Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pilot Project Program Under the Drug Supply Chain Security Act, 22085-22087 [2018-10051]
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Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices
The DSCSA Pilot Project Program
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: May 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10046 Filed 5–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0407]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Pilot Project
Program Under the Drug Supply Chain
Security Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by June 11,
2018.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Pilot Project Program Under the
Drug Supply Chain Security Act.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
sradovich on DSK3GMQ082PROD with NOTICES
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance:
SUPPLEMENTARY INFORMATION:
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OMB Control Number 0910—NEW
FDA will be establishing the Drug
Supply Chain Security Act (DSCSA)
(Title II of Pub. L. 113–54) Pilot Project
Program to implement section 582(j) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360eee–1).
This program will assist FDA in
developing an interoperable, electronic
system to identify and trace certain
prescription drugs as the drugs are
distributed in the United States by the
year 2023. The Pilot Project Program
goals include assessing the ability of
supply chain members to: (1) Satisfy the
requirements of section 582 of the FD&C
Act; (2) identify, manage, and prevent
the distribution of suspect and
illegitimate products as defined in
section 581(21) and (8) of the FD&C Act
(21 U.S.C. 360eee(21) and (8)),
respectively; and (3) demonstrate the
electronic, interoperable exchange of
product tracing information across the
pharmaceutical distribution supply
chain, in addition to identifying the
system attributes needed to implement
the requirements of section 582 of the
FD&C Act, particularly the requirement
to utilize a product identifier for
product tracing purposes. FDA plans to
coordinate with stakeholders that reflect
the diversity of the pharmaceutical
distribution supply chain, including
large and small entities from all
industry sectors.
Title: The DSCSA Pilot Project
Program.
Description of Respondents:
Respondents of this collection of
information are participants from the
pharmaceutical distribution supply
chain (authorized manufacturers,
repackagers, wholesale distributors, and
dispensers) and other stakeholders.
Background Information: FDA will be
seeking pilot project participants from
the pharmaceutical distribution supply
chain (authorized manufacturers,
repackagers, wholesale distributors, and
dispensers) and other stakeholders. FDA
expects that participants will propose
the design and execution of their pilot
project in their submission to FDA;
however, FDA also intends to meet with
all pilot project participants to ensure
that lessons learned from the pilot
project(s) will inform FDA’s
development of the electronic,
interoperable system that will take effect
in 2023. FDA encourages supply chain
members to focus their proposed pilot
project(s) on the DSCSA requirements
related to the interoperable, electronic
tracing of products at the package level.
Specifically, the pilot project(s) should
focus on the requirements for package-
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22085
level tracing and verification that take
effect in 2023. Such pilot projects will
be more useful than pilot projects
dedicated to lot-level tracing. If there are
adequate pilot project submissions, FDA
may establish more than one pilot
project to accomplish the goals of the
DSCSA Pilot Project Program.
Because there is an information
collection under the PRA associated
with the DSCSA Pilot Project Program,
this Federal Register notice is being
issued as part of the process for OMB
approval to collect this information.
After OMB approval of this information
collection, FDA will accept applications
to participate in the program and will
select qualified applications. FDA will
announce OMB’s approval in the
Federal Register, the date that
applications may be submitted, and
application submission procedures.
In the Federal Register of July 20,
2017 (82 FR 33497), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. A summary of the
comments and FDA’s responses are as
follows.
(Comment 1) Several comments raised
concerns with the proposed timelines
related to initiation of pilot projects,
duration of pilot projects, and final
reports. One comment expressed
concern that 4 months (after receiving a
letter of acceptance from FDA) may not
be enough time for a potential
participant to be ready to initiate their
pilot project. Another comment
suggested that the proposed duration of
pilot projects (no more than 6 months)
should be longer and FDA should give
the participant(s) more flexibility to
conduct the pilot project. In addition,
another comment expressed concern
with the proposed requirement that
final reports be completed within 30
days, because that may not be enough
time to complete a final report.
(Response 1) The proposed timelines
were intended to enable completion of
FDA’s Pilot Project Program within 1
year of the start date. FDA would like
to complete the program in a timely
manner so that the information learned
can be shared and utilized by supply
chain participants as they prepare and
implement remaining DSCSA
requirements that take effect between
2018 and 2023. To optimize the
program, FDA expects pilot project
participants to be ready to initiate their
pilot project within 4 months after
receiving a letter of acceptance from
FDA. This will help ensure that
participants have worked out funding,
resources, planning, and other issues in
advance of initiation of the pilot project.
