88 FR 200 pgs. 71873-71875 - Guidance Documents Referencing Pre-Existing Tobacco Products; Guidance for Industry; Availability; Withdrawal
Type: NOTICEVolume: 88Number: 200Pages: 71873 - 71875
Pages: 71873, 71874, 71875Docket number: [Docket No. FDA-2023-D-4128]
FR document: [FR Doc. 2023-22976 Filed 10-17-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-4128]
Guidance Documents Referencing Pre-Existing Tobacco Products; Guidance for Industry; Availability; Withdrawal
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of availability.
SUMMARY:
The Food and Drug Administration (FDA) is announcing the availability of revised final guidances for industry entitled "Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions," and "Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007." Following the issuance of the final rules entitled "Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports" (SE) and "Premarket Tobacco Product Applications and Recordkeeping Requirements" (PMTA), FDA has made minor updates to these guidances for consistency with the terminology used in those rules. FDA is also announcing the withdrawal of the final guidances entitled "Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products," and "Investigational Use of Deemed, Finished Tobacco Products That Were on the U.S. Market on August 8, 2016, During the Deeming Compliance Periods," and a draft guidance entitled "Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product," which are obsolete due to the issuance of the SE final rule or the end of the compliance period for deemed, finished tobacco products that were on the U.S. market on August 8, 2016.
DATES:
The announcement of the guidance is published in the Federal Register on October 18, 2023.
ADDRESSES:
You may submit either electronic or written comments on Agency guidances 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."
[top] Instructions: All submissions received must include the Docket No. FDA-2023-D-4128 for "Guidance Documents Referencing Pre-Existing Tobacco Products." Received comments will be placed in the docket and, except for those submitted as "Confidential
• 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.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of these guidances to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the guidances may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance documents.
FOR FURTHER INFORMATION CONTACT:
Natalie Gibson, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 877-287-1373, email: CTPRegulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control Act) was signed into law. The Tobacco Control Act grants FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by youth. FDA is announcing the availability of revised final guidances for industry, collectively entitled "Guidance Documents Referencing Pre-Existing Tobacco Products."
In the PMTA final rule (86 FR 55300, October 5, 2021) and the SE final rule (86 FR 55224, October 5, 2021), FDA has changed the term "grandfathered tobacco product" to "pre-existing tobacco product" because it more appropriately describes these products. Specifically, FDA considers a "pre-existing tobacco product" to mean a tobacco product that was commercially marketed in the United States as of February 15, 2007. FDA also made other minor changes to the revised guidances to reflect updated terminology used in the SE final rule, when appropriate. Details of the changes are described in the revision history page included with each guidance.
FDA is also withdrawing three guidances that are obsolete due to the issuance of the SE final rule or due to the end of the compliance period for deemed, finished tobacco products that were on the U.S. market on August 8, 2016. The guidances along with their docket numbers and status are listed in table 1.
| Title | Docket No. | Status |
|---|---|---|
| Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions | FDA-2011-D-0147 | Revised. |
| Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007 | FDA-2011-D-0125 | Revised. |
| Investigational Use of Deemed, Finished Tobacco Products That Were on the U.S. Market on August 8, 2016, During the Deeming Compliance Periods | FDA-2016-D-3276 | Withdrawn. |
| Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products | FDA-2010-D-0635 | Withdrawn. |
| Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product, Draft Guidance | FDA-2014-D-0800 | Withdrawn. |
The revised final guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115) and represent the current thinking of FDA on, among other things, the incorporation of the term "pre-existing tobacco product." They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While these guidances contain no collections of information, they do refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in FDA's guidance entitled "Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007" have been approved under OMB control number 0910-0775.
III. Electronic Access
[top] Persons with access to the internet may obtain an electronic version of the guidances at https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/TobaccoProducts/
Dated: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22976 Filed 10-17-23; 8:45 am]
BILLING CODE 4164-01-P