[Federal Register Volume 85, Number 209 (Wednesday, October 28, 2020)]
[Notices]
[Pages 68342-68344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23838]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1862]


The Drug Supply Chain Security Act Pilot Project Program and 
Enhanced Drug Distribution Security; Public Meeting; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the following virtual public meeting entitled ``The Drug 
Supply Chain Security Act Pilot Project Program and Enhanced Drug 
Distribution Security.'' The purpose of the public meeting is to 
provide members of the pharmaceutical distribution supply chain and 
other interested stakeholders an opportunity to discuss with FDA and 
provide input on strategies and issues related to the enhanced drug 
distribution security provisions of the Drug Supply Chain Security Act 
(DSCSA) and the results of FDA's DSCSA Pilot Project Program.

DATES: The public meeting will be held on December 8 and 9, 2020, from 
9 a.m. to 4 p.m., Eastern Time, each day, and will take place virtually 
(by webcast only). Submit either electronic or written comments on this 
public meeting by December 28, 2020.

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/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-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. Electronic and written comments must be submitted on or 
before December 28, 2020. The https://www.regulations.gov electronic 
filing system will accept comments until 11:59 p.m. Eastern Time at the 
end of December 28, 2020. 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.

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'').

[[Page 68343]]

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-2020-N-1862 for ``The Drug Supply Chain Security Act Pilot Project 
Program and Enhanced Drug Distribution Security; 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 
``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 for building 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(j) of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) (21 U.S.C. 360eee-1(j)), which was added by the DSCSA, 
directs FDA to establish one or more pilot projects, in coordination 
with authorized manufacturers, repackagers, wholesale distributors, and 
dispensers, to explore and evaluate methods to enhance the safety and 
security of the pharmaceutical distribution supply chain. 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 product tracing of product at the package 
level.

II. Topics for Discussion at the Public Meeting

    FDA will hold a virtual public meeting on December 8 and 9, 2020, 
on FDA's DSCSA Pilot Project Program and related enhanced drug 
distribution security issues. The purpose of this public meeting is to 
provide members of the pharmaceutical distribution supply chain and 
other interested stakeholders an opportunity to discuss with FDA, and 
provide input on, strategies and issues related to the enhanced drug 
distribution security provisions of the DSCSA and FDA's DSCSA Pilot 
Project Program. The public meeting will focus on the following topics 
for discussion:
     Findings and lessons learned from FDA's DSCSA Pilot 
Project Program.
     Other piloting or piloted activities related to DSCSA 
implementation.
     System attributes necessary for enabling secure product 
tracing of product at the package level. Examples of discussion topics 
include, but are not limited to, the system attributes, circumstances, 
and processes necessary for facilitating:
    [cir] Interoperability among trading partners in the pharmaceutical 
distribution supply chain, FDA, and other appropriate Federal or State 
official(s);
    [cir] enhanced product tracing activities involving the exchange of 
data in a secure manner, including management and maintenance of the 
data;
    [cir] the use of aggregation and inference for product tracing and/
or verification; and
    [cir] enhanced verification activities involving communications 
between trading partners and FDA and exchange of data in a secure 
manner, including management and maintenance of the data.

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/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security 7 days before the 
public meeting.

III. Participating in the Public Meeting

    Registration: To request registration for the public meeting, 
provide your information, including name, company or organization, 
address, telephone number, and email address, to FDA at https://www.fda.gov/drugs/news-events-human-drugs/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security. FDA 
may limit attendance to ensure manageability of the virtual public 
meeting and breakout sessions. In addition, FDA may limit the number of 
participants from each organization to help ensure that meeting 
participants represent the diversity of the pharmaceutical supply chain 
and other stakeholders. FDA recommends that

[[Page 68344]]

each organization determine who should register for the public meeting 
to represent his/her organization. Registrants will receive 
confirmation of participation for the meeting from FDA within 14 days 
before the meeting. There is no registration fee for the public 
meeting, and there will be no onsite 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/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security.
    If you need special accommodations due to a disability, please 
contact Kristle Green (see FOR FURTHER INFORMATION CONTACT) no later 
than 7 days before the public meeting.
    Streaming Webcast of the Public Meeting: Portions of the public 
meeting will be recorded and webcast on the day of the meeting. 
Information on how to access the webcast will be available at https://www.fda.gov/drugs/news-events-human-drugs/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security 
within 7 days before the public meeting. The webcast will be conducted 
in listening mode only.

    Dated: October 22, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23838 Filed 10-27-20; 8:45 am]
BILLING CODE 4164-01-P