke.is/8zckq.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. 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


