Pilot Project Program Under the Drug Supply Chain Security Act; Request for Comments, 33497-33503 [2017-15203]
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Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Notices
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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; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA or Agency) is
announcing its intent to establish a pilot
project program under the Drug Supply
Chain Security Act (the DSCSA Pilot
Project Program) to assist in
development of the electronic,
interoperable system that will identify
and trace certain prescription drugs as
these 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 will
be voluntary and will be open to
pharmaceutical distribution supply
chain members. FDA will be
particularly interested in participation
reflecting the diversity of the supply
chain, including large and small entities
from all industry sectors. This notice
describes the proposed DSCSA Pilot
Project Program, including proposed
instructions for submitting a request to
participate. FDA is soliciting comments
on the proposed collection of
information associated with
establishment of the DSCSA Pilot
Project Program before submitting the
proposed collection to the Office of
Management and Budget (OMB) for
approval. FDA does not intend to begin
the proposed DSCSA Pilot Project
Program or accept requests to
participate in the program until OMB
has approved the proposed collection of
information.
DATES: Submit written or electronic
comments on this pilot project program
by September 18, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before September 18,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 18, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
SUMMARY:
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33497
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–N–0407 for ‘‘Pilot Project Program
under the Drug Supply Chain Security
Act; Request for Comments.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
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Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Notices
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Daniel Bellingham, Office of
Compliance, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 50, Rm. 4285, Silver Spring,
MD 20993–0002, 301–796–3130,
DSCSAPilotProjects@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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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 the
new sections 581 and 582 to the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360eee and
360eee–1, respectively). Under section
582(j) of the FD&C Act, FDA is required
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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 will be establishing the DSCSA
Pilot Project Program to implement
section 582(j) of the FD&C Act. This
program will assist the development of
the interoperable electronic system to be
established by 2023. The new system
has the potential to reduce diversion of
drugs distributed domestically as well
as help reduce the influx of counterfeit
drugs from foreign sources. The 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 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 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,
particularly the requirement to utilize a
product identifier for product tracing
and verification purposes. FDA plans to
coordinate with stakeholders who
reflect the diversity of the
pharmaceutical distribution supply
chain, including large and small entities
from all industry sectors. The pilot
project is designed to allow industry to
identify and evaluate the most efficient
systems for their unique operational
systems.
II. The Proposed DSCSA Pilot Project
Program
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
intends to meet with all pilot project
participants to ensure that the learnings
from the pilot project(s) will be
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complementary in informing the
direction of the development of the
electronic, interoperable system that
will go into 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 packagelevel tracing and verification that go
into 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.
A. Products Eligible for Proposed Pilot
Projects
Proposed pilot projects may include
any prescription drug that is a
‘‘product’’ within the meaning of
section 581(13) of the FD&C Act. At its
discretion, FDA may also consider
proposed pilot projects involving
product types outside the scope of
section 581(13) of the FD&C Act (e.g.,
over-the-counter medicines) that could
further the objectives of the DSCSA
Pilot Project Program. Each package and
homogenous case of product that is part
of a pilot project should bear a ‘‘product
identifier’’ as described in sections
581(14) and 582(a)(9) of the FD&C Act.
B. Potential Issues To Examine and
Evaluation Methods To Use in Proposed
Pilot Projects
On April 5 and 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 has
identified several potential issues to
examine, and evaluation methods to
use, in pilot projects established under
the DSCSA Pilot Project Program. These
potential 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.
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33499
TABLE 1—POTENTIAL ISSUES TO EXAMINE AND EVALUATION METHODS TO USE IN PROPOSED PILOT PROJECTS
Pilot project focus area
Potential issues to examine
Potential evaluation methods
Product Identifier ..................
• Processes related to the requirement for manufacturers to affix or imprint a product identifier to each
package and homogenous case of product intended
to be introduced in a transaction into 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 NDC or serial number).
• Readability of barcode printed or affixed including impact of environmental and human factors.
• Application of linear and 2D barcodes on product ......
• Impacts of different representations of the product
identifier on systems or processes.
