[Federal Register Volume 63, Number 38 (Thursday, February 26, 1998)]
[Notices]
[Pages 9795-9843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4916]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0046]


Comprehensive List of Current Guidance Documents at the Food and 
Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a 
comprehensive list of all guidance documents currently in use at the 
agency. FDA committed to publishing this list in its February 1997 
``Good Guidance Practices'' (GGP's), which set forth the agency's 
policies and procedures for the development, issuance, and use of 
guidance documents. This list is intended to inform the public of the 
existence and availability of all current guidance documents, including 
those documents that were issued prior to the adoption of the GGP's.

DATES: General comments on this list and on agency guidance documents 
are welcome at any time.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFD-305), Food and Drug Administration, 12420 Parklawn Dr., rm 1-23, 
Rockville, MD 20857. Information on where to obtain single copies of a 
listed guidance document is provided for each agency center 
individually in the specific center's list of guidance documents.

FOR FURTHER INFORMATION CONTACT: Lisa L. Barclay, Office of Policy (HF-
22), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3360.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 27, 1997 (62 FR 8961), FDA 
published a notice announcing its ``Good Guidance Practices'' (GGP's), 
which set forth the agency's policies and procedures for the 
development, issuance, and use of guidance documents. The agency 
adopted the GGP's to ensure public involvement in the development of 
guidance documents and to enhance public understanding of the 
availability, nature, and legal effect of such guidance.
    As part of FDA's effort to ensure meaningful interaction with the 
public regarding guidance documents, the agency committed to publish a 
comprehensive list of all guidance documents that are currently in 
effect. This comprehensive list is maintained on the FDA World Wide Web 
home page. The list will be updated and published annually in the 
Federal Register. FDA also has committed to publish quarterly a Federal 
Register notice that lists all guidance documents that were issued and 
withdrawn during that quarter. FDA also has undertaken to publish, on a 
quarterly basis, a list of all new ``Level 2'' guidance documents 
issued by the agency under the GGP's. In a separate notice in a future 
issue of the Federal Register, FDA will publish its first quarterly 
update including a list of Level 2 guidance documents issued during 
that quarter.
    The following list of guidance documents represents all guidances 
issued by FDA that are currently in effect. The documents are organized 
by the issuing Center or Office within FDA, and are further grouped by 
the intended users or regulatory activities to which they pertain. 
Dates provided in the following list refer to the date of issuance or, 
where applicable, the date of last revision of the document. Document 
numbers are provided where available, and guidance documents that are 
still in draft form and on which public comment has been requested are 
so identified.
    This cumulative list includes guidance documents that were issued 
prior to the adoption of the GGP's. At the time such documents are 
substantively revised, FDA will update them to include the standard 
guidance elements and nomenclature described in the GGP's.

II. Guidance Documents Issued by the Center for Biologics 
Evaluation and Research (CBER)

[[Page 9796]]



                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                                                    How to Obtain a Hard Copy of
                                                             Grouped by Intended       the Document (Name and   
           Name of Document              Date of Issuance     User or Regulatory    Address, Phone, FAX, E-mail,
                                                                  Activity                  or Internet)        
----------------------------------------------------------------------------------------------------------------
Requirements for Infrequent             August 27, 1982     FDA Regulated          Office of Communication,     
 Plasmapheresis Donors                                       Industries             Training and Manufacturers  
                                                                                    Assistance, 1401 Rockville  
                                                                                    Pike, Rockville, MD 20852-  
                                                                                    1448, 301-827-1800 or 1-800-
                                                                                    835-4709, FAX Information   
                                                                                    System: 1-888-CBER-FAX      
                                                                                    (within U.S.) 301-827-3844  
                                                                                    (outside U.S. and local to  
                                                                                    Rockville, MD) Internet     
                                                                                    access: http://www.fda.gov/
cber/ Recommendations to Decrease the Risk    March 24, 1983      Do                     Do                           
 of Transmitting AIDS from Plasma                                                                               
 Donors                                                                                                         
Deferral of Blood Donors Who Have       February 28, 1984   Do                     Do                           
 Received the Drug Accutane                                                                                     
 (isotretinoin/Roche); 13-cis-retinoic                                                                          
 acid)                                                                                                          
Equivalent Methods for Compatibility    December 14, 1984   Do                     Do                           
 Testing                                                                                                        
Plasma Derived from Therapeutic Plasma  December 14, 1984   Do                     Do                           
 Exchange                                                                                                       
Reduction of the Maximum Platelet       June 2, 1986        Do                     Do                           
 Storage Period to 5 Days in an                                                                                 
 Approved Container                                                                                             
 Deferral of Donors Who Have Received   November 25, 1987   Do                     Do                           
 Human Pituitary-Derived Growth                                                                                 
 Hormone                                                                                                        
Recommendations for the Management of   December 2, 1987    Do                     Do                           
 Donors and Units That Are Initially                                                                            
 Reactive for Hepatitis B Surface                                                                               
 Antigen (HBsAg)                                                                                                
Extension of Dating Period for Storage  December 4, 1987    Do                     Do                           
 of Red Blood Cells, Frozen                                                                                     
To Licensed In-Vitro Diagnostic         December 23, 1987   Do                     Do                           
 Manufacturers: Handling of Human                                                                               
 Blood Source Materials                                                                                         
Recommendations for Implementation of   April 6, 1988       Do                     Do                           
 Computerization in Blood                                                                                       
 Establishments                                                                                                 
Control of Unsuitable Blood and Blood   April 6, 1988       Do                     Do                           
 Components                                                                                                     
Discontinuance of Prelicensing          July 7, 1988        Do                     Do                           
 Inspection for Immunization Using                                                                              
 Licensed Tetanus Toxoid and Hepatitis                                                                          
 B and Rabies Vaccines                                                                                          
Physician Substitutes                   August 15, 1988     Do                     Do                           
To Licensed Manufacturers of Blood       August 26, 1988    Do                     Do                           
 Grouping Reagents: Criteria for                                                                                
 Exemption of Lot Release                                                                                       
To Manufacturers of HTLV-I Antibody     October 18, 1988    Do                     Do                           
 Test Kits: Antibody to Human T-Cell                                                                            
 Lymphotropic Virus, Type I (HTLV-I)                                                                            
 Release Panel I                                                                                                
HTLV-1 Antibody Testing                 November 29, 1988   Do                     Do                           
Use of Recombigen HIV-1 LA Test         February 1, 1989    Do                     Do                           
Guidance for Autologous Blood and       March 15, 1989      Do                     Do                           
 Blood Components                                                                                               
HTLV-I Antibody Testing                 July 6, 1989        Do                     Do                           
Use of Recombigen HIV-1 Latex           August 1, 1989      Do                     Do                           
 Agglutination (LA) Test                                                                                        
Requirements for Computerization of     September 8, 1989   Do                     Do                           
 Blood Establishments                                                                                           
Abbott Laboratories' HIVAG-1 Test for   October 4, 1989     Do                     Do                           
 HIV-1 Antigen(s) Not Recommended for                                                                           
 Use as a Donor Screen                                                                                          
Autologous Blood Collection and         February 12, 1990   Do                     Do                           
 Processing Procedures                                                                                          
Use of Genetic Systems HIV-2 EIA        June 21, 1990       Do                     Do                           
Deficiencies Relating to the            March 20, 1991      Do                     Do                           
 Manufacture of Blood and Blood                                                                                 
 Components                                                                                                     
Responsibilities of Blood               March 20, 1991      Do                     Do                           
 Establishments Related to Errors &                                                                             
 Accidents in the Manufacture of Blood                                                                          
 and Blood Components                                                                                           
Revision to October 26, 1989 Guideline  April 17, 1991      Do                     Do                           
 for Collection of Blood or Blood                                                                               
 Products from Donors with Positive                                                                             
 Tests for Infectious Disease Markers                                                                           
 (High Risk Donors)                                                                                             
FDA Recommendations Concerning Testing  September 10, 1991  Do                     Do                           
 for Antibody to Hepatitis B Core                                                                               
 Antigen (Anti-HBc)                                                                                             
Disposition of Blood Products Intended  September 11, 1991  Do                     Do                           
 for Autologous Use That Test                                                                                   
 Repeatedly Reactive for Anti-HCV                                                                               

[[Page 9797]]

                                                                                                                
Clarification of FDA Recommendations    December 12, 1991   Do                     Do                           
 for Donor Deferral and Product                                                                                 
 Distribution Based on the Results of                                                                           
 Syphilis Testing                                                                                               
Revised Recommendations for the         April 23, 1992      Do                     Do                           
 Prevention of Human Immunodeficiency                                                                           
 Virus (HIV) Transmission by Blood and                                                                          
 Blood Products                                                                                                 
Use of Fluorognost HIV-1                April 23, 1992      Do                     Do                           
 Immunofluorescent Assay (IFA)                                                                                  
Revised Recommendations for Testing     April 23, 1992      Do                     Do                           
 Whole Blood, Blood Components, Source                                                                          
 Plasma and Source Leukocytes for                                                                               
 Antibody to Hepatitis C Virus Encoded                                                                          
 Antigen (Anti-HCV)                                                                                             
Exemptions to Permit Persons with a     April 23, 1992      Do                     Do                           
 History of Viral Hepatitis Before the                                                                          
 Age of Eleven Years to Serve as                                                                                
 Donors of Whole Blood and Plasma;                                                                              
 Alternative Procedures (21 CFR                                                                                 
 640.120)                                                                                                       
Changes in Equipment for Processing     July 21, 1992       Do                     Do                           
 Blood Donor Samples                                                                                            
Nomenclature for Monoclonal Blood       September 28, 1992  Do                     Do                           
 Grouping Reagents                                                                                              
Volume Limits for Automated Collection  November 4, 1992    Do                     Do                           
 of Source Plasma                                                                                               
Revision of October 7, 1988 Memo        December 16, 1992   Do                     Do                           
 Concerning Red Blood Cell                                                                                      
 Immunization Programs                                                                                          
Recommendations Regarding License       July 22, 1993       Do                     Do                           
 Amendments and Procedures for Gamma                                                                            
 Irradiation of Blood Products                                                                                  
Deferral of Blood and Plasma Donors     July 28, 1993       Do                     Do                           
 Based on Medications                                                                                           
Revised Recommendations for Testing     August 19, 1993     Do                     Do                           
 Whole Blood, Blood Components, Source                                                                          
 Plasma and Source Leukocytes for                                                                               
 Antibody to Hepatitis C Virus Encoded                                                                          
 Antigen (Anti-HCV)                                                                                             
Changes in Administrative Procedures    September 9, 1993   Do                     Do                           
Guidance Regarding Post Donation        December 10, 1993   Do                     Do                           
 Information Reports                                                                                            
Donor Suitability Related to            December 22, 1993   Do                     Do                           
 Laboratory Testing for Viral                                                                                   
 Hepatitis and a History of Viral                                                                               
 Hepatitis                                                                                                      
Recommendations for the Invalidation    January 3, 1994     Do                     Do                           
 of Test Results When Using Licensed                                                                            
 Viral Marker Assays to Screen Donors                                                                           
Recommendations for Deferral of Donors  July 26, 1994       Do                     Do                           
 for Malaria Risk                                                                                               
Use of and FDA Cleared or Approved      August 5, 1994      Do                     Do                           
 Sterile Docking Device (STCD) in                                                                               
 Blood Bank Practices (transmittal                                                                              
 memo 8/12/94) (corrects 7/29/94 Memo)                                                                          
Recommendations to Users of Medical     December 20, 1994   Do                     Do                           
 Devices That Test for Infectious                                                                               
 Disease Markers by Enzyme Immunoassay                                                                          
 (EIA) Test Systems                                                                                             
Timeframe for Licensing Irradiated      February 3, 1995    Do                     Do                           
 Blood Products                                                                                                 
Revision of 8/27/82 FDA Memo:           March 10, 1995      Do                     Do                           
 Requirements for Infrequent                                                                                    
 Plasmapheresis Donors                                                                                          
To All Establishments Performing Red    March 14, 1995      Do                     Do                           
 Blood Cell Immunizations: Revised                                                                              
 Recommendations for Red Blood Cell                                                                             
 Immunization Programs for Source                                                                               
 Plasma                                                                                                         
Recommendations for the Deferral of     June 8, 1995        Do                     Do                           
 Current and Recent Inmates of                                                                                  
 Correctional Institutions as Donors                                                                            
 of Whole Blood, Blood Components,                                                                              
 Source Leukocytes and Source Plasma                                                                            
Disposition of Products Derived from    August 8, 1995      Do                     Do                           
 Donors Diagnosed with, or at Known                                                                             
 High Risk for, Creutzfeldt-Jakob                                                                               
 Disease                                                                                                        
Recommendations for Labeling and Use    August 8, 1995      Do                     Do                           
 of Units of Whole Blood, Blood                                                                                 
 Components, Source Plasma, Recovered                                                                           
 Plasma or Source Leukocytes Obtained                                                                           
 from Donors with Elevated Levels of                                                                            
 Alanine Aminotransferase (ALT)                                                                                 

[[Page 9798]]

                                                                                                                
Precautionary Measures to Further       August 8, 1995      Do                     Do                           
 Reduce the Possible Risk of                                                                                    
 Transmission of Creutzfeldt-Jakob                                                                              
 Disease by Blood and Blood Products                                                                            
Recommendations for Donor Screening     August 8, 1995      Do                     Do                           
 with a Licensed Test for HIV-1                                                                                 
 Antigen                                                                                                        
Guidance Concerning Conversion to FDA-  November 13, 1995   Do                     Do                           
 Reviewed Software Products                                                                                     
Donor Deferral Due to Red Blood Cell    December 4, 1995    Do                     Do                           
 Loss During Collection of Source                                                                               
 Plasma by Automated Plasmapheresis                                                                             
Additional Recommendations for Donor    March 14, 1996      Do                     Do                           
 Screening With a Licensed Test for                                                                             
 HIV-1 Antigen                                                                                                  
Additional Recommendations for Testing  May 16, 1996        Do                     Do                           
 Whole Blood, Blood Components,                                                                                 
 SourcePlasma and Source Leucocytes                                                                             
 for Antibody to Hepatitis C Virus                                                                              
 Encoded Antigen (Anti-HCV)                                                                                     
Recommendations and Licensure           May 29, 1996        Do                     Do                           
 Requirements for Leukocyte-Reduced                                                                             
 Blood Products                                                                                                 
Recommendations for the Quarantine and  July 19, 1996       Do                     Do                           
 Disposition of Units from Prior                                                                                
 Collections from Donors with                                                                                   
 Repeatedly Reactive Screening Tests                                                                            
 for Hepatitis B Virus (HBV),                                                                                   
 Hepatitis C Virus (HCV) and Human T-                                                                           
 Lymphotropic Virus Type I (HTLV-I)                                                                             
Interim Recommendations for Deferral    December 11, 1996   Do                     Do                           
 of Donors at Increased Risk for HIV-1                                                                          
 Group O Infection                                                                                              
Revised Precautionary Measures to       December 11, 1996   Do                     Do                           
 Reduce the Possible Risk of                                                                                    
 Transmission of Creutzfeldt-Jakob                                                                              
 Disease (CJD) by Blood and Blood                                                                               
 Products                                                                                                       
Interstate Shipment of Interferon for   November 21, 1983   Do                     Do                           
 Investigational Use in Laboratory                                                                              
 Research Animals or Tests in Vitro                                                                             
Alternatives to Lot Release             July 20, 1993       Do                     Do                           
Application of Current Statutory        October 14, 1993    Do                     Do                           
 Authorities to Human Somatic Cell                                                                              
 Therapy Products and Gene Therapy                                                                              
 Products; Notice                                                                                               
Home Specimen Collection Kit Systems    February 23, 1995   Do                     Do                           
 Intended for Human Immunodeficiency                                                                            
 Virus (HIV-1 and/or HIV-2) Antibody                                                                            
 Testing; Revisions to Previous                                                                                 
 Guidance                                                                                                       
Interim Definition and Elimination of   December 8, 1995    Do                     Do                           
 Lot-by-Lot Release for Well-                                                                                   
 Characterized Therapeutic Recombinant                                                                          
 DNA-Derived and Monoclonal Antibody                                                                            
 Biotechnology Products                                                                                         
Guidance for Industry in Designing      June 24, 1996       Do                     Do                           
 Clinical Programs for Developing                                                                               
 Human Drugs, Medical Devices, or                                                                               
 Biological Products Intended for the                                                                           
 Treatment of Rheumatoid Arthritis;                                                                             
 Availability of Draft Guidance;                                                                                
 Notice of Public Workshop on Juvenile                                                                          
 Rheumatoid Arthritis                                                                                           
Draft Public Health Service Guideline   September 23, 1996  Do                     Do                           
 on Infectious Disease Issues in                                                                                
 Xenotransplantation; Notice                                                                                    
The Food and Drug Administration's      February 27, 1997   Do                     Do                           
 Development, Issuance, and Use of                                                                              
 Guidance Documents                                                                                             
Preclearance of Promotional Labeling;   March 5, 1997       Do                     Do                           
 Clarification                                                                                                  
Draft Guidance for Industry:            June 18, 1997       Do                     Do                           
 Computerized Systems Used in Clinical                                                                          
 Trials; Availability                                                                                           
Recommended Methods for Short Ragweed   November 1, 1985    Do                     Do                           
 Pollen Extracts                                                                                                
Information Relevant to the             August 23, 1989     Do                     Do                           
 Manufacture of Acellular Pertussis                                                                             
 Vaccine                                                                                                        
Recommended Methods for Blood Grouping  March 1, 1992       Do                     Do                           
 Reagents Evaluation                                                                                            
Recommended Methods for Evaluating      March 1, 1992       Do                     Do                           
 Potency, Specificity and Reactivity                                                                            
 of Anti-Human Globulin                                                                                         
Methods of the Allergenic Products      October 1, 1993     Do                     Do                           
 Testing Laboratory                                                                                             

[[Page 9799]]

                                                                                                                
Guide to Inspections of Blood Banks,    September 1, 1994   Do                     Do                           
 Division of Field Investigations,                                                                              
 Office of Regional Operations, Office                                                                          
 of Regulatory Affairs                                                                                          
Guide to Inspections of Infectious      June 1, 1996        Do                     Do                           
 Disease Marker Testing Facilities                                                                              
Guide to Inspections of Source Plasma   June 1, 1997        Do                     Do                           
 Establishments (Division of Field                                                                              
 Investigations, Office of Regional                                                                             
 Operations, Office of Regulatory                                                                               
 Affairs)                                                                                                       
Notification Process for Transfusion    October 7, 1997     Do                     Do                           
 Related Fatalities and Donation                                                                                
 Related Deaths (revised telephone                                                                              
 number)                                                                                                        
Submission Requirements for Requesting  October 15, 1997    Do                     Do                           
 Certificates for Exporting Products                                                                            
 to Foreign Countries                                                                                           
CBER Refusal to File (RTF) Guidance     July 12, 1993       Do                     Do                           
 for Product and Establishment License                                                                          
 Applications                                                                                                   
OELPS, Advertising and Promotional      August 1, 1994      Do                     Do                           
 Labeling Staff Procedural Guidance                                                                             
 Document (Draft)                                                                                               
Guidance on Alternatives to Lot         October 27, 1994    Do                     Do                           
 Release for Licensed Biological                                                                                
 Products                                                                                                       
Content and Format of Investigational   November 1, 1995    Do                     Do                           
 New Drug Applications (INDs) for                                                                               
 Phase 1 Studies of Drugs, Including                                                                            
 Well-Characterized, Therapeutic,                                                                               
 Biotechnology-derived Products                                                                                 
Computer Assisted Product License       March 1, 1996       Do                     Do                           
 Application (CAPLA) Guidance Manual                                                                            
FDA Guidance Concerning Demonstration   April 26, 1996      Do                     Do                           
 of Comparability of Human Biological                                                                           
 Products, Including Therapeutic                                                                                
 Biotechnology-Derived Products                                                                                 
Guidance for Industry--The Content and  May 23, 1996        Do                     Do                           
 Format for Pediatric Use Supplements                                                                           
Guidance on Applications for Products   May 24, 1996        Do                     Do                           
 Comprised of Living Autologous Cells                                                                           
 Manipulated Ex Vivo and Intended for                                                                           
 Structural Repair of Reconstruction                                                                            
Guidance for Industry for the           August 15, 1996     Do                     Do                           
 Submission of Chemistry,                                                                                       
 Manufacturing, and Controls                                                                                    
 Information for a Therapeutic                                                                                  
 Recombinant DNA-Derived Product or a                                                                           
 Monoclonal Antibody Product for In                                                                             
 Vivo Use                                                                                                       
Draft Guidance for Industry:            September 20, 1996  Do                     Do                           
 Manufacture, Processing or Holding of                                                                          
 Active Pharmaceutical Ingredients                                                                              
Draft Guidance for Industry;            November 4, 1996    Do                     Do                           
 Submitting Application Archival                                                                                
 Copies in Electronic Format                                                                                    
Draft Guidance for Industry;            November 4, 1996    Do                     Do                           
 Electronic Submission of Case Report                                                                           
 Forms and Case Report Tabulations                                                                              
Guidance for the Submission of          January 10, 1997    Do                     Do                           
 Chemistry, Manufacturing, and                                                                                  
 Controls Information and                                                                                       
 Establishment Description for                                                                                  
 Autologous Somatic Cell Therapy                                                                                
 Products                                                                                                       
Proposed Approach to Regulation of      February 28, 1997   Do                     Do                           
 Cellular and Tissue-Based Products                                                                             
Tables 1 and 2 from Proposed Approach    March 4, 1997      Do                     Do                           
 to Regulation of Cellular and Tissue-                                                                          
 Based Products                                                                                                 
Guidance for Industry-FDA Approval of   March 13, 1997      Do                     Do                           
 New Cancer Treatment Uses for                                                                                  
 Marketed Drug and Biological Products                                                                          
Guidance for Industry-Providing         March 13, 1997      Do                     Do                           
 Clinical Evidence of Effectiveness                                                                             
 for Human Drug and Biological                                                                                  
 Products                                                                                                       
Guidance for Industry for the           April 10, 1997      Do                     Do                           
 Evaluation of Combination Vaccines                                                                             
 for Preventable Diseases: Production,                                                                          
 Testing and Clinical Studies                                                                                   
Guidance for Industry--Changes to an    July 24, 1997       Do                     Do                           
 Approved Application: Biological                                                                               
 Products                                                                                                       
Guidance for Industry--Changes to an    July 24, 1997       Do                     Do                           
 Approved Application for Specified                                                                             
 Biotechnology and Specified Synthetic                                                                          
 Biological Products                                                                                            
Guidance for Industry--Screening and    July 29, 1997       Do                     Do                           
 Testing of Donors of Human Tissue                                                                              
 Intended for Transplantation                                                                                   

[[Page 9800]]

                                                                                                                
Guidance for Industry--Donor Screening  August 15, 1997     Do                     Do                           
 for Antibodies to HTLV-II                                                                                      
Guidance for Industry on Testing        August 25, 1997     Do                     Do                           
 Limits in Stability Protocols for                                                                              
 Standardized Grass Pollen Extracts                                                                             
Guidance for Industry - Postmarketing   August 27, 1997     Do                     Do                           
 Adverse Experience Reporting for                                                                               
 Human Drug and Licensed Biological                                                                             
 Products: Clarification of What to                                                                             
 Report                                                                                                         
Guidance for Industry Efficacy          September 1, 1997   Do                     Do                           
 Evaluation of Hemoglobin-and                                                                                   
 Perfluorocarbon-Based Oxygen Carriers                                                                          
Guidance for Industry--The Sourcing     October 7, 1997     Do                     Do                           
 and Processing of Gelatin to Reduce                                                                            
 the Potential Risk Posed by Bovine                                                                             
 Spongiform Encephalopathy (BSE) in                                                                             
 FDA-Regulated Products for Human Use                                                                           
Draft Guidance for Industry--For        December 29, 1997   Do                     Do                           
 Submission of Chemistry,                                                                                       
 Manufacturing and Controls and                                                                                 
 Establishment Description Information                                                                          
 for Human Plasma-Derived Biological                                                                            
 Products or Animal Plasma or Serum-                                                                            
 Derived Products                                                                                               
FDA's Policy Statement Concerning       November 25, 1992   Do                     Do                           
 Cooperative Manufacturing                                                                                      
 Arrangements for Licensed Biologics                                                                            
FDA Guidance Document Concerning Use    July 11, 1995       Do                     Do                           
 of Pilot Manufacturing Facilities for                                                                          
 the Development and Manufacture of                                                                             
 Biological Products; Availability                                                                              
Changes to be Reported for Product and  April 6, 1995       Do                     Do                           
 Establishment License Applications;                                                                            
 Guidance                                                                                                       
Advertising and Promotion; Guidance;    October 8, 1996     Do                     Do                           
 Notice                                                                                                         
Interpretative Guidelines of the        October 2, 1973     Do                     Do                           
 Source Plasma (Human) Standards                                                                                
Guidelines for Reviewing Amendments to  July 20, 1976       Do                     Do                           
 Include Plasmapheresis of                                                                                      
 Hemophiliacs                                                                                                   
Package Insert: Immune Serum Globulin   March 30, 1978      Do                     Do                           
 (Human)                                                                                                        
Guidelines for Interpretation of        April 12, 1979      Do                     Do                           
 Potency Test Results for All Forms of                                                                          
 Adsorbed Diphtheria and Tetanus                                                                                
 Toxoids                                                                                                        
Guidelines for Immunization of Source   June 1, 1980        Do                     Do                           
 Plasma (Human) Donors with Blood                                                                               
 Substances                                                                                                     
Collection of Human Leukocytes for      January 28, 1981    Do                     Do                           
 Further Manufacturing (Source                                                                                  
 Leukocytes)                                                                                                    
Platelet Testing Guidelines--Approval   July 1, 1981        Do                     Do                           
 of New Procedures and Equipment                                                                                
Revised Guideline for Adding Heparin    August 1, 1981      Do                     Do                           
 to Empty Containers for Collection of                                                                          
 Heparinized Source Plasma (Human)                                                                              
Guidelines for Meningococcal            July 17, 1985       Do                     Do                           
 Polysaccharide Vaccines                                                                                        
Guideline for the Uniform Labeling of   August 1, 1985      Do                     Do                           
 Blood and Blood Components                                                                                     
Guideline for Submitting Documentation  February 1, 1987    Do                     Do                           
 for the Stability of Human Drugs and                                                                           
 Biologics                                                                                                      
Guideline for Submitting Documentation  February 1, 1987    Do                     Do                           
 for Packaging for Human Drugs and                                                                              
 Biologics                                                                                                      
Guideline On General Principles of      May 1, 1987         Do                     Do                           
 Process Validation                                                                                             
Guideline On Sterile Drug Products      June 1, 1987        Do                     Do                           
 Produced by Aseptic Processing                                                                                 
Guideline On Validation of the Limulus  December 1, 1987    Do                     Do                           
 Amebocyte Lysate Test as an End-                                                                               
 Product Endotoxin Test for Human and                                                                           
 Animal Parenteral Drugs, Biological                                                                            
 Products, and Medical Devices                                                                                  
Revised Guideline for the Collection    October 7, 1988     Do                     Do                           
 of Platelets, Pheresis                                                                                         
Draft Guideline for the Design of       November 1, 1988    Do                     Do                           
 Clinical Trials for Evaluation of                                                                              
 Safety and Efficacy of Allergenic                                                                              
 Products for Therapeutic Uses                                                                                  
Guidelines for Release of Pneumococcal  February 1, 1989    Do                     Do                           
 Vaccine, Polyvalent                                                                                            
FDA Regulated Industries for Drug       September 1, 1989   Do                     Do                           
 Master Files                                                                                                   

[[Page 9801]]

