83_FR_22177 83 FR 22085 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pilot Project Program Under the Drug Supply Chain Security Act

83 FR 22085 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pilot Project Program Under the Drug Supply Chain Security Act

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 92 (May 11, 2018)

Page Range22085-22087
FR Document2018-10051

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).

Federal Register, Volume 83 Issue 92 (Friday, May 11, 2018)
[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22085-22087]
From the Federal Register Online  [www.thefederalregister.org]
[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



                                                                                 Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices                                              22085

                                                https://www.fda.gov/Drugs/Guidance                      The DSCSA Pilot Project Program                       level tracing and verification that take
                                                ComplianceRegulatoryInformation/                                                                              effect in 2023. Such pilot projects will
                                                                                                        OMB Control Number 0910—NEW
                                                Guidances/default.htm or https://                                                                             be more useful than pilot projects
                                                www.regulations.gov.                                       FDA will be establishing the Drug                  dedicated to lot-level tracing. If there are
                                                                                                        Supply Chain Security Act (DSCSA)                     adequate pilot project submissions, FDA
                                                  Dated: May 7, 2018.
                                                                                                        (Title II of Pub. L. 113–54) Pilot Project            may establish more than one pilot
                                                Leslie Kux,                                             Program to implement section 582(j) of                project to accomplish the goals of the
                                                Associate Commissioner for Policy.                      the Federal Food, Drug, and Cosmetic                  DSCSA Pilot Project Program.
                                                [FR Doc. 2018–10046 Filed 5–10–18; 8:45 am]             Act (FD&C Act) (21 U.S.C. 360eee–1).                     Because there is an information
                                                BILLING CODE 4164–01–P                                  This program will assist FDA in                       collection under the PRA associated
                                                                                                        developing an interoperable, electronic               with the DSCSA Pilot Project Program,
                                                                                                        system to identify and trace certain                  this Federal Register notice is being
                                                DEPARTMENT OF HEALTH AND                                prescription drugs as the drugs are                   issued as part of the process for OMB
                                                HUMAN SERVICES                                          distributed in the United States by the               approval to collect this information.
                                                                                                        year 2023. The Pilot Project Program                  After OMB approval of this information
                                                Food and Drug Administration                            goals include assessing the ability of                collection, FDA will accept applications
                                                                                                        supply chain members to: (1) Satisfy the              to participate in the program and will
                                                [Docket No. FDA–2016–N–0407]                            requirements of section 582 of the FD&C               select qualified applications. FDA will
                                                Agency Information Collection                           Act; (2) identify, manage, and prevent                announce OMB’s approval in the
                                                Activities; Submission for Office of                    the distribution of suspect and                       Federal Register, the date that
                                                Management and Budget Review;                           illegitimate products as defined in                   applications may be submitted, and
                                                                                                        section 581(21) and (8) of the FD&C Act               application submission procedures.
                                                Comment Request; Pilot Project
                                                                                                        (21 U.S.C. 360eee(21) and (8)),                          In the Federal Register of July 20,
                                                Program Under the Drug Supply Chain
                                                                                                        respectively; and (3) demonstrate the                 2017 (82 FR 33497), FDA published a
                                                Security Act
                                                                                                        electronic, interoperable exchange of                 60-day notice requesting public
                                                AGENCY:    Food and Drug Administration,                product tracing information across the                comment on the proposed collection of
                                                HHS.                                                    pharmaceutical distribution supply                    information. A summary of the
                                                ACTION:   Notice.                                       chain, in addition to identifying the                 comments and FDA’s responses are as
                                                                                                        system attributes needed to implement                 follows.
                                                SUMMARY:   The Food and Drug                            the requirements of section 582 of the                   (Comment 1) Several comments raised
                                                Administration (FDA, Agency, or we) is                  FD&C Act, particularly the requirement                concerns with the proposed timelines
                                                announcing that a proposed collection                   to utilize a product identifier for                   related to initiation of pilot projects,
                                                of information has been submitted to the                product tracing purposes. FDA plans to                duration of pilot projects, and final
                                                Office of Management and Budget                         coordinate with stakeholders that reflect             reports. One comment expressed
                                                (OMB) for review and clearance under                    the diversity of the pharmaceutical                   concern that 4 months (after receiving a
                                                the Paperwork Reduction Act of 1995                     distribution supply chain, including                  letter of acceptance from FDA) may not
                                                (PRA).                                                  large and small entities from all                     be enough time for a potential
                                                                                                        industry sectors.                                     participant to be ready to initiate their
                                                DATES:  Fax written comments on the                        Title: The DSCSA Pilot Project                     pilot project. Another comment
                                                collection of information by June 11,                   Program.                                              suggested that the proposed duration of
                                                2018.                                                      Description of Respondents:                        pilot projects (no more than 6 months)
                                                ADDRESSES:     To ensure that comments on               Respondents of this collection of                     should be longer and FDA should give
                                                the information collection are received,                information are participants from the                 the participant(s) more flexibility to
                                                OMB recommends that written                             pharmaceutical distribution supply                    conduct the pilot project. In addition,
                                                comments be faxed to the Office of                      chain (authorized manufacturers,                      another comment expressed concern
                                                Information and Regulatory Affairs,                     repackagers, wholesale distributors, and              with the proposed requirement that
                                                OMB, Attn: FDA Desk Officer, Fax: 202–                  dispensers) and other stakeholders.                   final reports be completed within 30
                                                395–7285, or emailed to oira_                              Background Information: FDA will be                days, because that may not be enough
                                                submission@omb.eop.gov. All                             seeking pilot project participants from               time to complete a final report.
                                                comments should be identified with the                  the pharmaceutical distribution supply                   (Response 1) The proposed timelines
                                                OMB control number 0910–NEW and                         chain (authorized manufacturers,                      were intended to enable completion of
                                                title ‘‘Pilot Project Program Under the                 repackagers, wholesale distributors, and              FDA’s Pilot Project Program within 1
                                                Drug Supply Chain Security Act.’’ Also                  dispensers) and other stakeholders. FDA               year of the start date. FDA would like
                                                include the FDA docket number found                     expects that participants will propose                to complete the program in a timely
                                                in brackets in the heading of this                      the design and execution of their pilot               manner so that the information learned
                                                document.                                               project in their submission to FDA;                   can be shared and utilized by supply
                                                                                                        however, FDA also intends to meet with                chain participants as they prepare and
                                                FOR FURTHER INFORMATION CONTACT:
                                                                                                        all pilot project participants to ensure              implement remaining DSCSA
                                                Domini Bean, Office of Operations,                      that lessons learned from the pilot                   requirements that take effect between
                                                Food and Drug Administration, Three                     project(s) will inform FDA’s                          2018 and 2023. To optimize the
                                                White Flint North, 10A–12M, 11601                       development of the electronic,                        program, FDA expects pilot project
                                                Landsdown St., North Bethesda, MD                       interoperable system that will take effect            participants to be ready to initiate their
sradovich on DSK3GMQ082PROD with NOTICES