FDA provided flexibility in the program
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Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices
by allowing the Agency to consider pilot
projects that may go beyond a 6-month
period; however, a pilot project duration
of 6 months or less is preferred.
(Comment 2) Another comment
requested clarification of the proposed
process for selecting participants. The
comment expressed concern that FDA’s
Pilot Project Program may include only
those entities that are most engaged in
DSCSA implementation currently. The
comment also described concern that
the findings and results may not
accurately reflect the current
environment, because the program may
not include supply chain members with
fewer resources, less sophisticated
compliance methods, or that are not as
closely connected as other trading
partners.
(Response 2) Participation in the Pilot
Project Program is open to anyone in the
pharmaceutical distribution supply
chain (authorized manufacturers,
repackagers, wholesale distributors, and
dispensers) and other stakeholders. FDA
plans to coordinate with stakeholders
that reflect the diversity of the
pharmaceutical distribution supply
chain, including large and small entities
from all industry sectors. FDA expects
that participants will propose the design
and execution of their pilot project in
their submission to FDA, which may
include coordination with partnering
entities. Such coordination may help
resolve some of the concern that the
findings and results may not accurately
reflect the current environment of
supply chain members that may have
fewer resources or less sophisticated
compliance methods.
(Comment 3) Another comment did
not support FDA considering products
for eligibility in proposed pilot projects
that may be outside the scope of the
DSCSA definition of ‘‘product,’’ such as
over-the-counter medications. The
comment suggested that if FDA is
expanding the scope of pilot projects to
include additional products, then the
timeline for pilot projects would need to
be delayed beyond 2023 to allow
sufficient time for supply chain
participants to adjust to the needs of
these expanded pilots.
(Response 3) Allowing FDA to
consider products eligible for the Pilot
Project Program that may be outside the
DSCSA definition of ‘‘product’’ was
intended to provide flexibility to
potential participants that may choose
to test a process or system involving
broader categories of products.
Including products that are outside the
DSCSA definition in pilot projects is not
a requirement; however, we believe
there may be an opportunity to learn
from such pilot projects. This
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consideration does not justify a need to
delay the timeline for the pilot projects
beyond 2023. It will be up to
participants to propose the design and
execution of their pilot project in their
submission to FDA. FDA will consider
multiple factors to ensure that the pilot
project(s) selected for the program will
support the program goals.
(Comment 4) Another comment
believed that having pilot participants
fund their pilot projects would conflict
with the need to include a diverse set
of supply chain stakeholders because
some supply chain stakeholders do not
have the resources to participate in a
pilot project.
(Response 4) There is no FDA funding
for the Pilot Project Program provided in
the DSCSA, and participation is on a
volunteer basis. FDA plans to
coordinate with stakeholders that reflect
the diversity of the pharmaceutical
distribution supply chain, including
large and small entities from all
industry sectors. FDA expects
participants to be responsible for
funding and providing resources to
support the pilot projects. Participants
will develop and propose the design
and execution of their pilot project in
their submission to FDA, which may
include coordination with partnering
entities in a manner that may resolve
resource concerns.
Reporting Burden Estimates: FDA
estimates that no more than 10
respondents will submit a request to
participate, and that it will take
approximately 80 hours to complete a
request and submit the request to FDA.
FDA estimates that it will select no
more than eight respondents for the
pilot program. The estimated total time
for respondents to submit a request to
participate in the program is 800 hours.
Once the request to participate is
accepted, the submitter is now a
participant of the DSCSA Pilot Project
Program. FDA estimates that the eight
respondents (i.e., participants) will
submit an average of five progress
reports to FDA. Because the duration of
a pilot project should not exceed 6
months, the frequency of the progress
reports will vary based on the length of
the individual pilot project. Pilot
projects of relatively shorter duration
may result in shorter time intervals
between progress reports so that the
reports will be sufficient to capture
progress while the pilot project is
ongoing. FDA estimates that it will take
approximately 8 hours to compile and
submit each progress report. The
estimated total number of hours for
submitting progress reports would be
320 hours. After completion of their
pilot project, each participant will
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provide one final report to FDA. FDA
estimates that it will take the eight
participants approximately 40 hours to
submit a final report. The estimated
total number of hours for submitting the
final report is 320 hours. The total hours
for the estimated reporting burden are
1,440 hours (table 1).
