81 FR 22279 - Pharmaceutical Distribution Supply Chain Pilot Projects; Request for Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 73 (April 15, 2016)

The Food and Drug Administration (FDA) is soliciting information regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information gathered from public comments will assist with the design and development of the pilot project(s) that FDA establishes under the DSCSA.

[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Pages 22279-22280]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08681]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1114]


Pharmaceutical Distribution Supply Chain Pilot Projects; Request 
for Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information.

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SUMMARY: The Food and Drug Administration (FDA) is soliciting 
information regarding issues related to utilizing the product 
identifier for product tracing, improving the technical capabilities of 
the supply chain, and identifying system attributes that are necessary 
to implement the requirements established under the Drug Supply Chain 
Security Act (DSCSA). The information gathered from public comments 
will assist with the design and development of the pilot project(s) 
that FDA establishes under the DSCSA.

DATES: Submit written or electronic comments and information by May 16, 
2016.
    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 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-1114 for ``Pharmaceutical Distribution Supply Chain Pilot 
Projects; Request for Information.'' 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, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On November 27, 2013, the 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 new sections 
581 and 582 to the Food Drug

[[Page 22280]]

and Cosmetic 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. The projects established by FDA will take into 
consideration any pilot projects that were conducted prior to enactment 
of the DSCSA.

II. Purpose of the Request for Information

    The request for information is intended to provide interested 
persons an opportunity to submit comments relating to FDA's 
implementation of the DSCSA. We are particularly interested in comments 
regarding past or present pilot projects related to enhancing the 
safety and security of the pharmaceutical distribution supply chain. 
Stakeholders that may be interested in responding to this request for 
information include: Manufacturers, repackagers, wholesale 
distributors, dispensers, State and Federal authorities, solution 
providers, standards organizations, and other interested persons. FDA 
is particularly interested in learning about the practices, processes, 
and systems that supply chain stakeholders have used or considered 
using in such pilot projects. This includes, but is not limited to, 
information about the following:
     Utilizing the product identifier for tracing of a product, 
which may include verification of the product identifier of a product, 
including the use of aggregation and inference;
     Technical capabilities each sector of the supply chain to 
comply with systems and processes needed to utilize the product 
identifier to enhance the tracing of a product; or
     System attributes that are necessary to implement the 
requirements established under the DSCSA.
    Interested persons are requested to provide any other relevant 
information that may assist with FDA's development of a pilot project 
under the DSCSA.

    Dated: April 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08681 Filed 4-14-16; 8:45 am]
 BILLING CODE 4164-01-P