—Number of errors.
—Time to process.
—Time to reconcile these differences.
Barcode Quality ...................
Interoperability ......................
Data/Database/System
Issues.
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Aggregation/Disaggregation
Verification/Notification .........
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• Distinguishing which barcode to read/use and when.
• Process and technical challenges due to variety of
solutions expected (e.g., type of database used and
system architecture for exchanging information
among trading partners).
• Maintaining the integrity of information contained in
the barcode of serialized product throughout the distribution supply chain (e.g., a trading partner goes
out of business or one acquires another business).
• Different methods for exchanging information (e.g.,
the use of Electronic Data Interchange, Electronic
Product Code Information Services, and other solutions separately).
• Data quality from beginning to end of the product
lifecycle and vice versa.
• System performance when full or partially loaded
with data.
• Data format or processes for data transfer .................
—Use of technical standards for defining data attributes
to enable interoperable transfers.
—Methods to handle the ‘‘master data’’ (product-specific data) and transaction data separately to minimize ‘‘master data’’ redundancy.
• Integration into individual/company data systems ......
• Control and access to data by trading partners, FDA
or other Federal or State officials (data governance).
• Ability of the system to record product status (e.g., to
indicate expired, illegitimate, in error, quarantined) at
all packaging levels.
• Multiple levels of adoption of inference, by different
trading partners..
—Impact of inference gaps, changes or errors in data,
particularly downstream when searching or examining the data; how can errors be corrected.
• Barcode read error rates.
—Number of items unnecessarily quarantined or held
up.
—Time and resource impacts.
• For both decentralized and centralized models, time
implications.
—To investigate suspect and illegitimate products.
—For notifications required within the statutory
timelines.
—Related to scaling up from pilot to full production.
• Product tracing information (across multiple partners).
—Capability to retrieve the information.
—Accuracy of the information (within and between systems).
• Security and access.
—Evaluate and document access levels for trading
partners.
• System Performance and Effectiveness.
—Time to access and use product tracing information,
once that data is received into a system.
—Quality of product tracing information.
—Number of breaches to system.
—Number of attempts to breach the system that were
prevented or minimized.
• Data and product flow.
—Number of unsuccessful attempts to access data and
operational impacts.
—Number of system interactions within one, and
amongst multiple, trading partners.
—Time and resource changes on operations when data
and product not moving at same time (e.g., product
arrives before data arrives).
—Time for location/ownership/status changes to be reflected in the system.
—Time of product flow delays and associated costs
due to system or data problems.
• Number of system and product interactions within
one, and amongst multiple, trading partners.
• Time required to conduct aggregate/disaggregate operations and transactions.
• Accuracy of aggregation data (measure error
counts).
• Time to gather aggregation/disaggregation data for
investigations and notifications.
• Time to resolve errors in data.
• Process for investigation of suspect or illegitimate • Response times: Current vs. future process.
product, including any communication or coordination. • Time needed to obtain product tracing information to
—Making and responding to verification requests .........
respond to a request for verification.
—Making, responding, and terminating notifications ...... • Time needed to make, respond to, or terminate a no—Responding to requests for information ......................
tification.
—Testing boundaries of the system ............................... • Time to gather product tracing information to support
an investigation for a suspect or illegitimate product,
or a recall.
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TABLE 1—POTENTIAL ISSUES TO EXAMINE AND EVALUATION METHODS TO USE IN PROPOSED PILOT PROJECTS—
Continued
Pilot project focus area
Potential issues to examine
Potential evaluation methods
• Identify ‘honest errors’ (e.g., over/under shipments,
clerical errors or aggregation errors).
• Correcting ‘honest errors’ ............................................
Special Scenarios ................
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Exception Handling/Errors/
Inconsistencies.
• Situations when data and product do not move together.
• Situations when serialized product are sold and distributed along with non-serialized product.
FDA also received input from the
workshop participants and in the
comments submitted to the public
docket on factors that the Agency
should take into consideration when
establishing pilot projects. These factors
described in the comments 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 time 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, FDA may establish a pilot
project based on a request to participate
in the program that does not satisfy one
or more of the factors listed in this
document.
