Pilot Project Program Under the Drug Supply Chain Security Act; Program Announcement
| Published date | 08 February 2019 |
| Citation | 84 FR 2879 |
| Record Number | 2019-01561 |
| Section | Notices |
| Court | Food And Drug Administration,Health And Human Services Department |
Federal Register, Volume 84 Issue 27 (Friday, February 8, 2019)
[Federal Register Volume 84, Number 27 (Friday, February 8, 2019)]
[Notices]
[Pages 2879-2883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01561]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0407]
Pilot Project Program Under the Drug Supply Chain Security Act;
Program Announcement
AGENCY: Food and Drug Administration, HHS.
[[Page 2880]]
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the start of the Pilot Project Program Under the Drug Supply Chain
Security Act (DSCSA Pilot Project Program). The DSCSA Pilot Project
Program is intended to assist FDA and members of the pharmaceutical
distribution supply chain in the development of the electronic,
interoperable system that will identify and trace certain prescription
drugs as they are distributed within the United States. Under this
program, FDA will work with stakeholders to establish one or more pilot
projects to explore and evaluate methods to enhance the safety and
security of the pharmaceutical distribution supply chain. Participation
in the DSCSA Pilot Project Program is voluntary and will be open to
pharmaceutical distribution supply chain members to apply to the
program. FDA will ensure that participation reflects the diversity of
the supply chain, including large and small entities from all industry
sectors. This notice establishes the DSCSA Pilot Project Program and
includes instructions for submitting a request to participate and
expectations for program participants.
DATES: FDA will be accepting applications for participation in the
DSCSA Pilot Project Program beginning February 8, 2019 and continuing
through March 11, 2019. The duration of the DSCSA Pilot Project Program
will depend on the pilot project(s) accepted into the program and when
the projects are completed.
FOR FURTHER INFORMATION CONTACT: Daniel Bellingham, Office of
Compliance, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-3130, DSCSAPilotProjects@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On November 27, 2013, the Drug Supply Chain Security Act (DSCSA)
(Title II of Pub. L. 113-54) was signed into law. The DSCSA outlines
critical steps to build an electronic, interoperable system by November
27, 2023, that will identify and trace certain prescription drugs as
they are distributed within the United States. Section 202 of the DSCSA
added sections 581 and 582 to the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360eee and 360eee-1, respectively). Under section
582(j) of the FD&C Act, FDA is required to establish one or more pilot
projects, in coordination with authorized manufacturers, repackagers,
wholesale distributors, and dispensers, to explore and evaluate methods
to enhance the safety and security of the pharmaceutical distribution
supply chain.
FDA is establishing the DSCSA Pilot Project Program to implement
section 582(j) of the FD&C Act. This program is intended to assist FDA
and members of the pharmaceutical distribution supply chain in the
development of the interoperable electronic system to be established by
2023. The 2023 system has the potential to reduce diversion of drugs
distributed domestically as well as help deter counterfeit drugs from
entering the supply chain. The pilot program will be designed to
explore issues related to utilizing the product identifier for product
tracing, improving the technical capabilities of the supply chain,
identifying the system attributes that are necessary to implement the
requirements established under the DSCSA, and any other issues
identified by FDA (see section 582(j)(2)(B) of the FD&C Act).
Particular program goals include: (1) 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 and verification purposes and (2) assessing the
ability of supply chain members to satisfy the requirements of section
582 of the FD&C Act; identify, manage, and prevent the distribution of
suspect and illegitimate products as defined in section 581(21) and
581(8) of the FD&C Act, respectively, and exchange product tracing
information across the pharmaceutical distribution supply chain in an
electronic and interoperable manner. FDA plans to coordinate with
stakeholders to ensure that pilot projects reflect the diversity of the
pharmaceutical distribution supply chain, including large and small
entities from all industry sectors. The DSCSA Pilot Project Program is
intended to help identify and evaluate the most efficient processes
and/or systems to operationalize supply chain security requirements.
II. The DSCSA Pilot Project Program
FDA is seeking pilot project participants from the pharmaceutical
distribution supply chain (e.g., authorized manufacturers, repackagers,
wholesale distributors, and dispensers) and other stakeholders. FDA
expects potential participants to propose the design and execution of
their pilot project in their submission to FDA; however, FDA intends to
meet with selected pilot project participants to ensure that the
learnings from the pilot project(s) will be complementary in informing
all stakeholders in the development of the electronic, interoperable
system that will go into effect in 2023. FDA encourages potential
participants 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 enhanced requirements for package-level tracing and
verification that go into effect in 2023. Such pilot projects will
likely be more useful than pilot projects dedicated to lot-level
tracing. If there is an adequate number of pilot project submissions,
FDA may establish more than one pilot project to accomplish the goals
of the DSCSA Pilot Project Program.
