[Federal Register Volume 63, Number 128 (Monday, July 6, 1998)]
[Notices]
[Pages 36413-36424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17702]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Quarterly List of Guidance Documents at the Food and Drug 
Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

[[Page 36414]]

SUMMARY: The Food and Drug Administration (FDA) is publishing the first 
quarterly update of all guidance documents issued and withdrawn since 
the compilation of the comprehensive list. FDA committed to publishing 
quarterly updates 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 
guidance documents issued since the comprehensive list was compiled. 
This list also includes some guidance documents that were inadvertently 
not included on the comprehensive list mentioned previously.

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 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Information on where to obtain single copies of 
listed guidance documents 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 an 
annual comprehensive list of guidance documents and quarterly Federal 
Register notices that list all guidance documents that were issued and 
withdrawn during that quarter, including ``Level 2'' guidance 
documents. The following list of guidance documents represents all 
guidances issued by FDA since the compilation of the February 26, 1998 
(63 FR 9795) list and guidance documents inadvertently not included in 
the comprehensive list. The guidance 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.

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

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                             Grouped by                                         
                                                          Intended User or     How to Obtain a Hard Copy of the 
          Name of Document            Date of Issuance       Regulatory       Document (Name and Address, Phone,
                                                              Activity            FAX, E-mail, or Internet)     
----------------------------------------------------------------------------------------------------------------
Guidance for Industry: Industry-     November 1997       FDA Regulated       Office of Communication, Training, 
 Supported Scientific and                                 Industry            and Manufacturers Assistance (HFM-
 Educational Activities                                                       40), Center for Biologics         
                                                                              Evaluation and Research (CBER),   
                                                                              Food and Drug Administration, 1401
                                                                              Rockville Pike, Rockville, MD     
                                                                              20852-1448, 1-800-835-4709 or 301-
                                                                              827-1800, FAX Information System: 
                                                                              1-888-CBER-FAX (within the United 
                                                                              States) or 301-827-3844 (outside  
                                                                              of the United States and local to 
                                                                              Rockville, MD). Internet access:  
                                                                              http://www.fda.gov/cber           
Draft Guidance for Industry:         December 1997       Do                  Do                                 
 Promoting Medical Products in a                                                                                
 Changing Healthcare Environment;                                                                               
 I. Medical Product Promotion by                                                                                
 Healthcare Organizations or                                                                                    
 Pharmacy Benefits Management                                                                                   
 Companies (PBMS)                                                                                               
Guidance for Industry: Year 2000     January 1998        Do                  Do                                 
 Date Change for Computer Systems                                                                               
 and Software Applications Used in                                                                              
 the Manufacture of Blood Products                                                                              
Draft Guidance for Industry:         January 1998        Do                  Do                                 
 Efficacy Studies to Support                                                                                    
 Marketing of Fibrin Sealant                                                                                    
 Products Manufactured for                                                                                      
 Commercial Use                                                                                                 
Draft Guidance for Industry:         January 1998        Do                  Do                                 
 Container and Closure Integrity                                                                                
 Testing in Lieu of Sterility                                                                                   
 Testing as a Component of the                                                                                  
 Stability Protocol for Sterile                                                                                 
 Products                                                                                                       
Draft Guidance for Industry:         February 1998       Do                  Do                                 
 Clinical Development of Programs                                                                               
 for Drugs, Devices and Biological                                                                              
 Products Intended for Treatment of                                                                             
 Osteoarthritis (OA)                                                                                            
Draft Guidance for Industry:         November 1997       Do                  Do                                 
 Environmental Assessment of Human                                                                              
 Drug and Biologics Applications                                                                                

[[Page 36415]]

                                                                                                                
Guidance for Industry:               February 1998       Do                  Do                                 
 Implementation of Section 126,                                                                                 
 Elimination of Certain Labeling                                                                                
 Requirements of the Food and Drug                                                                              
 Administration Modernization Act                                                                               
 of 1997                                                                                                        
Guidance for Industry: Clinical      March 1998          Do                  Do                                 
 Development Programs for Drugs,                                                                                
 Devices and Biological Products                                                                                
 for the Treatment of Rheumatoid                                                                                
 Arthritis (RA)                                                                                                 
Guidance for Industry: Supplemental  March 1998          Do                  Do                                 
 Testing and the Notification of                                                                                
 Consignees of Donor Test Results                                                                               
 for Antibody to Hepatitis C Virus                                                                              
 (Anti-HCV)                                                                                                     
Guidance for Industry: Guidance for  March 1998          Do                  Do                                 
 Human Somatic Cell Therapy and                                                                                 
 Gene Therapy                                                                                                   
Compliance Program Guidance Manual   1994                FDA Personnel       National Technical Information     
 (Drugs and Biologics) (Publication                                           Service (NTIS), 5285 Port Royal   
 No. 94-920699)                                                               Rd., Springfield, VA 22161, 703-  
                                                                              605-6050                          
----------------------------------------------------------------------------------------------------------------

