[Federal Register: July 21, 2000 (Volume 65, Number 141)]
[Notices]               
[Page 45427-45510]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jy00-120]                         


[[Page 45427]]

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Part II





Department of Health and Human Services





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Food and Drug Administration



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Annual Comprehensive List of Guidance Documents at the Food and Drug 
Administration; Notice


[[Page 45428]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0046]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing an annual 
comprehensive list of all guidance documents currently in use at the 
agency. We committed to publishing this list in our February 1997 
``Good Guidance Practices'' (GGP's), which set forth our policies and 
procedures for developing, issuing, and using guidance documents. This 
list is intended to inform the public of the existence and availability 
of all our current guidance documents.

DATES: We welcome general comments on this list and on agency guidance 
documents 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. We have provided information on where to obtain a 
single copy of any of the guidance documents listed in the specific 
Center's list of guidance documents.

FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy, 
Planning, and Legislation (HF-27), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7010.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 27, 1997 (62 FR 8961), we 
announced our GGP's--our policies and procedures for developing, 
issuing, and using guidance documents. We adopted the GGP's to ensure 
your involvement in the development of guidance documents and to 
enhance your understanding of the availability, nature, and legal 
effect of such guidance.
    As part of our effort to ensure meaningful interaction with the 
public regarding guidance documents, we committed to publish an annual 
comprehensive list of guidance documents and quarterly updates that 
list all guidance documents that were issued and withdrawn during that 
quarter, including ``Level 2'' guidance documents.

A. Plain Language in Guidance Documents

    On June 1, 1998, the President instructed all Federal agencies to 
ensure the use of ``plain language'' in all new documents. As part of 
this initiative, We use the principles of ``plain language'' set forth 
by the President when writing our guidance documents. We seek your 
comments on the clarity of our guidances.

B. How the List is Organized

    The following comprehensive list of guidance documents represents 
all guidances currently in effect. This comprehensive list is 
maintained on the FDA Internet home page. We will update and publish 
this list in the Federal Register every year. We organized the guidance 
documents in this comprehensive list by the issuing Center or Office 
within FDA, and we further grouped them by the pertinent intended users 
or regulatory activities. The dates in the list refer to the date we 
issued the guidances or, where applicable, the last date we revised a 
document. We also provide document numbers when they are available.

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

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Grouped by Intended User or
                Name of Document                      Date of Issuance          Regulatory  Activity        How to Obtain a Hard Copy of the Document
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interpretative Guidelines of the Source Plasma   October 2, 1973            FDA Regulated Industry       Office of Communication, Training, and
 (Human) Standards                                                                                        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 U.S.) or 301-827-3844
                                                                                                          (outside U.S. and local to Rockville, MD).
                                                                                                          Internet access: http://www.fda.gov/cber
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Reviewing Amendments to Include   July 20, 1976              Do                           Do
 Plasmapheresis of Hemophiliacs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Package Insert: Immune Serum Globulin (Human)    March 30, 1978             Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Interpretation of Potency Test    April 12, 1979             Do                           Do
 Results for All Forms of Adsorbed Diphtheria
 and Tetanus Toxoids
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Immunization of Source Plasma     June 1, 1980               Do                           Do
 (Human) Donors with Blood Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
Collection of Human Leukocytes for Further       January 28, 1981           Do                           Do
 Manufacturing (Source Leukocytes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Platelet Testing Guidelines--Approval of New     July 1, 1981               Do                           Do
 Procedures and Equipment
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45429]]


Revised Guideline for Adding Heparin to Empty    August 1, 1981             Do                           Do
 Containers for Collection of Heparinized
 Source Plasma (Human)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requirements for Infrequent Plasmapheresis       August 27, 1982            Do                           Do
 Donors
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations to Decrease the Risk of          March 24, 1983             Do                           Do
 Transmitting AIDS from Plasma Donors
--------------------------------------------------------------------------------------------------------------------------------------------------------
PTC in the Manufacture of In Vitro Monoclonal    June 20, 1983              Do                           Do
 Antibody Products Subject to Licensure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft PTC in the Production and Testing of       July 28, 1983              Do                           Do
 Interferon Intended for Investigational Use in
 Humans (Interferon Test Procedures)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interstate Shipment of Interferon for            November 21, 1983          Do                           Do
 Investigational Use in Laboratory Research
 Animals or Tests in Vitro
--------------------------------------------------------------------------------------------------------------------------------------------------------
Deferral of Blood Donors Who Have Received the   February 28, 1984          Do                           Do
 Drug Accutane (isotretinoin/Roche); 13-cis-
 retinoic acid)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Equivalent Methods for Compatibility Testing     December 14, 1984          Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Plasma Derived from Therapeutic Plasma Exchange  December 14, 1984          Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft PTC in the Production and Testing of New   April 10, 1985             Do                           Do
 Drugs and Biologicals Produced by Recombinant
 DNA Technology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Meningococcal Polysaccharide      July 17, 1985              Do                           Do
 Vaccines
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for the Uniform Labeling of Blood and  August 1, 1985             Do                           Do
 Blood Components
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommended Methods for Short Ragweed Pollen     November 1, 1985           Do                           Do
 Extracts
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reduction of the Maximum Platelet Storage        June 2, 1986               Do                           Do
 Period to 5 Days in an Approved Container
--------------------------------------------------------------------------------------------------------------------------------------------------------
To In Vitro Diagnostic Reagent Manufacturers:    December 6, 1986           Do                           Do
 Guidance On the Labeling of Human Blood
 Derived In Vitro Diagnostic Devices In Regard
 to Labeling for HTLV-III/LAV Antibody Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for Submitting Documentation for the   February 1, 1987           Do                           Do
 Stability of Human Drugs and Biologics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for Submitting Documentation for       February 1, 1987           Do                           Do
 Packaging for Human Drugs and Biologics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline On General Principles of Process       May 1, 1987                Do                           Do
 Validation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline On Sterile Drug Products Produced by   June 1, 1987               Do                           Do
 Aseptic Processing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Deferral of Donors Who Have Received Human       November 25, 1987          Do                           Do
 Pituitary-Derived Growth Hormone
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45430]]


Guideline On Validation of the Limulus           December 1, 1987           Do                           Do
 Amebocyte Lysate Test as an End-Product
 Endotoxin Test for Human and Animal Parenteral
 Drugs, Biological Products, and Medical
 Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for the Management of Donors     December 2, 1987           Do                           Do
 and Units That Are Initially Reactive for
 Hepatitis B Surface Antigen (HBsAg)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Extension of Dating Period for Storage of Red    December 4, 1987           Do                           Do
 Blood Cells, Frozen
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Licensed In-Vitro Diagnostic Manufacturers:   December 23, 1987          Do                           Do
 Handling of Human Blood Source Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for Implementation of            April 6, 1988              Do                           Do
 Computerization in Blood Establishments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Control of Unsuitable Blood and Blood            April 6, 1988              Do                           Do
 Components
--------------------------------------------------------------------------------------------------------------------------------------------------------
Discontinuance of Prelicensing Inspection for    July 7, 1988               Do                           Do
 Immunization Using Licensed Tetanus Toxoid and
 Hepatitis B and Rabies Vaccines
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physician Substitutes                            August 15, 1988            Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Licensed Manufacturers of Blood Grouping      August 26, 1988            Do                           Do
 Reagents: Criteria for Exemption of Lot
 Release
--------------------------------------------------------------------------------------------------------------------------------------------------------
Revised Guideline for the Collection of          October 7, 1988            Do                           Do
 Platelets, Pheresis
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Manufacturers of HTLV-I Antibody Test Kits:   October 18, 1988           Do                           Do
 Antibody to Human T-Cell Lymphotropic Virus,
 Type I (HTLV-I) Release Panel I
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guideline for the Design of Clinical       November 1, 1988           Do                           Do
 Trials for Evaluation of Safety and Efficacy
 of Allergenic Products for Therapeutic Uses
--------------------------------------------------------------------------------------------------------------------------------------------------------
HTLV-1 Antibody Testing                          November 29, 1988          Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Use of Recombigen HIV-1 LA Test                  February 1, 1989           Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Release of Pneumococcal Vaccine,  February 1, 1989           Do                           Do
 Polyvalent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Autologous Blood and Blood          March 15, 1989             Do                           Do
 Components
--------------------------------------------------------------------------------------------------------------------------------------------------------
HTLV-I Antibody Testing                          July 6, 1989               Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Use of Recombigen HIV-1 Latex Agglutination      August 1, 1989             Do                           Do
 (LA) Test
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft PTC in the Manufacture and Clinical        August 8, 1989             Do                           Do
 Evaluation of In Vitro Tests to Detect
 Antibodies to Human Immunodeficiency Virus
 Type 1 (1989)
--------------------------------------------------------------------------------------------------------------------------------------------------------
PTC in the Collection, Processing and Testing    August 22, 1989            Do                           Do
 of Ex Vivo Activated Mononuclear Leukocytes
 for Administration to Humans
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45431]]


Information Relevant to the Manufacture of       August 23, 1989            Do                           Do
 Acellular Pertussis Vaccine
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Regulated Industries for Drug Master Files   September 1, 1989          Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requirements for Computerization of Blood        September 8, 1989          Do                           Do
 Establishments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abbott Laboratories' HIVAG-1 Test for HIV-1      October 4, 1989            Do                           Do
 Antigen(s) Not Recommended for Requirements
 for Computerization of Blood Establishments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for Collection of Blood or Blood       October 26, 1989           Do                           Do
 Products from Donors With Positive Tests for
 Infectious Disease Markers (``High Risk''
 Donors)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for Determination of Residual          January 1, 1990            Do                           Do
 Moisture in Dried Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Autologous Blood Collection and Processing       February 12, 1990          Do                           Do
 Procedures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cytokine and Growth Factor Pre-Pivotal Trial     April 2, 1990              Do                           Do
 Information Package
--------------------------------------------------------------------------------------------------------------------------------------------------------
Use of Genetic Systems HIV-2 EIA                 June 21, 1990              Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
PTC in the Safety Evaluation of Hemoglobin-      August 21, 1990            Do                           Do
 Based Oxygen Carriers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline on the Preparation of Investigational  March 1, 1991              Do                           Do
 New Drug Products (Human & Animal)
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Request for Information on Blood Storage     March 15, 1991             Do                           Do
 Patterns and Red Cell Contamination by
 Yersinia Enterocolitica
--------------------------------------------------------------------------------------------------------------------------------------------------------
Revision to October 26, 1989 Guideline for       March 17, 1991             Do                           Do
 Collection of Blood or Blood Products from
 Donors with Positive Tests for Infectious
 Disease Markers (High Risk Donors)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Deficiencies Relating to the Manufacture of      March 20, 1991             Do                           Do
 Blood and Blood Components
--------------------------------------------------------------------------------------------------------------------------------------------------------
Responsibilities of Blood Establishments         March 20, 1991             Do                           Do
 Related to Errors & Accidents in the
 Manufacture of Blood and Blood Components
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Biologic Product Manufacturers--Controlling   May 3, 1991                Do                           Do
 Materials of Bovine or Ovine Origin
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Recommendations Concerning Testing for       September 10, 1991         Do                           Do
 Antibody to Hepatitis B Core Antigen (Anti-
 HBc)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disposition of Blood Products Intended for       September 11, 1991         Do                           Do
 Autologous Use That Test Repeatedly Reactive
 for Anti-HCV
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clarification of FDA Recommendations for Donor   December 12, 1991          Do                           Do
 Deferral and Product Distribution Based on the
 Results of Syphilis Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommended Methods for Blood Grouping Reagents  March 1, 1992              Do                           Do
 Evaluation
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45432]]


Recommended Methods for Evaluating Potency,      March 1, 1992              Do                           Do
 Specificity and Reactivity of Anti-Human
 Globulin
--------------------------------------------------------------------------------------------------------------------------------------------------------
PTC in the Design and Implementation of Field    March 1, 1992              Do                           Do
 Trials for Blood Grouping Reagents and Anti-
 Human Globulin
--------------------------------------------------------------------------------------------------------------------------------------------------------
PTC in the Manufacture of In Vitro Monoclonal    March 1, 1992              Do                           Do
 Antibody Products for Further Manufacturing
 into Blood Grouping Reagents and Anti-Human
 Globulin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supplement to the PTC in the Production and      April 6, 1992              Do                           Do
 Testing of New Drugs and Biologicals Produced
 by Recombinant DNA Technology: Nucleic Acid
 Characterization and Genetic Stability
--------------------------------------------------------------------------------------------------------------------------------------------------------
Revised Recommendations for the Prevention of    April 23, 1992             Do                           Do
 Human Immunodeficiency Virus (HIV)
 Transmission by Blood and Blood Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Use of Fluorognost HIV-1 Immunofluorescent       April 23, 1992             Do                           Do
 Assay (IFA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Revised Recommendations for Testing Whole        April 23, 1992             Do                           Do
 Blood, Blood Components, Source Plasma and
 Source Leukocytes for Antibody to Hepatitis C
 Virus Encoded Antigen (Anti-HCV)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemptions to Permit Persons with a History of   April 23, 1992             Do                           Do
 Viral Hepatitis Before the Age of Eleven Years
 to Serve as Donors of Whole Blood and Plasma;
 Alternative Procedures, 21 CFR 640.120
--------------------------------------------------------------------------------------------------------------------------------------------------------
Changes in Equipment for Processing Blood Donor  July 21, 1992              Do                           Do
 Samples
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nomenclature for Monoclonal Blood Grouping       September 28, 1992         Do                           Do
 Reagents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Volume Limits for Automated Collection of        November 4, 1992           Do                           Do
 Source Plasma
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA's Policy Statement Concerning Cooperative    November 25, 1992          Do                           Do
 Manufacturing Arrangements for Licensed
 Biologics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Revision of October 7, 1988 Memo Concerning Red  December 16, 1992          Do                           Do
 Blood Cell Immunization Programs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft PTC in the Characterization of Cell Lines  July 12, 1993              Do                           Do
 Used to Produce Biologicals
--------------------------------------------------------------------------------------------------------------------------------------------------------
CBER Refusal to File (RTF) Guidance for Product  July 12, 1993              Do                           Do
 and Establishment License Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alternatives to Lot Release                      July 20, 1993              Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations Regarding License Amendments     July 22, 1993              Do                           Do
 and Procedures for Gamma Irradiation of Blood
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Deferral of Blood and Plasma Donors based on     July 28, 1993              Do                           Do
 Medications
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45433]]


Revised Recommendations for Testing Whole        August 19, 1993            Do                           Do
 Blood, Blood Components, Source Plasma and
 Source Leukocytes for Antibody to Hepatitis C
 Virus Encoded Antigen (Anti-HCV)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Changes in administrative procedures             September 9, 1993          Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Sponsors of IND's using Retroviral Vectors    September 20, 1993         Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guideline for the Validation of Blood      September 28, 1993         Do                           Do
 Establishment Computer Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Methods of the Allergenic Products Testing       October 1, 1993            Do                           Do
 Laboratory
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application of Current Statutory Authorities to  October 14, 1993           Do                           Do
 Human Somatic Cell Therapy Products and Gene
 Therapy Products; Notice
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for Adverse Experience Reporting for   October 15, 1993           Do                           Do
 Licensed Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Regarding Post Donation Information     December 10, 1993          Do                           Do
 Reports
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Manufacturers: Bovine Derived Materials       December 17, 1993          Do                           Do
 (BSE)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Donor Suitability Related to Laboratory Testing  December 22, 1993          Do                           Do
 for Viral Hepatitis and a history of Viral
 Hepatitis
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Program Guidance Manual (Drugs and    1994                       Do                           National Technical Information Service (NTIS),
 Biologics)                                                                                               5285 Port Royal Rd., Springfield, VA 22161,
                                                                                                          703-605-6050, (Publication No. 94-920699)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for the Invalidation of Test     January 3, 1994            Do                           Office of Communication, Training, and
 Results When Using Licensed Viral Marker                                                                 Manufacturers Assistance (HFM-40), Center for
 Assays to Screen Donors                                                                                  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 U.S.) or 301-827-3844
                                                                                                          (outside U.S. and local to Rockville, MD).
                                                                                                          Internet access: http://www.fda.gov/cber
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Blood Establishment Computer Software         March 31, 1994             Do                           Do
 Manufacturers
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Sponsors of IND's for Human Immunoglobulin    May 23, 1994               Do                           Do
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Manufacturers of Licensed Anti-HIV Test Kits  May 26, 1994               Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for Deferral of Donors for       July 26, 1994              Do                           Do
 Malaria Risk
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline for Industry: Studies in Support   August 1, 1994             Do                           Do
 of Special Populations
--------------------------------------------------------------------------------------------------------------------------------------------------------
OELPS, Advertising and Promotional Labeling      August 1, 1994             Do                           Do
 Staff Procedural Guidance Document (Draft)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45434]]


Use of and FDA Cleared or Approved Sterile       August 5, 1994             Do                           Do
 Docking Device (STCD) in Blood Bank Practices
 (transmittal memo 8/12/94) (corrects 7/29/94
 Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline for Industry: Stability Testing    September 1, 1994          Do                           Do
 of New Drug Substances and Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Blood Banks, Division    September 1, 1994          FDA Personnel                Do
 of Field Investigations, Office of Regional
 Operations, Office of Regulatory Affairs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Manufacturers of Immune Globulin       October 3, 1994            FDA Regulated Industry       Do
 Intravenous (Human)(IGIV), Aseptic Meningitis
 Syndrome
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Alternatives to Lot Release for      October 27, 1994           Do                           Do
 Licensed Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: For the Submission of     November 1994              Do                           Do
 Chemistry, Manufacturing, and Controls
 Information for Synthetic Peptide Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations to Users of Medical Devices      December 20, 1994          Do                           Do
 That Test for Infectious Disease Markers by
 Enzyme Immunoassay (EIA) Test Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Manufacturers of Immune Globulin Products:    December 27, 1994          Do                           Do
 Testing for Hepatitis C Virus RNA
 Immunoglobulin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Timeframe for Licensing Irradiated Blood         February 3, 1995           Do                           Do
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Blood Establishment Computer Software         February 10, 1995          Do                           Do
 Manufacturers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Home Specimen Collection Kit Systems Intended    February 23, 1995          Do                           Do
 for Human Immunodeficiency Virus (HIV-1 and/or
 HIV-2) Antibody Testing; Revisions to Previous
 Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline for Industry: Clinical Safety      March 1, 1995              Do                           Do
 Data Management: Definitions and Standards for
 Expedited Reporting
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Manufacturers of Intramuscular Immune         March 3, 1995              Do                           Do
 Globulin Products: HCV RNA Testing by PCR
--------------------------------------------------------------------------------------------------------------------------------------------------------
Revision of August 27, 1982 FDA Memo:            March 10, 1995             Do                           Do
 Requirements for Infrequent Plasmapheresis
 Donors
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Manufacturers of Intramuscular Immune         March 13, 1995             Do                           Do
 Globulin Products: additional information
 regarding HCV RNA testing by PCR
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Health Professionals: Implementation of       March 14, 1995             Do                           Do
 Testing for HCV RNA by PCR for Immune Globulin
 Products for Intramuscular Administration
--------------------------------------------------------------------------------------------------------------------------------------------------------
To All Establishments Performing Red Blood Cell  March 14, 1995             Do                           Do
 Immunizations: Revised Recommendations for Red
 Blood Cell Immunization Programs for Source
 Plasma
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance, Computer Software             March 26, 1995             FDA Personnel                Do
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45435]]


Recommendations for the Deferral of Current and  June 8, 1995               FDA Regulated Industry       Do
 Recent Inmates of Correctional Institutions as
 Donors of Whole Blood, Blood Components,
 Source Leukocytes and Source Plasma
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for Quality Assurance in Blood         July 11, 1995              Do                           Do
 Establishments
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Guidance Document Concerning Use of Pilot    July 11, 1995              Do                           Do
 Manufacturing Facilities for the Development
 and Manufacture of Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disposition of Products Derived from Donors      August 8, 1995             Do                           Do
 Diagnosed with, or at Known HighRisk for,
 Creutzfeldt-Jakob Disease
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for Labeling and Use of Units    August 8, 1995             Do                           Do
 of Whole Blood, Blood
Components, Source Plasma, Recovered Plasma or
 Source Leukocytes Obtained from Donors with
 Elevated Levels of Alanine Aminotransferase
 (ALT)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Precautionary Measures to Further Reduce the     August 8, 1995             Do                           Do
 Possible Risk of Transmission of Creutzfeldt-
 Jakob Disease by Blood and Blood Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for Donor Screening with a       August 8, 1995             Do                           Do
 Licensed Test for HIV-1 Antigen
--------------------------------------------------------------------------------------------------------------------------------------------------------
PTC in the Manufacture and Testing of            August 22, 1995            Do                           Do
 Therapeutic Products for Human Use Derived
 from Transgenic Animals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Informed Consent for Plasmapheresis/             October 1, 1995            FDA Personnel                Do
 Immunization
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Reviewers' Guide: Changes in Personnel     October 1, 1995            FDA Personnel                Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disease Associated Antibody Collection Program   October 1, 1995            FDA Personnel                Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format of Investigational New Drug   November 1, 1995           FDA Regulated Industry       Do
 Applications (INDs) for Phase 1 Studies of
 Drugs, Including Well-Characterized,
 Therapeutic, Biotechnology-derived Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Concerning Conversion to FDA-Reviewed   November 13, 1995          Do                           Do
 Software Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Donor Deferral Due to Red Blood Cell Loss        December 4, 1995           Do                           Do
 During Collection of Source Plasma by
 Automated Plasmapheresis
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interim Definition and Elimination of Lot-by-    December 8, 1995           Do                           Do
 Lot Release for Well-Characterized Therapeutic
 Recombinant DNA-Derived and Monoclonal
 Antibody Biotechnology Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dear Colleague: Regarding Reverse Transcriptase  January 4, 1996            Do                           Do
 Activity in Viral Vaccines Produced in Chicken
 Cells
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requesting All Manufacturers Immediately to      January 4, 1996            Do                           Do
 Revise Warning Section for Package Insert on
 Thrombin
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45436]]


ICH Final Guideline: Quality of                  February 23, 1996          Do                           Do
 Biotechnological Products: Analysis of
the Expression Construct in Cells Used for
 Production of r-DNA Dervied Protein Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Final Guideline on the Need for Long-Term    March 1, 1996              Do                           Do
 Rodent Carcinogenicity Study of
 Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Additional Recommendations for Donor Screening   March 14, 1996             Do                           Do
 With a Licensed Test for HIV-1 Antigen
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Guidance Concerning Demonstration of         March 26, 1996             Do                           Do
 Comparability of Human Biological Products,
 Including Therapeutic Biotechnology-Derived
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline on the Detection of Toxicity to    April 5, 1996              Do                           Do
 Reproduction for Medicinal Products; Addendum
 on Toxicity to Male Fertility
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Specific Aspects of Regulatory   April 24, 1996             Do                           Do
 Genotoxicity Tests for Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Manufacturers of FDA-Regulated Drug/          May 9, 1996                Do                           Do
 Biological/Device Products, Bovine Spongiform
 Encephalopathy (BSE)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Additional Recommendations for Testing Whole     May 16, 1996               Do                           Do
 Blood, Blood Components, Source Plasma and
 Source Leucocytes for Antibody to Hepatitis C
 Virus Encoded Antigen (Anti-HCV)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--The Content and Format    May 23, 1996               Do                           Do
 for Pediatric Use Supplements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Applications for Products Comprised  May 24, 1996               Do                           Do
 of Living Autologous Cells Manipulated Ex Vivo
 and Intended for Structural Repair of
 Reconstruction
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations and Licensure Requirements for   May 29, 1996               Do                           Do
 Leukocyte-Reduced Blood Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Infectious Disease       June 1, 1996               FDA Personnel                Do
 Marker Testing Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Manufacturers: Implementation of testing for  June 13, 1996              FDA Regulated Industry       Do
 Hepatitis C virus RNA by Manufacturers:
 Implementation of testing for Hepatitis C
 virus RNA by polymerase chain reaction (PCR)
 of intramuscular immune globulin preparations
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Final Guidelines on Stablity Testing of      July 10, 1996
 Biotechnological/Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline on Structure and Content of        July 17, 1996              Do                           Do
 Clinical Study Reports
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for the Quarantine and           July 19, 1996              Do                           Do
 Disposition of Units from Prior Collections
 from Donors with Repeatedly Reactive Screening
 Tests for Hepatitis B Virus (HBV), Hepatitis C
 Virus (HCV) and Human T-Lymphotropic Virus
 Type I (HTLV-I)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45437]]


To Manufacturers: HIV-1 Group O                  July 31, 1996              Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry for the Submission of      August 15, 1996            Do                           Do
 Chemistry, Manufacturing, and Controls
 Information for a Therapeutic Recombinant DNA-
 Derived Product or a Monoclonal Antibody
 Product for In Vivo Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Revised Guidance: Single Dose Acute          August 26, 1996            Do                           Do
 Toxicity Testing for Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Public Health Service Guideline on         September 23, 1996         Do                           Do
 Infectious Disease Issues in
 Xenotransplantation; Notice
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Draft Guideline on Data Elements for         October 1, 1996            Do                           Do
 Transmission of Individual Case Reports
--------------------------------------------------------------------------------------------------------------------------------------------------------
To All Plasma Derivative Manufacturers and to    October 7, 1996            Do                           Do
 ABRA: Warning Statement for Plasma Derivative
 Product Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Advertising and Promotion; Guidance; Notice      October 8, 1996            Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Biologic Product Manufacturers: Revised       December 3, 1996           Do                           Do
 Procedures for Internal Labeling Review Number
 Assignment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interim Recommendations for Deferral of Donors   December 11, 1996          Do                           Do
 at Increased Risk for HIV-1 Group O Infection
--------------------------------------------------------------------------------------------------------------------------------------------------------
PTC on Plasmid DNA Vaccines for Preventive       December 22, 1996          Do                           Do
 Infectious Disease Indications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Chemistry,        January 1997               Do                           Do
 Manufacturing, and Controls Information and
 Establishment Description for Autologous
 Somatic Cell Therapy Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance for a Premarket Notification   January 13, 1997           FDA Personnel                Do
 Submission for Blood Establishment Computer
 Software
--------------------------------------------------------------------------------------------------------------------------------------------------------
The Food and Drug Administration's Development,  February 27, 1997          FDA Regulated Industry       Do
 Issuance, and Use of Guidance Documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed Approach to Regulation of Cellular and  February 27, 1997          Do                           Do
 Tissue-Based Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
PTC in the Manufacture and Testing of            February 28, 1997          Do                           Do
 Monoclonal Antibody Products for Human Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tables 1 and 2 from Proposed Approach to         March 4, 1997              Do                           Do
 Regulation of Cellular and Tissue-Based
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preclearance of Promotional Labeling;            March 5, 1997              Do                           Do
 Clarification
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry for the Evaluation of      April 1997                 Do                           Do
 Combination Vaccines for Preventable Diseases:
 Production, Testing and Clinical Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45438]]