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• 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.
• Percent errors detected: compare exceptions introduced vs. exceptions detected.
—Identify the first step in the process where error 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 heldup.
—Time and resource impacts.
• Error rates for special processes.
—Number of items unnecessarily quarantined or heldup.
—Time and resource impacts.
• Accuracy of linkage between original manufacturer
product identifier and repackager-issued product
identifier.
C. Proposed Instructions for Submitting
a Request To Participate in the
Proposed DSCSA Pilot Project Program
Once the DSCSA Pilot Project
Program is established, volunteers
interested in participating in the DSCSA
Pilot Project Program will be able to
submit a request to participate by email
to a designated FDA email address for
the program. For a group of entities that
partner to participate in a pilot project,
only one submission and one point-ofcontact 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. Proposed Content of the Submission
for a Request To Participate in the
Proposed 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 such pilot project
(name of company and name of
company representative).
• Type(s) of each partnering entity
participating in the pilot project
(partnering entities include authorized
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trading partners or other supply chain
stakeholders).
• Number of employees for each
partnering entity that would participate
in such pilot project.
• 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).
• 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 Proposed
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
G. Proposed Reports).
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F. Participation in Proposed Pilot
Projects
Prior to launching a pilot project, FDA
will hold a design strategy meeting with
the selected pilot participant(s) to
review the goal(s) and objective(s) for
the pilot project and discuss the plans
and other pertinent details. The
participant(s) will be responsible for
conducting their pilot project. A group
of entities (members of the
pharmaceutical distribution supply
chain and other stakeholders, including
trade associations) that partner to
conduct a pilot project may be
considered a single participant for
purposes of the DSCSA Pilot Project
Program. The partners in any pilot
project that is selected into the program
will be responsible for the funding and
resources necessary to conduct the pilot
project, and for determining each
partner’s role and responsibility in their
pilot project. Pilot project participants
will also be expected to submit reports
on the progress of their pilot projects to
FDA (see section G. Proposed Reports).
Participants should evaluate their pilot
project using the evaluation methods
they identified during the pilot project
design process.
project, however for a one-month pilot
project, FDA may ask for weekly
progress reports.
2. Final Report
Within 30 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 project and the final
report will support FDA’s DSCSA
implementation, including the statutory
requirements under section 582(j) 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. Proposed Final DSCSA Pilot Project
Program Report
Each pilot project is expected to be
completed within the proposed duration
time period, and participants will be
expected to report progress to FDA
while the pilot project is being
conducted, in addition to a final report
within 30 days of completing the pilot
project. These reports will provide
insight into the systems and process
needed to comply with certain DSCSA
requirements for enhance drug
distribution security.
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 of the
program’s pilot projects 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.
The information related to the DSCSA
Pilot Project Program and the final
program report will be posted on FDA’s
Web site.
1. Progress Report(s)
I. Proposed Recordkeeping
Each pilot project program participant
is expected to provide reports on the
progress of their pilot project to FDA.
The progress reports are intended to
capture the ongoing work during the
pilot project, including but not limited
to, current 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
Any records generated by a
participant for conducting a pilot
project should be maintained as an
entity would as in a normal course of
business. For participants that involve
partnering entities, the partnering
entities can decide who is responsible
for the records generated by conducting
a pilot project. FDA recommends that
the progress reports and the final report
that participants create and submit to
FDA for a pilot project should be
maintained for at least 1 year after
completion of the pilot project.
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G. Proposed Reports
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J. Initiation of FDA’s DSCSA Pilot
Project Program
FDA does not intend to begin the
proposed DSCSA Pilot Project Program
or accept requests to participate in the
program until OMB has approved the
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33501
proposed collection of information
described in this notice.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from OMB for each collection
of information that they conduct or
sponsor. ‘‘Collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA, 44
U.S.C. 3506(c)(2)(A), requires Federal
Agencies to provide a 60-day notice in
the Federal Register to solicit comment
for each proposed collection of
information before submitting the
collection to OMB for approval. To
comply with this requirement, FDA is
publishing this notice of the proposed
collection of information set forth in
this document.
