[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]


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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 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