A. Products Eligibility
Pilot projects should focus on applicable requirements to any
prescription drug that is a ``product'' within the meaning of section
581(13) of the FD&C Act. FDA anticipates that packages and homogenous
cases of product that are part of a pilot project will generally bear a
``product identifier'' as described in sections 581(14) and 582(a)(9)
of the FD&C Act. FDA may also consider proposed pilot projects
involving product that may be subject to a waiver, exception or
exemption of certain DSCSA requirements, products that are
grandfathered, in addition to products that are outside the scope of
section 581(13) of the FD&C Act (e.g., over-the-counter medicines) if
such project(s) could further the objectives of the DSCSA Pilot Project
Program.
B. Potential Issues To Examine and Evaluation Methods To Use in Pilot
Projects
On April 5-6, 2016, FDA held a public workshop entitled ``Proposed
Pilot Project(s) Under the Drug Supply Chain Security Act (DSCSA).''
This public workshop provided a forum for members of the pharmaceutical
distribution supply chain to discuss the design objectives of pilot
projects established by FDA under section 582(j) of the FD&C Act. Based
on the information gathered at that workshop and from the comments
submitted to the public docket for the workshop (Docket No. FDA-2016-N-
0407), FDA identified several potential issues to examine, and
evaluation methods to use, in pilot projects established under the
DSCSA Pilot Project Program. These potential
[[Page 2881]]
issues and evaluation methods are summarized in table 1. This table is
intended only to assist in the design of potential pilot projects; it
does not represent FDA's views or policies regarding the issues
described in the table. For ease of reference, the potential issues to
examine and evaluation methods have been grouped by focus areas for the
pilot projects.
Table 1--Potential Issues To Examine and Evaluation Methods To Use in
Pilot Projects
------------------------------------------------------------------------
Potential issues to Potential evaluation
Pilot project focus area examine methods
------------------------------------------------------------------------
Product Identifier.......... Processes Impacts of
related to the different
requirement for representations of
manufacturers to the product
affix or imprint a identifier on
product identifier systems or
to each package and processes:
homogenous case of --Number of errors.
product intended to --Time to process.
be introduced in a --Time to reconcile
transaction into differences.
commerce.
Methods
used to issue and
manage serial
numbers (e.g.,
including a
contract
manufacturer's role
if applicable or
how a repackager
associates its
product identifier
with the product
identifier assigned
by the original
manufacturer).
Different
representations for
the product
identifier (e.g.,
different formats
of the National
Drug Code or serial
number).
Barcodes.................... Readability Barcode
of a barcode either read error rates:
printed or affixed --Number of items
to product, unnecessarily
including impact of quarantined or held
environmental and up.
human factors. --Time and resource
Application impacts.
of linear barcode
and 2D barcode on
product.
Distinguishing
which barcode to
read/use.
Interoperability............ Process and For both
technical decentralized and
challenges due to a centralized models,
variety of time implications:
potential solutions --To investigate
(e.g., type of suspect and
database used and illegitimate
system architecture products.
for exchanging --For notifications
information among required within the
trading partners). statutory
Maintaining timelines.
the integrity of --Related to scaling
information up from pilot to
contained in the full production.
barcode of Product
serialized product tracing information
throughout the (across multiple
distribution supply partners):
chain (e.g., a --Capability to
trading partner retrieve the
goes out of information.
business or one --Accuracy of the
acquires another information (within
business). and between
Different systems).
methods for Security
exchanging and access:
information (e.g., --Evaluate and
the use of document access
Electronic Data levels for trading
Interchange, partners.
Electronic Product
Code Information
Services, and other
solutions
separately).
Data/Database/System Issues. Data System
quality from Performance and
beginning to end of Effectiveness:
the product --Time to access and
lifecycle and vice use product tracing
versa. information once
System that data is
performance when received into a
full or partially system.
loaded with data. --Quality of product
Data format tracing
or processes for information.
data transfer:. --Number of breaches
--Use of technical to system.
standards for --Number of attempts
defining data to breach the
attributes to system that were
enable prevented or
interoperable minimized.
transfers. Data and
--Methods to handle product flow.
the ``master data'' --Number of
(product-specific unsuccessful
data) and attempts to access
transaction data data and
separately to operational
minimize ``master impacts.
data'' redundancy. --Number of system
Integration interactions within
into individual/ one, and amongst
company data multiple, trading
systems. partners.
