Notice2022-24212
Drug Supply Chain Security Act Implementation and Readiness Efforts for 2023; Public Meeting; Request for Comments
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Published
November 7, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 stakeholders, in terms of costs, benefits, and regulatory burden.
Full Text
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<title>Federal Register, Volume 87 Issue 214 (Monday, November 7, 2022)</title>
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[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67047-67049]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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:
<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-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 <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 <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: 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,
<a href="/cdn-cgi/l/email-protection#46050203140902150f141633242a2f250b2323322f28213506202227682e2e3568212930"><span class="__cf_email__" data-cfemail="b6f5f2f3e4f9f2e5ffe4e6c3d4dadfd5fbd3d3c2dfd8d1c5f6d0d2d798dedec598d1d9c0">[email protected]</span></a>.
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
<bullet> Stakeholder experiences with implementation and overall
readiness regarding implementation of enhanced drug distribution
security requirements that will go into effect on November 27, 2023.
<bullet> DSCSA standards for the interoperable data exchange of
product tracing information for enhanced product tracing and
verification.
<bullet> 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
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distribution requirements under section 582(g) of the FD&C Act.
<bullet> 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.
<bullet> Technical capabilities and legal authorities, if any,
needed to establish interoperable, electronic product tracing at the
package level.
<bullet> 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 <a href="https://dscsapublicmeeting2022.eventbrite.com">https://dscsapublicmeeting2022.eventbrite.com</a>. 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 <a href="https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa-implementation-and-readiness-efforts-2023-12072022">https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa-implementation-and-readiness-efforts-2023-12072022</a> 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
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