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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-29/
- Published: 2021-01-24T12:00:00.000Z
- Updated: 2026-09-14T16:43:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148517

**New Tobacco Products Applications Guide Withdrawn**  
*Federal Register* notice: FDA has announced the withdrawal of a draft guidance entitled *Applications for Premarket Review of New Tobacco Products*. The document is being withdrawn because the topics discussed in it are addressed in the final rule entitled “Premarket Tobacco Product Applications and Recordkeeping Requirements.” To view the notice, click [here](https://public-inspection.federalregister.gov/2021-01353.pdf?ref=fdaweb.com). 1/21/2021  

**Rule on Premarket Tobacco Product Application Requirements**  
*Federal Register* notice: FDA has issued a final rule that outlines requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The rule is intended to help ensure that PMTAs contain sufficient information for FDA to determine whether a marketing granted order should be issued for a new tobacco product. The rule codifies the general procedures FDA will follow when evaluating PMTAs and creates postmarket reporting requirements for applicants that receive marketing granted orders. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-01212.pdf?ref=fdaweb.com). 1/21/2021  

**Rule on Tobacco Product Substantial Equivalence**  
*Federal Register* notice: FDA is issuing a final rule to provide additional information on the content and format of reports intended to demonstrate substantial equivalence of a tobacco product (SE Reports). The rule also establishes general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications with an applicant and data confidentiality in a SE Report. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-01214.pdf?ref=fdaweb.com). 1/21/2021  

**Revised Proposal Requests for Reimporting Insulin**  
*Federal Register* notice: FDA and HHS have revised proposal requests for reimporting insulin and the personal importation of prescription drugs that appeared in the 9/24/2020 *Federal Register*. Proposals submitted in response to the requests will be accepted and reviewed on a rolling basis, and until further notice. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-01-21/pdf/2021-01125.pdf?ref=fdaweb.com). 1/20/2021  

**Info Collection on Drug Communications Supporting Data**  
*Federal Register* notice: FDA has submitted to OMB an information collection extension entitled “Data to Support Drug Product Communications as Used by the Food and Drug Administration,” (OMB Control Number 0910–0695). The collection supports agency outreach efforts, such as testing of communication messages in advance of a communication campaign. The methods to be used include individual interviews, general public focus group interviews, intercept interviews, self-administered surveys, gatekeeper surveys, and professional clinician focus group interviews, all on a voluntary basis. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-01-19/pdf/2021-01030.pdf?ref=fdaweb.com). 1/19/2021