[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31874-31875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14147]
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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 or the Agency) is
reopening the comment period for the notices (requests for information)
that published in the Federal Register of April 15, 2016, and April 28,
2017. FDA is requesting 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
reopening of the comment period will allow supply chain stakeholders to
share information about relevant piloting activities that are conducted
outside of FDA's DSCSA Pilot Project Program to inform DSCSA
implementation by FDA and supply chain stakeholders.
DATES: FDA is reopening the comment period on the notices (requests for
information) published April 15, 2016 (81 FR 22279), and April 28, 2017
(82 FR 19737). Submit either electronic or written comments by June 28,
2022.
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 June 28, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 28, 2022. Comments received
by mail/hand delivery/courier
[[Page 31875]]
(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-1114 for ``Pharmaceutical Distribution Supply Chain Pilot
Projects; Reopening of Comment Period; Request for Information.''
Received comments, those filed in a timely manner (see ADDRESSES), 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 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., Silver Spring, MD 20993-0002,
301-796-3130, [email protected].
SUPPLEMENTARY INFORMATION: FDA is interested in comments regarding past
or present pilot projects related to enhancing the safety and security
of the pharmaceutical distribution supply chain; this may include
information related to piloting activities that are conducted outside
of FDA's DSCSA Pilot Project Program. 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 of each supply chain sector to
develop and implement the 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 implementation of the requirements
for enhanced product tracing and verification under the DSCSA.
FDA is reopening the comment period for the requests for
information for 3 years, until June 28, 2022. The Agency believes that
a 3-year comment period allows adequate time for interested persons to
submit new, additional, or updated comments on these important issues
as they work to implement requirements under the DSCSA.
Dated: June 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14147 Filed 7-2-19; 8:45 am]
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