ICH Draft Guideline on Dose Selection for        April 2, 1997              Do                           Do
 Carcinogenicity Studies for Pharmaceuticals:
 Addendum on the Limit Dose
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Draft Guideline on the Timing of             May 2, 1997                Do                           Do
 Nonclinical Studies for the Conduct of Human
 Clinical Trials for Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Draft Guideline on Impurities: Residual      May 2, 1997                Do                           Do
 Solvents                                        (Correction May 19, 1997)
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline on Stability Testing for New       May 9, 1997                Do                           Do
 Dosage Forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Draft Guideline on Statistical Principles    May 9, 1997                Do                           Do
 for Clinical Trials, Part III
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Good Clinical Practice: Consolidated         May 9, 1997                Do                           Do
 Guideline, Part II
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline for the Photostability Testing of  May 16, 1997               Do                           Do
 New Drug Substances and Products, Part II
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline on Impurities in New Drug          May 19, 1997               Do                           Do
 Products, Part IV
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline on Clinical Safety Data            May 19, 1997               Do                           Do
 Management: Periodic Safety Update Reports for
 marketed Drugs, Part VI
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guideline on the Validatioin of Analytical   May 19, 1997               Do                           Do
 Procedures: Methodology, Part V
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Plasma Fractionators--CBER's View on Product  May 29, 1997               Do                           Do
 Recalls Conducted by the Plasma Fractionation
 Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Draft Guideline on General Considerations    May 30, 1997               Do                           Do
 for Clinical Trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Source Plasma            June 1, 1997               FDA Personnel                Do
 Establishments (Division of Field
 Investigations, Office of Regional Operations,
 Office of Regulatory Affairs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Computerized        June 18, 1997              FDA Regulated Industry       Do
 Systems Used in Clinical Trials; Availability
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Changes to an Approved    July 1997                  Do                           Do
 Application: Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Changes to an Approved    July 1997                  Do                           Do
 Application for Specified Biotechnology and
 Specified Synthetic Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Screening and Testing of  July 1997                  Do                           Do
 Donors of Human Tissue Intended for
 Transplantation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Donor Screening for       August 1997                Do                           Do
 Antibodies to HTLV-II
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry on Testing Limits    August 1997                Do                           Do
 in Stability Protocols for Standardized Grass
 Pollen Extracts
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45439]]


Guidance for Industry--Postmarketing Adverse     August 1997                Do                           Do
 Experience Reporting for Human Drug and
 Licensed Biological Products: Clarification of
 What to Report
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry Efficacy Evaluation  September 1997             Do                           Do
 of Hemoglobin-and Perfluorocarbon-Based Oxygen
 Carriers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry -The Sourcing and          September 1997             Do                           Do
 Processing of Gelatin to Reduce the Potential
 Risk Posed by Bovine Spongiform Encephalopathy
 (BSE) in FDA-Regulated Products for Human Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification Process for Transfusion Related     October 7, 1997            Do                           Do
 Fatalities and Donation Related Deaths
 (revised telephone number)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission Requirements for Requesting           October 15, 1997           Do                           Do
 Certificates for Exporting Products to Foreign
 Countries
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Preclinical Safety Evaluation    November 18, 1997          Do                           Do
 of Biotechnology-Derived Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Genotoxicity: A Standard         November 21, 1997          Do                           Do
 Battery for Genotoxicity Testing for
 Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Nonclinical Safety Studies for   November 25 1997           Do                           Do
 the Conduct of Human Clinical Trials for
 Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Draft Guidance on Specifications: Test       November 25, 1997          Do                           Do
 Procedures and Acceptance Criteria for New
 Drug Substances and New Drug Products:
 Chemical Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for FDA and Industry: Direct Final      November 21, 1997          FDA Personnel and Regulated  Do
 Rule Procedures                                                             Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Promoting Medical   December 1997              FDA Regulated Industry       Do
 Products in a Changing Healthcare Environment;
 I. Medical Product Promotion by Healthcare
 Organizations or Pharmacy Benefits Management
 Companies (PBMS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Industry-Supported        December 3, 1997           Do                           Do
 Scientific and Educational Activities
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Dose Selection for               December 4, 1997           Do                           Do
 Carcinogenicity Studies of Pharmaceuticals:
 Addendum on a Limit Dose and Related Notes
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Biologic Product Manufacturers--Withdrawal    December 11, 1997          Do                           Do
 of Human Blood-Derived Materials Because
 Donors Diagnosed With, or At Increased Risk
 For, CJD
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Allergenic Extract Manufacturers--            December 23, 1997          Do                           Do
 Standardized Grass Pollen Extracts
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Data Elements for Transmission   January 15, 1998
 of Individual Case Safety Reports
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45440]]


Guidance for Industry: Year 2000 Date Change     January 1998               Do                           Do
 for Computer Systems and Software Applications
 Used in the Manufacture of Blood Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Container and       January 1998               Do                           Do
 Closure Integrity Testing in Lieu of Sterility
 Testing as a Component of the Stability
 Protocol for Sterile Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Testing for Carncinogenicity of  February 28, 1998
 Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Manufacturing,      March 1998                 Do                           Do
 Processing or Holding Active Pharmaceutical
 Ingredients
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Guidance for Human        March 1998                 Do                           Do
 Somatic Cell Therapy and Gene Therapy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Instructions for    May 1998                   Do                           Do
 Submitting Electronic Lot Release Protocols to
 the Center for Biologics Evaluation and
 Research
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Pilot Program for   May 1998                   Do                           Do
 Electronic Investigational New Drug (eIND)
 Applications for Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Submitting and Reviewing  May 1998                   Do                           Do
 Complete Responses to Clinical Holds
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Classifying               May 1998                   Do                           Do
 Resubmissions in Response to Action Letters
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Pharmacokinetics in       May 1998                   Do                           Do
 Patients with Impaired Renal Function--Study
 Design, Data Analysis and Impact on Dosing and
 Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Standards for the Prompt  May 1998                   Do                           Do
 Review of Efficacy Supplements, Including
 Priority Efficacy Supplements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Providing Clinical        May 1998                   Do                           Do
 Evidence of Effectiveness for Human Drugs and
 Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Stability Testing   June 1998                  Do                           Do
 of Drug Substances and Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Qualifying for Pediatric  June 1998                  Do                           Do
 Exclusivity Under Section 505A of the Federal
 Food, Drug and Cosmetic Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Errors and Accidents      June 1998                  Do                           Do
 Regarding Saline Dilution of Samples Used for
 Viral Marker Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Draft Guidance on Specifications: Test       June 9, 1998               Do                           Do
 Procedures and Acceptance Criteria for
 Biotechnological/Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Ethnic Factors in the            June 10, 1998              Do                           Do
 Acceptability of Foreign Clinical Data
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45441]]


Draft Guidance for Industry: Exports and         June 12, 1998              Do                           Do
 Imports Under the FDA Export Reform and
 Enhancement Act of 1996
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Implementation of         July 1998                  Do                           Do
 Section 126 of the Food and Drug
 Administration Modernization Act of 1997--
 Elimination of Certain Labeling Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Environmental Assessment  July 1998                  Do                           Do
 of Human Drug and Biologics Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Recommendations     July 1998                  Do                           Do
 for Collecting Red Blood Cells by Automated
 Apheresis Methods
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Current Good              September 1998             Do                           Do
 Manufacturing Practice for Blood and Blood
 Components: (1) Quarantine and Disposition of
 Units from Prior Collections from Donors with
 Repeatedly Reactive Screening Tests for
 Antibody to Hepatitis C Virus (Anti-HCV); (2)
 Supplemental Testing, and the Notification of
 Consignees and Blood Recipients of Donor Test
 Results for Anti-HCV
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Submitting          September 1998             Do                           Do
 Debarment Certification Statements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: How to Complete the       September 1998             Do                           Do
 Vaccine Adverse Reporting System Form (VAERS-
 1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Fast Track Drug           September 1998             Do                           Do
 Development Programs--Designation,
 Development, and Application Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Statistical Principles for       September 16, 1998         Do                           Do
 Clinical Trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Quality of Biotechnological/     September 21, 1998         Do                           Do
 Biological Products: Derivation and
 Characterization of Cell Substrates Used for
 Production of Biotechnological/Biological
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Viral Safety Evaluation of       September 24, 1998         Do                           Do
 Biotechnology Products Derived From Cell Lines
 of Human or Animal Origin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Developing Medical  October 1998               Do                           Do
 Imaging Drugs and Biologics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: on Advisory Committees:   October 1998               Do                           Do
 Implementing Section 120 of the Food and Drug
 Administration Act of 1997
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Document: United States Industry           December 1997 (Released    Do                           Do
 Consensus Standard for the Uniform Labeling of   November 1998)
 Blood and Blood Components Using ISBT 128
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: General             November 1998              Do                           Do
 Considerations for Pediatric Pharmacokinetic
 Studies for Drugs and Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Viral Vaccine IND Sponsors--Use of PCR-based  December 18, 1998          Do                           Do
 Reverse Transcriptase Assay
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45442]]


Guidance for Industry: FDA Approval of New       December 1998              Do                           Do
 Cancer Treatment Uses for Marketed Drug and
 Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Content and Format  December 1998              Do                           Do
 of Geriatric Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Product Name        January 1999               Do                           Do
 Placement, Size and Prominence in Advertising
 and Promotional Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Content and Format of     January 1999               Do                           Do
 Chemistry, Manufacturing and Controls
 Information and Establishment Description
 Information for a Vaccine or Related Product
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Amended Procedures for Advisory      January 1999               Do                           Do
 Panel Meetings
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Providing Regulatory      January 1999               Do                           Do
 Submissions in Electronic Format--General
 Considerations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Population                February 1999              Do                           Do
 Pharmacokinetics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: For the Submission of     February 1999              Do                           Do
 Chemistry, Manufacturing and Controls and
 Establishment Description Information for
 Human Plasma-Derived Biological Products,
 Animal Plasma or Serum-Derived Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: For the Submission of     February 1999              Do                           Do
 Chemistry, Manufacturing and Controls and
 Establishment Description Information for
 Human Plasma-Derived Biological Products,
 Animal Plasma or Serum-Derived Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: INDs for Phase 2    February 1999              Do                           Do
 and 3 Studies of Drugs, Including Specified
 Therapeutic Biotechnology-Derived Products,
 Chemistry Manufacturing and Controls Content
 and Format
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Accelerated         March 1999                 Do                           Do
 Approval Products--Submission of Promotional
 Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Content and Format of     March 1999                 Do                           Do
 Chemistry, Manufacturing and Controls
 Information and Establishment Description
 Information for a Biological In Vitro
 Diagnostic Product
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Public Health Issues      April 1999                 Do                           Do
 Posed by the Use of Nonhuman Primate
 Xenografts in Humans
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry On the Content and Format  April 1999                 Do                           Do
 of Chemistry, Manufacturing and Controls
 Information and Establishment Description
 Information for an Allergenic Extract or
 Allergen Patch Test
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45443]]


Guidance for Industry For the Submission of      May 1999                   Do                           Do
 Chemistry, Manufacturing and Controls and
 Establishment Description Information for
 Human Blood and Blood Components Intended for
 Transfusion or for Further Manufacture and For
 the Completion of the Form FDA 356h
 ``Application to Market a New Drug, Biologic
 or an Antibiotic Drug for Human Use''
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry For Platelet Testing and   May 1999                   Do                           Do
 Evaluation of Platelet Substitute Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Efficacy Studies to       May 1999                   Do                           Do
 Support Marketing of Fibrin Sealant Products
 Manufactured for Commercial Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Monoclonal          May 1999                   Do                           Do
 Antibodies Used as Reagents in Drug
 Manufacturing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Container Closure         May 1999                   Do                           Do
 Systems for Packaging Human Drugs and
 Biologics; Chemistry, Manufacturing, and
 Controls Documentation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Establishing        June 1999                  Do                           Do
 Pregnancy Registries
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Reviewer Guidance: Evaluation of Human     June 1999                  FDA Personnel                Do
 Pregnancy Outcome Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Current Good        June 1999                  FDA Regulated Industry       Do
 Manufacturing Practice for Blood and Blood
 Components: (1) Quarantine and Disposition of
 Prior Collections from donors with Repeatedly
 Reactive Screening Tests for Hepatitis C Virus
 (HCV); (2) Supplemental Testing, and the
 Notification of Consignees and Transfusion
 Recipients of donor Test Results for Antibody
 to HCV (Anti-HCV)
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on the Duration of Chronic          June 25, 1999              Do                           Do
 Toxicity Testing in Animals (Rodent and
 Nonrodent Toxicity Testing)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Clinical            July 1999                  Do                           Do
 Development Programs for Drugs, Devices, and
 Biological Products Intended for the Treatment
 of Osteoarthritis (OA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Interpreting        July 1999                  Do                           Do
 Sameness of Monoclonal Antibody Products Under
 the Orphan Drug Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Cooperative         August 1999                Do                           Do
 Manufacturing Arrangements for Licensed
 Biologics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Consumer-Directed         August 1999                Do                           Do
 Broadcast Advertisements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Information         August 1999                Do                           Do
 Request and Discipline Review Letters Under
 the Prescription Drug User Fee Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Possible Dioxin/PCB       August 1999                Do                           Do
 Contamination of Drug and Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45444]]


Guidance for Industry: Submission of             August 1999                Do                           Do
 Abbreviated Reports and Synopses in Support of
 Marketing Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
ICH Guidance on Specifications: Test Procedures  August 18, 1999            Do                           Do
 and Acceptance Criteria for Biotechnological/
 Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Revised             September 1999             Do                           Do
 Recommendations for the Invalidation of Test
 Results When Using Licensed and 510(k) Cleared
 Bloodborne Pathogen Assays to Test Donors
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Qualifying for Pediatric  September 1999             Do                           Do
 Exclusivity Under Section 505A of the Federal
 Food, Drug and Cosmetic Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation Draft  September 24, 1999         Do                           Do
 Guidance; Choice of Control Group in Clinical
 Trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Supplemental        November 1999              Do                           Do
 Guidance on Testing for Replication Competent
 Retrovirus in Retroviral Vector Based Gene
 Therapy Products and During Follow-up of
 Patients in Clinical Trials Using Retroviral
 Vectors
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Providing Regulatory      November 1999              Do                           Do
 Submissions to the Center for Biologics
 Evaluation and Research (CBER) in Electronic
 Format--Biologics Marketing Applications
 [Biologics License Application (BLA), Product
 License Application (PLA)/Establishment
 License Application (ELA) and New Drug
 Application (NDA)]--Revised
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Revised Precautionary     November 1999              Do                           Do
 Measures to Reduce the Possible Risk of
 Transmission of Creutzfeldt-Jakob Disease
 (CJD) and New Variant Creutzfeldt-Jakob
 Disease (nvCJD) by Blood and Blood Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: In Vivo Drug Metabolism/  November 1999              Do                           Do
 Drug Interaction Studies--Study Design, Data
 Analysis and Recommendations for Dosing and
 Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Application of      November 1999              Do                           Do
 Current Statutory Authority to Nucleic Acid
 Testing of Pooled Plasma
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Pharmacokinetics    November 1999              Do                           Do
 in Patients With Impaired Hepatic Function:
 Study Design, Data Analysis and Impact on
 Dosing and Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation of     November 8, 1999           Do                           Do
 Technical Requirements for Registration of
 Pharmaceuticals for Human Use M4: Common
 Technical Document
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: In the Manufacture and    December 1999              Do                           Do
 Clinical Evaluation of In Vitro Tests to
 Detect Nucleic Acid Sequences of Human
 Immunodeficiency Viruses Types 1 and 2
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45445]]


Draft Guidance for Industry: Precautionary       December 1999              Do                           Do
 Measures to Reduce the Possible Risk of
 Transmission of Zoonoses by Blood and Blood
 Products from Xenotransplantation Product
 Recipients and Their Contacts
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Special Protocol    December 1999              Do                           Do
 Assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Changes to an       January 2000               Do                           Do
 Approved Application: Biological Products:
 Human Blood and Blood Components Intended for
 Transfusion or for Further Manufacture
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Reviewers: Potency Limits     February 2000              FDA Personnel                Do
 for Standardized Dust Mite and Grass Allergen
 Vaccines: A Revised Protocol
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: IND Meetings for    February 2000              FDA Regulated Industry       Do
 Human Drugs and Biologics: Chemistry,
 Manufacturing, and Controls Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Formal Meetings With      February 2000              Do                           Do
 Sponsors and Applicants for PDUFA Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Formal Dispute            February 2000              Do                           Do
 Resolution: Appeals Above the Division Level
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Gamma Irradiation of      February 2000              Do                           Do
 Blood and Blood Components: A Pilot Program
 for Licensing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Information         March 2000                 Do                           Do
 Program on Clinical Trials for Serious or Life-
 Threatening Diseases: Establishment of a Data
 Bank
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation; E11:  April 12, 2000             Do                           Do
 Clinical Investigation of Medicinal Products
 in the Pediatric Population
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation;       April 21, 2000             Do                           Do
 Draft Revised Guidance on Q1A(R) Stability
 Testing of New Drug Substances and Products
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             How to Obtain a Hard Copy of the Document
                 Name of Document                        Date of Issuance       Grouped by Intended User     (Name and Address, Phone,  FAX, E-mail or
                                                                                or Regulatory  Activity                      Internet)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Accelerated Approval Products--Submission of        March 26, 1999             Advertising Draft          http://www.fda.gov/cder/guidance/index.htm
 Promotional Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Name, Placement, Size, and Prominence in    March 12, 1999             Do                         Do
 Advertising and Promotional Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Promoting Medical Products in a Changing            January 5, 1998            Do                         Do
 Healthcare Environment; Medical Product Promotion
 by Healthcare Organizations or Pharmacy Benefits
 Management Companies (PBMs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aerosol Steroid Product Safety Information in       January 12, 1998           Advertising                Do
 Prescription Drug Advertising and Promotional
 Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45446]]


Consumer-Directed Broadcast Advertisements          August 9, 1999             Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Antifungal (topical)                                February 24, 1990          Biopharmaceutic Draft      Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Antifungal (vaginal)                                February 24, 1990          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average, Population, and Individual Approaches to   August 27, 1999            Do                         Do
 Establishing Bioequivalence
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bioanalytical Methods Validations for Human         January 5, 1999            Do                         Do
 Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bioavailability and Bioequivalence Studies for      June 2, 1999               Do                         Do
 Nasal Aerosols and Nasal Sprays for Local Action
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bioavailability and Bioequivalence Studies for      August 27, 1999            Do                         Do
 Orally Administered Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Conjugated Estrogens, USP: LC-MS Method for Both    March 9, 2000              Do                         Do
 Qualitative Chemical Characterization and
 Documentation of Qualitative Pharmaceutical
 Equivalence
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food-Effect Bioavailability and Bioequivalence      December 20, 1997          Do                         Do
 Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Topical Dermatological Drug Product NDA's and       June 18, 1998              Do                         Do
 ANDA's--In Vivo
Bioavailability, Bioequivalence, In Vitro Release
 and Associated Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Waiver of In Vivo Bioavailability and               February 17, 1999          Do                         Do
 Bioequivalence Studies for Immediate Release
 Solid Oral Dosage Forms Containing Certain Active
 Moieties/Active Ingredients
--------------------------------------------------------------------------------------------------------------------------------------------------------
Buspirone Hydrochloride Tablets In Vivo             May 15, 1998               Biopharmaceutic            Do
 Bioequivalence and In Vitro Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cholestyramine Powder In Vitro Bioequivalence       July 15, 1993              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cimetidine Tablets In Vivo Bioequivalence and In    June 12, 1992              Do                         Do
 Vitro Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clozapine (Tablets) In Vivo Bioequivalence and In   November 15, 1996          Do                         Do
 Vitro Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Corticosteroids, Dermatologic (topical) In Vivo     June 2, 1995               Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diclofenac Sodium (tablets) In Vivo Bioequivalence  October 6, 1994            Do                         Do
 and In Vitro Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dissolution Testing of Immediate Release Solid      August 25, 1997            Do                         Do
 Oral Dosage Forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Extended Release Oral Dosage Forms: Development,    September 26, 1997         Do                         Do
 Evaluation, and Application of In Vitro/In Vivo
 Correlations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glipizide (Tablets) In Vivo Bioequivalence and In   April 23, 1993             Do                         Do
 Vitro Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glyburide Tablets In Vivo Bioequivalence and In     April 23, 1993             Do                         Do
 Vitro Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metaproterenol Sulfate and Albuterol Metered Dose   June 27, 1989              Do                         Do
 Inhalers In Vitro
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45447]]


Oral Extended (Controlled) Release Dosage Forms In  September 9, 1993          Do                         Do
 Vivo Bioequivalence and In Vitro Dissolution
 Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phenytoin/Phenytion Sodium (capsules, tablets,      March 4, 1994              Do                         Do
 suspension) In Vivo Bioequivalence and In Vitro
 Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Potassium Chloride (slow-release tablets and        June 6, 1994               Do                         Do
 capsules) In Vivo Bioequivalence and In Vitro
 Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Statistical Procedure for Bioequivalence Studies    July 1, 1992               Do                         Do
 Using a Standard Two-Treatment Crossover Design
--------------------------------------------------------------------------------------------------------------------------------------------------------
BACPAC I: Intermediates in Drug Substance           November 30, 1998          Chemistry Draft            Do
 Synthesis (Bulk Actives Postapproval Changes:
 Chemistry, Manufacturing, and Controls
 Documentation)
--------------------------------------------------------------------------------------------------------------------------------------------------------
IND Meetings for Human Drugs and Biologics;         February 4, 2000           Do                         Do
 Chemistry, Manufacturing, and Controls
 Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
IND's for Phase 2 and 3 Studies of Drugs,           April 20, 1999             Do                         Do
 Including Specified Therapeutic
Biotechnology-Derived Products; Chemistry,
 Manufacturing, and Controls Content and Format
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metered Dose Inhalers (MDI) and Dry Powder          November 19, 1998          Do                         Do
 Inhalers (DPI) Drug Products; Chemistry,
 Manufacturing, and Controls Documentation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Monoclonal Antibodies Used as Reagents in Drug      June 24, 1999              Do                         Do
 Manufacturing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nasal Spray and Inhalation Solution, Suspension,    June 2, 1999               Do                         Do
 and Spray Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Stability Testing of Drug Substances and Drug       June 8, 1998               Do                         Do
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Supporting Chemistry Documentation in    November 1, 1991           Do                         Do
 Radiopharmaceutical Drug Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUPAC-SS: Nonsterile Semisolid Dosage Forms         January 5, 1999            Do                         Do
 Manufacturing Equipment Addendum
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tracking of NDA and ANDA Reformulations for Solid,                             Do                         Do
 Oral, Immediate Release Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Changes to an Approved Application for Specified    July 24, 1997              Chemistry                  Do
 Biotechnology and Specified Synthetic Biological
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Changes to an Approved NDA or ANDA                  November 23, 1999          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Container Closure Systems for Packaging Human       July 7, 1999               Do                         Do
 Drugs and Biologics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drug Master Files                                   September 1, 1989          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drug Master Files for Bulk Antibiotic Drug          November 29, 1999          Do                         Do
 Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
Environmental Assessment of Human Drugs and         July 27, 1998              Do                         Do
 Biologics Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45448]]


FDA's Policy Statement for the Development of New   May 1, 1992                Do                         Do
 Stereoisomeric Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content for the CMC Section of an        September 1, 1994          Do                         Do
 Annual Report
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content of the Chemistry, Manufacturing  February 1, 1987           Do                         Do
 and Controls Section of an Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content of the Microbiology Section of   February 1, 1987           Do                         Do
 an Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDAs: Impurities in Drug Substances                 February 25, 2000          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
PAC-ALTS: Postapproval Changes--Analytical Testing  April 28, 1998             Do                         Do
 Laboratory Sites
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance: Validation of Chromatographic    November 1, 1994           Do                         Do
 Methods
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Chemistry, Manufacturing and          November 1, 1994           Do                         Do
 Controls Information for Synthetic Peptide
 Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Documentation for Sterilization       November 1, 1994           Do                         Do
 Process Validation Applications for Human and
 Veterinary Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Documentation for the Manufacturing of   February 1, 1987           Do                         Do
 and Controls for Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Documentation for the Stability of       February 1, 1987           Do                         Do
 Human Drugs and Biologics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Samples and Analytical Data for Methods  February 1, 1987           Do                         Do
 Validation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Supporting Documentation in Drug         February 1, 1987           Do                         Do
 Applications for the Manufacture of Drug
 Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Supporting Documentation in Drug         February 1, 1987           Do                         Do
 Applications for the Manufacture of Drug
 Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUPAC IR- Immediate-Release Solid Oral Dosage       November 30, 1995          Do                         Do
 Forms: Scale-Up and Post-
Approval Changes: Chemistry, Manufacturing and
 Controls, In Vitro Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUPAC IR/MR: Immediate Release and Modified         February 26, 1999          Do                         Do
 Release Solid Oral Dosage Forms, Manufacturing
 Equipment Addendum
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUPAC-IR Questions and Answers                      February 18, 1997          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUPAC-MR: Modified Release Solid Oral Dosage        October 6, 1997            Do                         Do
 Forms: Scale-Up and
Postapproval Changes: Chemistry, Manufacturing,
 and Controls, In Vitro Dissolution Testing, and
 In Vivo Bioequivalence Documentation
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUPAC-SS--Nonsterile Semisolid Dosage Forms; Scale- June 13, 1997              Do                         Do
 Up and Postapproval
Changes: Chemistry, Manufacturing, and Controls;
 In Vitro Release Testing and In Vivo
 Bioequivalence Documentation
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45449]]


Acute Bacterial Exacerbation of Chronic             July 22, 1998              Clinical Antimicrobial     Do
 Bronchitis; Developing Antimicrobial Drugs for                                 Draft
 Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Bacterial Meningitis; Developing              July 22, 1998              Do                         Do
 Antimicrobial Drugs for Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Bacterial Sinusitis; Developing               July 22, 1998              Do                         Do
 Antimicrobial Drugs for Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Otitis Media; Developing Antimicrobial Drugs  July 22, 1998              Do                         Do
 for Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacterial Vaginosis; Developing Antimicrobial       July 22, 1998              Do                         Do
 Drugs for Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Catheter-Related Bloodstream Infections--           October 18, 1999           Do                         Do
 Developing Antimicrobial Drugs for Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Considerations for Accelerated and         September 1, 1999          Do                         Do
 Traditional Approval of Antiretroviral Drugs
 Using Plasma HIV RNA Measurements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Community Acquired Pneumonia; Developing            July 22, 1998              Do                         Do
 Antimicrobial Drugs for Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Complicated Urinary Tract Infections and            July 22, 1998              Do                         Do
 Pylonephritis; Developing Antimicrobial Drugs for
 Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Developing Antimicrobial Drugs-General              July 22, 1998              Do                         Do
 Considerations for Clinical Trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
Empiric Therapy of Febrile Neutropenia; Developing  July 22, 1998              Do                         Do
 Antimicrobial Drugs for Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Evaluating Clinical Studies of Antimicrobials in    February 17, 1997          Do                         Do
 the Division of Anti-Infective Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lyme Disease; Developing Antimicrobial Drugs for    July 22, 1998              Do                         Do
 Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nosocomial Pneumonia; Developing Antimicrobial      July 22, 1998              Do                         Do
 Drugs for Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Secondary Bacterial Infections of Acute             July 22, 1998              Do                         Do
 Bronchitis; Developing Antimicrobial Drugs for
 Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Streptococcal Pharyngitis and Tonsillitis;          July 22, 1998              Do                         Do
 Developing Antimicrobial Drugs for Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Uncomplicated and Complicated Skin and Skin         July 22, 1998              Do                         Do
 Structure Infections; Developing Antimicrobial
 Drugs for Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Uncomplicated Gonorrhea--Cervical, Urethral,        July 22, 1998              Do                         Do
 Rectal, and/or Pharyngeal; Developing
 Antimicrobial Drugs for Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Uncomplicated Urinary Tract Infections; Developing  July 22, 1998              Do                         Do
 Antimicrobial Drugs for Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vuvlovaginal Candidiasis; Developing Antimicrobial  July 22, 1998              Do                         Do
 Drugs for Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Development and Labeling of Anti-          October 26, 1992           Clinical Antimicrobial     Do
 Infective Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Anti-Infective Drugs         September 1, 1977          Do                         Do
 (Systemic)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45450]]


