Department of Health and Human Services November 21, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 6 of 6
Development of an Enhanced Systematic Process for the Food and Drug Administration's Post-Market Assessment of Chemicals in Food; Public Meeting; Request for Comments; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the notice of public meeting; request for comments, published in the Federal Register of August 12, 2024. In that notice, FDA announced a public meeting entitled "Development of an Enhanced Systematic Process for the Food and Drug Administration's Post-Market Assessment of Chemicals in Food." FDA hosted the public meeting on September 25, 2024, and is now extending the comment period to allow interested persons additional time to submit comments about approaches to systematic post-market assessment of chemicals in food.
Inclusion of Terrain Factors in the Definition of Rural Area for Federal Office of Rural Health Policy Grants
HRSA's Federal Office of Rural Health Policy (FORHP) is modifying the definition of "rural area" for the purposes of determining geographic eligibility to apply for or receive services funded by FORHP's rural health grants. With a data-driven methodology, this update to the definition of rural area will integrate the new Road Ruggedness Score (RRS) released in 2023 by the Economic Research Service of the U.S. Department of Agriculture. This notice responds to comments received on proposed modifications to HRSA's FORHP definition published in the Federal Register on April 26, 2024.
510(k) Third Party Review Program and Third Party Emergency Use Authorization Review; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review." This guidance provides FDA's current thinking regarding the 510(k) Third Party (3P510k) Review Program and review of EUA requests by a third party review organization (3PEUA review). The 3P510k Review Program and 3PEUA review create an alternative process for manufacturers to seek review of 510(k) submissions and EUA requests to assist FDA in reviewing in a timely manner.
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