Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; Request for Information and Comments, 12943-12944 [2023-04206]

Download as PDF Federal Register / Vol. 88, No. 40 / Wednesday, March 1, 2023 / Notices requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, § 314.150(c) is without prejudice to refiling. Application No. Drug Applicant ANDA 075980 ...................... Tramadol Hydrochloride (HCl) Tablets, 50 milligrams (mg). Tramadol HCl Tablets, 50 mg ......................................... Pirmella 7/7/7 Tablets, 0.035 mg, 0.035 mg, 0.035 mg; 0.5 mg, 0.75 mg, 1 mg. Mylan Pharmaceuticals Inc., 3711 Collins Ferry Rd., Morgantown, WV 26505. Do. Lupin Pharmaceuticals, Inc., U.S. Agent for Lupin Ltd., 111 South Calvert St., Harborplace Tower, 21st Floor, Baltimore, MD 21202. Do. Mylan Pharmaceuticals Inc. ANDA 075986 ...................... ANDA 201510 ...................... ANDA 201512 ...................... ANDA 203803 ...................... ANDA 203900 ...................... ANDA 203946 ...................... ANDA 205923 ...................... Pirmella 1/35 Tablets, 0.035 mg; 1 mg .......................... Propafenone HCl, Extended-Release Capsules, 225 mg, 325 mg, and 425 mg. Tacrolimus Injection, Equivalent to (EQ) 5 mg base/milliliters (mL). Fludeoxyglucose F18 Injectable, 20–300 millicurie (mCi)/mL. Caspofungin Acetate Powder, 50 mg/vial, and 70 mg/ vial. ANDA 209571 ...................... Darifenacin Hydrobromide Extended-Release Tablets, EQ 7.5 mg/base and EQ 15 mg/base. ANDA 211972 ...................... ANDA 213222 ...................... Zileuton Extended-Release Tablets, 600 mg ................. Icatibant Acetate Injectable, EQ 30 mg base/3 mL (EQ 10 mg base/mL). Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of March 31, 2023. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on March 31, 2023 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: February 24, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–04175 Filed 2–28–23; 8:45 am] BILLING CODE 4164–01–P ddrumheller on DSK120RN23PROD with NOTICES by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under 12943 VerDate Sep<11>2014 18:10 Feb 28, 2023 Jkt 259001 Hospira, A Pfizer Company, 275 North Field Dr., Lake Forest, IL 60045. Essential Isotopes, LLC, 1513 Research Park Dr., Columbia, MO 65211. Xellia Pharmaceuticals USA, LLC, U.S. Agent for Xellia Pharmaceuticals ApS, 2150 East Lake Cook Rd., Suite 1015, Buffalo Grove, IL 60089. Xiromed, LLC., U.S. Agent for Xiromed Pharma Espan˜a, S.L., 180 Park Ave., Suite 101, Florham Park, NJ 07932. Lupin Pharmaceuticals, Inc. Glenmark Pharmaceuticals Inc., USA, U.S. Agent for Glenmark Pharmaceuticals Ltd., 750 Corporate Dr., Mahwah, NJ 07430. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–0487] Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; Request for Information and Comments AGENCY: Food and Drug Administration, HHS. Notice; establishment of a public docket; 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 a specific area 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 application of artificial intelligence (AI) to pharmaceutical manufacturing. The discussion paper includes a series of questions to stimulate feedback from the public, including CDER and the Center for Biologics Evaluation and Research (CBER) stakeholders. SUMMARY: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Submit either written or electronic comments and information by May 1, 2023. 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 May 1, 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. DATES: 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 E:\FR\FM\01MRN1.SGM 01MRN1 12944 Federal Register / Vol. 88, No. 40 / Wednesday, March 1, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES 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–0487 for ‘‘Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; 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 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 VerDate Sep<11>2014 18:10 Feb 28, 2023 Jkt 259001 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: I. Background Advanced manufacturing is a term that describes an innovative pharmaceutical manufacturing technology or approach that has the potential to improve the reliability and robustness of the manufacturing process and resilience of the supply chain. 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 where there are no defined best practices. Advanced manufacturing can be used for new or currently marketed large or small molecule drug products. FDA has recognized and embraced the potential of advanced manufacturing. In 2014, CDER established the Emerging Technology Program (ETP) to work collaboratively with companies to support the use of advanced manufacturing. CDER observed a rapid emergence of advanced manufacturing technologies through the ETP and recognized that regulatory policies and programs may need to evolve to enable timely technological adoption. The National Academies of Sciences, Engineering, and Medicine issued a 2021 report titled Innovation in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations, highlighting innovations in integrated pharmaceutical manufacturing processes. These innovations could have implications for measurement, modeling, and control technologies used PO 00000 Frm 00036 Fmt 4703 Sfmt 9990 in pharmaceutical manufacturing. AI may play a significant role in monitoring and controlling advanced manufacturing processes. This discussion paper presents areas associated with the application of AI to pharmaceutical manufacturing that FDA has identified for consideration as FDA evaluates our existing risk-based regulatory framework. CDER scientific and policy experts identified these areas from a comprehensive analysis of existing regulatory requirements applicable to the approval of drugs manufactured using AI technologies. The areas of consideration in this discussion paper are those for which FDA would like public feedback. There are additional areas of consideration not covered within this document, for example, difficulties that could result from ambiguity on how to apply existing regulations to AI or lack of Agency guidance or experience. The areas of consideration presented in this discussion paper focus on drug products that would be marketed under a new drug application (NDA), abbreviated new drug application (ANDA), or biologic license application (BLA). Public feedback will help inform CDER’s evaluation of our existing regulatory framework. While the initial analysis focused on products regulated by CDER, FDA’s CBER has also encountered a rapid emergence of advanced manufacturing technologies associated with AI. As such, both CDER and CBER stakeholders are invited to provide feedback on the discussion questions. II. Requested Information and Comments Interested persons are invited to provide detailed comments to CDER and CBER on all aspects described in the discussion paper. To facilitate input, FDA has developed a series of questions based on the considerations articulated 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. In all cases, FDA encourages stakeholders to provide the specific rationale and basis for their comments, including any available supporting data and information. Dated: February 24, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–04206 Filed 2–28–23; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\01MRN1.SGM 01MRN1