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

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                             Grouped by                                         
                                                          Intended User or     How to Obtain a Hard Copy of the 
          Name of Document            Date of Issuance       Regulatory       Document (Name and Address, Phone,
                                                              Activity             FAX, E-mail or Internet)     
----------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Tracking  February 19, 1998   OC                  Division of Small Manufacturers    
 (Docket #98D-0132)                                                           Assistance, 1-800-638-2041 or 301-
                                                                              827-0111 or (Fax) Facts-on-Demand 
                                                                              at 1-800-899-0381 or Internet at  
                                                                              http://www.fda.gov/cdrh           
Guidance on Lead Wires and Patient   March 9, 1998       OC                  Do                                 
 Cables                                                                                                         
Draft Guidance to Industry and CDRH  March 20, 1998      ODE                 Do                                 
 for PMA's and PMA Supplements: Use                                                                             
 of Published Literature, Use of                                                                                
 Previously Submitted Materials,                                                                                
 and Priority Review                                                                                            
PMA/510(k) Expedited Review--        March 20, 1998      ODE                 Do                                 
 Guidance for Industry and CDRH                                                                                 
 Staff                                                                                                          
Guidance on Amended Procedures for   March 20, 1998      ODE                 Do                                 
 Advisory Panel Meetings                                                                                        
Guidance on IDE Policies and         January 20, 1998    ODE                 Do                                 
 Procedures                                                                                                     
Early Collaboration Meetings Under   February 19, 1998   ODE                 Do                                 
 the FDA Modernization Act (FDAMA),                                                                             
 Guidance for Industry and CDRH                                                                                 
 Staff, Final Document (Docket #98D-                                                                            
 0078) (FOD #310)                                                                                               
Guidance on PMA Interactive          February 19, 1998   ODE                 Do                                 
 Procedures for Day-100 Meetings                                                                                
 and Subsequent Deficiencies--for                                                                               
 Use by CDRH and Industry (Docket                                                                               
 #98D-0079) (FOD #322)                                                                                          
Determination of Intended Use for    February 19, 1998   ODE                 Do                                 
 510(k) Devices: Final Document                                                                                 
 (Docket #98D-0081) (FOD #857)                                                                                  
30-Day Notices and 135-day PMA       February 19, 1998   ODE                 Do                                 
 Supplements for Manufacturing                                                                                  
 Method or Process Changes,                                                                                     
 Guidance for Industry and CDRH                                                                                 
 (Docket #98D-0080) (FOD #795)                                                                                  
New section 513(f)(2)--Evaluation    February 19, 1998   ODE                 Do                                 
 of Automatic Class III                                                                                         
 Designation: Guidance for Industry                                                                             
 and CDRH Staff (Docket #98D-0082)                                                                              
 (FOD #199)                                                                                                     
Procedures for Class II Device       February 25, 1998   ODE                 Do                                 
 Exemptions from Premarket                                                                                      
 Notification Guidance for Industry                                                                             
 and CDRH Staff (Docket #98D-0083)                                                                              
 (FOD #159)                                                                                                     
Electrocardiograph (ECG) Surface     February 11, 1997   ODE/DCRND           Do                                 
 Electrode Tester--Version 1.0                                                                                  

[[Page 36416]]

                                                                                                                
Guidance for the Submission of       January 1, 1997     ODE/DCRND           Do                                 
 510(k) Premarket Notifications for                                                                             
 Cardiovascular Intravascular                                                                                   
 Filters                                                                                                        
Guidance Document for Testing Bone   April 20, 1996      ODE/DGRD            Do                                 
 Anchor Devices (FOD #915)                                                                                      
ORDB 510(k) Sterility Review         July 3, 1997        ODE/DGRD                                               
 Guidance (FOD #659)                                                                                            
Guidance for Testing MR Interaction  May 22, 1996        ODE/DGRD            Do                                 
 With Aneurysm Clips (FOD #958)                                                                                 
Electroencephalograph Device Draft   June 25, 1997       ODE/DGRD            Do                                 
 Guidance for 510(k) Content (FOD                                                                               
 #767)                                                                                                          
Ophthalmic Device Triage List        July 25, 1997       ODE/DOD             Do                                 
Contact Lenses: The Better the Care  April 1, 1991       ODE/DOD             Do                                 
 the Safer the Wear (FDA                                                                                        
 Publication No. 91-4220)                                                                                       
An FDA Survey of U.S. Contact Lens   July 1, 1987        ODE/DOD             Do                                 
 Wearers (Carol L. Herman)                                                                                      
 Reprinted from Contact Lens                                                                                    
 Spectrum                                                                                                       
Facts for Consumers from the         April 1, 1986       ODE/DOD             Do                                 
 Federal Trade Commission--                                                                                     
 Eyeglasses                                                                                                     
Important Information About Rophae   August 20, 1992     ODE/DOD             Do                                 
 Intraocular Lenses                                                                                             
Intraocular Lens (IOL) Guidance      October 10, 1997    ODE/DOD             Do                                 
 Document                                                                                                       
FDA Guidance for Multifocal          May 1996            ODE/DOD             Do                                 
 Intraocular Lens IDE Studies and                                                                               
 PMA's                                                                                                          
Premarket Notification[510(k)]       May 12, 1994        ODE/DOD             Do                                 
 Guidance Document on Class II                                                                                  
 Daily Wear Contact Lenses                                                                                      
Electrocardiograph (ECG) Electrode-- February 11, 1997   ODE/DRAERD          Do                                 
 Version 1.0                                                                                                    
Electrocardiograph (ECG) Lead        February 11, 1997   ODE/DRAERD          Do                                 
 Switching Adapter--Version 1.0                                                                                 
Tympanostomy Tubes, Submission       January 14, 1998    ODE/DRAERD          Do                                 
 Guidance for a 510(k) Premarket                                                                                
 Notification                                                                                                   
Guidance for the Content of          February 5, 1998    ODE/DRAERD          Do                                 
 Premarket Notifications for Metal                                                                              
 Expandable Biliary Stents                                                                                      
FDA Modernization Act of 1997:       February 6, 1998    OHIP/Regs           Do                                 
 Guidance for the Device Industry                                                                               
 on Implementation of Highest                                                                                   
 Priority Provisions; Availability                                                                              
Policy Notebook in a Q/A Format      January 23, 1998    OHIP/DMQRP          Do                                 
 (Update to existing document)                                                                                  
The Small Entity Compliance Guide    January 1998        OHIP/DMQRP          Do                                 
Medical Device Appeals and           February 19, 1998   OHIP/DSMA           Do                                 
 Complaints: A Guidance on Dispute                                                                              
 Resolution                                                                                                     
Medical Device Quality Systems       December 1, 1996    OHIP/DSMA           Do                                 
 Manual: A Small Entity Compliance                                                                              
 Guide                                                                                                          
SMDA to FDAMA: Guidance on FDA's     February 19, 1998   OSB/DPS             Do                                 
 Transition Plan for Existing                                                                                   
 Postmarket Surveillance (FOD #318)                                                                             
Guidance on Procedures to Determine  February 19, 1998   OSB/DPS             Do                                 
 Application of Postmarket                                                                                      
 Surveillance Strategies (FOD #316)                                                                             
Guidance on Procedures for Review    February 19, 1998   OSB/DPS             Do                                 
 of Postmarket Surveillance                                                                                     
 Submissions (FOD #317)                                                                                         
MDR/Policy/Guidance for Endosseus    December 1992       OSB/DSS             Do                                 
 Implant Devices                                                                                                
MDR Guidance #4--External            September 1994      OSB/DSS             Do                                 
 Defibrillators                                                                                                 
MDR Guidance--Blood Loss Policy      December 1995       OSB/DSS             Do                                 
Summary Reporting Approval for       July 1997           OSB/DSS             Do                                 
 Adverse Events                                                                                                 
Common Problems: Baseline Reports                        OSB/DSS             Do                                 
 and MedWatch Form 3500A (letter to                                                                             
 manufacturers updated)                                                                                         
Guidance on the Recognition and Use  February 19, 1998   OST                 Do                                 
 of Consensus Standards                                                                                         
Withdrawn                                                                                                       

