Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees
Published Date: 7/27/2026
Notice
Summary
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Investigators Must Get Informed Consent
Investigators running research with radioactive drugs must obtain the proper written informed consent from each research subject under 21 CFR 361.1(d)(5). This rule is intended to make sure people know the risks before they join studies using radiopharmaceuticals.
Pregnancy Confirmation Required for Female Subjects
Each female research subject of childbearing potential must either state in writing that she is not pregnant or be confirmed as not pregnant by a pregnancy test, per 21 CFR 361.1(d)(5). This rule applies to people recruited into studies that administer radioactive drugs.
Adverse Effects Must Be Reported Immediately
Investigators must immediately report all adverse effects associated with use of the radioactive drug to the RDRC, and the RDRC must report adverse reactions probably attributed to the drug to FDA under 21 CFR 361.1(d)(8). This creates a formal pathway for safety problems discovered in human research to be escalated to FDA.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-15074, Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction
The Food and Drug Administration (FDA) is classifying the non- medicated topical formulation for treatment of erectile dysfunction into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the non-medicated topical formulation for treatment of erectile dysfunction. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
2026-15075, Medical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators
The Food and Drug Administration (FDA) is classifying the active noise attenuation system for infant incubators into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the active noise attenuation system for infant incubators. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
2026-14984, Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression
The FDA is officially putting a special kidney disease test into Class II, meaning it’s safe and effective but with some extra rules to keep it that way. This change helps patients get access to this cool new test faster by cutting down red tape. The new classification is effective July 24, 2026, and could save companies time and money while making sure the test works well.
2026-15021, Evonik Corporation, Filing of Food Additive Petition (Animal Use)
Evonik Corporation has asked the FDA to approve ethyl cellulose as a safe binder and coating for amino acids in food for ruminant animals like cows and sheep. This change could improve animal feed quality without extra costs or delays, with the petition officially filed on June 16, 2026. Farmers and feed producers should keep an eye out as this could soon become part of the rules.
Previous / Next Documents
Previous: 2026-15069, Sunshine Act Meetings
Next: 2026-15071, Child and Adult Care Food Program: National Average Payment Rates, Day Care Home Food Service Payment Rates, and Administrative Reimbursement Rates for Sponsoring Organizations of Day Care Homes for the Period July 1, 2026, Through June 30, 2027
This notice announces the annual adjustments to the national average payment rates for meals and snacks served in child care centers, outside-school-hours care centers, at-risk afterschool care centers, and adult day care centers; the food service payment rates for meals and snacks served in day care homes; and the administrative reimbursement rates for sponsoring organizations of day care homes, to reflect changes in the Consumer Price Index. Further adjustments are made to these rates to reflect the higher costs of providing meals in Alaska, Guam, Hawaii, Puerto Rico, and Virgin Islands. The adjustments contained in this notice are made on an annual basis each July, as required by the laws and regulations governing the Child and Adult Care Food Program.