[Federal Register Volume 66, Number 206 (Wednesday, October 24, 2001)]
[Notices]
[Pages 53836-53927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26650]



[[Page 53835]]

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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

  Federal Register / Vol. 66, No. 206 / Wednesday, October 24, 2001 / 
Notices  

[[Page 53836]]


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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 its 
annual comprehensive list of all guidance documents currently in use at 
the agency. This list is being published under 21 CFR 10.115(n)(2) of 
FDA's regulation on Good Guidance Practices (GGPs). This list is 
intended to inform the public of the existence and availability of all 
of our current guidance documents. It also provides information on 
guidance documents that have been added or withdrawn in the past year.

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. Submit electronic comments to http://www.fda.gov.dockets/ecomments. We have provided information in the 
tables below on where to obtain a single copy of any of the guidance 
documents listed.

FOR FURTHER INFORMATION CONTACT: Carol A. Kimbrough, Office of Policy, 
Planning, and Legislation (HF-26), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3480.

SUPPLEMENTARY INFORMATION:

I. Background

    We published our final rule on GGPs in the Federal Register of 
September 19, 2000 (65 FR 56468), and they became effective October 19, 
2000. GGPs are intended to ensure involvement of the public in the 
development of guidance documents, and to enhance understanding of the 
availability, nature, and legal effect of such guidance. We committed 
in the GGPs to publishing annually a comprehensive list of guidance 
documents. This list updates a comprehensive list published July 21, 
2000 (65 FR 45428).
    The following comprehensive list identifies all final guidances 
that have been issued and are in use, and all draft guidances that have 
been distributed for comment and not for implementation. Any guidances 
that have been withdrawn this year are also listed. We have organized 
the documents by the issuing Center or Office within FDA, and we have 
identified 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. Because each issuing 
Center or Office maintains its own database, there are slight 
variations in the way in which they provide information on the tables 
below.
    The following most frequently used Internet sites for agency 
guidances are provided for future reference:
    CBER: http://www.fda.gov/cber/guidelines.htm
    CDER: http://www.fda.gov/cder/guidance/index.htm
    CDRH: http://www.fda.gov/cdrh/guidance.html
    CFSAN: http://www.cfsan.fda.gov/6dms/guidance.html
    CVM: http://www.fda.gov/cvm/guidance/published.htm#documents
    ORA: http://www.fda.gov/ora/compliance--;ref

                                II. Guidance Documents Issued by the Center for Biologics Evaluation and Research (CBER)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Intended User or Regulatory
                Name of Document                      Date of Issuance                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 53837]]

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

[[Page 53838]]

 
Deferral of Donors Who Have Received Human       November 25, 1987          Do                           Do
 Pituitary-Derived Growth Hormone
--------------------------------------------------------------------------------------------------------------------------------------------------------
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-I 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)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53839]]

 
PTC in the Collection, Processing and Testing    August 22, 1989            Do                           Do
 of Ex Vivo Activated Mononuclear Leukocytes
 for Administration to Humans
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 PositiveTests 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 and 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 and 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
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53840]]

 
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 Reagent 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     December 16, 1992          Do                           Do
 Red 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
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53841]]

 
Guidance on Alternatives to Lot Release for      July 20, 1993              Do                           Do
 Licensed Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 INDs 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 (NTIS Order 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 Sponsors of INDs 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
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53842]]

 
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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 8/27/82 FDA Memo: Requirements for   March 10, 1995             Do                           Do
 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
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53843]]

 
Recommendations for the Deferral of Current and  June 8, 1995               Do                           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 High Risk 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Concerning Conversion to FDA-Reviewed   November 13, 1995          FDA Regulated Industry       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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53844]]

 
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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
To Manufacturers: HIV-1 Group O                  July 31, 1996              Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53845]]

 
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
PTC in the Manufacturing and Testing of          February 28, 1997          Do                           Do
 Monoclonal Antibody Products for Human Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed Approach to Regulation of Cellular and  February 27, 1997          Do                           Do
 Tissue-Based Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 (Correction    Do                           Do
 Solvents                                         May 19, 1997)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53846]]

 
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 Validation 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53847]]

 
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 Carcinogenicity 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
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53848]]

 
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: 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53849]]

 
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: On Advisory Committees:   October 1998               Do                           Do
 Implementing Section 120 of the Food and Drug
 Administration Act of 1997
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53850]]

 
Guidance for Industry: Providing Regulatory      January 1999               Do                           Do
 Submissions in Electronic Format--General
 Considerations
--------------------------------------------------------------------------------------------------------------------------------------------------------
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: Population                February 1999              Do                           Do
 Pharmacokinetics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Clinical Development      February 1999              Do                           Do
 Programs for Drugs, Devices and Biological
 Products for the Treatment of Rheumatoid
 Arthritis (RA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53851]]

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

[[Page 53852]]

 
International Conference on Harmonisation Draft  September 24, 1999         Do                           Do
 Guidance; Choice of Control Group in Clinical
 Trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 Harmonsation 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53853]]

 
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;       April 21, 2000             Do                           Do
 Draft Revised Guidance on Q1A(R) Stability
 Testing of New Drug Substances and Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Content and Format  May 2000                   Do                           Do
 of the Adverse Reactions Section of Labeling
 for Human Prescription Drugs and Biologics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Recognition and Use of a  June 2000                  Do                           Do
 Standard for the Uniform Labeling of Blood and
 Blood Components
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Recommendations     June 2000                  Do                           Do
 for Donor Questioning Regarding Possible
 Exposure to Malaria
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Pediatric Oncology  June 2000                  Do                           Do
 Studies in Response to a Written Request
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Availability of Licensed  June 2000                  Do                           Do
 Donor Screening Tests Labeled for Use With
 Cadaveric Blood Specimens (Level 2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Chronic Cutaneous   June 2000                  Do                           Do
 Ulcer and Burn Wounds--Developing Products for
 Treatment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: CBER Pilot          June 2000                  Do                           Do
 Licensing Program for Immunization of Source
 Plasma Donors Using Immunogen Red Blood Cells
 Obtained From an Outside Supplier
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Developing Medical  June 2000                  Do                           Do
 Imaging Drugs and Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation (ICH)  June 2000                  Do                           Do
 Draft Guidance; Good Manufacturing Practice
 Guide for Active Pharmaceutical Ingredients
 (March 17, 2000)
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation (ICH)  July 19, 2000              Do                           Do
 Draft Revised Guidance on Impurities in New
 Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53854]]

 
International Conference on Harmonisation (ICH)  July 20, 2000              Do                           Do
 Draft Revised Guidance on Impurities in New
 Drug Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation (ICH)  July 20, 2000              Do                           Do
 Draft Guideline: Organisation of the Common
 Technical Document for the Registration of
 Pharmaceuticals for Human Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation (ICH)  August 2000                Do                           Do
 Draft Guideline on Safety Pharmacology Studies
 for Human Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Analytical          August 2000                Do                           Do
 Procedures and Methods Validation--Chemistry,
 Manufacturing, and Controls Documentation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Considerations for   August 2000               Do                           Do
 Reproductive Toxicity Studies for Preventive
 Vaccines for Infectious Disease Indications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Q & A Content and Format  October 2000               Do                           Do
 of INDs for Phase 1 Studies of Drugs,
 Including Well-Characterized, Therapeutic,
 Biotechnology-Derived Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Supplemental Guidance on  October 2000               Do                           Do
 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: Submitting and Reviewing  October 2000               Do                           Do
 Complete Responses to Clinical Holds
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Cancer Drug and     November 2000              Do                           Do
 Biological Products--Clinical Data in
 Marketing Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Testing Limits in         November 2000              Do                           Do
 Stability Protocols for Standardized Grass
 Pollen Extracts
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Use of Sterile            November 2000              Do                           Do
 Connecting Devices in Blood Bank Practices
 (Level 2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Recommendations     November 2000              Do                           Do
 for Complying With the Pediatric Rule (21 CFR
 314.55(a) and 601.27(a))
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation (ICH)  December 2000              Do                           Do
 Guidance for Industry: E11 Clinical
 Investigation of Medicinal Products in the
 Pediatric Population
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Variances for       December 2000              Do                           Do
 Blood Collection From Individuals With
 Hereditary Hemochromatosis
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53855]]

