Notice2023-17140
Development of Small Dispensers Assessment Under the Drug Supply Chain Security Act; Request for Comments
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Published
August 10, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is seeking stakeholder comments on the development of a technology and software assessment that examines the feasibility of dispensers with 25 or fewer full-time employees conducting interoperable, electronic tracing of products at the package level. FDA would like to obtain information regarding issues to be addressed in the assessment related to the accessibility of the necessary software and hardware to such dispensers; whether the necessary software and hardware is prohibitively expensive to obtain, install, and maintain for such dispensers; and if the necessary hardware and software can be integrated into business practices.
Full Text
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<title>Federal Register, Volume 88 Issue 153 (Thursday, August 10, 2023)</title>
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[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54320-54322]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17140]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3103]
Development of Small Dispensers Assessment Under the Drug Supply
Chain Security Act; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is seeking
stakeholder comments on the development of a technology and software
assessment that examines the feasibility of dispensers with 25 or fewer
full-time employees conducting interoperable, electronic tracing of
products at the package level. FDA would like to obtain information
regarding issues to be addressed in the assessment related to the
accessibility of the necessary software and hardware to such
dispensers; whether the necessary software and hardware is
prohibitively expensive to obtain, install, and maintain for such
dispensers; and if the necessary hardware and software can be
integrated into business practices.
DATES: Either electronic or written comments on the notice must be
submitted by September 11, 2023.
ADDRESSES: 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 September 11, 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:
[[Page 54321]]
<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-2023-N-3103 for ``Development of Small Dispensers Assessment under
the Drug Supply Chain Security Act; 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: Daniel Bellingham, Office of
Compliance, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-3130, <a href="/cdn-cgi/l/email-protection#3f5b5e51565a53115d5a5353565158575e527f595b5e1157574c11585049"><span class="__cf_email__" data-cfemail="4e2a2f20272b22602c2b2222272029262f230e282a2f6026263d60292138">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
On November 27, 2013, the Drug Supply Chain Security Act (DSCSA)
(Title II of Pub. L. 113-54) was signed into law. The DSCSA outlines
steps to achieve interoperable, electronic tracing of products at the
package level to identify and trace certain prescription drugs as they
are distributed in the United States. Section 202 of the DSCSA added
the new sections 581 and 582 to the Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360eee and 360eee-1). Under section 582(g)(3), FDA is
required to enter into a contract with a private, independent
consulting firm with expertise to conduct a technology and software
assessment that looks at the feasibility of dispensers with 25 or fewer
full-time employees conducting interoperable, electronic tracing of
products at the package level. Under section 582(g)(1), dispensers and
other trading partners will be required to, amongst other requirements,
exchange transaction information and transaction statements in a
secure, interoperable, electronic manner for each package; implement
systems and processes for package-level verification, including the
standardized numerical identifier; and implement systems and processes
to facilitate the gathering of information necessary to produce the
transaction information and statement for each transaction going back
to the manufacturer if FDA or a trading partner requests an
investigation in the event of a recall or for purposes of investigating
a suspect or illegitimate product. These enhanced drug distribution
security requirements are also referred to as ``enhanced product
tracing'' or ``enhanced verification.''
II. Purpose of the Request for Comments
FDA is issuing this request for public comments prior to beginning
the assessment, in accordance with section 582(g)(3)(D). The statement
of work requires the selected firm to conduct an assessment that will
address the proposed questions articulated below. In addition to
commenting on the proposed questions below, stakeholders may provide
comments on any aspect of the small dispenser assessment under the
DSCSA.
Stakeholders that may be interested in responding to this request
for information include manufacturers, repackagers, wholesale
distributors, dispensers, State and Federal authorities, solution
providers, and standards organizations, among others. FDA is
particularly interested in receiving comments from the various sectors
of the dispenser community, particularly pharmacies. FDA is seeking
comments on the following proposed questions for small dispensers
(i.e., dispensers with 25 or fewer full-time employees). We are
interested in receiving feedback on the questions themselves and
whether or not they should be edited to be more useful for the
assessment. FDA is also interested in any new questions that
stakeholders may recommend.
