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RULESDocket 98F-0130, CFSAN98227. Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers. Pages 24943-24944 [FR Doc. 99-11737] [TXT] [PDF]
Docket No. 99N-0922, CDRH98134. Obstetrics and Gynecology Devices; Proposed Requirement for Premarket Approval and Change in Classification of Glans Sheath Devices. Pages 24967-24972 [FR Doc. 99-11733] [TXT] [PDF] Written comments by August 9, 1999; requests for a change in classification by May 26, 1999.
NOTICESDocket No. 99N-0791, OC9992. Agency Emergency Processing under OMB Review; Survey of Medical Device Manufacturers for Year 2000 Compliance of Manufacturing Systems. Pages 25045-25046[FR Doc. 99-11734] [TXT] [PDF] Written comments on the collection of information by
Docket No. 99N-1069, CDER993. Changes in the Procedures for Providing Public Notice of the Availability of Completed Environmental Assessments and Findings of No Significant Impact. Page 25046 [FR Doc. 99-11583] [TXT] [PDF]
Docket No. 98E-0487, OC99113. Determination of Regulatory Review Period for Purposes of Patent Extension; Denavir. Pages 25047-25048 [FR Doc. 99-11585] [TXT] [PDF]
Docket No. 98e-0611, OC99114. Determination of Regulatory Review Period for Purposes of Patent Extension; Femara. Pages 25046-25047 [FR Doc. 99-11584] [TXT] [PDF]
OC99118. Airline Catering Workshop on Sanitation, HACCP and the 1999 Food Code; Public Workshop. Page 25048 [FR Doc. 99-11736] [TXT] [PDF]
Docket No. 97D-0228, OC9991. Guidance for Industry: Computerized Systems Used in Clinical Trials; Availability. Pages 25048-25049 [FR Doc. 99-11582] [TXT] [PDF]
The GuidanceDocket No. 98D-0512, CBER996. Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establisment Description Information for Human Blood and Blood components Intended for Transfusion of for further manufacture and for the completion of the form FDA356h, Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use; Availability. Pages 25049-25050 [FR Doc. 99-11735] [TXT] [PDF]
The Guidance