Notice2025-20643
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Small Dispensers Assessment Under the Drug Supply Chain Security Act
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Published
November 21, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 90 Issue 223 (Friday, November 21, 2025)</title>
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[Federal Register Volume 90, Number 223 (Friday, November 21, 2025)]
[Notices]
[Pages 52678-52680]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-20643]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0668]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Small Dispensers
Assessment Under the Drug Supply Chain Security Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by December 22, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Small Dispensers Assessment Under the Drug
Supply Chain Security Act.'' Also include the FDA docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#326260736146535454725456531c5a5a411c555d44"><span class="__cf_email__" data-cfemail="0a5a584b597e6b6c6c4a6c6e6b24626279246d657c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Small Dispensers Assessment Under the Drug Supply Chain Security Act
OMB Control Number 0910-NEW
I. Information Collection Authority
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 \1\ 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 Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360eee and 360eee-1).
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\1\ As defined by section 581(11) of the FD&C Act, generally,
the term ``package'' means the smallest individual saleable unit or
smallest container of product for distribution by a manufacturer or
repackager that is intended by the manufacturer for ultimate sale to
the dispenser of such product.
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Under enhanced drug distribution security requirements in section
582(g)(1), dispensers and other trading partners will be required to,
among 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 gathering the 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 a suspect or
illegitimate product. These enhanced drug distribution security
requirements are also referred to as ``enhanced product tracing or
enhanced verification.''
We have developed a web page to provide more information to
industry regarding the DSCSA. It is available at <a href="https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa">https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa</a>.
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 (FTEs) conducting
interoperable, electronic tracing of products at the package level.
FDA's proposed study entitled, ``Small Dispensers Assessment under the
Drug Supply Chain Security Act'' (DSCSA Small Dispensers Assessment) is
intended to fulfill this requirement.
As described in section 582(g)(3)(C), issues to be addressed in the
assessment questions are 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. Respondents will
submit information by answering the assessment questions using a link
provided on FDA's website.
II. DSCSA Small Dispensers Assessment
A. Eligibility Requirements
Assessment respondents will include self-identified individuals
representing dispensers with a total of 25 or fewer FTEs (small
dispenser) and individuals representing small dispensers' third-
[[Page 52679]]
party entities (e.g., solution providers, wholesale distributors,
consultants).
B. Potential Issues To Examine and Evaluation Methods
The DSCSA Small Dispensers Assessment will look at the feasibility
of dispensers with a total of 25 or fewer FTEs of conducting
interoperable, electronic tracing of products at the package level. As
part of the qualitative data analysis, respondents will submit
information by answering specific questions for the assessment.
Evaluation methods and analyses are expected to include qualitative
analyses (for example, content analysis for responses), and
quantitative analyses using descriptive statistics. In cases where
quantitative data are collected, descriptive statistics--including
percentages and tabulations--will be calculated and presented, along
with demographic descriptions of respondents. For example, quantitative
analysis could include percentages or tabulations of small dispensers
with access to the necessary software and hardware to meet the
requirements in section 582(g)(1) of the FD&C Act. We have developed a
web page to further assist industry regarding the DSCSA Small
Dispensers Assessment, available at <a href="https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-assessment-small-dispensers">https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-assessment-small-dispensers</a>.
C. Instructions for Accessing the DSCSA Small Dispensers Assessment
After the DSCSA Small Dispensers Assessment is launched,
individuals representing small dispensers interested in participating
will use a link provided on the following web page, <a href="https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-assessment-small-dispensers">https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-assessment-small-dispensers</a>. After accessing
the link, the respondent will confirm they are eligible to participate
by attesting to being a small dispenser, or an entity representing a
small dispenser, before being able to start the questionnaire.
D. Participation
Once the assessment link is made available on FDA's website,
respondents will have 45 days to access the link and complete the
assessment questionnaire. Respondents will be expected to provide
responses to FDA via the assessment link.
E. Recordkeeping
FDA recommends that any records generated by a respondent while
responding to the assessment questionnaire be maintained as an entity
would in the normal course of business. FDA recommends that the
responses to the assessment questionnaire be maintained by the
respondent for at least 1 year after FDA publishes its final report of
the assessment.
G. Initiation of FDA's DSCSA Small Dispensers Assessment
FDA intends to begin the DSCSA Small Dispensers Assessment upon OMB
approval of the proposed collection of information.
III. Burden Estimates
In the Federal Register of March 13, 2024 (89 FR 18415), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comment letters from
pharmaceutical trade associations. We have adjusted our estimated
burden for the information collection to reflect the public comments,
discussed below. These adjustments result in an increase of 30,945
total annual responses and a corresponding increase of 6,327 total
hours from the estimates found in our 60-day notice.