 
Draft Guidance for Industry: Submitting          December 2000              Do                           Do
 Separate Marketing Applications and Clinical
 Data for Purposes of Assessing User Fees
--------------------------------------------------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation;       December 29, 2000          Do                           Do
 Guidance on Q6A Specifications: Test
 Procedures and Acceptance Criteria for New
 Drug Substances and New Drug Products:
 Chemical Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
PHS Guideline on Infectious Disease Issues in    January 19, 2001           Do                           Do
 Xenotransplantation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Pre-Storage         January 2001               Do                           Do
 Leukocyte Reduction of Whole Blood and Blood
 Components Intended for Transfusion
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Recommendations for       January 2001               Do                           Do
 Collecting Red Blood Cells by Automated
 Apheresis Methods
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Providing           January 2001               Do                           Do
 Regulatory Submissions in Electronic Format--
 Prescription Drug Advertising and Promotional
 Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Source Animal,      February 2001              Do                           Do
 Product, Preclinical and Clinical Issues
 Concerning the Use of Xenotransplantation
 Products in Humans
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Recommendations for       February 2001               Do                          Do
 Collecting Red Blood Cells by Automated
 Apheresis Methods--Technical Correction
 February 2001
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Disclosing          February 2001              Do                           Do
 Information Provided to Advisory Committees in
 Connection With Open Advisory Committee
 Meetings Related to the Testing or Approval of
 Biologic Products and Convened by the Center
 for Biologics Evaluation and Research
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Postmarketing       March 2001                 Do                           Do
 Safety Reporting for Human Drug and Biological
 Products Including Vaccines
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Acceptance of Foreign     March 2001                 Do                           Do
 Clinical Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Financial Disclosure by   March 2001                 Do                           Do
 Clinical Investigators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Monoclonal Antibodies     March 2001                 Do                           Do
 Used as Reagents in Drug Manufacturing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Reports on the      April 2001                 Do                           Do
 Status of Postmarketing Studies--
 Implementation of Section 130 of the Food and
 Drug Administration Modernization Act of 1997
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Using FDA-Approved  April 2001                 Do                           Do
 Patient Labeling in Consumer-Directed Print
 Advertisements
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53856]]

 
Draft Guidance for Industry: Forms for           April 2001                 Do                           Do
 Registration of Producers of Drugs and Listing
 of Drugs in Commercial Distribution
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Providing           May 2001                   Do                           Do
 Regulatory Submissions in Electronic Format--
 Postmarketing Expedited Safety Reports
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: E 10 Choice of Control    May 2001                   Do                           Do
 Group and Related Issues in Clinical Trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: IND Meetings for    May 2001                   Do                           Do
 Human Drugs and Biologics; Chemistry,
 Manufacturing and Controls Information
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                  III. Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Intended User or Regulatory
                Name of Document                      Date of Issuance                Activity              How to Obtain a Hard Copy of the Document
--------------------------------------------------------------------------------------------------------------------------------------------------------
Accelerated Approval Products--Submission of     March 26, 1999             Advertising Draft            http://www.fda.gov/cder/guidance/index.htm
 Promotional Materials--Draft                                                                             Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Name, Placement, Size, and Prominence    March 12, 1999             Do                           Do
 in Advertising and Promotional Labeling--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Promoting Medical Products in a Changing         January 5, 1998            Do                           Do
 Healthcare Environment; Medical Product
 Promotion by Healthcare Organizations or
 Pharmacy Management Companies--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Using FDA-Approved Patient Labeling in Consumer- April 23, 2001             Do                           Do
 Directed Print Advertisements--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aerosol Steroid Product Safety Information in    January 12, 1998           Advertising                  Do
 Prescription Drug Advertising and Promotional
 Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consumer-Directed Broadcast Advertisements       August 9, 1999             Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Industry-Supported Scientific and Educational    December 3, 1997           Do                           Do
 Activities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Antifungal (Topical)--Draft                      February 24, 1990          Biopharmaceutic Draft        Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Antifungal (Vaginal)--Draft                      February 24, 1990          Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bioavailability and Bioequivalence Studies for   June 2, 1999               Do                           Do
 Nasal Aerosols and Nasal Sprays for Local
 Action--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Conjugated Estrogens, USP: LC-MS Method for      March 9, 2000              Do                           Do
 Both Qualitative Chemical Characterization and
 Documentation of Qualitative Pharmaceutical
 Equivalence--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53857]]

 
Food-Effect Bioavailability and Bioequivalence   December 30, 1997          Do                           Do
 Studies--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vivo Bioequivalence Studies Based on          December 10, 1997          Do                           Do
 Population and Individual Bioequivalence
 Studies--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Topical Dermatological Drug Product NDAs and     June 18, 1998              Do                           Do
 ANDAs--In Vivo Bioavailability,
 Bioequivalence, In Vitro Release and
 Associated Studies--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bioanalytical Method Validation                  May 23, 2001               Biopharmaceutic              Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bioavailability and Bioequivalence Studies for   October 27, 2000           Do                           Do
 Orally Administered Drug Products--General
 Considerations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cholestyramine Powder In Vitro Bioequivalence    July 15, 1993              Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clozapine (Tablets) In Vivo Bioequivalence and   November 15, 1996          Do                           Do
 In Vitro Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Corticosteroids, Detmatologic (Topical) In Vivo  June 2, 1995               Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dissolution Testing of Immediate Release Solid   August 25, 1997            Do                           Do
 Oral Dosage Forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Extended Release Oral Dosage Forms:              September 26, 1997         Do                           Do
 Development, Evaluation, and Application of In
 Vitro/In Vivo Correlations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Levothyroxine Sodium Tablets--In Vivo            March 8, 2001              Do                           Do
 Pharmacokinetic and Bioavailability Studies
 and In Vitro Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metaproterenol Sulfate and Albuterol Metered     June 27, 1989              Do                           Do
 Dose Inhalers In Vitro
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 Approaches to Establishing           February 2, 2001           Do                           Do
 Bioequivalence
--------------------------------------------------------------------------------------------------------------------------------------------------------
Waiver of In Vivo Bioavailability and            August 31, 2000            Do                           Do
 Bioequivalence Studies for Immediate Release
 Solid Oral Dosage Forms Based on a
 Biopharmaceutics Classification System
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analytical Procedures and Methods Validation:    August 30, 2000            Chemistry Draft              Do
 Chemistry, Manufacturing, and Controls
 Documentation--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Botanical Drug Products--Draft                   August 11, 2000            Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
INDs 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--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53858]]

 
Metered Dose Inhalers (MDI) and Dry Powder       November 19, 1998          Do                           Do
 Inhalers (DPI) Drug Products; Chemistry,
 Manufacturing, and Controls Documentation--
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Monoclonal Antibodies Used as Reagents in Drug   June 24, 1999              Do                           Do
 Manufacturing--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nasal Spray and Inhalation Solution,             June 2, 1999               Do                           Do
 Suspension, and Spray Drug Products--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Stability Testing of Drug Substances and Drug    June 8, 1998               Do                           Do
 Products--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Supporting Chemistry Documentation    November 1, 1991           Do                           Division of Drug Information (HFD-200), Office
 in Radiopharmaceutical Drug Applications--                                                               of Training and Communications, Center for
 Draft                                                                                                    Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUPAC-SS: Nonsterile Semisolid Dosage Forms      January 5, 1999            Do                           http://www.fda.gov/cder/guidance/index.htm
 Manufacturing Equipment Addendum--Draft                                                                  Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tracking of NDA and NDA Reformulations for       April 12, 1989             Do                           Division of Drug Information (HFD-200), Office
 Solid, Oral, Immediate Release Drug Products--                                                           of Training and Communications, Center for
 Draft                                                                                                    Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
BACPAC1: Intermediates in Drug Substance         February 16, 2001          Chemistry                    Do
 Synthesis: Bulk Actives Postapproval Changes:
 Chemistry, Manufacturing, and Controls
 Documentation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Changes to an Approved Application for           July 24, 1997              Do                           Do
 Specified Biotechnology and Specified
 Synthetic Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Changes to an Approved NDA or ANDA               November 23, 1999          Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Changes to an Approved NDA or ANDA: Questions    January 22, 2001           Do                           Do
 and Answers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Container Closure Systems for Packaging Human    July 7, 1999               Do                           Do
 Drugs and Biologics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Development of New Stereoisomeric Drugs          May 1, 1992                Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content for the CMC Section of an     September 1, 1994          Do                           Do
 Annual Report
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content of the Chemistry,             February 1, 1987           Do                           Do
 Manufacturing and Controls Section of an
 Application
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53859]]

 
Format and Content of the Microbiology Section   February 1, 1987           Do                           Do
 of an Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
IND Meetings for Human Drugs and Biologics;      May 25, 2001               Do                           Do
 Chemistry, Manufacturing, and Controls
 Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Monoclonal Antibodies Used as Reagents in Drug   March 29, 2001             Do                           Do
 Manufacturing
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDAs: Impurities in Drug Substances              February 25, 2000          Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
PAC-ALTS: Postapproval Changes--Analytical       April 28, 1998             Do                           Do
 Testing Laboratory Sites
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance: Validation of                 November 1, 1994           Do                           Do
 Chromatographic 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   February 1, 1987           Do                           Do
 of 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       February 1, 1987           Do                           Do
 Methods Validation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Supporting Documentation in Drug      February 1, 1987           Do                           Do
 Applications for the Manufacture of Drug
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 and In Vivo
 Bioequivalence Documentation
--------------------------------------------------------------------------------------------------------------------------------------------------------
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;     June 13, 1997              Do                           Do
 Scale-Up and Postapproval Changes: Chemistry,
 Manufacturing, and Controls; In Vitro Release
 Testing and In Vivo Bioequivalence
 Documentation
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53860]]

