[Federal Register Volume 86, Number 197 (Friday, October 15, 2021)]
[Notices]
[Pages 57435-57437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22474]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1004]


Enhanced Drug Distribution Security at the Package Level Under 
the Drug Supply Chain Security Act; Public Meeting; Request for 
Comments

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing a virtual public meeting entitled ``Enhanced Drug 
Distribution Security at the Package Level Under the Drug Supply Chain 
Security Act (DSCSA).'' This public meeting is intended to provide 
members of the pharmaceutical distribution supply chain and other 
interested stakeholders an opportunity to discuss enhanced drug 
distribution security requirements of the DSCSA related to system 
attributes necessary to enable secure tracing of product at the package 
level.

DATES: The public meeting will be held on November 16, 2021, from 9 
a.m. to 4 p.m., and will take place virtually. Submit either electronic 
or written comments on this public meeting by January 18, 2022.

ADDRESSES: The public meeting will be held virtually and hosted by FDA. 
Registration to participate in this meeting and other information can 
be found at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security. See the SUPPLEMENTARY INFORMATION section for 
registration date and other information.
    Comments: To permit the widest possible opportunity to obtain 
public comment, FDA is soliciting either electronic or written comments 
on all aspects of the public meeting topics. You may submit comments as 
follows. Please note that late, untimely filed comments will not be 
considered. Please note that the deadline for submitting either 
electronic or written comments is 60 days after the meeting, January 
18, 2022, to which the comments relate. 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. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of the specified 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-2021-N-1004 for ``Enhanced Drug Distribution Security at the 
Package Level Under the Drug Supply Chain Security Act; Public Meeting; 
Request for Comments.'' 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, 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

[[Page 57436]]

``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: Kristle Green, Office of Compliance, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3130, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, the DSCSA (Title II, Pub. L. 113-54) was 
signed into law. The DSCSA outlines critical steps to build an 
electronic, interoperable system by 2023 to identify and trace certain 
prescription drugs as they are distributed within the United States. 
This system will enhance FDA's ability to protect U.S. consumers from 
exposure to drugs that may be counterfeit, diverted, stolen, 
intentionally adulterated, or otherwise harmful by improving the 
detection and removal of potentially dangerous drugs from the drug 
supply chain. Section 582(g)(1) of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) (21 U.S.C. 360eee-1(g)(1)) imposed requirements for the 
enhanced drug distribution security that go into effect on November 27, 
2023. Additionally, section 582(i) of the FD&C Act directs FDA to hold 
public meetings to enhance the safety and security of the 
pharmaceutical distribution supply chain and provide opportunities for 
comment from members of the pharmaceutical distribution supply chain 
and other interested stakeholders. Section 582(h)(3) of the FD&C Act 
directs FDA to conduct a public meeting and issue guidance addressing 
the system attributes necessary to enable secure tracing of product at 
the package level.

II. Topics for Discussion at the Public Meeting

    FDA will hold a virtual public meeting on November 16, 2021, on 
enhanced drug distribution security at the package level. The purpose 
of this public meeting is to provide members of the pharmaceutical 
distribution supply chain and other interested stakeholders an 
opportunity to provide input to FDA on the implementation of the 
enhanced drug distribution security provisions of the DSCSA that go 
into effect in 2023. FDA requests that stakeholders prepare comments 
responding to the following questions for one or more of the topics 
listed below:
     How is implementation of the 2023 enhanced system 
requirements progressing for your organization?
     What challenges are your organization facing?
     Are the proposed recommendations in FDA's draft guidance 
entitled ``Enhanced Drug Distribution Security at the Package Level 
Under the Drug Supply Chain Security Act'' (June 2021) helpful to 
achieve compliance with 2023 enhanced system requirements? If not, what 
additional information would be useful?
     Are there areas in which FDA could provide more clarity?

Topics

1. Enhanced Drug Distribution Security
     System Attributes
     Aggregation, Inference, and Physical Security Features
2. System Structure
     Data Architecture
     Adoption of Data and System Security
     Protecting Confidential Commercial Information and Trade 
Secrets
     System Access and Data Retrieval
3. Enhanced Product Tracing
     Serialized Transaction Information and Data Exchange 
(Incorporation of the Product Identifier into Product Tracing 
Information)
     Responsibilities of the Selling and Buying Trading 
Partners in Regard to the Product Tracing Information
     Handling Aggregation Errors and Other Discrepancies
4. Gathering of Relevant Product Tracing Information
5. Enhanced Verification
     Verification of Distributed Product
     Verification of Saleable Return Product
     Alerts for Illegitimate Product
6. Trading Partner Readiness
     Your organization's Overall Readiness for Implementation 
of the Enhanced Drug Distribution Security Provisions of the DSCSA That 
Go into Effect in 2023
     Components That Your Organization Is Furthest Along in 
Developing, Including the Components Being Prioritized and the 
Components That Are Easier or More Challenging to Implement:
    i. Technical Components
    ii. Technical Infrastructure
    iii. Business Processes
    iv. Employee Training

    FDA may include additional discussion topics. Materials for the 
public meeting will be provided on FDA's website at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security 7 
days before the public meeting.

III. Participating in the Public Meeting

    Registration: This will be a virtual public meeting and attendance 
is free. Individuals who wish to attend must register on or before 
October 26, 2021. To register for the public meeting, provide the 
following information on the public meeting registration page: Your 
name, organization name, stakeholder type, email address, and telephone 
number to FDA at https://dscsapublicmeeting2021.eventbrite.com. There 
will be no onsite or same-day registration. If registration reaches 
maximum capacity, FDA will post a notice closing registration for the 
meeting on FDA's website at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security.
    Request for Oral Presentations: This public meeting will include 
public comment sessions. Individuals who wish to present during a 
public comment session during this meeting must register as noted at 
https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security and identify the topics (see section II) they wish to 
address in their presentation and the stakeholder group they best 
associate with, if any, to help FDA organize the presentations. 
Individuals and organizations with common interests are urged to 
consolidate or coordinate their presentations and request time for a 
joint presentation. Presenters should submit an electronic copy of 
their presentation to [email protected] on or before 
November 2, 2021.
    FDA will do its best to accommodate requests to present during the 
public

[[Page 57437]]

comment session and will determine the amount of time allotted for each 
oral presentation and the approximate time that each oral presentation 
is scheduled to begin. FDA will notify registered presenters of their 
scheduled times and make available an agenda and background material at 
https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security on or before November 5, 2021.
    If you need special accommodations due to a disability, please 
contact Kristle Green (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance of the public meeting.

IV. Post-Public Meeting Materials

    FDA will provide a recording of the public meeting and materials 
from the meeting at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security after the public meeting.

    Dated: October 8, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22474 Filed 10-14-21; 8:45 am]
BILLING CODE 4164-01-P