Document ID: FDA-2016-N-0407-0022
Agency: fda
Document Type: Notice
Title: Pilot Project Program Under the Drug Supply Chain Security Act; Request for Comments
Posted Date: 2017-07-20T04:00Z

[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]

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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.

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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