(Comment) Both comment letters expressed concern that the
information collection burden estimates provided in the notice
reflected a decision that our sample size would be limited to 200. One
comment letter estimated that a sample size of 200 would only represent
roughly 1% of the independent pharmacies in the United States. This
comment argued that a 1% sample size would not allow FDA to adequately
assess the cost and burdens on small dispensers or determine
alternative methods of compliance that would not impose economic
hardship on small businesses.
(Response) The estimate of 200 respondents provided in our 60-day
notice represented our best estimate at that time regarding how many
respondents would complete the assessment questionnaire. In this
notice, we have revised our information collection burden estimates by,
among other things, increasing the estimated number of respondents who
will be sent an invitation to 18,430 and increasing the estimated
number of respondents who will complete the assessment questionnaire to
922, as described in section III of this notice. The revised
information collection burden estimates in this notice reflect the
interest we have received regarding the DSCSA Small Dispensers
Assessment. We also note that the intent of the proposed information
collection is to understand the experiences of small dispensers. We
expect this qualitative research to develop descriptions of themes of
those experiences. For the qualitative open-ended questions, past
research indicates that themes reach saturation within dozens of
respondents. For the proportional, multiple-choice questions, the
results will not be analyzed using metrics of statistical confidence
and margins of error.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated One-Time Reporting Burden \1\
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Number of
DSCSA small dispensers Number of responses per Total annual Average burden Total hours
assessment respondents respondent responses per response \2\
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Invitation email................ 18,430 1 18,430 0.1 1,843
Screener........................ 9,215 1 9,215 0.1 922
Assessment questions response... 922 1 922 2 1,844
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Total....................... .............. .............. 28,567 .............. 4,609
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Totals have been rounded to the nearest whole number.
We plan to invite small dispensers to participate in the assessment
by sending an email. We estimate that we will send 18,430 emails to
companies that are on our existing industry stakeholder list. We assume
that all emails we send will be opened and reviewed and estimate that
it will take 0.1 hour (6 minutes) to read the email invitation and
decide
[[Page 52680]]
how to respond to it, for a total of 1,843 hours. We assume that fifty
percent of the companies invited to participate, or 9,215 companies,
will decide to participate, navigate to our web page, and click on the
link to the assessment to access it. Once the company accesses the
assessment, it will be presented with a two-part screening question. We
estimate that all companies will answer the screening question and that
it will take 0.1 hour (6 minutes) to read and answer the screening
question, for a total of 921.5 hours, rounded to 922 hours. We estimate
that only ten percent of those companies, or 921.5 respondents, rounded
to 922 respondents, will complete the entire questionnaire. We estimate
that it will take, based on the various levels of availability and
resources by company, approximately 2 hours on average to compile the
necessary information and to respond to all of the questions in the
assessment questionnaire, for a total of 1,844 hours.
Table 2--Estimated One-Time Recordkeeping Burden \1\
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Number of Average burden
DSCSA small dispenser assessment Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Records related to assessment questions response................... 922 1 922 0.5 461
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We expect that companies will compile information needed to respond
to the questions in the assessment questionnaire and that they will
keep copies of that information in their records either electronically
or on paper. We recommend that companies retain these records for at
least a year after the assessment is completed. We estimate that these
recordkeeping activities will take approximately 0.5 hour per company,
for a total of 461 hours.
Table 3--Estimated One-Time Third-Party Disclosure Burden \1\
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Number of
DSCSA small dispensers assessment Number of disclosures per Total annual Average burden Total
respondents respondent disclosures per disclosure hours \2\
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Coordination with third-party 692 2 1,384 0.1 138
entities related to screener
questions........................
Coordination with third-party 461 2 922 2 1,844
entities related to assessment
questions response...............
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Total......................... .............. ................. 2,306 .............. 1,982
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Totals have been rounded to the nearest whole number.
We have taken into consideration the time that respondents will
spend coordinating with third-party entities (e.g., solution providers,
wholesale distributors, consultants). For the screener questions, we
assume seventy-five percent of the 922 respondents, or 691.5
respondents, rounded to 692, will work with their respective partnering
entities and the average number of partnering entities will be 2, for a
total of 1,384 disclosures. We estimate that each disclosure will take
approximately 0.1 hours (6 minutes) for a total of 138.4 hours, rounded
to 138 hours. For the assessment questionnaire response, we assume
fifty percent of the 922 respondents, or 461 respondents, will
coordinate with a total of two partners for a total of 922 disclosures.
We estimate it will take 2 hours to coordinate with each partner,
resulting in a total of 1,844 hours.
Lowell M. Zeta,
Deputy Commissioner of Strategic Initiatives, Acting, Deputy
Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-20643 Filed 11-20-25; 8:45 am]
BILLING CODE 4164-01-P
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