Recordkeeping Burden Estimates:
Recordkeeping activities include storing
and maintaining records related to
submitting a request to participate in the
program 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 10
respondents will have recordkeeping
activities related to program
participation. FDA believes that it will
take 0.5 hour/year to ensure that the
documents related to submitting a
request to participate in the program are
retained properly for a minimum of 1
year after the pilot project is completed
(as recommended by FDA). The
resulting total to maintain the records
related to submitting a request is 5
hours annually. For retaining records
related to progress reports and the final
report properly for a minimum of 1 year
after the pilot project is completed (as
recommended by FDA), FDA estimates
that it will take approximately 0.5 hour/
year. As noted previously, FDA
estimates that the eight respondents will
submit an average of five progress
reports and one final report to FDA. The
estimated total for maintaining progress
reports and the final report is 20 and 4
hours, respectively. The total
recordkeeping burden is estimated to be
29 hours (table 2).
In developing its burden estimate for
records associated with the proposed
pilot projects, FDA has taken account of
existing industry practices for
maintaining records in the normal
course of their business. In particular,
FDA is aware of various supply chain
stakeholders that have conducted pilot
projects over the past few years,
including some pilot projects that
occurred before the DSCSA was
enacted. These pilot projects covered
topics related to serialization,
movement of product data, aggregation
of data, and verification of product
identifiers of returned products.
Members of the supply chain who
conduct pilot projects of their own
accord created associated records as a
matter of usual and customary business
practice. Therefore, FDA considers these
activities associated with a pilot project
to be usual and customary business
practice, and the burden estimates for
like records are not included in the
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Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices
calculation of the recordkeeping burden
(see 5 CFR 1320.3(b)(2)).
Third-Party Disclosure Burden
Estimates: For those pilot projects that
involve a participant composed of
partnering entities in the program, FDA
is taking into consideration the time that
partnering entities will spend
coordinating with each other during a
pilot project. For the initial request to
participate, FDA estimates that eight
respondents will work with their
respective partnering entities, and the
average number of partnering entities
will be two. FDA estimates that each
respondent will spend 8 hours
coordinating with each partnering
entity. Thus, for 8 respondents with an
average of 2 partnering entities, the
estimated total burden for coordinating
with partnering entities related to the
submission of the request to participate
in the program is 128 hours. FDA
estimates that seven respondents will
need to coordinate with an average of
two partnering entities to create
progress reports and the final report to
submit to FDA. Earlier, FDA estimated
that an average of five progress reports
will be submitted to FDA per
respondent. If a respondent has an
average of 2 partners, it will coordinate
10 times with those partners on the
progress reports. FDA estimates that for
each progress report, it will take 4 hours
to coordinate with each partner,
resulting in a total of 280 hours. FDA
estimates that for each final report, it
will take approximately 20 hours to
coordinate with each partner, resulting
in a total of 280 hours. The total
estimation for third-party disclosure
burden is 688 hours (table 3).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
DSCSA pilot project program
Average
burden per
response
Total annual
responses
Total hours
Requests to participate ............................................
Progress reports ......................................................
Final report to FDA ..................................................
10
8
8
1
5
1
10
40
8
80
8
40
800
320
320
Total ..................................................................
........................
............................
........................
................................
1,440
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
records per
recordkeeper
Number of
recordkeepers
DSCSA pilot project program
Total annual
records
Average
burden per
recordkeeping
Total hours
Records related to requests to participate ..............
Records related to progress reports .......................
Records related to the final report to FDA ..............
10
8
8
1
5
1
10
40
8
0.5 (30 minutes) .....
0.5 (30 minutes) .....
0.5 (30 minutes) .....
5
20
4
Total ..................................................................
........................
............................
........................
................................
29
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Coordination with partnering entities related to requests to participate .............................................
Coordination with partnering entities related to
progress reports ...................................................
Coordination with partnering entities related to final
reports ..................................................................
