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NOTICES-FINAL GUIDANCES
Docket No. 2004D-0422, CVM 200450. Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act; Availability. Pages 57941-57942 [FR Doc. 04-21677] [TXT] [PDF] [PRE-PUB] Comments due October 28, 2004The Draft Guidance Word Version
The Draft Guidance Appendix - Word Version
The Draft Guidance PDF Version
The Draft Guidance Appendix - PDF Version
NOTICES-DRAFT GUIDANCES
Docket No. 2004D-0410, OC 2004200. Draft Guidance for Industry and Food and Drug Administration Staff: Application User Fees for Combination Products; Availability. Pages 57942-57943 [FR Doc. 04-21673] [TXT] [PDF] [PRE-PUB] Comments due November 29, 2004The Draft Guidance
NOTICES
Docket No. 2004E-0023, CDER 2004126. Determination of Regulatory Review Period for Purposes of Patent Extension; REYATAZ. Pages 57937-57939 [FR Doc. 04-21625] [TXT] [PDF] [PRE-PUB] Comments due November 29, 2004Docket No. 2004N-0045, OC 2004237. Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Health and Diet Survey--2004 Supplement. Page 57937 [FR Doc. 04-21674] [TXT] [PDF] [PRE-PUB] OMB approval no. 0910-0545 expires on September 30, 2007
Supporting Statement
Docket No. 2002E-0065, CDER 2004125. Determination of Regulatory Review Period for Purposes of Patent Extension; KINERET. Pages 57938-57939 [FR Doc. 04-21675] [TXT] [PDF] [PRE-PUB] Comments due November 29, 2004
Docket No. 2001E-0032, CDER 2004123. Determination of Regulatory Review Period for Purposes of Patent Extension; VISUDYNE. Pages 57939-57940 [FR Doc. 04-21678] [TXT] [PDF] [PRE-PUB] Comments due November 29, 2004
Docket No. 2004N-0367, CBER 200419. Cumulative List of Exceptions and Alternative Procedures Approved by the Director of the Center for Biologics Evaluation and Research. Pages 57943-57945 [FR Doc. 04-21624] [TXT] [PDF] [PRE-PUB]
MEETINGS
Docket No. 2004N-0423, CDRH 200457. Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting. Pages 57940-57941 [FR Doc. 04-21676] [TXT] [PDF] [PRE-PUB] Meeting on November 18, 2004 Meeting on November 18, 2004