FDA Seeks OMB Nod for Drug Research Paperwork
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
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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.
2026-18529, Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking
The FDA wants your thoughts on how they collect info to track medical devices. This affects companies that make or handle these devices and aims to keep things safe and clear. You’ve got until November 10, 2026, to share your comments—no cost, just your voice!
2026-18612, Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software
The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software 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 cardiovascular machine learning- based notification software. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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.
2026-18551, Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate
The Food and Drug Administration (FDA or Agency) is announcing the availability on its website of the final administrative order (final order) (OTC000008-1) titled "Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate." This final order amends "Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use" (Over- the-Counter (OTC) Monograph M020) to remove PABA and trolamine salicylate as sunscreen active ingredients. A sunscreen drug product containing PABA or trolamine salicylate is not generally recognized as safe and effective (GRASE).
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.