Preclinical Development of Antiviral Drugs          November 1, 1990           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abuse Liability Assessment                          July 1, 1990               Clinical Medical Draft     Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Development Programs for Drugs, Devices,   July 15, 1999              Do                         Do
 and Biological Products Intended for the
 Treatment of Osteoarthritis (OA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Anti-Anginal Drugs           January 1, 1989            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Anti-Arrhythmic Drugs        July 1, 1985               Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Antihypertensive Drugs       May 1, 1988                Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Drugs for the Treatment of   December 1, 1987           Do                         Do
 Congestive Heart Failure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Drugs for Ulcerative                                    Do                         Do
 Colitis (3rd draft)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Lipid-Altering Agents in     September 1, 1990          Do                         Do
 Adults and Children
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Motility-Modifying Drugs                                Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Weight-Control Drugs         September 24, 1996         Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Conducting a Clinical Safety Review of a New        November 22, 1996          Do                         Do
 Product Application and Preparing a Report on the
 Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
Conducting a Clinical Safety Review of a New        October 13, 1998           Do                         Do
 Product Application and Preparing a Report on the
 Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
Development and Evaluation of Drugs for the         February 12, 1992          Do                         Do
 Treatment of Psychoactive Substance Use Disorders
--------------------------------------------------------------------------------------------------------------------------------------------------------
Development of Parathyroid Hormone for the          June 14, 2000              Do                         Do
 Prevention and Treatment of Osteoporosis
--------------------------------------------------------------------------------------------------------------------------------------------------------
Establishing Pregnancy Registries                   June 4, 1999               Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Evaluation of Human Pregnancy Outcome Data          June 4, 1999               Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Female Sexual Dysfunction: Clinical Development of  May 19, 2000               Do                         Do
 Drug Products for Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vivo Pharmacokinetics and Bioavailability        June 10, 1999              Do                         Do
 Studies and In Vitro Dissolution Testing for
 Levothyroxine Sodium Tablets
--------------------------------------------------------------------------------------------------------------------------------------------------------
Institutional Review Boards, Clinical               March 30, 2000             Do                         Do
 Investigators, and Sponsors: Exception from
 Informed Consent Requirements for Emergency
 Research
--------------------------------------------------------------------------------------------------------------------------------------------------------
Levothyroxine Sodium                                August 18, 1999            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Treatment of Herpes Labialis with Antiviral     March 8, 2000              Do                         Do
 Agents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preclinical and Clinical Evaluation of Agents Used  April 1, 1994              Do                         Do
 in the Prevention or Treatment of Postmenopausal
 Osteoporosis
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparation of IND Applications for New Drugs       September 1, 1991          Do                         Do
 Intended for the Treatment of HIV-Infected
 Individuals
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45451]]


System Inflammatory Response Syndrome (SIRS) 1st                               Do                         Do
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Development Programs for Drugs, Devices,   February 17, 1999          Clinical Medical           Do
 and Biological Products for the Treatment of
 Rheumatoid Arthritis (RA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Development Programs for MDI and DPI Drug  September 19, 1994         Do                         Do
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Analgesic Drugs              December 1, 1992           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Antacid Drugs                April 1, 1978              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Anti-Inflammatory and        April 1, 1988              Do                         Do
 Antirheumatic Drugs (adults and children)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Antianxiety Drugs            September 1, 1977          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Antidepressant Drugs         September 1, 1977          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Antidiarrheal Drugs          September 1, 1977          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Antiepileptic Drugs (adults  January 1, 1981            Do                         Do
 and children)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Combination Estrogen/        March 20, 1995             Do                         Do
 Progestin-Containing Drug Products Used for
 Hormone Replacement Therapy of Postmenopausal
 Women
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Gastric Secretory            September 1, 1977          Do                         Do
 Depressant (GSD) Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of General Anesthetics          May 1, 1982                Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Hypnotic Drugs               September 1, 1977          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Laxative Drugs               April 1, 1978              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Local Anesthetics            May 1, 1982                Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Psychoactive Drugs in        July 1, 1979               Do                         Do
 Infants and Children
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Radiopharmaceutical Drugs    October 1, 1981            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format for Pediatric Use Supplements    May 24, 1996               Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format of Investigational New Drug      November 20, 1995          Do                         Do
 Applications (IND's) for Phase Studies of Drugs,
 Including Well-Characterized, Therapeutic,
 Biotechnology-Derived Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Development of Vaginal Contraceptive Drugs (NDA)    April 19, 1995             Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Approval of New Cancer Treatment Uses for       February 2, 1999           Do                         Do
 Marketed Drug and Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Requirements for Approval of Drugs to Treat     January 21, 1991           Do                         Do
 Non-Small Cell Lung Cancer
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Requirements for Approval of Drugs to Treat     June 20, 1989              Do                         Do
 Superficial Bladder Cancer
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content of the Clinical and Statistical  July 1, 1988               Do                         Do
 Sections of an Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content of the Summary for New Drug and  February 1, 1987           Do                         Do
 Antibiotic Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45452]]


Formatting, Assembling and Submitting New Drug and  February 1, 1987           Do                         Do
 Antibiotic Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Considerations for the Clinical Evaluation  February 1, 1978           Do                         Do
 of Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
 General Considerations for the Clinical            September 1, 1977          Do                         Do
 Evaluation of Drugs in Infants and Children
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oncologic Drugs Advisory Committee Discussion on    April 13, 1988             Do                         Do
 FDA Requirements for Approval of New Drugs for
 Treatment of Ovarian Cancer
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oncologic Drugs Advisory Committee Discussion on    April 19, 1988             Do                         Do
 FDA Requirements for Approval of New Drugs for
 Treatment of Colon and Rectal Cancer
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Treatment of Hypercholesterolemia               October 27, 1997           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Postmarketing Adverse Experience Reporting for      August 27, 1997            Do                         Do
 Human Drugs and Licensed Biological Products;
 Clarification of What to Report
--------------------------------------------------------------------------------------------------------------------------------------------------------
Postmarketing Reporting of Adverse Drug             March 1, 1992              Do                         Do
 Experiences
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preclinical Development of Immunomodulatory Drugs   September 4, 1992          Do                         Do
 for the Treatment of HIV Infection and Associated
 Disorders
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparation of Investigational New Drug Products    November 1, 1992           Do                         Do
 (Human and Animal)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Providing Clinical Evidence of Effectiveness for    May 15, 1998               Do                         Do
 Human Drug and Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study and Evaluation of Gender Differences in the   July 22, 1993              Do                         Do
 Clinical Evaluation of Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study of Drugs Likely to be Used in the Elderly     November 1, 1989           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Abbreviated Reports and Synopses in   September 13, 1999         Do                         Do
 Support of Marketing Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Considerations for Pediatric                November 30, 1998          Clinical Pharmacology      Do
 Pharmacokinetic Studies for Drugs and Biological                               Draft
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drug Metabolism/Drug Interaction Studies in the     April 7, 1997              Clinical Pharmacology      Do
 Drug Development Process: Studies In Vitro
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content of the Human Pharmacokinetics    February 1, 1987           Do                         Do
 and Bioavailability Section of an Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vivo Metabolism/Drug Interaction Studies--Study  November 24, 1999          Do                         Do
 Design, Data Analysis, and Recommendations for
 Dosing and Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pharmacokinetics and Pharmacodynamics in Patients   May 15, 1998               Do                         Do
 with Impaired Renal Function: Study Design, Data
 Analysis, and Impact on Dosing and Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pharmacokinetics in Patients With Impaired Hepatic  December 7, 1999           Do                         Do
 Function: Study Design, Data Analysis, and Impact
 on Dosing and Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Population Pharmacokinetics                         February 10, 1999          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45453]]


Investigating Out of Specification (OOS) Test       November 30, 1998          Compliance Draft           Do
 Results for Pharmaceutical Production
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacture, Processing or Holding of Active        April 17, 1998             Do                         Do
 Pharmaceutical Ingredients
--------------------------------------------------------------------------------------------------------------------------------------------------------
Repackaging of Solid Oral Dosage Form Drug          February 1, 1992           Do                         Do
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Review of FDA's Implementation of the Drug                                   Compliance                 Do
 Export Amendments of 1986
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compressed Medical Gases                            February 1, 1989           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Computerized Systems Used in Clinical Trials        May 10, 1999               Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Expiration Dating and Stability Testing of Solid    June 27, 1997              Do                         Do
 Oral Dosage Form Drugs Containing Iron
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Principles of Process Validation            May 1, 1987                Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Good Laboratory Practice Regulations Questions and                             Do                         Do
 Answers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Monitoring of Clinical Investigations               January 1, 1988            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nuclear Pharmacy Guideline Criteria for             May 1, 1984                Do                         Do
 Determining When to Register as a Drug
 Establishment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Possible Dioxin/PCB Contamination of Drug and       August 23, 1999            Do                         Do
 Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sterile Drug Products Produced by Aseptic           May 1, 1987                Do                         Do
 Processing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Validation of Limulus Amebocyte Lysate Test as an   December 1, 1987           Do                         Do
 End-Product Endotoxin Test for Human and Animal
 Parenteral Drugs, Biological Products, and
 Medical Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Submissions in Electronic Format;        January 28, 1999           Electronic Submissions     Do
 General Considerations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Submissions in Electronic Format; New    January 28, 1999           Do                         Do
 Drug Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
ANDA's: Blend Uniformity Analysis                   August 26, 1999            Generic Drug Draft         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
ANDA's: Impurities in Drug Products                 January 5, 1999            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abbreviated New Drug Application (ANDA)--Positron   April 18, 1997             Do                         Do
 Emission Tomography (PET) Drug Products--With
 specific information for ANDA's for
 Fludeoxyglucose F18 Injection
--------------------------------------------------------------------------------------------------------------------------------------------------------
ANDA's: Impurities in Drug Substances               December 3, 1999           Generic Drug               Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter announcing that the OGD will now accept the  August 18, 1995            Do                         Do
 ICH long-term storage conditions as well as the
 stability studies conducted in the past
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter describing efforts by the CDER & the ORA to  October 14, 1994           Do                         Do
 clarify the responsibilities of CDER chemistry
 review scientists and ORA field investigators in
 the new & abbreviated drug approval process in
 order to reduce duplication or redundancy in the
 process
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45454]]


Letter on incomplete Abbreviated Applications,      April 8, 1994              Do                         Do
 Convictions Under GDEA,
Multiple Supplements, Annual Reports for Bulk
 Antibiotics, Batch Size for
Transdermal Drugs, Bioequivalence Protocols,
 Research, Deviations from OGD Policy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter on the provision of new information          July 1, 1992               Do                         Do
 pertaining to new bioequivalence guidelines and
 refuse-to-file letters
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter on the provision of new procedures and       March 15, 1989             Do                         Do
 policies affecting the generic drug review
 process
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter on the request for cooperation of regulated  November 8, 1991           Do                         Do
 industry to improve the efficiency and
 effectiveness of the generic drug review process,
 by assuring the completeness and accuracy of
 required information and data submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter on the response to December 20, 1984 letter  March 26, 1985             Do                         Do
 from the Pharmaceutical Manufacturers Association
 about the Drug Price Competition and Patent Term
 Restoration Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to all ANDA and AADA applicants about the    January 15, 1993           Do                         Do
 Generic Drug Enforcement Act of 1992 (GDEA), and
 the Office of Generic Drugs intention to refuse
 to file incomplete submissions as required by the
 new law
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to regulated industry notifying interested   August 4, 1993             Do                         Do
 parties about important detailed information
 regarding labeling, scale-up, packaging, minor/
 major amendment criteria, and bioequivalence
 requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Major, Minor, Facsimile, and Telephone Amendments   May 1, 2000                Do                         Do
 to Original Abbreviated New Drug Applications
 (Revised)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Organization of an ANDA                             March 2, 1999              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Revising ANDA Labeling Following Revision of the    April 25, 2000             Do                         Do
 RLD Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Skin Irritation and Sensitization Testing of        February 3, 2000           Do                         Do
 Generic Transdermal Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Variations in Drug Products that May Be Included    January 27, 1999           Do                         Do
 in a Single ANDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
E10--Choice of Control Group in Clinical Trials     September 24, 1999         ICH Draft--Efficacy        Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
E11 Clinical Investigation of Medicinal Products    April 12, 2000             Do                         Do
 in the Pediatric Population
--------------------------------------------------------------------------------------------------------------------------------------------------------
M4 Common Technical Document: Request for comments  February 11, 2000          ICH Draft--Joint Safety/   Do
 on Initial Components                                                          Efficacy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q1A(R) Stability Testing of New Drug Substances     April 21, 2000             ICH Draft--Quality         Do
 and Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q6A Specifications: Test Procedures and Acceptance  November 25, 1997          Do                         Do
 Criteria for New Drug Substances and New Drug
 Products: Chemical Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45455]]


E1A The Extent of Population Exposure to Assess     March 1, 1995              ICH--Efficacy              Do
 Clinical Safety: for Drugs Intended for Long-Term
 Treatment of Non-Life-Threatening Conditions
--------------------------------------------------------------------------------------------------------------------------------------------------------
E2A Clinical Safety Data Management: Definitions    March 1, 1995              Do                         Do
 and Standards for Expedited Reporting
--------------------------------------------------------------------------------------------------------------------------------------------------------
E2B Data Elements for Transmission of Individual    January 15, 1998           Do                         Do
 Case Safety Reports
--------------------------------------------------------------------------------------------------------------------------------------------------------
E2C Clinical Safety Data Management: Periodic       May 19, 1997               Do                         Do
 Safety Update Reports for Marketed Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
E3 Structure and Content of Clinical Study Reports  July 17, 1996              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
E4 Dose-Response Information to Support Drug        November 9, 1994           Do                         Do
 Registration
--------------------------------------------------------------------------------------------------------------------------------------------------------
E5 Ethnic Factors in the Acceptability of Foreign   June 10, 1998              Do                         Do
 Clinical Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
E6 Good Clinical Practice: Consolidated Guideline   May 9, 1997                Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
E7 Studies in Support of Special Populations:       August 2, 1994             Do                         Do
 Geriatrics
--------------------------------------------------------------------------------------------------------------------------------------------------------
E8 General Considerations for Clinical Trials       December 24, 1997          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
E9 Statistical Principles for Clinical Trials       September 16, 1998         Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
M3 Nonclinical Safety Studies for the Conduct of    November 25, 1997          ICH--Joint Safety/         Do
 Human Clinical Trials for Pharmaceuticals                                      Efficacy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q1A Stability Testing of New Drug Substances and    September 22, 1994         ICH--Quality               Do
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q1B Photostability Testing of New Drug Substances   May 16, 1997               Do                         Do
 and Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q1C Stability Testing for New Dosage Forms          May 9, 1997                Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q2A Text on Validation of Analytical Procedures     May 1, 1995                Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q2B Validation of Analytical Procedures:            May 19, 1997               Do                         Do
 Methodology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q3A Impurities in New Drug Substances               January 4, 1996            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q3B Impurities in New Drug Products                 May 19, 1997               Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q3C Impurities: Residual Solvents                   December 24, 1997          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q5A Viral Safety Evaluation of Biotechnology        September 24, 1998         Do                         Do
 Products Derived From Cell Lines of Human or
 Animal Origin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q5B Quality of Biotechnology Products: Analysis of  February 23, 1996          Do                         Do
 the Expression Construct in Cells Used for
 Production of r-DNA Derived Protein Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q5C Quality of Biotechnological Products:           July 10, 1996              Do                         Do
 Stability Testing of Biotechnology/Biological
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45456]]


Q5D Quality of Biotechnological/Biological          September 21, 1998         Do                         Do
 Products: Derivation and Characterization of Cell
 Substrates Used for Production of
 Biotechnological/Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q6B--Test Procedures and Acceptance Criteria for    August 18, 1999            Do                         Do
 Biotechnological/Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
S1A The Need for Long-Term Rodent Carcinogenicity   March 1, 1996              ICH--Safety                Do
 Studies of Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
S1B Testing for Carcinogenicity in Pharmaceuticals  February 23, 1998          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
S1C Dose Selection for Carcinogenicity Studies of   March 1, 1995              Do                         Do
 Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
S1C(R) Dose Selection for Carcinogenicity Studies   December 4, 1997           Do                         DO
 of Pharmaceuticals: Addendum on a Limit Dose and
 Related Notes
--------------------------------------------------------------------------------------------------------------------------------------------------------
S2A Specific Aspects of Regulatory Genotoxicity     December 4, 1997           Do                         Do
 Tests for Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
S2B Genotoxicity: Standard Battery Testing          November 21, 1997          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
S3A Toxicokinetics: The Assessment of systemic      March 1, 1995              Do                         Do
 Exposure in Toxicity Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
S3B Pharmacokinetics: Guidance for Repeated Dose    March 1, 1995              Do                         Do
 Tissue Distribution Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
S4A Duration of Chronic Toxicity Testing in         June 25, 1999              Do                         Do
 Animals (Rodent and Nonrodent Toxicity Testing)
--------------------------------------------------------------------------------------------------------------------------------------------------------
S5A Detection of Toxicity to Reproduction for       September 22, 1994         Do                         Do
 Medicinal Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
S5B Detection of Toxicity to Reproduction for       April 5, 1996              Do                         Do
 Medicinal Products: Addendum on Toxicity to Male
 Fertility
--------------------------------------------------------------------------------------------------------------------------------------------------------
S6 Preclinical Safety Evaluation of Biotechnology-  November 18, 1997          Do                         Do
 Derived Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Revision in Sample Collection Under the           July 15, 1996              Industry Letters           o
 Compliance Program Pertaining to Pre-Approval
 Inspections
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certification Requirements for Debarred             July 27, 1992              Do                         Do
 Individuals in Drug Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Continuation of a series of letters communicating   June 1, 1990               Do                         Do
 interim and informal generic drug policy and
 guidance. Availability of Policy and Procedure
 Guides, and further operational changes to the
 generic drug review program
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fifth of a series of letters providing informal     April 10, 1987             Do                         Do
 notice about the Act, discussing the statutory
 mechanism by which ANDA applicants may make
 modifications in approved drugs where clinical
 data is required
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fourth of a series of letters providing informal    October 31, 1986           Do                         Do
 notice to all affected parties about policy
 developments and interpretations regarding the
 Act. Three year exclusivity provisions of Title I
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45457]]


Implementation of the Drug Price Competition and    October 11, 1984           Do                         Do
 Patent Term Restoration Act. Preliminary Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implementation Plan USP injection nomenclature      October 2, 1995            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for Filing Supplements Under the       April 11, 1996             Do                         Do
 Provisions of SUPAC-IR
--------------------------------------------------------------------------------------------------------------------------------------------------------
Seventh of a series of letters about the Act        July 29, 1988              Do                         Do
 providing guidance on the ``180-day exclusivity''
 provision of section 505(j)(4)(B)(iv) of the FD&C
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sixth of a series of informal notice letters about  April 22, 1988             Do                         Do
 the Act discussing 3- and 5-year exclusivity
 provisions of sections 505(c)(3)(D) and
 505(j)(4)(D) of the FD&C Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Streamlining Initiatives                            December 24, 1996          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supplement to 10/11/84 letter about policies,       November 16, 1984          Do                         Do
 procedures and implementation of the Act (Q & A
 format)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Third of a series of letters regarding the          May 1, 1985                Do                         Do
 implementation of the Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format for Geriatric Labeling           January 21, 1999           Labeling Draft             Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Non-Contraceptive Estrogen Drug Products--          January 8, 1999            Do                         Do
 Physician and Patient Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Noncontraceptive Estrogen Class Labeling            September 27, 1999         Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Topical Drug Products for the Treatment of      July 16, 1998              Do                         Do
 Vaginal Yeast Infections (Vulvovaginal
 Candidiasis)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Therapeutic Equivalence Code Placement on           January 28, 1999           Do                         Do
 Prescription Drug Labels and Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acetaminophen and Codeine Phosphate Oral Solution/  December 1, 1993           Labeling                   Do
 Suspension
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acetaminophen and Codeine Phosphate Tablets/        December 1, 1993           Do                         Do
 Capsules
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acetaminophen, Aspirin and Codeine Phosphate        December 1, 1993           Do                         Do
 Tablets/Capsules
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alprazolam Tablets USP                              August 1, 1996             Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amiloride Hydrochloride and Hydrochlorothiazide     September 1, 1997          Do                         Do
 Tablets USP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amlodipine Besylate Tablets                         September 1, 1997          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Astemizole Tablets                                  September 1, 1997          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Atenolol Tablets USP                                August 1, 1997             Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Barbiturate, Single Entity-Class Labeling           March 1, 1981              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Butalbital, Acetaminophen and Caffeine Capsules/    September 1, 1997          Do                         Do
 Tablets USP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Butalbital, Acetaminophen, Caffeine and Hydocodone  September 21, 1997         Do                         Do
 Bitartrate Tablets
--------------------------------------------------------------------------------------------------------------------------------------------------------
Butorphanol Tartrate Injection USP                  October 1, 1992            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45458]]


Captopril and Hydrochlorothiazide Tablets USP       April 1, 1995              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Captopril Tablets                                   February 1, 1995           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carbidopa and Levodopa Tablets USP                  February 1, 1992           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chlordiazepoxide Hydrochloride Capsules             January 1, 1988            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cimetidine Hydrochloride Injection                  September 1, 1995          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cimetidine Tablets                                  September 1, 1995          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cisapride Oral Suspension                           September 1, 1997          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cisapride Tablets                                   September 1, 1997          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clindamycin Phosphate Injection USP                 September 1, 1998          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clorazepate Dipotassium Capsules/Tablets            March 1, 1993              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combination Oral Contraceptives--Physician and      January 1, 1994            Do                         Do
 Patient Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cyproheptadine Hydrochloride Tablets/Syrup          December 1, 1986           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diclofenac Sodium Delayed-Release Tablets           January 1, 1997            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diltiazem Hydrochloride Extended-Release Capsules   September 1, 1995          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diphenoxylate Hydrochloride and Atropine Sulfate    April 1, 1995              Do                         Do
 Oral Solution USP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diphenoxylate Hydrochloride and Atropine Sulfate    April 1, 1995              Do                         Do
 Tablets USP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dipivefrin Hydrochloride Ophthalmic Solution, 0.1%  November 2, 1998           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ergoloid Mesylates Tablets                          January 1, 1988            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fludeoxyglucose F18 Injection                       January 1, 1997            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Flurbiprofen Tablets USP                            January 1, 1994            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fluvoxamine Maleate Tablets                         September 1, 1997          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Gentamicin Sulfate Ophthalmic Ointment and          April 1, 1992              Do                         Do
 Solution USP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Heparin Sodium Injection USP                        March 1, 1991              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hydrocodone Bitartrate and Acetaminophen Tablets    April 1, 1994              Do                         Do
 USP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hydroxyzine Hydrochloride Injection                 December 1, 1989           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hypoglycemic Oral Agents--Federal Register          April 1, 1984              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Indomethacin Capsules USP                           September 1, 1995          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Informal Labeling Guidance Texts for Estrogen Drug  August 1, 1992             Do                         Do
 Products--Patient Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Informal Labeling Guidance Texts for Estrogen Drug  August 1, 1992             Do                         Do
 Products--Professional Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Isoetharine Inhalation Solution                     March 1, 1989              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Itraconazole Capsules, USP                          September 1, 1998          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Leucovorin Calcium for Injection                    July 1, 1996               Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45459]]


Leucovorin Calcium Tablets, USP                     July 1, 1996               Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Local Anesthetics--Class Labeling                   September 1, 1982          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Meclofenamate Sodium Capsules                       July 1, 1992               Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medroxyprogesterone Acetate Tablets, USP            September 1, 1998          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metaproterenol Sulfate Inhalation Solution USP      May 1, 1992                Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metaproterenol Sulfate Syrup USP                    May 1, 1992                Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metaproterenol Sulfate Tablets                      May 1, 1992                Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metoclopramide Tablets USP/Oral Solution            February 1, 1995           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Naphazoline Hydrochloride Ophthalmic Solution       March 1, 1989              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Naproxen Sodium Tablets, USP                        September 1, 1997          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Naproxen Tablets, USP                               September 1, 1997          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Niacin Tablets                                      July 1, 1992               Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Paclitaxel Injection                                February 1, 1991           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phendimetrazine Tartrate Capsules/Tablets, and      February 1, 1991           Do                         Do
 Extended-Release Capsules
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phentermine Hydrochloride Capsules/Tablets          August 1, 1988             Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Promethazine Hydrochloride Tablets                  March 1, 1990              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Propantheline Bromide Tablets                       August 1, 1988             Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pyridoxine Hydrochloride Injection                  June 1, 1984               Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quinidine Sulfate Tablets/Capsules USP              October 1, 1995            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ranitidine Tablets USP                              November 1, 1993           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Risperidone Oral Solution                           September 1, 1997          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Risperidone Tablets                                 September 1, 1997          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sulfacetamide Sodium and Prednisolone Acetate       January 1, 1995            Do                         Do
 Ophthalmic Suspension and Ointment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sulfacetamide Sodium Ophthalmic Solution/Ointment   August 1, 1992             Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sulfamethoxazole and Phenazopyridine Hydrochloride  February 1, 1992           Do                         Do
 Tablets
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sulfamethoxazole and Trimethoprim Tablets and Oral  August 1, 1993             Do                         Do
 Suspension
--------------------------------------------------------------------------------------------------------------------------------------------------------
Theophylline Immediate-Release Dosage Forms         February 1, 1995           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Theophylline Intravenous Dosage Forms               September 1, 1995          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Thiamine Hydrochloride Injection                    February 1, 1988           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobramycin Sulfate Injection USP                    May 1, 1993                Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Venlafaxine Hydrochloride Tablets                   October 1, 1997            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Verapamil Hydrochloride Tablets                     October 1, 1991            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamin A Capsules                                  February 1, 1992           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45460]]


