[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]


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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.

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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\
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                                                                                        Number of
                    DSCSA pilot project program                        Number of      responses per    Total annual     Average  burden     Total hours
                                                                      respondents      respondent        responses       per  response
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Requests to participate...........................................              10                 1              10                  80             800
Progress reports..................................................               8                 5              40                   8             320
Final report to FDA...............................................               8                 1               8                  40             320
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    Total.........................................................  ..............  ................  ..............  ..................           1,440
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                  Number of
         DSCSA pilot project program             Number of       records per     Total annual      Average  burden per  recordkeeping       Total hours
                                               recordkeepers    recordkeeper        records
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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
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    Total...................................  ..............  ................  ..............  ........................................              29
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\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\
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                                                                                        Number of
                    DSCSA pilot project program                        Number of     disclosures per   Total annual     Average  burden     Total hours
                                                                      respondents      respondent       disclosures     per  disclosure
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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
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\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