With respect to the collection of
information associated with the DSCSA
Pilot Project Program, FDA invites
comments on the following topics: (1)
Whether the proposed information
collected is necessary for the proper
performance of FDA’s functions,
including whether the information will
have practical utility; (2) the accuracy of
FDA’s estimated burden of the proposed
information collected, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information collected; and (4) ways to
minimize the burden of information
collected on the respondents, including
through the use of automated collection
techniques, when appropriate, and other
forms of information technology.
The estimated burden for the
information collection associated with
the DSCSA Pilot Project Program
consists of the following:
Submitting a request to participate
and reporting activities. FDA estimates
that no more than 10 respondents (i.e.,
the submitter or point of contact
identified on the request to participate)
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
certain respondents will coordinate
with partnering entities to submit a
request to participate; the burden
estimate associated with that
coordination follows. FDA estimates
that it will select no more than eight
participants 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
E:\FR\FM\20JYN1.SGM
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Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Notices
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 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 respondent will
provide one final report to FDA. FDA
estimates that it will take the eight
respondents 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 2).
Recordkeeping activities.
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 3).
In developing its burden estimate for
records associated with the proposed
pilot projects, FDA has taken account of
existing industry practices for keeping
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, the burden
estimates for like records associated
with the proposed FDA pilot project
program are not included in the
calculation of the recordkeeping burden
(see 5 CFR 1320.3(b)(2)). FDA welcomes
comments on the activities identified for
conducting a pilot project that FDA
considers to be usual and customary
business practice.
Third-party disclosure activities. 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 in 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 eight respondents with
an average of two 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 4).
TABLE 2—ESTIMATED REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
DSCSA pilot project program
Total
responses
Hours per
response
Total hours
Requests to participate ..................................................
Progress reports ............................................................
Final report to FDA ........................................................
10
8
8
1
5
1
10
40
8
80
8
40
800
320
320
Total ........................................................................
..............................
........................
........................
........................
1,440
asabaliauskas on DSKBBXCHB2PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—RECORDKEEPING BURDEN 1
Number of
recordkeepers
DSCSA Pilot project program
Records related to requests to participate ..............
Records related to progress reports .......................
Records related to the final report to FDA ..............
VerDate Sep<11>2014
18:50 Jul 19, 2017
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Number of
records per
recordkeeper
10
8
8
Frm 00027
Fmt 4703
Total records
1
5
1
Sfmt 4703
E:\FR\FM\20JYN1.SGM
10
40
8
Hours per record
0.5 (30 minutes) ...
0.5 (30 minutes) ...
0.5 (30 minutes) ...
20JYN1
Total hours
5
20
4
33503
Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Notices
TABLE 3—RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
Number of
records per
recordkeeper
Total records
Hours per record
..............................
........................
........................
..............................
DSCSA Pilot project program
Total .................................................................
1 There
Total hours
29
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—THIRD-PARTY DISCLOSURE BURDEN 1
Coordination with partnering entities related to requests to participate ...................................................
Coordination with partnering entities related to
progress reports .........................................................
Coordination with partnering entities related to final reports ............................................................................
Total ........................................................................
1 There
[FR Doc. 2017–15203 Filed 7–19–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–3068]
Patient-Focused Drug Development for
Hereditary Angioedema; Public
Meeting; Request for Comments
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a public meeting and
an opportunity for public comment on
‘‘Patient-Focused Drug Development for
Hereditary Angioedema.’’ PatientFocused Drug Development is part of
FDA’s performance commitment under
the fifth authorization of the
Prescription Drug User Fee Act (PDUFA
V). The public meeting is intended to
allow FDA to obtain patients’
perspectives on the impact of hereditary
angioedema (HAE) on daily life. FDA
also is seeking patients’ views on
treatment approaches for HAE.