                                                                                                                
FDA Regulated Industries for            October 26, 1989    Do                     Do                           
 Collection of Blood or Blood Products                                                                          
 from Donors With Positive Tests for                                                                            
 Infectious Disease Markers (``High                                                                             
 Risk'' Donors)                                                                                                 
Guideline for Determination of          January 1, 1990     Do                     Do                           
 Residual Moisture in Dried Biological                                                                          
 Products                                                                                                       
Guideline on the Preparation of         March 1, 1991       Do                     Do                           
 Investigational New Drug Products                                                                              
 (Human & Animal)                                                                                               
Draft Guideline for the Validation of   September 28, 1993  Do                     Do                           
 Blood Establishment Computer Systems                                                                           
Guideline for Adverse Experience        October 15, 1993    Do                     Do                           
 Reporting for Licensed Biological                                                                              
 Products                                                                                                       
Guideline for Quality Assurance in      July 11, 1995       Do                     Do                           
 Blood Establishments                                                                                           
To Biologic Product Manufacturers--     May 3, 1991         Do                     Do                           
 controlling materials of bovine or                                                                             
 ovine origin                                                                                                   
To Sponsors of INDs using Retroviral    September 20, 1993  Do                     Do                           
 Vectors                                                                                                        
To Manufacturers: Bovine Derived        December 17, 1993   Do                     Do                           
 Materials (BSE)                                                                                                
To Blood Establishment Computer         March 31, 1994      Do                     Do                           
 Software Manufacturers                                                                                         
To Sponsors of INDs for Human           May 23, 1994        Do                     Do                           
 Immunoglobulin Products                                                                                        
To Manufacturers of Licensed Anti-HIV   May 26, 1994        Do                     Do                           
 Test Kits                                                                                                      
To Manufacturers of Immune Globulin     December 27, 1994                                                       
 Products: Testing for Hepatitis C                                                                              
 Virus RNA Immunoglobulin                                                                                       
To Blood Establishment Computer         February 10, 1995   Do                     Do                           
 Software Manufacturers                                                                                         
To Manufacturers of Intramuscular       March 3, 1995       Do                     Do                           
 Immune Globulin Products: HCV RNA                                                                              
 testing by PCR                                                                                                 
To Manufacturers of Intramuscular       March 13, 1995      Do                     Do                           
 Immune Globulin Products: Additional                                                                           
 information regarding HCV RNA testing                                                                          
 by PCR                                                                                                         
To Health Professionals:                March 14, 1995      Do                     Do                           
 implementation of testing for HCV RNA                                                                          
 by PCR for immune globulin products                                                                            
 for intramuscular administration                                                                               
Dear Colleague: Regarding Reverse       January 4, 1996     Do                     Do                           
 Transcriptase Activity in Viral                                                                                
 Vaccines Produced in Chicken Cells                                                                             
To Manufacturers of FDA--Regulated      May 9, 1996         Do                     Do                           
 Drug/Biological/Device Products,                                                                               
 Bovine Spongiform Encephalopathy                                                                               
 (BSE)                                                                                                          
To Manufacturers: Implementation of     June 13, 1996       Do                     Do                           
 testing for Hepatitis C virus RNA by                                                                           
 polymerase chain reaction (PCR) of                                                                             
 intramuscular immune globulin                                                                                  
 preparations                                                                                                   
To Manufacturers: HIV-1 Group O         July 31, 1996       Do                     Do                           
To All Plasma Derivative Manufacturers  October 7, 1996     Do                     Do                           
 and to ABRA: Warning Statement for                                                                             
 Plasma Derivative Product Labeling                                                                             
To Biologic Product Manufacturers:      December 3, 1996    Do                     Do                           
 Revised procedures for internal                                                                                
 labeling review number assignment                                                                              
To In Vitro Diagnostic Reagent          December 6, 1985    Do                     Do                           
 Manufacturers: Guidance On the                                                                                 
 Labeling of Human Blood Derived In                                                                             
 Vitro Diagnostic Devices In Regard to                                                                          
 Labeling for HTLV-III/LAV Antibody                                                                             
 Testing                                                                                                        
PTC in the Manufacture of In Vitro      June 20, 1983       Do                     Do                           
 Monoclonal Antibody Products Subject                                                                           
 to Licensure                                                                                                   
Draft PTC in the Production and         July 28, 1983       Do                     Do                           
 Testing of Interferon Intended for                                                                             
 Investigational Use in Humans                                                                                  
 (Interferon Test Procedures)                                                                                   
Draft PTC in the Production and         April 10, 1985      Do                     Do                           
 Testing of New Drugs and Biologicals                                                                           
 Produced by Recombinant DNA                                                                                    
 Technology                                                                                                     
Draft PTC in the Manufacture and        August 8, 1989      Do                     Do                           
 Clinical Evaluation of In Vitro Tests                                                                          
 to Detect Antibodies to Human                                                                                  
 Immunodeficiency Virus Type 1 (1989)                                                                           
PTC in the Collection, Processing and   August 22, 1989     Do                     Do                           
 Testing of Ex Vivo Activated                                                                                   
 Mononuclear Leukocytes for                                                                                     
 Administration to Humans                                                                                       

[[Page 9802]]

                                                                                                                
Cytokine and Growth Factor Pre-Pivotal  April 2, 1990       Do                     Do                           
 Trial Information Package                                                                                      
PTC in the Safety Evaluation of         August 21, 1990     Do                     Do                           
 Hemoglobin-Based Oxygen Carriers                                                                               
Draft PTC in Human Somatic Cell         August 27, 1991     Do                     Do                           
 Therapy and Gene Therapy                                                                                       
PTC in the Design and Implementation    March 1, 1992       Do                     Do                           
 of Field Trials for Blood Grouping                                                                             
 Reagents and Anti-Human Globulin                                                                               
PTC in the Manufacture of In Vitro      March 1, 1992       Do                     Do                           
 Monoclonal Antibody Products for                                                                               
 Further Manufacturing into Blood                                                                               
 Grouping Reagent and Anti-Human                                                                                
 Globulin                                                                                                       
Supplement to the PTC in the            April 6, 1992       Do                     Do                           
 Production and Testing of New Drugs                                                                            
 and Biologicals Produced by                                                                                    
 Recombinant DNA Technology: Nucleic                                                                            
 Acid Characterization and Genetic                                                                              
 Stability                                                                                                      
Draft PTC in the Characterization of    July 12, 1993       Do                     Do                           
 Cell Lines Used to Produce                                                                                     
 Biologicals                                                                                                    
PTC in the Manufacture and Testing of   August 22, 1995     Do                     Do                           
 Therapeutic Products for Human Use                                                                             
 Derived from Transgenic Animals                                                                                
Draft Addendum to the PTC in Human      January 2, 1996     Do                     Do                           
 Somatic Cell and Gene Therapy                                                                                  
PTC on Plasmid DNA Vaccines for         December 22, 1996   Do                     Do                           
 Preventive Infectious Disease                                                                                  
 Indications                                                                                                    
PTC in the Manufacture and Testing of   February 28, 1997   Do                     Do                           
 Monoclonal Antibody Products for                                                                               
 Human Use                                                                                                      
Reviewer Guidance, Computer Software    April 26, 1995      FDA Personnel          Do                           
Informed Consent for Plasmapheresis/    October 1, 1995     Do                     Do                           
 Immunization                                                                                                   
Draft Reviewers' Guide: Changes in      October 1, 1995     Do                     Do                           
 Personnel                                                                                                      
Disease Associated Antibody Collection  October 1, 1995     Do                     Do                           
 Program                                                                                                        
Centerwide Policy on Issuance of and    August 20, 1996     Do                     Do                           
 Response to Clinical Hold Letters for                                                                          
 Investigational New Drug Applications                                                                          
Reviewer Guidance for a Premarket       January 13, 1997    Do                     Do                           
 Notification Submission for Blood                                                                              
 Establishment Computer Software                                                                                
----------------------------------------------------------------------------------------------------------------

III. Guidance Documents Issued by the Center for Devices and 
Radiological Health (CDRH)

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                                                    How to Obtain a Hard Copy of
                                                             Grouped by Intended       the Document (Name and   
           Name of Document              Date of Issuance     User or Regulatory    Address, Phone, FAX, E-mail,
                                                                   Activity                 or Internet)        
----------------------------------------------------------------------------------------------------------------
MDR Reporting Guidance For Breast       August 7, 1996      Office of              Division of Small            
 Implants--E1996002                                          Surveillance and       Manufacturers Assistance, 1-
                                                             Biometrics (OSB)       800-638-2041 or 301-827-0111
                                                                                    or (Fax) Facts on Demand at 
                                                                                    1-800-899-0381 or Internet  
                                                                                    at http://www.fda.gov/cdrh  
Instructions for Completing Form 3417:  March 31, 1987      OSB                    Do                           
 Medical Device Reporting Baseline                                                                              
 Report [MDR]                                                                                                   
MDR Guidance Document No. 1--IOL--      August 7, 1996      Do                     Do                           
 E1996004                                                                                                       
MDR Guidance Document No. 3--           August 9, 1996      Do                     Do                           
 Needlestick & Blood Exposure--                                                                                 
 E1996003                                                                                                       
Statistical Guidance for Clinical       January 1, 1996     Do                     Do                           
 Trials of Non Diagnostic Medical                                                                               
 Devices (Replaces Clinical Study                                                                               
 Guidance)                                                                                                      
Medical Device Reporting: An Overview   April 1996          Do                     Do                           
Instructions for Completing FDA Form    December 15, 1995   Do                     Do                           
 3500A with Coding Manual for Form                                                                              
 3500A (MEDWATCH)                                                                                               
MEDWATCH FDA Form 3500A for Use by      June 1, 1993        Do                     Do                           
 User Facilities, Distributors, and                                                                             
 Manufacturers for Mandatory Reporting                                                                          

[[Page 9803]]

                                                                                                                
Amendment to Guidance on Discretionary  March 30, 1994      Do                     Do                           
 Postmarket Surveillance on Pacemaker                                                                           
 Leads                                                                                                          
Proposed Draft Guidance to Sponsors     October 7, 1994     Do                     Do                           
 Regarding Required Postmarket                                                                                  
 Surveillance Studies of Plasma--                                                                               
 Sprayed Porous-Coated Hip Prostheses                                                                           
Required Postmarket Surveillance        July 31, 1997       Do                     Do                           
 Section 522(a) Initial Device                                                                                  
 Categories Revised                                                                                             
MDR Guidance Document: Remedial Action  July 30, 1996       Do                     Do                           
 Exemption--E1996001                                                                                            
MDR Internet List Server (listserv)     August 29, 1996     Do                     Do                           
 Instruction sheet                                                                                              
Semi-Annual Report, Form 3419 (MDR)     September 24, 1996  Do                     Do                           
Variance from Manufacturer Report       July 16, 1996       Do                     Do                           
 Number Format (MDR letter)                                                                                     
Guidance to Manufacturers on the        November 8, 1991    Do                     Do                           
 Development of Required Postmarket                                                                             
 Surveillance Study Protocols Under                                                                             
 Section 522(a)(1) of the Federal                                                                               
 Food, Drug, and Cosmetic Act                                                                                   
Medical Device Reporting for            April 1996          Do                     Do                           
 Distributors                                                                                                   
Medical Device Reporting for            March 1997          Do                     Do                           
 Manufacturers                                                                                                  
Guidance to Sponsors on the             June 9, 1993        Do                     Do                           
 Development of a Discretionary                                                                                 
 Postmarket Surveillance Study for                                                                              
 Permanent Implantable Cardiac                                                                                  
 Pacemaker Electrodes (Leads)                                                                                   
Instructions for Completing Semi-       September 24, 1996  Do                     Do                           
 Annual Report, Form 3419 (MDR)                                                                                 
Variance from Manufacturer Report       August 12, 1996     Do                     Do                           
 Number Format                                                                                                  
Variance from Manufacturer Report       July 16, 1996       Do                     Do                           
 Number Format                                                                                                  
Statistical Aspects of Submissions to   June 1, 1984        Do                     Do                           
 FDA: A Medical Device Perspective                                                                              
 (also includes as Appendix the                                                                                 
 article Observed Uses and Abuses of                                                                            
 Statistical Procedures in Medical                                                                              
 Device                                                                                                         
Investigational Device Exemptions       June 1, 1996        Office of Health and   Do                           
 [IDE] Manual (FDA 96-4159)/DSMA                             Industry Programs                                  
                                                             (OHIP), Division of                                
                                                             Small Manufacturer's                               
                                                             Assistance (DSMA)                                  
Additional Guidance for Testing         September 1, 1993   Do                     Do                           
 Immunity to Radiated Electromagnetic                                                                           
 Fields--Infant Apnea Monitor Standard                                                                          
Premarket Approval (PMA) Manual (FDA    April 1, 1993       Do                     Do                           
 93-4214)                                                                                                       
Comparison Chart: 1996 Quality System                       Do                     Do                           
 Reg vs. 1978 Good Manufacturing                                                                                
 Practices Reg vs. ANSI/ISO/ASQC Q9001                                                                          
 and ISO/DI 13485:1996 (include 126)                                                                            
Obtaining CDRH Guidance Documents       October 21, 1997    Do                     Do                           
Regulatory Requirements for Devices     August 1, 1987      Do                     Do                           
 for the Handicapped (FDA 87-4221)                                                                              
Small Business Guide to FDA (FDA 96-    January 1, 1996     Do                     Do                           
 1092)                                                                                                          
MDR Documents Access Information        May 10, 1996        Do                     Do                           
MDR Documents Access Information for    February 29, 1996   Do                     Do                           
 CDRH Electronic Docket (ED)                                                                                    
MDR Documents Access Information for    February 29, 1996   Do                     Do                           
 CDRH Facts-On-Demand (FOD)                                                                                     
MDR Documents Access Information for    May 8, 1996         Do                     Do                           
 Industry Organizations                                                                                         
MDR Documents Access Information for    May 10, 1996        Do                     Do                           
 National Technical Information                                                                                 
 Service (NTIS)                                                                                                 
MDR Documents Access Information for    February 29, 1996   Do                     Do                           
 World Wide Web (WWW)                                                                                           
Addendum to What a Mammography          July 31, 1996       OHIP/Division of       MQSA                         
 Facility Should do to Prepare for an                        Mammography Quality                                
 MQSA Inspection                                             and Radiation                                      
                                                             Programs (DMQRP)/                                  
                                                             Mammography Quality                                
                                                             Standards Act (MQSA)                               
Handbook of Selected Tissue Doses for   September 1, 1995   Do                     Do                           
 Fluoroscopic and Cineangiographic                                                                              
 Examination of the Coronary Arteries                                                                           
 (in SI Units) FDA 95-8289, (Units of                                                                           
 milliray (mmmGy) tissue                                                                                        
Policy Statements in Question and       October 7, 1997     Do                     Do                           
 Answer Format                                                                                                  

[[Page 9804]]

                                                                                                                
What a Mammography Facility Should Do   June 30, 1995       Do                     Do                           
 to Prepare for an MQSA Inspection                                                                              
Classification Names for Medical        March 1, 1995       Do                     Do                           
 Devices and In Vitro Diagnostic                                                                                
 Products (FDA Pub No. 95-4246)                                                                                 
Import of Medical Devices--A Workshop   March 1, 1993       Do                     Do                           
 Manual (FDA 93-4228)                                                                                           
Labeling--Regulatory Requirements for   September 1, 1989   Do                     Do                           
 Medical Devices (FDA 89-4203)                                                                                  
List of Current CDRH Addresses for      July 30, 1996       Do                     Do                           
 Report Submission and Ordering of                                                                              
 CDRH Forms                                                                                                     
Premarket Notification: 510(k)--        August 1, 1995      Do                     Do                           
 Regulatory Requirements for Medical                                                                            
 Devices (FDA 95-4158)                                                                                          
Procedures for Laboratory Compliance    May 1, 1986         Do                     Do                           
 Testing of Television Receivers--part                                                                          
 of TV Packet                                                                                                   
U.S. Food and Drug Administration       May 1, 1996         Do                     Do                           
 Regulation of Medical Devices--                                                                                
 Background Information for Foreign                                                                             
 Officials                                                                                                      
Instructions for Completion of Medical  July 1, 1997        Do                     Do                           
 Device Registration and Listing Forms                                                                          
 FDA 2891, 2891a and 2892                                                                                       
In Vitro Diagnostic Devices: Guidance   January 1, 1997     Do                     Do                           
 for the Preparation of 510(k)                                                                                  
 Submissions (supersedes FDA 87-4224)                                                                           
An Introduction to Medical Device       January 1, 1992     Do                     Do                           
 Regulations (FDA 92-4222)                                                                                      
Do It By Design--An Introduction to     December 1, 1996    OHIP/Division of       Do                           
 Human Factors in Medical Devices                            Device User Programs                               
                                                             and Systems Analysis                               
                                                             (DDUPSA)                                           
Good Guidance Practices Standard        October 17, 1997    Do                     .............................
 Operating Procedures Manual for the                                                                            
 Development and Use of Guidance                                                                                
 Documents in CDRH                                                                                              
Human Factors Principles for Medical    September 1, 1993   Do                     Do                           
 Device Labeling                                                                                                
Medical Device Reporting for User       April 1996          Do                     Do                           
 Facilities                                                                                                     
Write it Right                          August 1, 1993      Do                     Do                           
Human Factors Points to Consider for    January 17, 1997    Do                     Do                           
 IDE Devices                                                                                                    
Medical Devices and EMI: The FDA        January 1, 1995     Office of Compliance   Do                           
 Perspective                                                                                                    
Enforcement Policy; Recalls (Including  June 16, 1978       Do                     Do                           
 Product Corrections)--Guidelines on                                                                            
 Policy; Procedures; and Industry                                                                               
 Responsibilities                                                                                               
Sec. 300.600 Commercial Distribution    September 24, 1987  Do                     Do                           
 with Regard to Premarket Notification                                                                          
 [Section 510(k)] [CPG 7124.19]                                                                                 
Procedures for Obtaining FDA Approval   January 13, 1995                           Do                           
 to Export Unapproved Medical Devices                                                                           
The FDA Export Reform and Enhancement   October 1, 1996     Do                     Do                           
 Act of 1996/Export Certification                                                                               
FDA Regulatory Procedures Manual        May 23, 1991        Do                     Do                           
 Chapter 8-10 Warning Letters                                                                                   
A Pocket Guide to Device GMP            November 1, 1991    Do                     Do                           
 Inspections--Inspections of Medical                                                                            
 Device Manufacturers and GMP                                                                                   
 Regulation Requirements                                                                                        
Commercial Distribution/Exhibit Letter  April 10, 1992      Do                     Do                           
 (Use instead of Hile letter)                                                                                   
 (Display)                                                                                                      
Diagnostic Ultrasound Guidance Update   January 30, 1987    Office of Compliance   Do                           
                                                             (OC)/Division of                                   
                                                             Enforcement I (DOE                                 
                                                             I)                                                 
Doppler Ultrasound Guidance Update      March 7, 1986       Do                     Do                           
Manufacturers/Assemblers of Diagnostic  October 13, 1993    Do                     Do                           
 X-ray Systems: Enforcement Policy for                                                                          
 Positive-Beam Limitation (PBL)                                                                                 
 Requirements in 21 CFR 1020.31(g)                                                                              
A Guide for the Submission of           March 1, 1996       Do                     Do                           
 Abbreviated Radiation Safety Reports                                                                           
 on Cephalometric X-Ray Devices:                                                                                
 Defined as Dental Units with an                                                                                
 Attachment for Mandible Work that                                                                              
 Holds a                                                                                                        
A Guide for the Submission of           March 1, 1996       Do                     Do                           
 Abbreviated Radiation Safety Reports                                                                           
 on Image Receptor Support Devices for                                                                          
 Mammographic X-Ray Systems                                                                                     

[[Page 9805]]

                                                                                                                
A Guide for the Submission of an        March 1, 1996       Do                                                  
 Abbreviated Radiation Safety Report                                                                            
 on X-Ray Tables, Cradles, Film                                                                                 
 Changers or Cassette Holders Intended                                                                          
 for Diagnostic Use                                                                                             
All Diagnostic Ultrasound               February 24, 1986   Do                     Do                           
 Manufacturers and Importers-Exemption                                                                          
 from Reporting under 21 CFR 1002                                                                               
Clarification of Radiation Control      March 1, 1989       Do                     Do                           
 Regulations for Diagnostic X-Ray                                                                               
 Equipment (FDA 89-8221)                                                                                        
Guide for the Submission of Initial     January 1, 1982     Do                     Do                           
 Reports on Diagnostic X-Ray Systems                                                                            
 and their Major Components                                                                                     
Letter to Medical Device Industry on    May 17, 1993        Do                     Do                           
 Endoscopy and Laparoscopy Accessories                                                                          
 (Galdi)                                                                                                        
Medical Device Tracking: Questions and  August 26, 1993     Do                     Do                           
 Answers Based on the Final Rule                                                                                
Guideline for the Manufacture of In     January 10, 1994    Do                     Do                           
 Vitro Diagnostic Products                                                                                      
Retention of Records Required by 21     August 24, 1981     Do                     Do                           
 CFR 1002                                                                                                       
Letter to Manufacturers/Repackers       April 22, 1994      OC/Division of         Do                           
 Using Cotton                                                Enforcement II (DOE                                
                                                             II)                                                
Condoms: Inspection and Sampling at     April 8, 1987       Do                     Do                           
 Domestic Manufacturers and of all                                                                              
 Repackers; Sampling from all                                                                                   
 Importers (Damaska Memo to Field on 4/                                                                         
 8/87)                                                                                                          
Hazards of Volume Ventilators and       September 15, 1993  Do                     Do                           
 Heated Humidifiers                                                                                             
Compliance Guide for Laser Products     September 1, 1985   Do                     Do                           
 (FDA 86-8260)                                                                                                  
Dental Handpiece Sterilization (Dear    September 28, 1992  Do                     Do                           
 Doctor Letter)                                                                                                 
Ethylene Oxide; Ethylene Chlorohydrin;  June 23, 1978       Do                     Do                           
 and Ethylene Glycol; Proposed Maximum                                                                          
 Residue Limits and Maximum Levels of                                                                           
 Exposure                                                                                                       
GLOVES Information About Medical        September 1, 1993   Do                     Do                           
 Gloves                                                                                                         
Letter--Manufacturers, Distributors     February 23, 1994   Do                     Do                           
 and Importers of Condom Products                                                                               
 [included in Condom Packet #398]                                                                               
Letter--Manufacturers, Importers, and   February 13, 1989   Do                     Do                           
 Repackagers of Condoms for                                                                                     
 Contraception or Sexually-Transmitted                                                                          
 Disease Prevention (Holt) [included                                                                            
 in Condom Packet #398]                                                                                         
Pesticide Regulation Notice 94-4:       June 30, 1994       Do                     Do                           
 Interim Measures for the Registration                                                                          
 of Antimicrobial Products/Liquid                                                                               
 Chemical Germicides with Medical                                                                               
 Device Use Claims Under the                                                                                    
Regulatory Requirements for Medical     September 1, 1996   Do                     Do                           
 Gloves--A Workshop Manual FDA                                                                                  
 Publication No. 96-4257                                                                                        
Standard Specification for Rubber       October 28, 1983    Do                     Do                           
 Contraceptives (Condoms) [included in                                                                          
 Condom Packet #398]                                                                                            
Sterilization: Questions and Answers    January 1, 1985     Do                     Do                           
 from FDA, from Medical Device and                                                                              
 Diagnostic Industry for January,                                                                               
 1985, page 132                                                                                                 
All U.S. Condom Manufacturers,          April 7, 1987       Do                     Do                           
 Importers and Repackagers                                                                                      
Letter to Ophthalmologists about        June 27, 1997       Do                     Do                           
 Lasers for Refractive Surgery                                                                                  
Manufacturers and Initial Distributors  May 23, 1996        Do                     Do                           
 of Hemodialyzers                                                                                               
Manufacturers and Users of Lasers for   October 10, 1996    Do                     Do                           
 Refractive Surgery                                                                                             
Manufacturers of Laparoscopic Trocars,  August 23, 1996     Do                     Do                           
 used for Abdominal Access                                                                                      
Prospective Manufacturers of Barrier    October 31, 1996    Do                     Do                           
 Devices used during Oral Sex for STD                                                                           
 Protection                                                                                                     
Impact Resistant Lenses: Questions and  September 1, 1987   Do                     Do                           
 Answers (FDA 87-4002) [see shelf--#                                                                            
 460]                                                                                                           
Letter to Industry, Powered Wheelchair  May 10, 1993        Do                     Do                           
 Manufacturers from RMJohnson                                                                                   

[[Page 9806]]

                                                                                                                
Manufacturers and Initial Distributors  February 3, 1994    Do                     Do                           
 of Sharps Containers and Destroyers                                                                            
 Used by Health Care Professionals                                                                              
Guide for Preparing Product Reports     September 1, 1995   Do                     Do                           
 for Lasers and Products Containing                                                                             
 Lasers                                                                                                         
Letter--Condom Manufacturers and        April 5, 1994       Do                     Do                           
 Distributors                                                                                                   
Suggested State Regulations for         January 1, 1982     OC/Division of         Do                           
 Control of Radiation--Volume II                             Enforcement III (DOE                               
 Nonionizing Radiation--Lasers (FDA                          III)                                               
 Pub No. 83-8220)                                                                                               
Quality Assurance Guidelines for        February 1, 1991    Do                     Do                           
 Hemodialysis Devices                                                                                           
Quality Control Guide for Sunlamp       March 1, 1988       Do                     Do                           
 Products (FDA 88-8234)                                                                                         
Quality Control Practices for           May 1, 1980         Do                     Do                           
 Compliance with the Federal Mercury                                                                            
 Vapor Lamp Performance Standard                                                                                
Reporting and Compliance Guide for      October 1, 1995     Do                     Do                           
 Television Products including Product                                                                          
 Report, Supplemental Report,                                                                                   
 Radiation Safety Abbreviated Report,                                                                           
 Annual Report, Informational Guidance                                                                          
Policy on Lamp Compatibility            September 2, 1986   Do                     Do                           
 (sunlamps)                                                                                                     
Policy on Maximum Timer Interval and    August 21, 1986     Do                     Do                           
 Exposure Schedule for Sunlamp                                                                                  
 Products                                                                                                       
Policy on Warning Label Required on     June 25, 1985       Do                     Do                           
 Sunlamp Products                                                                                               
Imports Radiation-Producing Electronic  November 1, 1988    Do                     Do                           
 Products (FDA 89-8008)                                                                                         
Information Requirements for Cookbooks  October 31, 1988    Do                     Do                           
 and User and Service Manuals                                                                                   
Keeping Up With the Microwave           March 1, 1990       Do                     Do                           
 Revolution (FDA Pub No. 91-4160)                                                                               
Laser Light Show Safety--Who's          May 1, 1986         Do                     Do                           
 Responsibility (FDA 86-8262)                                                                                   
Letter to All Foreign Manufacturers     May 28, 1981        Do                     Do                           
 and Importers of Electronic Products                                                                           
 for Which Applicable FDA Performance                                                                           
 Standards Exist                                                                                                
General Principles of Software          June 9, 1997        Do                     Do                           
 Validation; Draft Guidance                                                                                     
Reporting Guide for Laser Light Shows   September 1, 1995   Do                     Do                           
 and Displays (21 CFR 1002) (FDA 88-                                                                            
 8140)                                                                                                          
Reporting Guide for Product Reports on  September 1, 1995   Do                     Do                           
 High Intensity Mercury Vapor                                                                                   
 Discharge Lamps (21 CFR 1002)                                                                                  
Revised Guide for Preparing Annual      September 1, 1995   Do                     Do                           
 Reports on Radiation Safety Testing                                                                            
 of Laser and Laser Light Show                                                                                  
 Products (replaces FDA 82-8127)                                                                                
Safety of Electrically Powered          September 18, 1996  Do                     Do                           
 Products: Letter To Medical Device                                                                             
 and Electronic Product Manufacturers                                                                           
 From Lillian Gill & BHB correction                                                                             
 memo                                                                                                           
Unsafe Patient Lead Wires and Cables    September 3, 1993   Do                     Do                           
Design Control Guidance for Medical     March 11, 1997      Do                     Do                           
 Device Manufacturers                                                                                           
Final Design Control Inspectional       March 1, 1997       Do                     Do                           
 Strategy                                                                                                       
Guide for Preparing Abbreviated         September 1, 1996   Do                     Do                           
 Reports of Microwave and RF Emitting                                                                           
 Electronic Products Intended for                                                                               
 Medical Use                                                                                                    
Guide for Preparing Annual Reports for  September 1, 1996   Do                     Do                           
 Ultrasonic Therapy Products                                                                                    
Guide for Preparing Product Reports     September 1, 1996   Do                     Do                           
 for Medical Ultrasound Products                                                                                
Guide for Preparing Product Reports     August 1, 1996      Do                     Do                           
 for Ultrasonic Therapy Products                                                                                
 (physical therapy only)                                                                                        
Application for a Variance from 21 CFR  March 1, 1987       Do                     Do                           
 1040.11(c) for a Laser Light Show,                                                                             
 Display, or Device                                                                                             
Letter to Trade Association: ReUse of   December 27, 1995   Do                     Do                           
 Single-use or Disposable Medical                                                                               
 Devices                                                                                                        
Letter: Changes in Regulations          October 27, 1995    Do                     Do                           
 Concerning Records and Reports on                                                                              
 Radiation-Emitting Electronic                                                                                  
 Products                                                                                                       

[[Page 9807]]

