Dockets
Federal rulemakings, soonest-closing first — each gathers its documents and comments.
Agency ▾
Request that the FDA grant Formal Authorization of Human-Compatible Food-Based Waste Substrates or the Revocation of Sanitary Endorsements for Commercial Feline Analogs
Requests that the FDA issue a formal determination regarding the safety and sanitary classification of agricultural-derived products (e.g., corn, wheat, millet, soy) when used as substrates for animal waste versus human waste.
Request that the FDA declare that the drug product, generic ivermectin (1.87%) oral liquid is suitable for submission in an Abbreviated New Animal Drug Application (ANADA)
Requests that the FDA declare that an ANDA may be submitted for, Modafinil Tablets, USP 50 mg and 150 mg, 2 strengths that differ from the currently approved RLD, PROVIGIL (Modafinil) tablets from NUVO PHARMACEUTICALS (IRELAND) DAC, which FDA approved in 100 mg and 200 mg strengths on Dec 24th, 1998 under NDA #020717.
Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry.
Request that FDA order sponsors of immunotherapies for NSCLC to revise their respective Prescribing Information to reflect that patients with ROS1 and RET rearrangements should use targeted therapies as their first line option, relying on its statutory authority under section 505(o)(4) of the FDC Act.
Requests that the FDA review whether the two primary generic bicalutamide tablet suppliers can assure the safety, efficacy, and quality of bicalutamide tablets for the intended prostate cancer patient population.
Requests that the FDA declare that Cyproheptadine Hydrochloride Orally Disintegrating Tablets, 2 mg, 3 mg, 4 mg and 6 mg is suitable for submission as an ANDA.
Requests that the Food and Drug Administration issue a written determination regarding the regulatory status of fluoride compounds distributed for community water fluoridation
Docket for Submission of FMCSA Petitions for Rulemaking.
145 awaiting analysis
Burlington Northern Santa Fe Corporation - Waiver Petition
Shell Docket for the Federal Railroad Administration (FRA)
6 awaiting analysis