DATES: The public meeting will be held
on September 25, 2017, from 9 a.m. to
3 p.m. Registration to attend must be
received by August 10, 2017. Submit
SUMMARY:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Total
disclosures
Hours per
disclosure
Total hours
8
2
16
8
128
7
10
70
4
280
7
2
14
20
280
..............................
........................
........................
........................
688
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
AGENCY:
Number of
disclosures
per
respondent
Number of
respondents
DSCSA pilot project program
VerDate Sep<11>2014
18:50 Jul 19, 2017
Jkt 241001
either electronic or written comments
on the public meeting by November 20,
2017. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1, where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before November 20, 2017. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of November 20, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Since your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–3068 for ‘‘Patient-Focused Drug
E:\FR\FM\20JYN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)]
[Notices]
[Pages 33497-33503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15203]
=======================================================================
-----------------------------------------------------------------------
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;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
its intent to establish a pilot project program under the Drug Supply
Chain Security Act (the DSCSA Pilot Project Program) to assist in
development of the electronic, interoperable system that will identify
and trace certain prescription drugs as these 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 will be
voluntary and will be open to pharmaceutical distribution supply chain
members. FDA will be particularly interested in participation
reflecting the diversity of the supply chain, including large and small
entities from all industry sectors. This notice describes the proposed
DSCSA Pilot Project Program, including proposed instructions for
submitting a request to participate. FDA is soliciting comments on the
proposed collection of information associated with establishment of the
DSCSA Pilot Project Program before submitting the proposed collection
to the Office of Management and Budget (OMB) for approval. FDA does not
intend to begin the proposed DSCSA Pilot Project Program or accept
requests to participate in the program until OMB has approved the
proposed collection of information.
DATES: Submit written or electronic comments on this pilot project
program by September 18, 2017.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 18, 2017. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-N-0407 for ``Pilot Project Program under the Drug Supply Chain
Security Act; Request for Comments.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper
[[Page 33498]]
submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Daniel Bellingham, Office of
Compliance, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 50, Rm. 4285, 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 the new sections 581 and 582 to the Federal Food, Drug, and
Cosmetic Act (the 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 will be establishing the DSCSA Pilot Project Program to
implement section 582(j) of the FD&C Act. This program will assist the
development of the interoperable electronic system to be established by
2023. The new system has the potential to reduce diversion of drugs
distributed domestically as well as help reduce the influx of
counterfeit drugs from foreign sources. The 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 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 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,
particularly the requirement to utilize a product identifier for
product tracing and verification purposes. FDA plans to coordinate with
stakeholders who reflect the diversity of the pharmaceutical
distribution supply chain, including large and small entities from all
industry sectors. The pilot project is designed to allow industry to
identify and evaluate the most efficient systems for their unique
operational systems.
II. The Proposed DSCSA Pilot Project Program
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 intends to meet with all pilot project participants to ensure that
the learnings from the pilot project(s) will be complementary in
informing the direction of the development of the electronic,
interoperable system that will go into 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 go into 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.
A. Products Eligible for Proposed Pilot Projects
Proposed pilot projects may include any prescription drug that is a
``product'' within the meaning of section 581(13) of the FD&C Act. At
its discretion, FDA may also consider proposed pilot projects involving
product types outside the scope of section 581(13) of the FD&C Act
(e.g., over-the-counter medicines) that could further the objectives of
the DSCSA Pilot Project Program. Each package and homogenous case of
product that is part of a pilot project should bear a ``product
identifier'' as described in sections 581(14) and 582(a)(9) of the FD&C
Act.
B. Potential Issues To Examine and Evaluation Methods To Use in
Proposed Pilot Projects
On April 5 and 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 has identified several potential
issues to examine, and evaluation methods to use, in pilot projects
established under the DSCSA Pilot Project Program. These potential
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.
[[Page 33499]]
Table 1--Potential Issues To Examine and Evaluation Methods To Use in
Proposed 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 these 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 NDC or serial
number).
Barcode Quality............. Readability Barcode
of barcode printed read error rates.
or affixed --Number of items
including impact of unnecessarily
environmental and quarantined or held
human factors. up.