[[Page 36417]]

                                                                                                                
``Draft Guidance for the Content of  August 22, 1995     ODE/DCRND           Do                                 
 Preliminary Investigational Device                                                                             
 Exemptions (Pre-IDE)                                                                                           
 Presentations: Teleconferences,                                                                                
 Meetings and Written Submissions''                                                                             
Preliminary Guidance for Ambulatory  September 1, 1994   ODE/DCRND           Do                                 
 Electrocardiograph for Data to be                                                                              
 Submitted to FDA in Support of                                                                                 
 Premarket Notification                                                                                         
 Applications                                                                                                   
Preliminary Guidance for Data to be  December 1, 1994    ODE/DCRND           Do                                 
 Submitted in Support of Premarket                                                                              
 Notifications for Analyzing ECG's/                                                                             
 Interpretive ECG's                                                                                             
Preliminary Guidance for Data to be  April 25, 1994      ODE/DCRND           Do                                 
 Submitted to the FDA in Support of                                                                             
 Premarket Notification                                                                                         
 Applications for External                                                                                      
 Cardioverters and Defibrillators                                                                               
Reviewer Checklist for Monitors:     January 24, 1996    ODE/DCRND           Do                                 
 EMC, Battery and Software                                                                                      
Medical Device Tracking: Questions   August 26, 1993     OC/DOEI             Do                                 
 and Answers Based on the Final                                                                                 
 Rule                                                                                                           
510(k) Diagnostic Ultrasound         February 1993       ODE/DRAERD          Do                                 
 Guidance 4/91 Use of Medical Index                                                                             
 in Place of Peak Intensity in                                                                                  
 Determining Substantial                                                                                        
 Equivalency for Diagnostic                                                                                     
 Ultrasound Equip/Access/Rel. Meas.                                                                             
 Dev.                                                                                                           
Review of ``YAG'' Lasers for         N/A                 ODE/DGRD            Do                                 
 Neurosurgery                                                                                                   
FDA Public Health Advisory: Retinal  October 16, 1995    ODE/DOD             Do                                 
 Photic Injuries from Operating                                                                                 
 Microscopes During Cataract                                                                                    
 Surgery                                                                                                        
Sterilization: Questions and         January 1985        OC/DOEII            Do                                 
 Answers from FDA, from Medical                                                                                 
 Device Diagnostic Industry for                                                                                 
 January, 1985, page 132                                                                                        
Corrections                                                                                                     
Rechargeable Battery Preliminary     January 1, 1994     ODE/DCRND           Do                                 
 Guidance for Data to be Submitted                                                                              
 to FDA in Support of Premarket                                                                                 
 Notification Applications (FOD                                                                                 
 #873)                                                                                                          
Review Guidance for Anesthesia       May 15, 1991        ODE/DCRND           Do                                 
 Conduction Catheter (FOD #783)                                                                                 
Guidance for Peak Flow Meters for    June 1, 1993        ODE/DCRND           Do                                 
 Over-the-Counter Sale                                                                                          
Review Guidance for Oxygen           Undated             ODE/DCRND           Do                                 
 Generators and Oxygen Equipment                                                                                
Guidance for the Preparation and     December 4, 1987    ODE/DCRND           Do                                 
 Content of Applications to the                                                                                 
 Food and Drug Administration for                                                                               
 Ventricular Assist Devices and                                                                                 
 Total Artificial Hearts (draft)                                                                                
Draft Premarket Notification Review  June 1, 1994        ODE/DGRD            Do                                 
 Guidance for Evoked Response                                                                                   
 Somatosensory Stimulators                                                                                      
Draft Version--Guidance on           September 12, 1994  ODE/DGRD            Do                                 
 Biocompatibility Requirements for                                                                              
 Long Term Neurological Implants:                                                                               
 Part 3--Implant Model                                                                                          
Draft Version 1--Biofeedback         August 1, 1994      ODE/DGRD            Do                                 
 Devices--Draft Guidance for 510(k)                                                                             
 Content                                                                                                        
Draft Version Cranial Perforator     July 13, 1994       ODE/DGRD            Do                                 
 Guidance                                                                                                       
Draft Version Guidance for Clinical  August 20, 1992     ODE/DGRD            Do                                 
 Data to be Submitted for Premarket                                                                             
 Approval Application for Cranial                                                                               
 Electrotherapy Stimulators                                                                                     
Draft Version Guide for Cortical     August 10, 1992     ODE/DGRD            Do                                 
 Electrode 510(k) Content                                                                                       
Draft Version Neuro Endoscope        July 7, 1994        ODE/DGRD            Do                                 
 Guidance                                                                                                       
Galvanic Skin Response Measurement   August 23, 1994     ODE/DGRD            Do                                 
 Devices--Draft Guidance for 510(k)                                                                             
 Content                                                                                                        
Guidance for Studies for Pain        May 12, 1988        ODE/DGRD            Do                                 
 Therapy Devices--General                                                                                       
 Considerations in the Design of                                                                                
 Clinical Studies for Pain-                                                                                     
 Alleviating Devices                                                                                            
Guide for 510(k) Review of           June 26, 1990       ODE/DGRD            Do                                 
 Processed Human Dura Mater                                                                                     