Total ..................................................................
1 There
Number of
disclosures per
respondent
Number of
respondents
DSCSA pilot project program
Average
burden per
disclosure
Total annual
disclosures
8
2
16
8
128
7
10
70
4
280
7
2
14
20
280
........................
............................
........................
................................
688
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
sradovich on DSK3GMQ082PROD with NOTICES
[FR Doc. 2018–10051 Filed 5–10–18; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22085-22087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10051]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0407]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Pilot Project Program
Under the Drug Supply Chain Security Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 (PRA).
DATES: Fax written comments on the collection of information by June
11, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-NEW and
title ``Pilot Project Program 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,
[email protected].
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:
The DSCSA Pilot Project Program
OMB Control Number 0910--NEW
FDA will be establishing the Drug Supply Chain Security Act (DSCSA)
(Title II of Pub. L. 113-54) Pilot Project Program to implement section
582(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360eee-1). This program will assist FDA in developing an
interoperable, electronic system to identify and trace certain
prescription drugs as the drugs are distributed in the United States by
the year 2023. The Pilot Project Program goals include assessing the
ability of supply chain members to: (1) Satisfy the requirements of
section 582 of the FD&C Act; (2) identify, manage, and prevent the
distribution of suspect and illegitimate products as defined in section
581(21) and (8) of the FD&C Act (21 U.S.C. 360eee(21) and (8)),
respectively; and (3) demonstrate the electronic, interoperable
exchange of product tracing information across the pharmaceutical
distribution supply chain, in addition to identifying the system
attributes needed to implement the requirements of section 582 of the
FD&C Act, particularly the requirement to utilize a product identifier
for product tracing purposes. FDA plans to coordinate with stakeholders
that reflect the diversity of the pharmaceutical distribution supply
chain, including large and small entities from all industry sectors.
Title: The DSCSA Pilot Project Program.
Description of Respondents: Respondents of this collection of
information are participants from the pharmaceutical distribution
supply chain (authorized manufacturers, repackagers, wholesale
distributors, and dispensers) and other stakeholders.
Background Information: FDA will be seeking pilot project
participants from the pharmaceutical distribution supply chain
(authorized manufacturers, repackagers, wholesale distributors, and
dispensers) and other stakeholders. FDA expects that participants will
propose the design and execution of their pilot project in their
submission to FDA; however, FDA also intends to meet with all pilot
project participants to ensure that lessons learned from the pilot
project(s) will inform FDA's development of the electronic,
interoperable system that will take effect in 2023. FDA encourages
supply chain members to focus their proposed pilot project(s) on the
DSCSA requirements related to the interoperable, electronic tracing of
products at the package level. Specifically, the pilot project(s)
should focus on the requirements for package-level tracing and
verification that take effect in 2023. Such pilot projects will be more
useful than pilot projects dedicated to lot-level tracing. If there are
adequate pilot project submissions, FDA may establish more than one
pilot project to accomplish the goals of the DSCSA Pilot Project
Program.
Because there is an information collection under the PRA associated
with the DSCSA Pilot Project Program, this Federal Register notice is
being issued as part of the process for OMB approval to collect this
information. After OMB approval of this information collection, FDA
will accept applications to participate in the program and will select
qualified applications. FDA will announce OMB's approval in the Federal
Register, the date that applications may be submitted, and application
submission procedures.
In the Federal Register of July 20, 2017 (82 FR 33497), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. A summary of the comments and FDA's
responses are as follows.
(Comment 1) Several comments raised concerns with the proposed
timelines related to initiation of pilot projects, duration of pilot
projects, and final reports. One comment expressed concern that 4
months (after receiving a letter of acceptance from FDA) may not be
enough time for a potential participant to be ready to initiate their
pilot project. Another comment suggested that the proposed duration of
pilot projects (no more than 6 months) should be longer and FDA should
give the participant(s) more flexibility to conduct the pilot project.
In addition, another comment expressed concern with the proposed
requirement that final reports be completed within 30 days, because
that may not be enough time to complete a final report.