Zolpidem Tartrate Tablets                           September 1, 1997          Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling OTC Human Drug Products Using a Column     December 1, 1997           OTC Draft                  Do
 Format
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Actual Use Studies                              July 22, 1994              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Nicotine Substitutes                            March 1, 1994              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Enforcement Policy on Marketing OTC Combination
 Products (CPG 7132b.16)
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Guidelines for OTC Combination Products                                Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Upgrading Category III Antiperspirants to Category                             Do                         Do
 I (43 FR 46728-46731)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Photosafety Testing                                 January 10, 2000           Pharmacology/Toxicology    Do
                                                                                Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content of the Nonclinical Pharmacology/ February 1, 1987           Pharmacology/Toxicology    Do
 Toxicology Section of an Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nonclinical Pharmacology/Toxicology Development of                             Do                         Do
 Topical Drugs Intended
to Prevent the Transmission of Sexually
 Transmitted Diseases (STD) and/or for the
 Development of Drugs Intended to Act as Vaginal
 Contraceptives
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reference Guide for the Nonclinical Toxicity        February 1, 1989           Do                         Do
 Studies of Antiviral Drugs
Indicated for the Treatment of N/A Non-Life
 Threatening Disease: Evaluation of Drug Toxicity
 Prior to Phase I Clinical Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Single Dose Acute Toxicity Testing Toxicity         August 26, 1996            Do                         Do
 Testing for Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Applications Covered by Section 505(b)(2)           December 8, 1999           Procedural Draft           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format of New Drug Applications and     March 10, 2000             Do                         Do
 Abbreviated New Drug Applications for Certain
 Positron Emission Tomography Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disclosing Information Provided to Advisory         December 22, 1999          Do                         Do
 Committees in Connection with Open Advisory
 Committee Meetings Related to the Testing or
 Approval of New Drugs and Convened by CDER,
 Beginning January 1, 2000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information Program on Clinical Trials for Serious  March 29, 2000             Do                         Do
 or Life-Threatening Diseases: Establishment of a
 Data Bank
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information Request and Discipline Review Letters   August 17, 1999            Do                         Do
 Under the Prescription Drug User Fee Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Special Protocol Assessment                         February 9, 2000           Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Debarment Certification Statements       October 2, 1998            Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
180-Day Generic Drug Exclusivity Under the Hatch-   July 14, 1998              Procedural                 Do
 Waxman Amendments to the Federal Food, Drug, and
 Cosmetic Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Advisory Committees: Implementing Section 120 of    November 2, 1998           Do                         Do
 the Food and Drug Modernization Act of 1997
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45461]]


Court Decisions, ANDA Approvals, and 180-Day        March 30, 2000             Do                         Do
 Exclusivity Under the Hatch-Waxman Amendments to
 the Federal Food, Drug, and Cosmetic Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disclosure of Materials Provided to Advisory        November 30, 1999          Do                         Do
 Committees in Connection with Open Advisory
 Committee Meetings Convened by the Center for
 Drug Evaluation and Research Beginning on January
 1, 2000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Enforcement Policy During Implementation of         November 23, 1998          Do                         Do
 Section 503A of the Federal Food, Drug, and
 Cosmetic Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fast Track Drug Development Programs: Designation,  November 18, 1998          Do                         Do
 Development, and Application Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formal Dispute Resolution: Appeals Above the        March 7, 2000              Do                         Do
 Division Level
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formal Meetings With Sponsors and Applicants For    March 7, 2000              Do                         Do
 PDUFA Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implementation of Section 126 of the FDA            July 21, 1998              Do                         Do
 Modernization Act of 1997--Elimination of Certain
 Labeling Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
National Uniformity for Nonprescription Drugs       April 9, 1998              Do                         Do
 Ingredient Labeling for OTC Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Qualifying for Pediatric Exclusivity Under Section  October 1, 1999            Do                         Do
 505A of the Federal Food, Drug, and Cosmetic Act--
 Revised
--------------------------------------------------------------------------------------------------------------------------------------------------------
Refusal to File                                     July 12, 1993              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Repeal of Section 507 of the Federal Food, Drug,    June 15, 1998              Do                         Do
 and Cosmetic Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Standards for the Prompt Review of Efficacy         May 15, 1998               Do                         Do
 Supplements, Including Priority Efficacy
 Supplements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Street Drug Alternatives                            April 3, 2000              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Women and Minorities Guidance Requirements          July 28, 1998              Do                         Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information Request and Discipline Review Letters   August 17, 1999            User Fee Draft             Do
 Under the Prescription Drug User Fee Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Classifying Resubmissions in Response to Action     May 14, 1998               User Fee                   Do
 Letters
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting and Reviewing Complete Responses to      May 14, 1998               Do                         Do
 Clinical Holds
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              Grouped by Intended User or Regulatory      How to Obtain a Hard Copy of the Document (Name and
                     Name of Document                              Date of Issuance                          Activity                          Address, Phone,  FAX, E-mail or Internet)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Program Guidance Manual: Inspection of Medical  August 12, 1999                   Office of Compliance (OC)                 Division of Small Manufacturers Assistance; 1-800-638-
 Devices; Draft                                                                                                                         2041 or 301-827-0111 or (FAX) Facts-on-Demand at 1-800-
                                                                                                                                        899-0381 or Internet at http://www.fda.gov/cdrh/
ggpmain.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45462]]


Procedures for Laboratory Compliance Testing of            May 1, 1986                       Do                                        Do
 Television Receivers-part of TV Packet
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A Pocket Guide to Device GMP Inspections-Inspections of    November 1, 1991                  Do                                        Do
 Medical Device Manufacturers and GMP Regulation
 Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General Principles of Software Validation; Draft Guidance  June 9, 1997                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Global Harmonization Task Force Study Group 3-Process      February 1, 1999                  Do                                        Do
 Validation Guidance; Final Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Civil Money Penalty Policy; Guidance for FDA Staff         June 8, 1999                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Tracking; Guidance for          January 24, 2000                  Do                                        Do
 Industry and FDA Staff [FDAMA]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Enforcement Priorities for Single-Use Devices Reprocessed  February 8, 2000                  Do                                        Do
 by Third Parties and Hospitals, Draft Guidance-Not for
 Implementation; Guidance for Industry and for FDA Staff
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Cover Letter/Guidance Document on the Performance          March 9, 1998                     Do                                        Do
 Standard for Electrode Lead Wires and Patient Cable
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Commercial Distribution/Exhibit Letter                     April 10, 1992                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Working Draft of the Current Good Manufacturing Practice   July 1, 1995                      Do                                        Do
 (CGMP) Final Rule
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulating In Vitro Diagnostic Device (IVD) Studies;       December 17, 1999                 Office of Compliance (OC)/Division of     Do
 Guidance; Guidance for FDA Staff                                                             Bioresearch Monitoring (DBM)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Preparing Notices of Availability of Investigational       March 19, 1999                    Do                                        Do
 Medical Devices and for Recruiting Study Subjects
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A Guide for the Submission of Abbreviated Radiation        March 1, 1996                     Office of Compliance (OC)/Division of     Do
 Safety Reports on Cephalometric X-Ray Devices: Defined                                       Enforcement I (DOEI)
 as Dental Units with an Attachment for Mandible Work
 that Holds a Cassette and Beam Limiting Device
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A Guide for the Submission of Abbreviated Radiation        March 1, 1996                     Do                                        Do
 Safety Reports on Image Receptor Support Devices for
 Mammographic X-Ray Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A Guide for the Submission of an Abbreviated Radiation     March 1, 1996                     Do                                        Do
 Safety Report on X-Ray Tables, Cradles, Film Changers or
 Cassette Holders Intended for Diagnostic Use
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Clarification of Radiation Control Regulations for         March 1, 1989                     Do                                        Do
 Diagnostic X-Ray Equipment (FDA 89-8221)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
CPG 7133.19: Retention of Microwave Oven Test Record/      August 24, 1981                   Do                                        Do
 Cover Letter: August 24, 1981 Retention of Records
 Required by 21 CFR 1002
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45463]]


Exemption from Reporting and Recordkeeping Requirements    September 16, 1981                Do                                        Do
 for Certain Sunlamp Product Manufacturers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Program Guidance Manual; Field Compliance       March 15, 2000                    Do                                        Do
 Testing of Diagnostic (Medical) X-ray Equipment;
 Guidance for FDA Staff
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Information Disclosure by Manufacturers to     October 18, 1999                  Do                                        Do
 Assemblers for Diagnostic X-ray Systems; Guidance for
 Industry
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Electrosurgical Devices and the Application    November 15, 1999                 Do                                        Do
 of the Performance Standard for Electrode Lead Wires and
 Patient Cables
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for the Submission of Initial Reports on Diagnostic  January 1, 1982                   Do                                        Do
 X-Ray Systems and their Major Components
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for the Manufacture of In Vitro Diagnostic       January 10, 1994                  Do                                        Do
 Products
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Medical Device Industry on Endoscopy and         May 17, 1993                      Do                                        Do
 Laparoscopy Accessories (Galdi)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturers/Assemblers of Diagnostic X-ray Systems:      October 13, 1993                  Do                                        Do
 Enforcement Policy for Positive-Beam Limitation (PBL)
 Requirements in 21 CFR 1020.31(g)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Abbreviated Reports on Radiation Safety for Microwave      August 1, 1995                    Office of Compliance (OC)/Division of     Do
 Products (Other Than Microwave Ovens)- E.G. Microwave                                        Enforcement I & III (DOEI & III)
 Heating, Microwave Diathermy, RF Sealers, Induction,
 Dielectric Heaters, Security Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Abbreviated Reports on Radiation Safety of Non-Medical     August 1, 1995                    Do                                        Do
 Ultrasonic Products
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Filing Annual Reports for X-Ray Components and   July 1, 1980                      Do                                        Do
 Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Abbreviated Reports of Microwave and   September 1, 1996                 Do                                        Do
 RF Emitting Electronic Products Intended for Medical Use
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports for Medical            September 1, 1996                 Do                                        Do
 Ultrasound Products
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Reports on Radiation Safety of         March 1, 1985                     Do                                        Do
 Microwave Ovens
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on Accelerators        April 1, 1971                     Do                                        Do
 Intended to Emit X-Radiation Required Pursuant to 21 CFR
 1002.10
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Manufacturers and Importers of Microwave Ovens:  October 31, 1988                  Do                                        Do
 Information Requirements for Cookbooks and User and
 Service Manuals
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting and Compliance Guide for Television Products     October 1, 1995                   Do                                        Do
 including Product Report, Supplemental Report, Radiation
 Safety Abbreviated Report, Annual Report, Information
 and Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45464]]


Reporting Guide for Laser Light Shows and Displays (21     September 1, 1995                 Do                                        Do
 CFR 1002) (FDA 88-8140)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Revised Guide for Preparing Annual Reports on Radiation    September 1, 1995                 Do                                        Do
 Safety Testing of Laser and Laser Light Show Products
 (replaces FDA 82-8127)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
All U.S. Condom Manufacturers, Importers and Repackagers   April 7, 1987                     Office of Compliance (OC)/Division of     Do
                                                                                              Enforcement II (DOEII)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guide for Laser Products (FDA 86-8260)          September 1, 1985                 Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Condoms: Inspection and Sampling at Domestic               April 8, 1987                     Do                                        Do
 Manufacturers and of all Repackers; Sampling from all
 Importers (Damaska Memo to Field on April 8, 1987)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Dental Handpiece Sterilization (Dear Doctor Letter)        September 28, 1992                Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene        June 23, 1978                     Do                                        Do
 Glycol; Proposed Maximum Residue Limits and Maximum
 Levels of Exposure
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Quality System Regulation Information for      August 3, 1999                    Do                                        Do
 Various Premarket Submissions; Guidance for Industry;
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Quality System Regulation Information for      August 3, 1999                    Do                                        Do
 Various Premarket Submissions; Guidance for Industry;
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports for Lasers and         September 1, 1995                 Do                                        Do
 Products Containing Lasers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Hazards of Volume Ventilators and Heated Humidifiers       September 15, 1993                Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Latex Labeling Letter (Johnson)                            March 18, 1993                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Letter--Condom Manufacturers and Distributors              April 5, 1994                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Letter--Manufacturers, Distributors and Importers of       February 23, 1994                 Do                                        Do
 Condom Products
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Letter--Manufacturers, Importers, and Repackagers of       February 13, 1989                 Do                                        Do
 Condoms for Contraception or Sexually-Transmitted
 Disease Prevention (Holt)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to All Foreign Manufacturers and Importers of       May 28, 1981                      Do                                        Do
 Electronic Products for Which Applicable FDA Performance
 Standards Exist
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Industry, Powered Wheelchair Manufacturers from  May 10, 1993                      Do                                        Do
 RMJohnson
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Manufacturers/Repackers Using Cotton             April 22, 1994                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to: Manufacturers and Users of Lasers for           October 10, 1996                  Do                                        Do
 Refractive Surgery [excimer]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturers and Initial Distributors of Hemodialyzers    May 23, 1996                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45465]]


Manufacturers and Initial Distributors of Sharps           February 3, 1994                  Do                                        Do
 Containers and Destroyers Used by Health Care
 Professionals
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Pesticide Regulation Notice 94-4: Interim Measures for     June 30, 1994                     Do                                        Do
 the Registration of Antimicrobial Products/Liquid
 Chemical Germicides with Medical Device Use Claims Under
 the Memorandum of Understanding Between EPA and FDA
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Application for a Variance from 21 CFR 1040.11(c) for a    July 1, 1998                      Office of Compliance (OC)/Division of     Do
 Laser Light Show, Display, or Device [form FDA 3147]                                         Enforcement III (DOEIII)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Computerized Devices/Processes Guidance--Application of    May 1, 1992                       Do                                        Do
 the Medical Device GMP to Computerized Devices and
 Manufacturing Processes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Design Control Guidance for Medical Device Manufacturers   March 11, 1997                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Final Design Control Report and Guidance                   June 1, 1998                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Cabinet X-Ray System        February 1, 1975                  Do                                        Do
 Reports Pursuant to 21 CFR 1020.40
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports for Ultrasonic Therapy  September 1, 1996                 Do                                        Do
 Products
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on Radiation Safety     September 1, 1995                 Do                                        Do
 Testing of Sunlamps and Sunlamp Products (replaces FDA
 82-8127)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on Radiation Safety     September 1, 1995                 Do                                        Do
 Testing of Mercury Vapor Lamps (replaces FDA 82-8127)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on Radiation Safety     October 1, 1987                   Do                                        Do
 Testing of Electronic Products (General)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports for Ultrasonic         August 1, 1996                    Do                                        Do
 Therapy Products (physical therapy only)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports on Sunlamps and        September 1, 1995                 Do                                        Do
 Sunlamp Products (21 CFR 1002)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on Analytical X-Ray    April 30, 1974                    Do                                        Do
 Equipment Required Pursuant to 21 CFR 1002.10
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on Industrial          September 1, 1980                 Do                                        Do
 Radiofrequency Dielectric Heater and Sealer Equipment
 Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81-8137)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on Industrial X-Ray    March 1, 1973                     Do                                        Do
 Equipment Required Pursuant to 21 CFR 1002.10
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for the Submission of Initial Reports on Computed    September 1, 1984                 Do                                        Do
 Tomography X-Ray Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45466]]


Impact Resistant Lenses: Questions and Answers (FDA 87-    September 1, 1987                 Do                                        Do
 4002)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Keeping Medical Devices Safe from Electromagnetic          July 1, 1995                      Do                                        Do
 Interference
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Keeping Up With the Microwave Revolution (FDA Pub No. 91-  March 1, 1990                     Do                                        Do
 4160)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Laser Light Show Safety--Who's Responsibility (FDA 86-     May 1, 1986                       Do                                        Do
 8262)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Manufacturers and Importers of Microwave Ovens-- March 28, 1980                    Do                                        Do
 Open Door Operation of Microwave Ovens as a Result of
 Oven Miswiring
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Trade Association: ReUse of Single-use or        December 27, 1995                 Do                                        Do
 Disposable Medical Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Letter: Policy on Maximum Timer Interval and Exposure      August 21, 1986                   Do                                        Do
 Schedule for Sunlamp Products
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Electromagnetic Interference Issues,                                          Do                                        Do
 Problem Reports, Standards, and Recommendations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Devices and EMI: The FDA Perspective               January 1, 1995                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Policy on Lamp Compatability (sunlamps)                    September 2, 1986                 Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Policy on Warning Label Required on Sunlamp Products       June 25, 1985                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Quality Assurance Guidelines for Hemodialysis Devices      February 1, 1991                  Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Quality Control Guide for Sunlamp Products (FDA 88-8234)   March 1, 1988                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Quality Control Practices for Compliance with the Federal  May 1, 1980                       Do                                        Do
 Mercury Vapor Lamp Performance Standard
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting Guide for Product Reports on High Intensity      September 1, 1995                 Do                                        Do
 Mercury Vapor Discharge Lamps (21 CFR 1002)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting of New Model Numbers to Existing Model Families  June 14, 1983                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Safety of Electrically Powered Products: Letter To         September 18, 1996                Do                                        Do
 Medical Device and Electronic Product Manufacturers From
 Lillian Gill & BHB correction memo
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Shielded Trocars and Needles used for Abdominal Access     August 23, 1996                   Do                                        Do
 during Laparoscopy
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Suggested State Regulations for Control of Radiation--     January 1, 1982                   Do                                        Do
 Volume II Nonionizing Radiation--Lasers (FDA Pub No. 83-
 8220)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Unsafe Patient Lead Wires and Cables                       September 3, 1993                 Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Imports: Radiation-Producing Electronic Products (FDA 89-  November 1, 1988                  Do                                        Do
 8008)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45467]]


Guidance for Industry on the Likelihood of Facilities      August 5, 1999                    Office of Compliance (OC)/Division of     Do
 Inspections When Modifying Devices Subject to Premarket                                      Program Operations (DOP)
 Approval
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Medical Device Manufacturer on Pentium           February 14, 1995                 Office of Compliance (OC)/Office of the   Do
 Processors                                                                                   Center Director (OCD)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 300.600 Commercial Distribution with Regard to        September 24, 1987                Do                                        Do
 Premarket Notification [510(k)] [CPG 7124.19]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Industry, Powered Wheelchair/Scooter or          May 26, 1994                      Office of the Center Director (OCD)/      Do
 Accessory/ Component Manufacturer from Susan Alpert,                                         Office of Device Evaluation (ODE)
 Ph.D.,M.D.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General/Specific Intended Use; Guidance for Industry;      November 4, 1998                  Do                                        Do
 Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ODE Executive Secretary Guidance Manual                    August 7, 1987                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Preamendments Class III Strategy; SXAlpert                 April 19, 1994                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Early Collaboration Meetings Under the FDA Modernization   February 19, 1998                 Do                                        Do
 Act (FDAMA), Guidance for Industry and CDRH Staff
 [FDAMA]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
``Real-Time'' Review Program for Premarket Approval        April 22, 1997                    Office of Device Evaluation (ODE)         Do
 Application (PMA) Supplements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
30-Day Notices and 135-Day PMA Supplements for             February 19, 1998                 Do                                        Do
 Manufacturing Method or Process Changes, Guidance for
 Industry and CDRH [FDAMA]; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Quality Review Program (Blue Book Memo)             March 29, 1996                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Convenience Kits Interim Regulatory Guidance (include      May 20, 1997                      Do                                        Do
 874)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Determination of Intended Use for 510(k) Devices Guidance  January 30, 1998                  Do                                        Do
 for Industry and CDRH Staff [FDAMA]; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Distribution and Public Availability of Premarket          October 10, 1997                  Do                                        Do
 Approval Application Summary of Safety and Effectiveness
 Data Packages [Blue Book Memo #P98-1]; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Document Review by the Office of the Chief Counsel (Blue   June 6, 1996                      Do                                        Do
 Book Memo G96-1))
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Modifications to Devices Subject to Premarket Approval--   August 6, 1998                    Do                                        Do
 The PMA Supplement Decision Making Process; Guidance for
 Industry, Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Contents of Product Development Protocol; Guidance for     July 27, 1998                     Do                                        Do
 Industry, Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Frequently Asked Questions on The New 510(k) Paradigm;     October 22, 1998                  Do                                        Do
 Guidance for Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45468]]


Evidence Models for the Least Burdensome Means to Market;  September 1, 1999                 Do                                        Do
 Guidance for Industry and FDA Reviewers; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Supplements to Approved Applications for Class III         May 20, 1998                      Do                                        Do
 Medical Devices: Use of Published Literature, Use of
 Previously Submitted Materials, and Priority Review
 [FDAMA]; Guidance for Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
New Model Medical Device Development Process; Guidance     July 21, 1998                     Do                                        Do
 for Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Off-the-Shelf Software Use in Medical         September 9, 1999                 Do                                        Do
 Devices; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Submitting Reclassification Petition          June 1, 1989                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Amended Procedures for Advisory Panel          January 26, 1999                  Do                                        Do
 Meetings [FDAMA]; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on PMA Interactive Procedures for Day-100         February 19, 1998                 Do                                        Do
 Meetings and Subsequent Deficiencies--For Use by CDRH &
 Industry [FDAMA]; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Use of Standards in Substantial            March 12, 2000                    Do                                        Do
 Equivalence Determinations; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Shell Development and Modular Review; Guidances for    November 6, 1998                  Do                                        Do
 the Medical Device Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
New Section 513(f)(2)--Evaluation of Automatic Class III   February 19, 1998                 Do                                        Do
 Designation, Guidance for Industry and CDRH Staff
 [FDAMA]; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Procedures for Class II Device Exemptions from Premarket   February 19, 1998                 Do                                        Do
 Notification, Guidance for Industry and CDRH Staff
 [FDAMA]; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
SMDA Changes-Premarket Notification; Regulatory            April 17, 1992                    Do                                        Do
 Requirements for Medical Devices [510(k)] Manual Insert
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
The New 510(k) Paradigm-Alternate Approaches to            March 20, 1998                    Do                                        Do
 Demonstrating Substantial Equivalence in Premarket
 Notifications; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
4-of-A-Kind PMA's                                          October 1, 1991                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Application of the Device Good Manufacturing Practice      December 1, 1983                  Do                                        Do
 (GMP) Regulation to the Manufacture of Sterile Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH Submissions Coversheet [PMA/PDP/510k/IDE]             May 8, 1998                       Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH's 510(k)/IDE/PMA Refuse to Accept/Accept/File         June 30, 1993                     Do                                        Do
 Policies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Classified Convenience Kits                                April 30, 1993                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Color Additive Petitions (p. II-19 of PMA Manual)          June 1, 1987                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Color Additive Status List (Inspection Operations Manual)  February 1, 1989                  Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45469]]


Color Additives for Medical Devices (Snesko)               November 15, 1995                 Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Deciding When to Submit a 510(k) for a Change to an        January 10, 1997                  Do                                        Do
 Existing Device
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device Specific Guidance Documents (List)                  May 11, 1993                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Guide for Validation of Biological Indicator           January 1, 1986                   Do                                        Do
 Incubation Time
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Policy For The Regulation Of Computer Products         November 13, 1989                 Do                                        Do
 (DRAFT)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Format for IDE Progress Reports                            June 1996                         Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Submissions for      May 29, 1998                      Do                                        Do
 Software Contained in Medical Devices; Guidance for FDA
 and Reviewers and Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Preparation of PMA Manufacturing Information  August 1, 1992                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Establishing and Maintaining a Calibration       March 1, 1988                     Do                                        Do
 Constancy Intercomparison System for Microwave Oven
 Compliance Survey Instruments (FDA 88-8264)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for the Monitoring of Clinical Investigations    January 1, 1988                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline on General Principles of Process Validation      May 1, 1987                       Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline on Sterile Drug Products Produced by Aseptic     June 1, 1987                      Do                                        Do
 Processing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline on Validation of the Limulus Amebocyte Lysate    December 1, 1987                  Do                                        Do
 (LAL) Test as an End-Product Endotoxin Test
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Indications for Use Statement                              January 2, 1996                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Industry Representatives on Scientific Panels              March 27, 1987                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling Reusable Medical Devices for Reprocessing in      April 1, 1996                     Do                                        Do
 Health Care Facilities: FDA Reviewer Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Limulus Amebocyte Lysate; Reduction of Samples for         October 23, 1987                  Do                                        Do
 Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Master Files Part III; Guidance on Scientific and          June 1, 1987                      Do                                        Do
 Technical Information
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Electromagnetic Compatibility for Medical Devices: Issues  June 13, 1995                     Do                                        Do
 and Solutions; Memorandum
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Methods for Conducting Recall Effectiveness Checks         June 16, 1978                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Necessary Information for Diagnostic Ultrasound 510(k)     November 24, 1987                 Do                                        Do
 (Draft)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Review Schedule [P87-1]                                March 31, 1988                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider in the Characterization of Cell Lines   June 1, 1984                      Do                                        Do
 Used to Produce Biological Products (from John C.
 Petricciani, M.D.)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45470]]


Preamendment Class III Devices                             March 11, 1992                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Notification [510(k)] Status Request Form,       March 14, 1997                    Do                                        Do
 revised
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Preproduction Quality Assurance Planning: Recommendations  September 1, 1989                 Do                                        Do
 for Medical Device Manufacturers (FDA 90-4236)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Proposal for Establishing Mechanisms for Setting Review    June 30, 1993                     Do                                        Do
 Priorities Using Risk Assessment and Allocating Review
 Resources and T93-28 dated June 25, 1993 Device ``Fast
 Track'' Plan Announcement (include with 926 930)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Questions and Answers for the FDA Reviewer Guidance:       September 3, 1996                 Do                                        Do
 Labeling Reusable Medical Devices for Reprocessing in
 Health Care Facilities
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Shelf Life of Medical Devices                              March 1, 1991                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Substantial Equivalence (SE) Decision Making               January 1, 1990                   Do                                        Do
 Documentation ATTACHED: ``SE'' Decision Making Process
 (Detailed), i.e., the decision making tree
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Suggested Content for Original IDE Application Cover       February 27, 1996                 Do                                        Do
 Letter--Version 4
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Suggestions for Submitting a Premarket Approval (PMA)      April 1, 1993                     Do                                        Do
 Application
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Threshold Assessment of the Impact of Requirements for     January 1, 1990                   Do                                        Do
 Submission of PMA's for 31 Medical Devices Marketed
 Prior to May 28, 1976
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Interagency Agreement between FDA & HCFA; #D95-2,          September 15, 1995                Office of Device Evaluation (ODE)/        Do
 Attachment A                                                                                 BlueBook
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Criteria for Categorization of Investigational Devices     September 15, 1995                Do                                        Do
 (HCFA); #D95-2, Attachment B
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Deciding When to Submit a 510(k) for a Change to an        January 10, 1997                  Do                                        Do
 Exisiting Device; Blue Book Memo #K97-1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Additional Information Procedures #K93-1 (Blue      July 23, 1993                     Do                                        Do
 Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Refuse to Accept Procedures #K94-1 (Blue Book       May 20, 1994                      Do                                        Do
 Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Sign-Off Procedures #K94-2 (Blue Book Memo)         June 3, 1994                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Sterility Review Guidance and Revision of           February 12, 1990                 Do                                        Do
 November18/1994 #K90-1 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Announcement: Implementation of the FDA/HCFA Interagency   September 15, 1995                Do                                        Do
 Agreement Regarding Reimbursement Categorization of
 Investigational Devices, Att. A Interagency Agreement,
 Att. B Criteria for Categorization of Investigational
 Devices #D95-2 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Assignment of Review Documents #I90-2 (Blue Book Memo)     August 24, 1990                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45471]]


