Document ID: FDA-2016-N-1114-0010
Agency: fda
Document Type: Notice
Title: Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of
Comment Period; Request for Information
Posted Date: 2017-04-28T04:00Z

[Federal Register Volume 82, Number 81 (Friday, April 28, 2017)]
[Notices]
[Pages 19737-19738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08583]

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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; 
Reopening of Comment Period; Request for Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period; request for information.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the Request for Information that appeared in the 
Federal Register of April 15, 2016. In the Request for Information, FDA 
requested comments 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 additional public 
comments will further inform the design and development of the pilot 
project(s) that FDA establishes under the DSCSA. FDA is reopening the 
comment period to receive updated comments and any new information.

DATES: FDA is reopening the comment period on the Request for 
Information published April 15, 2016 (81 FR 22279). Submit either 
electronic or written comments by April 30, 2018. Late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before April 30, 2018. The https://www.regulations.gov/ 
electronic filing system will accept comments until midnight Eastern 
Time at the end of April 30, 2018. 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.

ADDRESSES: You may submit comments as follows:

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/.

[[Page 19738]]

     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; Reopening of Comment Period; Request for Information.'' 
Received comments, those filed in a timely manner (see DATES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://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 https://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: 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 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, DSCSAPilotProjects@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 15, 2016, 
FDA published a Request for Information with a 30-day comment period to 
request comments relating to FDA implementation of the DSCSA. To permit 
additional and update submissions, we are reopening this comment period 
and extending it for April 30, 2018. 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, and 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 inform FDA's development of a pilot project under 
the DSCSA.
    FDA is reopening the comment period for the Request for Information 
for 1 year, until April 30, 2018. The Agency believes that an 
additional comment period of 1 year will allow time for interested 
persons to submit new, additional, or updated comments on these 
important issues.

    Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08583 Filed 4-27-17; 8:45 am]
 BILLING CODE 4164-01-P