                                                                                                                
Medical Device Electromagnetic                              Do                     Do                           
 Interference Issues, Problem Reports,                                                                          
 Standards, and Recommendations                                                                                 
Computerized Devices/Processes          May 1, 1992         Do                     Do                           
 Guidance--Application of the Medical                                                                           
 Device GMP to Computerized Devices                                                                             
 and Manufacturing Processes                                                                                    
Keeping Medical Devices Safe from       July 1, 1995        Do                     Do                           
 Electromagnetic Interference                                                                                   
Latex Labeling Letter (Johnson)                             Do                     Do                           
Guide for Preparing Annual Reports on   September 1, 1995   Do                     Do                           
 Radiation Safety Testing of Mercury                                                                            
 Vapor Lamps (replaces FDA 82-8127)                                                                             
Guide for Preparing Annual Reports on   September 1, 1995   Do                     Do                           
 Radiation Safety Testing of Sunlamps                                                                           
 and Sunlamp Products (replaces FDA 82-                                                                         
 8127)                                                                                                          
Guide for Preparing Product Reports on  September 1, 1995   Do                     Do                           
 Sunlamps and Sunlamp Products (21 CFR                                                                          
 1002)                                                                                                          
Abbreviated Reports on Radiation        August 1, 1995      Do                     Do                           
 Safety for Microwave Products (Other                                                                           
 Than Microwave Ovens)--e.g.,                                                                                   
 Microwave Heating, Microwave                                                                                   
 Diathermy, RF Sealers, Induction,                                                                              
 Dielectric                                                                                                     
Abbreviated Reports on Radiation        August 1, 1995      Do                     Do                           
 Safety of Non-Medical Ultrasonic                                                                               
 Products                                                                                                       
Guidance for the Submission of Cabinet  February 1, 1975    Do                     Do                           
 X-Ray System Reports Pursuant to 21                                                                            
 CFR 1020.40                                                                                                    
Guide for Preparing Annual Reports on   October 1, 1987     Do                     Do                           
 Radiation Safety Testing of                                                                                    
 Electronic Products (General)                                                                                  
Guide for Preparing Initial Reports     April 1, 1989       Do                     Do                           
 and Model Change Reports on Medical                                                                            
 Ultraviolet (UV) Lamps and Products                                                                            
 Containing Such Lamps (21 CFR 1002.10                                                                          
 and 1002.12)                                                                                                   
Guide for Preparing Reports on          March 1, 1985       Do                     Do                           
 Radiation Safety of Microwave Ovens                                                                            
Guide for Submission of Information on  April 1, 1971       Do                     Do                           
 Accelerators Intended to Emit X-                                                                               
 Radiation Required Pursuant to 21 CFR                                                                          
 1002.10                                                                                                        
Guide for Submission of Information on  April 30, 1974      Do                     Do                           
 Analytical X-Ray Equipment Required                                                                            
 Pursuant to 21 CFR 1002.10                                                                                     
Guide for Submission of Information on  September 1, 1980   Do                     Do                           
 Industrial Radiofrequency Dielectric                                                                           
 Heater and Sealer Equipment Pursuant                                                                           
 to 21 CFR 1002.10 and 1002.12 (FDA 81-                                                                         
 8137)                                                                                                          
Guide for Submission of Information on  March 1, 1973       Do                     Do                           
 Industrial X-Ray Equipment Required                                                                            
 Pursuant to 21 CFR 1002.10                                                                                     
Guide for the Filing of Annual Reports  July 1, 1980        Do                     Do                           
 for X-Ray Components and Systems                                                                               
Guide for the Submission of Initial     September 1, 1984   OC/DOE I and III       Do                           
 Reports on Computed Tomography X-Ray                                                                           
 Systems                                                                                                        
Additional Information for Initial      April 9, 1993       Do                     Do                           
 Reports                                                                                                        
All Diagnostic Ultrasound               February 24, 1986   Do                     Do                           
 Manufacturers and Importers Exemption                                                                          
 from Reporting under 21 CFR 1002                                                                               
Guideline for Preparing Notices of      November 1, 1985    OC/Bioresearch         Do                           
 Availability of Investigational                             Monitoring (BIMO)                                  
 Medical Devices                                                                                                
Recommended Test Methods Infant Apnea   September 1, 1993   Office of Standards    Do                           
 Monitor Standard                                            and Technology (OST)                               
Draft Document--A Primer on Medical     February 7, 1997    Do                     Do                           
 Device Interactions with Magnetic                                                                              
 Resonance Imaging Systems                                                                                      
Letter to Medical Device Manufacturer   February 14, 1995   CDRH, Office of the    Do                           
 on Pentium Processors                                       Director (OD)                                      
``Real-Time'' Review Program for        April 22, 1997      Office of Device       Do                           
 Premarket Approval Application (PMA)                        Evaluation (ODE)                                   
 Supplements                                                                                                    
A New 510(k) Paradigm--Alternate        June 13, 1997       Do                     Do                           
 Approaches to Demonstrating                                                                                    
 Substantial Equivalence in Premarket                                                                           
 Notifications                                                                                                  
Freedom of Information/510(K) Process   May 15, 1997        Do                     Do                           
 Changes                                                                                                        

[[Page 9808]]

                                                                                                                
Reexamination of the Evaluation         May 19, 1997        Do                     Do                           
 Process for Liquid Chemical Sterilant                                                                          
 and High Level Disinfectants                                                                                   
Center for Devices and Radiological     June 30, 1993       Do                     Do                           
 Health's Investigational Device                                                                                
 Exemption (IDE) Refuse to Accept                                                                               
 Policy                                                                                                         
Center for Devices and Radiological     June 30, 1993       Do                     Do                           
 Health's Premarket Notification                                                                                
 [510(k)] Refuse to Accept Policy--                                                                             
 (updated Checklist 3/14/1995)                                                                                  
4-of-A-Kind PMA's                       October 1, 1991     Do                     Do                           
Application of the Device Good          December 1, 1983    Do                     Do                           
 Manufacturing Practice (GMP)                                                                                   
 Regulation to the Manufacture of                                                                               
 Sterile Devices                                                                                                
Biotechnology and FDA Regulation of     January 1, 1986     Do                     Do                           
 Hybridoma In-Vitro Diagnostic                                                                                  
 Products: List of Current Devices and                                                                          
 Guidelines for Manufacturers                                                                                   
CDRH's 510(k)/IDE/PMA Refuse to Accept/ June 30, 1993       Do                     Do                           
 Accept/File Policies (see #D94-1,                                                                              
 #K94-1, & #P94-1)                                                                                              
Classified Convenience Kits             April 30, 1993      Do                     Do                           
Color Additive Petitions (p. II-19 of   June 1, 1987        Do                     Do                           
 PMA Manual)                                                                                                    
Color Additive Status List (Inspection  February 1, 1989    Do                     Do                           
 Operations Manual)                                                                                             
Color Additives for Medical Devices     November 15, 1995   Do                     Do                           
 (Snesko)                                                                                                       
Deciding When to Submit a 510(k) for a  January 10, 1997    Do                     Do                           
 Change to an Existing Device [see                                                                              
 CDRH F-O-D #1935]                                                                                              
Device Specific Guidance Documents      May 11, 1993        Do                     Do                           
 (List)                                                                                                         
FDA Clinical Investigator Information   May 1, 1989         Do                     Do                           
 Sheets                                                                                                         
FDA Guide for Validation of Biological  January 1, 1986     Do                     Do                           
 Indicator Incubation Time (Source:                                                                             
 Sterilization Committee; through                                                                               
 Virginia Ross; HFZ-332)                                                                                        
FDA Policy For The Regulation Of        November 13, 1989   Do                     Do                           
 Computer Products (DRAFT) [See 2099]                                                                           
Format for IDE Progress Reports                             Do                     Do                           
Guidance for Preparation of PMA         August 1, 1992      Do                     Do                           
 Manufacturing Information                                                                                      
Guide for Establishing and Maintaining  March 1, 1988       Do                     Do                           
 a Calibration Constancy                                                                                        
 Intercomparison System for Microwave                                                                           
 Oven Compliance Survey Instruments                                                                             
 (FDA 88-8264)                                                                                                  
Guideline for the Monitoring of         January 1, 1988     ODE                    Do                           
 Clinical Investigations                                                                                        
Guideline on General Principles of      May 1, 1987         Do                     Do                           
 Process Validation                                                                                             
Guideline on Sterile Drug Products      June 1, 1987        Do                     Do                           
 Produced by Aseptic Processing                                                                                 
Guideline on Validation of the Limulus  December 1, 1987    Do                     Do                           
 Amebocyte Lysate (LAL) Test as an End-                                                                         
 Product Endotoxin Test                                                                                         
Indications for Use Statement           January 2, 1996     Do                     Do                           
Industry Representatives on Scientific  March 27, 1987      Do                     Do                           
 Panels                                                                                                         
Labeling Reusable Medical Devices for   April 1, 1996       Do                     Do                           
 Reprocessing in Health Care                                                                                    
 Facilities: FDA Reviewer Guidance                                                                              
 (see 1198)                                                                                                     
Limulus Amebocute Lysate; Reduction of  October 23, 1987    Do                     Do                           
 Samples for Testing                                                                                            
Master Files Part III; Guidance on      June 1, 1987        Do                     Do                           
 Scientific and Technical Information                                                                           
Memorandum: Electromagnetic             June 13, 1995       Do                     Do                           
 Compatibility for Medical Devices:                                                                             
 Issues and Solutions                                                                                           
Methods for Conducting Recall           June 16, 1978       Do                     Do                           
 Effectiveness Checks                                                                                           
Necessary Information for Diagnostic    November 24, 1987   Do                     Do                           
 Ultrasound 510(k) (Draft)                                                                                      
Perspectives on Clinical Studies for                        Do                     Do                           
 Medical Device Submissions                                                                                     
 (Statistical)                                                                                                  
PMA Review Schedule                     March 31, 1988      Do                     Do                           
PMA Review Statistical Checklist                            Do                     Do                           
Points to Consider in the               June 1, 1984        Do                     Do                           
 Characterization of Cell Lines Used                                                                            
 to Produce Biological Products (from                                                                           
 John C. Petricciani, M.D.)                                                                                     
Preamendment Class III Devices          March 11, 1992      Do                     Do                           

[[Page 9809]]

                                                                                                                
Premarket Notification [510(k)] Status  March 7, 1994       Do                     Do                           
 Request Form, revised                                                                                          
Premarket Submission Coversheet,        January 19, 1995    Do                     Do                           
 Instructions, and Survey                                                                                       
Preproduction Quality Assurance         September 1, 1989   Do                     Do                           
 Planning: Recommendations for Medical                                                                          
 Device Manufacturers (FDA 90-4236)                                                                             
Proposal for Establishing Mechanisms    June 30, 1993       Do                     Do                           
 for Setting Review Priorities Using                                                                            
 Risk Assessment and Allocating Review                                                                          
 Resources (include with 926-930)                                                                               
Questions and Answers for the FDA       September 3, 1996   Do                     Do                           
 Reviewer Guidance: Labeling Reusable                                                                           
 Medical Devices for Reprocessing in                                                                            
 Health Care Facilities                                                                                         
Reviewer Guidance for Computer          August 29, 1991     Do                     Do                           
 Controlled Medical Devices Undergoing                                                                          
 510(k) Review                                                                                                  
Shelf Life of Medical Devices           March 1, 1991       Do                     Do                           
Substantial Equivalence (SE) Decision   January 1, 1990     Do                     Do                           
 Making Documentation ATTACHED: ``SE''                                                                          
 Decision Making Process (Detailed)                                                                             
 i.e. the decision making tree                                                                                  
Suggested Content for Original IDE      February 27, 1996   Do                     Do                           
 Application Cover Letter--Version 4                                                                            
Suggestions for Submitting a Premarket  April 1, 1993       Do                     Do                           
 Approval (PMA) Application                                                                                     
Threshold Assessment of the Impact of   January 1, 1990     Do                     Do                           
 Requirements for Submission of PMA's                                                                           
 for 31 Medical Devices Marketed Prior                                                                          
 to May 28, 1976                                                                                                
Viable Bacteriophage in Co2 Laser                           Do                     Do                           
 Plume: Aerodynamic Size Distribution                                                                           
Drugs of Abuse Screening Test Devices   July 21, 1987       Do                     Do                           
Letter--Vascular Graft Industry         November 22, 1995   Do                     Do                           
 (Philip Phillips)                                                                                              
Letter to Industry, Powered Wheelchair/ May 26, 1994        Do                     Do                           
 Scooter or Accessory/Component                                                                                 
 Manufacturer from Susan Alpert,                                                                                
 Ph.D.,M.D.                                                                                                     
Preamendments Class III Strategy;       April 19, 1994      Do                     Do                           
 SXAlpert                                                                                                       
Draft Guidance to Firms on Biliary      August 2, 1990      ODE/Division of        Do                           
 Lithotripsy Studies                                         Reproductive,                                      
                                                             Abdominal, ENT, and                                
                                                             Radiological Devices                               
                                                             (DRAERD)                                           
Letter: Notice to Manufacturers of      September 25, 1997  Do                     Do                           
 Bone Mineral Densitometers                                                                                     
510(k) Checklist for Sterile            September 19, 1994  Do                     Do                           
 Lubricating Jelly Used With                                                                                    
 Transurethral Surgical Instruments                                                                             
CDRH Interim Regulatory Policy for      September 10, 1997  Do                     Do                           
 External Penile Rigidity Devices                                                                               
Checklist for Mechanical Lithotripters  November 1, 1994    Do                     Do                           
 and Stone Dislodgers used in                                                                                   
 Gastroenterology and Urology                                                                                   
Draft--510(k) Checklist for             November 23, 1994   Do                     Do                           
 Conditioned Response Enuresis Alarms                                                                           
Draft 510(k) Checklist for Condom       February 23, 1995   Do                     Do                           
 Catheters                                                                                                      
Draft 510(k) Checklist for Endoscopic   August 16, 1995     Do                     Do                           
 Electrosurgical Unit (ESU) and                                                                                 
 Accessories Used in Gastroenterology                                                                           
 and Urology                                                                                                    
Draft 510(k) Checklist for Endoscopic   June 22, 1995       Do                     Do                           
 Light Sources Used in                                                                                          
 Gastroenterology and Urology                                                                                   
Draft 510(k) Checklist for Non-         June 6, 1995        Do                     Do                           
 Implanted Electrical Stimulators Used                                                                          
 for the Treatment of Urinary                                                                                   
 Incontinence                                                                                                   
Draft 510(k) Checklist for Urological   August 1, 1995      Do                     Do                           
 Irrigation System and Tubing Set                                                                               
Draft Guidance for Clinical             November 11, 1994   Do                     Do                           
 Investigations of Devices Used for                                                                             
 the Treatment of Benign Prostatic                                                                              
 Hyperplasia (BPH)                                                                                              
Draft Guidance for Information on       February 5, 1992    Do                     Do                           
 Clinical Safety and Effectiveness                                                                              
 Data for Extracorporeal Shock Wave                                                                             
 Lithotripsy of Upper Urinary Tract                                                                             
 (Renal Pelvis, Renal)                                                                                          
Draft Guidance for Preclinical and      November 29, 1995   Do                     Do                           
 Clinical Investigations of Urethral                                                                            
 Bulking Agents Used in the Treatment                                                                           
 of Urinary Incontinence                                                                                        

[[Page 9810]]

                                                                                                                
Draft Guidance for Preparation of PMA   March 16, 1993      Do                     Do                           
 Applications for Penile Inflatable                                                                             
 Implants                                                                                                       
Draft Guidance for Preparation of PMA   March 16, 1993      Do                     Do                           
 Applications for Testicular                                                                                    
 Prostheses                                                                                                     
Draft Guidance for Preparation of PMA   May 1, 1995         Do                     Do                           
 Applications for the Implanted                                                                                 
 Mechanical/Hydraulic Urinary                                                                                   
 Continence Device (Artificial Urinary                                                                          
 Sphincter)                                                                                                     
Draft Guidance for the Clinical         November 2, 1995    Do                     Do                           
 Investigation of Urethral Stents                                                                               
Draft Guidance for the Content of       March 17, 1995      Do                     Do                           
 Premarket Notifications for                                                                                    
 Endoscopes used in Gastroenterology                                                                            
 and Urology                                                                                                    
Draft Guidance for the Content of       May 30, 1995        Do                     Do                           
 Premarket Notifications for Penile                                                                             
 Rigidity Implants                                                                                              
Draft Guidance for the Content of       January 24, 1992    Do                     Do                           
 Premarket Notifications for                                                                                    
 Urological Balloon Dilatation                                                                                  
 Catheters                                                                                                      
Draft Guidance Outline--Points to       November 30, 1993   Do                     Do                           
 Consider for Clinical Studies for                                                                              
 Vasovasostomy Devices                                                                                          
Guidance for the Content of Premarket   February 10, 1993   Do                     Do                           
 Notifications for Biopsy Devices Used                                                                          
 in Gastroenterology and Urology                                                                                
Guidance for the Content of Premarket   September 12, 1994  Do                     Do                           
 Notifications for Conventional and                                                                             
 Antimicrobial Foley Catheters                                                                                  
Guidance for the Content of Premarket   February 10, 1993   Do                     Do                           
 Notifications for Ureteral Stents                                                                              
Guidance for the Content of Premarket   June 7, 1994        Do                     Do                           
 Notifications for Urine Drainage Bags                                                                          
Guidance for the Content of Premarket   July 29, 1994       Do                     Do                           
 Notifications for Urodynamic/                                                                                  
 Uroflowmetry Systems                                                                                           
Guidance to Manufacturers on the                            Do                     Do                           
 Development of Required Postapproval                                                                           
 Epidemiologic Study Protocols for                                                                              
 Testicular Implants                                                                                            
510(k) Guide for Measuring and          December 1, 1985    Do                     Do                           
 Reporting Acoustic Output of                                                                                   
 Diagnostic Ultrasound Medical Devices                                                                          
Draft Guidance for Review of Bone       November 9, 1992    Do                     Do                           
 Densitometer 510(k) Submissions                                                                                
Draft MRI Guidance Update for dB/dt     October 11, 1995    Do                     Do                           
 [update, include with 8/2/88                                                                                   
 document]                                                                                                      
Guidance for Magnetic Resonance         September 29, 1997  Do                     Do                           
 Diagnostic Devices--Criteria for                                                                               
 Significant Risk Investigations                                                                                
Guidance for the Comment and Review of  August 1, 1993      Do                     Do                           
 510(k) Notifications for Picture                                                                               
 Archiving and Communications Systems                                                                           
 (PACS) and Related Devices [See 2099]                                                                          
Guidance for the Submission of 510(k)s  June 1, 1997        Do                     Do                           
 for Solid State X-Ray Imaging Devices                                                                          
Information for Manufacturers Seeking   April 11, 1997      Do                     Do                           
 Marketing Clearance of Diagnostic                                                                              
 Ultrasound Systems and Transducers                                                                             
Information for Manufacturers Seeking   June 19, 1996       Do                     Do                           
 Marketing Clearance of Digital                                                                                 
 Mammography Systems                                                                                            
Reviewer Guidance for Automatic X-Ray   February 1, 1990    Do                     Do                           
 Film Processor 510(k)                                                                                          
Simplified 510(k) procedures for        1994                Do                     Do                           
 certain radiology devices:3 letters                                                                            
 12/21/93; 1/31/94 and 3/31/94                                                                                  
ORDB 510(k) Sterility Review Guidance   July 3, 1997        Do                     Do                           
Condom Packet: 4/13/94 RJRivera         April 13, 1994      Do                     Do                           
 Letter, Condom Guidance & 7 Tabs,                                                                              
 General Guidance for Modifying Condom                                                                          
 Labeling to Include Shelf Life                                                                                 
Draft Guidance for the Content of       July 29, 1991       Do                     Do                           
 Premarket Notifications for Loop and                                                                           
 Rollerball Electrodes for GYN                                                                                  
 Electrosurgical Excisions                                                                                      
Draft Guidance for the Content of       May 25, 1995        Do                     Do                           
 Premarket Notifications for Menstrual                                                                          
 Tampons                                                                                                        
Draft Thermal Endometrial Ablation      March 14, 1996      Do                     Do                           
 Devices (Submission Guidance for an                                                                            
 IDE)                                                                                                           
Guidance (``Guidelines'') for           March 8, 1977       Do                     Do                           
 Evaluation of Fetal Clip Electrode                                                                             

[[Page 9811]]

                                                                                                                
Guidance (``Guidelines'') for           May 10, 1978        Do                     Do                           
 Evaluation of Hysteroscopic                                                                                    
 Sterilization Devices                                                                                          
Guidance (``Guidelines'') for                               Do                     Do                           
 Evaluation of Laparoscopic Bipolar                                                                             
 and Thermal Coagulators (and                                                                                   
 Accessories)                                                                                                   
Guidance (``Guidelines'') for           November 22, 1977   Do                     Do                           
 Evaluation of Tubal Occlusion Devices                                                                          
Guidelines for Evaluation of Non-Drug   September 28, 1976  Do                     Do                           
 IUD's                                                                                                          
Hysteroscopes and Gynecology            March 27, 1996      Do                     Do                           
 Laparoscopes--Submission Guidance for                                                                          
 a 510(k)--includes 00192                                                                                       
Hysteroscopes and Laparoscopic          August 1, 1995      Do                     Do                           
 Insufflators: Submission Guidance for                                                                          
 a 510(k)                                                                                                       
In-vivo Devices for the Detection of    June 14, 1997       Do                     Do                           
 Cervical Cancer and its Precursors:                                                                            
 Submission Guidance for an IDE Draft                                                                           
 Document                                                                                                       
Intrapartum Continuous Monitors for     June 14, 1997       Do                     Do                           
 Fetal Oxygen Saturation and Fetal pH;                                                                          
 Submission Guidance for a PMA; Draft                                                                           
 Document                                                                                                       
Premarket Testing Guidelines for        November 20, 1992   Do                     Do                           
 Falloposcopes                                                                                                  
510(k) Diagnostic Ultrasound Guidance4/ February 1993       Do                     Do                           
 91 Use of Medical Index in Place of                                                                            
 Spatial Peak Intensity in Determining                                                                          
 Substantial Equival for Diagnostic                                                                             
 Ultrasound Equip/Access/Rel Meas. Dev                                                                          
Premarket Testing Guidelines for        April 4, 1990       Do                     Do                           
 Female Barrier Contraceptive Devices                                                                           
 also intended to prevent sexually                                                                              
 transmitted diseases                                                                                           
Premarket Testing Guidelines for Home   March 31, 1993      Do                     Do                           
 Uterine Activity Monitors                                                                                      
Testing guidance for Male Condoms Made  June 29, 1995       Do                     Do                           
 from New Material (Non-Latex)                                                                                  
Information for a Latex Condom 510K     March 1994          Do                     Do                           
 Subm. for Obstetrics-Gynecology                                                                                
 Branch (draft)                                                                                                 
Guidance for Content and Review of a    October 11, 1995    Do                     Do                           
 Magnetic Resonance Diagnostic Device                                                                           
 510(k) Applic.                                                                                                 
Draft Guidance for Hemodialyzer Reuse   October 6, 1995     Do                     Do                           
 Labeling                                                                                                       
Draft Guidance for the Content of       May 30, 1997        Do                     Do                           
 Premarket Notifications for Water                                                                              
 Purification Components and Systems                                                                            
 for Hemodialysis                                                                                               
Guidelines for Premarket Testing of     March 1, 1982       Do                     Do                           
 New Conventional Hemodialyzers, High                                                                           
 Permeability Hemodialyzers, and                                                                                
 Hemofilters                                                                                                    
Draft of Suggested Information for      January 1, 1991     Do                     Do                           
 Reporting Extracorporeal Shock Wave                                                                            
 Lithotripsy Device Shock Wave                                                                                  
 Measurements                                                                                                   
Draft Guidance to Hearing Aid           August 5, 1994      Do                     Do                           
 Manufacturers for Substantiation of                                                                            
 Claims                                                                                                         
Guidance for Submission of a 510(k)     April 1, 1991       Do                     Do                           
 Premarket Notification for an Air                                                                              
 Conduction Hearing Aid                                                                                         
Guidance For The Arrangement and        May 1, 1990         Do                     Do                           
 Content of a Premarket Approval (PMA)                                                                          
 Application For A Cochlear Implant in                                                                          
 Children Ages 2 through to 17 Years                                                                            
Guidance for the Content of Premarket   October 21, 1996    Do                     Do                           
 Notification for Disposable, Sterile,                                                                          
 Ear, Nose and Throat Endoscope                                                                                 
 Sheaths with Protective Barrier                                                                                
 Claims                                                                                                         
Guideline for the Arrangement and       May 1, 1990         Do                     Do                           
 Content of a Premarket Approval (PMA)                                                                          
 Application for a Cochlear Implant in                                                                          
 Adults at Least 18 Years of Age                                                                                
Guidance for the Technical Content of   April 1, 1990       Do                     Do                           
 a Premarket Approval (PMA)                                                                                     
 Application for an Endolymphatic                                                                               
 Shunt Tube with Valve                                                                                          
Amendment 1: Draft Premarket            June 28, 1994       ODE/Division of        Do                           
 Notification [510(k)] Guidance                              Opthalmics Devices                                 
 Document for Class II Daily Wear                            (DOD)                                              
 Contact Lenses                                                                                                 
Certification Statement for the Impact  ..................  Do                     Do                           
 Resistance Test                                                                                                
Draft Premarket Notification 510(k)     May 1, 1997         Do                     Do                           
 Guidance for Contact Lens Care                                                                                 
 Products                                                                                                       

[[Page 9812]]

                                                                                                                
Eye Valve Implant (and all glaucoma     November 16, 1995   Do                     Do                           
 drainage devices) manufacturers                                                                                
 letter from NCBrogdon                                                                                          
FDA Public Health Advisory: Retinal     October 16, 1995    Do                     Do                           
 Photic Injuries from Operating                                                                                 
 Microscopes During Cataract Surgery                                                                            
New FDA Recommendations & Results of    May 30, 1989        Do                     Do                           
 Contact Lens Study (7 day letter)                                                                              
Sunglass Letter including 510(k)        October 8, 1996     Do                     Do                           
 format                                                                                                         
Sunglass Package                        February 3, 1995    Do                     Do                           
Third Party Review Guidance for         January 31, 1997    Do                     Do                           
 Aspiration and Cutting Device                                                                                  
 Premarket Notification (510(k))                                                                                
Third Party Review Guidance for         January 31, 1997    Do                     Do                           
 Phacofragmentation System Device                                                                               
 Premarket Notification (510(k))                                                                                
Announcement by Dr Alpert at 7/26/96    August 26, 1996     Do                     Do                           
 Ophthalmic Panel Meeting concerning                                                                            
 Manufacturers & Users of Lasers for                                                                            
 Refractive Surgery [excimer]                                                                                   
Announcement: Information for           September 22, 1997  Do                     Do                           
 Manufacturers & Users of Lasers for                                                                            
 Refractive Surgery [excimer]                                                                                   
Checklist of Information Usually        October 10, 1996    Do                     Do                           
 Submitted in an Investigational                                                                                
 Device Exemptions (IDE) Application                                                                            
 for Refractive Surgery Lasers                                                                                  
 [excimer]                                                                                                      
Discussion Points for Expansion of the  September 5, 1997   Do                     Do                           
 ``Checklist of Information Usually                                                                             
 Submitted in an Investigational                                                                                
 Device Exemption (IDE) Application                                                                             
 for Refractive Surgery Lasers''                                                                                
Letter to Manufacturers and Users of    October 10, 1996    Do                     Do                           
 Lasers for Refractive Surgery                                                                                  
 [excimer]                                                                                                      
Owners Certification of Lasers as PMA   September 26, 1996  Do                     Do                           
 Approved Devices [excimer]                                                                                     
Update on Excimer Lasers for            May 20, 1996        Do                     Do                           
 Nearsightedness                                                                                                
Draft Version Guidance for Clinical     August 20, 1992     ODE/Division of        Do                           
 Data to be Submitted for Premarket                          General and                                        
 Approval Application for Cranial                            Restorative Devices                                
 Electrotherapy Stimulators                                  (DGRD)                                             
Guidance for the Preparation of         August 30, 1994     Do                     Do                           
 Premarket Notifications for Extended                                                                           
 Laparoscopy Devices                                                                                            
510K Sterility Review Guidance          July 3, 1997        Do                     Do                           
Technological Reporting for Powered     January 1, 1992     Do                     Do                           
 Muscle Stimulator 510k Submissions                                                                             
Draft Version Guide for Cortical        August 10, 1992     Do                     Do                           
 Electrode 510(k) Content                                                                                       
Electrical Muscle Stimulator (EMS)      July 11, 1985       Do                     Do                           
 Labeling Indications,                                                                                          
 Contraindications, Warnings, etc.                                                                              
Galvanic Skin Response Measurement      August 23, 1994     Do                     Do                           
 Devices--Draft Guidance for 510 (k)                                                                            
 Content                                                                                                        
Guidance Document for the Preparation   July 26, 1995       Do                     Do                           
 for Premarket Notification (510(k))                                                                            
 Applications for Therapeutic                                                                                   
 Massagers and Vibrators                                                                                        
Guidance Document for the Preparation   August 12, 1988     Do                     Do                           
 of IDE and PMA Applications for Bone                                                                           
 Growth Stimulator Devices                                                                                      
Guidance Document for the Preparation   February 18, 1993   Do                     Do                           
 of IDE and PMA Applications for Intra-                                                                         
 Articular Prosthetic Knee Ligament                                                                             
 Devices                                                                                                        
Guidance Document for the Preparation   July 26, 1995       Do                     Do                           
 of Notification (510(k)) Applications                                                                          
 for Communication Systems (Powered                                                                             
 and Nonpowered) and Powered                                                                                    
 Environmental Control                                                                                          
Guidance Document for the Preparation   July 26, 1995       Do                     Do                           
 of Notification (510(k)) Applications                                                                          
 for Electromyograph Needle Electrodes                                                                          
Guidance Document for the Preparation   July 26, 1995       Do                     Do                           
 of Notification (510(k)) Applications                                                                          
 for Heating and Cooling Devices                                                                                
Guidance Document for the Preparation   July 26, 1995       Do                     Do                           
 of Notification (510(k)) Applications                                                                          
 for Powered Muscle Stimulators and                                                                             
 Ultrasound Diathermy and Muscle                                                                                
 Stimulator                                                                                                     

[[Page 9813]]