 
The Sourcing and Processing of Gelatin to        December 20, 2000          Do                           Do
 Reduce the Potential Risk Posed by Bovine
 Spongiform Encephalopathy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Bacterial Exacerbation of Chronic          July 22, 1998              Clinical Antimicrobial       Do
 Bronchitis; Developing Antimicrobial Drugs for                              Draft
 Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Bacterial Meningitis; Developing           July 22, 1998              Do                           Do
 Antimicrobial Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Bacterial Sinusitis; Developing            July 22, 1998              Do                           Do
 Antimicrobial Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute or Chronic Bacterial Prostatitis;          July 22, 1998              Do                           Do
 Developing Antimicrobial Drugs for Treatment--
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Otitis Media; Developing Antimicrobial     July 22, 1998              Do                           Do
 Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacterial Vaginosis; Developing Antimicrobial    July 22, 1998              Do                           Do
 Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Catheter-Related Bloodstream Infections--        October 18, 1999           Do                           Do
 Developing Antimicrobial Drugs for Treatment--
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Considerations for Accelerated and      September 1, 1999          Do                           Do
 Traditional Approval of Antiretroviral Drugs
 Using Plasma HIV RNA Measurements--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Community Acquired Pneumonia; Developing         July 22, 1998              Do                           Do
 Antimicrobial Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Complicated Urinary Tract Infections and         July 22, 1998              Do                           Do
 Pylonephritis; Developing Antimicrobial Drugs
 for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Developing Antimicrobial Drugs--General          July 22, 1998              Do                           Do
 Considerations for Clinical Trials--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Empiric Therapy of Febrile Neutropenia;          July 22, 1998              Do                           Do
 Developing Antimicrobial Drugs for Treatment--
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Evaluating Clinical Studies of Antimicrobials    February 17, 1997          Do                           Do
 in the Division of Anti-Infective Drug
 Products--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lyme Disease; Developing Antimicrobial Drugs     July 22, 1998              Do                           Do
 for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nosocomial Pneumonia; Developing Antimicrobial   July 22, 1998              Do                           Do
 Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Secondary Bacterial Infections of Acute          July 22, 1998              Do                           Do
 Bronchitis; Developing Antimicrobial Drugs for
 Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Streptococcal Pharyngitis and Tonsillitis;       July 22, 1998              Do                           Do
 Developing Antimicrobial Drugs for Treatment--
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Uncomplicated and Complicated Skin and Skin      July 22, 1998              Do                           Do
 Structure Infections; Developing Antimicrobial
 Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53861]]

 
Uncomplicated Gonorrhea--Cervical, Urethral,     July 22, 1998              Do                           Do
 Rectal, and/or Pharyngeal; Developing
 Antimicrobial Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Uncomplicated Urinary Tract Infections;          July 22, 1998              Do                           Do
 Developing Antimicrobial Drugs for Treatment--
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vulvovaginal Candidiasis; Developing             July 22, 1998              Do                           Do
 Antimicrobial Drugs for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preclinical Development of Antiviral Drugs       November 1, 1990           Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abuse Liability Assessment--Draft                July 1, 1990               Clinical Medical Draft       Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Allergic Rhinitis: Clinical Development          June 21, 2000              Do                           http://www.fda.gov/cder/guidance/index.htm
 Programs for Drug Products--Draft                                                                        Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cancer Drug and Biological Products--Clinical    November 9, 2000           Do                           Do
 Data in Marketing Applications--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic Cutaneous Ulcer and Burn Wounds--        June 28, 2000              Do                           Do
 Developing Products for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Development Programs for Drugs,         July 15, 1999              Do                           Do
 Devices, and Biological Products Intended for
 the Treatment of Osteoarthritis (OA)--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Anti-Anginal Drugs--      January 1, 1989            Do                           Division of Drug Information (HFD-200), Office
 Draft                                                                                                    of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Anti-Arrhythmic Drugs--   July 1, 1985               Do                           http://www.fda.gov/cder/guidance/index.htm
 Draft                                                                                                    Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Antihypertensive Drugs--  May 1, 1988                Do                           Do
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53862]]

 
Clinical Evaluation of Drugs for the Treatment   December 1, 1987           Do                           Division of Drug Information (HFD-200), Office
 of Congestive Heart Failure--Draft                                                                       of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Drugs for Ulcerative      January 7, 1991            Do                           Do
 Colitis (3rd draft)--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Lipid-Altering Agents In  September 1, 1990          Do                           http://www.fda.gov/cder/guidance/index.htm
 Adults and Children--Draft                                                                               Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Motility-Modifying        Date not available         Do                           Division of Drug Information (HFD-200), Office
 Drugs--Draft                                                                                             of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Weight-Control Drugs--    September 24, 1996         Do                           http://www.fda.gov/cder/guidance/index.htm
 Draft                                                                                                    Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Developing Medical Imaging Drugs and Biologics-- July 31, 2000              Do                           Do
 Revised--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Development and Evaluation of Drugs for the      February 12, 1992          Do                           Division of Drug Information (HFD-200), Office
 Treatment of Psychoactive Substance Use                                                                  of Training and Communications, Center for
 Disorders--Draft                                                                                         Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Development of Parathyroid Hormones for the      June 14, 2000              Do                           http://www.fda.gov/cder/guidance/index.htm
 Prevention and Treatment of Osteoporosis--                                                               Division of Drug Information (HFD-200), Office
 Draft                                                                                                    of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Establishing Pregnancy Registries--Draft         June 4, 1999               Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Evaluation of Human Pregnancy Outcome Data--     June 4, 1999               Do                           Do
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Female Sexual Dysfunction: Clinical Development  May 19, 2000               Do                           Do
 of Drug Products for Treatment--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Institutional Review Boards, Clinical            March 30, 2000             Do                           Do
 Investigators, and Sponsors: Exception From
 Informed Consent Requirements for Emergency
 Research--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Treatment of Herpes Labialis With Antiviral  March 8, 2000              Do                           Do
 Agents--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pediatric Oncology Studies in Response to a      June 21, 2000              Do                           Do
 Written Request--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53863]]

 
Postmarketing Safety Reporting for Human Drug    March 12, 2001             Do                           Do
 and Biological Products Including Vaccines--
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preclinical and Clinical Evaluation of Agents    April 1, 1994              Do                           Do
 Used in the Prevention or Treatment of
 Postmenopausal Osteoporosis--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparation of IND Applications for New Drugs    September 1, 1991          Do                           Division of Drug Information (HFD-200), Office
 Intended for the Treatment of HIV-Infected                                                               of Training and Communications, Center for
 Individuals--Draft                                                                                       Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for Complying With the           December 4, 2000           Do                           http://www.fda.gov/cder/guidance/index.htm
 Pediatric Rule--Draft                                                                                    Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
System Inflammatory Response Syndrome (SIRS)     July 1993                  Do                           Division of Drug Information (HFD-200), Office
 (1st draft)--Draft                                                                                       of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acceptance of Foreign Clinical Studies           March 13, 2001             Clinical Medical             http://www.fda.gov/cder/guidance/index.htm
                                                                                                          Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Development Programs for Drugs,         February 17, 1999          Do                           Do
 Devices, and Biological Products for the
 Treatment of Rheumatoid Arthritis (RA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Development Programs for MDI and DPI    September 19, 1994         Do                           Do
 Drug 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       January 1, 1981            Do                           Do
 (Adults 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
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53864]]

 
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       October 1, 1981            Do                           Do
 Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format for Pediatric Use             May 24, 1996               Do                           Do
 Supplements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format of Investigational New Drug   November 20, 1995          Do                           Do
 Applications (INDs) for Phase 1 Studies of
 Drugs, Including Well-Characterized,
 Therapeutic, Biotechnology-Derived Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Development of Vaginal Contraceptive Drugs       April 19, 1995             Do                           Do
 (NDA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 29, 1991           Do                           Do
 Non-Small 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           July 1, 1988               Do                           Do
 Statistical Sections of an Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content of the Summary for New Drug   February 1, 1987           Do                           Do
 and Antibiotic Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formatting, Assembling and Submitting New Drug   February 1, 1987           Do                           Do
 and Antibiotic Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Considerations for the Clinical          December 1, 1978           Do                           Do
 Evaluation of Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Considerations for the Clinical          September 1, 1977          Do                           Do
 Evaluation of Drugs in Infants and Children
--------------------------------------------------------------------------------------------------------------------------------------------------------
Levothyroxine Sodium Tablets--In Vivo            March 8, 2001              Do                           Do
 Pharmacokinetic and Bioavailability Studies
 and In Vitro Dissolution Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oncologic Drugs Advisory Committee Discussion    April 13, 1988             Do                           Do
 on FDA Requirements for Approval of New Drugs
 for Treatment of Ovarian Cancer
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oncologic Drugs Advisory Committee Discussion    April 19, 1988             Do                           Do
 on FDA Requirements for Approval of New Drugs
 for Treatment of Colon and Rectal Cancer
--------------------------------------------------------------------------------------------------------------------------------------------------------
Postmarketing Adverse Experience Reporting for   August 27, 1997            Do                           Do
 Human Drug and Licensed Biological Products;
 Clarification of What to Report
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53865]]