Application --Time and resource
of linear and 2D impacts.
barcodes on product.
Distinguishing
which barcode to
read/use and when.
Interoperability............ Process and For both
technical decentralized and
challenges due to centralized models,
variety of time implications.
solutions expected --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
exchanging
information (e.g.,
the use of
Electronic Data
Interchange,
Electronic Product
Code Information
Services, and other
solutions
separately).
Security
and access.
--Evaluate and
document access
levels for trading
partners.
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.
Data format --Quality of product
or processes for tracing
data transfer. information.
--Use of technical --Number of breaches
standards for to system.
defining data --Number of attempts
attributes to to breach the
enable system that were
interoperable prevented or
transfers. minimized.
--Methods to handle
the ``master data''
(product-specific
data) and
transaction data
separately to
minimize ``master
data'' redundancy.
Integration Data and
into individual/ product flow.
company data --Number of
systems. unsuccessful
Control and attempts to access
access to data by data and
trading partners, operational
FDA or other impacts.
Federal or State --Number of system
officials (data interactions within
governance). one, and amongst
Ability of multiple, trading
the system to partners.
record product --Time and resource
status (e.g., to changes on
indicate expired, operations when
illegitimate, in data and product
error, quarantined) not moving at same
at all packaging time (e.g., product
levels. arrives before data
arrives).
--Time for location/
ownership/status
changes to be
reflected in the
system.
--Time of product
flow delays and
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.. multiple, trading
--Impact of partners.
inference gaps, Time
changes or errors required to conduct
in data, aggregate/
particularly disaggregate
downstream when operations and
searching or transactions.
examining the data;
how can errors be
corrected.
Accuracy of
aggregation data
(measure error
counts).
Time to
gather aggregation/
disaggregation data
for investigations
and notifications.
Time to
resolve errors in
data.
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, to, or terminate a
responding, and notification.
terminating Time to
notifications. gather product
--Responding to tracing information
requests for to support an
information. investigation for a
--Testing boundaries suspect or
of the system. illegitimate
product, or a
recall.
[[Page 33500]]
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
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 error
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.
------------------------------------------------------------------------
FDA also received input from the workshop participants and in the
comments submitted to the public docket on factors that the Agency
should take into consideration when establishing pilot projects. These
factors described in the comments 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 time 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, FDA may establish a pilot project based on a request to
participate in the program that does not satisfy one or more of the
factors listed in this document.
C. Proposed Instructions for Submitting a Request To Participate in the
Proposed DSCSA Pilot Project Program
Once the DSCSA Pilot Project Program is established, volunteers
interested in participating in the DSCSA Pilot Project Program will be
able to submit a request to participate by email to a designated FDA
email address for the program. 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. Proposed Content of the Submission for a Request To Participate in
the Proposed 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
such pilot project (name of company and name of company
representative).
Type(s) of each partnering entity participating in the
pilot project (partnering entities include authorized trading partners
or other supply chain stakeholders).
Number of employees for each partnering entity that would
participate in such pilot project.
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).
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 Proposed 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 G. Proposed
Reports).
[[Page 33501]]
F. Participation in Proposed Pilot Projects
Prior to launching a pilot project, FDA will hold a design strategy
meeting with the selected pilot participant(s) to review the goal(s)
and objective(s) for the pilot project and discuss the plans and other
pertinent details. The participant(s) will be responsible for
conducting their pilot project. A group of entities (members of the
pharmaceutical distribution supply chain and other stakeholders,
including trade associations) that partner to conduct a pilot project
may be considered a single participant for purposes of the DSCSA Pilot
Project Program. The partners in any pilot project that is selected
into the program will be responsible for the funding and resources
necessary to conduct the pilot project, and for determining each
partner's role and responsibility in their pilot project. Pilot project
participants will also be expected to submit reports on the progress of
their pilot projects to FDA (see section G. Proposed Reports).
Participants should evaluate their pilot project using the evaluation
methods they identified during the pilot project design process.
