4164-01-P
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.
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:
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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-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 https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
•

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.govinfo.gov/content/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, 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, drugtrackandtrace@fda.hhs.gov.
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 (https://www.fda.gov/news-events/partnership-dscsagovernance-pdgfda-joint-public-meeting-dscsa-stabilization-period-midway), 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: 6/11/2024 8:45 am; Publication Date: 6/12/2024]