                                                                                                                
Guidance Document for the Preparation   July 26, 1995       Do                     Do                           
 of Notification (510(k)) Applications                                                                          
 for Powered Tables and Multi-function                                                                          
 Physical Therapy Tables                                                                                        
Guidance Document for the Preparation   July 26, 1995       Do                     Do                           
 of Notification (510(k)) Applications                                                                          
 for Submerged (underwater) Exercise                                                                            
 Equipment                                                                                                      
Guidance Document for the Preparation   July 26, 1995       Do                     Do                           
 of Notification (510(k)) Applications                                                                          
 of Immersion Hydrobaths                                                                                        
Guidance Document for the Preparation   July 26, 1995       Do                     Do                           
 of Premarket Notification (510(k))                                                                             
 Application for Beds                                                                                           
Guidance Document for the Preparation   July 26, 1995       Do                     Do                           
 of Premarket Notification [510k)]                                                                              
 Applications for Mechanical and                                                                                
 Powered Wheelchairs, and Motorized                                                                             
 Three-Wheeled Vehicles                                                                                         
Guidance for Studies for Pain Therapy   May 12, 1988        Do                     Do                           
 Devices--Gen. Consid. in the Design                                                                            
 of Clinical Studies for Pain-                                                                                  
 Alleviating Devices                                                                                            
Guide for TENS 510(k) Content (Draft)   August 1, 1994      Do                     Do                           
Alternate Suture Labeling Resulting                         Do                     Do                           
 from the January 11, 1993 Meeting                                                                              
 with HIMA                                                                                                      
Draft Guidance for Preparation of PMA   January 18, 1995    Do                     Do                           
 Applications for Silicone Inflatable                                                                           
 (Saline) Breast Prostheses                                                                                     
Draft Guidance for Preparation of PMA   May 11, 1992        Do                     Do                           
 Submissions of Silicone Gel-Filled                                                                             
 Breast Prosthesis                                                                                              
Draft Guidance for Testing of           September 1, 1994   Do                     Do                           
 Alternative Breast Prostheses                                                                                  
 (Nonsilicone Gel-filled)                                                                                       
Draft Guidance for the Preparation of   March 31, 1995      Do                     Do                           
 a Premarket Notification for a Non-                                                                            
 Interactive Wound and Burn Dressing                                                                            
 [510(k)]                                                                                                       
Draft Guidance for the Preparation of   April 1, 1995       Do                     Do                           
 IDE Submission for Interactive Wound                                                                           
 and Burn Dressing                                                                                              
Guide for 510(k) Review of Processed    June 26, 1990       Do                     Do                           
 Human Dura Mater                                                                                               
Letter: Core Study for Silicone Breast  January 11, 1996    Do                     Do                           
 Implants                                                                                                       
510(k) Information Needed for           February 20, 1997   Do                     Do                           
 Hydroxyapatite Coated Orthopedic                                                                               
 Implants                                                                                                       
Draft Guidance for Preparation of FDA   May 11, 1992        Do                     Do                           
 Submissions of Silicone Gel-Filled                                                                             
 Breast Prosthesis                                                                                              
Calcium Phosphate (Ca-P) Coating Draft  February 21, 1997   Do                     Do                           
 Guidance for Preparation of FDA                                                                                
 Submissions for Orthopedic and Dental                                                                          
 Endosseous Implants                                                                                            
Draft Data Requirements for Ultrahigh   March 28, 1995      Do                     Do                           
 Molecular Weight Polyethylene                                                                                  
 (Uhmupe) Used in Orthopedic Devices                                                                            
Draft Guidance Document for Femoral     August 1, 1995      Do                     Do                           
 Stem Prostheses                                                                                                
Draft Guidance Document for Testing     May 1, 1995         Do                     Do                           
 Acetabular Cup Prostheses                                                                                      
Draft Guidance Document for the         September 5, 1996   Do                     Do                           
 Preparation of Premarket Notification                                                                          
 [510(k)] Applications for Orthopedic                                                                           
 Devices-The Basic Elements                                                                                     
Draft Guidance for the Preparation of   April 1, 1993       Do                     Do                           
 Premarket Notifications [510(k)]s for                                                                          
 Cemented, Semi-Constrained Total Knee                                                                          
 Prostheses                                                                                                     
Draft Guideline for Reviewing Spinal    January 9, 1997     Do                     Do                           
 Fixation Device Systems                                                                                        
Draft of Guidance Document for Testing  October 25, 1995    Do                     Do                           
 of Orthopedic Implants with Metallic                                                                           
 Plasma Sprayed Porous Coatings                                                                                 
 Subject to Required Post Market                                                                                
 Surveillance                                                                                                   
Draft Outline for a Guidance Document   November 1, 1993    Do                     Do                           
 for Testing Orthopedic Bone Cement,                                                                            
 request for comments by December 10,                                                                           
 1993                                                                                                           
Guidance Document for Testing           April 20, 1996      Do                     Do                           
 Biodegradable Polymer Implant Devices                                                                          
Guidance Document for Testing Bone      April 20, 1996      Do                     Do                           
 Anchor Devices Draft                                                                                           

[[Page 9814]]

                                                                                                                
Guidance Document for Testing Non-      May 1, 1995         Do                     Do                           
 Articulating ``Mechanically Locked''                                                                           
 Modular Implant Components                                                                                     
Guidance Document for Testing           April 28, 1994      Do                     Do                           
 Orthopedic Implants with Modified                                                                              
 Metallic Surfaces Apposing Bone Or                                                                             
 Bone Cement                                                                                                    
Guidance Document For The Preparation   January 10, 1995    Do                     Do                           
 of Premarket Notification For Ceramic                                                                          
 Ball Hip Systems                                                                                               
510(k) Sterility Review Guidance        July 3, 1997        Do                     Do                           
Reviewers Guidance Checklist for        February 21, 1997   Do                     Do                           
 Intramedullary Rods                                                                                            
Reviewers Guidance Checklist for        February 21, 1997   Do                     Do                           
 Orthopedic External Fixation Devices                                                                           
Draft 510(k) Guideline for General      May 10, 1995        Do                     Do                           
 Surgical Electrosurgical Devices                                                                               
Draft Guidance for Arthroscopes and     May 1, 1994         Do                     Do                           
 Accessory 510(k)s                                                                                              
Draft Premarket Notification Review     June 1, 1994        Do                     Do                           
 Guidance for Evoked Response                                                                                   
 Somatosensory Stimulators                                                                                      
Draft Version 1--Biofeedback Devices--  August 1, 1994      Do                     Do                           
 Draft Guidance for 510(k) Content                                                                              
Draft Version Cranial Perforator        July 13, 1994       Do                     Do                           
 Guidance                                                                                                       
Draft Version Neuro Endoscope Guidance  July 7, 1994        Do                     Do                           
Guidance on the Content and             June 1, 1995        Do                     Do                           
 Organization of a Premarket                                                                                    
 Notification for a Medical Laser                                                                               
Guidelines for Reviewing Premarket                          Do                     Do                           
 Notifications that Claim Substantial                                                                           
 Equivalence to Evoked Response                                                                                 
 Stimulators                                                                                                    
Review of ``YAG'' Lasers for                                Do                     Do                           
 Neurosurgery                                                                                                   
Draft Version--Guidance on              September 12, 1994  Do                     Do                           
 Biocomatibility Requirements for Long                                                                          
 Term Neurological Implants: Part 3--                                                                           
 Implant Model                                                                                                  
Protocol for Dermal Toxicity for                            Do                     Do                           
 Devices in Contact with Skin (Draft)                                                                           
Addendum to Guidance on the Content     March 9, 1994       ODE/Division of        Do                           
 and Format of Premarket Notification                        Dental Infection                                   
 [510(k)] Submissions for General                            Control and General                                
 Purpose Disinfectants                                       Hospital Devices                                   
                                                             (DDIGD)                                            
Guidance on Premarket Notification      August 1, 1993      Do                     Do                           
 [510(k)] Submissions for Automated                                                                             
 Endoscope Washers, Washer/                                                                                     
 Disinfectors, and Disinfectors                                                                                 
 Intended for Use in Health Care                                                                                
 Facilities                                                                                                     
Guidance on Premarket Notification      August 1, 1993      Do                     Do                           
 [510(k)] Submissions for Surgical                                                                              
 Gowns and Surgical Drapes                                                                                      
Guidance on the Content and Format of   December 6, 1996    Do                     Do                           
 Premarket Notification 510(k)                                                                                  
 Submissions for Liquid Chemical                                                                                
 Germicides                                                                                                     
Guidance on the Content and Format of   October 1, 1993     Do                     Do                           
 Premarket Notification [510(k)]                                                                                
 Submissions for General Purpose                                                                                
 Disinfectants                                                                                                  
Guidance on the Content and Format of   October 1, 1993     Do                     Do                           
 Premarket Notification [510(k)]                                                                                
 Submissions for Sharps Containers                                                                              
Draft Supplementary Guidance on the     March 1, 1995       Do                     Do                           
 Content of Premarket Notification                                                                              
 [510(k)] Submissions for Medical                                                                               
 Devices with Sharps Injury Prevention                                                                          
 Features (Anti-stick)                                                                                          
Guidance on 510(k) Submissions for      October 1, 1990     Do                     Do                           
 Implanted Infusion Ports                                                                                       
Guidance on Premarket Notification      March 16, 1995      Do                     Do                           
 [510(K)] Submissions for Short-Term                                                                            
 and Long-Term Intravascular Catheters                                                                          
Guidance on the Content of Premarket    March 1, 1993       Do                     Do                           
 Notification [510(K)] Submissions for                                                                          
 Clinical Electronic Thermometers                                                                               
Guidance on the Content of Premarket    March 1, 1993       Do                     Do                           
 Notification [510(k)] Submissions for                                                                          
 External Infusion Pumps                                                                                        
Guidance on the Content of Premarket    April 1, 1993       Do                     Do                           
 Notification [510(K)] Submissions for                                                                          
 Hypodermic Single Lumen Needles                                                                                

[[Page 9815]]

                                                                                                                
Guidance on the Content of Premarket    April 1, 1993       Do                     Do                           
 Notification [510(K)] Submissions for                                                                          
 Piston Syringes                                                                                                
510(k) Guidance for Screw Type          August 11, 1992     Do                     Do                           
 Endosseous Implants for Prosthetic                                                                             
 Attachment                                                                                                     
510(k) Information Needed for           July 6, 1993        Do                     Do                           
 Hydroxyapatite Coated Titanium                                                                                 
 Endosseous Implants                                                                                            
510(k) Information Needed for           August 12, 1993     Do                     Do                           
 Metallurgical Endosseous Implants                                                                              
510(k) Information Needed for Ti-       July 13, 1993       Do                     Do                           
 Powder Coated Titanium Endosseous                                                                              
 Implants                                                                                                       
Draft Guidance Document for the         March 3, 1997       Do                     Do                           
 Preparation of Premarket Notification                                                                          
 [510(k)'S] for Dental Alloys                                                                                   
Guidance Document for the Preparation   January 23, 1995    Do                     Do                           
 of Premarket Notifications (510(k)'s)                                                                          
 for Temporomandibular Joint Implants                                                                           
Guidance For The Arrangement and        May 16, 1989        Do                     Do                           
 Content of a Premarket Approval (PMA)                                                                          
 Application For An Endosseous Implant                                                                          
 For Prosthetic Attachment                                                                                      
Guidance for the Preparation of                             Do                     Do                           
 Premarket Notification [510(k)] for                                                                            
 Resorbable Periodontal Barriers                                                                                
Information Necessary for Premarket     December 9, 1996    Do                     Do                           
 Notification Submissions For Screw-                                                                            
 Type Endosseous Implants                                                                                       
Outline of Recommended Procedures for                       Do                     Do                           
 a Clinical Investigation of                                                                                    
 Endosseous Implants Under a 510(k)                                                                             
Outline of Recommended Procedures for                       Do                     Do                           
 Animal Laboratory Studies of                                                                                   
 Endosseous Implants                                                                                            
Recommendations of the Dental Products                      Do                     Do                           
 Panel Subcommittee on Dental Lasers                                                                            
Guidance Document on Dental Handpieces  July 1, 1995        Do                     Do                           
Groups Capable of Testing for Latex     July 28, 1997                                                           
 Skin Sensitization (Addendum to #994)                                                                          
Draft Percutaneous Transluminal         February 7, 1995    ODE/Division of        Do                           
 Coronary Angioplasty Package Insert                         Cardiovascular,                                    
 Template                                                    Respiratory and                                    
                                                             Neurological Devices                               
                                                             (DCRND)                                            
Medical Device Labeling--Suggested      April 25, 1997      Do                     Do                           
 Format and Content; Draft Document                                                                             
Guidance for Off-the-Shelf Software     June 4, 1997        Do                     Do                           
 Use in Medical Devices; Draft                                                                                  
 Document                                                                                                       
Carotid Stent--Suggestions for Content  October 26, 1996    Do                     Do                           
 of Submissions to the Food and Drug                                                                            
 Administration in Support of                                                                                   
 Investigational Devices Exemption                                                                              
 (IDE) Applications                                                                                             
Non-Invasive Blood Pressure (NIBP)      March 10, 1997      Do                     Do                           
 Monitor Guidance                                                                                               
Draft Guidance for the Content of       August 22, 1995     Do                     Do                           
 Preliminary Investigational Device                                                                             
 Exemptions (Pre-IDE) Presentations:                                                                            
 Teleconferences, Meetings and Written                                                                          
 Submissions                                                                                                    
Electrocardiograph (ECG) Electrode--    February 11, 1997   Do                     Do                           
 Version 1.0 Electrocardiograph (ECG)                                                                           
 Lead Switching Adapter--Version 1.0                                                                            
Electrocardiograph (ECG) Surface        February 11, 1997   Do                     Do                           
 Electrode Tester--Version 1.0                                                                                  
Guidance for the Preparation and        December 4, 1987    Do                     Do                           
 Content of Applications to the Food                                                                            
 and Drug Administration for                                                                                    
 Ventricular Assist Devices and Total                                                                           
 Artificial Hearts (draft)                                                                                      
Guidance for the Submission of 510(k)                       Do                     Do                           
 Premarket Notifications for                                                                                    
 Cardiovascular Intravascular Filters                                                                           
Preliminary Guidance for Ambulatory     September 1, 1994   Do                     Do                           
 Electrocardiograph for Data to be                                                                              
 Submitted to FDA in Support of                                                                                 
 Premarket Notification Applications                                                                            
Preliminary Guidance for Data to be     December 1, 1994    Do                     Do                           
 Submitted in Support of Premarket                                                                              
 Notifications for Analyzing ECGs/                                                                              
 Interpretive ECGs                                                                                              

[[Page 9816]]

                                                                                                                
Preliminary Guidance for Data to be     April 25, 1994      Do                     Do                           
 Submitted to the FDA in Support of                                                                             
 Premarket Notification Applications                                                                            
 for External Cardioverters and                                                                                 
 Defibrillators                                                                                                 
Reviewer Checklist for Monitors: EMC,   January 24, 1996    Do                     Do                           
 Battery and Software                                                                                           
510(k) Reviewer Guidelines--                                Do                     Do                           
 Tracheostomy Tubes 868.5800                                                                                    
Automated Defibrillators: Operator's    August 8, 1991      Do                     Do                           
 Shift Checklist and Manual                                                                                     
 Defibrillators: Operator's Shift                                                                               
 Checklist                                                                                                      
Balloon Valvuloplasty Guidance For The  January 1, 1989     Do                     Do                           
 Submission Of an IDE Application and                                                                           
 a PMA Application                                                                                              
Battery Guidance (Draft) (Albert        July 12, 1993       Do                     Do                           
 Moyal)                                                                                                         
Catheter Guidance                       May 15, 1991        Do                     Do                           
Coronary and Cerebrovascular Guidewire  January 1, 1995     Do                     Do                           
 Guidance                                                                                                       
DCRND--Draft Guidance for Format and    July 19, 1995       Do                     Do                           
 Content for Premarket Notification                                                                             
 510(k) [replaces 908]                                                                                          
 [cardiovascular, respiratory,                                                                                  
 neurological]                                                                                                  
Determining Equivalence of Intraaortic  January 24, 1989    Do                     Do                           
 Balloon Catheters Under the 510(k)                                                                             
 Regulations                                                                                                    
Draft 510(K) Submission Requirements    January 13, 1994    Do                     Do                           
 for Peak Flow Meters                                                                                           
Draft Emergency Resuscitator Guidance   April 14, 1993      Do                     Do                           
Draft Guidance for Implantable          June 19, 1996       Do                     Do                           
 Cardioverter-Defibrillators                                                                                    
Draft Guidance for the Preparation of   August 1, 1993      Do                     Do                           
 Research and Marketing Applications                                                                            
 for Vascular Graft Prostheses                                                                                  
Draft Guidance for the Submission of    May 1, 1995         Do                     Do                           
 Research and Marketing Applications                                                                            
 for Interventional Cardiology                                                                                  
 Devices: PTCA Catheters, Atherectomy                                                                           
 Catheters, Lasers, Intravascular                                                                               
Draft Guidance: Human Heart Valve       June 21, 1991       Do                     Do                           
 Allografts                                                                                                     
Draft Premarket Notification Review     June 1, 1994        Do                     Do                           
 Guidance for Evoked Response                                                                                   
 Somatosensory Stimulators                                                                                      
Draft Replacement Heart Valve Guidance  October 14, 1994    Do                     Do                           
Draft Reviewer Guidance for             July 1, 1995        Do                     Do                           
 Ventilators                                                                                                    
Draft Reviewer Guidance on Face Masks   March 16, 1996      Do                     Do                           
 and Shield for CPR                                                                                             
Draft Version--Guidance on              September 12, 1994  Do                     Do                           
 Biocompatibility Requirements for                                                                              
 Long Term Neurological Implants: Part                                                                          
 3--Implant Model                                                                                               
Draft Version 1--Biofeedback Devices--  August 1, 1994      Do                     Do                           
 Draft Guidance for 510(k) Content                                                                              
Draft Version Cardiac Ablation          March 1, 1995       Do                     Do                           
 Preliminary Guidance (Data to be                                                                               
 Submitted to the FDA in Support                                                                                
 Investigation Device Exemption                                                                                 
 Application                                                                                                    
Draft Version Cranial Perforator        July 13, 1994       Do                     Do                           
 Guidance                                                                                                       
Draft Version Electrode Recording       March 1, 1995       Do                     Do                           
 Catheter Preliminary Guidance (Data                                                                            
 to be Submitted to the FDA in Support                                                                          
 of Premarket Notifications                                                                                     
Draft Version Guidance for Clinical     August 20, 1992     Do                     Do                           
 Data to be Submitted for Premarket                                                                             
 Approval Application for Cranial                                                                               
 Electrotherapy Stimulators                                                                                     
Draft Version Guide for Cortical        August 10, 1992     Do                     Do                           
 Electrode 510(k) Content                                                                                       
Draft Version Neuro Endoscope Guidance  July 7, 1994        Do                     Do                           
Excerpts Related to EMI from November   November 1, 1993    Do                     Do                           
 1993 Anesthesiology and Respiratory                                                                            
 Devices Branch (to be used with EMI                                                                            
 standard)                                                                                                      
Galvanic Skin Response Measurement      August 23, 1994     Do                     Do                           
 Devices--Draft Guidance for 510(k)                                                                             
 Content                                                                                                        
General Guidance Document: Non-         September 7, 1992   Do                     Do                           
 Invasive Pulse Oxymeter                                                                                        
Guidance for Oxygen Conserving Device   February 1, 1989    Do                     Do                           
 510(k) Review 73 BZD 868.5905 Non-                                                                             
 continuous Ventilator Class II                                                                                 
Guidance for Peak Flow Meters for Over-                     Do                     Do                           
 the-Counter Sale                                                                                               

[[Page 9817]]

                                                                                                                
Guidance for Safety and Effectiveness   March 1, 1983       Do                     Do                           
 Data Required in Premarket                                                                                     
 Notification (510(k)) Applications                                                                             
 for Blood Oxygenators                                                                                          
Guidance for Studies for Pain Therapy   May 12, 1988        Do                     Do                           
 Devices--General Considerations in                                                                             
 the Design of Clinical Studies for                                                                             
 Pain-Alleviating Devices                                                                                       
Guidance for the Preparation of the     April 1, 1990       Do                     Do                           
 Annual Report to the PMA Approved                                                                              
 Heart Valve Prostheses                                                                                         
Guide for 510(k) Review of Processed    June 26, 1990       Do                     Do                           
 Human Dura Mater                                                                                               
Guide for TENS 510(k) Content (Draft)   August 1, 1994      Do                     Do                           
Guidelines for Reviewing Premarket                          Do                     Do                           
 Notifications that Claim Substantial                                                                           
 Equivalence to Evoked Response                                                                                 
 Stimulators                                                                                                    
Heated Humidifier Review Guidance       August 30, 1991     Do                     Do                           
Implantable Pacemaker Lead Testing      September 1, 1989   Do                     Do                           
 Guidance For The Submission of a                                                                               
 Section 510(k) Notification                                                                                    
Implantable Pacemaker Testing Guidance  January 12, 1990    Do                     Do                           
Policy for Expiration Dating (DCRND     October 30, 1992    Do                     Do                           
 RB92-G)                                                                                                        
Protocol for Dermal Toxicity Testing                        Do                     Do                           
 for Devices in Contact with Skin                                                                               
 (Draft)                                                                                                        
Review Guidelines for Oxygen                                Do                     Do                           
 Generators and Oxygen Equipment                                                                                
Review of ``YAG'' Lasers for                                Do                     Do                           
 Neurosurgery                                                                                                   
Reviewer Guidance for Nebulizers,       November 9, 1990    Do                     Do                           
 Metered Dose Inhalers, Spacers and                                                                             
 Actuators                                                                                                      
Reviewer's Guidance for Oxygen          August 30, 1991     Do                     Do                           
 Concentrator                                                                                                   
Draft Intravascular Brachytherapy--     May 24, 1996        Do                     Do                           
 Guidance for Data to be Submitted to                                                                           
 the Food and Drug Administration in                                                                            
 Support of Investigational Device                                                                              
 Exemption (IDE) Applications                                                                                   
Assessing the Safety/Effectiv. of Home- October 1, 1988     ODE/Division of        Do                           
 use In Vitro Diagnostic Devices                             Clinical Laboratory                                
 (IVDs): Draft Points to Consider                            Devices (DCLD)                                     
 Regarding Labeling and Premarket                                                                               
 Submissions                                                                                                    
Review Proposal for Reagents and        March 14, 1995      Do                     Do                           
 Analyzer Systems                                                                                               
Data for Commercialization of Original  June 10, 1996       Do                     Do                           
 Equipment Manufacturer, Secondary and                                                                          
 Generic Reagents for Automated                                                                                 
 Analyzers                                                                                                      
DCLD Tier/Triage lists (include 931)    May 31, 1996        Do                     Do                           
Draft Criteria for Assessment of In     August 31, 1995     Do                     Do                           
 Vitro Diagnostic Devices for Drugs of                                                                          
 Abuse Assays Using Various                                                                                     
 Methodologies                                                                                                  
Draft Document entitled Proposed        April 28, 1992      Do                     Do                           
 Format: Package Insert for                                                                                     
 Immunohistochemistry Products (cover                                                                           
 memo dated 5/12/92)                                                                                            
Draft Guidance Document for 510(k)      July 29, 1992       Do                     Do                           
 Submission of Fecal Occult Blood                                                                               
 Tests                                                                                                          
Draft Guidance Document for 510(k)      September 30, 1991  Do                     Do                           
 Submission of Glycohemoglobin                                                                                  
 (Glycated or Glycosylated) Hemoglobin                                                                          
 for IVDs                                                                                                       
Draft Guidance Document for 510(k)      September 1, 1992   Do                     Do                           
 Submission of Immunoglobulins A,G,M,D                                                                          
 and E Immunoglobulin System In Vitro                                                                           
 Devices                                                                                                        
Draft Guidance for 510(k) Submission    September 26, 1991  Do                     Do                           
 of Lymphocyte Immunophenotyping IVDs                                                                           
 using Monoclonal Antibodies                                                                                    
Draft Guidance For Submission of        April 17, 1995      Do                     Do                           
 Immunohistochemistry Applications to                                                                           
 the FDA/cover letter                                                                                           
Draft Review Criteria for Nucleic Acid  June 14, 1993       Do                     Do                           
 Amplification Based In Vitro                                                                                   
 Diagnostic Devices for Direct                                                                                  
 Detection of Infectious                                                                                        
 Microorganisms                                                                                                 
Draft: Premarketing Approval Review     September 10, 1992  Do                     Do                           
 Criteria for Premarket Approval of                                                                             
 Estrogen (ER) or Progesterone (PGR)                                                                            
 Receptors In Vitro Diagnostic Devices                                                                          
 Using Steroid Hormone                                                                                          
Guidance Criteria for Cyclosporine      January 24, 1992    Do                     Do                           
 PMAs                                                                                                           

[[Page 9818]]

                                                                                                                
Labeling Requirements for Drugs of      January 27, 1987    Do                     Do                           
 Abuse Screening Test Kits                                                                                      
Points to Consider & Questions and      October 19, 1993    Do                     Do                           
 Answers on Immunohistochemistry                                                                                
 Products (cover memo dated 10/18/                                                                              
 1993)                                                                                                          
Points to Consider for Cervical         July 25, 1994       Do                     Do                           
 Cytology Devices                                                                                               
Points to Consider for Collection of    September 26, 1994  Do                     Do                           
 Data in Support of In-Vitro Device                                                                             
 Submissions for 510(k) Clearance                                                                               
Points to Consider for Portable Blood   February 20, 1996   Do                     Do                           
 Glucose Monitoring Devices Intended                                                                            
 for Bedside Use in the Neonate                                                                                 
 Nursery                                                                                                        
Points to Consider for Review of        February 1, 1996    Do                     Do                           
 Calibration and Quality Control                                                                                
 Labeling for In Vitro Diagnostic                                                                               
 Devices/Cover Letter dated 3/14/1996                                                                           
Review Criteria for In Vitro            February 1, 1994    Do                     Do                           
 Diagnostic Devices for the Assessment                                                                          
 of Thyroid Autoantibodies using                                                                                
 Indirect Immunofluorescence Assay                                                                              
 (IFA), Indirect                                                                                                
Review Criteria for Assessment of       July 15, 1994       Do                     Do                           
 Alpha-Fetoprotein (AFP) in vitro                                                                               
 Diagnostic Devices for Fetal Open                                                                              
 Neural Tube Defects Using                                                                                      
 Immunological Test Methodologies                                                                               
Review Criteria for Assessment of       May 31, 1991        Do                     Do                           
 Antimicrobial Susceptibility Devices                                                                           
Review Criteria for Assessment of       July 15, 1991       Do                     Do                           
 Cytogenetic Analysis Using Automated                                                                           
 and Semi-Automated Chromosome                                                                                  
 Analyzers                                                                                                      
Review Criteria for Assessment of       September 27, 1995  Do                     Do                           
 Human Chorionic Gonadotropin (hCG) In                                                                          
 Vitro Diagnostic Devices (IVDs)                                                                                
Review Criteria for Assessment of In    January 1, 1992     Do                     Do                           
 Vitro Diagnostic Devices for Direct                                                                            
 Detection of Chlamydiae in Clinical                                                                            
 Specimens                                                                                                      
Review Criteria for Assessment of In    July 6, 1993        Do                     Do                           
 Vitro Diagnostic Devices for Direct                                                                            
 Detection of Mycobacterium Spp.                                                                                
 [Tuberculosis (TB)]                                                                                            
Review Criteria for Assessment of       September 17, 1992  Do                     Do                           
 Laboratory Tests for the Detection of                                                                          
 Antibodies to Helicobacter pylori                                                                              
Review Criteria for Assessment of       February 14, 1996   Do                     Do                           
 Portable Blood Glucose In Vitro                                                                                
 Diagnostic Devices Using Glucose                                                                               
 Oxidase, Dehydrogenase, or Hexokinase                                                                          
 Methodology                                                                                                    
Review Criteria for Blood Culture       August 12, 1991     Do                     Do                           
 Systems                                                                                                        
Review Criteria for Devices Assisting   May 31, 1990        Do                     Do                           
 in the Diagnosis of C. Difficile                                                                               
 Associated Diseases                                                                                            
Review Criteria for Devices Intended    December 30, 1991   Do                     Do                           
 for the Detection of Hepatitis B                                                                               
 ``e'' Antigen and Antibody to HBe                                                                              
Review Criteria for In Vitro            August 1, 1992      Do                     Do                           
 Diagnostic Devices for Detection of                                                                            
 IGM Antibodies to Viral Agents                                                                                 
Review Criteria for In Vitro            February 15, 1996   Do                     Do                           
 Diagnostic Devices that Utilize                                                                                
 Cytogenetic In Situ Hybridization                                                                              
 Technology for the Detection of Human                                                                          
 Genetic Mutations (Germ Line and                                                                               
Review Criteria For Premarket Approval  May 15, 1992        Do                     Do                           
 of In Vitro Diagnostic Devices for                                                                             
 Detection of Antibodies to Parvovirus                                                                          
 B19                                                                                                            
Review Criteria for the Assessment of   March 2, 1993       Do                     Do                           
 Allergen-Specific Immunoglobulin E                                                                             
 (IGE) In-Vitro Diagnostic Devices                                                                              
 Using Immunological Test                                                                                       
 Methodologies                                                                                                  
Review Criteria for the Assessment of   September 1, 1992   Do                     Do                           
 Anti-nuclear Antibodies (ANA) In-                                                                              
 Vitro Diagnostic Devices Using                                                                                 
 Indirect Immunofluorescence Assay                                                                              
 (IFA),                                                                                                         
Guidance Document for the Submission    September 19, 1996  Do                     Do                           
 of Tumor Associated Antigen Premarket                                                                          
 Notification [510(k)] to FDA                                                                                   

[[Page 9819]]