Control and --Time and resource
access to data by changes on
trading partners, operations when
FDA, or other data and product
federal or state not moving at same
officials (data time (e.g., product
governance). arrives before data
Ability of arrives).
the system to --Time for location/
record product ownership/status
status (e.g., to changes to be
indicate expired, reflected in the
illegitimate, in system.
error, quarantined) --Time of product
at all packaging flow delays and
levels. associated costs
due to system or
data problems.
Aggregation/Disaggregation.. Multiple Number of
levels of adoption system and product
of inference, by interactions within
different trading one, and amongst
partners. Impact of multiple, trading
inference gaps, partners.
changes or errors Time
in data, required to conduct
particularly aggregate/
downstream when disaggregate
searching or operations and
examining the data; transactions.
how can errors be Accuracy of
corrected. aggregation data
(measure error
counts).
Time to
gather aggregation/
disaggregation data
for investigations
and notifications.
Time to
resolve errors in
data.
[[Page 2882]]
Verification/Notification... Process for Response
investigation of times: Current vs.
suspect or future process.
illegitimate Time needed
product, including to obtain product
any communication tracing information
or coordination:. to respond to a
--Making and request for
responding to verification.
verification Time needed
requests. to make, respond
--Making, responding to, or terminate a
to, and termination notification.
of notifications. Time to
--Responding to gather product
requests for tracing information
information. to support an
--Testing boundaries investigation for a
of the system. suspect or
illegitimate
product, or a
recall.
Percentage
of items that are
successfully
verified vs. those
that were targeted
for verification.
Number of
connections/queries
needed to gather
product tracing
information in
response to a
verification or
notification
request.
Exception Handling/Errors/ Identify Percent of
Inconsistencies. `honest errors' errors detected:
(e.g., over/under Compare exceptions
shipments, clerical introduced vs.
errors, or exceptions
aggregation errors). detected:
Correcting --Identify the first
`honest errors'. step in the process
where an error is
detected.
Number of
new or changed
processes needed to
accomplish DSCSA
goals:
--Time and resource
impacts.
`Honest
Errors':
--Number of items
unnecessarily
quarantined and
held up.
--Time required to
detect and correct
errors.
--Impact on trading
partners to correct
errors.
Barcode
read error rates:
--Number of items
unnecessarily
quarantined or held
up.
--Time and resource
impacts.
Special Scenarios........... Situations Error rates
when data and for special
product do not move processes:
together. --Number of items
Situations unnecessarily
when serialized quarantined or held
product are sold up.
and distributed --Time and resource
along with non- impacts.
serialized product. Accuracy of
linkage between
original
manufacturer
product identifier
and repackager-
issued product
identifier.
------------------------------------------------------------------------
In addition to the information in table 1, workshop participants
and comments submitted to the public docket recommended factors that
FDA should take into consideration when establishing pilot projects.
The recommended factors include the extent to which the pilot projects:
Represent the mix of products and levels of packaging in the
supply chain
Include a diverse set of supply chain stakeholders (types and
sizes) and transaction types
Use adaptive design to make the pilot projects more efficient.
Target known weaknesses in the supply chain
Can be completed in such a time frame to provide useful
information for trading partners
Evaluate human factors that could present implementation
challenges
Simulate illegitimate products/transactions to test a process
or system
Document costs to implement, use, and maintain piloted
solutions
Although the Agency intends to take these factors into
consideration when establishing pilot projects, FDA also recognizes
that a single pilot project is unlikely to satisfy every factor.
Accordingly, requests to establish a pilot project need not satisfy all
the factors listed in this document.
C. Instructions for Submitting a Request To Participate in the DSCSA
Pilot Project Program
Stakeholders interested in participating in the DSCSA Pilot Project
Program may submit a request to participate by email to
DSCSAPilotProjects@fda.hhs.gov. For a group of entities that partner to
participate in a pilot project, only one submission and one point-of-
contact for the proposed pilot project should be provided in the
request to participate. Requests to participate may also consider other
ideas for a pilot project that are not included in this notice.
