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Food and Drug Administration, HHS.
Notice of public meeting; request for comments.
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.
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.
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.
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
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.
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.
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.
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.
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:
○ Interoperability among trading partners in the pharmaceutical distribution supply chain, FDA, and other appropriate Federal or State official(s);
○ enhanced product tracing activities involving the exchange of data in a secure manner, including management and maintenance of the data;
○ the use of aggregation and inference for product tracing and/or verification; and
○ 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.
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 ( printed 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
Comments on this document are being accepted at Regulations.gov. Submit a public comment