<bullet> Have you begun preparations for DSCSA requirements
regarding the interoperable, electronic tracing of products at the
package level required under section 582(g)(1) of the FD&C Act (i.e.,
enhanced product tracing or enhanced verification)?
<bullet> How are you currently exchanging data with your trading
partners (e.g., by
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paper-based methods, electronic methods, or both)?
<bullet> If not currently exchanging data with trading partners in
a fully electronic manner, will you be able to in the near future? If
not, what are the barriers? Elaborate on why or how, as appropriate.
Please specify issues related to:
<bullet> accessibility of necessary software and hardware;
<bullet> cost to obtain, install, and maintain necessary software
and hardware, particularly if it is prohibitively expensive;
<bullet> integration of necessary software and hardware into
business practices, such as with wholesale distributors;
<bullet> other relevant information related to feasibility of
dispensers with 25 or fewer full-time employees to conduct
interoperable, electronic tracing of product at the package level.
<bullet> What type of software systems and hardware do you
currently utilize to facilitate the electronic exchange of DSCSA-
related data for transactions of products?
<bullet> What new or modified software systems and hardware do you
anticipate putting in place to comply with the interoperable,
electronic tracing requirements?
<bullet> How likely are you to change and upgrade your existing
software systems that are already in use so that you can comply with
the interoperable, electronic tracing requirements?
<bullet> Have you or do you plan to connect your system(s) with
your trading partner(s) (e.g., manufacturer(s), repackager(s), or
wholesale distributor(s)) in order to facilitate electronic DSCSA-
related data exchange? If so, have you experienced technical issues
when attempting to establish connectivity? If not, how do you or how do
you plan to manage electronic DSCSA-related data received from an
upstream trading partner (e.g., maintain the data in your dispenser
system or use a third-party agreement for another entity to
confidentially maintain the DSCSA-related data on your behalf (e.g.,
use of a secure web portal provided by your wholesale distributor))?
<bullet> Have you considered data integrity and security concerns
when establishing agreements with third-party entities (e.g., solution
providers or wholesale distributors) for electronic data exchange and
maintenance?
<bullet> Have you ever received transaction information from a
trading partner, such as your wholesale distributor, that does not
match the product that you received? If so, how long did it take to
resolve the discrepancy on average? What if any unique challenges arose
from these situations? How often does this happen?
<bullet> If you currently routinely scan a 2D data matrix barcode,
how often do you receive a 2D data matrix barcode of the product
identifier that cannot be scanned or read? Why are you unable to scan
or read the 2D data matrix barcode (e.g., barcode quality, scanner
performance, software issue) and what is your process for handling
these situations, including when manual steps are taken by your staff
when an automated process was inadequate or failed?
<bullet> If you currently routinely scan the 2D data matrix
barcode, how often you encounter a 2D data matrix barcode with missing
or inaccurate data? What are the reasons for this and what is your
process for handling these situations, including when manual steps are
taken by your staff when an automated process was inadequate or failed?
<bullet> What new demands do you expect the DSCSA requirements in
section 582(g)(1) of the FD&C Act to have on your current staff
resources?
<bullet> How long do you expect it will take to train staff on the
new requirements, how to use any new software or hardware, and any
process changes? What additional resources do you anticipate needing to
comply with the interoperable, electronic tracing requirements?
<bullet> Are there additional challenges not already identified
when operationalizing new systems and processes for interoperable,
electronic tracing of products at the package level required under
section 582(g)(1) of the FD&C Act (i.e., enhanced product tracing or
enhanced verification)?
Stakeholders may provide other relevant information that may inform
the development of the small dispenser assessment under the DSCSA.
Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17140 Filed 8-9-23; 8:45 am]
BILLING CODE 4164-01-P
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