⚗️Usona Institute Seeks Registration to Import Controlled Substances
Usona Institute. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💉FDA Notice on DPD Deficiency and Fluoropyrimidine Drugs
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit public comment for information on dihydropyrimidine dehydrogenase (DPD) deficiency and the use of fluorouracil and capecitabine (both fluoropyrimidine chemotherapy drugs). The purposes of the docket establishment are to foster Agency transparency and to solicit input on the currently available information on DPD deficiency and the use of fluorouracil and capecitabine.
Learn More🧠NIH Brain Development Cohorts Data Use Certification Review Notice
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Learn More🏥HRSA's Proposed Information Collection for HIV/AIDS Program Activities
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Learn More🏥Public Comment Request on Shortage Designation Management System
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Learn More📄IRS Seeks Comments on Health Plan Notification Requirements
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments regarding the burden associated with the requirement of informing each participant (in the individual market, primary subscriber) of the terms of the plan or coverage and their right to designate a primary care provider.
Learn More💊FDA Notice on Regulatory Review Period for ELAHERE Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ELAHERE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More💊FDA Announces Public Meeting on Generic Drug User Fee Reauthorization
The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 to 2032. At the end of September 2027, new legislation will be required for FDA to continue to collect generic drug user fees for future FYs. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization, we publish a notice in the Federal Register requesting public input on the reauthorization; hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (i.e., the GDUFA III Commitment Letter) (https://www.fda.gov/industry/ generic-drug-user-fee-amendments/gdufa-iii-reauthorization); provide a period of 30 days after the public meeting to obtain written comments from the public; and publish the comments on FDA's website. FDA invites public comment on the GDUFA program and suggestions regarding the features FDA should propose for the next GDUFA program cycle. These comments will be published and available on FDA's website.
Learn More🏥Proposed Information Collection on Infection Prevention in Healthcare
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project (new): "The AHRQ Safety Program for Healthcare Associated Infection Prevention." This proposed information collection was previously published in the Federal Register on November 20, 2024 and allowed 60 days for public comment. AHRQ received comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Learn More💊Executive Order on Most-Favored-Nation Drug Pricing Impact
Executive Order 14297 aims to rectify the disparity in pharmaceutical pricing between the U.S. and other developed countries. It emphasizes the need for Americans to access drugs at the most-favored-nation prices and outlines immediate policy actions to address foreign pricing disparities. The order also encourages direct-to-consumer sales at these pricing levels, asserting that U.S. patients should benefit from fair drug pricing relative to global standards.
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