                                                20852, 301–796–5733, PRAStaff@                          in 2023. FDA encourages supply chain                  pilot project within 4 months after
                                                fda.hhs.gov.                                            members to focus their proposed pilot                 receiving a letter of acceptance from
                                                SUPPLEMENTARY INFORMATION:    In                        project(s) on the DSCSA requirements                  FDA. This will help ensure that
                                                compliance with 44 U.S.C. 3507, FDA                     related to the interoperable, electronic              participants have worked out funding,
                                                has submitted the following proposed                    tracing of products at the package level.             resources, planning, and other issues in
                                                collection of information to OMB for                    Specifically, the pilot project(s) should             advance of initiation of the pilot project.
                                                review and clearance:                                   focus on the requirements for package-                FDA provided flexibility in the program


                                           VerDate Sep<11>2014   19:21 May 10, 2018   Jkt 244001   PO 00000   Frm 00089   Fmt 4703   Sfmt 4703   E:\FR\FM\11MYN1.SGM   11MYN1


                                                22086                            Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices

                                                by allowing the Agency to consider pilot                consideration does not justify a need to              provide one final report to FDA. FDA
                                                projects that may go beyond a 6-month                   delay the timeline for the pilot projects             estimates that it will take the eight
                                                period; however, a pilot project duration               beyond 2023. It will be up to                         participants approximately 40 hours to
                                                of 6 months or less is preferred.                       participants to propose the design and                submit a final report. The estimated
                                                   (Comment 2) Another comment                          execution of their pilot project in their             total number of hours for submitting the
                                                requested clarification of the proposed                 submission to FDA. FDA will consider                  final report is 320 hours. The total hours
                                                process for selecting participants. The                 multiple factors to ensure that the pilot             for the estimated reporting burden are
                                                comment expressed concern that FDA’s                    project(s) selected for the program will              1,440 hours (table 1).
                                                Pilot Project Program may include only                  support the program goals.                               Recordkeeping Burden Estimates:
                                                those entities that are most engaged in                   (Comment 4) Another comment                         Recordkeeping activities include storing
                                                DSCSA implementation currently. The                     believed that having pilot participants               and maintaining records related to
                                                comment also described concern that                     fund their pilot projects would conflict              submitting a request to participate in the
                                                the findings and results may not                        with the need to include a diverse set                program and compiling reports.
                                                accurately reflect the current                          of supply chain stakeholders because                  Respondents can use current record
                                                environment, because the program may                    some supply chain stakeholders do not                 retention capabilities for electronic or
                                                not include supply chain members with                   have the resources to participate in a                paper storage to achieve these activities.
                                                fewer resources, less sophisticated                     pilot project.                                        FDA estimates that no more than 10
                                                compliance methods, or that are not as                    (Response 4) There is no FDA funding                respondents will have recordkeeping
                                                closely connected as other trading                      for the Pilot Project Program provided in             activities related to program
                                                partners.                                               the DSCSA, and participation is on a                  participation. FDA believes that it will
                                                   (Response 2) Participation in the Pilot              volunteer basis. FDA plans to                         take 0.5 hour/year to ensure that the
                                                Project Program is open to anyone in the                coordinate with stakeholders that reflect             documents related to submitting a
                                                pharmaceutical distribution supply                      the diversity of the pharmaceutical
                                                                                                                                                              request to participate in the program are
                                                chain (authorized manufacturers,                        distribution supply chain, including
                                                                                                                                                              retained properly for a minimum of 1
                                                repackagers, wholesale distributors, and                large and small entities from all
                                                                                                                                                              year after the pilot project is completed
                                                dispensers) and other stakeholders. FDA                 industry sectors. FDA expects
                                                                                                                                                              (as recommended by FDA). The
                                                plans to coordinate with stakeholders                   participants to be responsible for
                                                                                                                                                              resulting total to maintain the records
                                                that reflect the diversity of the                       funding and providing resources to
                                                                                                                                                              related to submitting a request is 5
                                                pharmaceutical distribution supply                      support the pilot projects. Participants
