[Federal Register Volume 89, Number 114 (Wednesday, June 12, 2024)]
[Notices]
[Pages 49884-49885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]]

     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, [email protected].

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-dscsa-governance-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 6-11-24; 8:45 am]
BILLING CODE 4164-01-P