D. Submission Content for Requesting To Participate in the DSCSA Pilot
Project Program
The following information should be included in the request:
Contact information for the submitter or point of contact, if
different from the submitter (name, mailing address, phone number,
email address)
Names of all partnering entities that would participate in the
pilot project (name of company and name of company representative)
Type(s) of each partnering entity participating in the pilot
project (e.g., manufacturer, repackagers, wholesale distributor,
dispenser, third-party logistics provider, solution provider, trade
association, etc.); Partnering entities may include authorized trading
partners or other supply chain stakeholders
Number of employees for each partnering entity to reflect
company size
Proposed start and finish dates of the pilot project
Commitment to start the pilot project within 4 months of
receiving a letter of acceptance from FDA
Product(s) that will be used in the pilot project
Location(s) where pilot project will be performed (facility
address)
[[Page 2883]]
Description of the proposed pilot project, including, but not
limited to, the goals, objectives, processes that will be studied, and
evaluation methods
E. Initiation and Duration of Pilot Projects
The selected participants should be ready to start their pilot
project within 4 months of receiving a letter of acceptance from FDA
into the program. The duration of a pilot project should not exceed 6
months. FDA may consider a pilot project with a later start date or
longer duration depending on the proposed goal(s) and objective(s).
Each pilot project is expected to be completed within the proposed
duration time period. This time period does not include an additional
30 days for completion of a final report (see Section II.G. Reports).
F. Participation in Pilot Projects
Each participant that is selected into the program will be
responsible for conducting its pilot project. A group of entities
(e.g., members of the pharmaceutical distribution supply chain or other
stakeholders, including trade associations) that partners to conduct a
pilot project will be considered a single participant for purposes of
the DSCSA Pilot Project Program. The participant will be responsible
for the funding and resources necessary to conduct the pilot project,
and for determining each partner's role and responsibility in its pilot
project.
Prior to launch of a pilot project, FDA intends to hold a design
strategy meeting with the selected pilot participant(s) to review the
goal(s) and objective(s)s for the pilot project and discuss the project
plans and other pertinent details. FDA also expects pilot project
participants to submit reports on the progress of their pilot projects
to FDA (see Section II.G. Reports). Participants should evaluate their
pilot projects using the evaluation methods they identified during the
pilot project design process.
G. Reports
Each pilot project is expected to be completed within the proposed
duration time period, and FDA asks that all participants submit
periodic progress reports to FDA while the pilot project is being
conducted, in addition to submitting a final report after completing
the pilot project. These reports will provide insight into the systems
and process needed to comply with certain DSCSA requirements for
enhanced drug distribution security.
1. Progress Report(s)
Each pilot project program participant is expected to provide
reports on the progress of its pilot project to FDA. The progress
reports are intended to capture the ongoing work during the pilot
project, including but not limited to, status or results, changes,
challenges, and/or lessons learned. FDA will work with participants to
develop an appropriate schedule for the submission of progress reports
based on the design and duration of the pilot project. Because the
duration of a pilot project should not exceed 6 months, the frequency
of 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. For example, FDA
may ask for monthly progress reports for a 6-month pilot project,
however for a 1-month pilot project, FDA may ask for weekly progress
reports.
2. Final Report
Within 30 to 45 business days of completing a pilot project, each
participant is expected to provide a final report to FDA that captures
the description, objectives, methods, evaluation, costs and key
findings, and lessons learned from the project. Timely completion of
pilot projects and the final report will support FDA's DSCSA
implementation, including the statutory requirements under section
582(j) of the FD&C Act to consider information from pilot projects in
the development of guidances for unit-level tracing and standards for
the interoperable data exchange in section 582(h)(3) and (4) of the
FD&C Act. FDA may also request that the participants meet with the
Agency upon the completion of their pilot project or the final report.
H. Final DSCSA Pilot Project Program Report
To ensure that all supply chain members benefit from the
information generated by the DSCSA Pilot Project Program, FDA intends
to make the following information about each pilot project of the
program available to the public in a final program report: (1) The
names and industry sector(s) of the pilot project participant(s); (2)
the pilot project's objectives and evaluation methods; (3) the duration
of the pilot project; and (4) the key findings and lessons learned from
the pilot project. FDA intends to post the information related to the
DSCSA Pilot Project Program and the final program report on FDA's
website.
I. Recordkeeping
Any records generated by a participant while conducting a pilot
project should be maintained in accordance with the participant's
normal recordkeeping practices. For pilot projects that involve
partnering entities, the partnering entities should decide who is
responsible for the records generated in the course of conducting the
pilot project. FDA recommends that participants maintain the progress
reports and final report for its pilot project for at least 1 year
after completion of the pilot project.
III. Paperwork Reduction Act of 1995
This notice contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in this notice was approved under OMB control
number 0910-0859.
Dated: February 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01561 Filed 2-7-19; 8:45 am]
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