                                                                                                                
Review Criteria for Assessment of       February 21, 1997   Do                     Do                           
 Rheumatoid Factor (RF) In Vitro                                                                                
 Diagnostic Devices Using Engzyme-                                                                              
 Linked Immunoassay (EIA), Enzyme                                                                               
 Linked Immunosorbent Assay (ELISA),                                                                            
 Particle                                                                                                       
Guidance for 510(k)s on Cholesterol     July 14, 1995       Do                     Do                           
 Tests for Clinical Laboratory,                                                                                 
 Physicians' Office Laboratory, and                                                                             
 Home Use                                                                                                       
Clinical Utility and Premarket          May 3, 1991         ODE                    Do                           
 Approval #P91-1 (blue book memo)                                                                               
Criteria for Panel Review of PMA        January 30, 1986    Do                     Do                           
 Supplements #P86-3 (blue book memo)                                                                            
Panel Report and Recommendations on     April 18, 1986      Do                     Do                           
 PMA Approvals #P86-5 (blue book memo)                                                                          
Panel Review of ``Me-Too'' Devices      July 1, 1986        Do                     Do                           
 #P86-6 (blue book memo)                                                                                        
Panel Review of Premarket Approval      May 3, 1991         Do                     Do                           
 Applications #P91-2 (blue book memo)                                                                           
PMA Compliance Program #P91-3 (blue     May 3, 1991         Do                     Do                           
 book memo)                                                                                                     
PMA Filing Decisions #P90-2 (blue book  May 18, 1990        Do                     Do                           
 memo)                                                                                                          
PMA Refuse to File Procedures #P94-1    May 20, 1994        Do                     Do                           
 (blue book memo)                                                                                               
PMA Supplements: ODEs letter to         April 24, 1990      Do                     Do                           
 manufacturers; identifies situations                                                                           
 which may require the submission of a                                                                          
 PMA supplement (When PMA Supplements                                                                           
 are Required) #P90-1 (blue book memo)                                                                          
PMAs--Early Review and Preparation of   January 27, 1986    Do                     Do                           
 Summaries of Safety and Effectiveness                                                                          
 #P86-1 (blue book memo)                                                                                        
Premarket Approval Application (PMA)    July 8, 1994        Do                     Do                           
 Closure #P94-1 (blue book memo)                                                                                
Review and Approval of PMAs of          October 22, 1990    Do                     Do                           
 Licensees #P86-4 (blue book memo)                                                                              
Review of Final Draft Medical Device    August 29, 1991     Do                     Do                           
 Labeling #P91-4 (blue book memo)                                                                               
Assignment of Review Documents #I90-2   August 24, 1990     Do                     Do                           
 (blue book memo)                                                                                               
Document Review Processing #I91-1       February 12, 1992   Do                     Do                           
 (blue book memo)                                                                                               
Integrity of Data and Information       May 29, 1991        Do                     Do                           
 Submitted to ODE #I91-2 (blue book                                                                             
 memo)                                                                                                          
Meetings with the Regulated Industry    November 20, 1989   Do                     Do                           
 #I89-3 (blue book memo)                                                                                        
Nondisclosure of Financially Sensitive  March 5, 1992       Do                     Do                           
 Information #I92-1 (blue book memo)                                                                            
Policy Development and Review           February 15, 1990   Do                     Do                           
 Procedures #I90-1 (blue book memo)                                                                             
Telephone Communications Between ODE    January 29, 1993    Do                     Do                           
 Staff and Manufacturers #I93-1 (blue                                                                           
 book memo)                                                                                                     
Delegation of IDE Actions #D88-1 (blue  April 26, 1988      Do                     Do                           
 book memo)                                                                                                     
Goals and Initiatives for the IDE       July 12, 1995       Do                     Do                           
 Program #D95-1 (blue book memo)                                                                                
IDE Refuse to Accept Procedures #D94-1  May 20, 1994        Do                     Do                           
 (blue book memo)                                                                                               
Implementation of the FDA/HCFA          September 15, 1995  Do                     Do                           
 Interagency Agreement Regarding                                                                                
 Reimbursement Categorization of                                                                                
 Investigational Devices, Att. A                                                                                
 Interagency Agreement, Att. B                                                                                  
 Criteria                                                                                                       
Overdue IDE Annual Progress Report      July 23, 1993       Do                     Do                           
 Procedures #D93-1 (blue book memo)                                                                             
Review of IDEs for Feasibility Studies  May 17, 1989        Do                     Do                           
 #D89-1 (blue book memo)                                                                                        
Consolidated Review of Submissions for  October 19, 1990    Do                     Do                           
 Diagnostic Ultrasound Equipment,                                                                               
 Accessories and Related Measurement                                                                            
 Devices #G90-2 (blue book memo)                                                                                
Consolidated Review of Submissions for  October 19, 1990    Do                     Do                           
 Lasers and Accessories #G90-1 (blue                                                                            
 book memo)                                                                                                     
Device Labeling Guidance #G91-1 (blue   March 8, 1991       Do                     Do                           
 book memo)                                                                                                     

[[Page 9820]]

                                                                                                                
Documentation and Resolution of         December 23, 1993   Do                     Do                           
 Differences of Opinion on Product                                                                              
 Evaluations #G93-1 (blue book memo)                                                                            
ODE Regulatory Information for the      May 15, 1987        Do                     Do                           
 Office of Compliance - Information                                                                             
 Sharing Procedures #G87-2 (blue book                                                                           
 memo)                                                                                                          
PMA/510(k) Expedited Review #G94-2      May 20, 1994        Do                     Do                           
 (blue book memo)                                                                                               
PMA/510(k) Triage Review Procedures     May 20, 1994        Do                     Do                           
 #G94-1 (blue book memo)                                                                                        
Review of Laser Submissions #G88-1      April 15, 1988      Do                     Do                           
 (blue book memo)                                                                                               
Toxicology Risk Assessment Committee    August 9, 1989      Do                     Do                           
 #G89-1 (blue book memo)                                                                                        
Use of International Standard ISO-      May 1, 1995         Do                     Do                           
 10993, ``Biological Evaluation of                                                                              
 Medical Devices Part 1: Evaluation                                                                             
 and Testing'' (Replaces #G87-1 #8294)                                                                          
 (blue book memo)                                                                                               
510(k) Additional Information           July 23, 1993       Do                     Do                           
 Procedures #K93-1 (blue book memo)                                                                             
510(k) Refuse to Accept Procedures      May 20, 1994        Do                     Do                           
 #K94-1 (blue book memo)                                                                                        
510(k) Sign-Off Procedures #K94-2       June 3, 1994        Do                     Do                           
 (blue book memo)                                                                                               
510(k) Sterility Review Guidance - and  February 12, 1990   Do                     Do                           
 Revision of 11/18/1994 #K90-1 (blue                                                                            
 book memo)                                                                                                     
Cover Letter: 510(k) Requirements       November 21, 1995   Do                     Do                           
 During Firm-Initiated Recalls;                                                                                 
 Attachment A: Guidance on Recall and                                                                           
 Premarket Notification Review                                                                                  
 Procedures During Firm-Initiated                                                                               
 Recalls of Legally Marketed Drugs                                                                              
 (blue book #K95-1)                                                                                             
Guidance on the Center for Devices and  June 30, 1986       Do                     Do                           
 Radiological Health's Premarket                                                                                
 Notification Review Program #K86-3                                                                             
 (blue book memo)                                                                                               
Premarket Notification - Consistency    February 28, 1989   Do                     Do                           
 of Reviews #K89-1 (blue book memo)                                                                             
Review of 510(k)s for Computer          August 29, 1991     Do                     Do                           
 Controlled Medical Devices #K91-1                                                                              
 (blue book memo)                                                                                               
Continued Access to Investigational     July 15, 1996       Do                     Do                           
 Devices During PMA Preparation and                                                                             
 Review (blue book memo)                                                                                        
Use of IEC 60601 Standards Medical      October 10, 1997    Do                     Do                           
 Electrical Equipment; Draft Document                                                                           
 [blue book memo #G97-X]                                                                                        
(blue book memo #K97-1) Deciding When   January 10, 1997    Do                     Do                           
 to Submit a 510(k) for a Change to an                                                                          
 Existing Device [see CDRH F-O-D #935]                                                                          
Memorandum of Understanding Regarding   August 9, 1996      Do                     Do                           
 Patient Labeling Review (blue book                                                                             
 memo #G96-3))                                                                                                  
#D95-2, Attachment A (Interagency       September 15, 1995  Do                     Do                           
 Agreement between FDA & HCFA)                                                                                  
#D95-2, Attachment B (Criteria for      September 15, 1995  Do                     Do                           
 Categorization of Investigational                                                                              
 Devices (HCFA)                                                                                                 
510(k) Quality Review Program (blue     March 29, 1996      Do                     Do                           
 book memo)                                                                                                     
Distribution and Public Availability    October 10, 1997    Do                     Do                           
 of PMA Summary of Safety and                                                                                   
 Effectiveness Data Packages                                                                                    
Document Review by the Office of the    June 6, 1996        Do                     Do                           
 Chief Counsel (blue book memo G96-1))                                                                          
Draft Guidance for Testing MR           May 22, 1996        Do                     Do                           
 Interaction with Aneurysm Clips                                                                                
HCFA Reimbursement Categorization       September 15, 1995  Do                     Do                           
 Determinations for FDA-approved IDEs                                                                           
ODE Executive Secretary Guidance        August 7, 1987      Do                     Do                           
 Manual                                                                                                         
Tripartie Biocompatibility Guidance     April 24, 1984      Do                     Do                           
Guidance for Submitting                                     Do                     Do                           
 Reclassification Petition                                                                                      
Product Development Protocol            October 1, 1997     Do                     Do                           
Exemption from Reporting and Record     September 16, 1981  Do                     Do                           
 keeping Requirements for Certain                                                                               
 Sunlamp Product Manufacturers                                                                                  

[[Page 9821]]

                                                                                                                
Reporting of New Model Numbers to       June 14, 1983       Do                     Do                           
 Existing Model Families                                                                                        
----------------------------------------------------------------------------------------------------------------

IV. Guidance Documents Issued by the Center for Drug Evaluation and 
Research (CDER)

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                                                    How to Obtain a Hard Copy of
                                                             Grouped by Intended       the Document (Name and   
           Name of Document              Date of Issuance     User or Regulatory    Address, Phone, FAX, E-mail,
                                                                   Activity                 or Internet)        
----------------------------------------------------------------------------------------------------------------
Consumer-Directed Broadcast             August 12, 1997     Advertising (Draft)    Office of Training and       
 Advertisements                                                                     Communications, Drug        
                                                                                    Information Branch, Food and
                                                                                    Drug Administration, 5600   
                                                                                    Fishers Lane, Rockville, MD 
                                                                                    20857, 301-827-4573 or      
                                                                                    Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Promoting Med Products (Multicenter)    January 5, 1998     Do                     Do                           
Aerosol Steroid Product Safety          January 12, 1998    Do                     Do                           
 Information in Prescript. Drug                                                                                 
 Advertising and Promotional Labeling                                                                           
 DDMAC 2                                                                                                        
Dissemination of Reprints of Certain    October 8, 1996      Advertising           Do                           
 Published, Original Data                                                                                       
Funded Dissemination of Reference       October 8, 1996     Do                     Do                           
 Texts                                                                                                          
Antifungal (topical)                    February 24, 1990   Biopharmaceutic        Drug Information Branch      
                                                             (Draft)                                            
Antifungal (vaginal)                    February 24, 1990   Do                     Do                           
Food-Effect Bioavailability and         December 30, 1997   Do                     Do                           
 Bioequivalence                                                                                                 
In Vivo Bioequivalence Studies Based    December 30, 1997   Do                     Do                           
 on Population and Individual                                                                                   
 Bioequivalence Approaches                                                                                      
Pharmacokinetics and Pharmacodynamics   June 16, 1997       Do                     Drug Information Branch or   
 in Patients with Impaired Renal                                                    Internet at http://
 Function: Study Design, Data                                                       www.fda.gov/cder/guidance/
 Analysis, and Impact on Dosing and                                                 index.htm                   
 Labeling                                                                                                       
Population Pharmacokinetics             September 18, 1997  Do                     Do                           
Waiver Policy                           March 29, 1993      Do                     Drug Information Branch      
Acetohexamide (tablets) In Vivo         August 1, 1988      Biopharmaceutic        Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Albuterol Inhalation Aerosols (Metered  January 27, 1994    Do                     Do                           
 Dose Inhalers) In Vivo Bioequivalence                                                                          
 and In Vitro Dissolution Testing                                                                               
Albuterol Sulfate (tablets) In Vivo     May 29, 1987        Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Allopurinol (tablets) In Vivo           July 15, 1985       Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Alprazolam Tablets In Vivo              November 27, 1992   Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Amiloride Hydrochloride (tablets) In    March 29, 1985      Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Aminophylline (suppositories) In Vivo   July 5, 1983        Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Amitriptyline Hydrochloride (tablets)   July 5, 1983        Do                     Do                           
 In Vivo Bioequivalence and In Vitro                                                                            
 Dissolution Testing                                                                                            
Amoxapine (tablets) In Vivo             August 5, 1988      Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Amoxicillin (capsules, tablets and      June 10, 1988       Do                     Do                           
 suspension) In Vivo Bioequivalence                                                                             
 and In Vitro Dissolution Testing                                                                               
Approaches to Statistical Data          November 1, 1985    Do                     Do                           
 Analysis of Bioavailability/                                                                                   
 Bioequivalence Studies                                                                                         
Atenolol (tablets) In Vivo              October 6, 1988     Do                     Drug Information Branch or   
 Bioequivalence and In Vitro                                                        Internet at http://
 Dissolution Testing                                                                www.fda.gov/cder/guidance/
index.htm                   
Baclofen (tablets) In Vivo              May 5, 1986         Do                     Drug Information Branch      
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Bioavailability Policies and                                Do                     Do                           
 Guidelines                                                                                                     

[[Page 9822]]

                                                                                                                
Bumetanide Tablets In Vivo              April 23, 1993      Do                     Drug Information Branch or   
 Bioequivalence and In Vitro                                                        Interent at http://
 Dissolution Testing                                                                www.fda.gov/cder/guidance/
index.htm                   
Buspirone Hydrochloride Tablets In      August 13, 1993     Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Captopril Tablets In Vivo               May 13, 1993        Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Carbamazepine (tablets) In Vivo         January 20, 1988    Do                     Drug Information Branch      
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Carbidopa and Levodopa Tablets In Vivo  June 19, 1992       Do                     Drug Information Branch or   
 Bioequivalence and In Vitro                                                        Internet at http://
 Dissolution Testing                                                                www.fda.gov/cder/guidance/
index.htm                   
Cefaclor Capsules and Suspension In     April 23, 1993      Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Cefadroxil (capsules, tablets and       October 7, 1986     Do                     Drug Information Branch      
 suspension) In Vivo Bioequivalence                                                                             
 and In Vitro Dissolution Testing                                                                               
Cephalexin (tablets and capsules) In    March 19, 1987      Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Cephradine (Capsule and Suspension)     September 10, 1986  Do                     Do                           
Chlordiazepoxide (Tablets)              July 5, 1983        Do                     Do                           
Chlordiazepoxide Hydrochloride          July 5, 1983        Do                     Do                           
 (Capsules)                                                                                                     
Chlorpropamide (Tablets)                July 5, 1983        Do                     Do                           
Chlorthalidone (Tablets)                July 5, 1983        Do                     Do                           
Cholestyramine Powder In Vitro          July 15, 1993       Do                     Drug Information Branch or   
 Bioequivalence                                                                     Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Cimetidine Tablets In Vivo              June 12, 1992       Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Clindamycin Hydrochloride (capsules)    May 31, 1988        Do                     Drug Information Branch      
 In Vivo Bioequivalence and In Vitro                                                                            
 Dissolution Testing                                                                                            
Clofibrate (Capsules)                   April 7, 1986       Do                     Do                           
Clonidine Hydrochloride (Tablets)       December 5, 1984    Do                     Do                           
Clorazepate Dipotassium (Capsules and   February 17, 1987   Do                     Do                           
 Tablets)                                                                                                       
Clozapine (Tablets) In Vivo             November 15, 1996   Do                     Drug Information Branch or   
 Bioequivalence and In Vitro                                                        Internet at http://
 Dissolution Testing                                                                www.fda.gov/cder/guidance/
index.htm                   
Controlled Release Dosage Forms:        September 10, 1985  Do                     Drug Information Branch      
 Issues and Controversies (Conference                                                                           
 Report)                                                                                                        
Corticosteroids, Dermatologic           June 2, 1995        Do                     Do                           
 (topical) In Vivo                                                                                              
Cyclobenzaprine Hydrochloride           January 25, 1988    Do                     Do                           
 (tablets) In Vivo Bioequivalence and                                                                           
 In Vitro Dissolution Testing                                                                                   
Desipramine Hydrochloride (Tablets)     September 22, 1987  Do                     Do                           
Diazepam (Tablets)                      July 8, 1985        Do                     Do                           
Diclofenac Sodium (tablets) In Vivo     October 6, 1994     Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Dicyclomine Hydrochloride (Tablets and  August 1, 1984      Do                     Do                           
 Capsules)                                                                                                      
Diflunisal Tablets In Vivo              May 16, 1992        Do                     Drug Information Branch or   
 Bioequivalence and In Vitro                                                        Internet at http://
 Dissolution Testing                                                                www.fda.gov/cder/guidance/
index.htm                   
Diltiazem Hydrochloride Tablets In      May 16, 1992        Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Dipyridamole (Tablets)                  September 25, 1987  Do                     Drug Information Branch      
Disopyramide Phosphate (Capsules)       July 9, 1985        Do                     Do                           
Dissolution Testing (General)           April 1, 1978       Do                     Do                           
Dissolution Testing of Immediate        August 25, 1997     Do                     Drug Information Branch or   
 Release Solid Oral Dosage Forms                                                    Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Division Guidelines for the Evaluation  April 18, 1984      Do                     Drug Information Branch      
 of Controlled Release Drug Products                                                                            
Doxepin Hydrochloride (Capsules)        October 9, 1986     Do                     Do                           
Doxycycline Hyclate (Capsules and       April 11, 1988      Do                     Do                           
 Tablets)                                                                                                       
Erythromycin Capsules (Enteric Coated   September 21, 1988  Do                     Do                           
 Pellets)                                                                                                       
Estropipate Tablets In Vivo             August 26, 1992     Do                     Drug Information Branch or   
 Bioequivalence and In Vitro                                                        Internet at http://
 Dissolution Testing                                                                www.fda.gov/cder/guidance/
index.htm                   
Extended Release Oral Dosage Forms:     September 26, 1997  Do                     Do                           
 Development, Evaluation, and                                                                                   
 Application of In Vitro/In Vivo                                                                                
 Correlations (BP2)                                                                                             

[[Page 9823]]

                                                                                                                
Fenoprofen (capsules and tablets) In    February 3, 1988    Do                     Drug Information Branch      
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Flurazepam Hydrochloride (capsules) In  October 15, 1985    Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Flurbiprofen (tablets) In Vivo          June 8, 1995        Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Format and Content of the Human         February 1, 1987    Do                     Do                           
 Pharmacokinetics and Bioavailability                                                                           
 Section of an Application*\1\                                                                                  
Gemfibrozil Capsules or Tablets In      June 15, 1992       Do                     Drug Information Branch or   
 Vivo Bioequivalence and In Vitro                                                   Internet at http://
 Dissolution Testing                                                                www.fda.gov/cder/guidance/
index.htm                   
Glipizide (Tablets) In Vivo             April 23, 1993      Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Glyburide Tablets In Vivo               April 23, 1993      Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Guanabenz Acetate Tablets In Vivo       April 23, 1993      Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Haloperidol (tablets) In Vivo           April 30, 1987      Do                     Drug Information Branch      
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Hydrochlorothiazide (tablets) In Vivo   September 28, 1987  Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Hydroxychloroquine Sulfate (tablets)    December 28, 1995   Do                     Do                           
 In Vivo Bioequivalence and In Vitro                                                                            
 Dissolution Testing                                                                                            
Hydroxyzine Hydrochloride (tablets)     March 4, 1986       Do                     Do                           
 (dissolution only)                                                                                             
Hydroxyzine Pamoate (capsules) In Vivo  September 28, 1987  Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Indapamide (tablets) In Vivo            April 23, 1993      Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Indomethacin (capsules) In Vivo         January 27, 1988    Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Isopropamide Iodide (tablets) In Vivo   May 12, 1982        Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Isosorbide Dinitrate (chewable          September 22, 1987  Do                     Do                           
 tablets, oral tablets, and sublingual                                                                          
 tablets) In Vivo Bioequivalence and                                                                            
 In Vitro Dissolution Testing                                                                                   
Isosorbide Dinitrate Controlled         November 6, 1985    Do                     Do                           
 Release Products                                                                                               
Ketoprofen (capsules) In Vivo           April 23, 1993      Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Leucovorin Calcium (tablets) In Vivo    August 4, 1988      Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Lorazepam (tablets) In Vivo             September 16, 1987  Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Loxapine Succinate (capsules) In Vivo   September 10, 1987  Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Maprotiline Hydrochloride (tablets) In  August 27, 1987     Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Meclofenamate Sodium (capsules) In      November 12, 1986   Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Medroxyprogesterone Acetate (tablets)   September 17, 1987  Do                     Do                           
 In Vivo Bioequivalence and In Vitro                                                                            
 Dissolution Testing                                                                                            
Megestrol Acetate (tablets) In Vivo     August 17, 1987     Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Metaproterenol Sulfate (tablets) In     March 18, 1988      Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Metaproterenol Sulfate and Albuterol    June 27, 1989       Do                     Do                           
 Metered Dose Inhalers In Vitro                                                                                 
Metaproterenol Sulfate and Albuterol    June 27, 1989       Do                     Do                           
 Metered Dose Inhalers In Vitro                                                                                 
Methylprednisolone (tablets) In Vivo    June 12, 1986       Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Metoclopramide Hydrochloride (tablets)  December 27, 1984   Do                     Do                           
 In Vivo Bioequivalence and In Vitro                                                                            
 Dissolution Testing                                                                                            
Metoprolol Tartrate (tablets) In Vivo   June 12, 1992       Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Minoxidil (Tablets)                     June 12, 1986       Do                     Do                           
Nadolol (tablets) In Vivo               May 16, 1992        Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Nafcillin Sodium (Capsules and          September 10, 1987  Do                     Do                           
 Tablets)                                                                                                       
Nalidixic Acid (Tablets)                August 19, 1997     Do                     Do                           

[[Page 9824]]

                                                                                                                
Naproxen (tablets) In Vivo              June 8, 1995        Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Nitrofurantion Macrocrystalline         January 10, 1986    Do                     Do                           
 (capsules) In Vivo Bioequivalence and                                                                          
 In Vitro Dissolution Testing                                                                                   
Nitroglycerin (Ointment)                December 17, 1986   Do                     Do                           
Norethindrone and Ethinyl Estradiol     March 18, 1988      Do                     Do                           
 (tablets) In Vivo Bioequivalence and                                                                           
 In Vitro Dissolution Testing                                                                                   
Norethindrone and Mestranol (tablets)   May 13, 1988        Do                     Do                           
 In Vivo Bioequivalence and In Vitro                                                                            
 Dissolution Testing                                                                                            
Nortriptyline Hydrochloride (capsules)  June 12, 1992       Do                     Do                           
 In Vivo Bioequivalence and In Vitro                                                                            
 Dissolution Testing                                                                                            
Oral Extended (controlled) Release In   September 9, 1993   Do                     Drug Information Branch or   
 Vivo Bioequivalence and In Vitro                                                   Internet at http://
 Dissolution Testing                                                                www.fda.gov/cder/guidance/
index.htm                   
Orphenadrine Citrate (tablets) In Vivo  July 22, 1983       Do                     Drug Information Branch      
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Pentoxifylline (extended-release        December 22, 1995   Do                     Do                           
 tablets) In Vivo Bioequivalence and                                                                            
 In Vitro Dissolution Testing                                                                                   
Perphenazine (tablets) In Vivo          August 27, 1987     Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Perphenazine/Amitriptyline (tablets)    August 27, 1987     Do                     Do                           
 In Vivo Bioequivalence and In Vitro                                                                            
 Dissolution Testing                                                                                            
Pharmacokinetic Considerations in Drug  N/A                 Do                     Do                           
 Studies                                                                                                        
Phenylbutazone Oxyphenbutazone          September 28, 1987  Do                     Do                           
 (capsules and tablets) In Vivo                                                                                 
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Phenytoin/Phenytion Sodium (capsules,   March 4, 1994       Do                     Do                           
 tablets, suspension) In Vivo                                                                                   
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Pindolol (tablets) In Vivo              April 23, 1993      Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Piroxicam (capsules) In Vivo            June 15, 1992       Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Potassium Chloride (slow-release        May 15, 1987        Do                     Do                           
 tablets and capsules) In Vivo                                                                                  
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Prazepam (capsules and tablets) In      July 26, 1988       Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Prednisone (tablets) (dissolution       July 10, 1985       Do                     Do                           
 only)                                                                                                          
Probenecid (Tablets)                    July 26, 1983       Do                     Do                           
Procainamide Hydrochloride              September 28, 1987  Do                     Do                           
Propoxyphene Napsylate with             March 26, 1980      Do                     Do                           
 Acetaminphen (Tablets)                                                                                         
Propranolol Hydrochloride (tablets) In  August 1, 1984      Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Propylthiouracil (tablets) In Vivo      August 13, 1986     Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Quinidine Gluconate (tablets,           September 22, 1987  Do                     Do                           
 controlled release) In Vivo                                                                                    
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Ranitidine Hydrochloride (tablets) In   April 23, 1993      Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Rifampin (capsules) In Vivo             September 8, 1988   Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Ritodrine Hydrochloride (tablets) In    August 27, 1987     Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Selegiline Hydrochloride (tablets) In   December 22, 1995   Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Silver Sulfadiazine (cream)             May 7, 1987         Do                     Do                           
Spironolactone (Tablets)                January 1, 1986     Do                     Do                           
Statistical Procedure for               July 1, 1992        Do                     Do                           
 Bioequivalence Studies Using a                                                                                 
 Standard Two-Treatment Crossover                                                                               
 Design                                                                                                         
Submission of Data for Bioequivalence   N/A                 Do                     Do                           
 Studies in Computer Format                                                                                     
Sulfasalazine (tablets) In Vivo         October 8, 1987     Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Sulfinpyrazone (Capsules and Tablets)   September 25, 1987  Do                     Do                           
Sulfones (tablets) In Vivo              November 7, 1986    Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            

[[Page 9825]]

                                                                                                                
Sulindac (tablets) In Vivo              July 18, 1988       Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Temazepam (Capsules)                    August 8, 1985      Do                     Do                           
Theophylline (conventional dosage       September 1, 1984   Do                     Do                           
 form) In Vivo Bioequivalence and In                                                                            
 Vitro Dissolution Testing                                                                                      
Timolol Maleate (tablets) In Vivo       August 9, 1988      Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Tolazamide (tablets) In Vivo            May 30, 1986        Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Tolbutamide (tablets) In Vivo           December 1, 1983    Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Tolmetin Sodium (tablets and capsules)  October 6, 1994     Do                     Do                           
 In Vivo Bioequivalence and In Vitro                                                                            
 Dissolution Testing                                                                                            
Trazodone Hydrochloride (tablets) In    April 30, 1988      Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Triazolam (tablets) In Vivo             December 24, 1992   Do                     Do                           
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Trimipramine Maleate (capsules) In      August 18, 1987     Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Verapamil Hydrochloride (tablets) In    July 18, 1985       Do                     Do                           
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Submission of Documentation in Drug     July 15, 1997       Chemistry (Draft)      Drug Information Branch or   
 Applications for Container Closure                                                 Internet at http://
 Systems Used for the Packaging of                                                  www.fda.gov/cder/guidance/
 Human Drugs and Biologics                                                          index.htm                   
Submitting Supporting Chemistry         November 1, 1991    Do                     Drug Information Branch      
 Documentation in Radiopharmaceutical                                                                           
 Drug Applications*                                                                                             
Tracking of NDA and ANDA                N/A                 Do                     Do                           
 Reformulations for Solid, Oral,                                                                                
 Immediate Release Drug Products                                                                                
 (Docket No. 89N-0066)                                                                                          
Drug Master Files                       September 1, 1989   Chemistry              Drug Information Branch or   
                                                                                    Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
FDA's Policy Statement for the          May 1, 1992         Do                     Do                           
 Development of New Stereoisomeric                                                                              
 Drugs                                                                                                          
Format and Content for the CMC Section  September 1, 1994   Do                     Do                           
 of an Annual Report (CMC 1)                                                                                    
Format and Content of the Chemistry,    February 1, 1987    Do                     Drug Information Branch      
 Manufacturing and Controls Section of                                                                          
 an Application*                                                                                                
Format and Content of the Microbiology  February 1, 1987    Do                     Do                           
 Section of an Application* (Docket                                                                             
 No. 85D-0245)                                                                                                  
Reviewer Guidance: Validation of        November 1, 1994    Do                     Drug Information Branch or   
 Chromatographic Methods (CMC 3)                                                    Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Submission of an Environmental          November 13, 1995   Do                     Drug Information Branch or   
 Assessment in Human Drug Applications                                              Internet at http://
 and Supplements (CMC 6)                                                            www.fda.gov/cder/guidance/
index.htm                   
Submission of Chemistry, Manufacturing  November 1, 1994    Do                     Drug Information Branch or   
 and Controls Information for                                                       Internet at http://
 Synthetic Peptide Substances (CMC 4)                                               www.fda.gov/cder/guidance/
index.htm                   
Submission of Documentation for         November 1, 1994    Do                     Drug Information Branch or   
 Sterilization Process Validation                                                   Internet at http://
 Applications for Human and Veterinary                                              www.fda.gov/cder/guidance/
 Drug Products (CMC 2)                                                              index.htm                   
Submitting Documentation for Packaging  February 1, 1987    Do                     Do                           
 for Human Drugs and Biologics*                                                                                 
Submitting Documentation for the        February 1, 1987    Do                     Drug Information Branch      
 Manufacturing of and Controls for                                                                              
 Drug Products*                                                                                                 
Submitting Documentation for the        February 1, 1987    Do                     Do                           
 Stability of Human Drugs and                                                                                   
 Biologics*                                                                                                     
Submitting Samples and Analytical Data  February 1, 1987    Do                     Drug Information Branch or   
 for Methods Validation*                                                            Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Submitting Supporting Documentation in  February 1, 1987    Do                     Do                           
 Drug Applications for the Manufacture                                                                          
 of Drug Substances*                                                                                            
SUPAC IR-Immediate-Release Solid Oral   November 30, 1995   Do                     Drug Information Branch or or
 Dosage Forms: Scale-Up and Post-                                                   Internet at http://
 Approval Changes: Chemistry,                                                       www.fda.gov/cder/guidance/
 Manufacturing and Controls, In Vitro                                               index.htm                   
 Dissolution Testing, and In Vivo                                                                               
 Bioequivalence Documentation (CMC 5)                                                                           

