Alcohol, Tobacco, Firearms, and Explosives Bureau July 31, 2015 – Federal Register Recent Federal Regulation Documents
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International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #198 entitled ``Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products'' (VICH GL45). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance is an annex to a VICH guidance GFI #73 entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)'' VICH GL3(R). This VICH guidance document is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in VICH GL3(R).
Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America Inc.; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening the period for public comment on modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America Inc. for 10 tobacco products and announcing the availability for public comment of amendments to the MRTPAs. The notice of availability for the originally-filed applications appeared in the Federal Register of August 27, 2014 (79 FR 51183). In that notice, FDA requested comments on the 10 originally-filed MRTPAs that are posted on https:// www.regulations.gov and FDA's Web site. The comment period on these originally-filed applications closed on February 23, 2015. FDA is reopening the comment period to seek comment specifically on amendments made to the originally-filed MRTPAs submitted by Swedish Match North America Inc.
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