[[Page 36418]]

                                                                                                                
Guide for TENS 510(k) Content        August 1, 1994      ODE/DGRD            Do                                 
 (Draft)                                                                                                        
Guidelines for Reviewing Premarket   N/A                 ODE/DGRD            Do                                 
 Notifications that Claim                                                                                       
 Substantial Equivalence to Evoked                                                                              
 Response Stimulators                                                                                           
Protocol for Dermal Toxicity         N/A                 ODE/DGRD            Do                                 
 Testing for Devices in Contact                                                                                 
 With Skin (Draft)                                                                                              
Premarket Notification 510(k)        May 1, 1997         ODE/DOD             Do                                 
 Guidance for Contact Lens Care                                                                                 
 Products                                                                                                       
Amendment 1: Premarket Notification  June 28, 1994       ODE/DOD             Do                                 
 [510(k)] Guidance Document for                                                                                 
 Class II Daily Wear Contact Lenses                                                                             
Premarket Approval (PMA) Manual      July 1, 1997        OHIP/DSMA           Do                                 
 (FDA 97-4214)                                                                                                  
Required Postmarket Surveillance     September 30, 1997  OSB/DPS             Do                                 
 Section 522(a) Initial Device                                                                                  
 Categories Revised                                                                                             
Guidance to Manufacturers on the     July 16, 1996       OSB/DPS             Do                                 
 Development of Required Postmarket                                                                             
 Surveillance Study Protocols Under                                                                             
 Section 522(a)(1) of the Federal                                                                               
 Food, Drug, and Cosmetic Act                                                                                   
Variance from Manufacturer Report    August 12, 1996     OSB/DSS             Do                                 
 Number Format                                                                                                  
----------------------------------------------------------------------------------------------------------------

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

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                             Grouped by                                         
                                                          Intended User or     How to Obtain a Hard Copy of the 
          Name of Document            Date of Issuance       Regulatory       Document (Name and Address, Phone,
                                                              Activity            Fax, E-mail, or Internet)     
----------------------------------------------------------------------------------------------------------------
Level 1 Guidances                                                                                               
Environmental Assessment of Human    February 12, 1998   Chemistry           Office of Training and             
 Drugs and Biologics Applications                                             Communications, Drug Information  
                                                                              Branch, 5600 Fishers Lane,        
                                                                              Rockville, MD 20857, 301-827-4573 
                                                                              or Internet at <a href="http://www.fda.gov/
cder/guidance/index.htm">http://www.fda.gov/
cder/guidance/index.htm</a>           
PAC-ALTS: Postapproval Changes--     April 28, 1998      Do                  Do                                 
 Analytical Laboratory Testing                                                                                  
 Sites                                                                                                          
SUPAC IR/MR: Immediate Release and   April 28, 1998      Do                  Do                                 
 Modified Release Solid Oral Dosage                                                                             
 Forms, Manufacturing Equipment                                                                                 
 Addendum                                                                                                       
Clinical Development Programs for    March 18, 1998      Clinical            Do                                 
 Drugs, Devices, and Biological                                                                                 
 Products for the Treatment of                                                                                  
 Rheumatoid Arthritis (RA)                                                                                      
Clinical Development Programs for    February 18, 1998   Do                  Do                                 
 Drugs, Devices, and Biological                                                                                 
 Products Intended for the                                                                                      
 Treatment of Osteoarthritis (OA)                                                                               
Manufacture, Processing or Holding   April 17, 1998      Compliance          Do                                 
 of Active Pharmaceutical                                                                                       
 Ingredients                                                                                                    
S1B Testing for Carcinogenicity in   February 23, 1998   International       Do                                 
 Pharmaceuticals                                          Conference on                                         
                                                          Harmonization                                         
Implementation of Section 126,       February 18, 1998   FDA Modernization   Do                                 
 Elimination of Certain Labeling                          Act                                                   
 Requirements, of the FDA                                                                                       
 Modernization Act of 1997                                                                                      
National Uniformity for              May 5, 1998         Do                  Do                                 
 Nonprescription Drugs Ingredient                                                                               
 Labeling for OTC Drugs                                                                                         
Repeal of Section 507 of the         February 5, 1998    Do                  Do                                 
 Federal Food, Drug, and Cosmetic                                                                               
 Act                                                                                                            
Level 2 Guidances                                                                                               
Drug Metabolism/Drug Interaction     April 7, 1997       Clinical            Do                                 
 Studies in the Drug Development                                                                                
 Process: Studies In Vitro                                                                                      

[[Page 36419]]

