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Proposed Rule2023-045922023-03-10

Proposed Requirements for Tobacco Product Manufacturing Practice; Public Hearing; Request for Comments

Health and Human Services Department, Food and Drug Administration

Abstract

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public oral hearing entitled "Proposed Requirements for Tobacco Product Manufacturing Practice." The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to prescribe current good manufacturing practice (cGMP) or hazard analysis and critical control point methodology (HACCP) regulations related to the manufacture, preproduction design validation, packing, and storage of tobacco products to protect public health and ensure compliance with the FD&C Act. In accordance with this provision, FDA is proposing requirements for tobacco product manufacturing practice (TPMP) elsewhere in this issue of the Federal Register. The FD&C Act further requires FDA to afford an opportunity for an oral hearing on the proposed regulation. We are holding this public oral hearing to carry out this statutory mandate and obtain information and views on the proposed TPMP requirements.

Action & Dates

Action
Public hearing; request for comments.
Dates
The public oral hearing will be held virtually on April 12, 2023, from 9:30 a.m. to 5 p.m. Eastern Time. All written notices of participation must be received by March 31, 2023 (email written notices of participation to: CTPoutreach@fda.hhs.gov). Either electronic or written comments on this public hearing must be submitted by September 6, 2023. See the SUPPLEMENTARY INFORMATION section for registration date and information. FDA also reminds the public that commenters may submit either electronic or written comments on the proposed rule published elsewhere in this issue of the Federal Register by September 6, 2023.
Effective Date
2023-04-12

CFR References

Public Comment

Comments Close
2023-09-06

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 1120 [Docket No. FDA-2013-N-0227] ( printed page 14962) AGENCY: Food and Drug Administration, HHS. ACTION: Public hearing; request for comments. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing a public oral hearing entitled “Proposed Requirements for Tobacco Product Manufacturing Practice.” The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to prescribe current good manufacturing practice (cGMP) or hazard analysis and critical control point methodology (HACCP) regulations related to the manufacture, preproduction design validation, packing, and storage of tobacco products to protect public health and ensure compliance with the FD&C Act. In accordance with this provision, FDA is proposing requirements for tobacco product manufacturing practice (TPMP) elsewhere in this issue of the Federal Register . The FD&C Act further requires FDA to afford an opportunity for an oral hearing on the proposed regulation. We are holding this public oral hearing to carry out this statutory mandate and obtain information and views on the proposed TPMP requirements. DATES: The public oral hearing will be held virtually on April 12, 2023, from 9:30 a.m. to 5 p.m. Eastern Time. All written notices of participation must be received by March 31, 2023 (email written notices of participation to: CTPoutreach@fda.hhs.gov ). Either electronic or written c

Read full document on FederalRegister.gov →

Related Documents

Other Federal Register documents from the same docket.

Full Document

Citation: 88 FR 14962