Department of Health and Human Services October 18, 2023 – Federal Register Recent Federal Regulation Documents

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Tobacco Products That Were on the U.S. Market on August 8, 2016, During the Deeming Compliance Periods,'' and a draft guidance entitled ``Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product,'' which are obsolete due to the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.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Updating the Framework for AHRQ's National Healthcare Quality and Disparities Report (NHQDR), which is currently being conducted by the AHRQ's Evidence- based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed information collection entitled ``Improving the Quality and Representativeness of the Treatment Center Program DataData Modifications to the Current Survey Instrument Format to Minimize Misclassification.''

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements.'' The guidance document addresses certain requirements that apply to blood establishments that collect blood and blood components, including Source Plasma. Specifically, the guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment's failure to comply with certain requirements in FDA's regulations regarding donation suitability, donor eligibility, and quarantine hold for Source Plasma. FDA expects that the compliance policy described in the guidance will increase the availability of blood and blood components, including Source Plasma, while maintaining the health of blood donors and the safety of blood and blood components. The guidance announced in this document finalizes the draft guidance of the same title dated May 2022, and supersedes the guidance entitled ``Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency; Guidance for Industry,'' dated April 2020.

This notice announces the dates and times of the virtual Healthcare Common Procedure Coding System (HCPCS) public meeting to be held November 28, 2023 through November 30, 2023 to discuss our preliminary coding, Medicare benefit category, and payment determinations for new revisions to the HCPCS Level II code set for non-drug and non-biological products, as well as how to register for those meetings.