G. Proposed Reports
Each pilot project is expected to be completed within the proposed
duration time period, and participants will be expected to report
progress to FDA while the pilot project is being conducted, in addition
to a final report within 30 days of completing the pilot project. These
reports will provide insight into the systems and process needed to
comply with certain DSCSA requirements for enhance drug distribution
security.
1. Progress Report(s)
Each pilot project program participant is expected to provide
reports on the progress of their pilot project to FDA. The progress
reports are intended to capture the ongoing work during the pilot
project, including but not limited to, current 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 one-month pilot project, FDA may ask for weekly
progress reports.
2. Final Report
Within 30 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 project and the final report will support FDA's DSCSA
implementation, including the statutory requirements under section
582(j) 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. Proposed 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 of the program's pilot
projects 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. The information related to the DSCSA Pilot Project
Program and the final program report will be posted on FDA's Web site.
I. Proposed Recordkeeping
Any records generated by a participant for conducting a pilot
project should be maintained as an entity would as in a normal course
of business. For participants that involve partnering entities, the
partnering entities can decide who is responsible for the records
generated by conducting a pilot project. FDA recommends that the
progress reports and the final report that participants create and
submit to FDA for a pilot project should be maintained for at least 1
year after completion of the pilot project.
J. Initiation of FDA's DSCSA Pilot Project Program
FDA does not intend to begin the proposed DSCSA Pilot Project
Program or accept requests to participate in the program until OMB has
approved the proposed collection of information described in this
notice.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from OMB for each
collection of information that they conduct or sponsor. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes Agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires
Federal Agencies to provide a 60-day notice in the Federal Register to
solicit comment for each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing this notice of the proposed collection
of information set forth in this document.
With respect to the collection of information associated with the
DSCSA Pilot Project Program, FDA invites comments on the following
topics: (1) Whether the proposed information collected is necessary for
the proper performance of FDA's functions, including whether the
information will have practical utility; (2) the accuracy of FDA's
estimated burden of the proposed information collected, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information collected; and (4)
ways to minimize the burden of information collected on the
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
The estimated burden for the information collection associated with
the DSCSA Pilot Project Program consists of the following:
Submitting a request to participate and reporting activities. FDA
estimates that no more than 10 respondents (i.e., the submitter or
point of contact identified on the request to participate) 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
certain respondents will coordinate with partnering entities to submit
a request to participate; the burden estimate associated with that
coordination follows. FDA estimates that it will select no more than
eight participants 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
[[Page 33502]]
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 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 respondent will provide
one final report to FDA. FDA estimates that it will take the eight
respondents 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 2).
Recordkeeping activities. 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 3).
In developing its burden estimate for records associated with the
proposed pilot projects, FDA has taken account of existing industry
practices for keeping 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, the burden estimates
for like records associated with the proposed FDA pilot project program
are not included in the calculation of the recordkeeping burden (see 5
CFR 1320.3(b)(2)). FDA welcomes comments on the activities identified
for conducting a pilot project that FDA considers to be usual and
customary business practice.
Third-party disclosure activities. 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 in 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
eight respondents with an average of two 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 4).
Table 2--Estimated Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
DSCSA pilot project program Number of responses per Total Hours per Total hours
respondents respondent responses 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 3--Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
DSCSA Pilot project program Number of records per Total records Hours per record Total hours
recordkeepers recordkeeper
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------
[[Page 33503]]
Total.................................... ................. .............. .............. ...................................... 29
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 4--Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
DSCSA pilot project program Number of disclosures Total Hours per Total hours
respondents per respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
Coordination with partnering 8 2 16 8 128
entities related to requests
to participate..............
Coordination with partnering 7 10 70 4 280
entities related to progress
reports.....................
Coordination with partnering 7 2 14 20 280
entities related to final
reports.....................
----------------------------------------------------------------------------------
Total.................... ................. .............. .............. .............. 688
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: July 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15203 Filed 7-19-17; 8:45 am]
BILLING CODE 4164-01-P
