[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67047-67049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24212]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2671]


Drug Supply Chain Security Act Implementation and Readiness 
Efforts for 2023; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following virtual public meeting entitled ``Drug Supply 
Chain Security Act Implementation and Readiness Efforts for 2023'' to 
allow supply chain stakeholders an opportunity to share their 
perspectives. The topics to be discussed are stakeholder experiences 
with implementation and overall readiness regarding implementation of 
enhanced drug distribution security requirements that will go into 
effect on November 27, 2023, standards for the interoperable data 
exchange of product tracing information, requests for product tracing 
information or verification from FDA for the purpose of investigating 
suspect or illegitimate products or for recalls, steps taken to build 
capacity for package-level tracing, pharmaceutical distribution supply 
chain best practices, and, in general, the impact that the Drug Supply 
Chain Security Act (DSCSA) requirements would have on public health, 
including patient safety and access to prescription drugs, and on

[[Page 67048]]

stakeholders, in terms of costs, benefits, and regulatory burden.

DATES: The public meeting will be held on December 7 and 8, 2022, from 
10 a.m. to 3 p.m. eastern time and will take place virtually. Either 
electronic or written comments on this public meeting must be submitted 
by February 6, 2023. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public meeting will be held virtually and hosted by FDA.
    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 February 6, 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-2022-N-2671 for ``Drug Supply Chain Security Act Implementation and 
Readiness Efforts for 2023; Public Meeting; Request for 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: Kristle Green, Office of Compliance, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave. Silver Spring, MD 20993, 301-796-3130, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, the DSCSA (title II, Pub. L. 113-54) was 
signed into law. The DSCSA outlines critical steps to achieve 
electronic, interoperable tracing at the package level by 2023 to 
identify and trace certain prescription drugs as they are distributed 
within the United States. DSCSA requirements enhance FDA's ability to 
protect U.S. consumers from exposure to drugs that may be counterfeit, 
diverted, stolen, intentionally adulterated, or otherwise harmful by 
improving the detection and removal of potentially dangerous drugs from 
the drug supply chain.
    Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 360eee-1(g)(1)) imposed requirements for enhanced drug 
distribution security that go into effect on November 27, 2023. Section 
582(i) of the FD&C Act directs FDA to hold public meetings to enhance 
the safety and security of the pharmaceutical distribution supply chain 
and provide opportunities for comment from members of the 
pharmaceutical distribution supply chain and other interested 
stakeholders. Since enactment of the law, FDA has held multiple public 
meetings that address specific topics as they relate to implementation 
of DSCSA requirements. As the capabilities of the pharmaceutical 
distribution supply chain have progressed and matured, this public 
meeting will be used to gather stakeholder perspectives on DSCSA 
implementation.

II. Topics for Discussion at the Public Meeting

     Stakeholder experiences with implementation and overall 
readiness regarding implementation of enhanced drug distribution 
security requirements that will go into effect on November 27, 2023.
     DSCSA standards for the interoperable data exchange of 
product tracing information for enhanced product tracing and 
verification.
     FDA requests to trading partners for product tracing 
information, verification for the purpose of investigations of suspect 
or illegitimate products, or recalls to support enhanced drug

[[Page 67049]]

distribution requirements under section 582(g) of the FD&C Act.
     Steps taken by the pharmaceutical distribution supply 
chain to build capacity for package-level tracing, including the 
ability of the healthcare system to maintain patient access to 
medicines, scalability of DSCSA requirements, and best practices.
     Technical capabilities and legal authorities, if any, 
needed to establish interoperable, electronic product tracing at the 
package level.
     General impact that the DSCSA requirements would have on 
public health, including patient safety and access to prescription 
drugs, and on stakeholders, in terms of costs, benefits, and regulatory 
burden.
    If other topics are identified as appropriate, FDA will post these 
on the designated public meeting web page prior to the meeting.

III. Participating in the Public Meeting

    Registration: This will be a virtual public meeting and there are 
no fees for this meeting. FDA may limit registration once the meeting 
capacity is reached. Individuals who wish to attend the general session 
of the public meeting must register by December 2, 2022, and provide 
the following information on the public meeting registration page: Your 
name, organization name, stakeholder type, email address, and telephone 
number to FDA at https://dscsapublicmeeting2022.eventbrite.com. Meeting 
information for virtual participation will be emailed by December 5, 
2022, to those that registered.
    If you need special accommodations due to a disability, please 
contact Kristle Green (see FOR FURTHER INFORMATION CONTACT) no later 
than 7 days before the public meeting.
    Breakout Sessions: Any person interested in participating in small 
group discussions must register by November 28, 2022, following the 
instructions above, and indicate your request for breakout session 
participation. There will be no same-day registration for breakout 
sessions. FDA will organize breakout sessions based on registration and 
interest to help ensure varied stakeholder representation, including 
across the pharmaceutical distribution supply chain. FDA may limit the 
number of participants from each organization if interest exceeds 
breakout session capacity.
    Request for Oral Presentations: Any person interested in presenting 
during the public meeting must register by November 28, 2022, following 
the instructions above, and indicate your request to present. There 
will be no same-day registration for oral presentations. FDA will do 
its best to accommodate requests for oral presentations. Individuals 
and organizations with common interests are encouraged to consolidate 
or coordinate their presentations and can submit a single request to 
present. Time allotted for each presentation will depend on the number 
of requests received and may be limited.
    FDA has verified the website addresses in this document, as of the 
date this document publishes in the Federal Register, but websites are 
subject to change over time.
    Other Issues for Consideration: FDA will provide a recording of the 
public meeting and materials from the meeting at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa-implementation-and-readiness-efforts-2023-12072022 after the public meeting.

    Dated: November 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24212 Filed 11-4-22; 8:45 am]
BILLING CODE 4164-01-P