Center for Devices and Radiological Health's               June 30, 1993                     Do                                        Do
 Investigational Device Exemption (IDE) Refuse to Accept
 Policy
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Devices and Radiological Health's Premarket     June 30, 1993                     Do                                        Do
 Notification [510(k)] Refuse to Accept Policy--(updated
 Checklist March 14, 1995)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Utility and Premarket Approval #P91-1 (Blue Book  May 3, 1991                       Do                                        Do
 Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Consolidated Review of Submissions for Diagnostic          October 19, 1990                  Do                                        Do
 Ultrasound Equipment, Accessories and Related
 Measurement Devices #G90-2 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Consolidated Review of Submissions for Lasers and          October 19, 1990                  Do                                        Do
 Accessories #G90-1 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Continued Access to Investigational Devices During PMA     July 15, 1996                     Do                                        Do
 Preparation and Review (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Cover Letter: 510(k) Requirements During Firm-Initiated    November 21, 1995                 Do                                        Do
 Recalls; Attachment A: Guidance on Recall and Premarket
 Notification Review Procedures During Firm-Initiated
 Recalls of Legally Marketed Devices (Blue Book Memo #K95-
 1)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Criteria for Panel Review of PMA Supplements #P86-3 (Blue  January 30, 1986                  Do                                        Do
 Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Delegation of IDE Actions #D88-1 (Blue Book Memo)          April 26, 1988                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device Labeling Guidance #G91-1 (Blue Book Memo)           March 8, 1991                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Document Review Processing #I91-1 (Blue Book Memo)         February 12, 1992                 Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Documentation and Resolution of Differences of Opinion on  December 23, 1993                 Do                                        Do
 Product Evaluations #G93-1 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Executive Secretaries Guidance Manual #G87-3               August 7, 1987                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Goals and Initiatives for the IDE Program #D95-1 (Blue     July 12, 1995                     Do                                        Do
 Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Center for Devices and Radiological        June 30, 1986                     Do                                        Do
 Health's Premarket Notification Review Program #K86-3
 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
HCFA Reimbursement Categorization Determinations for FDA-  October 31, 1995                  Do                                        Do
 approved IDEs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
IDE Refuse to Accept Procedures #D94-1 (Blue Book Memo)    May 20, 1994                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Integrity of Data and Information Submitted to ODE #I91-2  May 29, 1991                      Do                                        Do
 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Meetings with the Regulated Industry #I89-3 (Blue Book     November 20, 1989                 Do                                        Do
 Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45472]]


Memorandum of Understanding Regarding Patient Labeling     August 9, 1996                    Do                                        Do
 Review (Blue Book Memo #G96-3))
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Nondisclosure of Financially Sensitive Information #I92-1  March 5, 1992                     Do                                        Do
 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ODE Regulatory Information for the Office of Compliance--  May 15, 1987                      Do                                        Do
 Information Sharing Procedures #G87-2 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Overdue IDE Annual Progress Report Procedures #D93-1       July 23, 1993                     Do                                        Do
 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Panel Report and Recommendations on PMA Approvals #P86-5   April 18, 1986                    Do                                        Do
 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Panel Review of ``Me-Too'' Devices #P86-6 (Blue Book       July 1, 1986                      Do                                        Do
 Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Panel Review of Premarket Approval Applications #P91-2     May 3, 1991                       Do                                        Do
 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Compliance Program #P91-3 (Blue Book Memo)             May 3, 1991                       Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Filing Decisions #P90-2 (Blue Book Memo)               May 18, 1990                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Refuse to File Procedures #P94-1 (Blue Book Memo)      May 20, 1994                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Supplements: ODE letter to manufacturers; identifies   April 24, 1990                    Do                                        Do
 situations which may require the submission of a PMA
 supplement (When PMA Supplements are Required) #P90-1
 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMA/510(k) Triage Review Procedures #G94-1 (Blue Book      May 20, 1994                      Do                                        Do
 Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMA's--Early Review and Preparation of Summaries of        January 27, 1986                  Do                                        Do
 Safety and Effectiveness #P86-1 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Policy Development and Review Procedures #I90-1 (Blue      February 15, 1990                 Do                                        Do
 Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Approval Application (PMA) Closure #P94-1 (Blue  July 8, 1994                      Do                                        Do
 Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Notification--Consistency of Reviews #K89-1      February 28, 1989                 Do                                        Do
 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review and Approval of PMA's of Licensees #P86-4 (Blue     October 22, 1990                  Do                                        Do
 Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review of 510(k)s for Computer Controlled Medical Devices  August 29, 1991                   Do                                        Do
 #K91-1 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review of Final Draft Medical Device Labeling #P91-4       August 29, 1991                   Do                                        Do
 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review of IDEs for Feasibility Studies #D89-1 (Blue Book   May 17, 1989                      Do                                        Do
 Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review of Laser Submissions #G88-1 (Blue Book Memo)        April 15, 1988                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45473]]


Telephone Communications Between ODE Staff and             January 29, 1993                  Do                                        Do
 Manufacturers #I93-1 (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Toxicology Risk Assessment Committee #G89-1 (Blue Book     August 9, 1989                    Do                                        Do
 Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Use of International Standard ISO-10993, ``Biological      May 1, 1995                       Do                                        Do
 Evaluation of Medical Devices Part 1: Evaluation and
 Testing'' (Replaces #G87-1 #8294) (Blue Book Memo)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for Portable Blood Glucose Monitoring   February 20, 1996                 Office of Device Evaluation (ODE)/        Do
 Devices Intended for Bedside Use in the Neonate Nursery                                      Division of Clinical Laboratory Devices
                                                                                              (DCLD)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to IVD Manufacturers on Streamlined PMA; Final      December 22, 1997
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Assessing the Safety/Effectiveness of Home-use In Vitro    October 1, 1988                   Do                                        Do
 Diagnostic Devices (IVD's): Points to Consider Regarding
 Labeling and Premarket Submissions; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Data for Commercialization of Original Equipment           June 10, 1996                     Do                                        Do
 Manufacturer, Secondary and Generic Reagents for
 Automated Analyzers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Criteria for Assessment of In Vitro Diagnostic Devices     August 31, 1995                   Do                                        Do
 for Drugs of Abuse Assays Using Various Methodologies;
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for 510(k) Submission of Fecal Occult    July 29, 1992                     Do                                        Do
 Blood Tests; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for 510(k) Submission of                 September 30, 1991                Do                                        Do
 Glycohemoglobin (Glycated or Glycosylated) Hemoglobin
 for IVDs; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for 510(k) Submission of                 September 1, 1992                 Do                                        Do
 Immunoglobulins A, G, M, D and E Immunoglobulin System
 In Vitro Devices; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for 510(k) Submission of Lymphocyte               September 26, 1991                Do                                        Do
 Immunophenotyping IVDs using Monoclonal Antibodies;
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Approval Applications for Assays Pertaining to   October 8, 1999                   Do                                        Do
 Hepatitis C Viruses (HCV) that are Indicated for
 Diagnosis or Monitoring of HCV Infection or Associated
 Disease; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Nucleic Acid Amplification Based In    June 14, 1993                     Do                                        Do
 Vitro Diagnostic Devices for Direct Detection of
 Infectious Microorganisms; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarketing Approval Review Criteria for Premarket        September 10, 1992                Do                                        Do
 Approval of Estrogen (ER) or Progesterone (PGR)
 Receptors In Vitro Diagnostic Devices Using Steroid
 Hormone Binding (SBA) with Dextran-Coated Charcoal (DCC)
 Separation, Histochemical Receptor Bi; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Criteria for Cyclosporine PMA's                   January 24, 1992                  Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45474]]


Guidance Document for the Submission of Tumor Associated   September 19, 1996                Do                                        Do
 Antigen Premarket Notification [510(k)] to FDA
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for 510(k)s on Cholesterol Tests for Clinical     July 14, 1995                     Do                                        Do
 Laboratory, Physicians' Office Laboratory, and Home Use
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Abbreviated 510(k) Submissions for  February 22, 1999                 Do                                        Do
 In Vitro Diagnostic Calibrators; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Document for Special Controls for Erythropoietin Assay     April 28, 1999                    Do                                        Do
 Premarket Notifications [510(k)s] Guidance for Industry;
 Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Premarket Submissions for Kits for Screening  December 30, 1998                 Do                                        Do
 Drugs of Abuse to Be Used By The Consumer; Guidance for
 Industry; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Labeling for Laboratory Tests; Guidance for    June 24, 1999                     Do                                        Do
 Industry; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test        July 6, 1998                      Do                                        Do
 System; Guidance for Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Chloride Test System; Guidance for     July 6, 1998                      Do                                        Do
 Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic C-Reactive Protein Immunological Test  July 20, 1998                     Do                                        Do
 System; Guidance for Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Creatinine Test System; Guidance for   July 2, 1998                      Do                                        Do
 Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Glucose Test System; Guidance for      July 6, 1998                      Do                                        Do
 Industry ; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--In Vitro Diagnostic Potassium Test  July 6, 1998                      Do                                        Do
 System; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Sodium Test System; Guidance for       July 6, 1998                      Do                                        Do
 Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Urea Nitrogen Test System; Guidance    July 6, 1998                      Do                                        Do
 for Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider Guidance Document on Assayed and        February 3, 1999                  Do                                        Do
 Unassayed Quality Control Material; Guidance for
 Industry;
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Fibrin Monomer Paracoagulation Test;   April 27, 1999                    Do                                        Do
 Guidance for Industry and FDA Reviewers/Staff; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Labeling for Over-the-Counter Sample          December 21, 1999                 Do                                        Do
 Collection Systems for Drugs of Abuse Testing; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Submission of Immunohistochemistry            June 3, 1998                      Do                                        Do
 Applications to the FDA
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for Cervical Cytology Devices           July 25, 1994                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for Collection of Data in Support of    September 26, 1994                Do                                        Do
 In-Vitro Device Submissions for 510(k) Clearance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45475]]


Points to Consider for Hematology Quality Control          September 30, 1997                Do                                        Do
 Materials
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for Review of Calibration and Quality   February 1, 1996                  Do                                        Do
 Control Labeling for In Vitro Diagnostic Devices/Cover
 Letter dated March 14/1996
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Alpha-Fetoprotein (AFP)  July 15, 1994                     Do                                        Do
 in vitro Diagnostic Devices for Fetal Open Neural Tube
 Defects Using Immunological Test Methodologies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Review Criteria for Assessment of              March 8, 2000                     Do                                        Do
 Antimicrobial Susceptibility Devices; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Antimicrobial            October 30, 1996                  Do                                        Do
 Susceptibility Test Discs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Cytogenetic Analysis     July 15, 1991                      Do                                        Do
 Using Automated and Semi-Automated Chromosome Analyzers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Human Chorionic          September 27, 1995                Do                                        Do
 Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of In Vitro Diagnostic      July 6, 1993                      Do                                        Do
 Devices for Direct Detection of Mycobacterium Spp.
 Tuberculosis [(TB)]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of In Vitro Diagnostic      January 1, 1992                   Do                                        Do
 Devices for Direct Detection of Chlamydiae in Clinical
 Specimens
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Laboratory Tests for     September 17, 1992                Do                                        Do
 the Detection of Antibodies to Helicobacter pylori
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Portable Blood Glucose   February 14, 1996                 Do                                        Do
 In Vitro Diagnostic Devices Using Glucose Oxidase,
 Dehydrogenase, or Hexokinase Methodology
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Rheumatoid Factor(RF)    February 21, 1997                 Do                                        Do
 In Vitro Diagnostic Devices Using Enzyme-Linked
 Immunoassay (EIA), Enzyme Linked Immunosorbent Assay
 (ELISA), Particle Agglutination Tests, and Laser and
 Rate Nephelometry
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Blood Culture Systems                  August 12, 1991                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Devices Assisting in the Diagnosis of  May 31, 1990                      Do                                        Do
 C. Difficile Associated Diseases
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Devices Intended for the Detection of  December 30, 1991                 Do                                        Do
 Hepatitis B ``e'' Antigen and Antibody to Hbe
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro Diagnostic Devices for        August 1, 1992                    Do                                        Do
 Detection of IGM Antibodies to Viral Agents
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45476]]


Review Criteria for In Vitro Diagnostic Devices for the    February 1, 1994                  Do                                        Do
 Assessment of Thyroid Autoantibodies using Indirect
 Immunofluorescence Assay (IFA), Indirect
 Hemagglutination Assay (IHA), Radioimmunoasay (RIA), and
 Enzyme Linked Immunosorbent Assay (ELISA).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro Diagnostic Devices that       February 15, 1996                 Do                                        Do
 Utilize Cytogenetic In Situ Hybridization Technology for
 the Detection of Human Genetic Mutations (Germ Line and
 Somatic)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria For Premarket Approval of In Vitro         May 15, 1992                      Do                                        Do
 Diagnostic Devices for Detection of Antibodies to
 Parvovirus B19
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for the Assessment of Allergen-Specific    March 2, 1993                     Do                                        Do
 Immunoglobulin E (IGE) In-Vitro Diagnostic Devices Using
 Immunological Test Methodologies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for the Assessment of Anti-nuclear         September 1, 1992                 Do                                        Do
 Antibodies (ANA) In-Vitro Diagnostic Devices Using
 Indirect Immunofluorescence Assay (IFA), Immunodiffusion
 (IMD) and Enzyme Linked Immunosorbant Assay (ELISA).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA; Guidance for Indwelling     February 21, 2000                 Office of Device Evaluation (ODE)/        Do
 Blood Gas Analyzer 510(k) Submissions                                                        Division of Cardiovascular, Respiratory
                                                                                              & Neurological Devices (DCRND)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Balloon Valvuloplasty Guidance For The Submission Of an    January 1, 1989                   Do                                        Do
 IDE Application and a PMA Application
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Battery Guidance                                           July 12, 1993                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Carotid Stent--Suggestions for Content of Submissions to   October 26, 1996                  Do                                        Do
 the Food and Drug Administration in Support of
 Investigational Devices Exemption (IDE) Applications
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Coronary and Cerebrovascular Guidewire Guidance            January 1, 1995                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(K) Submission Requirements for Peak Flow Meters;       January 13, 1994                  Do                                        Do
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Emergency Resuscitator Guidance; Draft                     April 14, 1993                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Implantable Cardioverter-Defibrillators;      June 24, 1996                     Do                                        Do
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of Research and Marketing     August 1, 1993                    Do                                        Do
 Applications for Vascular Graft Prostheses; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Research and Marketing      May 1, 1995                       Do                                        Do
 Applications for Interventional Cardiology Devices: PTCA
 Catheters, Atherectomy Catheters, Lasers, Intravascular
 Stents; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance: Human Heart Valve Allografts; Draft              June 21, 1991                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45477]]


Intravascular Brachytherapy--Guidance for Data to be       May 24, 1996                      Do                                        Do
 Submitted to the Food and Drug Administration in Support
 of Investigational Device Exemption (IDE) Applications;
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Percutaneous Transluminal Coronary Angioplasty Package     February 7, 1995                  Do                                        Do
 Insert Template; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Replacement Heart Valve Guidance; Draft                    October 14, 1994                  Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance for Ventilators; Draft                   July 1, 1995                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance on Face Masks and Shield for CPR; Draft  March 16, 1994                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Cardiac Ablation Preliminary Guidance (Data to be          March 1, 1995                     Do                                        Do
 Submitted to the FDA in Support Investigation Device
 Exemption Application; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Electrode Recording Catheter Preliminary Guidance (Data    March 1, 1995                     Do                                        Do
 to be Submitted to the FDA in Support of Premarket
 Notifications [510(k)s]) ; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Excerpts Related to EMI from November 1993 Anesthesiology  November 1, 1993                  Do                                        Do
 and Respiratory Devices Branch/EMC Standard for Medical
 Devices (to be used with EMI Standard)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General Guidance Document: Non-Invasive Pulse Oximeter     September 7, 1992                 Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document: Electrocardiograph (ECG) Surface        February 11, 1997                 Do                                        Do
 Electrode Tester--Version 1.0
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Premarket Notification Submission    January 24, 2000                  Do                                        Do
 for Nitric Oxide Delivery Apparatus, Nitric Oxide
 Analyzer and Nitrogen Dioxide Analyzer; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Vascular Prostheses 510(k)           November 26, 1999                 Do                                        Do
 Submission; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Annuloplasty Rings 510(k) Submissions; Final  November 26, 1999                 Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Cardiopulmonary Bypass Arterial Line Blood    February 21, 2000                 Do                                        Do
 Filter 510(k) Submissions; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Cardiopulmonary Bypass Oxygenators 510(k)     January 17, 2000                  Do                                        Do
 Submissions; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Cardiovascular Intravascular Filter 510(k)    November 26, 1999                 Do                                        Do
 Submission; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Extracorporeal Blood Circuit Defoamer 510(k)  February 16, 2000                 Do                                        Do
 Submissions; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Cardiac Monitor Guidance (including Cardiotachometer and   November 5, 1998                  Do                                        Do
 Rate Alarm); Guidance for Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Diagnostic ECG Guidance (Including Non-Alarming ST         November 5, 1998                  Do                                        Do
 Segment Measurement); Guidance for Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45478]]


Recommended Clinical Study Design for Ventricular          May 7, 1999                       Do                                        Do
 Tachycardia Ablation; Guidance for Industry and for FDA
 Reviewers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Oxygen Conserving Device 510(k) Review 73     February 1, 1989                  Do                                        Do
 BZD 868.5905 Non-continuous Ventilator Class II
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Peak Flow Meters for Over-the-Counter Sale    June 23, 1992                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of the Annual Report to the   April 1, 1990                     Do                                        Do
 PMA Approved Heart Valve Prostheses
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of 510(k) Premarket            February 11, 1997                 Do                                        Do
 Notifications for Electrocardiograph (ECG) Electrode
 Version 1.0
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of 510(k) Premarket            February 11, 1997                 Do                                        Do
 Notifications for Electrocardiograph (ECG) Lead
 Switching Adapter Version 1.0
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Research and Marketing      January 14, 2000                  Do                                        Do
 Applications for Permanent Pacemaker Leads and for
 Pacemaker Lead Adaptor 510(k) Submissions; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Heated Humidifier Review Guidance                          August 30, 1991                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Implantable Pacemaker Testing Guidance                     January 12, 1990                  Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Vascular Graft Manufacturer, Developer, or                 May 11, 1990                      Do                                        Do
 Representative; Letter/Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Labeling--Suggested Format and Content;     April 25, 1997                    Do                                        Do
 Draft Document
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Non-Invasive Blood Pressure (NIBP) Monitor Guidance        March 10, 1997                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Policy for Expiration Dating (DCRND RB92-G)                October 30, 1992                  Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review Guidelines for Oxygen Generators and Oxygen         April 14, 1993                    Do                                        Do
 Equipment; Draft Document
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance for Nebulizers, Metered Dose Inhalers,   October 1, 1993                   Do                                        Do
 Spacers and Actuators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance for Nebulizers, Metered Dose Inhalers,   November 9, 1990                  Do                                        Do
 Spacers and Actuators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer's Guidance for Oxygen Concentrator                August 30, 1991                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Conducting Stability Testing to Support an    November 16, 1999                 Office of Device Evaluation (ODE)/        Do
 Expiration Date Labeling Claim for Medical Gloves; Draft                                     Division of Dental,
                                                                                               Infection Control and General Hospital
                                                                                              Devices (DDIGD)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Devices for the Treatment and/or Diagnosis of              June 10, 1998                     Do                                        Do
 Temporomandibular Joint Dysfunction and/or Orofacial
 Pain; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket            November 5, 1998                  Do                                         Do
 Notification [510(k)] Submission of Washers and Washer-
 Disinfectors; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45479]]


Guidance Document for Washers and Washer-Disinfectors      June 2, 1998                      Do                                        Do
 Intended for Processing Reusable Medical Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Overview of Information Necessary for Premarket            April 21, 1999                    Do                                        Do
 Notification Submissions for Endoseous Implants; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reprocessing and Reuse of Single-Use Devices: Review       February 8, 2000                  Do                                        Do
 Prioritization Scheme; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification [510(k)] Submissions    September 19, 1995                Do                                        Do
 for Sterilizers Intended for Use in Health Care
 Facilities; Addendum
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket         March 3, 1997                     Do                                        Do
 Notification [510(k)'S] for Dental Alloys; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Supplementary Guidance on the Content of Premarket         March 1, 1995                     Do                                        Do
 Notification [510(k)] Submissions for Medical Devices
 with Sharps Injury Prevention Features (Antistick);
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance and Format of Premarket Notification [510(k)]     January 3, 2000                   Do                                        Do
 Submissions for Liquid Chemical Sterilants/High Level
 Disinfectants; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document on Dental Handpieces                     July 1, 1995                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Notification [510(k)] Submissions for Testing    January 13, 1999                  Do                                        Do
 for Skin Sensitization to Chemicals in Natural Latex
 Products; Guidance for Industry and FDA Reviewers/Staff;
 Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Testing for Sensitizing Chemicals in Natural Rubber Latex  July 27, 1997
 Medical Devices; (Addendum to Premarket Notification
 [510(k) Submissions for Testing for Skin Sensitization
 to Chemicals in Natural Latex Products; Guidance for
 Industry and FDA Reviewers/Staff; Final)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Neonatal and Neonatal Transport Incubators-Premarket       September 18, 1998                Do                                        Do
 Notifications; Guidance for Industry and FDA Reviewers;
 Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Dental Cements Premarket Notification; Final               August 18, 1998                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance For The Arrangement and Content of a Premarket    May 16, 1989                      Do                                        Do
 Approval (PMA) Application For An Endosseous Implant For
 Prosthetic Attachment
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a Premarket Notification   November 27, 1998                 Do                                        Do
 [510(k)] for Direct Filling Dental Composites
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of Premarket Notification     April 1991                        Do                                        Do
 [510(k)] for Resorbable Periodontal Barriers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on 510(k) Submissions for Implanted Infusion      October 1, 1990                   Do                                        Do
 Ports
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45480]]


Guidance on Premarket Notification [510(k)] Submissions    August 1, 1993                    Do                                        Do
 for Automated Endoscope Washers, Washer/Disinfectors,
 and Disinfectors Intended for Use in Health Care
 Facilities
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification [510(K)] Submissions    March 16, 1995                    Do                                        Do
 for Short-Term and Long-Term Intravascular Catheters
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification [510(k)] Submissions    March 1, 1993                     Do                                        Do
 for Sterilizers Intended for Use in Health Care
 Facilities
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification [510(k)] Submissions    August 1, 1993                    Do                                        Do
 for Surgical Gowns and Surgical Drapes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket            February 13, 1998                 Do                                        Do
 Notification [510(k)] for Testing for Skin Sensitization
 to Chemicals in Latex Products [Draize Testing]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket            October 1, 1993                   Do                                        Do
 Notification [510(k)] Submissions for Sharps Containers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket            October 1, 1993                   Do                                        Do
 Notification [510(k)] Submissions for General Purpose
 Disinfectants (includes Addendum of March 9, 1994)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket            December 6, 1996                  Do                                        Do
 Notification 510(k) Submissions for Liquid Chemical
 Germicides
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification          December 1, 1995                  Do                                        Do
 [510(k)] Submissions for Protective Restraints
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification          April 1, 1993                     Do                                        Do
 [510(K)] Submissions for Hypodermic Single Lumen Needles
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification          April 1, 1993                     Do                                        Do
 [510(K)] Submissions for Piston Syringes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification          March 1, 1993                     Do                                        Do
 [510(K)] Submissions for Clinical Electronic
 Thermometers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification          March 1, 1993                     Do                                        Do
 [510(k)] Submissions for External Infusion Pumps
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Dental Impression Materials Premarket Notification; Final  August 17, 1998                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Denture Cushions, Pads, Reliners, Repair Kits and      August 18, 1998                   Do                                        Do
 Partially Fabricated Denture Kits; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Information Necessary for Premarket Notification           December 9, 1996                  Do                                        Do
 Submissions For Screw-Type Endossesous Implants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Information Needed for Hydroxyapatite Coated        February 20, 1997                 Office of Device Evaluation (ODE)/        Do
 Orthopedic Implants                                                                          Division of General & Restorative
                                                                                              Devices (DGRD)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45481]]


Alternate Suture Labeling Resulting From the January 11,   January 11, 1993                  Do                                        Do
 1993 Meeting with HIMA (Reformatted December 17, 1997)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Calcium Phosphate (Ca-P) Coating Draft Guidance for        February 21, 1997                 Do                                        Do
 Preparation of FDA Submissions for Orthopedic and Dental
 Endosseous Implants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Copy of October 9, 1992 Letter and Original Suture         October 9, 1992                   Do                                        Do
 Labeling Guidance (Reformatted December 17, 1997)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Guideline for General Surgical Electrosurgical      May 10, 1995                      Do                                        Do
 Devices; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Data Requirements for Ultrahigh Molecular Weight           March 28, 1995                    Do                                        Do
 Polyethylene (Uhmupe) Used in Orthopedic Devices; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Femoral Stem Prostheses; Draft       August 1, 1995                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Acetabular Cup Prostheses;   May 1, 1995                        Do                                       Do
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket         July 16, 1997                     Do                                        Do
 Notification [510(k)] Applications for Orthopedic
 Devices-The Basic Elements; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Arthroscopes and Accessory 510(k)s; Draft     May 1, 1994                       Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Testing MR Interaction with Aneurysm Clips;   May 22, 1996                      Do                                        Do
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a Premarket Notification   May 31, 1995                      Do                                        Do
 for a Non-Interactive Wound and Burn Dressing [510(k)] ;
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a Premarket Notification   August 30, 1994                   Do                                        Do
 for Extended Laparoscopy Devices (ELD); Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of an IDE Submission for a    April 4, 1995                     Do                                        Do
 Interactive Wound and Burn Dressing; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of Premarket Notifications    April 1, 1993                     Do                                        Do
 [510(k)] s for Cemented, Semi-Constrained Total Knee
 Prostheses; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Outline for a Guidance Document for Testing Orthopedic     November 1, 1993                  Do                                        Do
 Bone Cement, request for comments by December 10, 1993;
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Notification Review Guidance for Evoked          June 1, 1994                      Do                                        Do
 Response Somatosensory Stimulators; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Biocompatibility Requirements for Long Term    September 12, 1994                Do                                        Do
 Neurological Implants: Part-3 Implant Model; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Biofeedback Devices--Guidance for 510(k) Content; Draft    August 1, 1994                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Cranial Perforator Guidance; Draft                         July 13, 1994                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45482]]