 
Postmarketing Reporting of Adverse Drug          March 1, 1992              Do                           Do
 Experiences
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preclinical Development of Immunomodulatory      September 4, 1992          Do                           Do
 Drugs for the Treatment of HIV Infection and
 Associated Disorders
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparation of Investigational New Drug          November 1, 1992           Do                           Do
 Products (Human and Animal)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Providing Clinical Evidence of Effectiveness     May 15, 1998               Do                           Do
 for Human Drug and Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study and Evaluation of Gender Differences in    July 22, 1993              Do                           Do
 the 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   September 13, 1999         Do                           Do
 in Support of Marketing Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Considerations for Pediatric             November 30, 1998          Clinical Pharmacology Draft  Do
 Pharmacokinetic Studies for Drugs and
 Biological Products--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pharmacokinetics in Patients With Impaired       December 7, 1999           Do                           Do
 Hepatic Function: Study Design, Data Analysis,
 and Impact on Dosing and Labeling--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
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                  February 1, 1987           Do                           Do
 Pharmacokinetics and Bioavailability Section
 of an Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vivo Metabolism/Drug Interaction Studies--    November 24, 1999          Do                           Do
 Study Design, Data Analysis, and
 Recommendations for Dosing and Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pharmacokinetics and Pharmacodynamics in         May 15, 1998               Do                           Do
 Patients With Impaired Renal Function: Study
 Design, Data Analysis, and Impact on Dosing
 and Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Population Pharmacokinetics                      February 10, 1999          Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for IRBs, Clinical Investigators, and   March 30, 2000             Compliance Draft             Do
 Sponsors: Exception from Informed Consent
 Requirements for Emergency Research (21 CFR
 50.24)--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Investigating Out of Specification (OOS) Test    September 30, 1998         Do                           Do
 Results for Pharmaceutical Production--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacture, Processing or Holding of Active     April 17, 1998             Do                           Do
 Pharmaceutical Ingredients--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Repacking of Solid Oral Dosage Form Drug         February 1, 1992           Do                           Do
 Products--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53866]]

 
A Review of FDA's Implementation of the Drug                                Compliance                   Do
 Export Amendments of 1986
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compressed Medical Gases                         December 1, 1989           Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Computerized Systems Used in Clinical Trials     May 10, 1999               Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Expiration Dating and Stability Testing of       June 27, 1997              Do                           Do
 Solid Oral Dosage Form Drugs Containing Iron
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Principles of Process Validation         May 1, 1987                Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Good Laboratory Practice Regulations Questions                              Do                           Do
 and Answers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Hospitals, Nursing Homes, and       April 6, 2001              Do                           Do
 Other Health Care Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Street Drug Alternatives                         April 3, 2000              Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Validation of Limulus Amebocyte Lysate Test as   December 1, 1987           Do                           Do
 an End-Product Endotoxin Test for Human and
 Animal Parenteral Drugs, Biological Products,
 and Medical Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Providing Regulatory Submissions in Electronic   May 4, 2001                Electronic Submission Draft  Do
 Format--Postmarketing Expedited Safety
 Reports--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Providing Regulatory Submissions in Electronic   January 31, 2001           Do                           Do
 Format: Prescription Drug Advertising and
 Promotional Labeling--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparing Data for Electronic Submissions in     September 23, 1999         Electronic Submission        Do
 ANDAs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Submissions in Electronic Format;     January 28, 1999           Do                           Do
 General Considerations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Submissions in Electronic Format;     January 28, 1999           Do                           Do
 New Drug Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
ANDAs; Blend Uniformity Analysis--Draft          August 26, 1999            Generic Drug Draft           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
ANDAs; Impurities in Drug Products--Draft        January 5, 1999            Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format of an Abbreviated New Drug    April 18, 1997             Do                           Do
 Application (ANDA)--Positron Emission
 Tomography (PET) Drug Products--With Specific
 Information for ANDAs for Fludeoxyglucose F18
 Injection--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alternate Source of Active Pharmaceutical        December 12, 2000          Do                           Do
 Ingredients in Pending ANDAs--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53867]]

 
ANDAs: Impurities in Drug Substances             December 3, 1999           Generic Drugs                Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter Announcing That the OGD Will Now Accept   August 18, 1995            Do                           Do
 the ICH Long-Term Storage Conditions as Well
 as the Stability Studies Conducted in the Past
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter Describing Efforts by CDER and ORA to     October 14, 1994           Do                           Do
 Clarify the Responsibilities of CDER Chemistry
 Review Scientists and ORA Field Investigators
 in the New and Abbreviated Drug Approval
 Process in Order to Reduce Duplication or
 Redundancy in the Process
--------------------------------------------------------------------------------------------------------------------------------------------------------
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         November 8, 1991           Do                           Do
 Regulated Industry to Improve the Efficiency
 and Effectiveness of the Generic Drug Review
 Process, by Assuring the Completeness and
 Accuracy of Required Information and Data
 Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter on the Response to 12/20/84 Letter From   March 26, 1985             Do                           Do
 the Pharmaceutical Manufacturers Association
 About the Drug Price Competition and Patent
 Term Restoration Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to all ANDA and AADA Applicants About     January 15, 1993           Do                           Do
 the Generic Drug Enforcement Act of 1992
 (GDEA), and the Office of Generic Drugs
 intention to Refuse-to-File Incomplete
 Submissions as Required by the New Law
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Regulated Industry Notifying           August 4, 1993             Do                           Do
 Interested Parties About Important Detailed
 Information Regarding Labeling, Scale-up,
 Packaging, Minor/major Amendment Criteria, and
 Bioequivalence Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Major, Minor, Facsimile, and Telephone           May 1, 2000                Do                           Do
 Amendments to Original Abbreviated New Drug
 Applications (Revised)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Organization of an ANDA                          March 2, 1999              Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Revising ANDA Labeling Following Revision of     April 25, 2000             Do                           Do
 the RLD Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53868]]

 
Skin Irritation and Sensitization Testing of     February 3, 2000           Do                           Do
 Generic Transdermal Drug Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Variations in Drug Products That May Be          January 27, 1999           Do                           Do
 Included ANDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Conducting a Clinical Safety Review of a New     November 22, 1996          Good Review Practices Draft  Do
 Product Application and Preparing a Report on
 the Review--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pharmacology/Toxicology Review Format            May 10, 2001               Good Review Practices        Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q1A(R)--Stability Testing of New Drug            April 21, 2000             ICH Draft--Quality           Do
 Substances and Products--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q3A(R)--Impurities in New Drug Substances--      July 20, 2000              Do                           Do
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q3B(R)--Impurities in New Drug Products--Draft   July 19, 2000              Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q6A--Specifications: Test Procedures and         November 25, 1997          Do                           Do
 Acceptance Criteria for New Drug Substances
 and New Drug Products: Chemical Substances--
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q7A--Good Manufacturing Practice for Active      August 1, 2000             Do                           Do
 Pharmaceutical Ingredients--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
S7--Safety Pharmacology Studies for Human        August 7, 2000             ICH Draft--Safety            Do
 Pharmaceuticals--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
E12 A--Principles for Clinical Evaluation of     August 9, 2000             ICH Draft--Efficacy          Do
 New Antihypertensive Drugs--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
M4--Common Technical Document--Draft             August 24, 2000            ICH Draft--Joint Safety/     Do
                                                                             Efficacy
                                                                             (Multidisciplinary)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q1A--Stability Testing of New Drug Substances    September 22, 1994         ICH--Quality                 Do
 and Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
QIB--Photostability Testing of New Drug          May 16, 1997               Do                           Do
 Substances and Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
QIC--Stability Testing for New Dosage Forms      May 9, 1997                Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q2A--Text on Validation of Analytical            March 1, 1995              Do                           Do
 Procedures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q2B--Validation of Analytical Procedures:        May 19, 1997               Do                           Do
 Methodology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q3A--Impurities in New Drug Substances           January 4, 1996            Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q3B(R)-- Impurities in New Drug Products         July 19, 2000              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:          February 23, 1996          Do                           Do
 Analysis of the Expression Construct in Cells
 Used for Production of r-DNA Derived Protein
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53869]]