                                                                                                                                                              hours annually. For retaining records
                                                chain, including large and small entities               will develop and propose the design
                                                                                                                                                              related to progress reports and the final
                                                from all industry sectors. FDA expects                  and execution of their pilot project in
                                                                                                                                                              report properly for a minimum of 1 year
                                                that participants will propose the design               their submission to FDA, which may
                                                and execution of their pilot project in                 include coordination with partnering                  after the pilot project is completed (as
                                                their submission to FDA, which may                      entities in a manner that may resolve                 recommended by FDA), FDA estimates
                                                include coordination with partnering                    resource concerns.                                    that it will take approximately 0.5 hour/
                                                entities. Such coordination may help                      Reporting Burden Estimates: FDA                     year. As noted previously, FDA
                                                resolve some of the concern that the                    estimates that no more than 10                        estimates that the eight respondents will
                                                findings and results may not accurately                 respondents will submit a request to                  submit an average of five progress
                                                reflect the current environment of                      participate, and that it will take                    reports and one final report to FDA. The
                                                supply chain members that may have                      approximately 80 hours to complete a                  estimated total for maintaining progress
                                                fewer resources or less sophisticated                   request and submit the request to FDA.                reports and the final report is 20 and 4
                                                compliance methods.                                     FDA estimates that it will select no                  hours, respectively. The total
                                                   (Comment 3) Another comment did                      more than eight respondents for the                   recordkeeping burden is estimated to be
                                                not support FDA considering products                    pilot program. The estimated total time               29 hours (table 2).
                                                for eligibility in proposed pilot projects              for respondents to submit a request to                   In developing its burden estimate for
                                                that may be outside the scope of the                    participate in the program is 800 hours.              records associated with the proposed
                                                DSCSA definition of ‘‘product,’’ such as                Once the request to participate is                    pilot projects, FDA has taken account of
                                                over-the-counter medications. The                       accepted, the submitter is now a                      existing industry practices for
                                                comment suggested that if FDA is                        participant of the DSCSA Pilot Project                maintaining records in the normal
                                                expanding the scope of pilot projects to                Program. FDA estimates that the eight                 course of their business. In particular,
                                                include additional products, then the                   respondents (i.e., participants) will                 FDA is aware of various supply chain
                                                timeline for pilot projects would need to               submit an average of five progress                    stakeholders that have conducted pilot
                                                be delayed beyond 2023 to allow                         reports to FDA. Because the duration of               projects over the past few years,
                                                sufficient time for supply chain                        a pilot project should not exceed 6                   including some pilot projects that
                                                participants to adjust to the needs of                  months, the frequency of the progress                 occurred before the DSCSA was
                                                these expanded pilots.                                  reports will vary based on the length of              enacted. These pilot projects covered
                                                   (Response 3) Allowing FDA to                         the individual pilot project. Pilot                   topics related to serialization,
                                                consider products eligible for the Pilot                projects of relatively shorter duration               movement of product data, aggregation
                                                Project Program that may be outside the                 may result in shorter time intervals                  of data, and verification of product
                                                DSCSA definition of ‘‘product’’ was                     between progress reports so that the                  identifiers of returned products.
                                                intended to provide flexibility to                      reports will be sufficient to capture                 Members of the supply chain who
                                                potential participants that may choose                  progress while the pilot project is                   conduct pilot projects of their own
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                                                to test a process or system involving                   ongoing. FDA estimates that it will take              accord created associated records as a
                                                broader categories of products.                         approximately 8 hours to compile and                  matter of usual and customary business
                                                Including products that are outside the                 submit each progress report. The                      practice. Therefore, FDA considers these
                                                DSCSA definition in pilot projects is not               estimated total number of hours for                   activities associated with a pilot project
                                                a requirement; however, we believe                      submitting progress reports would be                  to be usual and customary business
                                                there may be an opportunity to learn                    320 hours. After completion of their                  practice, and the burden estimates for
                                                from such pilot projects. This                          pilot project, each participant will                  like records are not included in the