                                                                                                                
Organization of an Abbreviated New   April 7, 1997       Generic Drug        Do                                 
 Drug Application and an                                                                                        
 Abbreviated Antibiotic Application                                                                             
Aerosol Steroid Product Safety       January 12, 1998    Advertising         Do                                 
 Information in Prescription Drug                                                                               
 Advertising and Promotional                                                                                    
 Labeling                                                                                                       
Withdrawn                                                                                                       
Biopharmaceutic Considerations in    November 1, 1983    Biopharmaceutic                                        
 Designing and Evaluating Novel                                                                                 
 Drug Delivery Systems                                                                                          
Clinical Evaluation of Drugs to      November 2, 1978    Clinical                                               
 Prevent Dental Caries                                                                                          
Clinical Evaluation of Drugs to      November 1, 1978    Do                                                     
 Prevent, Control and/or Treat                                                                                  
 Periodontal Disease                                                                                            
Conjugated Estrogens (Tables) In     August 21, 1991     Biopharmaceutic                                        
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Current Good Manufacturing           April 22, 1997      Compliance                                             
 Practices for Positron Emission                                                                                
 Tomographic (PET) Drug Products                                                                                
Diphenhydramine Hydrochloride        June 1, 1986        Labeling                                               
 Capsules/Elixir                                                                                                
Ergotamine Tartrate and Caffeine     December 1, 1981    Do                                                     
 Tablets and Suppositories                                                                                      
Glyburide Tablets                    April 1, 1993       Do                                                     
Haloperidol Tablets/Oral Solution    February 1, 1990    Do                                                     
 (Concentrate)                                                                                                  
Regulatory Aspects Pertinent to the  February 2, 1985    Biopharmaceutic                                        
 Development of Transdermal Drug                                                                                
 Delivery Systems                                                                                               
Supplements to New Applications,     December 12, 1994   Compliance                                             
 Abbreviated Antibiotic                                                                                         
 Applications for Nonsterile Drug                                                                               
 Products                                                                                                       
Terfenadine (Tablets) In Vivo        September 11, 1995  Biopharmaceutic                                        
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Positron Emission Tomography         October 24, 1996    Generic Drug                                           
 Questions and Answers 1                                                                                        
Positron Emission Tomography         April 18, 1997      Do                                                     
 Questions and Answers 2                                                                                        
Submission of an Environmental       November 13, 1995   Chemistry                                              
 Assessment in Human Drug                                                                                       
 Applications and Supplements                                                                                   
Submission of an Environmental       November 13, 1995   Do                                                     
 Assessment in Human Drug                                                                                       
 Applications and Supplements                                                                                   
Acetohexamide (tablets) In Vivo      August 1, 1988      Biopharmaceutic                                        
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Allopurinol (tablets) In Vivo        July 15, 1985       Do                                                     
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Amiloride Hydrochloride (tablets)    March 29, 1985      Do                                                     
 In Vivo Bioequivalence and In                                                                                  
 Vitro Dissolution Testing                                                                                      
Aminophylline (suppositories) In     July 5, 1983        Do                                                     
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Amitriptyline Hydrochloride          July 5, 1983        Do                                                     
 (tablets) In Vivo Bioequivalence                                                                               
 and In Vitro Dissolution Testing                                                                               
Amoxicillin (capsules, tablets and   June 10, 1988       Do                                                     
 suspension) In Vivo Bioequivalence                                                                             
 and In Vitro Dissolution Testing                                                                               
Baclofen (tablets) In Vivo           May 5, 1988         Do                                                     
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Cefadroxil (capsules, tablets and    October 7, 1988     Do                                                     
 suspension) In Vivo Bioequivalence                                                                             
 and In Vitro Dissolution Testing                                                                               
Cephalexin (tablets and capsules)    March 19, 1987      Do                                                     
 In Vivo Bioequivalence and In                                                                                  
 Vitro Dissolution Testing                                                                                      

[[Page 36420]]

                                                                                                                
Cephradine (Capsule and Suspension)  September 10, 1986  Do                                                     
 In-Vivo Bioequivalence Studies                                                                                 
Chlordiazepoxide and                 July 5, 1983        Do                                                     
 Chlordiazepoxide HCl                                                                                           
 Bioavailability and Dissolution                                                                                
 Studies                                                                                                        
Chlorpropamide In-Vivo               July 5, 1983        Do                                                     
 Bioavailability Studies                                                                                        
Chlorthalidone (Tablets)             July 5, 1983        Do                                                     
Clinical Evaluation of Drugs for                         Do                                                     
 the Treatment of Peripheral                                                                                    
 Vascular Disease                                                                                               
Clofibrate In Vivo Bioavailability   April 7, 1986       Do                                                     
 Studies                                                                                                        
Clonidine Hydrochloride Drug         December 5, 1984    Do                                                     
 Products In Vivo Bioequivalence                                                                                
 Study and In Vitro Dissolution                                                                                 
 Testing                                                                                                        
Clorazepate In Vivo Bioequivalence   February 17, 1987   Do                                                     
 Study and In Vitro Dissolution                                                                                 
 Testing                                                                                                        
Cyclobenzaprine Hydrochloride        January 25, 1988    Do                                                     
 (tablets) In Vivo Bioequivalence                                                                               
 and In Vitro Dissolution Testing                                                                               
Desipramine Hydrochloride (Tablets)  September 22, 1987  Do                                                     
 In Vivo Bioequivalence Studies                                                                                 
Dicyclomine Hydrochloride Drug       August 10, 1984     Do                                                     
 Products In Vivo Bioequivalence                                                                                
Dissolution Testing (General)        April 1, 1978       Do                                                     
Estropipate Tablets In Vivo          August 26, 1992     Do                                                     
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing (I)                                                                                        
Flurazepam Hydrochloride (capsules)  October 15, 1985    Do                                                     
 In Vivo Bioequivalence and In                                                                                  
 Vitro Dissolution Testing                                                                                      
Hydrochlorothiazide (tablets) In     September 28, 1987  Do                                                     
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Hydroxyzine Hydrochloride (tablets)  March 4, 1986       Do                                                     
 (dissolution only)                                                                                             
Indomethacin (capsules) In Vivo      January 27, 1988    Do                                                     
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Isopropamide Iodide (tablets) In     May 12, 1982        Do                                                     
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Loxapine Succinate (capsules) In     September 10, 1987  Do                                                     
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Maprotiline Hydrochloride (tablets)  August 27, 1987     Do                                                     
 In Vivo Bioequivalence and In                                                                                  
 Vitro Dissolution Testing                                                                                      
Meclofenamate Sodium (capsules) In   November 12, 1986   Do                                                     
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Metaproterenol Sulfate (tablets) In  March 18, 1986      Do                                                     
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Metoclopramide Hydrochloride         December 27, 1984   Do                                                     
 (tablets) In Vivo Bioequivalence                                                                               
 and In Vitro Dissolution Testing                                                                               
Nalidixic Acid In Vivo               August 19, 1987     Do                                                     
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Nitrofurantion Macrocrystalline      January 10, 1986    Do                                                     
 (capsules) In Vivo Bioequivalence                                                                              
 and In Vitro Dissolution Testing                                                                               
Nitroglycerin Ointment In Vivo       December 17, 1986   Do                                                     
 Bioequivalence Studies                                                                                         
Perphenazine (tablets) In Vivo       August 27, 1987     Do                                                     
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Perphenazine/Amitriptyline           August 27, 1987     Do                                                     
 (tablets) In Vivo Bioequivalence                                                                               
 and In Vitro Dissolution Testing                                                                               
Phenylbutazone Oxyphenbutazone       September 28, 1987  Do                                                     
 (capsules and tablets) In Vivo                                                                                 
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            