 
Q5C--Quality of Biotechnological Products:       July 10, 1996              Do                           Do
 Stability Testing of Biotechnology/Biological
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q5D--Quality of Biotechnological/Biological      September 21, 1998         Do                           Do
 Products: Derivation and Characterization of
 Cell Substrates Used for Production of
 Biotechnological/Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q6A--Specifications: Test Procedures and         December 29, 2000          Do                           Do
 Acceptance Criteria for New Drug Substances
 and New Drug Products: Chemical Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q6B--Test Procedures and Acceptance Criteria     August 18, 1999            Do                           Do
 for Biotechnological/Biological Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
S1A--The Need for Long-Term Rodent               March 1, 1996              ICH--Safety                  Do
 Carcinogenicity Studies of Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
S1B--Testing for Carcinogenicity in              February 23, 1998          Do                           Do
 Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
S1C--Dose Selection for Carcinogenicity Studies  March 1, 1995              Do                           Do
 of Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
S1C(R)--Dose Selection for Carcinogenicity       December 4, 1997           Do                           Do
 Studies of Pharmaceuticals: Addendum on a
 Limit Dose and Related Notes
--------------------------------------------------------------------------------------------------------------------------------------------------------
S2A--Specific Aspects of Regulatory              April 24, 1996             Do                           Do
 Genotoxicity 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     March 1, 1995              Do                           Do
 Dose 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             November 18, 1997          Do                           Do
 Biotechnology-Derived Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
S7A--Safety Pharmacology Studies for Human       July 13, 2001              Do                           Do
 Pharmaceuticals
--------------------------------------------------------------------------------------------------------------------------------------------------------
EIA--The Extent of Population Exposure to        March 1, 1995              ICH--Efficacy                Do
 Assess Clinical Safety: for Drugs Intended for
 Long-Term Treatment of Non-Life-Threatening
 Conditions
--------------------------------------------------------------------------------------------------------------------------------------------------------
E2A--Clinical Safety Data Management:            March 1, 1995              Do                           Do
 Definitions and Standards for Expedited
 Reporting
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53870]]

 
E2B--Data Elements for Transmission of           January 15, 1998           Do                           Do
 Individual 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      July 17, 1996              Do                           Do
 Reports
--------------------------------------------------------------------------------------------------------------------------------------------------------
E4--Dose-Response Information to Support Drug    November 9, 1994           Do                           Do
 Registration
--------------------------------------------------------------------------------------------------------------------------------------------------------
E5--Ethnic Factors in the Acceptability of       June 10, 1998              Do                           Do
 Foreign Clinical Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
E6--Good Clinical Practice: Consolidated         May 9, 1997                Do                           Do
 Guideline
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
E10--International Conference on Harmonisation:  May 14, 2001               Do                           Do
 Choice of Control Group and Related Issues in
 Clinical Trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
E11--Clinical Investigation of Medicinal         December 15, 2000          Do                           Do
 Products in the Pediatric Population
--------------------------------------------------------------------------------------------------------------------------------------------------------
M3--Nonclinical Safety Studies for the Conduct   November 25, 1997          ICH--Joint Safety/Efficacy   Do
 of Human Clinical Trials for Pharmaceuticals                                (Multidisciplinary)
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Revision in Sample Collection Under the        July 15, 1996              Industry Letters             Division of Drug Information (HFD-200), Office
 Compliance Program Pertaining to Pre-Approval                                                            of Training and Communications, Center for
 Inspections                                                                                              Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certification Requirements for Debarred          June 1, 1990               Do                           Do
 Individuals in Drug Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Continuation of a Series of Letters              March 2, 1998              Do                           Http://www.fda.gov/cder/guidance/index.htm
 Communicating Interim and Informal Generic                                                               Division of Drug Information (HFD-200), Office
 Drug Policy and Guidance. Availability of                                                                of Training and Communications, Center for
 Policy and Procedure Guides, and Further                                                                 Drug Evaluation and Research, Food and Drug
 Operational Changes to the Generic Drug Review                                                           Administration, 5600 Fishers Lane, Rockville,
 Program                                                                                                  MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
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          October 31, 1986           Do                           Do
 Informal Notice to Affected Parties About
 Policy Developments and Interpretations
 Regarding the Act. Three-Year Exclusivity
 Provisions of Title 1
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53871]]

 
Implementation of the Drug Price Competition     October 11, 1984           Do                           Do
 and 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                           Division of Drug Information (HFD-200), Office
 Provisions of SUPAC-IR                                                                                   of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Seventh of a Series of Letters About the Act     July 29, 1988              Do                           Http://www.fda.gov/cder/guidance/index.htm
 Providing Guidance on the ``180-Day                                                                      Division of Drug Information (HFD-200), Office
 Exclusivity'' Provision of Section                                                                       of Training and Communications, Center for
 505(j)(4)(B)(iv) of the Act                                                                              Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sixth of a Series of Informal Notice Letters     April 28, 1988             Do                           Do
 About the Act Discussing 3- and 5-year
 Exclusivity Provisions of Section 505(c)(3)(D)
 and (j)(4)(D) of the Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Streamlining Initiative                          December 24, 1996          Do                           Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supplement to 10/11/84 Letter About Policies,    November 16, 1984          Do                           http://www.fda.gov/cder/guidance/index.htm
 Procedures and Implementation of the Act (Q &                                                            Division of Drug Information (HFD-200), Office
 A Format)                                                                                                of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Third of a Series of Letters Regarding the       May 1, 1985                Do                           Do
 Implementation of the Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Y2K Letter From Dr. Janet Woodcock               October 19, 1998           Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combined Oral Contraceptives--Labeling for       July 10, 2000              Labeling Draft               Do
 Healthcare Providers and Patients--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format for Geriatric Labeling--      January 21, 1999           Do                           Do
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format of the Adverse Reactions      June 21, 2000              Do                           Do
 Section of Labeling for Human Prescription
 Drugs and Biologics--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Non-Contraceptive Estrogen Drug Products--       January 8, 1999            Do                           Do
 Physician and Patient Labeling--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Noncontraceptive Estrogen Class Labeling--Draft  September 27, 1999         Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling of OTC Topical Drug Products for the    July 16, 1998              Do                           Do
 Treatment of Vaginal Yeast Infections
 (Vulvovaginal Candidiasis)--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53872]]

 
Referencing Discontinued Labeling for Listed     October 26, 2000           Do                           Do
 Drugs in Abbreviated New Drug Applications--
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Therapeutic Equivalence Code Placement on        January 28, 1999           Do                           Do
 Prescription Drug Labels and Labeling--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acetaminophen and Codeine Phosphate Tablets/     December 1, 1993           Labeling                     Do
 Capsules
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acetaminophen and Codeine Phosphate Oral         December 1, 1993           Do                           Do
 Solution/Suspension
--------------------------------------------------------------------------------------------------------------------------------------------------------
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                           Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Butalbital, Acetaminophen and Caffeine Capsules/ September 1, 1997          Do                           http://www.fda.gov/cder/guidance/index.htm
 Tablets USP                                                                                              Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Butalbital, Acetaminophen, Caffeine and          September 21, 1997         Do                           Do
 Hydocodone Bitartrate Tablets
--------------------------------------------------------------------------------------------------------------------------------------------------------
Butorphanol Tartrate Injection USP               October 1, 1992            Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53873]]

 
Clorazepate Dipotassium Capsules/Tablets         March 1, 1993              Do                           Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
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                           http://www.fda.gov/cder/guidance/index.htm
                                                                                                          Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diltiazem Hydrochloride Extended-Release         September 1, 1995          Do                           Do
 Capsules
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diphenoxylate Hydrochloride and Atropine         April 1, 1995              Do                           Do
 Sulfate Oral Solution USP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diphenoxylate Hydrochloride and Atropine         April 1, 1995              Do                           Do
 Sulfate Tablets USP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dipivefrin Hydrochloride Ophthalmic Solution,    November 2, 1998           Do                           Division of Drug Information (HFD-200), Office
 0.1%                                                                                                     of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ergoloid Mesylates Tablets                       January 1, 1988            Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fludeoxyglucose F18 Injection                    January 1, 1997            Do                           http://www.fda.gov/cder/guidance/index.htm
                                                                                                          Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
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         April 1, 1994              Do                           Do
 Tablets USP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hydroxyzine Hydrochloride Injection              December 1, 1989           Do                           Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hypoglycemic Oral Agents Federal Register        April 1, 1984              Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53874]]

 
Indomethacin Capsules USP                        September 1, 1995          Do                           http://www.fda.gov/cder/guidance/index.htm
                                                                                                          Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Informal Labeling Guidance Texts for Estrogen    August 1, 1992             Do                           Division of Drug Information (HFD-200), Office
 Drug Products Patient Labeling                                                                           of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Informal Labeling Guidance Texts for Estrogen    August 1, 1992             Do                           Do
 Drug Products: Professional Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Isoetharine Inhalation Solution                  March 1, 1989              Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Itraconazole Capsules, USP                       September 1, 1998          Do                           http://www.fda.gov/cder/guidance/index.htm
                                                                                                          Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Leucovorin Calcium for Injection                 July 1, 1996               Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Leucovorin Calcium Tablets, USP                  July 1, 1996               Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Local Anesthetics Class Labeling                 September 1, 1982          Do                           Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Meclofenamate Sodium Capsules                    July 1, 1992               Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medroxyprogesterone Acetate Tablets, USP         September 1, 1998          Do                           http://www.fda.gov/cder/guidance/index.htm
                                                                                                          Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
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                           Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53875]]

