DRAFT GUIDANCES - FEDERAL REGISTER NOTICES - 2001

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

December

Vol. 66 (December 21, 2001): Docket No. 01D-0493.  Draft Guidance for Industry: Exemptions from the Warning Label Requirement for ice-Recommendations for Effectively Achieving a 5-Log Reduction; Availability.  Pages  65978-65979 [FR Doc. 01-31453]  [ TXT ] [ PDF ] Written/electronic comments by February 19, 2002

The Draft Guidance

Vol. 66 (December 20, 2001): Docket No. 01D-0514.  Medical Devices; Guidance on Labeling of Reprocessed Single Use Devices; Request for Comments and Information.  Pages  65723--65724 [FR Doc. 01-31334]  [ TXT ] [ PDF ]Comments by March 20, 2002

Vol. 66 (December 18, 2001): Docket No. 01D-0503.  Draft Compliance Policy Guide: "Filth from Insects, Rodents, and Other Pests in Food;" Availability.  Page  65214 [FR Doc. 01-31024]  [ TXT ] [ PDF ] Written/electronic comments by February 19, 2002

The Draft Guidance

Vol. 66 (December 13, 2001): Docket No. 01D-0501.  International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on "Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSU's)" (VICH GL29); Request for Comments; Availability.  Pages  64450--64451 [FR Doc. 01-30766]  [ TXT ] [ PDF ] Written/electronic comments by January 14, 2002

The Draft Guidance

Vol. 66 (December 11, 2001): Docket No. 01D-0510.  Draft Guidance for Industry on Integration of Dose-Counting Mechanisms into MDI Drug Products; Availability.  Pages  64045--64046 [FR Doc. 01-30491]  [ TXT ] [ PDF ] Comments by February 11, 2002

The Draft Guidance

Vol. 66 (December 7, 2001): Docket No. 01D-0519.  Medical Devices: Draft Guidance on Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Availability.  Pages  63546--63547 [FR Doc. 01-30330]  [ TXT ] [ PDF ] Comments by March 7, 2002

The Draft Guidance

November

Vol. 66 (November 28, 2001): Docket No. 01D-0488.  Draft Guidance for Industry on Food-Effect Bioavailability and Fed Bioequivalence Studies: Study Design, Data Analysis, and Labeling.  Page  59433 [FR Doc. 01-29510]  [ TXT ] [ PDF ] Comments by January 28, 2002

The Draft Guidance

Vol. 66 (November 28, 2001): Docket No. 01D-0435.  International Conference on Harmonisation; Draft Guidance on Electronic Common Technical Document Specification; Availability.  Pages  59431--59432 [FR Doc. 01-29511]  [ TXT ] [ PDF ] Comments by February 26, 2002

The Draft Guidance

Vol. 66 (November 20, 2001): Docket No. 01D-0489.  Draft "Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees;" Availability.  Pages  58151--58153 [FR Doc. 01-28962]  [ TXT ] [ PDF ] Comments by February 19, 2002

The Draft Guidance

Vol. 66 (November 20, 2001): Docket No. 01D-0269.  Draft Guidance for Industry on the Clinical Studies Section of Labeling for Prescription Drugs and Biologics-Content and Format; Availability; Reopening of Comment Period.  Pages  58150--58151 [FR Doc. 01-28961]  [ TXT ] [ PDF ] Comments by November 26, 2001

The Draft Guidance

Vol. 66 (November 16, 2001): Docket No. 01D-0475.  Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-ANDAs; Availability.  Pages  57721-57722 [FR Doc. 01-28681]  [ TXT ] [ PDF ] Written/electronic comments by January 15, 2002

The Draft Guidance

Vol. 66 (November 13, 2001): Docket No. 99N-2079.  Draft Guidance for Reviewers on the Integration of Study Results to Assess Concerns About Human Reproductive and Developmental Toxicities; Availability.  Pages  56830--56831 [FR Doc. 01-28258]  [ TXT ] [ PDF ] Comments by March 13, 2002

The Draft Guidance

Vol. 66 (November 6, 2001): Docket No. 01D-0432.  Draft Guidance for Industry on the Evaluation of the Effects of Orally Inhaled and Intranasal Corticosteroids on Growth in Children; Availability.  Pages  56109-56110 [FR Doc. 01-27756]  [ TXT ] [ PDF ] Written/electronic comments by February 4, 2002