(Response 1) The proposed timelines were intended to enable
completion of FDA's Pilot Project Program within 1 year of the start
date. FDA would like to complete the program in a timely manner so that
the information learned can be shared and utilized by supply chain
participants as they prepare and implement remaining DSCSA requirements
that take effect between 2018 and 2023. To optimize the program, FDA
expects pilot project participants to be ready to initiate their pilot
project within 4 months after receiving a letter of acceptance from
FDA. This will help ensure that participants have worked out funding,
resources, planning, and other issues in advance of initiation of the
pilot project. FDA provided flexibility in the program
[[Page 22086]]
by allowing the Agency to consider pilot projects that may go beyond a
6-month period; however, a pilot project duration of 6 months or less
is preferred.
(Comment 2) Another comment requested clarification of the proposed
process for selecting participants. The comment expressed concern that
FDA's Pilot Project Program may include only those entities that are
most engaged in DSCSA implementation currently. The comment also
described concern that the findings and results may not accurately
reflect the current environment, because the program may not include
supply chain members with fewer resources, less sophisticated
compliance methods, or that are not as closely connected as other
trading partners.
(Response 2) Participation in the Pilot Project Program is open to
anyone in the pharmaceutical distribution supply chain (authorized
manufacturers, repackagers, wholesale distributors, and dispensers) and
other stakeholders. FDA plans to coordinate with stakeholders that
reflect the diversity of the pharmaceutical distribution supply chain,
including large and small entities from all industry sectors. FDA
expects that participants will propose the design and execution of
their pilot project in their submission to FDA, which may include
coordination with partnering entities. Such coordination may help
resolve some of the concern that the findings and results may not
accurately reflect the current environment of supply chain members that
may have fewer resources or less sophisticated compliance methods.
(Comment 3) Another comment did not support FDA considering
products for eligibility in proposed pilot projects that may be outside
the scope of the DSCSA definition of ``product,'' such as over-the-
counter medications. The comment suggested that if FDA is expanding the
scope of pilot projects to include additional products, then the
timeline for pilot projects would need to be delayed beyond 2023 to
allow sufficient time for supply chain participants to adjust to the
needs of these expanded pilots.
(Response 3) Allowing FDA to consider products eligible for the
Pilot Project Program that may be outside the DSCSA definition of
``product'' was intended to provide flexibility to potential
participants that may choose to test a process or system involving
broader categories of products. Including products that are outside the
DSCSA definition in pilot projects is not a requirement; however, we
believe there may be an opportunity to learn from such pilot projects.
This consideration does not justify a need to delay the timeline for
the pilot projects beyond 2023. It will be up to participants to
propose the design and execution of their pilot project in their
submission to FDA. FDA will consider multiple factors to ensure that
the pilot project(s) selected for the program will support the program
goals.
(Comment 4) Another comment believed that having pilot participants
fund their pilot projects would conflict with the need to include a
diverse set of supply chain stakeholders because some supply chain
stakeholders do not have the resources to participate in a pilot
project.
(Response 4) There is no FDA funding for the Pilot Project Program
provided in the DSCSA, and participation is on a volunteer basis. FDA
plans to coordinate with stakeholders that reflect the diversity of the
pharmaceutical distribution supply chain, including large and small
entities from all industry sectors. FDA expects participants to be
responsible for funding and providing resources to support the pilot
projects. Participants will develop and propose the design and
execution of their pilot project in their submission to FDA, which may
include coordination with partnering entities in a manner that may
resolve resource concerns.
Reporting Burden Estimates: FDA estimates that no more than 10
respondents will submit a request to participate, and that it will take
approximately 80 hours to complete a request and submit the request to
FDA. FDA estimates that it will select no more than eight respondents
for the pilot program. The estimated total time for respondents to
submit a request to participate in the program is 800 hours. Once the
request to participate is accepted, the submitter is now a participant
of the DSCSA Pilot Project Program. FDA estimates that the eight
respondents (i.e., participants) will submit an average of five
progress reports to FDA. Because the duration of a pilot project should
not exceed 6 months, the frequency of the progress reports will vary
based on the length of the individual pilot project. Pilot projects of
relatively shorter duration may result in shorter time intervals
between progress reports so that the reports will be sufficient to
capture progress while the pilot project is ongoing. FDA estimates that
it will take approximately 8 hours to compile and submit each progress
report. The estimated total number of hours for submitting progress
reports would be 320 hours. After completion of their pilot project,
each participant will provide one final report to FDA. FDA estimates
that it will take the eight participants approximately 40 hours to
submit a final report. The estimated total number of hours for
submitting the final report is 320 hours. The total hours for the
estimated reporting burden are 1,440 hours (table 1).
