Notice2021-22474
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Public Meeting; Request for Comments
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Published
October 15, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 197 (Friday, October 15, 2021)</title>
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[Federal Register Volume 86, Number 197 (Friday, October 15, 2021)]
[Notices]
[Pages 57435-57437]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security">https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security</a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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:
<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-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
<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
[[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: <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: 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,
<a href="/cdn-cgi/l/email-protection#d1929594839e9582988381a4b3bdb8b29cb4b4a5b8bfb6a291b7b5b0ffb9b9a2ffb6bea7"><span class="__cf_email__" data-cfemail="cd8e89889f82899e849f9db8afa1a4ae80a8a8b9a4a3aabe8daba9ace3a5a5bee3aaa2bb">[email protected]</span></a>.
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:
<bullet> How is implementation of the 2023 enhanced system
requirements progressing for your organization?
<bullet> What challenges are your organization facing?
<bullet> 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?
<bullet> Are there areas in which FDA could provide more clarity?
Topics
1. Enhanced Drug Distribution Security
<bullet> System Attributes
<bullet> Aggregation, Inference, and Physical Security Features
2. System Structure
<bullet> Data Architecture
<bullet> Adoption of Data and System Security
<bullet> Protecting Confidential Commercial Information and Trade
Secrets
<bullet> System Access and Data Retrieval
3. Enhanced Product Tracing
<bullet> Serialized Transaction Information and Data Exchange
(Incorporation of the Product Identifier into Product Tracing
Information)
<bullet> Responsibilities of the Selling and Buying Trading
Partners in Regard to the Product Tracing Information
<bullet> Handling Aggregation Errors and Other Discrepancies
4. Gathering of Relevant Product Tracing Information
5. Enhanced Verification
<bullet> Verification of Distributed Product
<bullet> Verification of Saleable Return Product
<bullet> Alerts for Illegitimate Product
6. Trading Partner Readiness
<bullet> Your organization's Overall Readiness for Implementation
of the Enhanced Drug Distribution Security Provisions of the DSCSA That
Go into Effect in 2023
<bullet> 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 <a href="https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security">https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security</a> 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 <a href="https://dscsapublicmeeting2021.eventbrite.com">https://dscsapublicmeeting2021.eventbrite.com</a>. 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 <a href="https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security">https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security</a>.
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
<a href="https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security">https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security</a> 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 <a href="/cdn-cgi/l/email-protection#f2b1b6b7a0bdb6a1bba0a287909e9b91bf9797869b9c9581b2949693dc9a9a81dc959d84"><span class="__cf_email__" data-cfemail="9cdfd8d9ced3d8cfd5cecce9fef0f5ffd1f9f9e8f5f2fbefdcfaf8fdb2f4f4efb2fbf3ea">[email protected]</span></a> 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
<a href="https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security">https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security</a> 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 <a href="https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security">https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security</a> 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
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