DRAFT GUIDANCES - FEDERAL REGISTER NOTICES - 2006

Draft guidances published in the Federal Register in: Current Year | 2005 | 2004| 2003| 2002| 2001| 2000| 1999

Final guidance published in the Federal Register in: Current Year | 2005| 2004| 2003| 2002| 2001} 2000| 1999

Draft Guidances

July

Vol. 71 (July 20, 2006): Docket No. 2006D-0246.  Draft Manufactured Food Regulatory Program Standards; Availability.  Pages  41221-41223 [FR Doc. E6-11539]  [ TXT ] [ PDF ] Comments due September 18, 2006

The Draft Guidance

June

Vol. 71 (June 28, 2006): Docket No. 2006D-0254.  Draft Guidance for Industry: Analytical Methods Description for Type C Medicated Feeds; Availability.  Pages  36813-36814 [FR Doc. 06-05860]  [ TXT ] [ PDF ] Comments due September 11, 2006

The Draft Guidance

Vol. 71 (June 20, 2006): Docket No. 2006D-0228.  Draft Guidance for Industry and Food and Drug Administration Staff; the Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program; Availability.  Pages  35436-35437 [FR Doc. E6-9653]  [ TXT ] [ PDF ] Comments due September 18, 2006

The Draft Guidance

Vol. 71 (June 19, 2006): Docket No. 2006D-0063.  Guidance for Industry and Food and Drug Administration Staff; the Review and Inspection of Premarket Approval Application Manufacturing Information and Operations; Availability.  Pages  35275-35276 [FR Doc. E6-9505]  [ TXT ] [ PDF ] Comments due September 18, 2006

The Draft Guidance

May

Vol. 71 (May 23, 2006): Docket No. 2006D-0056.  Draft Compliance Policy Guide; Guidance Levels for 3-MCPD (3-chloro-1,2-propanediol) in Acid-Hydrolyzed Protein and Asian-Style Sauces; Availability.  Page  29651 [FR Doc. E6-07796 ]  [ TXT ] [ PDF ]Comments due July 24, 2006

The Draft Guidance pdf version
The Draft Guidance html version

Vol. 71 (May 23, 2006): Docket No. 2006D-0191.  Draft Guidance for Industry and Food and Drug Administration Staff; Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials; Availability.  Pages  29651-29652 [FR Doc. E6-07855 ]  [ TXT ] [ PDF ] Comments due August 21, 2006

The Draft Guidance

Vol. 71 (May 10, 2006): Docket No. 2006D-0172.  Draft Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Pediatric Referrals to the Food and Drug Administration: Additional Safeguards for Children in Clinical Investigations.  Pages  27264-27266 [FR Doc. E6-07058 ]  [ TXT ] [ PDF ] Comments due July 10, 2006

The Draft Guidance

Vol. 71 (May 2, 2006): Docket No. 2000D-1632.  (Formerly 00D-1632) International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products; Draft Revised Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports; Request for Comments; Availability.  Pages  25846-25848 [FR Doc. E6-6602]  [ TXT ] [ PDF ] Comments due June 1, 2006

The Draft Guidance

Vol. 71 (May 2, 2006): Docket No. 2006D-0170.  International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products; Data Elements for Submission of Adverse Event Reports (VICH GL42); Requests for Comments; Availability.  Pages  25845-25846 [FR Doc. E6-6601]  [ TXT ] [ PDF ] Comments due June 1, 2006

The Draft Guidance

Vol. 71 (May 1, 2006): Docket No. 2005D-0401.  Guidance for Industry and Food and Drug Administration Staff: Compliance With the Medical Device User Fee and Modernization Act of 2002, as amended--Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices; Availability.  Pages  25594-25595 [FR Doc. E6-06458]  [ TXT ] [ PDF ]

The Guidance

April

Vol. 71 (April 27, 2006): Docket No. 2006D-0108.  Draft Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs; Availability.  Pages  24857-24859 [FR Doc. E6-06314]  [ TXT ] [ PDF ] Comments due July 26, 2006

The Draft Guidance

Vol. 71 (April 25, 2006): Docket No. 2006D-0150.  Guidance for Sponsors, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable; Availability.  Pages  23924-23925 [FR Doc. E6-06145]  [ TXT ] [ PDF ]

The Guidance

Vol. 71 (April 14, 2006): Docket No. 2006D-0138.  Draft Guidance for Industry: Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims; Availability.  Pages  19526-19527 [FR Doc. E6-05527]  [ TXT ] [ PDF ] Comments due June 28, 2006

The Draft Guidance

Vol. 71 (April 14, 2006): Docket No. 2006D-0139.  International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Revised Guidance for Industry on Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision); Request for Comments; Availability.  Pages  19525-19526 [FR Doc. E6-05525]  [ TXT ] [ PDF ] Comments due May 15, 2006

The Draft Guidance

Vol. 71 (April 13, 2006): Docket No. 2005D-0022.  International Conference on Harmonisation; Guidance on S8 Immunotoxity Studies for Human Pharmaceuticals; Availability.  Pages  19193-19194 [FR Doc. E6-05495]  [ TXT ] [ PDF ]

The Guidance

Vol. 71 (April 11, 2006): Docket No. 2000D-1341.  Draft Guidance for Industry: Center for Biologics and Evaluation Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from an Outside Supplier; Withdrawal of Guidance.  Page  18341 [FR Doc. E6-5220]  [ TXT ] [ PDF ]