Guidance for Clinical Data to be Submitted for Premarket   August 20, 1992                   Do                                        Do
 Approval Application for Cranial Electrotherapy
 Stimulators; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Cortical Electrode 510(k) Content; Draft         August 10, 1992                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Neuro Endoscope Guidance; Draft                            July 7, 1994                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Electroencephalograph Devices Guidance for 510(k)          November 3, 1997                  Do                                        Do
 Content; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Galvanic Skin Response Measurement Devices-Draft Guidance  August 1, 1994                    Do                                        Do
 for 510(k) Content
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of IDEs for Spinal   January 13, 2000                  Do                                        Do
 Systems; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Preparation of Investigational Device Exemptions and       March 18, 1998                    Do                                        Do
 Premarket Approval Applications for Bone Growth
 Stimulator Devices; Guidance Document for Industry and
 CDRH Staff; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 Guidance Document for Surgical Lamp 510Ks; Final          July 13, 1998                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Biodegradable Polymer        April 20, 1996                    Do                                        Do
 Implant Devices; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Bone Anchor Devices; Draft   April 20, 1996                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Non-Articulating,            May 1, 1995                       Do                                        Do
 ``Mechanically Locked'', Modular Implant Components;
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Orthopedic Implants with     April 28, 1994                    Do                                        Do
 Modified Metallic Surfaces Apposing Bone or Bone Cement
 (replaces 8623 and 8093)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of IDE and PMA       February 18, 1993                 Do                                        Do
 Applications for Intra-Articular Prosthetic Knee
 Ligament Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket         July 26, 1995                     Do                                        Do
 Notification [510(k)] Applications for Submerged
 (Underwater) Exercise Equipment
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket         July 26, 1995                     Do                                        Do
 Notification [510(k)] Applications for Electromyograph
 Needle Electrodes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket         July 26, 1995                     Do                                        Do
 Notification [510(k)] Applications for Exercise
 Equipment
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket         July 26, 1995                     Do                                        Do
 Notification [510k)] Applications for Mechanical and
 Powered Wheelchairs, and Motorized Three-Wheeled
 Vehicles
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket         July 26, 1995                     Do                                        Do
 Notification [510(k)] Applications for Beds
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45483]]


Guidance Document for the Preparation of Premarket         July 26, 1995                     Do                                        Do
 Notification [510(k)] Applications for Immersion
 Hydrobaths
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket         July 26, 1995                     Do                                        Do
 Notification [510(k)] Applications for Powered Tables
 and Multifunctional Physical Therapy Tables
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket         July 26, 1995                     Do                                        Do
 Notification [510(k)] Applications for Communications
 Systems (Powered and Non-Powered) and Powered
 Environmental Control Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket         July 26, 1995                     Do                                        Do
 Notification [510(k)] Applications for Therapeutic
 Massagers and Vibrators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket         July 26, 1995                     Do                                        Do
 Notification [510(k)] Applications for Heating and
 Cooling Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document For The Preparation of Premarket         January 10, 1995                  Do                                        Do
 Notification For Ceramic Ball Hip Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Dura Substitute Devices; Final       August 13, 1999                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Neurological Embolization Devices;   August 13, 1999                   Do                                        Do
 Guidance for Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 Guidance for the Preparation of a Premarket Notification  August 30, 1999                   Do                                        Do
 Application for Processed Human Dura Mater; Guidance for
 Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Dermabrasion Devices; Final                   March 2, 1999                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Preclinical and Clinical Data and Labeling     October 5, 1999                   Do                                        Do
 for Breast Prostheses; Guidance for Industry; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Spinal System 510(k)s; Final                  May 7, 1999                       Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Powered Suction Pump 510(k)s;        October 30, 1998                  Do                                        Do
 Guidance for Industry and/or for FDA Reviewers/Staff and/
 or Compliance; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Powered Muscle Stimulator 510(k)s;   June 9, 1999                      Do                                         Do
 Guidance for Industry, FDA Reviewers/Staff and
 Compliance; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for    April 28, 1998                    Do                                        Do
 Esophageal and Tracheal Prostheses; Guidance for
 Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Studies for Pain Therapy Devices--General     May 12, 1988                      Do                                        Do
 Considerations in the Design of Clinical Studies for
 Pain-Alleviating Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a Premarket Notification   March 2, 1999                     Do                                        Do
 Application for a Surgical Mesh; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45484]]


Guidance on the Content and Organization of a Premarket    June 1, 1995                      Do                                        Do
 Notification for a Medical Laser
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for TENS 510(k) Content; Draft                       August 1, 1994                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Reviewing Premarket Notifications that      February 1997                     Do                                        Do
 Claim Substantial Equivalence to Evoked Response
 Stimulators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Core Study for Silicone Breast Implants; Letter            January 11, 1996                  Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ORDB 510(k) Sterility Review Guidance                      July 3, 1997                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Protocol for Dermal Toxicity Testing for Devices in        January 1985                      Do                                        Do
 Contact with Skin; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewers Guidance Checklist for Intramedullary Rods       February 21, 1997                 Do                                         Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewers Guidance Checklist for Orthopedic External       February 21, 1997                 Do                                        Do
 Fixation Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Notification [510(k)] Guidance Document for      June 28, 1994                     Office of Device Evaluation (ODE)/        Do
 Class II Daily Wear Contact Lenses; Amendment 1; Draft                                       Division of Ophthalmic Devices (DOD)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Premarket Submission of Orthokeratology       April 10, 2000                    Do                                        Do
 Rigid Gas Permeable Contact Lenses; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
An FDA Survey of U.S. Contact Lens Wearers (Carol L.       July 1, 1987                      Do                                        Do
 Herman) Reprinted from Contact Lens Spectrum
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Announcement by Dr. Alpert at July 26, 1996 Ophthalmic     August 26, 1996                   Do                                        Do
 Panel Meeting concerning Manufacturers & Users of Lasers
 for Refractive Surgery [Excimer]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Announcement: Information for Manufacturers & Users of     September 22, 1997                Do                                        Do
 Lasers for Refractive Surgery [Excimer]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Checklist of Information Usually Submitted in an           October 10, 1996                  Do                                        Do
 Investigational Device Exemptions (IDE) Application for
 Refractive Surgery Lasers [Excimer]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Contact Lenses: The Better the Care the Safer the Wear;    April 1, 1991                     Do                                        Do
 Publication No. FDA 91-4220
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Discussion Points for Expansion of the ``Checklist of      September 5, 1997                 Do                                        Do
 Information Usually Submitted in an Investigational
 Device Exemption (IDE) Application for Refractive
 Surgery Lasers''; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Notification [510(k)] Guidance Document for      May 12, 1994                      Do                                        Do
 Class II Daily Wear Contact Lenses and June 28, 1994
 corrections to pages 18 & 20; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Notification 510(k) Guidance for Contact Lens    May 1, 1997                       Do                                        Do
 Care Products; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Facts for Consumers from the Federal Trade Commission-     April 1, 1986                     Do                                        Do
 Eyeglasses
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45485]]


FDA Guidelines for Multifocal Intraocular Lens IDE         May 29, 1997                      Do                                        Do
 Studies and PMA's
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Ophthalmoscope Guidance (Direct and Indirect); Guidance    July 8, 1998                      Do                                        Do
 for Industry
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Nonprescription Sunglasses; Final    October 9, 1998                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Retinoscope Guidance; Final                                July 8, 1998                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Slit Lamp Guidance; Final                                  July 13, 1998                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Revised Procedures for Adding Lens Finishing Laboratories  August 11, 1998                   Do                                        Do
 to Approved Premarket Approval (PMA) Applications for
 Class III Rigid Gas Permeable Contact Lenses for
 Extended Wear; Guidance for Industry and FDA Staff;
 Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Accountability Analysis for Clinical Studies for           August 4, 1999                    Do                                        Do
 Ophthalmic Devices; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Aqueous Shunts--510(k) Submissions; Final                  November 16, 1998                 Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on 510(k) Submissions for Keratoprostheses;       March 3, 1999                     Do                                        Do
 Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket            January 16, 1998                  Do                                        Do
 Notification [510(k)] Submissions for Surgical Mask;
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Important Information About Rophae Intraocular Lenses      August 20, 1992                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Intraocular Lens (IOL) Guidance Document; Draft            October 14, 1999                  Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
New FDA Recommendations & Results of Contact Lens Study    May 30, 1989                      Do                                        Do
 (7 Day Letter)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Owners Certification of Lasers as PMA Approved Devices     September 26, 1996                Do                                        Do
 Excimer]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Third Party Review Guidance for Vitreous Aspiration and    January 31, 1997                  Do                                        Do
 Cutting Device Premarket Notification [510(k)]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Update on Excimer Lasers for Nearsightedness               May 20, 1996                      Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Manufacturers Seeking Marketing Clearance of  March 12, 2000                    Do                                        Do
 Ear, Nose, and Throat Endoscope Sheaths Used as
 Protective Barriers; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Checklist for Sterile Lubricating Jelly Used With   September 19, 1994                Office of Device Evaluation (ODE)/        Do
 Transurethral Surgical Instruments                                                           Division of Reproductive, Abdominal,
                                                                                              ENT & Radiological Devices (DRAERD)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Hemodialyzer Reuse Labeling; Draft            November 6, 1995                  Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Content of Premarket Notification for Hemodialysis         August 7, 1998                    Do                                        Do
 Delivery Systems; Guidance for Industry and CDRH
 Reviewers; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45486]]


Guidance for the Content of Premarket Notifications        February 8, 1999                  Do
 (510(k)s) for Extracorporeal Shock Wave Lithotripters
 Indicated for the Fragmentation of Kidney and Ureteral
 Calculi
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH Interim Regulatory Policy for External Penile         September 10, 1997                Do                                        Do
 Rigidity Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Checklist for Mechanical Lithotripters and Stone           November 1, 1994                  Do                                        Do
 Dislodgers used in Gastroenterology and Urology
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Checklist for Conditioned Response Enuresis         November 23, 1994                 Do                                        Do
 Alarms; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Checklist for Condom Catheters; Draft               February 23, 1995                 Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Checklist for Endoscopic Electrosurgical Unit       August 16, 1995                   Do                                        Do
 (ESU) and Accessories Used in Gastroenterology and
 Urology; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Checklist for Endoscopic Light Sources Used in      June 22, 1995                     Do                                        Do
 Gastroenterology and Urology; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Checklist for Non-Implanted Electrical Stimulators  June 6, 1995                      Do                                        Do
 Used for the Treatment of Urinary Incontinence; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Checklist for Urological Irrigation System and      August 1, 1995                    Do                                        Do
 Tubing Set; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Clinical Investigations of Devices Used for   November 11, 1994                 Do                                        Do
 the Treatment of Benign Prostatic Hyperplasia (BPH);
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Information on Clinical Safety and            February 5, 1992                  Do                                        Do
 Effectiveness Data for Extracorporeal Shock Wave
 Lithotripsy of Upper Urinary Tract (Renal Pelvis, Renal
 Calyx and Upper Ureteral) Calculi; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Preclinical and Clinical Investigations of    November 29, 1995                 Do                                        Do
 Urethral Bulking Agents Used in the Treatment of Urinary
 Incontinence; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Preparation of PMA Applications for Penile    March 16, 1993                    Do                                        Do
 Inflatable Implants; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Preparation of PMA Applications for           March 16, 1993                    Do                                        Do
 Testicular Prostheses; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Preparation of PMA Applications for the       May 1, 1995                       Do                                        Do
 Implanted Mechanical/Hydraulic Urinary Continence Device
 (Artificial Urinary Sphincter); Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Review of Bone Densitometer 510(k)            November 9, 1992                  Do                                        Do
 Submissions; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Clinical Investigation of Urethral        November 2, 1995                  Do                                        Do
 Stents; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for    March 17, 1995                    Do                                        Do
 Endoscopes used in Gastroenterology and Urology; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45487]]


Guidance for the Content of Premarket Notifications for    July 29, 1991                     Do                                        Do
 Loop and Rollerball Electrodes for GYN Electrosurgical
 Excisions; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for    May 25, 1995                      Do                                        Do
 Menstrual Tampons; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for    January 24, 1992                  Do                                        Do
 Urological Balloon Dilatation Catheters; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for    May 30, 1997                      Do                                        Do
 Water Purification Components and Systems for
 Hemodialysis; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Outline-Points to Consider for Clinical Studies   November 30, 1993                 Do                                        Do
 for Vasovasostomy Devices; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance to Firms on Biliary Lithotripsy Studies; Draft    August 2, 1990                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Suggested Information for Reporting Extracorporeal Shock   January 18, 1991                  Do                                        Do
 Wave Lithotripsy Device Shock Wave Measurements; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Thermal Endometrial Ablation Devices (Submission Guidance  March 14, 1996                    Do                                        Do
 for an IDE); Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Devices Used for In Vitro Fertilization and Related        September 10, 1998                Do                                        Do
 Assisted Reproduction Procedures: Submission Guidance
 for a 510(k); Draft Availability
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 Guidance for the Content of Premarket Notifications for   November 30, 1998                 Do                                        Do
 Intracorporeal Lithotripters; Guidance for Industry;
 Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for Evaluation of Fetal Clip     March 8, 1977                     Do                                        Do
 Electrode
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for Evaluation of Hysteroscopic  May 10, 1978                      Do                                        Do
 Sterilization Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for Evaluation of Laparoscopic   May 1978                          Do                                        Do
 Bipolar and Thermal Coagulators (and Accessories)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for Evaluation of Tubal          November 22, 1977                 Do                                        Do
 Occlusion Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Premarket Notifications     December 3, 1998                  Do                                        Do
 for Emission Computed Tomography Devices and Accessories
 (SPECT and PET) and Nuclear Tomography Systems; Guidance
 for Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Premarket Notifications     November 20, 1998                 Do                                        Do
 for Radionuclide Dose Calibrators; Guidance for
 Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Premarket Notifications     November 14, 1998                 Do                                        Do
 for Magnetic Resonance Diagnostic Devices; Guidance for
 Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45488]]


Harmonic Imaging With/Without Contrast Premarket           November 16, 1998                 Do                                        Do
 Notification; Guidance for Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Non-Automated Sphygmomanometer (Blood Pressure Cuff)       November 19, 1998                 Do                                        Do
 Guidance; Version 1; Guidance for Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Uniform Contraceptive Labeling; Guidance for Industry;     July 23, 1998                     Do                                        Do
 Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for    January 16, 2000                  Do                                        Do
 Penile Rigidity Implants; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Electro-optical Sensors for the In Vivo Detection of       August 25, 1999                   Do                                        Do
 Cervical Cancer and its Precursors: Submission Guidance
 for an IDE/PMA; Guidance for Industry; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Noise Claims in Hearing Aid Labeling; Final                October 21, 1998                  Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Magnetic Resonance Diagnostic Devices--       September 29, 1997                Do                                        Do
 Criteria for Significant Risk Investigations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Resorbable Adhesion Barrier Devices for Use   December 16, 1999                 Do                                        Do
 in Abdominal and/or Pelvic Surgery; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Arrangement and Content of a Premarket    May 1, 1990                       Do                                        Do
 Approval (PMA) Application for a Cochlear Implant in
 Children Ages 2 through 17 Years
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Comment and Review of 510(k)              August 1, 1993                    Do                                        Do
 Notifications for Picture Archiving and Communications
 Systems (PACS) and Related Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for    February 10, 1993                 Do                                        Do
 Biopsy Devices Used in Gastroenterology and Urology
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for    September 12, 1994                Do                                        Do
 Conventional and Antimicrobial Foley Catheters
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for    February 5, 1998                  Do                                        Do
 Metal Expandable Biliary Stents; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for    February 10, 1993                 Do                                        Do
 Urethral Stents
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for    June 7, 1994                      Do                                        Do
 Urine Drainage Bags
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for    July 29, 1994                     Do                                        Do
 Urodynamic/Uroflowmetry Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of 510(k)'s for Solid State X- August 6, 1999                    Do                                        Do
 ray Imaging Devices; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Technical Content of a Premarket          April 1, 1990                     Do                                        Do
 Approval (PMA) Application for an Endolymphatic Shunt
 Tube with Valve
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45489]]


Guidance for the Content of Premarket Notifications for    August 7, 1998                    Do                                        Do
 Conventional and Permeability Hemodialyzers; Guidance to
 Industry and CDRH Reviewers; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for the Arrangement and Content of a Premarket   May 1, 1990                       Do                                        Do
 Approval (PMA) Application for a Cochlear Implant in
 Adults at Least 18 Years of Age
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Evaluation of Non-Drug IUD's                September 28, 1976                Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Home Uterine Activity Monitors: Guidance for the           July 30, 1999                     Do                                        Do
 Submission of 510(k) Premarket Notifications; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Hysteroscopes and Gynecology Laparoscopes--Submission      March 27, 1996                    Do                                        Do
 Guidance for a 510(k) includes 00192
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Hysteroscopic and Laparoscopic Insufflators: Submission    August 1, 1995                    Do                                        Do
 Guidance for a 510(k)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Information for a Latex Condom 510(k) Submission for       July 1, 1997                      Do                                        Do
 Obstetrics-Gynecology Devices Branch; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Information for Manufacturers Seeking Marketing Clearance  September 30, 1997                Do                                        Do
 of Diagnostic Ultrasound Systems and Transducers; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Intrapartum Continuous Monitors for Fetal Oxygen           June 14, 1997                     Do                                        Do
 Saturation and Fetal pH; Submission Guidance for a PMA;
 Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Latex Condoms for Men-Information for 510(k) Premarket     July 23, 1998                     Do                                        Do
 Notifications: Use of Consensus Standards for
 Abbreviated Submissions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Notice to Manufacturers of Bone Mineral Densitometers;     September 25, 1997                Do                                        Do
 Letter
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Testing Guidelines for Falloposcopes             November 20, 1992                 Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Testing Guidelines for Female Barrier            April 4, 1990                     Do                                        Do
 Contraceptive Devices Also Intended to Prevent Sexually
 Transmitted Diseases
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance for Automatic X-Ray Film Processor       February 1, 1990                  Do                                        Do
 510(k)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Simplified 510(k) Procedures For Certain Radiology         December 21, 1993                 Do                                        Do
 Devices (December 21, 1993 letter from L Yin, ODE/
 DRAERD, to NEMA)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Information for Manufacturers Seeking Marketing Clearance  June 19, 1996                     Do                                        Do
 of Digital Mammography Systems; Status Update
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Testing Guidance for Male Condoms Made from New Material   June 29, 1995                     Do                                        Do
 (Non-Latex)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tympanostomy Tubes Submission Guidance for a 510(k)        January 14, 1998                  Do                                        Do
 Premarket Notification; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45490]]


Guidance on Amended Procedures for Advisory Panel          March 20, 1998                    ODE/Program Operations Staff (POS)        Do
 Meetings [FDAMA] Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMA/510(k) Expedited Review-Guidance for Industry and      March 20, 1998                    Do                                        Do
 CDRH Staff [FDAMA] Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMA/510(k) Expedited Review #G98-4 (Blue Book Memo)        March 20, 1998                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on IDE Policies and Procedures [FDAMA]; Final     January 20, 1998                  Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Modernization Act of 1997 Guidance for the Device      February 6, 1998                  Office of Health and Industry Programs    Do
 Industry on Implementation of Highest Priority                                               (OHIP)
 Provisions [FDAMA]; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Overview of FDA Modernization Act of 1997 Medical Device   June 5, 1998                      Do                                        Do
 Provisions [FDAMA]; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance: The Mammography Quality Standards Act Final      March 4, 1999                     Office of Health and Industry Programs    Do
 Regulations Document #1; Final                                                               (OHIP)/Division of Mammography Quality
                                                                                              and Radiation Programs (DMQRP)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance: The Mammography Quality Standards Act Final      February 25, 2000                 Do                                        Do
 Regulations Document #2; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance: The Mammography Quality Standards Act Final      December 8, 1999                  Do                                        Do
 Regulations Document #3; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance The Mammography Quality Standards Act Final       May 5, 1999                       Do                                        Do
 Regulations--Mammography Facility Survey and Medical
 Physicist Qualification Requirements Under MQSA; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance The Mammography Quality Standards Act Final       May 5, 1999                       Do                                        Do
 Regulations--Preparing for MQSA Inspections; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Request and Issuance of Interim Notice        May 4, 1999                       Do                                        Do
 Letters for Mammography Facilities Under the Mammography
 Quality Standards Act, 42 U.S.C. Section 263(b); Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Review of Cases of Possible Suspension or     March 26, 1998                    Do                                        Do
 Revocation of Mammography Facility Certificates Under
 the Mammography Quality Standards Act, 42 U.S.C. 263(b);
 Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Review of Requests for Reconsideration of     March 26, 1998                    Do                                        Do
 Adverse Decisions on Accreditation of Mammography
 Facilities Under the Mammography Quality Standards Act,
 42 U.S. C. 263(b); Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Submission of Request for Reconsideration of  March 26, 1998                    Do                                        Do
 Adverse Decisions on Accreditation of Mammography
 Facilities Under the Mammography Quality Standards Acts,
 42 U.S.C. 263(b); Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45491]]


Accidental Radioactive Contamination of Human Food and     August 13, 1998                   Do                                        Do
 Animal Feeds: Recommendations for State and Local
 Agencies; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Policy and Standard Operating Procedures      April 15, 1998                    Do                                        Do
 When Mammography Facilities in States that Have
 Accreditation Bodies Intend to Change Accreditation
 Bodies; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance: The Mammography Quality Standards Act Final      May 5, 1999                       Do                                        Do
 Regulations Preparing for MQSA Inspections; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance: The Mammography Quality Standards Act Final      March 23, 1999                    Do                                        Do
 Regulations Motion of Tube-Image Receptor Assembly;
 Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance: The Mammography Quality Standards Act Final      December 7, 1999                  Do                                        Do
 Regulations: Quality Assurance Documentation; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Notification: 510(k)-Regulatory Requirements     August 1, 1995                    Office of Health and Industry Programs    Do
 for Medical Devices (FDA 95-4158) [available on disk]                                        (OHIP)/Division of Small Manufacturers
                                                                                              Assistance (DSMA)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling-Regulatory Requirements for Medical Devices (FDA  September 1, 1989                 Do                                        Do
 89-4203)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Classification Names for Medical Devices and In Vitro      March 1, 1995                     Do                                        Do
 Diagnostic Products (FDA Pub No. 95-4246)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
An Introduction to Medical Device Regulations (FDA 92-     January 1, 1992                   Do                                        Do
 4222)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Comparison Chart: 1996 Quality System Reg vs. 1978 Good    November 11, 1996                 Do                                        Do
 Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and
 ISO/DI 13485:1996
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Glove Guidance Manual; FDA 99-4257; Draft          August 30, 1999                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Devices: Guidance for the Preparation  January 1, 1997                   Do                                        Do
 of 510(k) Submissions (FDA 97-4224) [available on disk]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for Completion of Medical Device              July 1, 1997                      Do                                        Do
 Registration and Listing Forms FDA 2891, 2891a and 2892
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Investigational Device Exemptions [IDE] Manual (FDA 96-    June 1, 1996                      Do                                        Do
 4159) [available on disk]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Appeals and Complaints: A Guidance on       February 19, 1998                 Do                                        Do
 Dispute Resolution; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Reporting for Manufacturers [available on   March 1, 1997                     Do                                        Do
 disk]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Approval (PMA) Manual; Final                     January 1, 1998                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Requirements for Devices for the Handicapped    August 1, 1987                    Do                                        Do
 (FDA 87-4221)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Small Business Guide to FDA (FDA 96-1092)                  January 1, 1996                   Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45492]]


The FDA Export Reform and Enhancement Act of 1996/Export   February 7, 2000                  Do                                        Do
 Certification Package including ``Instructions for
 Requests for Certificate to Foreign Governments''; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
U.S.-FDA-Regulation of Medical Devices; Background         April 14, 1999                    Do                                        Do
 Information for International Officials (entire document
 available on disk); Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Manual-Premarket Notification: 510(k)-Regulatory    August 1, 1995                    Do                                        Do
 Requirements for Medical Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Export--Foreign Liaison (part of ``Exporting Medical        December 2, 1998                 Do                                        Do
 Devices,'' February 25, 1999)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Exporting Medical Devices; Final                           February 25, 1999                 Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Third Party Programs Under the Sectoral Annex on Medical   January 6, 1999                   Do                                        Do
 Devices to the Agreement on Mutual Recognition Between
 the United States of America and the European Community
 (MRA); Guidance for Staff, Industry, and Third Parties;
 Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Implementation of Third Party Programs Under the FDA       October 30, 1998                  Do                                        Do
 Modernization Act of 1997; Guidance for Staff, Industry,
 and Third Parties; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Quality Systems Manual: A Small Entity      December 1, 1996                  Do                                        Do
 Compliance Guide
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Do It By Design--An Introduction to Human Factors in       December 1, 1996                  Office of Health and Industry Programs    Do
 Medical Devices                                                                              (OHIP)/Division of Device User Programs
                                                                                              and Systems Analysis (DUPSA)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Patient Labeling; Guidance for  March 3, 2000                     Do                                        Do
 Industry; Draft                                                                               DUPSA
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device Use Safety: Incorporating Human Factors in Risk     August 3, 1999                    Do                                        Do
 Management; Guidance For Industry and FDA Premarket and                                       DUPSA
 Postmarket Review Staff; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Human Factors Points to Consider for IDE Devices; Draft    January 17, 1997                  Do                                        Do
                                                                                               DUPSA
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Human Factors Principles for Medical Device Labeling       September 1, 1993                 Do                                        Do
                                                                                               DUPSA
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Reporting for User Facilities               April 1, 1996                     Do                                        Do
                                                                                               DUPSA
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Write it Right; Recommendations for Developing User        August 1, 1993                    Do                                        Do
 Instruction Manuals for medical Devices Used in Home
 Health Care
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Perspectives on Clinical Studies for Medical Device        Unknown Pre-1997                  Office of Surveillance and Biometrics     Do
 Submissions (Statistical)                                                                    (OSB)/
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Review Statistical Checklist                           Unknown Pre-1997                  Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Statistical Aspects of Submissions to FDA: A Medical       June 1, 1984                      Office of Surveillance and Biometrics     Do
 Device Perspective (also includes an Appendix the                                            (OSB)/Division of Biostatistics (DB)
 article ``Observed Uses and Abuses of Statistical
 Procedures in Medical Device Submissions''
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45493]]