[[Page 36421]]

                                                                                                                
Prazepam (capsules and tablets) In   July 26, 1988       Do                                                     
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Prednisone (tablets) (dissolution    July 10, 1985       Do                                                     
 only)                                                                                                          
Probenecid Drug Products             July 26, 1983       Do                                                     
 Bioavailability Study                                                                                          
Propoxyphene Napsylate With          March 26, 1980      Do                                                     
 Acetaminphen (Tablets)                                                                                         
Propranolol Hydrochloride (tablets)  August 1, 1984      Do                                                     
 In Vivo Bioequivalence and In                                                                                  
 Vitro Dissolution Testing                                                                                      
Propylthiouracil (tablets) In Vivo   August 13, 1986     Do                                                     
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Quinidine Gluconate (tablets,        September 22, 1987  Do                                                     
 controlled release) In Vivo                                                                                    
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Ritodrine Hydrochloride (tablets)    August 27, 1987     Do                                                     
 In Vivo Bioequivalence and In                                                                                  
 Vitro Dissolution Testing                                                                                      
Sulfinpyrazone (Capsules and         September 25, 1987  Do                                                     
 Tablets)                                                                                                       
Sulfones (tablets) In Vivo           November 7, 1986    Do                                                     
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Temazepam In Vivo Bioequivalence     August 8, 1985      Do                                                     
 Studies and In Vitro Dissolution                                                                               
 Testing                                                                                                        
Tolazamide (tablets) In Vivo         May 30, 1986        Do                                                     
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Tolbutamide (tablets) In Vivo        December 1, 1983    Do                                                     
 Bioequivalence and In Vitro                                                                                    
 Dissolution Testing                                                                                            
Trimipramine Maleate (capsules) In   August 18, 1987     Do                                                     
 Vivo Bioequivalence and In Vitro                                                                               
 Dissolution Testing                                                                                            
Verapamil Hydrochloride (tablets)    July 18, 1985       Do                                                     
 In Vivo Bioequivalence and In                                                                                  
 Vitro Dissolution Testing                                                                                      
----------------------------------------------------------------------------------------------------------------

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

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                             Grouped by                                         
                                                          Intended User or     How to Obtain a Hard Copy of the 
          Name of Document            Date of Issuance       Regulatory       Document (Name and Address, Phone,
                                                              Activity            FAX, E-mail, or Internet)     
----------------------------------------------------------------------------------------------------------------
Level I Guidance Documents Not                                                                                  
 Included in the February 1998                                                                                  
 Comprehensive List                                                                                             
Draft Working Guide to Minimize      1998                Farmers and Food    Lou Carson, Food Safety Initiative 
 Microbial Hazards for Fresh Fruits                       Packers             (HFS-3), FDA-CFSAN, 200 C St. SW.,
 and Vegetable                                                                Washington, DC 20204 or           
                                                                              <a href="/cdn-cgi/l/email-protection#204a53414c54534d414e6042414e474154450e4644410e474f56"><span class="__cf_email__" data-cfemail="0e647d6f627a7d636f604e6c6f60696f7a6b20686a6f20696178">[email protected]</span></a>         
Iron-containing Supplements and      1997                Dietary Supplement  Office of Special Nutritionals (HFS-
 Drugs: Label Warning and Unit Dose                       Manufacturers;      450), FDA-CFSAN, 200 C St. SW.,   
 Packaging; Small Entity Compliance                       Small Entities      Washington, DC 20204              
 Guide                                                                                                          
Level 2 Guidance Documents                                                                                      
Partial List of Enzyme Preparations  1998                FDA Regulated       Office of Premarket Approval (HFS- 
 That Are Used in Foods                                   Industry            200), FDA-CFSAN, 200 C St. SW.,   
                                                                              Washington, DC 20204              
Partial List of Microorganisms and   1998                Do                  Do                                 
 Microbial-Derived Ingredients That                                                                             
 Are Used in Food                                                                                               
Fish and Fishery Products Hazards    January 1998        Do                  Office of Seafood (HFS-400), FDA-  
 and Controls Guide, 2nd Ed.                                                  CFSAN, 200 C St. SW., Washington, 
                                                                              DC 20204                          
HACCP Regulations for Fish and       1997                Do                  Do                                 
 Fishery Products: Questions and                                                                                
 Answers                                                                                                        
----------------------------------------------------------------------------------------------------------------


[[Page 36422]]

