0910-AA01 200010 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Over-the-Counter (OTC) Drug Review The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. NOTE: NPRM for "Antidotes, Toxic Ingestion Products" was combined with NPRM for "Emetic Products" and reproposed as "Poison Treatment Products." NPRM for "Astringent (Wet Dressings) Products" was included in the NPRM for "Skin Protectant Products." NPRM for "Diaper Rash Products" was included in NPRMs for "Antifungal," "Antimicrobial," "External Analgesic" and "Skin Protectant Products." NPRM for "Fever Blister/Cold Sore Products (External)" was included in NPRMs for "External Analgesic" and "Skin Protectant Products." NPRM for "Insect Bites and Stings (Relief) Products" was included in NPRMs for "External Analgesic" and "Skin Protectant Products." "Poison Ivy/Oak/Sumac Prevention" was included in NPRMs for "External Analgesic" and "Skin Protectant Products." NPRM for "Mercurial (Topical) Products" was included in revised NPRM for "Antimicrobial Products." NPRM for "Alcohol (Topical) Products" was included in revised NPRM for "Antimicrobial Products." The NPRM for "Antimicrobial Products" was updated and split into two sections: First Aid Products and Health Care Antiseptic Products. SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the individual rulemaking. However, the Agency anticipates that the rules would not have a significant economic impact on a substantial number of small entities as defined by the Regulatory Flexibility Act. Routine and Frequent Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 310 21 CFR 340 21 CFR 341 21 CFR 342 21 CFR 343 21 CFR 344 21 CFR 345 21 CFR 330 21 CFR 333 21 CFR 334 21 CFR 335 21 CFR 336 21 CFR 337 21 CFR 338 ... 21 CFR 339 21 USC 321p 21 USC 351 21 USC 352 21 USC 353 21 USC 355 21 USC 360a 21 USC 371a 21 USC 331 21 USC 360 21 USC 360b 21 USC 361 21 USC 371 No 0910-AC88 Acne (Topical) Products 0910-AD30 Alcohol (Oral) in OTC Drug Products 0910-AC65 Anorectal Products 0910-AC77 Antacid Drug Products 0910-AC78 Anthelmintic Products 0910-AD14 Antibiotic First Aid Products 0910-AC70 Anticaries Products 0910-AC82 Antidiarrheal Products 0910-AD63 Antidotes, Toxic Ingestion Prdts (New Poison Treatment Prdts) 0910-AC71 Antiemetic Products 0910-AD05 Antiflatulent Drug Products 0910-AD15 Antifungal (Topical) Products 0910-AC83 Antimicrobial Products 0910-AC89 Antiperspirant Products 0910-AC75 Aphrodisiac Products 0910-AD39 Aspirin (OTC Professional Use Warning) 0910-AC94 Aspirin (Heart Labeling) 0910-AD59 Astringent (Wet Dressings) Prdts (Merged w/other rulemkg) 0910-AD34 Benign Prostatic Hypertrophy Products 0910-AC60 Boil Ointments 0910-AD16 Camphorated Oil Drug Products 0910-AD00 Cholecystokinetic Products 0910-AD23 Corn and Callus Remover Products 0910-AD35 Cough/Cold (Anticholinergic) Products 0910-AD31 Cough/Cold (Antihistamine) Products 0910-AD24 Cough/Cold (Antitussive) Products 0910-AD33 Cough/Cold (Bronchodilator) Products 0910-AD25 Cough/Cold (Combination) Products 0910-AD36 Cough/Cold (Diphenhydramine) Products 0910-AD26 Cough/Cold (Expectorant) Products 0910-AD42 Cough/Cold (Expectorant/Ipecac) Products 0910-AD43 Cough/Cold (Nasal Decongestant) Products 0910-AD64 Dandruff, Seborrheic Dermatitis and Psoriasis Control Products 0910-AC63 Daytime Sedatives 0910-AD49 Diaper Rash Products (Merged w/other rulemkg) 0910-AC84 Digestive Aid Products 0910-AD52 Eligibility Criteria for Additional Conditions 0910-AC61 Emetic Products 0910-AD45 Exocrine Pancreatic Insufficiency Products 0910-AD06 External Analgesic Products 0910-AD27 Fever Blister Products (Internal) 0910-AC76 First Aid Antiseptic 0910-AD65 Fvr Blister/Cold Sore Prdts (Ext.) (To be merged w/other rulemkg) 0910-AD50 Hair Grower and Hair Loss Prevention Products 0910-AD17 Healthcare Antiseptic Products 0910-AD01 Hormone (Topical) Products 0910-AD20 Hypo/Hyperphosphatemia Products 0910-AD21 Ingrown Toenail Relief Products 0910-AD60 Insect Bite & Sting (Relief) Prdts (Merged w/other rulemkg) 0910-AD44 Insect Repellent Drug Products (Internal) 0910-AD07 Internal Analgesic Products 0910-AD08 Internal Deodorant Products 0910-AD47 Labeling of Drug Products for OTC Human Use 0910-AC64 Laxative Products 0910-AD51 Leg Muscle Cramps (Nocturnal Relief) Products 0910-AD29 Male Genital Desensitizer Products 0910-AC66 Menstrual Products 0910-AD61 Mercurial (Topical) Products (To be merged w/other rulemkg) 0910-AD46 Nailbiting/Thumbsucking Deterrent Products 0910-AD11 Nighttime Sleep Aid Products 0910-AC95 NDA Labeling Exclusivity 0910-AC72 Ophthalmic Products 0910-AD28 Oral Discomfort (Relief) Products 0910-AC98 Oral Health Care Products 0910-AD10 Oral Wound Healing Products 0910-AD40 Otic Products (Dry Water-Clogged Ears) 0910-AC86 Otic Products (Earwax) 0910-AD12 Otic Products (Swimmers Ear) 0910-AC91 Overindulgence Remedies 0910-AD53 Overindulgence Remedies/Prevention of Inebriation 0910-AC79 Pediculicide Products 0910-AD41 Phenylpropanolamine Products (Labeling) 0910-AD57 Poison Ivy/Oak/Sumac Prevention (Merged w/other rulemkg) 0910-AC99 Poison Treatment Products 0910-AC73 Quinine for Malaria 0910-AD02 Salicylate (Reye Syndrome) 0910-AC92 Skin Bleaching Products 0910-AC96 Skin Protectant Products 0910-AD03 Smoking Deterrent Products 0910-AD54 Status of Certain Category II and III Ingredients 0910-AD32 Stimulant (Overindulgence) Products 0910-AC67 Stimulant Products 0910-AD04 Stomach Acidifier Products 0910-AC68 Sunscreen Products 0910-AC87 Sweet Spirits of Nitre 0910-AD62 Topical Drug Products Containing Benzoyl Peroxide (Labeling) 0910-AD19 Vaginal Contraceptive Products 0910-AC80 Vaginal Drug Products 0910-AC97 Vitamin/Mineral Products 0910-AC81 Wart Remover Products 0910-AC69 Water Soluble Gums 0910-AC93 Weight Control Products Previously reported under RIN 0905-AA06. NOTE: Reinventing government applies only to the Antacid Drug Products final action. No None NA Not Collected Gerald Rachanow M. 0910 Food and Drug Administration FDA 301 827-2241 301 827-2315 gerald.rachanow@fda.hhs.gov HFD-560, Center for Drug Evaluation and Research (HFD-560), 5600 Fishers Lane, Rockville MD 20857 Not Procurement Related Eliminating Existing Text