Amendment to Guidance on Discretionary Postmarket          March 30, 1994                    Office of Surveillance and Biometrics     Do
 Surveillance on Pacemaker Leads; Final                                                       (OSB)/Issues Management Staff (IMS)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Procedures for Review of Postmarket            February 19, 1998                 Do                                        Do
 Surveillance Submissions [FDAMA]; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Procedures to Determine Application of         February 19, 1998                 Do                                        Do
 Postmarket Surveillance Strategies [FDAMA]; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
SMDA to FDAMA: Guidance on FDA's Transition Plan for       November 2, 1998                  Do                                        Do
 Existing Postmarket Surveillance Protocols [FDAMA];
 Guidance for Industry and FDA Staff; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance to Sponsors on the Development of a               June 9, 1993                      Do                                        Do
 Discretionary Postmarket Surveillance Study for
 Permanent Implantable Cardiac Pacemaker Electrodes
 (Leads); Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Testing of Metallic Plasma Sprayed Coatings on Orthopedic  February 2, 2000                  Office of Surveillance and Biometrics     Do
 Implants to Support Reconsideration of Postmarket                                            (OSB)/Division of Postmarket
 Surveillance Requirements; Guidance for Industry; Final                                      Surveillance (DPS)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Common Problems: Baseline Reports and Medwatch Form 3500A  January 1997                      Office of Surveillance and Biometrics     Do
                                                                                              (OSB)/Division of Surveillance Systems
                                                                                              (DSS)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for Completing FDA Form 3500A with Coding     December 15, 1995                 Do                                        Do
 Manual for Form 3500A (MEDWATCH) (MDR)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Documents Access Information for National Technical    May 10, 1996                       Do                                       Do
 Information Service (NTIS)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Internet List Server (listserv) Instruction sheet      August 29, 1996                    Do                                       Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
MEDWATCH FDA Form 3500A For Use By User Facilities,        June 1, 1993                      Do                                        Do
 Distributors and Manufacturers for Mandatory Reporting
 (MDR)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Reporting Guidance For Breast Implants--E1996002       August 7, 1996                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Addendum to the Instructions for Completing FDA Form       June 9, 1999                      Do                                        Do
 3500A with Coding Manual (MEDWATCH) (MDR)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for Completing Form 3417: Medical Device      March 31, 1997                    Do                                        Do
 Reporting Baseline Report MDR]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Summary Reporting Approval for Adverse Events; Letter to   July 31, 1997                     Do                                        Do
 Manufacturers; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Guidance Document No. 1--IOL--E1996004                 August 7, 1996                    Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Guidance Document No. 3-Needlestick & Blood Exposure-- August 9, 1996                    Do                                        Do
 E1996003
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Guidance Document: Remedial Action Exemption--         July 30, 1996                     Do                                        Do
 E1996001
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45494]]


MDR Reporting Guidance for Date-Related Problems           April 16, 1999                    Do                                        Do
 Including Y2K
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Reporting: An Overview; Final               April 1, 1996                     Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Variance from Manufacturer Report Number Format [MDR       July 16, 1996                     Do                                        Do
 letter]; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A Primer on Medical Device Interactions with Magnetic      February 7, 1997                  Office of Science and Technology (OST)    Do
 Resonance Imaging Systems; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Frequently Asked Questions on Recognition of Consensus     December 21, 1998                 Do                                        Do
 Standards [FDAMA]; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Viable Bacteriophage in CO2 Laser Plume: Aerodynamic Size  Unknown pre-1997                  Do                                        Do
 Distribution
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Recognition and Use of Consensus           February 19, 1998                 Do                                        Do
 Standards/Appendix A [FDAMA]; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH Standard Operating Procedures for the Identification  August 6, 1999                    Do                                        Do
 and Evaluation of Candidate Consensus Standard for
 Recognition; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Devices Containing Materials Derived from Animal   November 16, 1998                 Do                                        Do
 Sources (Except for In Vitro Diagnostic Devices),
 Guidance for FDA Reviewers and Industry; Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on FDA's Expectations of Medical Device           May 15, 1998                      Do                                        Do
 Manufacturers Concerning the Year 2000 Date Problems;
 Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Immunotoxicity Testing; Final                  May 6, 1999                       Office of Science and Technology (OST)/   Do
                                                                                              Division of Life Sciences (DLS)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      How To Obtain A Hard Copy of The
               Name of Document                       Date of Issuance             Grouped by Intended User or       Document (Name and Address, Phone,
                                                                                       Regulatory Activity                Fax, E-Mail or Internet)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guides Manual                1998                           FDA Regulated Industries              National Technical Information
                                                                                                                     Service (NTIS), 5285 Port Royal
                                                                                                                     Rd., Springfield, VA 22161, PB96-
                                                                                                                     920500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Programs Guidance Manual            1995                           FDA Regulated Industries              National Technical Information
                                                                                                                     Service (NTIS), 5285 Port Royal
                                                                                                                     Rd., Springfield, VA 22161, PB95-
                                                                                                                     915499
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Recall Policy                              1995                           FDA Regulated Industries              Industry Activities Staff (HFS-565),
                                                                                                                     Center for Food Safety and Applied
                                                                                                                     Nutrition, FDA, 200 C St. SW.,
                                                                                                                     Washington, DC 20204
--------------------------------------------------------------------------------------------------------------------------------------------------------
Investigators' Operations Manual               May 1996                       FDA Regulated Industries              National Technical Information
                                                                                                                     Service (NTIS), 5285 Port Royal
                                                                                                                     Rd., Springfield, VA 22161, PB-95-
                                                                                                                     913399
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45495]]


Regulatory Procedures Manual                   August 1995                    FDA Regulated Industries              National Technical Information
                                                                                                                     Service (NTIS), 5285 Port Royal
                                                                                                                     Rd., Springfield, VA 22161, PB95-
                                                                                                                     265534
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requirements of Laws and Regulations Enforced  1997                           FDA Regulated Industries              Superintendent of Documents,
 by the U.S. Food and Drug Administration                                                                            Government Printing Office,
 ``Blue Book''                                                                                                       Washington, DC 20402
--------------------------------------------------------------------------------------------------------------------------------------------------------
Action Levels for Poisonous or Deleterious     1995                           Food and Animal Feed Industries       Industry Activities Staff (HFS-565),
 Substances in Human   Food and Animal Feed                                                                          Center for Food Safety and Applied
                                                                                                                     Nutrition, FDA, 200 C St. SW.,
                                                                                                                     Washington, DC 20204, PB96-920500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pesticides Analytical Manual                    1994                           Food Industry                         National Technical Information
                                                                                                                     Service (NTIS), 5285 Port Royal
                                                                                                                     Rd., Springfield, VA 22161, PB94-
                                                                                                                     911899
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Advisory for Deoxynivanol (DON) in         September 16, 1993              Food and Animal Feed Industries      Office of Plant & Dairy Foods &
 Finished Wheat Products Intended for Human                                                                          Beverages, Food and Drug
 Consumption and in Grain and Grain By-                                                                              Administration (HFS-306), 200 C St.
 Products for Animal Feed                                                                                            SW., Washington, DC 20204, 202-205-
                                                                                                                     4681
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA's Cosmetic Labeling Manual                  October 1991                   Cosmetic Industry                    Food and Drug Administration, Office
                                                                                                                     of Colors and Cosmetics (HFS-105),
                                                                                                                     200 C St. SW., Washington, DC
                                                                                                                     20204, 202-205-4493
--------------------------------------------------------------------------------------------------------------------------------------------------------
Statement of Policy: Foods Derived from New    May 29, 1992 (57 FR 22984)     Developers of New Plant Food          Office of Premarket Approval, Food
 Plant Varieties: Notice                                                       Varieties                             and Drug Administration (HFS-200),
                                                                                                                     200 C St. SW., Washington, DC
                                                                                                                     20204, 202-418-3100
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Food Labeling Guide                           May 1997                      Food Industry                         Industry Activities Staff (HFS-565),
                                                                                                                     Center for Food Safety and Applied
                                                                                                                     Nutrition, FDA, 200 C St. SW.,
                                                                                                                     Washington, DC 20204, 202-205-5251
--------------------------------------------------------------------------------------------------------------------------------------------------------
Appendix I--Model Small Business Food          June 1996                      Food Industry                         Do
 Labeling Exemption Notice
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Labeling: Questions and Answers            August 1994                    Food Industry                        Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Labeling: Questions and Answers: Volume   February 1996                  Food Industry                          Superintendent of Documents,
 II                                                                                                                  Government Printing Office,
                                                                                                                     Washington, DC 20420, 202-512-1800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fair Packaging and Labeling Act Manual         June 1978                      Food Industry                          National Technical Information
                                                                                                                     Service (NTIS), 5285 Port Royal
                                                                                                                     Rd., Springfield, VA 22161, 703-487-
                                                                                                                     4650, PB-83-222117
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacteriological Analytical Manual 7th Edition   1992                           FDA Regulated Industries              AOAC International, 481 N.
                                                                                                                     Frederick Ave., Suite 500,
                                                                                                                     Gaithersburg, MD, 20877-2417, 301-
                                                                                                                     924-7077
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Food Importer's Guide for Low-Acid Canned   1985                           Food Industry                         Industry Activities Staff (HFS-
 and Acidified Foods                                                                                                 565), Center for Food Safety and
                                                                                                                     Applied Nutrition, FDA, 200 C St.
                                                                                                                     SW., Washington, DC 20204, 202-205-
                                                                                                                     5251
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45496]]


Fabrication of Single Service Containers and   1995                            States                                Milk Safety Branch (HFS-626),
 Closures for Milk and Milk Products                                                                                 Center for Food Safety and Applied
                                                                                                                     Nutrition, 200 C St. SW.,
                                                                                                                     Washington, DC 20202, 202-205-9175
--------------------------------------------------------------------------------------------------------------------------------------------------------
Evaluation of Milk Laboratories                 1995                           States                               Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Methods of Making Sanitation Ratings Of Milk    1995                           States                               Do
 Supplies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dry Milk Ordinance                              1995                           States                               Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Procedures Governing the Cooperative State-    1995                           Dairy Industry                        Do
 Public Health Service/Food and Drug
 Administration Program for Certification of
 Interstate Milk Shippers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Frozen Dessert Processing Guidelines            1989                           Dairy Industry                       Office of Plant and Dairy Foods and
                                                                                                                     Beverages (HFS-302), Center for
                                                                                                                     Food Safety and Applied Nutrition,
                                                                                                                     200 C St. SW., Washington, DC
                                                                                                                     20204, 202-205-9175
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pasteurized Milk Ordinance                     1995                            States                               Milk Safety Branch (HFS-626), Center
                                                                                                                     for Food Safety and Applied
                                                                                                                     Nutrition 200 C St. SW.,
                                                                                                                     Washington, DC 20204, 202-205-9175
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Nutrition Labeling Manual: A Guide for     1993                           Food Industry                         Office of Nutritional Products,
 Developing and Using Databases                                                                                      Labeling, and Dietary Supplements,
                                                                                                                     Food and Drug Administration (HFS-
                                                                                                                     800), 200 C St. SW., Washington, DC
                                                                                                                     20204, 202-205-4561
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Determining Metric Equivalents  October 1, 1993                Food Industry                         Do
 of Household Measures
--------------------------------------------------------------------------------------------------------------------------------------------------------
List of Food Defect Action Levels (DALS)       1995                            Food and Animal Feed Industries       Industry Activities Staff (HFS-
                                                                                                                     565), Center for Food Safety and
                                                                                                                     Applied Nutrition, FDA, 200 C St.
                                                                                                                     SW., Washington, DC 20204, 202-205-
                                                                                                                     5251
--------------------------------------------------------------------------------------------------------------------------------------------------------
Action Levels for Poisonous or Deleterious      1995                           Food and Animal                      Do
 Substances in Human Food and Feed (Also
 Found in CPG's)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1997 FDA Food Code                              1997                          States                                National Technical Information
                                                                                                                     Service (NTIS), 5285 Port Royal
                                                                                                                     Rd., Springfield, VA 22161, 703-487-
                                                                                                                     4650
--------------------------------------------------------------------------------------------------------------------------------------------------------
Seafood List                                   1993                            Seafood Industry                     Superintendent of Documents,
                                                                                                                     Government Printing Office,
                                                                                                                     Washington, DC 20402, 202-512-1800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manual of Operations National Shellfish        1992                           States                                Office of Seafood, Office of Seafood
 Sanitation                                                                                                          (HFS-407), Shellfish Sanitation
                                                                                                                     Branch, 200 C St. SW., Washington,
                                                                                                                     DC 20204, 202-418-3150
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fish and Fisheries Products Hazards and        1996                           Seafood Industry                      Do
 Controls Guide
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45497]]


Guidance for Submitting Requests under 21 CFR  1996                           Food Packaging Industry,              Office of Premarket Approval, Food
 170.39, Threshold of Regulation for                                                                                 and Drug Administration (HFS-200),
 Substances Used in Food Articles                                                                                    200 C St. SW., Washington, DC
                                                                                                                     20204, 202-418-3100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for the Preparation of Petition      1996                           Food Ingredient or Packaging         Do
 Submissions                                                                   Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Approval of Color Additives in  1996                           Color or Contact Lens Industry        Do
 Contact Lenses Intended as Colors
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Recommendations for Submission of          February 1993                  Color Additives Industry              Do
 Chemical and Technological Data on Color
 Additives for Food, Drugs or Cosmetics Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for the Use of Recycled     December 1992                  Food Packaging Industry               Do
 Plastics in Food Packaging: Chemistry
 Considerations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for Submission of Chemical     May 1993                       Food Packaging Industry               Do
 and Technological Data for Direct Food
 Additive and GRAS Food Ingredient Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for Chemistry Data for          June 1995                      Food Packaging Industry              Do
 Indirect Food Additive Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Enzyme Preparations: Chemistry                 January 1993                    Food Enzyme Industry                 Do
 Recommendations for Food Additive and GRAS
 Affirmation Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimating Exposure to Direct Food Additive    September 1995                 Food and Food Ingredient Industry     Do
 and Chemical Contaminants in the Diet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Toxicological Principles for the Safety         1982                           Petitioners for Food or Color        Do
 Assessment of Direct Food Additives and                                       Additives
 Color Additives Used in Food (also known as
 Redbook I)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Environmental Assessment Technical Handbook     March 1987                     Petitioners for Food or Color         National Technical Inion Service
                                                                               Additives                             (NTIS), 5285 Port Royal Rd.,
                                                                                                                     Springfield, VA 22161, Pub. No.
                                                                                                                     PB87175345-AS, Ab-01
--------------------------------------------------------------------------------------------------------------------------------------------------------
Color Additive Petitions Information and       1996                            Petitioners for Color Additives       Office of Premarket Approval, Food
 Guidance                                                                                                            and Drug Administration (HFS-200),
                                                                                                                     200 C St. SW., Washington, DC
                                                                                                                     20204, 202-418-3100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Toxological Testing of Food Additives           1983                           Petitioners for Food or Color         Office of Premarket Approval, Food
                                                                               Additives                             and Drug Administration (HFS-200),
                                                                                                                     200 C St. SW., Washington, DC
                                                                                                                     20204, 202-418-3100
--------------------------------------------------------------------------------------------------------------------------------------------------------
List of Products for Each Product Category      October 8, 1992                Food Industry                         Office of Nutritional Products,
                                                                                                                     Labeling, and Dietary Supplements
                                                                                                                     (HFS-800), Food and Drug
                                                                                                                     Administration, 200 C St. SW.,
                                                                                                                     Washington, DC 20204, 202-205-4561
--------------------------------------------------------------------------------------------------------------------------------------------------------
Label Declaration of Allergenic Substances in  June 10, 1996                   Food Industry                        Do
 Foods; Notice to Manufacturers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Labeling of Foods that Need         February 24, 1997 (62 FR       Food Industry                        Do
 Refrigeration by Consumers                     8248)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45498]]


Guidelines Concerning Notification and          1985                           Infant Formula Manufacturers         Do
 Testing of Infant Formula
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Testing of Infant Formulas with        1988                           Infant Formula Manufacturers         Do
 Respect to Nutritional Suitability for Term
 Infants
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for the Evaluation of the Safety    1988                           Infant Formula Manufacturers          Do
 and Suitability of New Infant Formulas for
 Feeding Infants with Allergic Diseases
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for the Evaluation of the Safety     1990                           Infant Formula Manufacturers         Do
 and Suitability of Infant Formulas for
 Feeding Infants with Allergic Diseases
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for the Clinical Evaluation of New   1987                           Infant Formula Manufacturers         Do
 Products Used in the Dietary Management of
 Infants, Children and Pregnant Women with
 Metabolic Disorders
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Arsenic (Trace Elements   January 1993                   States                                Office of Seafood, Food and Drug
 in Seafood)                                                                                                         Administration (HFS-400), 200 C St.
                                                                                                                     SW., Washington, DC 20204, 202-418-
                                                                                                                     3150, Internet: FDA Home Page Http:/
                                                                                                                     /vm.cfsan.fda.gov/list.html
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Cadmium (Trace Elements  January 1993                    States                               Do
 in Seafood)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Chromium (Trace           January 1993                   States                               Do
 Elements in Seafood)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Lead (Trace Elements in   August 1993                    States                               Do
 Seafood)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Nickel (Trace Elements    January 1993                   States                               Do
 in Seafood)
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA's Policy for Foods Developed by             1995                           Food Industry                        Do
 Biotechnology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bovine Spongiform Encephalopathy (BSE) In       1997                           Food Industry                         Office of Plant and Dairy Foods and
 Products for Human Use                                                                                              Beverages (HFS-302), Center for
                                                                                                                     Food Safety and Applied Nutrition,
                                                                                                                     200 C St. SW., Washington, DC
                                                                                                                     20204, 202-205-9175, Internet: FDA
                                                                                                                     Home Page Http://www.fda.gov/opacom/
                                                                                                                     morechoices/industry/guidance/
                                                                                                                     gelguide.htm
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interim Guidance on the Voluntary Labeling of  February 1994                   Regulated Industry                   Office of Nutritional Products,
 Milk and Milk Products that have not been                                                                           Labeling, and Dietary Supplements
 treated with Recombinant Bovine Somatropin                                                                          (HFS-800), Food and Drug
                                                                                                                     Administration, 200 C St. SW.,
                                                                                                                     Washington, DC 20204, 202-205-4168
--------------------------------------------------------------------------------------------------------------------------------------------------------
Shellfish Sanitation Model Ordinance            1995                           States                               Shellfish Program Implementation
                                                                                                                     Branch, Division of Cooperative
                                                                                                                     Programs Office of Field Programs
                                                                                                                     (HFS-628), 200 C St. SW.,
                                                                                                                     Washington, DC 20204, 202-205-8137
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Minimize Microbial Hazards for Fresh   1998                          Farmers and Food Packers               Lou Carson, Food Safety Initiative
 Fruits and Vegetables                                                                                               (HFS-3), FDA-CFSAN, 200 C St. SW.,
                                                                                                                     Washington, DC 20204 or
                                                                                                                     jsaltsman@bangate.fda.gov
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45499]]


Iron-Containing Supplements and Drugs: Label    1997                          Dietary Supplement Manufacturers:     Office of Nutritional Products,
 Warning and Unit Dose Packaging; Small                                        Small Entities                        Labeling, and Dietary Supplements
 Entity Compliance Guide                                                                                             (HFS-450), FDA-CFSAN, 200 C. St.
                                                                                                                     SW., Washington, DC 20204
--------------------------------------------------------------------------------------------------------------------------------------------------------
Partial List of Enzyme Preparations That are    1998                          FDA Regulated Industry                Do
 Used in Foods
--------------------------------------------------------------------------------------------------------------------------------------------------------
Partial List of Microorganisms and Microbial-   1998                           FDA Regulated Industry               Office of Premarket Approval (HFS-
 Derived Ingredients That Are Used in Food                                                                           200), FDA-CFSAN, 200 C St. SW.,
                                                                                                                     Washington, DC 20204
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fish and Fishery Products Hazards and          January 1998                   FDA Regulated Industry                Office of Seafood (HFS-400), FDA-
 Controls Guide, 2nd Edition                                                                                         CFSAN, 200 C St. SW., Washington DC
                                                                                                                     20204
--------------------------------------------------------------------------------------------------------------------------------------------------------
HACCP Regulations for Fish and Fishery         1998                           FDA Regulated Industry                Do
 Products: Questions and Answers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of a Health Claim or Nutrient      1998                          FDA Regulated Industry                Office of Nutritional Products,
 Content Claim Based on an Authoritative                                                                             Labeling, and Dietary Supplements
 Statement of a Scientific Body                                                                                      (HFS-150), 200 C St. SW.,
                                                                                                                     Washington, DC 20204
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small Business Juice Labeling: Questions and    1998                          Small Business                        Office of Nutritional Products,
 Answers                                                                                                             Labeling, and Dietary Supplements
                                                                                                                     (HFS-150), 200 C St. SW.,
                                                                                                                     Washington, DC 20204, Geraldine
                                                                                                                     June, 202-205-5099
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Nutrition Labeling Manual, A Guide for     March 1998                     FDA Regulated Industry                Office of Nutritional Products,
 Developing and Using Data Bases                                                                                     Labeling, and Dietary Supplements
                                                                                                                     (HFS-150), 200 C St. SW.,
                                                                                                                     Washington, DC 20204
--------------------------------------------------------------------------------------------------------------------------------------------------------
HACCP Regulation for Fish and Fishery          January 1999                   Seafood Processors                    Office of Seafood, CFSAN/FDA (HFS-
 Products: Questions and Answers, Issue                                                                              400), 200 C St. SW., Washington, DC
 Three, Revised January 1999                                                                                         20204, Ellen Nesheim, 202-418-3150
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foods--Adulteration Involving Hard or Sharp    February 1999                  FDA Field Offices                     Office of Plant and Dairy Foods and
 Foreign Objects (CPG)                                                                                               Beverages (HFS-300), 200 C. St.
                                                                                                                     SW., Washington, DC 20204
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Additive Petition Expedited Review        January 1999                   Guidance for Industry and Center for  Robert L. Martin (HFS-215), OPA/
                                                                               Food Safety and Applied Nutrition     CFSAN/FDA, 200 C St. SW.,
                                                                               Staff                                 Washington, DC 20204, 202-418-3074,
                                                                                                                     premarkt@cfsan.fda.gov OR http://
vm.cfsan.fda.gov/>dms/
                                                                                                                     opa-expe.html
--------------------------------------------------------------------------------------------------------------------------------------------------------
Use of Antibiotic Resistance Marker Genes in   September 1998                 Guidance for Industry                 Nega Beru (HFS-206), OPA/CFSAN/FDA,
 Transgenic Plants                                                                                                   200 C. St. SW., Washington, DC
                                                                                                                     20204, 202-418-3097,
                                                                                                                     premarkt@cfsan.fda.gov OR http://
vm.cfsan.fda.gov//dms/ opa-
                                                                                                                     armg.html
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance: Channels of Trade Policy for    June 2000                      Regulated Industry                    Office of Plant and Dairy Foods and
 Commodities with Methyl Parathion Residues                                                                          Beverages, Center for Food Safety
                                                                                                                     and Applied Nutrition (HFS-300),
                                                                                                                     FDA, 200 C St. SW., Washington, DC
                                                                                                                     20204, http://vm.cfsan.fda.gov/dms
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45500]]


Draft Guidance: Fumonisin Levels in Human       June 2000                      Regulated Industry                   Do
 Foods and Animal Feeds
--------------------------------------------------------------------------------------------------------------------------------------------------------
Statement of Identity, Nutrition Labeling,      January 1999                   Small Business Entities              Industry Activities Staff (HFS-565),
 and Ingredient Labeling of Dietary                                                                                  Center for Food Safety and Applied
 Supplements Small Entity Compliance Guide                                                                           Nutrition, FDA, 200 C St. SW.,
                                                                                                                     Washington, DC 20204, 202-205-5251
--------------------------------------------------------------------------------------------------------------------------------------------------------
Significant Scientific Agreement in the         December 1999                  Regulated Industry,                  Office of Nutritional Products,
 Review of Health Claims for Conventional                                                                            Labeling, and Dietary Supplements,
 Foods and Dietary Supplements (December                                                                             Center For Food Safety and Applied
 1999)                                                                                                               Nutrition, FDA, 200 C St. SW.,
                                                                                                                     Washington, DC 20204, 202-205-4561
--------------------------------------------------------------------------------------------------------------------------------------------------------
Antimicrobial Food Additives                    July 1999                      Regulated Industry                    Office of Premarket Approval (HFS-
                                                                                                                     200), Center for Food Safety and
                                                                                                                     Applied Nutrition, FDA, 200 C St.
                                                                                                                     SW., Washington, DC 20204, 202-418-
                                                                                                                     3100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparation of Premarket Notifications for      November 1999                  Regulated Industry                   Do
 Food Contact Substances: Chemistry
 Recommendations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparation of Premarket Notifications for      November 1999                  Regulated Industry                   Do
 Food Contact Substances: Toxicology
 Recommendations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Small Businesses: Submission of   October 1999                    Small Business Entities              Division of Market Studies (HFS-
 Comments for CFSAN Rulemaking                                                                                       726), Center for Food Safety and
                                                                                                                     Applied Nutrition, Food and Drug
                                                                                                                     Administration, Washington, DC
                                                                                                                     20204, 202-401-4590
--------------------------------------------------------------------------------------------------------------------------------------------------------
Warning and Notice Statement: Labeling of      September 1998                  Regulated Industry                   Office of Nutritional Products,
 Juice Products Small Entity Compliance Guide                                                                        Labeling, and Dietary Supplements,
                                                                                                                     Center For Food Safety and Applied
                                                                                                                     Nutrition, FDA, 200 C St. SW.,
                                                                                                                     Washington, DC 20204, 202-205-4561
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reducing Microbial Food Safety Hazards for     October 1999                   Regulated Industry                    Office of Plant and Dairy Foods and
 Sprouted Seeds                                                                                                      Beverages, Center for Food Safety
                                                                                                                     and Applied Nutrition, FDA, 200 C
                                                                                                                     St. SW., Washington, DC 20204, 202-
                                                                                                                     205-4064
--------------------------------------------------------------------------------------------------------------------------------------------------------
Seafood HACCP Transition Policy                December 1999                  Regulated Industry                     Office of Seafood (HFS-400), 200 C
                                                                                                                     St. SW., Washington DC 20204, 202-
                                                                                                                     205-3150
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Grouped by Intended User or         How to Obtain a Hard Copy of the Document (Name and
                      Name of Document                                Date of Issuance                   Regulatory Activity                   Address, Phone, FAX, E-mail or Internet)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 3--General Principles for Evaluating the Safety    July 1994                           Animal Drug Industry                Internet via: http://www.fda.gov/cvm or Communications
 of Compounds Used in Food-Producing Animals                                                                                          Staff (HFV-12), FDA/CVM, 7500 Standish Pl., Rockville, MD
                                                                                                                                      20855, 301-594-1755, FAX 301-594-1831
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 4--Guidelines for Efficacy Studies for Systemic                                        Do                                  Do
 Sustained Release Sulfonamide Boluses for Cattle
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45501]]


