[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54320-54322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17140]


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

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.

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

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 https://www.regulations.gov 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]]

     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-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 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: 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, [email protected].

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.
     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)?
     How are you currently exchanging data with your trading 
partners (e.g., by

[[Page 54322]]

paper-based methods, electronic methods, or both)?
     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:
     accessibility of necessary software and hardware;
     cost to obtain, install, and maintain necessary software 
and hardware, particularly if it is prohibitively expensive;
     integration of necessary software and hardware into 
business practices, such as with wholesale distributors;
     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.
     What type of software systems and hardware do you 
currently utilize to facilitate the electronic exchange of DSCSA-
related data for transactions of products?
     What new or modified software systems and hardware do you 
anticipate putting in place to comply with the interoperable, 
electronic tracing requirements?
     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?
     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))?
     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?
     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?
     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?
     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?
     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?
     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?
     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