Selected Dockets CLOSING for the Period October 1, 2004 through January, 2006

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November, 2004

Docket No. 2004N-0289, Proposed Rule. Determination Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph for Over-the-Counter Nasal Decongestant Drug Products. Pages 46119-46122 [FR Doc. 04-17445] [TXT] [PDF] Comments due November 2, 2004

Docket No. 2004N-0355. Scientific Considerations Related to Developing Follow-On Protein Products. Pages 50386-50388 [FR Doc. 04-18627 ] [TXT] [PDF] Public Workshop on September 14, 2004 and September 15, 2004 Comments due November 12, 2004

Docket No. 2004N-0355. Scientific Considerations Related to Developing Follow-On Protein Products; Correction. Page 54149 [FR Doc. 04-20289] [TXT] [PDF]

Docket No. 2004N-0401, OC 2004225. Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys. Pages 55823-55824 [FR Doc. 04-20811] [TXT] [PDF] Comments due November 15, 2004

Docket No. 2004N-0186. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fees and Fee Waivers and Reductions. Pages 61023-61024 [FR Doc. 04-23104] [TXT] [PDF] Comments due November 15, 2004

Docket No. 2004S-0233, OC 2004261. Stimulating Innovation in Medical Technologies, Public Meeting. Pages 61018-61019 [FR Doc. 04-23064] [TXT] [PDF] Meeting on November 8, 2004 Comments due November 15, 2004

Docket No. 2004N-0214, Notice of Proposed Rule. Public Information Regulations; Companion Document to Direct Final Rule. Pages 53662-53664 [FR Doc. 04-19995] [TXT] [PDF] Comments by November 16, 2004

Docket No. 2004N-0214, Direct Final Rule. Public Information Regulations. Pages 53615-53616 [FR Doc. 04-19996] [TXT] [PDF] Effective January 17, 2005 Comments due November 16, 2004

Docket No. 2004N-0395. Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program. Pages 56228-56229 [FR Doc. 04-21075] [TXT] [PDF] Comments due November 19, 2004

Docket No. 2004N-0346. Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Antidiarrheal Ingredient (Notice of eligibility; request for data and information). Pages 51852-51853 [FR Doc. 04-19180] [TXT] [PDF] Comments due November 22, 2004

Docket No. 2004D-0352. Global Harmonization Task Force, Study Groups 1 and 2; New Proposed Documents; Availability. Pages 51853-51854 [FR Doc. 04-19181] [TXT] [PDF] Comments due November 22, 2004

Study Group 1
Study Group 2

Docket No. 2004D-0343. Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability. Page 52907 [FR Doc. 04-19656] [TXT] [PDF] Comments by November 29, 2004

The Draft Guidance

Docket No. 2004D-0410. 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] Comments due November 29, 2004

The Draft Guidance

Docket No. 2004E-0023. Determination of Regulatory Review Period for Purposes of Patent Extension; REYATAZ. Pages 57937-57939 [FR Doc. 04-21625] [TXT] [PDF] Comments due November 29, 2004

Docket No. 2002E-0065. Determination of Regulatory Review Period for Purposes of Patent Extension; KINERET. Pages 57938-57939 [FR Doc. 04-21675] [TXT] [PDF] Comments due November 29, 2004

Docket No. 2001E-0032. Determination of Regulatory Review Period for Purposes of Patent Extension; VISUDYNE. Pages 57939-57940 [FR Doc. 04-21678] [TXT] [PDF] Comments due November 29, 2004

Docket No. 2003E-0260. Determination of Regulatory Review Period for Purposes of Patent Extension; AMEVIVE. Pages 58445-58446 [FR Doc. 04-21874] [TXT] [PDF] Comments due November 29, 2004

Docket No. 2003E-0033 . Determination of Regulatory Review Period for Purposes of Patent Extension; DERMAGRAFT. Pages 58176-58177 [FR Doc. 04-21749] [TXT] [PDF] Comments due November 29, 2004

Docket No. 2004D-0453. Draft Revised Compliance Policy Guide Sec. 560.400--Imported Milk and Cream--Federal Import Milk Act (CPG 7119.05); Availability. Pages 63158-63159 [FR Doc. 04-24153] [TXT] [PDF] Comments due November 29, 2004

The Draft Guidance Pdf Version
The Draft Guidance Word Version

December 2004

Docket Nos. 1998N-0337, 1996N-0420, 1995N-0259, 1990P-0201. Over-the-Counter Human Drugs; Labeling Requirements; Partial Delay of Compliance Date. Pages 53801-53804 [FR Doc. 04-18842] [TXT] [PDF] Effective October 4, 2004 Comments due December 2, 2004

Docket No. 2004D-0431, OC 2004219. Draft Guidance for Industry and the Food and Drug Administration; Current Good Manufacturing Practices for Combination Products; Availability. Page 59239 [FR Doc. 04-222205] [TXT] [PDF] Comments due December 3, 2004

