0910-AF31 201804 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--Cough/Cold (Antihistamine) Products

FDA will be proposing a rule to add the common cold indication to certain over-the-counter (OTC) antihistamine active ingredients. This proposed rule is the result of collaboration under the U.S.-Canada Regulatory Cooperation Council (RCC) as part of efforts to reduce unnecessary duplication and differences. This pilot exercise will help determine the feasibility of developing an ongoing mechanism for alignment in review and adoption of OTC drug monograph elements. 

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No Deregulatory 21 CFR 201 21 CFR 310 21 CFR 330 to 358 21 U.S.C. 321p 21 U.S.C. 331 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 371 No Reopening of Administrative Record 08/25/2000 65 FR 51780 Comment Period End 11/24/2000 NPRM (Amendment) (Common Cold) 11/00/2018 Yes Businesses Local State Yes Yes Yes 0910-AA01 Split from Janice Adams-King Regulatory Health Project Manager 0910 Food and Drug Administration FDA 301 796-3713 301 796-9899 janice.adams-king@fda.hhs.gov Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring MD 20993