Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Public Meeting; Request for Comments, 57435-57437 [2021-22474]

Download as PDF Federal Register / Vol. 86, No. 197 / Friday, October 15, 2021 / Notices this screening tool will help ensure the health and safety of children and staff at care provider facilities by helping to identify and reduce potential exposure to COVID–19. 57435 Respondents: Staff and visitors at ORR care provider facilities. ANNUAL BURDEN ESTIMATES Instrument Total number of respondents Annual responses per respondent Average burden hours per response Annual burden hours COVID–19 Verbal Screening and Temperature Check .................................. 15,000 260 .033 128,700 Authority: 6 U.S.C. 279. Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2021–22477 Filed 10–14–21; 8:45 am] BILLING CODE 4184–45–P 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 Food and Drug Administration, Department of Health and Human Services (HHS). ACTION: Notice of public meeting; request for comments. AGENCY: 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/publicmeeting-enhanced-drug-distributionsecurity-package-level-under-drugsupply-chain-security. See the SUPPLEMENTARY INFORMATION section for registration date and other information. SUMMARY: VerDate Sep<11>2014 16:50 Oct 14, 2021 Jkt 256001 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’’). PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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 E:\FR\FM\15OCN1.SGM 15OCN1 57436 Federal Register / Vol. 86, No. 197 / Friday, October 15, 2021 / Notices ‘‘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-201509-18/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, CDERODSIRPublicMeetings@ fda.hhs.gov. 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. VerDate Sep<11>2014 16:50 Oct 14, 2021 Jkt 256001 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 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 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/publicmeeting-enhanced-drug-distributionsecurity-package-level-under-drugsupply-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:// dscsapublicmeeting 2021.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/publicmeeting-enhanced-drug-distributionsecurity-package-level-under-drugsupply-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-eventshuman-drugs/public-meeting-enhanceddrug-distribution-security-packagelevel-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 CDERODSIRPublic Meetings@fda.hhs.gov on or before November 2, 2021. FDA will do its best to accommodate requests to present during the public E:\FR\FM\15OCN1.SGM 15OCN1 Federal Register / Vol. 86, No. 197 / Friday, October 15, 2021 / Notices 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-eventshuman-drugs/public-meeting-enhanceddrug-distribution-security-packagelevel-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/publicmeeting-enhanced-drug-distributionsecurity-package-level-under-drugsupply-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 DEPARTMENT OF HOMELAND SECURITY Cybersecurity and Infrastructure Security Agency [Docket No. CISA–2021–0016] Notice of President’s National Security Telecommunications Advisory Committee Meeting Cybersecurity and Infrastructure Security Agency (CISA), Department of Homeland Security (DHS). ACTION: Notice of Federal Advisory Committee Act (FACA) meeting; request for comments. AGENCY: CISA is publishing this notice to announce the following President’s National Security Telecommunications Advisory Committee (NSTAC) meeting. This meeting will be partially closed to the public. DATES: Meeting Registration: Registration to attend the meeting is required and must be received no later than 5:00 p.m. Eastern Time (ET) on October 26, 2021. For more information on how to participate, please contact NSTAC@cisa.dhs.gov. SUMMARY: VerDate Sep<11>2014 16:50 Oct 14, 2021 Jkt 256001 Speaker Registration: Registration to speak during the meeting’s public comment period must be received no later than 5:00 p.m. ET on October 26, 2021. Written Comments: Written comments must be received no later than 5:00 p.m. ET on October 26, 2021. Meeting Date: The NSTAC will meet on November 2, 2021, from 10:00 a.m. to 3:15 p.m. ET. The meeting may close early if the committee has completed its business. ADDRESSES: The November 2021 NSTAC Meeting’s open session is set to be held in person at 1717 H Street NW, Washington, DC. Capacity and location are subject to change based on DHS protocol regarding COVID–19 pandemic restrictions at the time of the meeting. Due to pandemic restrictions, members of the public may only participate via teleconference. Requests to participate will be accepted and processed in the order in which they are received. For access to the conference call bridge, information on services for individuals with disabilities, or to request special assistance, please email NSTAC@ cisa.dhs.gov by 5:00 p.m. ET on October 26, 2021. Comments: Members of the public are invited to provide comment on issues that will be considered by the committee as listed in the SUPPLEMENTARY INFORMATION section below. Associated materials that may be discussed during the meeting will be made available for review at https:// www.cisa.gov/nstac on October 18, 2021. Comments should be submitted by 5:00 p.m. ET on October 26, 2021 and must be identified by Docket Number CISA–2021–0016. Comments may be submitted by one of the following methods: • Federal eRulemaking Portal: www.regulations.gov. Please follow the instructions for submitting written comments. • Email: NSTAC@cisa.dhs.gov. Include the Docket Number CISA–2021– 0016 in the subject line of the email. Instructions: All submissions received must include the words ‘‘Department of Homeland Security’’ and the Docket Number for this action. Comments received will be posted without alteration to www.regulations.gov, including any personal information provided. Docket: For access to the docket and comments received by the NSTAC, please go to www.regulations.gov and enter docket number CISA–2021–0016. A public comment period is scheduled to be held during the meeting from 2:40 p.m. to 2:50 p.m. ET. Speakers PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 57437 who wish to participate in the public comment period must email NSTAC@ cisa.dhs.gov to register. Speakers should limit their comments to 3 minutes and will speak in order of registration. Please note that the public comment period may end before the time indicated, following the last request for comments. FOR FURTHER INFORMATION CONTACT: Elizabeth Gauthier, 202–821–6620, NSTAC@cisa.dhs.gov. SUPPLEMENTARY INFORMATION: The NSTAC was established by Executive Order (E.O.) 12382, 47 FR 40531 (September 13, 1982), as amended and continued under the authority of E.O. 13889, dated September 27, 2019. Notice of this meeting is given under FACA, 5 U.S.C. Appendix (Pub. L. 92– 463). The NSTAC advises the President on matters related to national security and emergency preparedness (NS/EP) telecommunications and cybersecurity policy. Agenda: The NSTAC will meet in an open session on Thursday, November 2, 2021, to discuss current NSTAC activities and the Government’s ongoing cybersecurity and NS/EP communications initiatives. This open session will include: (1) A keynote address on fortifying the Nation’s cybersecurity posture; (2) an update on Administration actions to NSTAC and joint NS/EP communications; (3) a deliberation and vote on the NSTAC Report to the President on Software Assurance in the Information and Communications Technology and Services Supply Chain; and (4) a status update from the NSTAC Zero-Trust and Trusted Identity Management Subcommittee. The committee will also meet in a closed session from 10:00 a.m. to 12:00 p.m. during which time senior Government intelligence officials will provide a threat briefing concerning threats to NS/EP communications and engage NSTAC members in follow-on discussion. Basis for Closure: In accordance with section 10(d) of FACA and 5 U.S.C. 552b(c)(9)(B), The Government in the Sunshine Act, it has been determined that a portion of the agenda requires closure, as the disclosure of the information that will be discussed would not be in the public interest. This agenda item is the classified threat briefing and discussion, which will provide NSTAC members the opportunity to discuss information concerning threats to NS/EP communications with senior Government intelligence officials. The briefing is anticipated to be classified at E:\FR\FM\15OCN1.SGM 15OCN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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