Recordkeeping Burden Estimates: Recordkeeping activities include
storing and maintaining records related to submitting a request to
participate in the program 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 10
respondents will have recordkeeping activities related to program
participation. FDA believes that it will take 0.5 hour/year to ensure
that the documents related to submitting a request to participate in
the program are retained properly for a minimum of 1 year after the
pilot project is completed (as recommended by FDA). The resulting total
to maintain the records related to submitting a request is 5 hours
annually. For retaining records related to progress reports and the
final report properly for a minimum of 1 year after the pilot project
is completed (as recommended by FDA), FDA estimates that it will take
approximately 0.5 hour/year. As noted previously, FDA estimates that
the eight respondents will submit an average of five progress reports
and one final report to FDA. The estimated total for maintaining
progress reports and the final report is 20 and 4 hours, respectively.
The total recordkeeping burden is estimated to be 29 hours (table 2).
In developing its burden estimate for records associated with the
proposed pilot projects, FDA has taken account of existing industry
practices for maintaining records in the normal course of their
business. In particular, FDA is aware of various supply chain
stakeholders that have conducted pilot projects over the past few
years, including some pilot projects that occurred before the DSCSA was
enacted. These pilot projects covered topics related to serialization,
movement of product data, aggregation of data, and verification of
product identifiers of returned products. Members of the supply chain
who conduct pilot projects of their own accord created associated
records as a matter of usual and customary business practice.
Therefore, FDA considers these activities associated with a pilot
project to be usual and customary business practice, and the burden
estimates for like records are not included in the
[[Page 22087]]
calculation of the recordkeeping burden (see 5 CFR 1320.3(b)(2)).
Third-Party Disclosure Burden Estimates: For those pilot projects
that involve a participant composed of partnering entities in the
program, FDA is taking into consideration the time that partnering
entities will spend coordinating with each other during a pilot
project. For the initial request to participate, FDA estimates that
eight respondents will work with their respective partnering entities,
and the average number of partnering entities will be two. FDA
estimates that each respondent will spend 8 hours coordinating with
each partnering entity. Thus, for 8 respondents with an average of 2
partnering entities, the estimated total burden for coordinating with
partnering entities related to the submission of the request to
participate in the program is 128 hours. FDA estimates that seven
respondents will need to coordinate with an average of two partnering
entities to create progress reports and the final report to submit to
FDA. Earlier, FDA estimated that an average of five progress reports
will be submitted to FDA per respondent. If a respondent has an average
of 2 partners, it will coordinate 10 times with those partners on the
progress reports. FDA estimates that for each progress report, it will
take 4 hours to coordinate with each partner, resulting in a total of
280 hours. FDA estimates that for each final report, it will take
approximately 20 hours to coordinate with each partner, resulting in a
total of 280 hours. The total estimation for third-party disclosure
burden is 688 hours (table 3).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
DSCSA pilot project program Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests to participate........................................... 10 1 10 80 800
Progress reports.................................................. 8 5 40 8 320
Final report to FDA............................................... 8 1 8 40 320
-------------------------------------------------------------------------------------
Total......................................................... .............. ................ .............. .................. 1,440
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
DSCSA pilot project program Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records related to requests to participate.. 10 1 10 0.5 (30 minutes)........................ 5
Records related to progress reports......... 8 5 40 0.5 (30 minutes)........................ 20
Records related to the final report to FDA.. 8 1 8 0.5 (30 minutes)........................ 4
-----------------------------------------------------------------------------------------------------------
Total................................... .............. ................ .............. ........................................ 29
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
DSCSA pilot project program Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Coordination with partnering entities related to requests to 8 2 16 8 128
participate......................................................
Coordination with partnering entities related to progress reports. 7 10 70 4 280
Coordination with partnering entities related to final reports.... 7 2 14 20 280
-------------------------------------------------------------------------------------
Total......................................................... .............. ................ .............. .................. 688
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10051 Filed 5-10-18; 8:45 am]
BILLING CODE 4164-01-P
