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Federal Register
Monday April 28, 2008

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FDA Federal Register Documents

PROPOSED RULES

Docket No. FDA-2008-N-0163 (formerly Docket No. 2001N-0067), CDRH 20087.  Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Reopening of Comment Period.  Pages  22877-22879 [FR Doc. 08–1187]  [TXT] [PDF] [PRE-PUB] Comments due July 28, 2008

NOTICES-DRAFT GUIDANCES

Docket No. FDA-2008-D-0233, CBER 200722.  Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Availability.  Pages  22958-22959 [FR Doc. E8–9253]  [TXT] [PDF] [PRE-PUB] Comments due July 28, 2008

The Draft Guidance

NOTICES

Docket No. FDA-2007-N-0154 (formerly Docket No. 2007N-0444), OC 200893.  Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Recordkeeping and Records Access Requirements for Food Facilities.  Page  22951 [FR Doc. E8–9155]  [TXT] [PDF] [PRE-PUB] OMB control number 0910-0560 Expires March 31, 2011

Docket No. FDA-2008-N-0240, OC 2008.  Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals.  Pages  22951-22955 [FR Doc. E8–9157]  [TXT] [PDF] [PRE-PUB] Comments due June 27, 2008

Docket No. FDA-2008-N-0239, OC 200897.  Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring.  Pages  22955-22956 [FR Doc. E8–9159]  [TXT] [PDF] [PRE-PUB] Comments due June 27, 2008

OC 200878.  Cooperative Agreement to Support the World Health Organization International Programe on Chemical Safety.  Pages  22956-22958 [FR Doc. E8–9251]  [TXT] [PDF] [PRE-PUB]

Docket No. FDA-2008-N-0238, CDER 200810.  Determination That TAPAZOLE Tablets and 18 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness.  Pages  22960-22961 [FR Doc. E8–9161]  [TXT] [PDF] [PRE-PUB]

MEETINGS

Docket No. FDA-2008-N-0226, OC 200884.  Risk Communication Advisory Committee; Notice of Meeting.  Pages  22959-22960 [FR Doc. E8–9177]  [TXT] [PDF] [PRE-PUB] Meeting on May 15, 2008 and May 16, 2008 Comments due June 16, 2008

FINAL RULES

Docket No. 2004N-0018, CDER 200482.  Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application.  Pages  22800-22816 [FR Doc. E8–9200]  [TXT] [PDF] [PRE-PUB] Effective date October 27, 2008

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Table of Contents for Entire Federal Register
Monday, April 28, 2008 (TXT)  (PDF)

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