[Federal Register Volume 89, Number 50 (Wednesday, March 13, 2024)]
[Notices]
[Pages 18415-18418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05294]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-0668]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Proposed 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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on the Proposed Small Dispensers Assessment under the 
Drug Supply Chain Security Act (DSCSA).

DATES: Either electronic or written comments on the collection of 
information must be submitted by May 13, 2024.

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 May 13, 2024. 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-2024-N-0668 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Proposed Small Dispensers 
Assessment under the Drug Supply Chain Security Act (DSCSA).'' 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

[[Page 18416]]

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: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Proposed Small Dispensers Assessment Under the Drug Supply Chain 
Security Act

OMB Control Number 0910-NEW

I. Background

    On November 27, 2013, the 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). 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.
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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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    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. 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.''

II. Proposed DSCSA Small Dispensers Assessment

A. Eligibility Requirements

    Assessment participants will include self-identified individuals 
representing dispensers with a total of 25 or fewer FTEs (small 
dispenser) and individuals representing small dispensers' third-party 
entities (e.g., solution providers, wholesale distributors, 
consultants).

B. Potential Issues To Examine and Evaluation Methods

    The proposed 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 proposed DSCSA Small 
Dispensers Assessment, available at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-assessment-small-dispensers.

C. Proposed Instructions for Enrollment for the Proposed DSCSA Small 
Dispensers Assessment

    After the proposed DSCSA Small Dispensers Assessment is 
established, volunteers interested in participating will enroll by 
submitting participant information using a link to be provided on the 
same web page mentioned above, https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-assessment-small-dispensers. Only one point-of-contact per company 
should be provided for the enrollment.

D. Proposed Content of the Enrollment for the Proposed DSCSA Small 
Dispensers Assessment

    The following information should be included:

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     Contact information (name, email address, phone number, 
mailing address)
     Confirm you are a dispenser that has 25 or fewer FTEs or 
you are an individual representing a small dispensers' third-party 
entity (e.g., solution providers, wholesale distributors, consultants)
     Commitment to answer the questions contained in the 
assessment within 45 days of receiving
     Applicable state license number

E. Participation

    Assessment participants will include those who have met eligibility 
requirements and completed enrollment. The assessment is expected to be 
completed within the proposed duration of 45 days of receiving, and 
participants will be expected to provide responses to FDA via the 
designated FDA online tool/platform.

F. Proposed Recordkeeping

    Any records generated by a participant in the assessment should be 
maintained as an entity would in a normal course of business. FDA 
recommends that the responses that participants create and submit to 
FDA for the assessment be maintained for at least 1 year after FDA 
publishes its final report of the assessment.

G. Initiation of FDA's Proposed DSCSA Small Dispensers Assessment

    FDA does not intend to begin the proposed DSCSA Small Dispensers 
Assessment or accept enrollment to participate in the assessment until 
OMB has approved the proposed collection of information described in 
this notice.
    FDA estimates the burden of this one-time collection of information 
as follows:

                                 Table 1--Estimated Annual 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
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Enrollment......................             200               1             200             0.5             100
Assessment Questions Response...             100               1             100               2             200
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    Total.......................             300  ..............  ..............  ..............             300
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Submitting an enrollment and reporting activities. FDA estimates 
that no more than 200 respondents (i.e., the submitter or point of 
contact) will submit an enrollment, and that it will take, based on the 
various levels of resources by company, an average of 0.5 hours to 
complete an enrollment to FDA. FDA estimates that it will receive no 
more than 100 participants for the assessment. The estimated total time 
for respondents to submit an enrollment to participate in the 
assessment is 100 hours. FDA estimates that it will take, based on the 
various levels of resources by company, an average of 2 hours to 
compile and submit a response to the assessment. The estimated total 
number of hours for submitting a response to the assessment would be 
200 hours. The total hours for the estimated reporting burden are 300 
hours (table 1).

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                    Average burden
     DSCSA small dispensers          Number of      records per    Total annual         per         Total hours
           assessment              recordkeepers   recordkeeper       records      recordkeeping
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Records related to enrollment...             200               1             200             0.5             100
Records related to Assessment                100               1             100             0.5              50
 Questions Response.............
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    Total.......................             300  ..............  ..............  ..............             150
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Recordkeeping activities. Recordkeeping activities include storing 
and maintaining records related to submitting to enroll to participate 
in the assessment and compiling reports. Respondents can use current 
record retention capabilities for electronic or paper storage to 
achieve these activities. FDA estimates that no more than 200 
respondents will have recordkeeping activities related to assessment 
participation. FDA believes that it will take 0.5 hour to ensure that 
the documents related to enrollment to participate in the assessment 
are retained properly for a minimum of 1 year after the assessment is 
completed (as recommended by FDA). The resulting total to maintain the 
records related to submitting a request is 100 hours annually.
    For retaining records related to the response to the assessment 
properly for a minimum of 1 year after the assessment is completed (as 
recommended by FDA), FDA estimates that it will take approximately 0.5 
hour. As noted above, FDA estimates that the 100 respondents will 
submit one response for the assessment. The estimated total for 
maintaining records related to the assessment is 50 hours respectively. 
The total recordkeeping burden is estimated to be 150 hours (table 2).

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                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                     Number of
     DSCSA small dispensers          Number of      disclosures    Total annual   Average burden    Total hours
           assessment               respondents   per respondent    disclosures   per disclosure
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Coordination with third-party                 75               2             150             0.5              75
 entities related to enrollment.
Coordination with third-party                 50               2             100               2             200
 entities related to assessment
 questions response.............
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    Total.......................             125  ..............  ..............  ..............             275
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Third-party disclosure activities. For those assessment 
participants that involve third-party activities, FDA is taking into 
consideration the time that participants will spend coordinating with 
third-party entities (e.g., solution providers, wholesale distributors, 
consultants). For the enrollment, FDA estimates that 75 respondents 
will work with their respective partnering entities and the average 
number of partnering entities will be 2. FDA estimates that each 
respondent will spend 2 hours coordinating with each third-party 
entity. Thus, for 150 respondents with an average of 2 partnering 
entities, the estimated total burden for coordinating with partnering 
entities related to the enrollment is 75 hours. FDA estimates that for 
each of the 100 lists of assessment responses, it will take 
approximately 2 hours to coordinate with each partner, resulting in a 
total of 200 hours. The total estimation for third-party disclosure 
burden is 275 hours (table 3).

    Dated: March 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05294 Filed 3-12-24; 8:45 am]
BILLING CODE 4164-01-P