[[Page 9826]]

                                                                                                                
SUPAC-IR: Immediate Release Solid Oral  October 21, 1997    Do                     Drug Information Branch or   
 Dosage Forms; Manufacturing Equipment                                              Internet at http://
 Addendum (CMC 9)                                                                   www.fda.gov/cder/guidance/
index.htm                   
SUPAC-IR Questions and Answers          February 18, 1997   Do                     Do                           
SUPAC-MR: Modified Release Solid Oral   October 6, 1997     Do                     Drug Information Branch or   
 Dosage Forms: Scale-Up and                                                         Internet at http://
 Postapproval Changes: Chemistry,                                                   www.fda.gov/cder/guidance/
 Manufacturing, and Controls, In Vitro                                              index.htm                   
 Dissolution Testing, and In Vivo                                                                               
 Bioequivalence Documentation (CMC 8)                                                                           
SUPAC-SS--Nonsterile Semisolid Dosage   June 13, 1997       Do                     Drug Information Branch or   
 Forms; Scale-Up and Postapproval                                                   Internet at http://
 Changes: Chemistry, Manufacturing,                                                 www.fda.gov/cder/guidance/
 and Controls; In Vitro Release                                                     index.htm                   
 Testing and In Vivo Bioequivalence                                                                             
 Documentation (CMC 7)                                                                                          
Abuse Liability Assessment              July 1, 1990        Clinical (Draft)       Drug Information Branch      
Clinical Development Programs for       January 10, 1997    Do                     Drug Information Branch or   
 Drugs, Devices, and Biological                                                     Internet at http://
 Products for the Treatment of                                                      www.fda.gov/cder/guidance/
 Rheumatoid Arthritis (RA)                                                          index.htm                   
Clinical Evaluation of Agents Used in   April 1, 1994       Do                     Drug Information Branch      
 the Prevention or Treatment of                                                                                 
 Postmenopausal Osteoporosis                                                                                    
Clinical Evaluation of Anti-Anginal     January 1, 1989     Do                     Do                           
 Drugs                                                                                                          
Clinical Evaluation of Anti-Arrhythmic  July 1, 1985        Do                     Do                           
 Drugs                                                                                                          
Clinical Evaluation of                  May 1, 1988         Do                     Do                           
 Antihypertensive Drugs                                                                                         
Clinical Evaluation of Drugs for the    December 1, 1987    Do                     Do                           
 Treatment of Congestive Heart Failure                                                                          
Clinical Evaluation of Drugs for the    N/A                 Do                     Do                           
 Treatment of Peripheral Vascular                                                                               
 Disease                                                                                                        
Clinical Evaluation of Drugs for        N/A                 Do                     Do                           
 Ulcerative Colitis (3rd draft)                                                                                 
Clinical Evaluation of Motility-        N/A                 Do                     Do                           
 Modifying Drugs                                                                                                
Clinical Evaluation of Weight-Control   July 12, 1995       Do                     Do                           
 Drugs                                                                                                          
Conducting a Clinical Safety Review of  November 22, 1996   Do                     Do                           
 a New Product Application and                                                                                  
 Preparing a Report on the Review (96N-                                                                         
 0443)                                                                                                          
Development and Evaluation of Drugs     February 12, 1992   Do                     Do                           
 for the Treatment of Psychoactive                                                                              
 Substance Use Disorders                                                                                        
Evaluating Clinical Studies of          February 18, 1997   Do                     Drug Information Branch or   
 Antimicrobials in the Division of                                                  Internet at http://
 Anti-Infective Drug Products                                                       www.fda.gov/cder/guidance/
index.htm                   
FDA Approval of New Cancer Treatment    March 13, 1997      Do                     Do                           
 Uses for Marketed Drug and Biological                                                                          
 Products                                                                                                       
Points to Consider for System           N/A                 Do                     Drug Information Branch      
 Inflammatory Response Syndrome (SIRS)                                                                          
 1st Draft                                                                                                      
Points to Consider in the Preparation   September 1, 1991   Do                     Do                           
 of IND Applications for New Drugs                                                                              
 Intended for the Treatment of HIV-                                                                             
 Infected Individuals                                                                                           
Providing Clinical Evidence of          March 13, 1997      Do                     Drug Information Branch or   
 Effectiveness for Human Drug and                                                   Internet at http://
 Biological Products                                                                www.fda.gov/cder/guidance/
index.htm                   
Clinical Evaluation of Analgesic Drugs  December 1, 1992    Clinical               Drug Information Branch      
 (FDA 93-3093)                                                                                                  
Clinical Evaluation of Antacid Drugs    April 1, 1978       Do                     Drug Information Branch      
 (FDA 78-3065)                                                                                                  
Clinical Evaluation of Anti-Infective   November 1, 1992    Do                     Drug Information Branch      
 Drugs (Systemic) (FDA 77-3046)                                                                                 
Clinical Evaluation of Anti-            May 26, 1993        Do                     Drug Information Branch      
 Inflammatory and Antirheumatic Drugs                                                                           
 (adults and children)                                                                                          
Clinical Evaluation of Antianxiety      N/A                 Do                     Drug Information Branch      
 Drugs (FDA 77-3043)                                                                                            
Clinical Evaluation of Antidepressant   September 1, 1977   Do                     Drug Information Branch      
 Drugs (FDA 77-3042)                                                                                            
Clinical Evaluation of Antidiarrheal    September 1, 1977   Do                     Drug Information Branch      
 Drugs (FDA 78-3049)                                                                                            
Clinical Evaluation of Antiepileptic    January 1, 1981     Do                     Drug Information Branch      
 Drugs (adults and children) (FDA 81-                                                                           
 3110)                                                                                                          
Clinical Evaluation of Bronchodilator   N/A                 Do                     Drug Information Branch      
 Drugs (FDA 79-3073)                                                                                            
Clinical Evaluation of Combination      March 20, 1995      Do                     Drug Information Branch      
 Estrogen/Progestin-Containing Drug                                                                             
 Products Used for Hormone Replacement                                                                          
 Therapy of Postmenopausal Women                                                                                

[[Page 9827]]

                                                                                                                
Clinical Evaluation of Drugs to         November 1, 1978    Do                     Drug Information Branch      
 Prevent, Control and/or Treat                                                                                  
 Periodontal Disease (FDA 79-3074)                                                                              
Clinical Evaluation of Gastric          September 1, 1977   Do                     Drug Information Branch      
 Secretory Depressant (GSD) Drugs (FDA                                                                          
 78-3050)                                                                                                       
Clinical Evaluation of General          May 1, 1982         Do                     Drug Information Branch      
 Anesthetics (FDA 78-3052)                                                                                      
Clinical Evaluation of Hypnotic Drugs   September 1, 1977   Do                     Drug Information Branch      
 (FDA 78-3051)                                                                                                  
Clinical Evaluation of Laxative Drugs   April 1, 1978       Do                     Drug Information Branch      
 (FDA 78-3067)                                                                                                  
Clinical Evaluation of Lipid-Altering   N/A                 Do                     Drug Information Branch      
 Agents in Adults and Children (FDA 80-                                                                         
 3103)                                                                                                          
Clinical Evaluation of Local            May 1, 1982         Do                     Drug Information Branch      
 Anesthetics (FDA 82-3053)                                                                                      
Clinical Evaluation of Psychoactive     July 1, 1979        Do                     Drug Information Branch      
 Drugs in Infants and Children (FDA 79-                                                                         
 3055)                                                                                                          
Clinical Evaluation of                  October 1, 1981     Do                     Drug Information Branch      
 Radiopharmaceutical Drugs (FDA 81-                                                                             
 3120)                                                                                                          
Content and Format for Pediatric Use    May 24, 1996        Do                     Drug Information Branch or   
 Supplements (CLIN 1)                                                               Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Content and Format of Investigational   November 20, 1995   Do                     Drug Information Branch or   
 New Drug Applications (INDs) for                                                   Internet at http://
 Phase 1 Studies of Drugs, Including                                                www.fda.gov/cder/guidance/
Well-Characterized, Therapeutic,                                                   index.htm                   
 Biotechnology-Derived Products (CLIN                                                                           
 2)                                                                                                             
Development of Vaginal Contraceptive    April 19, 1995      Do                     Drug Information Branch      
 Drugs (NDA) (95D-0004)                                                                                         
Drug Metabolism/Drug Interaction        April 7, 1997       Do                     Drug Information Branch or   
 Studies in the Drug Development                                                    Internet at http://
 Process: Studies In Vitro (CLIN 3)                                                 www.fda.gov/cder/guidance/
index.htm                   
FDA Requirements for Approval of Drugs  January 29, 1991    Do                     Drug Information Branch      
 to Treat Non-Small Cell Lung Cancer                                                                            
FDA Requirements for Approval of Drugs  June 20, 1989       Do                     Do                           
 to Treat Superficial Bladder Cancer                                                                            
Format and Content of the Clinical and  July 1, 1988        Do                     Drug Information Branch or   
 Statistical Sections of New Drug                                                   Internet a http://
 Applications*                                                                      www.fda.gov/cder/guidance/
index.htm                   
Format and Content of the Summary for   February 1, 1987    Do                     Drug Information Branch      
 New Drug and Antibiotic Applications*                                                                          
Formatting, Assembling and Submitting   February 1, 1987    Do                     Do                           
 New Drug and Antibiotic Applications*                                                                          
General Considerations for the          December 1, 1978    Do                     Drug Information Branch      
 Clinical Evaluation of Drugs (FDA 77-                                                                          
 3040)                                                                                                          
General Considerations for the          N/A                 Do                     Drug Information Branch      
 Clinical Evaluation of Drugs in                                                                                
 Infants and Children (FDA 77-3041)                                                                             
Oncologic Drugs Advisory Committee      April 13, 1988      Do                     Drug Information Branch      
 Discussion on FDA Requirements for                                                                             
 Approval of New Drugs for Treatment                                                                            
 of Ovarian Cancer                                                                                              
Oncologic Drugs Advisory Committee      N/A                 Do                     Do                           
 Discussion on FDA Requirements for                                                                             
 Approval of New Drugs for Treatment                                                                            
 of Colon and Rectal Cancer                                                                                     
OTC Treatment of Hypercholesterolemia   October 27, 1997    Do                     Drug Information Branch or   
 (CLIN 5)                                                                           Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Points to Consider in the Clinical      October 26, 1992    Do                     Drug Information Branch      
 Development and Labeling of Anti-                                                                              
 Infective Drug Products                                                                                        
Points to Consider in the Preclinical   November 1, 1990    Do                     Do                           
 Development of Antiviral Drugs                                                                                 
Points to Consider in the Preclinical   May 1, 1993         Do                     Do                           
 Development of Immunomodulatory Drugs                                                                          
 for the Treatment of HIV Infection                                                                             
 and Associated Disorders                                                                                       
Points to Consider: Clinical            September 19, 1994  Do                     Do                           
 Development Programs for MDI and DPI                                                                           
 Drug Products                                                                                                  
Postmarketing Adverse Experience        August 27, 1997     Do                     Drug Information Branch or   
 Reporting for Human Drugs and                                                      Internet at http://
 Licensed Biological Products;                                                      www.fda.gov/cder/guidance/
 Clarification of What to Report (CLIN                                              index.htm                   
 4)                                                                                                             
Postmarketing Reporting of Adverse      March 1, 1992       Do                     Drug Information Branch      
 Drug Experiences (85D-0249)                                                                                    
Preparation of Investigational New      March 1, 1991       Do                     Drug Information Branch      
 Drug Products (Human and Animal)                                                                               

[[Page 9828]]

                                                                                                                
Study and Evaluation of Gender          July 22, 1993       Do                     Do                           
 Differences in the Clinical                                                                                    
 Evaluation of Drugs                                                                                            
Study of Drugs Likely to be Used in     November 1, 1989    Do                     Do                           
 the Elderly                                                                                                    
Computerized Systems Used in Clinical   June 18, 1997       Compliance (Draft)     Drug Information Branch or   
 Trials                                                                             Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Manufacture, Processing or Holding of   September 20, 1996  Do                     Do                           
 Active Pharmaceutical Ingredients                                                                              
Repackaging of Solid Oral Dosage Form   February 1, 1992    Do                     Drug Information Branch      
 Drug Products (92D-0345)                                                                                       
Supplements to New Applications,        December 12, 1994   Do                     Drug Information Branch      
 Abbreviated New Drug Applications or                                                                           
 Abbreviated Antibiotic Applications                                                                            
 for Nonsterile Drug Products (93D-                                                                             
 0403)                                                                                                          
A Review of FDA's Implementation of     N/A                 Compliance             Drug Information Branch      
 the Drug Export Amendments of 1986                                                                             
Compressed Medical Gases                December 1, 1989    Do                     Do                           
Current Good Manufacturing Practices    April 22, 1997      Do                     Drug Information Branch or   
 for Positron Emission Tomographic                                                  Internet at http://
 (PET) Drug Products (CP 1)                                                         www.fda.gov/cder/guidance/
index.htm                   
Expiration Dating and Stability         June 27, 1997       Do                     Drug Information Branch or   
 Testing of Solid Oral Dosage Form                                                  Internet at http://
 Drugs Containing Iron (CP 2)                                                       www.fda.gov/cder/guidance/
index.htm                   
General Principles of Process           May 1, 1987         Do                     Drug Information Branch or   
 Validation                                                                         Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Good Laboratory Practice Regulations    N/A                 Do                     Drug Information Branch      
 Questions and Answers                                                                                          
Monitoring of Clinical Investigations   January 1, 1988     Do                     Do                           
Nuclear Pharmacy Guideline Criteria     May 1, 1984         Do                     Do                           
 for Determining When to Register as a                                                                          
 Drug Establishment                                                                                             
Sterile Drug Products Produced by       May 1, 1987         Do                     Do                           
 Aseptic Processing                                                                                             
Validation of Limulus Amebocyte Lysate  December 1, 1987    Do                     Do                           
 Test as an End-Product Endotoxin Test                                                                          
 for Human and Animal Parenteral                                                                                
 Drugs, Biological Products, and                                                                                
 Medical Devices                                                                                                
Content and Format of an Abbreviated    April 18, 1997      Generic Drug (Draft)   Drug Information Branch or   
 New Drug Application (ANDA)--Positron                                              Internet at http://
 Emission Tomography (PET) Drug                                                     www.fda.gov/cder/guidance/
Products_With Specific Information                                                index.htm                   
 for ANDAs for Fludeoxyglucose F18                                                                              
 Injection                                                                                                      
Letter announcing that the OGD will     August 18, 1995     Generic Drug           Drug Information Branch      
 now accept the ICH long-term storage                                                                           
 conditions as well as the stability                                                                            
 studies conducted in the past.                                                                                 
Letter describing efforts by the CDER   October 14, 1994    Do                     Do                           
 and the ORA to clarify the                                                                                     
 responsibilities of CDER chemistry                                                                             
 review scientists and ORA field                                                                                
 investigators in the new and                                                                                   
 abbreviated drug approval process in                                                                           
 order to reduce duplication or                                                                                 
 redundancy                                                                                                     
Letter on incomplete Abbreviated        April 8, 1994       Do                     Do                           
 Applications, Convictions Under GDEA,                                                                          
 Multiple Supplements, Annual Reports                                                                           
 for Bulk Antibiotics, Batch Size for                                                                           
 Transdermal Drugs, Bioequivalence                                                                              
 Protocols, Research, Deviations from                                                                           
 OGD Policy                                                                                                     
Letter on the provision of new          July 1, 1992        Do                     Do                           
 information pertaining to new                                                                                  
 bioequivalence guidelines and refuse-                                                                          
 to-file letters                                                                                                
Letter on the provision of new          March 15, 1989      Do                     Do                           
 procedures and policies affecting the                                                                          
 generic drug review process                                                                                    
Letter on the request for cooperation   November 8, 1991    Do                     Do                           
 of regulated industry to improve the                                                                           
 efficiency and effectiveness of the                                                                            
 generic drug review process, by                                                                                
 assuring the completeness and                                                                                  
 accuracy of required information and                                                                           
 data submissions                                                                                               
Letter on the response to 12/20/84      March 26, 1985      Do                     Do                           
 letter from the Pharmaceutical                                                                                 
 Manufacturers Association about the                                                                            
 Drug Price Competition and Patent                                                                              
 Term Restoration Act                                                                                           

[[Page 9829]]

                                                                                                                
Letter to all ANDA and AADA applicants  January 15, 1993    Do                     Do                           
 about the Generic Drug Enforcement                                                                             
 Act of 1992 (GDEA), and the Office of                                                                          
 Generic Drugs intention to refuse-to-                                                                          
 file incomplete submissions as                                                                                 
 required by the new law                                                                                        
Letter to regulated industry notifying  August 4, 1993      Do                     Do                           
 interested parties about important                                                                             
 detailed information regarding                                                                                 
 labeling, scale-up, packaging, minor/                                                                          
 major amendment criteria, and                                                                                  
 bioequivalence requirements                                                                                    
Organization of an Abbreviated New      April 7, 1997       Do                     Drug Information Branch or   
 Drug Application and an Abbreviated                                                Internet at http://
 Antibiotic Application (OGD 1)                                                     www.fda.gov/cder/guidance/
index.htm                   
Positron Emission Tomography Questions  October 24, 1996    Do                     Drug Information Branch or   
 and Answers 1                                                                      Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Positron Emission Tomography Questions  April 18, 1997      Do                     Do                           
 and Answers 2                                                                                                  
A Revision in Sample Collection Under   July 15, 1996       Industry letters       Drug Information Branch      
 the Compliance Program Pertaining to                                                                           
 Pre-Approval Inspections                                                                                       
Certification Requirements for          July 27, 1992       Do                     Do                           
 Debarred Individuals in Drug                                                                                   
 Applications                                                                                                   
Continuation of a series of letters     June 1, 1990        Do                     Do                           
 communicating interim and informal                                                                             
 generic drug policy and guidance.                                                                              
 Availability of Policy and Procedure                                                                           
 Guides, and further operational                                                                                
 changes to the generic drug review                                                                             
 program                                                                                                        
Fifth of a series of letters providing  April 10, 1987      Do                     Do                           
 informal notice about the Act,                                                                                 
 discussing the statutory mechanism by                                                                          
 which ANDA applicants may make                                                                                 
 modifications in approved drugs where                                                                          
 clinical data is required                                                                                      
Fourth of a series of letters           October 31, 1986    Do                     Do                           
 providing informal notice to all                                                                               
 affected parties about policy                                                                                  
 developments and interpretations                                                                               
 regarding the Act. Three year                                                                                  
 exclusivity provisions of Title I                                                                              
Implementation of the Drug Price        October 11, 1984    Do                     Do                           
 Competition and Patent Term                                                                                    
 Restoration Act. Preliminary Guidance                                                                          
Implementation Plan USP injection       October 2, 1995     Do                     Do                           
 nomenclature                                                                                                   
In Vivo Bioequivalence Studies of       April 22, 1996      Do                     Do                           
 Clozapine                                                                                                      
Instructions for Filing Supplements     April 11, 1996      Do                     Do                           
 Under the Provisions of SUPAC-IR                                                                               
Seventh of a series of letters about    July 29, 1988       Do                     Do                           
 the Act providing guidance on the                                                                              
 ``180-day exclusivity'' provision of                                                                           
 section 505(j)(4)(B)(iv) of the FD&C                                                                           
Sixth of a series of informal notice    April 28, 1988      Do                     Do                           
 letters about the Act discussing 3-                                                                            
 and 5-year exclusivity provisions of                                                                           
 sections 505(c)(3)(D) and                                                                                      
 505(j)(4)(D) of the FD&C Act                                                                                   
Streamlining Initiatives                December 24, 1996   Do                     Do                           
Supplement to 10/11/84 letter about     November 16, 1984   Do                     Do                           
 policies, procedures and                                                                                       
 implementation of the Act (Q & A                                                                               
 format)                                                                                                        
Third of a series of letters regarding  May 1, 1985         Do                     Do                           
 the implementation of the Act                                                                                  
Archiving Submissions in Electronic     September 23, 1997  Information            Drug Information Branch or   
 Format--NDAs (IT 1)                                         Technology             Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
CANDA (Computer Assisted New Drug       October 1, 1994     Do                     Drug Information Branch      
 Application) Guidance Manual (92D-                                                                             
 0296)                                                                                                          
Acetaminophen and Codeine Phosphate     December 1, 1993    Labeling               Drug Information Branch      
 Oral Solution/Suspension                                                                                       
Acetaminophen and Codeine Phosphate     December 1, 1993    Do                     Do                           
 Tablets/Capsules                                                                                               
Acetaminophen, Aspirin and Codeine      December 1, 1993    Do                     Drug Information Branch or   
 Phosphate Tablets/Capsules                                                         Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Alprazolam Tablets                      May 1, 1993         Do                     Do                           

[[Page 9830]]

                                                                                                                
Amiloride Hydrochloride and             October 1, 1992     Do                     Do                           
 Hydrochlorothiazide Tablets USP                                                                                
Amlodipine Besylate Tablets (OGD-L-1)   September 1, 1997   Do                     Do                           
Antihistamine Guidance                  April 1, 1983       Do                     Drug Information Branch      
Astemizole Tablets (OGD-L-16)           September 1, 1997   Do                     Do                           
Atenolol Tablets                        June 1, 1995        Do                     Drug Information Branch or   
                                                                                    Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Barbiturate, Single Entity-Class        March 1, 1981       Do                     Drug Information Branch      
 Labeling                                                                                                       
Butalbital, Acetaminophen and Caffeine  April 1, 1993       Do                     Drug Information Branch or   
 Capsules/Tablets                                                                   Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Butalbital, Acetaminophen, Caffeine     September 21, 1997  Do                     Drug Information Branch      
 and Hydocodone Bitartrate Tablets                                                                              
 (OGD-L-6-R1)                                                                                                   
Butorphanol Tartrate Injection USP      October 1, 1992     Do                     Drug Information Branch or   
                                                                                    Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Captopril and Hydrochlorothiazide       April 1, 1995       Do                     Do                           
 Tablets                                                                                                        
Captopril Tablets                       February 1, 1995    Do                     Drug Information Branch      
Carbidopa and Levodopa Tablets          February 1, 1992    Do                     Drug Information Branch or   
                                                                                    Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Chlordiazepoxide Hydrochloride          January 1, 1988     Do                     Drug Information Branch      
 Capsules                                                                                                       
Cimetidine Hydrochloride Injection      September 1, 1995   Do                     Drug Information Branch or   
                                                                                    Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Cimetidine Tablets                      September 1, 1995   Do                     Do                           
Cisapride Oral Suspension (OGD-L-3)     September 1, 1997   Do                     Do                           
Cisapride Tablets (OGD-L-4)             September 1, 1997   Do                     Do                           
Clindamycin Phosphate Injection USP     May 1, 1992         Do                     Do                           
Clorazepate Dipotassium Capsules/       March 1, 1993       Do                     Drug Information Branch      
 Tablets                                                                                                        
Combination Oral Contraceptives--       January 1, 1994     Do                     Do                           
 Physician and Patient Labeling                                                                                 
Cyproheptadine Hydrochloride Tablets/   December 1, 1986    Do                     Do                           
 Syrup                                                                                                          
Diclofenac Sodium Delayed-Release       February 1, 1995    Do                     Drug Information Branch or   
 Tablets                                                                            Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Diltiazem Hydrochloride Extended-       September 1, 1995   Do                     Do                           
 Release Capsules (twice a day dosage)                                                                          
Diphenoxylate Hydrochloride and         April 1, 1995       Do                     Do                           
 Atropine Sulfate Oral Solution                                                                                 
Diphenoxylate Hydrochloride and         April 1, 1995       Do                     Do                           
 Atropine Sulfate Tablets                                                                                       
Dipivefrin Hydrochloride Ophthalmic     May 1, 1992         Do                     Drug Information Branch      
 Solution, 0.1%                                                                                                 
Ergoloid Mesylates Tablets              January 1, 1988     Do                     Do                           
Estrogen Class Labeling Guidance        August 1, 1992      Do                     Do                           
Fludeoxyglucose F18 Injection           January 1, 1997     Do                     Drug Information Branch or   
                                                                                    Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Flurbiprofen Tablets USP                January 1, 1994     Do                     Do                           
Fluroxamine Maleate Tablets (OGD-L-15)  September 1, 1997   Do                     Do                           
Gentamicin Sulfate Ophthalmic Ointment  April 1, 1992       Do                     Do                           
 and Solution                                                                                                   
Heparin Sodium Injection USP            March 1, 1991       Do                     Do                           
Hydrocodone Bitartrate and              April 1, 1994       Do                     Do                           
 Acetaminophen Tablets                                                                                          
Hydroxyzine Hydrochloride Injection     December 1, 1989    Do                     Drug Information Branch      
Hydroxyzine Hydrochloride Tablets/      May 1, 1986         Do                     Do                           
 Syrup                                                                                                          
Hypoglycemic Oral Agents--Federal       April 1, 1984       Do                     Do                           
 Register                                                                                                       
Indomethacin Capsules USP               September 1, 1995   Do                     Drug Information Branch or   
                                                                                    Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Informal Labeling Guidance Texts for    December 1, 1992    Do                     Drug Information Branch      
 Estrogen Drug Products--Patient                                                                                
 Labeling                                                                                                       
Informal Labeling Guidance Texts for    December 1, 1992    Do                     Do                           
 Estrogen Drug Products--Professional                                                                           
 Labeling                                                                                                       
Isoetharine Inhalation Solution         March 1, 1989       Do                     Do                           
Leucovorin Calcium for Injection        N/A                 Do                     Drug Information Branch or   
                                                                                    Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Leucovorin Calcium Tablets, USP         July 1, 1996        Do                     Drug Information Branch      

[[Page 9831]]

                                                                                                                
Local Anesthetics--Class Labeling       September 1, 1982   Do                     Do                           
Meclofenamate Sodium Capsules           July 1, 1992        Do                     Do                           
Medroxy-progesterone Acetate Tablets,   November 1, 1997    Do                     Do                           
 USP OGD-L-36                                                                                                   
Metaproterenol Sulfate Inhalation       May 1, 1992         Do                     Drug Information Branch or   
 Solution, 5%                                                                       Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Metaproterenol Sulfate Syrup            May 1, 1992         Do                     Do                           
Metaproterenol Sulfate Tablets          May 1, 1992         Do                     Do                           
Metoclopramide Tablets USP/Oral         February 1, 1995    Do                     Do                           
 Solution                                                                                                       
Naphazoline Hydrochloride Ophthalmic    March 1, 1989       Do                     Drug Information Branch      
 Solution                                                                                                       
Naproxen Sodium Tablets, USP OGD-L-10-  September 1, 1997   Do                     Drug Information Branch or   
 R1                                                                                 Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Naproxen Tablets, USP OGD-L-9-R1        September 1, 1997   Do                     Do                           
Niacin Tablets                          July 1, 1992        Do                     Drug Information Branch      
Paclitaxel Injection OGD-L-8            September 1, 1997   Do                     Do                           
Phendimetrazine Tartrate Capsules/      February 1, 1991    Do                     Do                           
 Tablets, and Extended-Release                                                                                  
 Capsules                                                                                                       
Phentermine Hydrochloride Capsules/     August 1, 1988      Do                     Do                           
 Tablets                                                                                                        
Promethazine Hydrochloride Tablets      March 1, 1990       Do                     Do                           
Propantheline Bromide Tablets           August 1, 1988      Do                     Do                           
Pyridoxine Hydrochloride Injection      June 1, 1984        Do                     Do                           
Quinidine Sulfate Tablets/Capsules      October 1, 1995     Do                     Do                           
Ranitidine Tablets                      November 1, 1993    Do                     Drug Information Branch or   
                                                                                    Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Risperidone Oral Solution OGD-L-18      September 1, 1997   Do                     Do                           
Risperidone Tablets OGD-L-17            September 1, 1997   Do                     Do                           
Sulfacetamide Sodium and Prednisolone   January 1, 1995     Do                     Do                           
 Acetate Ophthalmic Suspension and                                                                              
 Solution                                                                                                       
Sulfacetamide Sodium Ophthalmic         August 1, 1992      Do                     Do                           
 Solution/Ointment                                                                                              
Sulfamethoxazole and Phenazopyridine    February 1, 1992    Do                     Drug Information Branch      
 Hydrochloride Tablets                                                                                          
Sulfamethoxazole and Trimethoprim       August 1, 1993      Do                     Drug Information Branch or   
 Tablets and Oral Suspension                                                        Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Theophylline Immediate-Release Dosage   February 1, 1995    Do                     Drug Information Branch      
 Forms                                                                                                          
Theophylline Intravenous Dosage Forms   February 9, 1996    Do                     Do                           
Thiamine Hydrochloride Injection        February 1, 1988    Do                     Do                           
Tobramycin Sulfate Injection            May 1, 1993         Do                     Drug Information Branch      
                                                                                    Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Topical Corticosteroids Class Labeling  N/A                 Do                     Drug Information Branch      
Venlafaxine Hydrochloride Tablets OGD-  October 1, 1997     Do                     Do                           
 L-30                                                                                                           
Verapamil Hydrochloride Tablets         October 1, 1991     Do                     Drug Information Branch or   
                                                                                    Internet at http://
www.fda.gov/cder/guidance/
index.htm                   
Vitamin A Capsules                      February 1, 1992    Do                     Drug Information Branch      
Zolpidem Tartrate Tablets OGD-L-13      September 1, 1997   Do                     Do                           
Points to Consider for OTC Actual Use   July 22, 1994       OTC (Draft)            Do                           
 Studies                                                                                                        
Enforcement Policy on Marketing OTC     N/A                 OTC                    Do                           
 Combination Products (CPG 7132b.16)                                                                            
General Guidelines for OTC Combination  N/A                 Do                     Do                           
 Products (78D-0322)                                                                                            
OTC Nicotine Sustitutes                 March 1, 1994       Do                     Drug Information Branch      
Upgrading Category III Antiperspirants  N/A                 Do                     Do                           
 to Category I (43 FR 46728-46731)                                                                              
Format and Content of the Nonclinical   February 1, 1987    Pharmacology/          Do                           
 Pharmacology/Toxicology Section of an                       Toxicology                                         
 Application*                                                                                                   
Points to Consider in the Nonclinical   N/A                 Do                     Drug Information Branch or   
 Pharmacology/Toxicology Development                                                Internet at http://
 of Topical Drugs Intended to Prevent                                               www.fda.gov/cder/guidance/
 the Transmission of Sexually                                                       index.htm                   
 Transmitted Diseases (STD) and/or for                                                                          
 the Development of Drugs Intended to                                                                           
 Act as Vaginal Contraceptives                                                                                  