The Draft Guidance

October

September

Vol. 66 (September 25, 2001): Docket No. 01D-0361.  International Conference on Harmonisation; Draft Guidance on ICH Q1D Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products; Availability.  Pages  49029-49030 [FR Doc. 01-23981]  [ TXT ] [ PDF ] Written/electronic comments by November 26, 2001

The Draft Guidance

Vol. 66 (September 24, 2001): Docket No. 00D-1543.  Draft Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Glossary of Terms; Availability.  Pages  48886-48887 [FR Doc. 01-23699]  [ TXT ] [ PDF ] Comments due December 24, 2001

The Draft Guidance html version
The Draft Guidance

Vol. 66 (September 24, 2001): Docket No. 00D-1538.  Draft Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Validation; Availability.  Page  48886 [FR Doc. 01-23698]  [ TXT ] [ PDF ] Comments due December 24, 2001

The Draft Guidance
The Draft Guidance htm

Vol. 66 (September 6, 2001): Docket No. 01D-0318.  Medical Devices; Draft Guidance; Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Availability.  Pages  46641--46642 [FR Doc. 01-22287]  [ TXT ] [ PDF ] Comments by December 5, 2001

The Draft Guidance

Vol. 66 (September 5, 2001): Docket No. 01D-0368.  Draft Guidance for Industry on Submitting Marketing Applications According to the ICH/CTD Format; General Considerations; Availability.  Pages  46464--46465 [FR Doc. 01-22199]  [ TXT ] [ PDF ] Comments by November 5, 2001

The Draft Guidance

August

Vol. 66 (August 31, 2001): Draft Multi-Agency Radiological Laboratory Analytical Protocols Manual (NOTE: This is a multi agency published Federal Register Notice which includes DHHS and FDA. There is no FDA [pre-pub] display.  Pages  45972--45974 [FR Doc. 01-22017]  [ TXT ] [ PDF ]

The Draft Guidance This link will take you to the cover sheet and the table of contents, which has been linked to the 20 chapters and the appendices. If you print the entire document it will be in excess of 1400 pages.

Vol. 66 (August 29, 2001): Docket No. 97D-0318.  Draft "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products;".  Pages  45683--45684 [FR Doc. 01-21920]  [ TXT ] [ PDF ] Comments by September 28, 2001

The Draft Guidance

Vol. 66 (August 23, 2001): Docket No. 01D-0278.  Draft "Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research;" Availability.  Pages  44356--44357 [FR Doc. 01-21246]  [ TXT ] [ PDF ] Comments by November 21, 2001

The Draft Guidance

Vol. 66 (August 15, 2001): Docket No. 01D-0311.  Medical Devices: Draft Guidance on "Class II Special Control Guidance Document: Endolymphatic Shunt Tube With Valve; Draft Guidance for Industry and FDA;" Availability.  Pages  42870--42871 [FR Doc. 01-20572]  [ TXT ] [ PDF ] Comments by November 13, 2001

The Draft Guidance

Vol. 66 (August 13, 2001): Docket No. 01D-0221.  Draft Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Other Than Blood and Blood Components; Availability.  Pages  42547--42548 [FR Doc. 01-20158]  [ TXT ] [ PDF ] Comments by November 13, 2001

The Draft Guidance

Vol. 66 (August 13, 2001): Docket No. 01D-0220, CBER 200024.  Draft Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments; Availability.  Pages  42546--42547 [FR Doc. 01-20157]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments by November 13, 2001

The Draft Guidance

Vol. 66 (August 3, 2001): Docket No. 01D-0262.  Draft Guidance for FDA Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments; Availability.  Pages  40708--40709 [FR Doc. 01-19462]  [ TXT ] [ PDF ] ] Written comments by November 1, 2001

The Draft Guidance

July

Vol. 66 (July 31, 2001): Docket Nos. 01D-0294 , 01D-0295.  Draft Guidances for Industry on Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format: General Considerations and for Food Additive and Color Additive Petitions; Availability.  Pages  39517-39521 [FR Doc. 01-18948 ]  [ TXT ] [ PDF ] Comments by October 1, 2001

The Draft Guidance Docket No. 01D-0294 - Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format: General Considerations
The Draft Guidance Docket No. 01D-0295 - Regulatory Submissions to Office of Food Additive Safety in Electronic Format for Food Additive and Color Additive Petitions