 
Naproxen Sodium Tablets, USP                     September 1, 1997          Do                           http://www.fda.gov/cder/guidance/index.htm
                                                                                                          Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Naproxen Tablets, USP                            September 1, 1997          Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Niacin Tablets                                   July 1, 1982               Do                           Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Paclitaxel Injection                             September 1, 1997          Do                           http://www.fda.gov/cder/guidance/index.htm
                                                                                                          Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phendimetrazine Tartrate Capsules/T Nets, and    February 1, 1991           Do                           Division of Drug Information (HFD-200), Office
 Extended-Release Capsules                                                                                of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
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                           http://www.fda.gov/cder/guidance/index.htm
                                                                                                          Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ranitidine Tablets USP                           November 1, 1993           Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Risperidone Oral Solution                        September 1, 1997          Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Risperidone Tablets                              September 1, 1997          Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sulfacetainide Sodium and Prednisolone Acetate   January 1, 1995            Do                           Do
 Ophthalmic Suspension and Ointment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sulfacetamide Sodium Ophthalmic Solution/        August 1, 1992             Do                           Do
 Ointment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sulfamethoxazole and Phenazopyridine             February 1, 1992           Do                           Division of Drug Information (HFD-200), Office
 Hydrochloride Tablets                                                                                    of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53876]]

 
Sulfamethoxazole and Trimethoprim Tablets and    August 1, 1993             Do                           http://www.fda.gov/cder/guidance/index.htm
 Oral Suspension                                                                                          Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Theophylline Immediate-Release Dosage Forms      February 1, 1995           Do                           Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Theophylline Intravenous Dosage Forms            September 1, 1995          Do                           http://www.fda.gov/cder/guidance/index.htm
                                                                                                          Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Thiamine Hydrochloride Injection                 February 1, 1988           Do                           Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobramycin Sulfate Injection USP                 May 1, 1993                Do                           http://www.fda.gov/cder/guidance/index.htm
                                                                                                          Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
Venlafaxine Hydrochloride Tablets                October 1, 1997            Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Verapamil Hydrochloride Tablets                  October 1, 1991            Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamin A Capsules                               February 1, 1992           Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Zolpidem Tartrate Tablets                        September 1, 1997          Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Demonstration of Comparability of Human          April 1, 1996              Microbiology                 Do
 Biological Products, Including Therapeutic
 Biotechnology-Derived Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling OTC Human Drug Products--Submitting     December 19, 2000          OTC Draft                    Do
 Requests for Exemptions and Deferrals--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling OTC Human Drug Products: Updating       February 22, 2001          Do                           Do
 Labeling in ANDAs--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Actual Use Studies--Draft                    July 22, 1994              Do                           Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Nicotine Substitutes--Draft                  March 1, 1994              Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53877]]

 
Enforcement Policy on Marketing OTC Combination                             OTC                          http://www.fda.gov/cder/guidance/index.htm
 Products (CPG 7132b.16)                                                                                  Division of Drug Information (HFD-200), Office
                                                                                                          of Training and Communications, Center for
                                                                                                          Drug Evaluation and Research, Food and Drug
                                                                                                          Administration, 5600 Fishers Lane, Rockville,
                                                                                                          MD 20857, 301-827-4573
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Guidelines for OTC Combination Products                             Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling OCT Human Drug Products Using a Column  December 19, 2000          Do                           Do
 Format
--------------------------------------------------------------------------------------------------------------------------------------------------------
Upgrading Category III Antiperspirants to                                   Do                           Do
 Category 1 (43 FR 46728-46731)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carcinogenicity Study Protocol Submissions--     November 7, 2000           Pharmacology/Toxicology      Do
 Draft                                                                       Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Immunotoxicology Evaluation of Investigational   May 11, 2001               Do                           Do
 New Drugs--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Photosafety Testing--Draft                       January 10, 2000           Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Statistical Aspects of the Design, Analysis,     May 8, 2001                Do                           Do
 and Interpretation of Chronic Rodent
 Carcinogenicity Studies of Pharmaceuticals--
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format of INDs for Phase 1 Studies   October 4, 2000            Pharmacology/Toxicology      Do
 of Drugs Including Well-Characterized,
 Therapeutic, Biotechnology-Derived Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and Content of the Nonclinical            February 1, 1987           Do                           Do
 Pharmacology/Toxicology Section of an
 Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nonclinical Pharmacology/Toxicology Development  October 16, 1996           Do                           Do
 of 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
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Content and Format of New Drug Applications and  March 10, 2000             Do                           Do
 Abbreviated New Drug Applications for Certain
 Positron Emission Tomography Drug Products--
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
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--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53878]]

 
Forms for Registration of Producers of Drugs     May 15, 2001               Do                           Do
 and Listing of Drugs in Commercial
 Distribution--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information Program on Clinical Trials for       March 29, 2000             Do                           Do
 Serious or Life-Threatening Diseases:
 Establishment of a Data Bank--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information Program on Clinical Trials for       July 9, 2001               Do                           Do
 Serious or Life-Threatening Diseases:
 Implementation Plan--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information Request and Discipline Review        August 17, 1999            Do                           Do
 Letters Under the Prescription Drug User Fee
 Act--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
PET Drug Applications--Content and Format for    March 10, 2000             Do                           Do
 NDAs and ANDAs--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Postmarketing Safety Reporting for Human Drug    March 12, 2001             Do                           Do
 and Biological Products Including Vaccines--
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Potassium Iodide as a Thyroid Blocking Agent in  January 4, 2001            Do                           Do
 Radiation Emergencies--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reports on the Status of Postmarketing Studies-- April 4, 2001              Do                           Do
 Implementation of Section 130 of the Food and
 Drug Administration Modernization Act of 1997--
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Special Protocol Assessment--Draft               February 9, 2000           Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Debarment Certification Statements--  October 2, 1998            Do                           Do
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
180-Day Generic Drug Exclusivity Under the       July 14, 1998              Procedural                   Do
 Hatch-Waxman Amendments to the Federal Food,
 Drug, and Cosmetic Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Advisory Committees: Implementing Section 120    November 2, 1998           Do                           Do
 of the Food and Drug Modernization Act of 1997
--------------------------------------------------------------------------------------------------------------------------------------------------------
Court Decisions, ANDA Approvals, and 130-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:            November 18, 1998          Do                           Do
 Designation, Development, and Application
 Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
Financial Disclosure by Clinical Investigators   March 20, 2001             Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formal Dispute Resolution: Appeals Above the     March 7, 2000              Do                           Do
 Division Level
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53879]]

 
Formal Meetings With Sponsors and Applicants     March 7, 2000              Do                           Do
 for PDUFA Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implementation of Section 120 of the FDA         November 20, 1998          Do                           Do
 Modernization Act of 1997--Advisory Committees
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implementation of Section 126 of the FDA         July 21, 1998              Do                           Do
 Modernization Act of 1997--Elimination of
 Certain Labeling Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Levothyroxine Sodium Products--Enforcement of    July 13, 2001              Do                           Do
 August 14, 2001, Compliance Date and
 Submission of New Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
National Uniformity for Nonprescription Drugs    April 9, 1998              Do                           Do
 Ingredient Labeling for OTC Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Qualifying for Pediatric Exclusivity Under       October 1, 1999            Do                           Do
 Section 505A of the Federal Food, Drug, and
 Cosmetic Act--Revised
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reduction of Civil Money Penalties for Small     March 20, 2001             Do                           Do
 Business Entities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Refusal to File                                  July 12, 1993              Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Repeal of Section 507 of the Federal Food,       June 15, 1998              Do                           Do
 Drug, and Cosmetic Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Standards for the Prompt Review of Efficacy      May 15, 1998               Do                           Do
 Supplements Including Priority Efficacy
 Supplements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Women and Minorities Guidance Requirements       July 20, 1998              Do                           Do
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information Request and Discipline Review        August 17, 1999            User Fee Draft               Do
 Letters Under the Prescription Drug User Fee
 Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting Separate Marketing Applications and   February 22, 2001          Do                           Do
 Definitions of Clinical Data for Purposes of
 Assessing User Fees--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Waivers of and Reductions in User Fees           July 16, 1993              Do                           Do
 (Attachment G)--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Applicability of User Fees to: (1) Applications  July 12, 1993              User Fee                     Do
 Withdrawn Before Filing Decision, or (2)
 Applications the Agency Has Refused to File
 and That Are Resubmitted or Filed Over Protest
 (Attachment F)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application, Product, and Establishment Fees:    December 16, 1994          Do                           Do
 Common Issues and Their Resolution (Attachment
 D)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Classifying Resubmissions in Response to Action  May 14, 1998               Do                           Do
 Letters
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fees-Exceed-the-Costs Waivers Under the          August 25, 1999            Do                           Do
 Prescription Drug User Fee Act
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formal Meetings With Sponsors and Applicants     March 7, 2000              Do                           Do
 for PDUFA Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submitting and Reviewing Complete Responses to   October 26, 2000           Do                           Do
 Clinical Holds (Revised)
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 53880]]