[[Page 9832]]

                                                                                                                
Reference Guide for the Nonclinical     February 1, 1989    Do                     Drug Information Branch      
 Toxicity Studies of Antiviral Drugs                                                (REMOVE)                    
 Indicated for the Treatment of Non-                                                                            
 Life Threatening Disease: Evaluation                                                                           
 of Drug Toxicity Prior to Phase I                                                                              
 Clinical Studies                                                                                               
----------------------------------------------------------------------------------------------------------------
\1\ Star (*) indicates that the guidance is one of 13, formerly known as the ``NDA Guidelines,'' or ``Rainbow   
  Pack,'' that are available as a set from the Drug Information Branch.                                         

V. Guidance Documents Issued by the Center for Food Safety and 
Applied Nutrition (CFSAN)

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                                                    How to Obtain a Hard Copy of
                                                             Grouped by Intended       the Document (Name and   
           Name of Document              Date of Issuance     User or Regulatory    Address, Phone, FAX, E-mail,
                                                                   Activity                 or Internet)        
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guides Manual, PB96-  1996                FDA Regulated          National Technical           
 920500                                                      Industries             Information Service (NTIS), 
                                                                                    5285 Port Royal Rd.,        
                                                                                    Springfield, VA 22161       
Compliance Programs Guidance Manual,    1995                Do                     NTIS                         
 PB95-915499                                                                                                    
FDA Recall Policy                       1995                Do                     Industry Activities Staff    
                                                                                    (HFS-565), Center for Food  
                                                                                    Safety and Applied          
                                                                                    Nutrition, Food and Drug    
                                                                                    Administration, 200 C St.   
                                                                                    SW., Washington, DC 20204   
Inspection Operations Manual, PB-95-    October 1994        Do                     NTIS                         
 913399                                                                                                         
Regulatory Procedures Manual, PB95-     August 1995         Do                     NTIS                         
 265534                                                                                                         
Requirements of Laws and Regulations    1997                Do                     Superintendent of Documents, 
 Enforced by the U.S. Food and Drug                                                 Government Printing Office, 
 Administration ``Blue Book''                                                       Washington, DC 20402        
Action Levels for Poisonous or          1995                Food and Animal Feed   Industry Activities Staff    
 Deleterious Substances in Human Food                        Industries                                         
 and Animal Feed, PB96-920500                                                                                   
Pesticides Analytical Manual, PB94-     1994                Food Industry          NTIS                         
 911899                                                                                                         
FDA Advisory for Deoxynivanol (DON) in  September 16, 1993  Food and Animal Feed   Office of Plant and Dairy    
 Finished Wheat Products Intended for                        Industries             Foods and Beverages, Food   
 Human Consumption and in Grain and                                                 and Drug Administration (HFS-
 Grain By-Products for Animal Feed                                                  306), 200 C St. SW.,        
                                                                                    Washington, DC 20204, 202-  
                                                                                    205-4681                    
FDA's Cosmetic Labeling Manual          October 1991        Cosmetic Industry      Office of Colors and         
                                                                                    Cosmetics (HFS-105), Food   
                                                                                    and Drug Administration, 200
                                                                                    C St. SW., Washington, DC   
                                                                                    20204, 202-205-4493         
Statement of Policy: Foods Derived      May 29, 1992 (57    Developers of New      Office of Premarket Approval,
 from New Plant Varieties: Notice        FR 22984)           Plant Food Varieties   Food and Drug Administration
                                                                                    (HFS-200), 200 C St. SW.,   
                                                                                    Washington, DC 20204, 202-  
                                                                                    418-3100                    
 A Food Labeling Guide                  September 1994      Food Industry          Superintendent of Documents, 
Appendix I--Model Small Business Food    August 7, 1993     Do                     Industry Activities Staff    
 Labeling Exemption Notice                                                                                      
Food Labeling: Questions and Answers    August 1993         Do                     Industry Activities Staff    
Food Labeling: Questions and Answers:   August 1995         Do                     Superintendent of Documents  
 Volume II                                                                                                      
Fair Packaging and Labeling Act         June 1978           Do                     NTIS                         
 Requirements and Interpretations, PB-                                                                          
 83-222117                                                                                                      
Bacteriological Analytical Manual, 7th   1992               FDA Regulated          AOAC International, 481 N.   
 Edition                                                     Industries             Frederick Ave., Suite 500,  
                                                                                    Gaithersburg, MD 20877-2417,
                                                                                    301-924-7077                
FDA Food Importer's Guide for Low-Acid   1995               Food Industry          Industry Activities Staff    
 Canned and Acidified Foods                                                                                     
Fabrication of Single Service           1995                States                 Milk Safety Branch (HFS-626),
 Containers and Closures for Milk and                                               Center for Food Safety and  
 Milk Products                                                                      Applied Nutrition, 200 C St.
                                                                                    SW., Washington, DC 20204,  
                                                                                    202-205-9175                
Evaluation of Milk Laboratories         1995                Do                     Do                           
Methods of Making Sanitation Ratings    1995                Do                     Do                           
 Of Milk Supplies                                                                                               

[[Page 9833]]

                                                                                                                
Dry Milk Ordinance                      1995                Do                     Do                           
Procedures Governing the Cooperative    1995                Dairy Industry         Do                           
 State-Public Health Service/Food and                                                                           
 Drug Administration Program for                                                                                
 Certification of Interstate Milk                                                                               
 Shippers                                                                                                       
Frozen Dessert Processing Guidelines    1989                Do                     Office of Plant and Dairy    
                                                                                    Foods and Beverages (HFS-   
                                                                                    302), Center for Food Safety
                                                                                    and Applied Nutrition, 200 C
                                                                                    St. SW., Washington, DC     
                                                                                    20204, 202-205-9175         
Pasteurized Milk Ordinance              1995                States                 Milk Safety Branch           
FDA Nutrition Labeling Manual: A Guide  1993                Food Industry          Office of Food Labeling, Food
 for Developing and Using Databases                                                 and Drug Administration (HFS-
                                                                                    150), 200 C St. SW.,        
                                                                                    Washington, DC 20204, 202-  
                                                                                    205-4561                    
Guidelines for Determining Metric        October 1, 1993     Do                    Do                           
 Equivalents of Household Measures                                                                              
List of Food Defect Action Levels       1995                Food and Animal Feed   Industry Activities Staff    
 (DALS)                                                      Industries                                         
Action Levels for Poisonous or          1995                Do                     Do                           
 Deleterious Substances in Human Food                                                                           
 and Feed (Also Found in CPG's)                                                                                 
1997 FDA Food Code                      1997                States                 NTIS                         
Seafood List                            1993                Seafood Industry       Superintendent of Documents  
Manual of Operations National           1992                States                 Office of Seafood (HFS-407), 
 Shellfish Sanitation                                                               Shellfish Sanitation Branch,
                                                                                    200 C St. SW., Washington,  
                                                                                    DC 20204, 202-418-3150      
Fish and Fisheries Products Hazards     1996                Seafood Industry       Office of Seafood, Food and  
 and Controls Guide                                                                 Drug Administration (HFS-   
                                                                                    400), 200 C St. SW.,        
                                                                                    Washington, DC 20204, 202-  
                                                                                    418-3150                    
Guidance for Submitting Requests under  1996                Food Packaging         Office of Premarket Approval 
 21 CFR 170.39, Threshold of                                 Industry                                           
 Regulation for Substances Used in                                                                              
 Food Articles                                                                                                  
Guidelines for the Preparation of       1996                Food Ingredient or     Do                           
 Petition Submissions                                        Packaging Industry                                 
Guidelines for Approval of Color        1996                Color or Contact Lens  Do                           
 Additives in Contact Lenses Intended                        Industry                                           
 as Colors                                                                                                      
FDA Recommendations for Submission of   February 1993       Color Additives        Do                           
 Chemical and Technological Data on                          Industry                                           
 Color Additives for Food, Drugs or                                                                             
 Cosmetics Use                                                                                                  
Points to Consider for the Use of       December 1992       Food Packaging         Do                           
 Recycled Plastics in Food Packaging:                        Industry                                           
 Chemistry Considerations                                                                                       
Recommendations for Submission of       May 1993            Do                     Do                           
 Chemical and Technological Data for                                                                            
 Direct Food Additive and GRAS Food                                                                             
 Ingredient Petitions                                                                                           
Recommendations for Chemistry Data for  June 1995           Do                     Do                           
 Indirect Food Additive Petitions                                                                               
Enzyme Preparations: Chemistry          January 1993        Food Enzyme Industry   Do                           
 Recommendations for Food Additive and                                                                          
 GRAS Affirmation Petitions                                                                                     
Estimating Exposure to Direct Food      September 1995      Food and Food          Office of Premarket Approval 
 Additive and Chemical Contaminants in                       Ingredient Industry                                
 the Diet                                                                                                       
Toxicological Principles for the        1982                Petitioners for Food   NTIS                         
 Safety Assessment of Direct Food                            or Color Additives                                 
 Additives and Color Additives Used in                                                                          
 Food (also known as Redbook I), PR-83-                                                                         
 170696                                                                                                         
Environmental Assessment Technical      March 1987          Do                     Do                           
 Handbook, PB87175345-AS, A-01                                                                                  
Preparing Environmental Assessments:    August 1990         Do                     Office of Premarket Approval 
 General Suggestions                                                                                            
Step-by-Step Guidance for Preparing     March 1987          Do                     Do                           
 Environmental Assessments                                                                                      
Environmental Assessment of Food-       February 1994       Do                     Do                           
 packaging Materials with Enhanced                                                                              
 Degradation Characteristics                                                                                    
Color Additive Petitions Information    1996                Petitioners for Color  Do                           
 and Guidance                                                Additives                                          
Toxological Testing of Food Additives   1983                Petitioners for Food   Do                           
                                                             or Color Additives                                 
List of Products for Each Product       October 8, 1992     Food Industry          Office of Food Labeling      
 Category                                                                                                       

[[Page 9834]]

                                                                                                                
Label Declaration of Allergenic         June 10, 1996       Do                     Do                           
 Substances in Foods; Notice to                                                                                 
 Manufacturers                                                                                                  
Guidance on Labeling of Foods that      February 24, 1997   Do                     Do                           
 Need Refrigeration by Consumers         (62 FR 8248)                                                           
Interim Guidance on the Voluntary       February 10, 1994   Do                     Do                           
 Labeling of Milk and Milk Products      (59 FR 6279)                                                           
 that have not been treated with                                                                                
 Recombinant Bovine Somatropin                                                                                  
Guidelines Concerning Notification and  1985                Infant Formula         Office of Special            
 Testing of Infant Formula                                   Manufacturers          Nutritionals (HFS-450), Food
                                                                                    and Drug Administration, 200
                                                                                    C St. SW., Washington, DC   
                                                                                    20204                       
Clinical Testing of Infant Formulas     1985                Do                     Do                           
 with Respect to Nutritional                                                                                    
 Suitability for Term Infants                                                                                   
Guidelines for the Evaluation of the    1988                Do                     Do                           
 Safety and Suitability of New Infant                                                                           
 Formulas for Feeding Infants with                                                                              
 Allergic Diseases                                                                                              
Guidelines for the Evaluation of the    1990                Do                     Do                           
 Safety and Suitability of Infant                                                                               
 Formulas for Feeding Infants with                                                                              
 Allergic Diseases                                                                                              
Guidelines for the Clinical Evaluation  1987                Do                     Do                           
 of New Products Used in the Dietary                                                                            
 Management of Infants, Children and                                                                            
 Pregnant Women with Metabolic                                                                                  
 Disorders                                                                                                      
Guidance Document for Arsenic (Trace    January 1993        States                 Office of Seafood (HFS-400)  
 Elements in Seafood)                                                               or via Internet: FDA Home   
                                                                                    Page at http://
vm.cfsan.fda.gov/list.html  
Guidance Document for Cadmium (Trace    January 1993        Do                     Office of Seafood (HFS-400)  
 Elements in Seafood)                                                               or via Internet: FDA Home   
                                                                                    Page at http://
vm.cfsan.fda.gov            
Guidance Document for Chromium (Trace   January 1993        Do                     Do                           
 Elements in Seafood)                                                                                           
Guidance Document for Lead (Trace       August 1993         Do                     Do                           
 Elements in Seafood)                                                                                           
Guidance Document for Nickel (Trace     January 1993        Do                     Do                           
 Elements in Seafood)                                                                                           
FDA's Policy for Foods Developed by     1995                Food Industry          Office of Premarket Approval 
 Biotechnology                                                                      or via Internet: FDA Home   
                                                                                    Page at http://
vm.cfsan.fda.gov            
Bovine Spongiform Encephalopathy (BSE)  1997                Do                     Office of Plant and Dairy    
 In Products for Human Use                                                          Foods and Beverages or via  
                                                                                    Internet: FDA Home Page at  
                                                                                    http://www.fda.gov/opacom/
morechoices/industry/
guidance/gelguide.htm       
Shellfish Sanitation Model Ordinance    1995                States                 Shellfish Program            
                                                                                    Implementation Branch,      
                                                                                    Division of Cooperative     
                                                                                    Programs, Office of Field   
                                                                                    Programs (HFS-628), 200 C   
                                                                                    St. SW., Washington, DC     
                                                                                    20204, 202-205-8137         
----------------------------------------------------------------------------------------------------------------

VI. Guidance Documents Issued by the Center for Veterinary Medicine 
(CVM)

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                                                    How to Obtain a Hard Copy of
                                                             Grouped by Intended       the Document (Name and   
           Name of Document              Date of Issuance     User or Regulatory    Address, Phone, FAX, E-mail,
                                                                   Activity                 or Internet)        
----------------------------------------------------------------------------------------------------------------
Citizen Petitions: Policy and           June 7, 1994        Do                     Do                           
 Procedures (Guide No. 1240.2030)                                                                               
CVM's Implementation of the Agency's    June 15, 1994       Do                     Do                           
 Fraud, Untrue Statements of Material                                                                           
 Facts, Bribery & Illegal Gratuities                                                                            
 Policy (Guide No. 1240.2040)                                                                                   
Intra-Agency Relationship (Guide No.    August 11, 1993     Do                     Do                           
 1240.2100)                                                                                                     
Procedures for Resolving Disagreements  April 10, 1991      Do                     Do                           
 within CVM (Guide No. 1240.2110)                                                                               
Product Manager (Guide No. 1240.2120)   August 11, 1993     Do                     Do                           

[[Page 9835]]

                                                                                                                
CVM P & P Manual Utilization and        September 3, 1997   Do                     Do                           
 Maintenance (Guide No. 1240.2140)                                                                              
CVM Small Business (Guide No.           April 10, 1991      Do                     Do                           
 1240.2150)                                                                                                     
CVM Public Affairs Program (Guide No.   April 7, 1995       Do                     Do                           
 1240.2152)                                                                                                     
Evaluation of Proposed Legislation      April 7, 1995        Do                    Do                           
 (Guide No. 1240.2154)                                                                                          
Voluntary Compliance (Guide No.         August 11, 1992     Do                     Do                           
 1240.2202)                                                                                                     
Approval of New Animal Drug             August 11, 1992     Do                     Do                           
 Applications and their Supplements                                                                             
 (Guide No. 1240.2210)                                                                                          
Classification of OTC and Rx Drugs      January 15, 1985    Do                     Do                           
 (Guide No. 1240.2220)                                                                                          
Processing General Correspondence by    June 28, 1993       Do                     Do                           
 Individual Offices in CVM (Guide No.                                                                           
 1240.2300)                                                                                                     
Routing of Congressional                April 9, 1997       Do                     Do                           
 Correspondence (Guide No. 1240.2302)                                                                           
Correspondence to Practicing            June 28, 1993       Do                     Do                           
 Veterinarians, Vet Med Associations,                                                                           
 and other Scientific Disciplines                                                                               
 (Guide No. 1240.2310)                                                                                          
Communication and Liaison with other    May 7, 1991         Do                     Do                           
 Centers and Agencies (Guide No.                                                                                
 1240.2320)                                                                                                     
Intercommunication between CVM and      June 28, 1993       Do                     Do                           
 Office of Chief Counsel (Guide No.                                                                             
 1240.2322)                                                                                                     
CVM Guidance on Media Inquiries (Guide  July 1, 1997        Do                     Do                           
 No. 1240.2325)                                                                                                 
Consultative Reviews and Opinions       May 7, 1991         Do                     Do                           
 (Guide No. 1240.2330)                                                                                          
Freedom of Information Requests (Guide  September 4, 1997   Do                     Do                           
 No. 1240.2500)                                                                                                 
Public Availability of Food Additive    June 25, 1993       Do                     Do                           
 Petitions (Guide No. 1240.2501)                                                                                
Advisory Opinions and Informal          October 23, 1985    Do                     Do                           
 Requests for Information (Guide No.                                                                            
 1240.2510)                                                                                                     
Confidentiality of Center Files (Guide  June 25, 1993       Do                     Do                           
 No. 1240.2520)                                                                                                 
Industry Conferences (Guide No.         June 11, 1990       Do                     Do                           
 1240.2600)                                                                                                     
Meetings with Representatives from      September 8, 1994   Do                     Do                           
 Foreign Governments (Guide No.                                                                                 
 1240.2601)                                                                                                     
Trade Media Visits to CVM (Guide No.    September 8, 1994   Do                     Do                           
 1240.2610)                                                                                                     
New Animal Drugs for Investigational    September 30, 1996  Do                     Do                           
 Use (Guide No. 1240.3000)                                                                                      
Processing Original Investigational     September 30, 1996  Do                     Do                           
 New Animal Drug Applications (Guide                                                                            
 No. 1240.3010)                                                                                                 
Processing Amendments to An             September 30, 1996  Do                     Do                           
 Investigational New Animal Drug                                                                                
 Application (Guide No. 1240.3020)                                                                              
Non-Routine Invest. New Animal Drugs    September 30, 1996  Do                     Do                           
 (Guide No. 1240.3025)                                                                                          
Initial Processing of an NADA (Guide    March 25, 1991      Do                     Do                           
 No. 1240.3100)                                                                                                 
Review of Animal Safety and             August 1, 1989      Do                     Do                           
 Effectiveness Data (Guide No.                                                                                  
 1240.3101)                                                                                                     
Use of Foreign Non-Clinical and         September 6, 1989   Do                     Do                           
 Clinical Data in an NADA (Guide No.                                                                            
 1240.3102)                                                                                                     
Review of Vet. Med. Guidelines (Guide   November 23, 1993   Do                     Do                           
 No. 1240.3103)                                                                                                 
Specialty Reviews of NADAs (Guide No.   December 17, 1993   Do                     Do                           
 1240.3110)                                                                                                     
Preparation of NADA Decision Package    November 23, 1993   Do                     Do                           
 (Guide No. 1240.3120)                                                                                          
Routing of NADA Decision Package        November 23, 1993   Do                     Do                           
 (Guide No. 1240.3122)                                                                                          
CVM Appeals Procedure Guide (Guide No.  November 23, 1993   Do                     Do                           
 1240.3130)                                                                                                     
Animal Drug Applications Expedited      November 23, 1993   Do                     Do                           
 Review Guideline (Guide No.                                                                                    
 1240.3135)                                                                                                     
Labeling Policy for Animal Drugs that   October 13, 1994    Do                     Do                           
 may be Human Carcinogens (Guide No.                                                                            
 1240.3140)                                                                                                     
NADA Review of Dosage Form Oral         October 13, 1994    Do                     Do                           
 Electrolytes (Guide No. 1240.3150)                                                                             
Food Additive Petition Review (Guide    December 7, 1993    Do                     Do                           
 No. 1240.3300)                                                                                                 

[[Page 9836]]

                                                                                                                
Nutritional Ingredients in Animal       March 23, 1993      Do                     Do                           
 Drugs and Feeds (Guide No. 1240.3420)                                                                          
New Animal Drug Determination (Guide    July 24, 1989       Do                     Do                           
 No. 1240.3500)                                                                                                 
New Animal Drug Regulation (Guide No.   September 4, 1991   Do                     Do                           
 1240.3502)                                                                                                     
Drug Experience Reporting Requirements  November 23, 1993   Do                     Do                           
 (Guide No. 1240.3510)                                                                                          
Additional Sources of Adverse Reaction  November 23, 1993   Do                     Do                           
 and Injury Reports (Guide No.                                                                                  
 1240.3512)                                                                                                     
 Drug Experience Reporting by           May 7, 1997         Do                     Do                           
 Veterinarians (Guide No. 1240.3514)                                                                            
Adverse Reactions as a Basis for        November 23, 1993   Do                     Do                           
 Regulatory Action (Guide No.                                                                                   
 1240.3520)                                                                                                     
Animal Health Hazard Evaluation         March 28, 1986      Do                     Do                           
 Committee (Guide No. 1240.3521)                                                                                
 Review and Evaluation of Drug          November 23, 1993   Do                     Do                           
 Experience Reports (Guide No.                                                                                  
 1240.3522)                                                                                                     
Criteria for Veterinary Medical Review  November 23, 1993   Do                     Do                           
 of Establishment Inspection Reports                                                                            
 (Guide No. 1240.3524)                                                                                          
Procedures for Processing Drug          November 23, 1993   Do                     Do                           
 Experience Reports (Guide No.                                                                                  
 1240.3530)                                                                                                     
Consumer Complaint Letters (Guide No.   September 6, 1989   Do                     Do                           
 1240.3532)                                                                                                     
NADAs, Withdrawal of Approvals (Guide   November 23, 1993   Do                     Do                           
 No. 1240.3540)                                                                                                 
Implementation of Causal Reviews        November 23, 1993   Do                     Do                           
 (Guide No. 1240.3542)                                                                                          
Surveillance at Professional and Trade  November 23, 1993   Do                     Do                           
 Meetings (Guide No. 1240.3550)                                                                                 
Registration of Producers of Drugs and  September 9, 1997   Do                     Do                           
 Listing Of Drugs in Commercial                                                                                 
 Distribution (Guide No. 1240.3560)                                                                             
Types of Enforcement Activities (Guide  September 9, 1997   Do                     Do                           
 No. 1240.3600)                                                                                                 
Types of Regulatory Actions (Guide No.  September 9, 1997   Do                     Do                           
 1240.3601)                                                                                                     
Regulating Animal Foods with Drug       September 9, 1997   Do                     Do                           
 Claims (Guide No. 1240.3605)                                                                                   
Request for CGMP Establishment          September 9, 1997   Do                     Do                           
 Inspections (Guide No. 1240.3620)                                                                              
Good Manufacturing Practice Compliance  September 9, 1997   Do                     Do                           
 Status (Guide No. 1240.3622)                                                                                   
Tissue Residue Reporting (Guide No.     September 9, 1997   Do                     Do                           
 1240.3630)                                                                                                     
Diversion of Unfit Food to Animal Use   September 9, 1997   Do                     Do                           
 (Guide No. 1240.3650)                                                                                          
Development of Compliance Policy        September 9, 1997   Do                     Do                           
 Guides Affecting Veterinary Products                                                                           
 (Guide No. 1240.3660)                                                                                          
Preparation of Compliance Programs and  September 9, 1997   Do                     Do                           
 Program Circulars (Guide No.                                                                                   
 1240.3661)                                                                                                     
Management of Formal Evidentiary        September 9, 1997   Do                     Do                           
 Hearings (Guide No. 1240.3670)                                                                                 
Center for Veterinary Medicine          November 3, 1993    Do                     Do                           
 Research Activities (Guide No.                                                                                 
 1240.3700)                                                                                                     
Initiation and Approval of Research     November 3, 1993    Do                     Do                           
 Projects (Guide No. 1240.3710)                                                                                 
Identification/Promotion of NADA        September 10, 1997  Do                     Do                           
 Product Approval (Guide No.                                                                                    
 1240.4000)                                                                                                     
Procedure for Center Recommended        September 10, 1997  Do                     Do                           
 Labeling Changes (Guide No.                                                                                    
 1240.4005)                                                                                                     
Antibacterials Labeled for Secondary    September 10, 1997  Do                     Do                           
 Infections (Guide No. 1240.4010)                                                                               
Uniformity in Labeling (Guide No.       September 10, 1997  Do                     Do                           
 1240.4020)                                                                                                     
General Policies for Animal Drug Label  September 10, 1997  Do                     Do                           
 Review (Guide No. 1240.4021)                                                                                   
Therapeutic Use Directions for          September 10, 1997  Do                     Do                           
 Medicated Feed and Drinking Water                                                                              
 (Guide No. 1240.4025)                                                                                          
Established Names (Guide No.            September 10, 1997  Do                     Do                           
 1240.4030)                                                                                                     
Clinical Investigator Sanctions & the   September 10, 1997  Do                     Do                           
 Videotex Method of Obtaining                                                                                   
 Information on Ineligible                                                                                      
 Investigators (Guide No. 1240.4040)                                                                            
Criteria for the Approval of            January 5, 1987     Do                     Do                           
 Euthanasia Products (Guide No.                                                                                 
 1240.4112)                                                                                                     

[[Page 9837]]

                                                                                                                
Sterility of Ophthalmic Products        December 7, 1993    Do                     Do                           
 (Guide No. 1240.4120)                                                                                          
Sterility and Pyrogen Requirements for  November 27, 1989   Do                     Do                           
 Injectable Drug Products (Guide No.                                                                            
 1240.4122)                                                                                                     
Overformulation in Animal Drug          January 2, 1992     Do                     Do                           
 Products (Guide No. 1240.4130)                                                                                 
Continuous Use Production Drugs &       April 16, 1990      Do                     Do                           
 Short-Term Therapeutic Treatments in                                                                           
 Feeds (Guide No. 1240.4145)                                                                                    
Ownership Transfer or Corporate         January 2, 1992     Do                     Do                           
 Identity Change of an Application                                                                              
 (Guide No. 1240.4150)                                                                                          
Policy on Sterilization of New Animal   September 10, 1997  Do                     Do                           
 Drug Products and Containers by                                                                                
 Irradiation (Guide No. 1240.4160)                                                                              
CVM Medically Necessary Veterinary      June 30, 1994       Do                     Do                           
 Drug Product Shortage Management                                                                               
 (Guide No. 1240.4170)                                                                                          
 Drug Use in Aquaculture Enforcement    October 29, 1997    Do                     Do                           
 Priorities (Guide No. 1240.4200)                                                                               
Extra-label Use of Approved Drugs in    October 29, 1997    Do                     Do                           
 Aquaculture (Guide No. 1240.4210)                                                                              
Drug-Pesticide Issues (Guide No.        October 29, 1997    Do                     Do                           
 1240.4220)                                                                                                     
Regulation of Fish Identification       October 29, 1997    Do                     Do                           
 Products (Guide No. 1240.4230)                                                                                 
Safe Levels of Unapproved Drugs in      October 29, 1997    Do                     Do                           
 Aquaculture (Guide No. 1240.4240)                                                                              
Classification of Aquaculture Species/  October 29, 1997    Do                     Do                           
 Population as Food or Non-Food (Guide                                                                          
 No. 1240.4260)                                                                                                 
Use of Drugs in Outdoor Aquatic         October 29, 1997    Do                     Do                           
 Research Facilities (Guide No.                                                                                 
 1240.4270)                                                                                                     
Generic Animal Drug and Patent Term     November 23, 1988   Animal drug industry   Communications Staff (HFV-   
 Restoration Act (GADPTRA) Policy                                                   12), FDA/CVM, 7500 Standish 
 Letter 1.--Describes patent and                                                    Pl., Rockville, MD 20855,   
 exclusivity information to be                                                      301-594-1755, FAX 301-594-  
 submitted to FDA by holders of                                                     1831                        
 approved NADAs and NADA applicants                                                                             
GADPTRA Policy Letter 2.--Describes     June 7, 1989        Do                     Do                           
 format and content for suitability                                                                             
 petitions, format and content for                                                                              
 ANADAs, manufacturing requirements                                                                             
 for ANADAs, and environmental review                                                                           
 of generic animal drugs                                                                                        
GADPTRA Policy Letter 3.--              July 2, 1989        Do                     Do                           
 ``Exclusivity for human food safety                                                                            
 data submitted in supplemental                                                                                 
 application,'' ``Withdrawal period                                                                             
 for generic drugs,'' ``Substitution                                                                            
 of an active ingredient in a                                                                                   
 combination drug or in a feed use                                                                              
 combination,'' ``Labeling                                                                                      
 Requirements for Generic Drugs,''                                                                              
 ``Can a generic animal drug sponsor                                                                            
 obtain exclusivity for an innovation                                                                           
 approved under a supplement to an                                                                              
 ANADA and can the pioneer drug                                                                                 
 sponsor copy the generic innovation                                                                            
 without submitting additional data?''                                                                          
GADPTRA Policy Letter 4.--``Actions     November 2, 1989    Do                     Do                           
 concerning ANADAs when a pioneer drug                                                                          
 has been withdrawn from sale,''                                                                                
 ``Effect of GADPTRA on approval of                                                                             
 pre-62 drugs under the DESI                                                                                    
 program,'' ``Generic feed use                                                                                  
 combination drugs''                                                                                            
GADPTRA Policy Letter 5.--              April 12, 1990      Do                     Do                           
 Bioequivalence Guideline                                                                                       
GADPTRA Policy Letter 6.--``Withdrawal  October 17, 1990    Do                     Do                           
 period for generic animal drug                                                                                 
 products,'' ``Eligibiliity of a new                                                                            
 salt or ester for a pioneer animal                                                                             
 drug''                                                                                                         
GADPTRA Policy Letter 7.--``Guidance    March 20, 1991      Do                     Do                           
 for analytical methods for ANADAs,''                                                                           
 ``ANADAs, NADAs and supplemental                                                                               
 approvals for subtherapeutic                                                                                   
 antibiotics,'' ``Hybrid                                                                                        
 applications,'' ``Waivers of In Vivo                                                                           
 bioequivalence studies for topical                                                                             
 products''                                                                                                     
GADPTRA Policy Letter 8.--Generic       July 23,1991        Do                     Do                           
 copying of certain drugs that were                                                                             
 subject to review under the Drug                                                                               
 Efficacy Study Implementation (DESI)                                                                           
 program                                                                                                        

