Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act, 18415-18418 [2024-05294]
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<![CDATA[
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Federal Register / Vol. 89, No. 50 / Wednesday, March 13, 2024 / Notices
Estimated Program Burden:
ACL estimates the annual burden
associated with this collection of
information as follows:
Number of
respondents
Respondent/data collection activity
Responses
per
respondent
Hours
per
response
Annual
burden
hours
Area Agency on Aging: Respondent selection process ..................................
Service recipients (i.e., Congregate and Home-Delivered Meal nutrition programs, Case Management, Homemaker, Transportation services) + Rotating Module ................................................................................................
National Family Caregiver Support Program clients + Rotating Module ........
300
1
4.0
1,200
4,000
2,000
1
1
0.75
0.75
3,000
1,500
Total ..........................................................................................................
6,300
1
* 0.90
5,700
* Weighted mean.
Dated: March 7, 2024.
Alison Barkoff,
Principal Deputy Administrator for the
Administration for Community Living,
performing the delegable duties of the
Administrator and the Assistant Secretary for
Aging.
[FR Doc. 2024–05310 Filed 3–12–24; 8:45 am]
BILLING CODE 4154–01–P
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.
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
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SUMMARY:
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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
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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
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Federal Register / Vol. 89, No. 50 / Wednesday, March 13, 2024 / Notices
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/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, PRAStaff@fda.hhs.gov.
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.
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SUPPLEMENTARY INFORMATION:
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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.
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.’’
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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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’ thirdparty 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/drugsupply-chain-security-act-dscsa/drugsupply-chain-security-act-dscsaassessment-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-supplychain-security-act-dscsa/drug-supplychain-security-act-dscsa-assessmentsmall-dispensers. Only one point-ofcontact 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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Federal Register / Vol. 89, No. 50 / Wednesday, March 13, 2024 / Notices
• 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 onetime collection of information as
follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
DSCSA small dispensers assessment
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Enrollment ............................................................................
Assessment Questions Response .......................................
200
100
1
1
200
100
0.5
2
100
200
Total ..............................................................................
300
........................
........................
........................
300
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
Number of
recordkeepers
DSCSA small dispensers assessment
Total annual
records
Average
burden per
recordkeeping
Total hours
Records related to enrollment .............................................
Records related to Assessment Questions Response ........
200
100
1
1
200
100
0.5
0.5
100
50
Total ..............................................................................
300
........................
........................
........................
150
1 There
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Number of
records per
recordkeeper
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
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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
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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
Number of
respondents
DSCSA small dispensers assessment
Average
burden per
disclosure
Total annual
disclosures
Total hours
Coordination with third-party entities related to enrollment
Coordination with third-party entities related to assessment
questions response ..........................................................
75
2
150
0.5
75
50
2
100
2
200
Total ..............................................................................
125
........................
........................
........................
275
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Annual Reportable Labeling Changes
for New Drug Applications and
Abbreviated New Drug Applications for
Nonprescription Drug Products; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a draft
guidance for industry entitled ‘‘Annual
Reportable Labeling Changes for NDAs
SUMMARY:
VerDate Sep<11>2014
17:33 Mar 12, 2024
Jkt 262001
and ANDAs for Nonprescription Drug
Products.’’ This draft guidance provides
recommendations to applicants of
approved new drug applications (NDAs)
and abbreviated new drug applications
(ANDAs) for nonprescription drug
products on documenting minor
labeling changes in the next annual
report and provides examples of minor
labeling changes that may be submitted
in an annual report. The
recommendations in this draft guidance
address the types of minor labeling
changes that may be appropriate to
submit in an annual report to ensure
that consumers have timely access to
the most current labeling for a
nonprescription drug product to ensure
the product’s safe and effective use. We
anticipate that these recommendations
may assist industry in understanding
the circumstances in which it would be
appropriate to document minor changes
in the applicant’s next annual report
rather than submitting a prior approval
supplement or ‘‘changes being effected’’
supplement, thereby reducing burden
on industry and FDA.
DATES: Submit either electronic or
written comments on the draft guidance
by May 13, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
[Docket No. FDA–2023–D–5616]
lotter on DSK11XQN23PROD with NOTICES1
Number of
disclosures
per
respondent
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
PO 00000
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Sfmt 4703
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–D–5616 for ‘‘Annual Reportable
Labeling Changes for NDAs and ANDAs
for Nonprescription Drug Products.’’
Received comments 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
E:\FR\FM\13MRN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
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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:
[[Page 18417]]
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
