[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7807-7809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02977]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0407]


Proposed Pilot Project(s) Under the Drug Supply Chain Security 
Act; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Proposed Pilot Project(s) under the Drug Supply 
Chain Security Act (DSCSA).'' This public workshop will provide a forum 
for discussing proposed design objectives of pilot projects that will 
explore and evaluate methods to enhance the safety and security of the 
pharmaceutical distribution supply chain. FDA would like to obtain 
information and input from interested pharmaceutical distribution 
supply chain members about issues related to utilizing the product 
identifier for product tracing, improving the technical capabilities of 
the supply chain, and identifying the system attributes that are 
necessary to implement the requirements established under the DSCSA. 
The information gathered from the workshop and the public comments 
submitted to the docket will further inform FDA's development of its 
pilot project program.

DATES: The public workshop will be held on April 5, 2016, from 9 a.m. 
to 5 p.m. and April 6, 2016, from 9 a.m. to 12:15 p.m. The deadline for 
submitting either electronic or written comments on this workshop is 
April 21, 2016. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the confirmed 
public workshop participants (non-FDA employees) is through Building 1 
where routine security check procedures will be performed. For parking 
and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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

[[Page 7808]]

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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 ``Proposed Pilot Project(s) under the Drug Supply 
Chain Security Act; Public Workshop; Request for Comments.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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., Silver Spring, MD 20993-0002, 
301-796-3130, [email protected] (include ``DSCSA 
pilot projects'' in the subject line).

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, which 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 Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 360eee and 360eee-1). Under section 582(j), 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 intends to establish a pilot project program to implement 
section 582(j) of the FD&C Act. The overarching goals of this program 
include assessing the ability of supply chain members to satisfy the 
requirements of section 582 and to identify, manage, and prevent the 
distribution of suspect and illegitimate drugs; identifying the system 
attributes needed to implement the requirements of section 582, 
particularly the requirement to utilize a product identifier for 
product tracing purposes; and demonstrating the electronic, 
interoperable exchange of product tracing information across the 
pharmaceutical distribution supply chain. FDA intends to coordinate its 
pilot project program efforts with stakeholders that reflect the 
diversity of the pharmaceutical distribution supply chain, including 
large and small entities from all industry sectors.

II. Purpose of the Public Workshop

    This public workshop is intended to provide an opportunity for 
interested persons to provide comments on and discuss the proposed 
design objectives of pilot projects that will explore and evaluate 
methods to enhance the safety and security of the pharmaceutical 
distribution supply chain. FDA would like to obtain information and 
input from interested pharmaceutical distribution supply chain members 
about issues related to utilizing the product identifier for product 
tracing, improving the technical capabilities of the pharmaceutical 
distribution supply chain, and identifying the system attributes that 
are necessary to implement the requirements under section 582. FDA 
would also like to learn more about the practices, processes, and 
systems that supply chain stakeholders currently use or plan to use to 
meet the requirements under section 582, particularly the product 
tracing and verification requirements. These practices, processes, and 
systems may include those that supply chain stakeholders would consider 
using in pilot projects or those that supply chain stakeholders have 
already used in other previous pilot projects.
    By March 29, 2016, FDA will post the workshop agenda and other 
relevant materials under the DSCSA section of its Web site at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. Supply chain stakeholders 
that might be interested in attending the public workshop include 
manufacturers, repackagers, wholesale distributors, dispensers, State 
and Federal authorities, solution providers, and standards 
organizations. Participants at the workshop will not be asked to 
develop consensus opinions during the discussion, but rather to provide 
their individual perspectives.
    Regardless of attendance at the public workshop, interested 
stakeholders may submit comments to the public docket related to any of 
the public workshop materials, including the agenda and other posted 
materials on FDA's Web site, in addition to comments specific to the 
design of pilot projects that will explore and evaluate methods to

[[Page 7809]]

enhance the safety and security of the pharmaceutical distribution 
supply chain. Stakeholders may comment on utilizing the product 
identifier for product tracing and the technical capabilities of the 
pharmaceutical distribution supply chain and the system attributes that 
are necessary to implement the requirements under section 582. The 
information gathered from the workshop participants and from the 
comments submitted to the docket for the public workshop will further 
inform FDA's development of its pilot project program under section 
582(j) of the FD&C Act.

III. Registration for the Public Workshop

    To request registration for the public workshop, provide your 
information including name, company or organization, address, telephone 
number, and email address to FDA at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. Registration requests should be received by 
March 11, 2016. FDA is limiting workshop attendance due to limited 
space. FDA may limit the number of participants from each organization 
based on space limitations. FDA recommends that each organization 
determine who should register for the workshop to represent his/her 
organization. This will help ensure that the workshop will have broad 
and varied representation across the pharmaceutical distribution supply 
chain. Registrants will receive confirmation of participation for the 
workshop from FDA by March 18, 2016. There is no registration fee for 
the public workshop. There will be no onsite registration. If 
registration reaches maximum capacity, FDA will post a notice closing 
registration for the workshop on FDA's Web site at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. If you need special accommodations due 
to a disability, please contact Daniel Bellingham (see FOR FURTHER 
INFORMATION CONTACT) at least 7 days in advance of the public workshop.

IV. Webcasting of the Public Workshop

    Portions of this public workshop will be recorded and Webcasted on 
the day of the workshop. Information for how to access the Webcast will 
be available at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm by 
March 29, 2016. The Webcast will be conducted in listening-mode only.

    Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02977 Filed 2-12-16; 8:45 am]
 BILLING CODE 4164-01-P