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                                                                                             Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices                                                                                              22087

                                                calculation of the recordkeeping burden                                    respondent will spend 8 hours                                               respondent. If a respondent has an
                                                (see 5 CFR 1320.3(b)(2)).                                                  coordinating with each partnering                                           average of 2 partners, it will coordinate
                                                   Third-Party Disclosure Burden                                           entity. Thus, for 8 respondents with an                                     10 times with those partners on the
                                                Estimates: For those pilot projects that                                   average of 2 partnering entities, the                                       progress reports. FDA estimates that for
                                                involve a participant composed of                                          estimated total burden for coordinating                                     each progress report, it will take 4 hours
                                                partnering entities in the program, FDA                                    with partnering entities related to the                                     to coordinate with each partner,
                                                is taking into consideration the time that                                 submission of the request to participate                                    resulting in a total of 280 hours. FDA
                                                partnering entities will spend                                             in the program is 128 hours. FDA                                            estimates that for each final report, it
                                                coordinating with each other during a                                      estimates that seven respondents will                                       will take approximately 20 hours to
                                                pilot project. For the initial request to                                  need to coordinate with an average of                                       coordinate with each partner, resulting
                                                participate, FDA estimates that eight                                      two partnering entities to create                                           in a total of 280 hours. The total
                                                respondents will work with their                                           progress reports and the final report to                                    estimation for third-party disclosure
                                                respective partnering entities, and the                                    submit to FDA. Earlier, FDA estimated                                       burden is 688 hours (table 3).
                                                average number of partnering entities                                      that an average of five progress reports                                      FDA estimates the burden of this
                                                will be two. FDA estimates that each                                       will be submitted to FDA per                                                collection of information as follows:

                                                                                                                      TABLE 1—ESTIMATED REPORTING BURDEN 1
                                                                                                                                                                Number of                                                       Average
                                                                                                                                    Number of                                                Total annual
                                                                DSCSA pilot project program                                                                   responses per                                                   burden per                  Total hours
                                                                                                                                   respondents                                                responses
                                                                                                                                                                respondent                                                     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                                                    Average
                                                                                                                                   Number of                                                Total annual
                                                                DSCSA pilot project program                                                                     records per                                                  burden per                   Total hours
                                                                                                                                 recordkeepers                                                records
                                                                                                                                                               recordkeeper                                                recordkeeping

                                                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                                                     Average
                                                                                                                                    Number of                                                Total annual
                                                                DSCSA pilot project program                                                                   disclosures per                                                 burden per                  Total hours
                                                                                                                                   respondents                                               disclosures
                                                                                                                                                                respondent                                                    disclosure

                                                Coordination with partnering entities related to re-
                                                  quests to participate .............................................                                  8                              2                        16                                    8             128
                                                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]
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                                                BILLING CODE 4164–01–P




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Document Created: 2018-11-02 09:49:49
Document Modified: 2018-11-02 09:49:49
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by June 11, 2018.
ContactDomini 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]
FR Citation83 FR 22085 

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