[[Page 9838]]

                                                                                                                
GADPTRA Policy Letter 9.--``Policy      June 27, 1995       Do                     Do                           
 Statement on Environmental Review of                                                                           
 Generic Animal Drugs'' (Revision of a                                                                          
 policy statement of the same title in                                                                          
 Generic Policy Letter #2                                                                                       
Guide for Reporting Drug Shipment(s)    June 19, 1992       Do                     Do                           
 for Clinical Trials in Non-Food                                                                                
 Animals                                                                                                        
Guide for Reporting The Details of      no date             Do                     Do                           
 Clinical Trials Using Investigational                                                                          
 New Animal Drug(s) in Food-Producing                                                                           
 Animals                                                                                                        
Aquaculture Drug Use: Answers to        June 1995           Do                     Do Internet via http://
 Commonly Asked Questions                                                           www.cvm.fda.gov/ Guideline 3.--General Principles for    July 1994           Do                     Do                           
 Evaluating the Safety of Compounds                                                                             
 Used in Food-Producing Animals                                                                                 
Guideline 4.--Guidelines for Efficacy   no date             Do                     Do                           
 Studies for Systemic Sustained                                                                                 
 Release Sulfonamide Boluses for                                                                                
 Cattle                                                                                                         
Guideline 5.--Stability Guidelines      December 1990       Do                     Do                           
Guideline 6.--Guidelines for            March 1976          Do                     Do                           
 Submitting NADA's for Generic Drugs                                                                            
 Reviewed by NAS/NRC                                                                                            
Guideline 9.--Preclearance Guidelines   October 1975        Do                     Communications Staff         
 for Production Drugs                                                                                           
Guideline 10.--Amendment of Section     October 1975        Do                     Do Internet at http://
 II(G)(1)(b)(4) of the Preclearance                                                 www.cvm.fda.gov/
 Guidelines                                                                                                     
Guideline 13.--Guidelines for           January 1985        Do                     Do                           
 Evaluation of Effectiveness of New                                                                             
 Animal Drugs for Use in Free-Choice                                                                            
 Feeds (revision of Medicated Block)                                                                            
Guideline 14.--Guideline and Format     no date             Do                     Do                           
 for Reporting the Details of Clinical                                                                          
 Trials Using An Investigational New                                                                            
 Animal Drug in FOOD Producing Animals                                                                          
Guideline 15.--Guideline and Format     February 1977       Do                     Do                           
 for Reporting the Details of Clinical                                                                          
 Trials Using An Investigational New                                                                            
 Animal Drug in NON-FOOD Producing                                                                              
 Animals                                                                                                        
Guideline 16.--FOI Summary Guideline    May 1985            Do                     Do                           
Guideline 18.--Antibacterial Drugs in   no date             Do                     Do                           
 Animal Feeds: Human Health Safety                                                                              
 Criteria                                                                                                       
Guideline 19.--Antibacterial Drugs in   no date             Do                     Do                           
 Animal Feeds: Animal Health Safety                                                                             
 Criteria                                                                                                       
Guideline 20.--Antibacterial Drugs in   no date             Do                     Do                           
 Animal Feeds: Antibacterial                                                                                    
 Effectiveness Criteria                                                                                         
Guideline 22.--Guideline Labeling of    no date             Do                     Do                           
 Arecoline Base Drugs Intended for                                                                              
 Animal Use                                                                                                     
Guideline 23.--Medicated Free Choice    July 1985           Do                     Do                           
 Feeds--Manufacturing Control                                                                                   
Guideline 24.----Guidelines for Drug    October 1983        Do                     Do                           
 Combinations for Use in Animals                                                                                
Guideline 25.--Guidelines for the       January 1979        Do                     Do                           
 Efficacy Evaluation of Equine                                                                                  
 Anthelmintics                                                                                                  
Guideline 26.--Guidelines for the       April 1986          Do                     Do                           
 Preparation of Data to Satisfy the                                                                             
 Requirements of Section 512 of the                                                                             
 Act Regarding Animal Safety,                                                                                   
 Effectiveness, Human Food Safety and                                                                           
 Environmental Considerations for                                                                               
 Minor Use of New Animal Drugs                                                                                  
Guideline 29.--Guidelines for the       September 1980      Do                     Do                           
 Effectiveness Evaluation of Swine                                                                              
 Anthelmintics                                                                                                  
Guideline 31.--Guidelines for the       July 1981           Do                     Do                           
 Evaluation of Bovine Anthelmintics                                                                             
Guideline 33.--Target Animal Safety     June 1989           Do                     Do                           
 Guidelines for New Animal Drugs                                                                                
Guideline 35.--Bioequivalence           1996                Do                     Do                           
 Guideline--Final (1996)                                                                                        
Guideline 36.--Guidelines for Efficacy  July 1985           Do                     Do                           
 Evaluation of Canine/Feline                                                                                    
 Anthelmintics                                                                                                  
Guideline 37.--Guidelines for           March 1984          Do                     Do                           
 Evaluation of Effectiveness of New                                                                             
 Animal Drugs for Use in Poultry Feed                                                                           
 for Pigmentation                                                                                               
Guideline 38.--Guideline for            August 1984         Do                     Do                           
 Effectiveness Evaluation of Topical/                                                                           
 Otic Animal Drugs                                                                                              

[[Page 9839]]

                                                                                                                
Guideline 40.--Draft Guideline for the  April 1992          Do                     Do                           
 Evaluation of the Efficacy of                                                                                  
 Anticoccidial Drugs and Anticoccidial                                                                          
 Drug Combinations in Poultry                                                                                   
Guideline 41.--Draft Guideline:         June 1992           Do                     Do                           
 Formatting, Assembling, and                                                                                    
 Submitting New Animal Drug                                                                                     
 Applications                                                                                                   
Guideline 42.--Series of four           1994                Do                     Do                           
 guidelines entitled ``Animal Drug                                                                              
 Manufacturing Guidelines, 1994''                                                                               
Guideline 43.--Guidance on Generic      October 1995        Do                     Do                           
 Animal Drug Products Containing                                                                                
 Fermentation-Derived Drug Substances                                                                           
Guideline 45.--Guideline for Uniform    August 1993         Do                     Do                           
 Labeling of Drugs for Dairy and Beef                                                                           
 Cattle                                                                                                         
Guideline 48.--Guidance for Industry    November 1994       Do                     Communications Staff         
 for the Submission of Documentation                                                                            
 for Sterilization Process Validation                                                                           
 in Applications for Human and                                                                                  
 Veterinary Drug Products                                                                                       
Guideline 49.--Guidance Document for    April 1996          Do                     Do                           
 Target Animal Safety and Drug                                                                                  
 Effectiveness Studies for Anti-                                                                                
 Microbial Bovine Mastitis Products                                                                             
Guideline 50.--Draft Guideline for      February 1993       Do                     Do                           
 Target Animal and Human Food Safety,                                                                           
 Drug Efficacy, Environmental and                                                                               
 Manufacturing Studies for Teat                                                                                 
 Antiseptic Products                                                                                            
Guideline 51.--Points to Consider       1993                Do                     Do                           
 Guideline--Development of a                                                                                    
 Pharmacokinetic Guideline Enabling                                                                             
 Flexible Labeling of Therapeutic                                                                               
 Antimicrobials                                                                                                 
Guideline 52.--Guidance--               January 1996        Do                     Do                           
 Microbiological Testing of                                                                                     
 Antimicrobial Drug Residues in Food                                                                            
Guideline 53.--Guideline for the        May 1994            Do                     Do                           
 Evaluation of the Utility of Food                                                                              
 Additives in Diets Fed to Aquatic                                                                              
 Animals                                                                                                        
Guideline 54.--Draft Guideline for      June 1994           Do                     Do                           
 Utility Studies for Anti-Salmonella                                                                            
 Chemical Food Additives in Animal                                                                              
 Feeds                                                                                                          
Guideline 55.--Supportive Data for Cat  June 1994           Do                     Do                           
 Food Labels Bearing ``Reduces Urinary                                                                          
 pH Claims: Guideline in Protocol                                                                               
 Development''                                                                                                  
Guideline 56.--Protocol Development     November 1994       Do                     Do                           
 Guideline for Clinical Effectiveness                                                                           
 and Target Animal Safety Trials                                                                                
Guideline 57.--Master Files--Guidance   July 1995           Do                     Do                           
 for Industry for the Preparation and                                                                           
 Submission of Veterinary Master Files                                                                          
Guideline 58.--Guidance for Industry    May 1997            Do                     Do                           
 for Good Target Animal Study                                                                                   
 Practices: Clinical Investigators and                                                                          
 Monitors                                                                                                       
Guideline 59.--Guidance to Industry     June 1997           Do                     Do                           
 Submitting Notices of Claimed                                                                                  
 Investigational Exemption in                                                                                   
 Electronic Format to CVM Via E-mail                                                                            
Guideline 60.--Guidance for Industry    June 1997           Do                     Do                           
 Animal Proteins Prohibited From                                                                                
 Animal Feed, Small Entity Compliance                                                                           
 Guide                                                                                                          
Guideline 61.--Draft Guidance for       September 1997      Do                     Do                           
 Industry--FDA Approval of Animal                                                                               
 Drugs for Minor Uses and for Minor                                                                             
 Species                                                                                                        
Guideline 62.--Draft Guidance for       August 1997         Do                     Do                           
 Industry--Consumer-Directed Broadcast                                                                          
 Advertisements                                                                                                 
NADA Pre-approval Inspections (No.      November 1, 1993    FDA investigators and  Freedom of Information Staff 
 7368.001)                                                   analysts and           (HFI-35), Food and Drug     
                                                             regulated industry     Administration, 5600 Fishers
                                                                                    Lane, Rockville, MD 20857,  
                                                                                    301-443-6310, FAX 301-443-  
                                                                                    1726                        
Drug Process and New Animal Drug        October 8, 1996     Do                     Do                           
 Inspections (No. 7371.001)                                                                                     
Illegal Sales of Veterinary             August 17, 1993     Do                     Do                           
 Prescription Drugs (No. 7371.002)                                                                              
Feed Contaminants (No. 7371.003)        November 1, 1993    Do                     Do                           
                                         (July 31, 1996--                                                       
                                         Partial Revision)                                                      
Medicated Feeds (No. 7371.004)          July 7, 1995        Do                     Do                           

[[Page 9840]]

                                                                                                                
Type A Medicated Articles (No.          January 1, 1992     Do                     Do                           
 7371.005)                                                                                                      
Illegal Drug Residues in Meat and       September 9, 1996   Do                     Do                           
 Poultry (No. 7371.006)                                                                                         
Imported Bulk New Animal Drugs (No.     October 1, 1991     Do                     Do                           
 7371.007)                                                                                                      
Center for Veterinary Medicine Public   May 3, 1996         Do                     Do                           
 Affairs Specialist Program (No.                                                                                
 7371.826)                                                                                                      
CVM Initiates Veterinary Drug Listing   February 3, 1994    Public information     Communications Staff, FDA/   
 Verification                                                                       CVM, 7500 Standish Pl. (HFV-
                                                                                    12), Rockville, MD 20855,   
                                                                                    301-594-1755, FAX 301-594-  
                                                                                    1831                        
FDA Position on the Extra-Label Use of  September 14, 1995  Do                     Do                           
 Fluoroquinolones                                                                                               
CVM Announces Opinion on Dipyrone       December 6, 1995    Do                     Do                           
 Products                                                                                                       
Regulation of Animal Electronic         January 17, 1996    Do                     Do                           
 Identification Products                                                                                        
Update on Extra-Label Use of            July 16, 1996       Do                     Do Internet via http://
 Fluoroquinolones                                                                   www.cvm.fda.gov/ Caution Urged in Using Warbex           October 4, 1996     Do                     Do                           
Revised Labeling for Some Medicated     January 30, 1997    Do                     Do                           
 Feed Products                                                                                                  
Colloidal Silver Not Approved For       February 12, 1997   Do                     Do                           
 Treating Animals                                                                                               
CVM Policy on Competitive Exclusion     February 21, 1997   Do                     Do                           
 Products                                                                                                       
Updated Policy on the Use of Animal     March 14, 1997      Do                     Do                           
 Electronic Identification Products in                                                                          
 Swine                                                                                                          
Human Drug Product not Equivalent to    July 16, 1997       Do                     Do                           
 Veterinary Ceftiofur                                                                                           
FDA Requests That Ball Clay Not be      October 14, 1997    Do                     Do                           
 Used in Animal Feeds                                                                                           
----------------------------------------------------------------------------------------------------------------

VII. Guidance Documents Issued by the Office of Policy

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                                                    How to Obtain a Hard Copy of
                                                             Grouped by Intended       the Document (Name and   
           Name of Document              Date of Issuance     User or Regulatory    Address, Phone, FAX, E-mail,
                                                                   Activity                 or Internet)        
----------------------------------------------------------------------------------------------------------------
FDA's Development, Issuance and Use of  February 1997       Internal FDA and       Internet via www.fda.gov/
 Guidance Documents                                          regulated industry     opacom/morechoices/         
                                                                                    moreindu.html or Office of  
                                                                                    Policy 301-827-3360         
Industry Supported Scientific and       December 1997       Regulated industry     Internet via www.fda.gov/cder/
 Educational Activities                                                             guidance/index.htm or Office
                                                                                    of Policy 301-827-3360      
Draft Guidance on Consumer Directed     February 1997       Do                     Do                           
 Broadcast Advertisements                                                                                       
Direct Final Rule Guidance              November 1997       Internal FDA           Internet via www.fda.gov/
opacom/morechoices/industry/
preguide.htm or Marquita    
                                                                                    Steadman 301-443-3480       
Small Entities Compliance Guide On:     February 1997       Regulated industry     Internet via www.fda.gov/
 Regulations to Restrict the Sale and                                               opacom/campaigns/tobacco/   
 Distribution of Cigarettes and                                                     tobret.htm or 1-888-FDA-    
 Smokeless Tobacco in Order to Protect                                              4KIDS                       
 Children and Adolescents (21 CFR Part                                                                          
 897)                                                                                                           
Children and Tobacco--Frequently Asked  July 1997           Do                     Internet via www.fda.gov/
 Questions About the New Regulations-                                               opacom/campaigns/tobacco/   
 Draft Guidance                                                                     tobret.htm or 1-888-FDA-    
                                                                                    4KIDS                       
Children & Tobacco--A Retailer's Guide  October 1997        Do                     Internet via www.fda.gov/
 to the New Federal Regulations                                                     opacom/campaigns/tobacco/   
                                                                                    tobret.htm or 1-888-FDA-    
                                                                                    4KIDS                       
Children & Tobacco--A Guide to the New  October 1997        Do                     Internet via www.fda.gov/
 Federal Regulations                                                                opacom/campaigns/tobacco/   
                                                                                    tobret.htm or 1-888-FDA-    
                                                                                    4KIDS                       
FDA's Standards Policy                  October 1995        Internal FDA and       60 FR 53078, October 11, 1995
                                                             regulated industry     or Office of Policy 301-827-
                                                                                    3360                        
----------------------------------------------------------------------------------------------------------------


[[Page 9841]]

VIII. Guidance Documents Issued by the Office of Regulatory Affairs

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                                                    How to Obtain a Hard Copy of
                                                             Grouped by Intended       the Document (Name and   
           Name of Document              Date of Issuance     User or Regulatory    Address, Phone, FAX, E-mail,
                                                                   Activity                 or Internet)        
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guides Manual (PB96-  August 1996         FDA Staff Personnel    National Technical           
 915499)                                                                            Information Service (NTIS), 
                                                                                    5285 Port Royal Rd.,        
                                                                                    Springfield, VA 22161 or via
                                                                                    Internet at www.fda.gov/ora/
compliance_ref/cpg/
cpgtc.html                  
FDA/ORA International Inspection        May 1997            Do                     FDA, Division of Emergency   
 Manual and Travel Guide                                                            and Investigational         
                                                                                    Operations (HFC-130), 5600  
                                                                                    Fishers Lane, Rockville, MD 
                                                                                    20857 or via Internet at    
                                                                                    www.fda.gov/ora/inspect_ref/
itob/itob.html              
Glossary of Computerized System and     August 1995         Do                     NTIS or via Internet at      
 Software Development Terminology                                                   www.fda.gov/ora/inspect_ref/
 (PB96-127352)                                                                      igs/iglist.html             
Import Alerts                           continuously        Do                     FDA, Freedom of Information  
                                                                                    Staff (HFI-35), 5600 Fishers
                                                                                    Lane, Rockville, MD 20857,  
                                                                                    or via Internet at          
                                                                                    www.fda.gov/ora/fiars/ora_
import_alerts.html         
Investigations Operations Manual (PB96- May 1996            Do                     NTIS or via Internet at      
 913399)                                                                            www.fda.gov/ora/inspect_ref/
iom/iomtc.html              
Laboratory Procedures Manual            June 1994           Do                     FDA, Division of Field       
                                                                                    Science (HFC-141), 5600     
                                                                                    Fishers Lane, rm. 12-41,    
                                                                                    Rockville, MD 20857, ATTN:  
                                                                                    Denise I. Jones or via      
                                                                                    Internet at www.fda.gov/ora/
science_ref/lpm/lpmtc.html 
Regulatory Procedures Manual (PB97-     August 1997         Do                     NTIS or via Internet at      
 196182)                                                                            www.fda.gov/ora/compliance_
ref/rpm/rpmtc.html          
Guide to Inspections of Bulk            May 1994            Do                     NTIS or via Internet at      
 Pharmaceutical Chemicals (PB96-                                                    www.fda.gov/ora/inspect_ref/
 127154)                                                                            igs/iglist.html             
Guide to Inspections of Pharmaceutical  July 1993           Do                     Do                           
 Quality Control Laboratories (PB96-                                                                            
 127279)                                                                                                        
Guide to Inspections of                 July 1993           Do                     Do                           
 Microbiological Pharmaceutical                                                                                 
 Quality Control Laboratories (PB96-                                                                            
 127287)                                                                                                        
Guide to Inspections of Validation of   July 1993           Do                     Do                           
 Cleaning Processes (PB96-127246)                                                                               
Guide to Inspections of Lyophilization  July 1993           Do                     Do                           
 of Parenterals (PB96-127253)                                                                                   
Guide to Inspections of High Purity     July 1993           Do                     Do                           
 Water Systems (PB96-127261)                                                                                    
Guide to Inspections of Dosage Form     October 1993        Do                     Do                           
 Drug Manufacturers-CGMPs (PB96-                                                                                
 127212)                                                                                                        
Guide to Inspections of Oral Solid      January 1994        Do                     Do                           
 Dosage Forms Pre/Post Approval Issues                                                                          
 for Development and Validation (PB96-                                                                          
 127345)                                                                                                        
Guide to Inspections of Topical Drug    July 1994           Do                     Do                           
 Products (PB96-127394)                                                                                         
Guide to Inspections of Sterile Drug    July 1994           Do                     Do                           
 Substance Manufacturers (PB96-127295)                                                                          
Guide to Inspections of Oral Solutions  August 1994         Do                     Do                           
 and Suspensions (PB96-127147)                                                                                  
Guide to Inspections of Nutritional     February 1995       Do                     Do                           
 Labeling and Education Act (NLEA)                                                                              
 Requirements (PB96-127378)                                                                                     
Guide to Inspections of Interstate      April 1995          Do                     Do                           
 Carriers and Support Facilities (PB96-                                                                         
 127386)                                                                                                        
Guide to Inspections of Dairy Product   April 1995          Do                     Do                           
 Manufacturers (PB96-127329)                                                                                    
Guide to Inspections of Miscellaneous   May 1995            Do                     Do                           
 Foods Vol. I (PB96-127220)                                                                                     
Guide to Inspections of Miscellaneous   September 1996      Do                     Do                           
 Foods Vol. II (PB97-196133)                                                                                    
Guide to Inspections of Low Acid        November 1996       Do                     Do                           
 Canned Foods Manufacturers, Part 1--                                                                           
 Administrative Procedures/Scheduled                                                                            
 Processes (PB97-196141)                                                                                        

[[Page 9842]]

                                                                                                                
Guide to Inspections of Low Acid        April 1997          Do                     Do                           
 Canned Foods Manufacturers, Part 2--                                                                           
 Processes/Procedures (PB97-196158)                                                                             
Guide to Inspections of Cosmetic        February 1995       Do                     Do                           
 Product Manufacturers (PB96-127238)                                                                            
Guide to Inspections of Blood Banks     September 1994      Do                     Do                           
 (PB96-127303)                                                                                                  
Guide to Inspections of Source Plasma   December 1994       Do                     Do                           
 Establishments (PB96-127360)                                                                                   
Guide to Inspections of Infectious      June 1996           Do                     Do                           
 Disease Marker Testing Facilities                                                                              
 (PB96-199476)                                                                                                  
Biotechnology Inspections Guide (PB96-  November 1991       Do                     Do                           
 127402)                                                                                                        
Guide to Inspections of Computerized    February 1983       Do                     Do                           
 Systems in Drug Processing (PB96-                                                                              
 127337)                                                                                                        
Guide to Inspections of Foreign         September 1995      Do                     Do                           
 Medical Device Manufacturers (PB96-                                                                            
 127311)                                                                                                        
Guide to Inspections of Foreign         May 1996            Do                     Do                           
 Pharmaceutical Manufacturers (PB96-                                                                            
 199468)                                                                                                        
----------------------------------------------------------------------------------------------------------------

IX. International Conference on Harmonization Guidances (CDER)

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                                                    How to Obtain a Hard Copy of
                                                             Grouped by Intended       the Document (Name and   
           Name of Document              Date of Issuance     User or Regulatory    Address, Phone, FAX, E-mail,
                                                                   Activity                 or Internet)        
----------------------------------------------------------------------------------------------------------------
E1A The Extent of Population Exposure   March 1, 1995       Do                     Do                           
 to Assess Clinical Safety: for Drugs                                                                           
 Intended for Long-Term Treatment of                                                                            
 Non-Life-Threatening Conditions                                                                                
E2A Clinical Safety Data Management:    March 1, 1995       Do                     Do                           
 Definitions and Standards for                                                                                  
 Expedited Reporting                                                                                            
E2B Data Elements for Transmission of   October 1, 1996     Do                     Do                           
 Individual Case Safety Reports                                                                                 
E2C Clinical Safety Data Management:    May 19, 1997        Do                     Do                           
 Periodic Safety Update Reports for                                                                             
 Marketed Drugs                                                                                                 
E3 Structure and Content of Clinical    July 17, 1996       Do                     Do                           
 Study Reports                                                                                                  
E4 Dose-Response Information to         November 9, 1994    Do                     Do                           
 Support Drug Registration                                                                                      
E5 Ethnic Factors in the Acceptability  July 31, 1997       Do                     Do                           
 of Foreign Clinical Data                                                                                       
E6 Good Clinical Practices;             May 9, 1997         Do                     Do                           
 Consolidated Guideline                                                                                         
E7 Studies in Support of Special        August 2, 1994      Do                     Do                           
 Populations: Geriatrics                                                                                        
E8 General Considerations for Clinical  May 30, 1997        Do                     Do                           
 Trials                                                                                                         
E9 Statistical Principles for Clinical  May 9, 1997         Do                     Do                           
 Trials                                                                                                         
M3 Timing of Nonclinical Studies for    May 2, 1997         Do                     Do                           
 the Conduct of Human Clinical Trials                                                                           
 for Pharmaceuticals                                                                                            
Q1A Stability Testing of New Drug       September 22, 1994  Do                     Do                           
 Substances and Products                                                                                        
Q2A Text on Validation of Analytical    March 1, 1995       Do                     Do                           
 Procedures                                                                                                     
Q3A Impurities in New Drug Substances   January 4, 1996     Do                     Do                           
Q5A Biotechnological/Biological         May 10, 1996        Do                     Do                           
 Pharmaceutical Products; Viral Safety                                                                          
 Evaluation                                                                                                     
Q6A Specifications; Test Procedures     November 25, 1997   Do                     Do                           
 and Acceptance Criteria for New Drug                                                                           
 Substances and New Drug Products                                                                               
 Chemical Substances                                                                                            
Q1B Photostability Testing of New Drug  May 16, 1997        Do                     Do                           
 Substances and Products                                                                                        
Q1C Stability Testing for New Dosage    May 9, 1997         Do                     Do                           
 Forms                                                                                                          
Q2B Validation of Analytical            May 19,1997         Do                     Do                           
 Procedures: Methodology                                                                                        
Q3B Impurities in New Drug Products     May 19, 1997        Do                     Do                           
Q5B Quality of Biotechnology Products:  February 23, 1996   Do                     Do                           
 Analysis of the Expression Construct                                                                           
 in Cells Used for Production of r-DNA                                                                          
 Derived Protein Products                                                                                       
Q3C Impurities: Residual Solvents       May 2, 1997         Do                     Do                           

[[Page 9843]]

                                                                                                                
Q5C Quality of Biotechnological         July 10, 1996       Do                     Do                           
 Products: Stability Testing of                                                                                 
 Biotechnology/Biological Products                                                                              
Q5D Quality of Biotechnological/        May 2, 1997         Do                     Do                           
 Biological Products: Derivation and                                                                            
 Characterization of Cell Substrates                                                                            
 Used for Production of                                                                                         
 Biotechnological/Biological Products                                                                           
S1A The Need for Long-Term Rodent       March 1, 1996       Do                     Do                           
 Carcinogenicity Studies of                                                                                     
 Pharmaceuticals                                                                                                
S3A Toxicokinetics: The Assessment of   March 1, 1995       Do                     Do                           
 Systemic Exposure in Toxicity Studies                                                                          
S5A Detection of Toxicity to            September 22, 1994  Do                     Do                           
 Reproduction for Medicinal Products                                                                            
S1C Dose Selection for Carcinogenicity  March 1, 1995       Do                     Do                           
 Studies of Pharmaceuticals                                                                                     
S1C (R) Carcinogenicity Studies of      April 2, 1997       Do                     Do                           
 Pharmaceuticals: Addendum to Dose                                                                              
 Selection                                                                                                      
S2A Specific Aspects of Regulatory      April 24, 1996      Do                     Do                           
 Genotoxicity Tests for                                                                                         
 Pharmaceuticals                                                                                                
S3B Pharmacokinetics: Guidance for      March 1, 1995       Do                     Do                           
 Repeated Dose Tissue Distribution                                                                              
 Studies                                                                                                        
S2B Genotoxicity: Standard Battery      April 3, 1997       Do                     Do                           
 Testing                                                                                                        
S4A Duration of Chronic Toxicity        November 18, 1997   Do                     Do                           
 Testing in Animals (Rodent and                                                                                 
 Nonrodent Toxicity)                                                                                            
S5B Detection of Toxicity to            April 5, 1996       Do                     Do                           
 Reproduction for Medicinal Products:                                                                           
 Addendum on Toxicity to Male                                                                                   
 Fertility                                                                                                      
S6 Preclinical Testing of               April 4, 1997       Do                     Do                           
 Biotechnology-Derived Pharmaceuticals                                                                          
----------------------------------------------------------------------------------------------------------------


    Dated: February 20, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-4916 Filed 2-25-98; 8:45 am]
BILLING CODE 4160-01-F