Agencies

[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Notices]
[Pages 12943-12944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04206]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0487]


Discussion Paper: Artificial Intelligence in Drug Manufacturing, 
Notice; Request for Information and Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; 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 a specific area 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 application of artificial intelligence 
(AI) to pharmaceutical manufacturing. The discussion paper includes a 
series of questions to stimulate feedback from the public, including 
CDER and the Center for Biologics Evaluation and Research (CBER) 
stakeholders.

DATES: Submit either written or electronic comments and information by 
May 1, 2023.

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 May 1, 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

[[Page 12944]]

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-0487 for ``Discussion Paper: Artificial Intelligence in Drug 
Manufacturing, Notice; 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 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 term that describes an innovative 
pharmaceutical manufacturing technology or approach that has the 
potential to improve the reliability and robustness of the 
manufacturing process and resilience of the supply chain. 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 where there are no defined best 
practices. Advanced manufacturing can be used for new or currently 
marketed large or small molecule drug products.
    FDA has recognized and embraced the potential of advanced 
manufacturing. In 2014, CDER established the Emerging Technology 
Program (ETP) to work collaboratively with companies to support the use 
of advanced manufacturing. CDER observed a rapid emergence of advanced 
manufacturing technologies through the ETP and recognized that 
regulatory policies and programs may need to evolve to enable timely 
technological adoption.
    The National Academies of Sciences, Engineering, and Medicine 
issued a 2021 report titled Innovation in Pharmaceutical Manufacturing 
on the Horizon: Technical Challenges, Regulatory Issues, and 
Recommendations, highlighting innovations in integrated pharmaceutical 
manufacturing processes. These innovations could have implications for 
measurement, modeling, and control technologies used in pharmaceutical 
manufacturing. AI may play a significant role in monitoring and 
controlling advanced manufacturing processes.
    This discussion paper presents areas associated with the 
application of AI to pharmaceutical manufacturing that FDA has 
identified for consideration as FDA evaluates our existing risk-based 
regulatory framework. CDER scientific and policy experts identified 
these areas from a comprehensive analysis of existing regulatory 
requirements applicable to the approval of drugs manufactured using AI 
technologies. The areas of consideration in this discussion paper are 
those for which FDA would like public feedback.
    There are additional areas of consideration not covered within this 
document, for example, difficulties that could result from ambiguity on 
how to apply existing regulations to AI or lack of Agency guidance or 
experience. The areas of consideration presented in this discussion 
paper focus on drug products that would be marketed under a new drug 
application (NDA), abbreviated new drug application (ANDA), or biologic 
license application (BLA). Public feedback will help inform CDER's 
evaluation of our existing regulatory framework.
    While the initial analysis focused on products regulated by CDER, 
FDA's CBER has also encountered a rapid emergence of advanced 
manufacturing technologies associated with AI. As such, both CDER and 
CBER stakeholders are invited to provide feedback on the discussion 
questions.

II. Requested Information and Comments

    Interested persons are invited to provide detailed comments to CDER 
and CBER on all aspects described in the discussion paper. To 
facilitate input, FDA has developed a series of questions based on the 
considerations articulated 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. 
In all cases, FDA encourages stakeholders to provide the specific 
rationale and basis for their comments, including any available 
supporting data and information.

    Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04206 Filed 2-28-23; 8:45 am]
BILLING CODE 4164-01-P
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