Vol. 71 (April 6, 2006): Docket No. 2006D-0112.  Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities.  Pages  17476-17477 [FR Doc. E6-4961]  [ TXT ] [ PDF ] Comments due July 5, 2006

The Draft Guidance

March

Vol. 71 (March 31, 2006): Docket No. 2006D-0128.  Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format—Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions; Availability.  Pages  16317-16318 [FR Doc. E6-4709]  [ TXT ] [ PDF ] Comments due May 30, 2006

The Draft Guidance

Vol. 71 (March 16, 2006): Docket No. 2005D-0103.  Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trial; Availability.  Pages  13605-13606 [FR Doc. E6-03785]  [ TXT ] [ PDF ]

The Guidance

Vol. 71 (March 15, 2006): Docket No. 2005D-0004.  Guidance of Industry on Nonclinical Safety Evaluation of Drug or Biologic Combinations; Availability.  Pages  13410-13411 [FR Doc. E6-3713]  [ TXT ] [ PDF ]

The Guidance

Vol. 71 (March 10, 2006): Docket No. 2006D-0083, CBER 200611.  Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines; Availability.  Page  12367 [FR Doc. E6-3370]  [ TXT ] [ PDF ] Comments due June 8, 2006

The Draft Guidance

Vol. 71 (March 10, 2006): Docket No. 2006D-0088.  Draft Guidance for Industry on Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines; Availability.  Pages  12366-12367 [FR Doc. E6-03371]  [ TXT ] [ PDF ] Comments due June 8, 2006

The Draft Guidance

Vol. 71 (March 10, 2006): Docket No. 2004D-0343.  Guidance for Industry and Food and Drug Administration; Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment; Availability.  Pages  12365-12366 [FR Doc. E6-03369]  [ TXT ] [ PDF ]

The Guidance

Vol. 71 (March 6, 2006): Docket No. 2006D-0079.  Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-Cut and Vegetables: Availability.  Pages  11209-11212 [FR Doc. E6-03084]  [ TXT ] [ PDF ] Comments due May 5, 2006

The Draft Guidance

February

Vol. 71 (February 17, 2006): Docket No. 2006D-0066.  Draft Guidance for Industry and FDA Staff: Whole Grains Label Statements; Availability.  Page  8597 [FR Doc. 06-1509 ]  [ TXT ] [ PDF ] Comments due April 18, 2006

The Draft Guidance

Vol. 71 (February 15, 2006): Docket No. 2003D-0420.  Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: Radiology Devices; Class II Special Controls Guidance Document: Bone Sonometers; Availability.  Pages  7976-7977 [FR Doc. E6-02078 ]  [ TXT ] [ PDF ] Comments due May 16, 2006

The Draft Guidance

Vol. 71 (February 9, 2006): Docket No. 2006D-0012.  Draft Guidance for Industry and Food and Drug Administration Staff; Pharmacogenetic Test and Genetic Tests for Heritable Markers; Availability.  Pages  6779-6781 [FR Doc. E6-01787]  [ TXT ] [ PDF ] Comments due May 10, 2006

The Draft Guidance

Vol. 71 (February 9, 2006): Docket No. 2006D-0020.  Draft Guidance for Industry and Food and Drug Administration Staff; Draft Class II Special Controls Guidance Document: Intervertebral Body Fusion Device; Availability.  Pages  6778-6779 [FR Doc. E6-01735]  [ TXT ] [ PDF ] Comments due May 10, 2006

The Draft Guidance

Vol. 71 (February 3, 2006): Docket No. 2006D-0044.  Draft Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Products Development to Support Labeling Claims; Availability.  Pages  5862-5863 [FR Doc. E6-1433]  [ TXT ] [ PDF ] Comments due April 4, 2006

The Guidance Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

January

Vol. 71 (January 24, 2006): Docket No. 2005D-0011.  Draft Guidances for Industry on the Content and Format of Labeling for Human Prescription Drug and Biological Products; Availability.  Pages  3998-3999 [FR Doc. 06-543 ]  [ TXT ] [ PDF ] Comments due April 24, 2006

The Draft Guidance Labeling for Human Prescription Drug and Biological Products - Implementing the New Content and Format Requirements
The Draft Guidance Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products Content and Format

Vol. 71 (January 17, 2006): Docket No. 2005D-0286.  Draft Guidance for Industry on Investigational New Drugs; Approaches to Complying with Current Good Manufacturing Practice During Phase 1; Availability.  Pages  2552-2554 [FR Doc. 06-352]  [ TXT ] [ PDF ] Comments due March 20, 2006

The Draft Guidance

Vol. 71 (January 17, 2006): Docket No. 2005D-0122.  Guidance for Industry on Exploratory Investigational New Drug Studies; Availability.  Pages  2551-2552 [FR Doc. 06-354]  [ TXT ] [ PDF ]

The Guidance

Vol. 71 (January 9, 2006): Docket No. 2005D-0468.  Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays; Availability.  Pages  1432-1433 [FR Doc. 06-00174 ]  [ TXT ] [ PDF ] Comments due April 10, 2006

The Draft Guidance

Vol. 71 (January 4, 2006): Docket No. 1999D-2215, 99D-2215.  International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Revised Guidance for Industry on Impurities in New Veterinary Drug Substances (Revision); Request for Comments; Availability.  Pages  351-352 [FR Doc. E5-08222]  [ TXT ] [ PDF ] Comments due February 3, 2006

The Draft Guidance