Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under the Federal Food, Drug, and Cosmetic Act; Notice; Request for Information and Comments; Reopening of the Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; establishment of a public docket; request for information and comments; reopening of the comment period.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is publishing this request for information to better understand the status of trading partners' interoperable systems and processes for enhanced drug distribution security as required by the Food, Drug and Cosmetic Act (FD&C Act). FDA is reopening the comment period for the notice, published in the Federal Register of November 20, 2023, establishing a public docket and requesting information and comments, to allow interested persons additional time to comment.

DATES:

FDA is reopening the comment period on the notice published November 20, 2023 (88 FR 80726). Either electronic or written comments must be submitted by September 12, 2024.

ADDRESSES:

You may submit information and comments at any time as follows:

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-2023-N-4806 for “Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act.” Received comments 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:

Sarah Venti, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4258, Silver Spring, MD 20993, 301-796-3130, drugtrackandtrace@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

In the Federal Register of November 20, 2023 (88 FR 80726), FDA established a public docket to solicit comments on “Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act.” The request for information highlights areas for consideration and policy development identified by the Center for Drug Evaluation and Research (CDER). The notice includes a series of questions to stimulate feedback from the public, including CDER and the Center for Biologics Evaluation and Research stakeholders.

Interested persons were originally given until February 20, 2024, to comment on the docket.

Following publication of the November 20, 2023, notice, and in consideration of the joint public meeting organized by FDA and Partnership for DSCSA Governance (PDG): “PDG-FDA Joint Public Meeting: DSCSA Stabilization Period Midway Checkpoint” scheduled for June 17-18, 2024 ( https://www.fda.gov/news-events/partnership-dscsa-governance-pdgfda-joint-public-meeting-dscsa-stabilization-period-midway ), FDA has decided to reopen the public docket to allow interested persons additional time to comment.