                                                                       Withdrawals
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Intended User or Regulatory
                     Name of Document                             Date of Issuance                 Activity                   Date of Withdrawal
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dissemination and Reprints of Certain Published Original    October 8, 1996              Advertising                  February 16, 2000
 Data (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Funded Dissemination of Reference Texts (No Replacement)    October 8, 1996              Advertising                  February 16, 2000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Buspirone Hydrochloride Tablets In Vivo Bioequivalence (No  May 14, 1998                 Biopharmaceutics             November 30, 2000
 Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cimetidine Tablets In Vivo Bioequivalence and In Vitro      Unknown                      Biopharmaceutics             November 30, 2000
 Dissolution (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Diclofenac Sodium (Tablets) In Vivo Bioequivalence and In   October 6, 1994              Biopharmaceutics             November 30, 2000
 Vitro Dissolution Testing (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glipizide In Vivo Bioequivalence and In Vivo Dissolution    Unknown                      Biopharmaceutics             November 30, 2000
 Testing (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glyburide In Vivo Bioequivalence and In Vivo Dissolution    Unknown                      Biopharmaceutics             November 30, 2000
 Testing (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Oral Extended (Controlled) Release Dosage Forms In Vivo     Unknown                      Biopharmaceutics             November 30, 2000
 Bioequivalence and In Vitro Dissolution Testing (No
 Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Statistical Procedures for Bioequivalence Studies Using a   July 1, 1992                 Biopharmaceutics             November 30, 2000
 Standard Two-Treatment Crossover Design (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Drugs to Prevent Dental Caries (No   November 1, 1978             Clinical Medical             May 18, 2000
 Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Drugs to Prevent, Control, and/or    November 1, 1978             Clinical Medical             May 18, 2000
 Treat Periodontal Disease (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Treatment of Hypercholesterolemia (No Replacement)      October 27, 1997             OTC                          August 3, 2000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Levothyroxine Sodium: Questions and Answers (Replaced by    March 8, 2001                Procedural                   July 13, 2001
 Levothyroxine Sodium Products Enforcement of August 14,
 2001, Compliance Date and Submission of New Applications
 issued on July 13, 2001)
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                 IV. Guidance Documents Issued by the Center for Devices and Radiological Health (CDRH)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                How to Obtain a Hard Copy
                                                                                          Intended User or      of the Document (Name and
                    Name of Document                           Date of Issuance         Regulatory Activity      Address, Phone, FAX, E-      FOD No.
                                                                                                                    mail or Internet)
--------------------------------------------------------------------------------------------------------------------------------------------------------
The FDA Export Reform and Enhancement Act of 1996/Export  February 7, 2000           Office of Compliance (OC)  Division of Small          865
 Certification Package Including ``Instructions for                                                              Manufacturers
 Requests for Certificate to Foreign Governments''                                                               Assistance; 1-800-638-
                                                                                                                 2041 or 301-827-0111 or
                                                                                                                 (FAX) Facts-on-Demand
                                                                                                                 (FOD) at 1-800-899-0381
                                                                                                                 or Internet at http://www.fda.gov/ cdrh/
                                                                                                                 ggpmain.html
--------------------------------------------------------------------------------------------------------------------------------------------------------
Commercial Distribution/Exhibit Letter                    April 10, 1992             OC                         Do                         246
--------------------------------------------------------------------------------------------------------------------------------------------------------
Color Additive Status List (Inspection Operations         February 1, 1989           OC                         Do                         268
 Manual)
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Guide for Validation of Biological Indicator          January 1, 1986            OC                         Do                         283
 Incubation Time
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53881]]

 
Guide for Establishing and Maintaining a Calibration      March 1, 1988              OC                         Do                         286
 Constancy Intercomparison System for Microwave Oven
 Compliance Survey Instruments (FDA 88-8264)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preproduction Quality Assurance Planning:                 September 1, 1989          OC                         Do                         295
 Recommendations for Medical Device Manufacturers (FDA
 90-4236)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Color Additive Petitions (p. 11-19 of PMA Manual)         June 1, 1987               OC                         Do                         296
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Preparation of PMA Manufacturing             August 1, 1992             OC                         Do                         448
 Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Civil Money Penalty Policy; Guidance for FDA Staff        June 8, 1999               OC                         Do                         1124
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Principles of Software Validation; Draft          June 9, 1997               OC                         Do                         938
 Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Classification Names for Medical Devices and In Vitro     March 1, 1995              OC                         Do                         10
 Diagnostic Products (FDA Pub. No. 95-4246)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cover Letter/Guidance Document on the Performance         March 9, 1998              OC                         Do                         1197
 Standard for Electrode Lead Wires and Patient Cable
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Tracking [FDAMA]; Guidance     January 24, 2000           OC                         Do                         169
 for Industry and FDA Staff
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Program Guidance Manual: Inspection of         August 12, 1999            OC                         Do                         1702
 Medical Devices; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Procedures for Laboratory Compliance Testing of           May 1, 1986                OC                         Do                         945
 Television Receivers--Part of TV Packet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 300.600 Commercial Distribution with Regard to       September 24, 1987         OC                         Do                         181
 Premarket Notification [510(k)] [CPG 7124.19]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Medical Device Manufacturer on Pentium          February 14, 1995          OC                         Do                         456
 Processors
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implementation of the Biomaterials Access Assurance Act   April 2, 2001              OC                         Do                         1324
 of 1998
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for the Monitoring of Clinical Investigations   January 1, 1988            OC                         Do                         428
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulating In Vitro Diagnostic Device (IVD) Studies;      December 17, 1999          OC/Division of             Do                         1132
 Guidance for FDA Staff                                                               Bioresearch Monitoring
                                                                                      (DBM)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparing Notices of Availability of Investigational      March 19, 1999             OC/DBM                     Do                         2229
 Medical Devices and for Recruiting Study Subjects
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Electrosurgical Devices and the Application   November 15, 1999          OC/Division of             Do                         1129
 of the Performance Standard for Electrode Lead Wires                                 Enforcement (DOE) I
 and Patient Cables
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Quality System Regulation Information for     August 3, 1999             OC/DOEII                   Do                         1140
 Various Premarket Submissions; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surveillance and Detention Without Physical Examination   July 26, 2000              OC/DOEII                   Do                         1141
 of Surgeons' and/or Patient Examination Gloves;
 Guidance for Industry--Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturers/Assemblers of Diagnostic X-Ray Systems:     October 13, 1993           OC/DOEI                    Do                         116
 Enforcement Policy for Positive-Beam Limitation (PBL)
 Requirements in 21 CFR 1020.31(g)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for the Submission of Initial Reports on            January 1, 1982            OC/DOEI                    Do                         257
 Diagnostic X-Ray Systems and their Major Components
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53882]]

 
Exemption From Reporting and Recordkeeping Requirements   September 16, 1981         OC/DOEI                    Do                         343
 for Certain Sunlamp Product Manufacturers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Medical Device Industry on Endoscopy and        May 17, 1993               OC/DOEI                    Do                         545
 Laparoscopy Accessories (Galdi)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clarification of Radiation Control Regulations for        March 1, 1989              OC/DOEI                    Do                         758
 Diagnostic X-Ray Equipment (FDA 89-8221)
--------------------------------------------------------------------------------------------------------------------------------------------------------
CPG 7133.19: Retention of Microwave Oven Test Record/     March 1, 1995              OC/DOEI                    Do                         880
 Cover Letter: 08/24, 1981 Retention of Records Required
 by 21 CFR [Part] 1002
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for the Manufacture of In Vitro Diagnostic      January 10, 1994           OC/DOEI                    Do                         918
 Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Guide for the Submission of Abbreviated Radiation       March 1, 1996              OC/DOEI                    Do                         977
 Safety Reports on Cephalometric X-Ray Devices: Defined
 as Dental Units With an Attachment for Mandible Work
 That Holds a Cassette and Beam Limiting Device
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Guide for the Submission of an Abbreviated Radiation    March 1, 1996              OC/DOEI                    Do                         978
 Safety Report on X-Ray Tables, Cradles, Film Changers
 or Cassette Holders Intended for Diagnostic Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Guide for the Submission of Abbreviated Radiation       March 1, 1996              OC/DOEI                    Do                         979
 Safety Reports on Image Receptor Support Devices for
 Mammographic X-Ray Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Program Guidance Manual; Field Compliance      March 15, 2000             OC/DOEI                    Do                         1133
 Testing of Diagnostic (Medical) X-Ray Equipment;
 Guidance for FDA Staff
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information Disclosure by Manufacturers to Assemblers     April 2, 2001              OC/DOEI                    Do                         2619
 for Diagnostic X-Ray Systems; Final Guidance for
 Industry and FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on Accelerators       April 1, 1971              OC/DOEI&III                Do                         235
 Intended to Emit X-Radiation Required Pursuant to 21
 CFR 1002.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abbreviated Reports on Radiation Safety for Microwave     August 1, 1995             OC/DOEI&III                Do                         236
 Products (Other Than Microwave Ovens)--E.G. Microwave
 Heating, Microwave Diathermy, RF Sealers, Induction,
 Dielectric Heaters, Security Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Reports on Radiation Safety of        March 1, 1985              OC/DOEI&III                Do                         239
 Microwave Ovens
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting Guide for Laser Light Shows and Displays (21    September 1, 1995          OC/DOEI&III                Do                         251
 CFR [Part] 1002) (FDA 88-8140)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Filing Annual Reports for X-Ray Components and  July 1, 1980               OC/DOEI&III                Do                         253
 Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting and Compliance Guide for Television Products    October 1, 1995            OC/DOEI&III                Do                         260
 Including Product Report, Supplemental Report,
 Radiation Safety Abbreviated Report, Annual Report,
 Information and Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Revised Guide for Preparing Annual Reports on Radiation   September 1, 1995          OC/DOEI&III                Do                         264
 Safety Testing of Laser and Laser Light Show Products
 (Replaces FDA 82-8127)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53883]]