The Draft Guidance (PDF)
The Draft Guidance (Word)

Docket No. 2004D-0443. Draft Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations; Availability. Page 59256 [FR Doc. 04-22206] [TXT] [PDF] Comments due December 3, 2004

The Draft Guidance (PDF)
The Draft Guidance (Word)

Docket No. 2004N-0454. Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting. Pages 61680-61684 [FR Doc. 04-23439] [TXT] [PDF] Meeting on November 15, 2004 Comments due December 3, 2004

Docket No. 2004N-0441, OC 2004250. Agency Information Collection Activities; Proposed Collection; Comment Request; Application for FDA Approval to Market a New Drug. Pages 60402-60405 [FR Doc. 04-22815] [TXT] [PDF] Comments by December 7, 2004

Docket No. 2004D-0377. International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; Availability. Pages 55163-55164 [FR Doc. 04-20565] [TXT] [PDF] Comments due December 13, 2004

The Draft Guidance (Word)
The Draft Guidance (PDF)

Docket No. 2004D-0378. International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; Availability. Pages 55164-55165 [FR Doc. 04-20564] [TXT] [PDF] Comments due December 13, 2004

The Draft Guidance (PDF)
The Draft Guidance (Word)

Docket No. 2004N-0442. Agency Information Collection Activities; Proposed Collection; Comment Request; Recall Regulations (Guidelines). Pages 60630-60632 [FR Doc. 04-22763] [TXT] [PDF] Comments due December 13, 2004

Docket No. 2004N-0437. Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act, Third-Party Premarket Submission Review, and Quality System Inspections Under the United States/European Community Mutual Recognition Agreement. Pages 61021-61023 [FR Doc. 04-23103] [TXT] [PDF] Comments by December 13, 2004

Docket No. 2004N-0436. Agency Information Collection Activities: Proposed Collection; Comment Request; Medical Device Registration and Listing. Pages 63156-63158 [FR Doc. 04-24192] [TXT] [PDF] Comments due December 28, 2004

Docket No. 2003P-0564, Proposed Rule. Microbiology Devices; Reclassification of Hepatitis A Virus (HAV) Serological Assays (IgM Antibody, IgG Antibody and Total Antibodies (IgM and IgG)). Pages 58371-58374 [FR Doc. 04-22009] [TXT] [PDF] Comments by December 29, 2004

Docket No. 2004D-0385. Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Hepatitis A Serological Assays for the Clinical Laboratory Diagnosis of Hepatitis A Virus; Availability. Pages 58448-58449 [FR Doc. 04-22010] [TXT] [PDF] Comments due December 29, 2004

Draft Guidance

January 2005

Docket No. 2004D-0440. Draft Guidance for Industry on Computerized Systems Used in Clinical Trials; Availability. Pages 59239-59240 [FR Doc. 04-22204] [TXT] [PDF] Comments due January 3, 2005

The Draft Guidance (PDF)
The Draft Guidance (Word)

Docket Nos. 2003E-0405, 2003E-0452. Determination of Regulatory Review Period for Purposes of Patent Extension; NEUTERSOL. Pages 40944-40945 [FR Doc. 04-15301] [TXT] [PDF] Comments due September 7, 2004 Due Diligence Petitions due January 3, 2005

Docket No. 2003E-0251. Dermatologic Determination of Regulatory Review Period for Purposes of Patent Extension; DAPTACEL. Pages 40945-40946 [FR Doc. 04-15274] [TXT] [PDF] Comments due September 7, 2004 Due Diligence Petitions due January 3, 2005

Docket No. 2003E-0257. Determination of Regulatory Review Period for Purposes of Patent Extension; Neotame. Page 40946 [FR Doc. 04-15275] [TXT] [PDF] Comments due September 7, 2004 Due Diligence Petitions due January 3, 2005

Docket No. 2004D-0462. Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes; Availability. Pages 62903-62904 [FR Doc. 04-24066] [TXT] [PDF] Comments due by January 26, 2005

April, 2005

Docket No. 1978N-0064, Final Rule. Antiperspirant Drug Products for Over-the-Counter Human Use; Final Monograph; Partial Stay; Reopening of the Administrative Record. Pages 61148-61150 [FR Doc. 04-23106] [TXT] [PDF] Effective date no later than December 9, 2004 Comments due April 5, 2005

July 2005

Docket No. 2004N-0330. Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee; Amendment of Notice. Page 51853 [FR Doc. 04-19224] [TXT] [PDF] Comments due July 29, 2005

January 2006

Docket No. 2004N-0033. Establishing a Docket for the Factor VIII Inhibitor Public Workshop; Availability. Pages 40639-40640 [FR Doc. 04-15135] [TXT] [PDF] Comments due January 6, 2006