Guideline 5--Stability Guidelines                            December 1990                       Do                                  Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 6--Guidelines for Submitting NADA's for Generic                                        Do                                  Do
 Drugs Reviewed by NAS/NRC
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 9--Preclearance Guidelines for Production Drugs    October 1975                        Do                                  Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 10--Amendment of Section II (G)(1)(b)(4) of the    October 1975                        Do                                  Do
 Preclearance Guidelines
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 13--Guidelines for Evaluation of Effectiveness of  January 1985                        Do                                  Do
 New Animal Drugs for Use in Free-Choice Feeds
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 14--Guideline and Format for Reporting the                                             Do                                  Do
 Details of Clinical Trials Using An Investigational New
 Animal Drug in FOOD Producing Animals
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 15--Guideline and Format for Reporting the         February 1977                       Do                                  Do
 Details of Clinical Trials Using An Investigational New
 Animal Drug in Non-Food Producing Animals
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 16--FOI Summary Guideline                          May 1985                            Do                                  Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 18--Antibacterial Drugs in Animal Feeds: Human                                         Do                                  Do
 Health Safety Criteria
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 19--Antibacterial Drugs in Animal Feeds: Animal                                        Do                                  Do
 Health Safety Criteria
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 20--Antibacterial Drugs in Animal Feeds:                                               Do                                  Do
 Antibacterial Effectiveness Criteria
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 22--Guideline Labeling of Arecoline Base Drugs                                         Do                                  Do
 Intended for Animal Use
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 23--Medicated Free Choice Feeds--Manufacturing     July 1985                           Do                                  Do
 Control
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 24--Guidelines for Drug Combinations for Use in    October 1983                        Do                                  Do
 Animals
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 25--Guidelines for the Efficacy Evaluation of      January 1979                        Do                                  Do
 Equine Anthelmintics
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 29--Guidelines for the Effectiveness Evaluation    September 1980                      Do                                  Do
 of Swine Anthelmintics
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 31-- Guidelines for the Evaluation of Bovine       July 1981                           Do                                  Do
 Anthelmintics
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 33--Target Animal Safety Guidelines for New        June 1989                           Do                                  Do
 Animal Drugs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 35--Bioequivalence Guideline--Final                1996                                Do                                  Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 36--Guidelines for Efficacy Evaluation of Canine/  July 1985                           Do                                  Do
 Feline Anthelmintics
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 37--Guidelines for Evaluation of Effectiveness of  March 1984                          Do                                  Do
 New Animal Drugs for Use in Poultry Feed for Pigmentation
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 38--Guideline for Effectiveness Evaluation of      August 1984                         Do                                  Do
 Topical/Otic Animal Drugs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 40--Draft Guideline for the Evaluation of the      April 1992                          Do                                  Do
 Efficacy of Anticoccidial Drugs and Anticoccidial Drug
 Combinations in Poultry
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45502]]


Guideline 41--Draft Guideline: Formatting, Assembling, and   June 1992                           Do                                  Do
 Submitting New Animal Drug Applications
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 42--Animal Drug Manufacturing Guidelines, 1994     1994                                Do                                  Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 43--Guidance on Generic Animal Drug Products       October 1995                        Do                                  Do
 Containing Fermentation-Derived Drug Substances
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 45--Guideline for Uniform Labeling of Drugs for    August 1993                         Do                                  Do
 Dairy and Beef Cattle
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 48--Guidance for Industry for the Submission of    November 1994                       Do                                  Do
 Documentation for Sterilization Process Validation in
 Applications for Human and Veterinary Drug Products
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 49--Guidance Document for Target Animal Safety     April 1996                          Do                                  Do
 and Drug Effectiveness Studies for Anti-Microbial Bovine
 Mastitis Products
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 50--Draft Guideline for Target Animal and Human    February 1993                       Do                                  Do
 Food Safety, Drug Efficacy, Environmental and
 Manufacturing Studies for Teat Antiseptic Products
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 52--Guidance--Microbiological Testing of           January 1996                        Do                                  Do
 Antimicrobial Drug Residues in Food
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 53--Guideline for the Evaluation of the Utility    May 1994                            Do                                  Do
 of Food Additives in Diets Fed to Aquatic Animals
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 54--Draft Guideline for Utility Studies for Anti-  June 1994                           Do                                  Do
 Salmonella Chemical Food Additives in Animal Feeds
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 55--Supportive Data for Cat Food Labels Bearing    June 1994                           Do                                  Do
 ``Reduces Urinary pH Claims: Guideline in Protocol
 Development''
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 56--Protocol Development Guideline for Clinical    November 1994                       Do                                  Do
 Effectiveness and Target Animal Safety Trials
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 57--Master Files--Guidance for Industry for the    July 1995                           Do                                  Do
 Preparation and Submission of Veterinary Master Files
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 58--Guidance for Industry for Good Target Animal   May 1997                            Do                                  Do
 Study Practices: Clinical Investigators and Monitors
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 59--Guidance for Industry: Submitting a Notice of  January 1999                        Do                                  Do
 Claimed Investigational Exemption in Electronic Format to
 CVM via E-Mail
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance 61--Guidance for Industry--FDA Approval of Animal   January 1999                        Do                                  Do
 Drugs for Minor Uses and for Minor Species
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 62--Guidance for Industry--Consumer-Directed       August 1997                         Do                                  Do
 Broadcast Advertisements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 63--Guidance for Industry--Validation of           December 1997                       Do                                  Do
 Analytical Procedures: Definition and Terminology--Draft
 Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45503]]


Guideline 64--Guidance for Industry--Validation of           December 1997                       Do                                  Do
 Analytical Procedures: Methodology--Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 65--Guidance for Industry--Industry-Supported      November 1997                       Do                                  Do
 Scientific and Educational Activities
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 66--Guidance for Industry-- Professional Flexible  January 1998                        Do                                  Do
 Labeling of Antimicrobial Drugs--Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 67--Guidance for Industry--Small Entities          February 1998                       Do                                  Do
 Compliance Guide for Renderers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 68--Guidance for Industry--Small Entities          February 1998                       Do                                  Do
 Compliance Guide for Protein Blenders, Feed Manufacturers,
 and Distributors
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 69--Guidance for Industry--Small Entities          February 1998                       Do                                  Do
 Compliance Guide for Feeders of Ruminant Animals With On-
 Farm Feed Mixing Operations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 70--Guidance for Industry--Small Entities          February 1998                       Do                                  Do
 Compliance Guide for Feeders of Ruminant Animals Without
 On-Farm Feed Mixing Operations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 71--Guidance for Industry--Use of Human Chorionic  April 1998                          Do                                  Do
 Gonadotropic (HCG) as a Spawning Aid for Fish
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 72--Guidance for Industry--GMP's for Medicated     May 1998                            Do                                  Do
 Feed Manufacturers Not Required to Register and Be
 Licensed With FDA
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 73--Draft Guidance for Industry--Stability         July 1998                           Do                                  Do
 Testing of New Animal Drug Substances and Products
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 74--Draft Guidance for Industry--Stability         July 1998                           Do                                  Do
 Testing for New Dosage Forms of New Animal Drugs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 75--Guidance for Industry--Stability Testing:      July 1998                           Do                                  Do
 Photostability Testing of New Animal Drug Substances and
 Products: Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 76--Guidance for Industry--Questions and Answers-- September 1998                      Do                                  Do
 BSE Feed Regulation
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 77--Guidance for Industry--Interpretation of On-   September 1998                      Do                                  Do
 Farm Feed Manufacturing and Mixing Operations--Draft
 Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline 78--Guidance for Industry--Evaluation of the       December 1999                       Do                                  Do
 Human Health Impact of the Microbial Effects of
 Antimicrobial New Animal Drugs Intended for Use in Food-
 Producing Animals
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Chemistry, Manufacturing and          June 1999                           Do                                  Do
 Controls Changes to an Approved NADA or ANADA: Draft
 Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Good Clinical Practices         July 1999                           Do                                  Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45504]]


Guidance for Industry: Efficacy of Anthelmintics: General    July 1999                           Do                                  Do
 Recommendations: Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Stability Testing for Medicated       July 1999                           Do                                  Do
 Premixes Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Impurities in New Veterinary Drug     July 1999                           Do                                  Do
 Substances Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Impurities in New Veterinary Medical  July 1999                           Do                                  Do
 Products Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Efficacy of Anthelmintics: Specific   July 1999                           Do                                  Do
 Recommendations for Bovines: Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Efficacy of Anthelmintics: Specific   July 1999                           Do                                  Do
 Recommendations for Ovines: Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Validation of Analytical Procedures:  July 1999                           Do                                  Do
 Definition and Terminology
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Validation of Analytical Procedures:  July 1999                           Do                                  Do
 Methodology: Final Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Efficacy of Anthelmintics: Specific   July 1999                           Do                                  Do
 Recommendations for Caprines: Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Manufacture and Distribution of       August 1999                         Do                                  Do
 Unapproved Piperazine Products
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Possible Dioxin/PCB Contamination of  August 1999                         Do                                  Do
 Drug and Biological Products
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Consumer-Directed Broadcast           August 1999                         Do                                  Do
 Advertisements: Final Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Stability Testing of New Veterinary   September 1999                      Do                                  Do
 Dosage Forms VICH GL4: Final Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Stability Testing of New Veterinary   September 1999                      Do                                  Do
 Drug Substances and Medicinal Products VICH GL3: Final
 Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Environmental Impact Assessments      September 1999                      Do                                  Do
 (EIA's) for Veterinary Medicinal Products (VMP's)--Phase
 I: Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Quality of Biotechnological Products  September 1999                      Do                                  Do
 in the Veterinary Field: Stability Testing of
 Biotechnological/Biological Products VICH GL 17: Draft
 Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Impurities: Residual Solvents VICH    September 1999                      Do                                  Do
 GL 18: Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Content and Format of Effectiveness   September 1999                      Do                                  Do
 and Target Animal Safety Technical Sections and Final
 Study Reports for Submission to the Division of
 Therapeutic Drugs for Non-Food Animals
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Stability Testing: Photostability     September 1999                      Do                                  Do
 Testing of New Veterinary Drug Substances and Medicinal
 Products: Final Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45505]]


Computerized Systems Used in Clinical Trials                 October 1999                        Do                                  Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Dioxin in Anti-Caking Agents Used in Animal Feed and Feed    October 1999                        Do                                  Do
 Ingredients
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Evaluation of the Human Health        December 1999                       Do                                  Do
 Impact of the Microbial Effects of Antimicrobial New
 Animal Drugs Intended for Use in Food-Producing Animals
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Development of Supplemental           January 2000                        Do                                  Do
 Applications for Approved New Animal Drugs--Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Stability Testing for Medicated       March 2000                          Do                                  Do
 Premixes Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: The Use of Published Literature in    April 11, 2000                      Do                                  Do
 Support of New Animal Drug Approval--Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Dioxin In Anti-Caking Agents Used In  Revised April 12, 2000              Do                                  Do
 Animal Feed And Feed Ingredients
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Fumonisin Levels in Human Foods and   June 6, 2000                        Do                                  Do
 Animal Feeds--Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

VII. Guidance Documents Issued by the Office of Policy (OP)

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                       How To Obtain A Hard Copy of The
                   Name of Document                          Date of Issuance          Grouped by Intended User or    Document (Name and Address, Phone,
                                                                                           Regulatory Activity            FAX, E-mail, or Internet)
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA's Development, Issuance, and Use of Guidance       February 27, 1997             FDA Personnel and Regulated     Internet via www.fda.gov/opacom/
 Documents                                                                            Industry                        morechoices/moreindu.html or
                                                                                                                      Office of Policy (301-827-3360)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry; Exports and Imports       June 12, 1998                 Regulated Industry              Internet via www.fda.gov/opacom/
 under the FDA Export Reform and Enhancement Act of                                                                   fedregister/frexport.html
 1996
--------------------------------------------------------------------------------------------------------------------------------------------------------
Direct Final Rule Guidance                             November 21, 1997             FDA Personnel                   Internet via www.fda.gov/opacom/
                                                                                                                      morechoices/industry/guidedc.htm
                                                                                                                      or Carol Kimbrough (301-827-3480)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Industry Supported Scientific and Educational          December 3, 1997              Regulated Industry              Internet via www.fda.gov/cder/
 Activities                                                                                                           guidance/index.htm or Office of
                                                                                                                      Policy (301-827-3360)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance of Broadcast Advertisements             February 1997                 Do                              Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small Entities Compliance Guide On: Regulations to      February 1997                Do                              Internet via www.fda.gov/opacom/
 Restrict the Sale and Distribution of Cigarettes and                                                                 campaigns/tobacco/tobret.htm or 1-
 Smokeless Tobacco in Order to Protect Children and                                                                   888-FDA-4KIDS
 Adolescents (21 CFR Part 897)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children & Tobacco--Frequently Asked Questions about   July 1997                     Do                              Do
 the new regulations (DRAFT)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children & Tobacco--A Retailer's Guide to the New      October 1997                  Do                              Do
 Federal Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children & Tobacco--A Guide to the New Federal         October 1997                  Do                              Do
 Regulations
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45506]]


FDA's Standards Policy                                 October 1995                  FDA Personnel and Regulated     60 FR 53078, October 11, 1995 or
                                                                                      Industry                        Office of Policy (301-827-3360)
--------------------------------------------------------------------------------------------------------------------------------------------------------

VIII. Guidance Documents Issued by the Office of Regulatory Affairs 
(ORA)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              Grouped by Intended User or         How To Obtain A Hard Copy of The Document (Name and Address,
                     Name of Document                             Date of Issuance                Regulatory  Activity                          Phone, FAX, E-mail, or Internet)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guides Manual                             August 1996                   FDA Staff Personnel                  National Technical Information Service (NTIS), 5285 Port Royal
                                                                                                                                Rd., Springfield, VA 22161 (Order No. PB96-915499) or via
                                                                                                                                Internet www.fda.gov/ora/compliance__ref/cpg/cpgtc.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide-DRAFT Commercialization of In       January 5, 1998               Do                                   Do--Internet at www.fda.gov/cdrh/comp/ivddrfg.html
 Vitro Diagnostic Devices (IVD's) Labeled for Research Use
 Only or Investigational Use Only
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide 675.400 (CPG 7126.24) REVISION      November 13, 1998             Do                                   Do--Internet at www.fda.gov/ora/compliance__ref/cpg/cpgvet/
 Rendered Animal Feed Ingredients                                                                                               cpg675.400.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide DRAFT Distributor Medical Device    August 28, 1997               FDA Staff Personnel and Regulated    Do--Internet at www.fda.gov/ora/compliance__ref/cpg__mdr3.txt
 Reporting                                                                                 Industry
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Chapter 5, Sec. 555.425, NEW:      March 23, 1999                FDA Staff Personnel                  Do--Internet at http://www.fda.gov/ora/compliance__ref/cpg/cpgfod/
Foods Adulteration Involving Hard or Sharp Foreign                                                                             cpg555-425.htm
 Objects
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Chapter 1, Sec.160.800, NEW:Year   April 26, 1999                Do                                   Do--Internet at http://www.fda.gov/ora/compliance__ref/cpg/
2000 (Y2K) Computer Compliance                                                                                                 cpggenl/cpt160.800.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Chapter 1, Sec. 140.100, REVISION/ April 26, 1999                Do                                   Do--Internet at http://www.fda.gov/ora/compliance__ref/cpg/cpgfod/
DRAFT: Regulatory Policy on the Disposition of                                                                                 draftrev-cpg715313.htm
 Publications That Constitute Labeling (CPG 7153.13)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Chapter 1, Sec. 160.850: NEW,      May 13, 1999                  Do                                   Do--Internet at htpp://www.fda.gov/ora/compliance__ref/cpg/
 Enforcement Policy: 21 CFR Part 11; Electronic Records;                                                                        cpggenl/cpg160-180.htm
 Electronic Signatures (CPG 7153.17)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Chapter 2, Sec. 230.140, NEW,      July 9, 1999                  Do                                   Do--Internet at http://www.fda.gov/ora/compliance__ref/
Evaluation and Processing of Post Donation Information                                                                         default.htm
 Reports
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Chapter 2, Sec. 252.110, NEW:      March 6, 2000                 Do                                   Do--Internet at http://www.fda.gov/ora/compliance__ref/cpgbio/
Volume Limits for Automated Collection of Source Plasma                                                                        cpg252.110.htm
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Chapter 2, Sec. 257.100, REVISED:  March 22, 2000                Do                                   Do--Internet at http://www.fda.gov/ora/cmpliance__ref/cpg/cpgbio/
Deferral of Source Plasma Donors Due to Red Cell Loss                                                                          cpg257.100.htm
 During Collection of Source Plasma by Automated
 Plasmapheresis
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Chapter 1, Sec. 110.100: REVISED:  April 14, 2000                Do                                   Do--Internet at http://www.fda.gov/ora/compliance__ref/cpg/
Certificates for Export                                                                                                        cpggenl/cpg110-100.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Warning Letter Pilot                         March 8, 1999                 FDA Staff Personnel and Regulated    Do--Internet at http://www.fda.gov/ohrms/Dockets/98fr/030899e.pdf
                                                                                           Industry
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45507]]


Draft Guidance Policy Statement: Draft Civil Money Penalty  May 18, 1999                  Do                                   Do--Internet at http://www.fda.gov/ohrms/Dockets/98fr/051899.txt
 Reduction Policy for Small Entities
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Glossary of Computerized System and Software Development    August 1995                   Do                                   National Technical Information Service (NTIS), 5285 Port Royal
 Terminology                                                                                                                    Rd., Springfield, VA 22161 (Order No. PB96-127352) or via
                                                                                                                                Internet www.fda.gov/ora/inspect__ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Entry Review of Radiation-Emitting           March 12, 1999                FDA Staff Personnel                  Division of Import Operations and Policy (HFC-170), Office of
 Electronic Devices                                                                                                             Regional Operations, Food and Drug Administration, 5600 Fishers
                                                                                                                                Lane, Rockville, MD 20857, 301-594-1218
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Import Alerts                                               Continuous                    Do                                   FDA/Freedom of Information Staff (HFI-35), 5600 Fishers Lane,
                                                                                                                                Rockville, MD 20857 or via Internetwww.fda.gov/ora/fiars/
                                                                                                                                ora__import__alerts.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Investigations Operations Manual                            March 2000                    Do                                   Division of Emergency and Investigational Operations (HFC-130),
                                                                                                                                Office of Regional Operations, Food and Drug Administration,
                                                                                                                                5600 Fishers Lane, Rockville, MD 20857 301-443-3276 2000 Edition
                                                                                                                                is not yet available on Internet. 1999 Edition is available on
                                                                                                                                Internet at http:// www.fda.gov/ora/inspect__ref/iom/iomtc.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Investigations Operations Manual, REVISION: Chapter 4,      July 1998                     Do                                   Do
 Sampling
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Investigations Operations Manual, REVISION: Chapter 5,      July 1998                     Do                                   Do
 Establishment Inspections
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Memorandum: ORA Investigational Strategy on Gamma-          May 15, 2000                  Do                                   Do--Not available on Internet
 Butyrolactone (GBL) and Related Products
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Laboratory Procedures Manual                                June 1994                     Do                                   Division of Field Science (HFC-141), Food and Drug
                                                                                                                                Administration, 5600 Fishers Lane, rm. 12-41, Rockville, MD
                                                                                                                                20857, ATTN: Donna Porter or via Internet www.fda.gov/ora/
                                                                                                                                science__ref/lpm/lpmtc.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Laboratory Procedures Manual, Chapter X, NEW: Method        May 1999                      Do                                   Do--Not available on Internet
 Validation Samples
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual                                August 1997                   Do                                   National Technical Information Service (NTIS), 5285 Port Royal
                                                                                                                                Rd., Springfield, VA 22161 (Order No. PB97-196182) or via
                                                                                                                                Internet www.fda.gov/ora/compliance__ref/rpm/rpmtc.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: UPDATE/New Subchapter/        March 1998                    Do                                   Division of Compliance Policy (HFC-230), Office of Enforcement,
 Application Integrity Policy                                                                                                   Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
                                                                                                                                20857, 301-827-0420 or via Internet www.fda.gov/ora/
                                                                                                                                compliance__ref/rpm/rpmtc.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: UPDATE Subchapter/Warning     March 1998                    Do                                   Do
 Letters
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: UPDATE/REVISION Subchapter/   April 1998                    Do                                   Do
 Import Procedures
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual; UPDATE/REVISION Subchapter/   April 1998                    Do                                   Do
 Priority Enforcement Strategy for Problem Importers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45508]]


Regulatory Procedures Manual: UPDATE/REVISION Subchapter/   April 1998                    Do                                   Do
 Import Procedures
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: UPDATE/REVISION Subchapter/   April 1998                    Do                                   Do
 Notice of Sampling
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: UPDATE/NEW Subchapter/        May 1998                      Do                                   Do
 Granting and Denying Transportation and Exportation (T&E)
 Entries
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: UPDATE/REVISION Subchapter/   June 1998                     Do                                   Do--Internet at www.fda.gov/ora/compliance__ref/rpm__new2/
 Seizure                                                                                                                        ch6.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: UPDATE/REVISION Subchapter/   June 1998                     Do                                   Do--Internet at www.fda.gov/ora/compliance__ref/rpm__new2/
 Supervisory Charges                                                                                                            ch9chgs.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: NEW Subchapter/Civil          July 1998                     Do                                   Do--Internet at www.fda.gov/ora/compliance__ref/ch6civpen.html
 Penalties--Electronic Product Radiation Control
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual, UPDATE/REVISION: Chapter 4,   March 21, 2000                Do                                   Do Internet at http://www.fda.gov/ora/compliance__ref/rpm__new2/
Subchapter/Warning Letters                                                                                                     ch4.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Bulk Pharmaceutical Chemicals       May 1994                      Do                                   National Technical Information Service (NTIS), 5285 Port Royal
                                                                                                                                Rd., Springfield, VA 22161 (Order No. PB96-127154) or via
                                                                                                                                Internet www.fda.gov/ora/inspect__ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Pharmaceutical Quality Control      July 1993                     Do                                   Do--(NTIS Order No. PB96-127279)
 Laboratories
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Microbiological Pharmaceutical      July 1993                     Do                                   Do--(NTIS Order No. PB96-127287)
 Quality Control Laboratories
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Validation of Cleaning Processes    July 1993                     Do                                   Do--(NTIS Order No. PB96-127246)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Lyophilization of Parenterals       July 1993                     Do                                   Do--(NTIS Order No. PB96-127253)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of High Purity Water Systems           July 1993                     Do                                   Do--(NTIS Order No. PB96-127261)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Dosage Form Drug Manufacturers-     October 1993                  Do                                   Do--(NTIS Order No. PB96-127212)
 CGMPs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Oral Solid Dosage Forms Pre/Post    January 1994                  Do                                   Do--(NTIS Order No. PB96-127345)
 Approval Issues for Development and Validation
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Topical Drug Products               July 1994                     Do                                   Do--(NTIS Order No. PB96-127394)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Sterile Drug Substance              July 1994                     Do                                   Do--(NTIS Order No. PB96-127295)
 Manufacturers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Oral Solutions and Suspensions      August 1994                   Do                                   Do--(NTIS Order No. PB96-127147)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Nutritional Labeling and Education  February 1995                 Do                                   Do--(NTIS Order No. PB96-127378)
 Act (NLEA) Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Interstate Carriers and Support     April 1995                    Do                                   Do--(NTIS Order No. PB96-127386)
 Facilities
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45509]]


Guide to Inspections of Dairy Product Manufacturers         April 1995                    Do                                   Do--(NTIS Order No. PB96-127329)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Miscellaneous Foods Vol. I          May 1995                      Do                                   Do--(NTIS Order No. PB96-127220)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Miscellaneous Foods Vol. II         September 1996                Do                                   Do--(NTIS Order No. PB97-196133)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Low Acid Canned Foods               November 1996                 Do                                   Do--(NTIS Order No. PB97-196141)
 Manufacturers, Part 1-Administrative Procedures/Scheduled
 Processes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Low Acid Canned Foods               April 1997                    Do                                   Do--(NTIS Order No. PB97-196158)
 Manufacturers, Part 2- Processes/Procedures
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Cosmetic Product Manufacturers      February 1995                 Do                                   Do--(NTIS Order No. PB96-127238)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Blood Banks                         September 1994                Do                                   Do--(NTIS Order No. PB96-127303)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Source Plasma Establishments        December 1994                 Do                                   Do--(NTIS Order No. PB96-127360)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Infectious Disease Marker Testing   June 1996                     Do                                   Do--(NTIS Order No. PB96-199476)
 Facilities
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Biotechnology Inspections Guide                             November 1991                 Do                                   Do--(NTIS Order No. PB96-127402)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Computerized Systems in Drug        February 1983                 Do                                   Do--(NTIS Order No. PB96-127337)
 Processing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Foreign Medical Device              September 1995                Do                                   Do--(NTIS Order No. PB96-127311)
 Manufacturers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Foreign Pharmaceutical              May 1996                      Do                                   Do--(NTIS Order No. PB96-199468)
 Manufacturers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Mammography Quality Standards Act (MQSA) Auditors Guide     January 1998                  Do                                   Do--(NTIS Order No. PB98-127178)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Electromagnetic Compatibility       December 1997                 Do                                   Do--(NTIS Order No. PB98-127152)
 Aspects of Medical Device Quality Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Grain Product Manufacturers         March 1998                    Do                                   Division of Emergency and Investigational Operations (HFC-130),
                                                                                                                                Office of Regional Operations, Food and Drug Administration,
                                                                                                                                5600 Fishers Lane, Rockville, MD 20857 301-443-3276
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Bioresearch Monitoring Inspections of In Vitro     February 1998                 Do                                   Do
 Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Viral Clearance Processes for       March 1998                    Do                                   Do
 Plasma Derivatives
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Traceback of Fresh Fruits and Vegetables           August 1998                   Do                                   Do
 Implicated in Epidemiological Investigations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Computerized Systems in the Food    August 1998                   Do                                   Do--Internet at www.fda.gov/ora/inspect__ref/igf/iglist.html
 Processing Industry
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to International Inspections and Travel, REVISION     July 1999                     Do                                   Do Revision not available on Internet
 (Formerly: FDA/ORA International Inspection Manual and
 Travel Guide)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Quality Systems                     August 1999                   Do                                   Do--Internet at http://www.fda.gov/ora/inspect__ref/igs/qsit/
QSITGUIDE.PDF
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45510]]


Guideline for the Monitoring of Clinical Investigators      January 1988                  FDA Regulated Industry               Division of Compliance Policy (HFC-230), Office of Enforcement,
                                                                                                                                Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
                                                                                                                                20857, 301-827-0420
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Computerized Systems Used in Clinical Trials                April 1999                    Do                                   Do--Internet at http://www.fda.gov/ora/compliance__ref/bimo/
ffinalcct.htm
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Institutional Review Boards, Clinical    March 30, 2000                Do                                   Do--Internet at http;//www.fda.gov/ora/compliance__ref/bimo__err-
 Investigators, and Sponsors: Exception from Informed                                                                           guide.htm
 Consent Requirements for Emergency Research
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Compliance Program 7348.808: Bioresearch Monitoring; Good   Revised August 17, 1998       FDA Staff Personnel                  Do--Internet http://www.fda.gov/ora/compliance__ref/bimo/
Laboratory Practices (Nonclinical)                                                                                             default.html
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Compliance Program 7348.810: Sponsors, Contract Research    Revised October 30, 1998      Do                                   Do
 Organizations and Monitors
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Compliance Program 7348.811: Bioresearch Monitoring;        Revised September 2, 1998     Do                                   Do
 Clinical Investigations
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Food Laboratory Practice Program (Nonclinical               October 1, 1991               Do                                   Division of Compliance Policy (HFC-230), Office of Enforcement,
 Laboratories) 7348.808A; EPA Data Audit Inspections                                                                            Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
                                                                                                                                20857, 301-827-0420
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Compliance Program 7348.809; Bioresearch Monitoring;        August 18, 1994               Do                                   Do
 Institutional Review Board
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Good Laboratory Practice Regulations Management Briefings   August 1979                   Do                                   Do--Internet at www.fda.gov/ora/compliance__ref/bimo/default.html
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    Dated: July 14, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-18497 Filed 7-20-00; 8:45 am]
BILLING CODE 4160-01-F