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

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                             Grouped by                                         
                                                          Intended User or     How to Obtain a Hard Copy of the 
          Name of Document            Date of Issuance       Regulatory       Document (Name and Address, Phone,
                                                              Activity            FAX, E-mail, or Internet)     
----------------------------------------------------------------------------------------------------------------
Validation of Analytical             December 1997       Regulated Industry  Center for Veterinary Medicine (HFV-
 Procedures; Definition and                                                   12), Communications Staff, Food   
 Terminology; Draft                                                           and Drug Administration, 7500     
                                                                              Standish Pl., Rockville, MD 20855,
                                                                              301-594-1755.                     
Validation of Analytical             December 1997       Do                  Do                                 
 Procedures; Methodology; Draft                                                                                 
Industry-Supported Scientific and    November 1997       Do                  Do                                 
 Educational Activities                                                                                         
Professional Flexible Labeling of    January 1998        Do                  Do                                 
 Antimicrobial Drugs; Draft                                                                                     
Small Entities Compliance Guide for  February 1998       Do                  Do                                 
 Renderers                                                                                                      
Small Entities Compliance Guide for  February 1998       Do                  Do                                 
 Protein Blenders, Feed                                                                                         
 Manufacturers, and Distributors                                                                                
Small Entities Compliance Guide for  February 1998       Do                  Do                                 
 Feeders of Ruminant Animals With                                                                               
 On-Farm Feed Mixing Operations                                                                                 
Small Entities Compliance Guide for  February 1998       Do                  Do                                 
 Feeders of Ruminant Animals                                                                                    
 Without On-Farm Feed Mixing                                                                                    
 Operations                                                                                                     
CVM Program Policy and Procedures    March 19, 1998      Do                  Do                                 
 Manual; Index (Guide No.                                                                                       
 1240.0000)                                                                                                     
CVM Guidance on Media Inquiries      December 17, 1997   Do                  Do                                 
 (Guide No. 1240.2325)                                                                                          
Requirements for Importation of      March 27, 1992      Do                  Do                                 
 Investigational New Animal Drugs                                                                               
 (Guide No. 1240.3032)                                                                                          
Animal Drug Applications Expedited   December 3, 1997    Do                  Do                                 
 Review (Guide No. 1240.3135)                                                                                   
CVM Research Activities (Guide No.   January 6, 1998     Do                  Do                                 
 1240.3700)                                                                                                     
Initiation and Approval of Research  January 6, 1998     Do                  Do                                 
 Projects (Guide No. 1240.3710)                                                                                 
Ownership Transfer or Corporate      March 19, 1998      Do                  Do                                 
 Identity Change of an Application                                                                              
 (Guide No. 1240.4150)                                                                                          
CVM Makes the Analysis of Comments   January 15, 1998    Do                  Do                                 
 on the Fluoroquinolone and                                                                                     
 Glycopeptide Prohibition Available                                                                             
 to the Public                                                                                                  
Withdrawn                                                                                                       
CVM Program Policy and Procedures    October 29, 1997                                                           
 Manual; Index (Guide No.                                                                                       
 1240.0000)                                                                                                     
CVM Guidance on Media Inquiries      July 1, 1997                                                               
 (Guide No. 1240.2325)                                                                                          
CVM Research Activities (Guide No.   November 3, 1993                                                           
 1240.3700)                                                                                                     
Initiation and Approval of Research  November 3, 1993                                                           
 Projects (Guide No. 1240.3710)                                                                                 
Criteria for the Approval of         February 13, 1990                                                          
 Euthanasia Products (Guide No.                                                                                 
 1240.4112)                                                                                                     
Sterility of Ophthalmic Products     December 7, 1993                                                           
 (Guide No. 1240.4120)                                                                                          
Sterility and Pyrogen Requirements   November 27, 1989                                                          
 for Injectable Drug Products                                                                                   
 (Guide No. 1240.4122)                                                                                          
Overformulation in Animal Drug       January 2, 1992                                                            
 Products (Guide No. 1240.4130)                                                                                 
Continuous Use Production Drugs and  April 16, 1990                                                             
 Short-Term Therapeutic Treatments                                                                              
 in Feeds (Guide No. 1240.4145)                                                                                 
Policy on Sterilization of New       September 10, 1997                                                         
 Animal Drug Products and                                                                                       
 Containers by Irradiation (Guide                                                                               
 No. 1240.4160)                                                                                                 
CVM Medically Necessary Veterinary   June 30, 1994                                                              
 Drug Product Shortage Management                                                                               
 (Guide No. 1240.4170)                                                                                          

[[Page 36423]]

                                                                                                                
Small Entities Compliance Guide on   June 1997                                                                  
 Animal Proteins Prohibited from                                                                                
 Animal Feed                                                                                                    
----------------------------------------------------------------------------------------------------------------

