Notice2024-05294
Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 13, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 89 Issue 50 (Wednesday, March 13, 2024)</title>
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[Federal Register Volume 89, Number 50 (Wednesday, March 13, 2024)]
[Notices]
[Pages 18415-18418]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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:
<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-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 <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
[[Page 18416]]
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: 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,
<a href="/cdn-cgi/l/email-protection#4b1b190a183f2a2d2d0b2d2f2a65232338652c243d"><span class="__cf_email__" data-cfemail="39696b786a4d585f5f795f5d581751514a175e564f">[email protected]</span></a>.
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 <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. 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, <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>. 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:
[[Page 18417]]
<bullet> Contact information (name, email address, phone number,
mailing address)
<bullet> 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)
<bullet> Commitment to answer the questions contained in the
assessment within 45 days of receiving
<bullet> 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
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