Notice2024-12857
Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under the Federal Food, Drug, and Cosmetic Act; Notice; Request for Information and Comments; Reopening of the Comment Period
Primary source
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Published
June 12, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is publishing this request for information to better understand the status of trading partners' interoperable systems and processes for enhanced drug distribution security as required by the Food, Drug and Cosmetic Act (FD&C Act). FDA is reopening the comment period for the notice, published in the Federal Register of November 20, 2023, establishing a public docket and requesting information and comments, to allow interested persons additional time to comment.
Full Text
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<title>Federal Register, Volume 89 Issue 114 (Wednesday, June 12, 2024)</title>
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[Federal Register Volume 89, Number 114 (Wednesday, June 12, 2024)]
[Notices]
[Pages 49884-49885]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-12857]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4806]
Implementing Interoperable Systems and Processes for Enhanced
Drug Distribution Security Requirements Under the Federal Food, Drug,
and Cosmetic Act; Notice; Request for Information and Comments;
Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for
information and comments; reopening of the comment period.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
this request for information to better understand the status of trading
partners' interoperable systems and processes for enhanced drug
distribution security as required by the Food, Drug and Cosmetic Act
(FD&C Act). FDA is reopening the comment period for the notice,
published in the Federal Register of November 20, 2023, establishing a
public docket and requesting information and comments, to allow
interested persons additional time to comment.
DATES: FDA is reopening the comment period on the notice published
November 20, 2023 (88 FR 80726). Either electronic or written comments
must be submitted by September 12, 2024.
ADDRESSES: You may submit information and comments at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
[[Page 49885]]
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2023-N-4806 for ``Implementing Interoperable Systems and Processes
for Enhanced Drug Distribution Security Requirements Under Section
582(g)(1) of the Federal Food, Drug, and Cosmetic Act.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Sarah Venti, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4258, Silver Spring, MD 20993, 301-796-
3130, <a href="/cdn-cgi/l/email-protection#d9bdabacbeadabb8bab2b8b7bdadabb8babc99bfbdb8f7b1b1aaf7beb6af"><span class="__cf_email__" data-cfemail="d0b4a2a5b7a4a2b1b3bbb1beb4a4a2b1b3b590b6b4b1feb8b8a3feb7bfa6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of November 20, 2023
(88 FR 80726), FDA established a public docket to solicit comments on
``Implementing Interoperable Systems and Processes for Enhanced Drug
Distribution Security Requirements Under Section 582(g)(1) of the
Federal Food, Drug, and Cosmetic Act.'' The request for information
highlights areas for consideration and policy development identified by
the Center for Drug Evaluation and Research (CDER). The notice includes
a series of questions to stimulate feedback from the public, including
CDER and the Center for Biologics Evaluation and Research stakeholders.
Interested persons were originally given until February 20, 2024,
to comment on the docket.
Following publication of the November 20, 2023, notice, and in
consideration of the joint public meeting organized by FDA and
Partnership for DSCSA Governance (PDG): ``PDG-FDA Joint Public Meeting:
DSCSA Stabilization Period Midway Checkpoint'' scheduled for June 17-
18, 2024 (<a href="https://www.fda.gov/news-events/partnership-dscsa-governance-pdgfda-joint-public-meeting-dscsa-stabilization-period-midway">https://www.fda.gov/news-events/partnership-dscsa-governance-pdgfda-joint-public-meeting-dscsa-stabilization-period-midway</a>), FDA has
decided to reopen the public docket to allow interested persons
additional time to comment.
Dated: June 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12857 Filed 6-11-24; 8:45 am]
BILLING CODE 4164-01-P
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