Vol. 66 (July 25, 2001): Docket No. 01D-0281.  Medical Devices; A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Draft Guidance for Industry and FDA Staff; Availability.  Pages  38714--38716 [FR Doc. 01-18480]  [ TXT ] [ PDF ] Written/electronic comments by September 24, 2001

The Draft Guidance

Vol. 66 (July 18, 2001): Docket No. 01D-0297.  Medical Devices; Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff; Availability.  Page  37483 [FR Doc. 01-17976]  [ TXT ] [ PDF ] Comments by October 16, 2001

The Draft Guidance

Vol. 66 (July 10, 2001): Docket No. 01D-0276.  Draft Guidance for Industry: Channels of Trade Policy for Commodities With Vinclozolin Residues; Availability.  Pages  35990--35992 [FR Doc. 01-17047]  [ TXT ] [ PDF ] Written comments by September 10, 2001

The Draft Guidance

Vol. 66 (July 9, 2001): Docket No. 00D-1033.  Draft Guidance for Industry on Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Implementation Plan; Availability.  Pages  35798--35799 [FR Doc. 01-17050]  [ TXT ] [ PDF ] Written comments by September 7, 2001

The Draft Guidance

Vol. 66 (July 9, 2001): Docket No. 01D-0269.  Draft Guidance for Industry on the Clinical Studies Section of Labeling for Prescription Drugs and Biologics-Content and Format; Availability.  Pages  35797--35798 [FR Doc. 01-17048]  [ TXT ] [ PDF ] Written comments by October 9, 2001

The Draft Guidance

June

Vol. 66 (June 26, 2001): Docket No. 01D-0232.  Medical Devices Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff; Availability; Correction.  Page  33966 [FR Doc. 01-15911]  [ TXT ] [ PDF ]

Vol. 66 (June 13, 2001): Docket No. 01D-0224.  Draft Guidance for Industry: Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues; Availability.  Pages  31938--31939 [FR Doc. 01-14813]  [ TXT ] [ PDF ] Written comments by September 11, 2001

The Draft Guidance

Vol. 66 (June 1, 2001): Docket No. 01D-0232.  Medical Devices Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff; Availability (NOTE: [PRE-PUB] and (TXT) documents are set up to accept electronic comments).  Pages  29822-29823 [FR Doc. 01-13731 ]  [ TXT ] [ PDF ] Written comments by August 30, 2001

The Draft Guidance

May

Vol. 66 (May 21, 2001): Docket No. 01D-0193.  Medical Devices: Draft Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers; Availability. Page  [FR Doc. 01-12624]  [ TXT ] [ PDF ] Written comments by August 20, 2001

The Draft Guidance

Vol. 66 (May 15, 2001): Docket No. 01D-0192.  Draft Guidance for Industry on Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution; Availability.  Pages  26867-26868 [FR Doc. 01-12179]  [ TXT ] [ PDF ] Written comments by July 16, 2001

The Draft Guidance

Vol. 66 (May 11, 2001): Docket No. 01D-01771.  Draft Guidance for Industry on Immunotoxicology Evaluation of Investigational New Drugs; Availability.  Pages  24145-24146 [FR Doc. 01-11879]  [ TXT ] [ PDF ] Written comments by August 9, 2001

The Draft Guidance

Vol. 66 (May 8, 2001): Docket No. 01D-0194.  Draft Guidance for Industry on the Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals; Availability.  Pages  23266-23267 [FR Doc. 01-11450]  [ TXT ] [ PDF ] Written comments by August 6, 2001

The Draft Guidance

Vol. 66 (May 4, 2001): Docket No. 01D-01851.  Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Postmarketing Expedited Safety Reports; Availability.  Pages  22514 -22515 [FR Doc. 01-11235]  [ TXT ] [ PDF ] Written comments by July 3, 2001

The Guidance

Vol. 66 (May 3, 2001): Docket No. 01D-0202.  Medical Devices: Draft The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Availability.  Pages  22241-22242 [FR Doc. 01-11231]  [ TXT ] [ PDF ] Written comments by August 1, 2001

The Draft Guidance

April

Vol. 66 (April 27, 2001): Docket No. 99D-3028.  Draft Guidance for Industry; Premarket Approval Applications for In Vitro Diagnostic Devices Pertaining to Hepatitis C Viruses (HCV); Assays Intended for Diagnosis, Prognosis, or Monitoring of HCV Infection, Hepatitis C, or Other HCV-Associated Disease; Availability.  Pages  21160-21161 [FR Doc. 01-10528]  [ TXT ] [ PDF ] Written comments by July 26, 2001