VII. Guidance Documents Issued by the Office of Regulatory Affairs

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                             Grouped by                                         
                                                          Intended User or     How to Obtain a Hard Copy of the 
          Name of Document            Date of Issuance       Regulatory       Document (Name and Address, Phone,
                                                              Activity            FAX, E-mail, or Internet)     
----------------------------------------------------------------------------------------------------------------
Investigations Operations Manual     January 1998        FDA Staff           National Technical Information     
 (PB98-913399)                                            Personnel           Service (NTIS), 5285 Port Royal   
                                                                              Rd., Springfield, VA 22161, or via
                                                                              Internet at <a href="http://www.fda.gov/ora/
inspect_ref/iom/iomtc.html">www.fda.gov/ora/
inspect_ref/iom/iomtc.html</a>       
Mammography Quality Standards Act    January 1998        Do                  NTIS or via Internet at www.fda.gov/
 (MQSA) Auditors Guide (PB98-                                                 ora/inspect--ref/igs/iglist.html  
 127178)                                                                                                        
Guide to Inspections of              December 1997       Do                  Do                                 
 Electromagnetic Compatibility                                                                                  
 Aspects of Medical Device Quality                                                                              
 Systems (PB98-127152)                                                                                          
Guide to Inspections of Grain        March 1998          Do                  Division of Emergency and          
 Product Manufacturers                                                        Investigational Operations (HFC-  
                                                                              130), Food and Drug               
                                                                              Administration, 5600 Fishers Lane,
                                                                              Rockville, MD 20857               
Guide to Bioresearch Monitoring      February 1998       Do                  Do                                 
 Inspections of In Vitro Devices                                                                                
Guide to Inspections of Viral        March 1998          Do                  Do                                 
 Clearance Processes for Plasma                                                                                 
 Derivatives                                                                                                    
Guide to Inspections of              March 1998          Do                  Do                                 
 Computerized Systems in the Food                                                                               
 Processing Industry                                                                                            
Regulatory Procedures Manual;        March 1998          Do                  Division of Compliance Policy (HFC-
 Update/New Subchapter; Application                                           230), Office of Enforcement, Food 
 Integrity Policy                                                             and Drug Administration, 5600     
                                                                              Fishers Lane, Rockville, MD 20857,
                                                                              301-827-0420 or via Internet at   
                                                                              <a href="http://www.fda.gov/ora/compliance__ref/
rpm/rpmtc.html">www.fda.gov/ora/compliance__ref/
rpm/rpmtc.html</a>                    
Regulatory Procedures Manual;        March 1998          Do                  Do                                 
 Update Subchapter; Warning Letters                                                                             
Regulatory Procedures Manual:        April 1998          Do                  Do                                 
 Update/Revised Subchapter; Import                                                                              
 Procedures                                                                                                     
Regulatory Procedures Manual:        April 1998          Do                  Do                                 
 Updated/Revised Subchapter;                                                                                    
 Priority Enforcement Strategy for                                                                              
 Problem Importers                                                                                              
Regulatory Procedures Manual:        April 1998          Do                  Do                                 
 Updated/Revised Subchapter; Import                                                                             
 Procedures                                                                                                     
Regulatory Procedures Manual:        April 1998          Do                  Do                                 
 Updated/Revised Subchapter; Notice                                                                             
 of Sampling                                                                                                    
Regulatory Procedures Manual:        April 1998          Do                  Do                                 
 Updated/Revised Subchapter;                                                                                    
 Supervisory Charges                                                                                            
Regulatory Procedures Manual:        May 1998            Do                  Do                                 
 Update/New Subchapter; Granting                                                                                
 and Denying Transportation and                                                                                 
 Exportation (T&E) Entries                                                                                      
Import Alerts                        Continuously        Do                  Freedom of Information Staff (HFI- 
                                                                              35), Food and Drug Administration,
                                                                              5600 Fishers Lane, Rockville, MD  
                                                                              20857, or via Internet at         
                                                                              <a href="http://www.fda.gov/ora/fiars/
ora__imports__alerts.html">www.fda.gov/ora/fiars/
ora__imports__alerts.html</a>         
Guidance Documents Not Included in                                                                              
 the February 1998 Comprehensive                                                                                
 List                                                                                                           
Guideline for the Monitoring of      January 1998        Regulated Industry  Division of Compliance Policy (HFC-
 Clinical Investigations                                                      230), Office of Enforcement, Food 
                                                                              and Drug Administration, 5600     
                                                                              Fishers Lane, Rockville, MD 20857,
                                                                              301-827-0420 or via Internet at   
                                                                              <a href="http://www.fda.gov/ora/compliance__ref/
rpm/rpmtc.html">www.fda.gov/ora/compliance__ref/
rpm/rpmtc.html</a>                    
Computerized Systems Used in         June 18, 1997       Do                  Do                                 
 Clinical Trials                                                                                                

[[Page 36424]]

                                                                                                                
Compliance Program 7348.808;         August 8, 1994      FDA Staff           Do                                 
 Bioresearch Monitoring; Good                             Personnel                                             
 Laboratory Practices (GLP)                                                                                     
 (Nonclinical)                                                                                                  
Food Laboratory Practice Program     October 1, 1991     Do                  Do                                 
 (Nonclinical Laboratories)                                                                                     
 7348.808A: EPA Data Audit                                                                                      
 Inspections                                                                                                    
Compliance Program 7348.810:         August 18, 1994     Do                  Do                                 
 Sponsors, Contract Research                                                                                    
 Organizations and Monitors                                                                                     
Compliance Program 7348.809:         August 18, 1994     Do                  Do                                 
 Bioresearch Monitoring;                                                                                        
 Institutional Review Board                                                                                     
Compliance Program 7348.811:         August 18, 1994     Do                  Do                                 
 Bioresearch Monitoring; Clinical                                                                               
 Investigations                                                                                                 
----------------------------------------------------------------------------------------------------------------

VIII. International Conference on Harmonization Guidances (CDER)

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                                             Grouped by                                         
                                                          Intended User or     How to Obtain a Hard Copy of the 
          Name of Document            Date of Issuance       Regulatory       Document (Name and Address, Phone,
                                                              Activity            FAX, E-mail, or Internet)     
----------------------------------------------------------------------------------------------------------------
E2B Data Elements for Transmission   January 15, 1998    Regulated Industry  Drug Information Branch (HFD-210), 
 of Individual Case Safety Reports                                            Center for Drug Evaluation and    
                                                                              Research, 5600 Fishers Lane,      
                                                                              Rockville, MD 20857, 301-827-4573 
                                                                              or Office of Communication,       
                                                                              Training, and Manufacturers       
                                                                              Assistance (HFM-40), Center for   
                                                                              Biologics Evaluation and Research 
                                                                              (CBER), Food and Drug             
                                                                              Administration, 1401 Rockville    
                                                                              Pike, Rockville, MD 20852-1448, 1-
                                                                              800-835-4709 or 301-827-1800, FAX 
                                                                              Information System: 1-888-CBER-FAX
                                                                              (within the United States)or 301- 
                                                                              827-3844 (outside of the United   
                                                                              States and local to Rockville,    
                                                                              MD). Internet at <a href="http://
www.fda.gov/cder/guidance/
index.htm">http://
www.fda.gov/cder/guidance/
index.htm</a> or <a href="http://www.fda.gov/
cber/publications.htm">http://www.fda.gov/
cber/publications.htm</a>             
E8 General Considerations for        December 17, 1997   Do                  Do                                 
 Clinical Trials                                                                                                
M3 Timing of Nonclinical Studies     November 25, 1997   Do                  Do                                 
 for the Conduct of Human Clinical                                                                              
 Trials of Pharmaceuticals                                                                                      
QC3 Impurities; Residual Solvents    December 24, 1997   Do                  Do                                 
S1B Testing for Carcinogenicity of   February 23, 1998   Do                  Do                                 
 Pharmaceuticals                                                                                                
S1C(R) Dose Selection for            December 4, 1997    Do                  Do                                 
 Carcinogenicity Studies of                                                                                     
 Pharmaceuticals: Addendum on a                                                                                 
 Limit Dose and Related Notes                                                                                   
----------------------------------------------------------------------------------------------------------------


    Dated: June 25, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-17702 Filed 7-2-98; 8:45 am]
BILLING CODE 4160-01-F


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