The Draft Guidance

Vol. 66 (April 23, 2001): Docket No. 01D-0162.  Draft Guidance for Industry on Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements; Availability.  Pages  20468-20469 [FR Doc. 01-09948]  [ TXT ] [ PDF ] Written comments by July 23, 2001

The Draft Guidance

Vol. 66 (April 4, 2001): Docket No. 01D-0146.  Draft Guidance for Industry and Reviewers on How the Center for Veterinary Medicine Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug; Availability.  Page  17914 [FR Doc. 01-08200]  [ TXT ] [ PDF ] Written comments by July 3, 2001

The Draft Guidance

Vol. 66 (April 2, 2001): Docket No. 01D-0129.  Medical Devices Draft Guidance for the Implementation of the Biomaterials Access Assurance Act of 1998; Availability.  Pages  17562-17564 [FR Doc. 01-07956]  [ TXT ] [ PDF ] Comments by July 2, 2001

The Draft Guidance

March

Vol. 66 (March 21, 2001): Docket No. 01D-0086.  Draft Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research; Availability.  Pages  15877-15880 [FR Doc. 01-06937]  [ TXT ] [ PDF ] Comments due May 21, 2001

The Draft Guidance

Vol. 66 (March 12, 2001): Docket No. 01D-0056.  Draft Guidance for Industry on Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines; Availability.  Pages  14391-14392 [FR Doc. 01-06053]  [ TXT ] [ PDF ] Written comments by May 11, 2001

The Draft Guidance

Vol. 66 (March 1, 2001): Docket No. 01D-0044.  Medical Devices Draft Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Availability.  Pages  12939-12940 [FR Doc. 01-04963]  [ TXT ] [ PDF ] Written comments by May 30, 2001

The Draft Guidance

February

Vol. 66 (February 22, 2001): Docket No. 01D-0059.  Draft Guidance for Industry on Separate Marketing Applications and Definition of Clinical Data for Purposes of Assessing User Fees; Availability.  Pages  11175-11176 [FR Doc. 01-04311]  [ TXT ] [ PDF ] Written comments on draft guidance by March 6, 2001

The Draft Guidance

Vol. 66 (February 22, 2001): Docket No. 01D-0005, CDOTC 20007.  Draft Guidance for Industry on Labeling Over-the-Counter Human Drug Products; Updating Labeling in ANDA's; Availability.  Pages  11174-11175 [FR Doc. 01-04312]  [ TXT ] [ PDF ] Written comments on draft guidance by April 23, 2001

The Draft Guidance

Vol. 66 (February 7, 2001): Docket No. 00D-1662.  Draft Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans; Availability.  Page  9348 [FR Doc. 01-03202]  [ TXT ] [ PDF ] Written comments by May 8, 2001

The Draft Guidance

January

Vol. 66 (January 31, 2001): Docket No. 01D-0033, CDER 46.  Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format, Prescription Drug Advertising and Promotional Labeling; Availability.  Pages  8411-8412 [FR Doc. 01-02631 ]  [ TXT ] [ PDF ] Comments by April 2, 2001

The Draft Guidance

Vol. 66 (January 31, 2001): Docket No. 01D-0037.  Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion;'' Availability.  Pages  8410-8411 [FR Doc. 01-02584]  [ TXT ] [ PDF ] Comments by May 1, 2001

The Draft Guidance

Vol. 66 (January 18, 2001): Docket No. 00D-1598.  Draft Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Availability.  Pages  4839-4842 [FR Doc. 01-1047]  [ TXT ] [ PDF ] Written comments by March 19, 2001 Written comments on information collection by March 19, 2001

The Draft Guidance

Vol. 66 (January 16, 2001): Docket No. 00D-1679.  Draft Compliance Policy Guidance for FDA Employees and Industry on Blood Donor Incentives; Availability.  Page  3605 [FR Doc. 01-1127]  [ TXT ] [ PDF ] Written comments by March 19, 2001

The Draft Guidance

Vol. 66 (January 4, 2001): Docket No. 00D-1681.  Draft Guidance on Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies; Availability.  Pages  800-801 [FR Doc. 01-00189]  [ TXT ] [ PDF ] Comments by February 5, 2001

The Draft Guidance