 
Guide for Preparing Abbreviated Reports of Microwave and  September 1, 1996          OC/DOEI&III                Do                         399
 RF Emitting Electronic Products Intended for Medical
 Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Manufacturers and Importers of Microwave        October 31, 1988           OC/DOEI&III                Do                         697
 Ovens: Information Requirements for Cookbooks and User
 and Service Manuals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abbreviated Reports on Radiation Safety of Non-Medical    August 1, 1995             OC/DOEI&III                Do                         951
 Ultrasonic Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports for Medical           September 1, 1996          OC/DOEI&III                Do                         960
 Ultrasound Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter--Manufacturers, Distributors and Importers of      February 23, 1994          OC/DOEII                   Do                         52
 Condom Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter--Manufacturers, Importers, and Repackagers of      February 13, 1989          OC/DOEII                   Do                         53
 Condoms for Contraception or Sexually-Transmitted
 Disease Prevention (Holt)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter--Condom Manufacturers and Distributors             April 5, 1994              OC/DOEII                   Do                         56
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Manufacturers/Repackers Using Cotton            April 22, 1994             OC/DOEII                   Do                         101
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports for Lasers and        September 1, 1995          OC/DOEII                   Do                         277
 Products Containing Lasers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guide for Laser Products (FDA 86-8260)         September 1, 1985          OC/DOEII                   Do                         278
--------------------------------------------------------------------------------------------------------------------------------------------------------
Condoms: Inspection and Sampling at Domestic              April 8, 1987              OC/DOEII                   Do                         293
 Manufacturers and of All Repackers; Sampling From All
 Importers (Damaska Memo to Field on 4/8, 1987)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dental Handpiece Sterilization (Dear Doctor Letter)       September 28, 1992         OC/DOEII                   Do                         589
--------------------------------------------------------------------------------------------------------------------------------------------------------
Latex Labeling Letter (Johnson)                           March 18, 1993             OC/DOEII                   Do                         831
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pesticide Regulation Notice 94-4: Interim Measures for    June 30, 1994              OC/DOEII                   Do                         851
 the Registration of Antimicrobial Products/Liquid
 Chemical Germicides With Medical Device Use Claims
 Under the Memorandum of Understanding Between EPA and
 FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Industry, Powered Wheelchair Manufacturers      May 10, 1993               OC/DOEII                   Do                         869
 From RM Johnson
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hazards of Volume Ventilators and Heated Humidifiers      September 15, 1993         OC/DOEII                   Do                         901
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturers and Initial Distributors of Sharps          February 3, 1994           OC/DOEII                   Do                         933
 Containers and Destroyers Used by Health Care
 Professionals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene       June 23, 1978              OC/DOEII                   Do                         1019
 Glycol; Proposed Maximum Residue Limits and Maximum
 Levels of Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to: Manufacturers and Users of Lasers for          October 10, 1996           OC/DOEII                   Do                         1093
 Refractive Surgery [Excimer]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Shielded Trocars and Needles Used for Abdominal Access    August 23, 1996            OC/DOEII                   Do                         1122
 During Laparoscopy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surveillance and Detention Without Physical Examination   August 14, 2000            OC/DOEII                   Do                         1139
 of Condoms; Guidance for Industry; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
All U.S. Condom Manufacturers, Importers and Repackagers  April 7, 1987              OC/DOEII                   Do                         2510
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53884]]

 
Manufacturers and Initial Distributors of Hemodialyzers   May 23, 1996               OC/DOEII                   Do                         2507
--------------------------------------------------------------------------------------------------------------------------------------------------------
Laser Light Show Safety--Who's Responsible? (FDA 86-      May 1, 1986                OC/DOEIII                  Do                         13
 8262)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Suggested State Regulations for Control of Radiation--    January 1, 1982            OC/DOEIII                  Do                         70
 Volume II Nonionizing Radiation--Lasers (FDA Pub. No.
 83-8220)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to All Foreign Manufacturers and Importers of      May 28, 1981               OC/DOEIII                  Do                         231
 Electronic Products for Which Applicable FDA
 Performance Standards Exist
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on Industrial X-Ray   March 1, 1973              OC/DOEIII                  Do                         237
 Equipment Required Pursuant to 21 CFR 1002.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on Analytical X-Ray   April 30, 1974             OC/DOEIII                  Do                         240
 Equipment Required Pursuant to 21 CFR 1002.10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Cabinet X-Ray System       February 1, 1975           OC/DOEIII                  Do                         241
 Reports Pursuant to 21 CFR 1020.40
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on Radiation Safety    October 1, 1987            OC/DOEIII                  Do                         243
 Testing of Electronic Products (General)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Computerized Devices/Processes Guidance--Application of   May 1, 1992                OC/DOEIII                  Do                         247
 the Medical Device GMP to Computerized Devices and
 Manufacturing Processes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports for Ultrasonic        August 1, 1996             OC/DOEIII                  Do                         249
 Therapy Products (Physical Therapy Only)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Submission of Information on Industrial         September 1, 1980          OC/DOEIII                  Do                         254
 Radiofrequency Dielectric Heater and Sealer Equipment
 Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81-8137)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports for Ultrasonic         September 1, 1996          OC/DOEIII                  Do                         261
 Therapy Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on Radiation Safety    September 1, 1995          OC/DOEIII                  Do                         262
 Testing of Sunlamps and Sunlamp Products (Replaces FDA
 82-8127)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Annual Reports on Radiation Safety    September 1, 1995          OC/DOEIII                  Do                         263
 Testing of Mercury Vapor Lamps (Replaces FDA 82-8127)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quality Control Guide for Sunlamp Products (FDA 88-8234)  March 1, 1988              OC/DOEIII                  Do                         270
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for the Submission of Initial Reports on Computed   September 1, 1984          OC/DOEIII                  Do                         271
 Tomography X-Ray Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for Preparing Product Reports on Sunlamps and       September 1, 1995          OC/DOEIII                  Do                         279
 Sunlamp Products (21 CFR [Part] 1002)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter: Policy on Maximum Timer Interval and Exposure     August 21, 1986            OC/DOEIII                  Do                         342
 Schedule for Sunlamp Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting Guide for Product Reports on High Intensity     September 1, 1995          OC/DOEIII                  Do                         348
 Mercury Vapor Discharge Lamps (21 CFR [Part] 1002)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quality Control Practices for Compliance With the         May 1, 1980                OC/DOEIII                  Do                         349
 Federal Mercury Vapor Lamp Performance Standard
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53885]]

 
Keeping Up With the Microwave Revolution (FDA Pub. No.    March 1, 1990              OC/DOEIII                  Do                         356
 91-4160)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quality Assurance Guidelines for Hemodialysis Devices     February 1, 1991           OC/DOEIII                  Do                         507
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Manufacturers and Importers of Microwave        March 28, 1980             OC/DOEIII                  Do                         646
 Ovens--Open Door Operation of Microwave Ovens as a
 Result of Oven Miswiring
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting of New Model Numbers to Existing Model          June 14, 1983              OC/DOEIII                  Do                         675
 Families
--------------------------------------------------------------------------------------------------------------------------------------------------------
Import: Radiation-Producing Electronic Products (FDA 89-  November 1, 1988           OC/DOEIII                  Do                         756
 8008)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Unsafe Patient Lead Wires and Cables                      September 3, 1993          OC/DOEIII                  Do                         889
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application for a Variance from 21 CFR 1040.11(c) for a   July 1, 1998               OC/DOEIII                  Do                         903
 Laser Light Show, Display, or Device [Form FDA 3147]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Trade Association: Reuse of Single-Use or       December 27, 1995          OC/DOEIII                  Do                         961
 Disposable Medical Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Design Control Guidance for Medical Device Manufacturers  March 11, 1997             OC/DOEIII                  Do                         994
--------------------------------------------------------------------------------------------------------------------------------------------------------
Keeping Medical Devices Safe From Electromagnetic         July 1, 1995               OC/DOEIII                  Do                         1081
 Interference
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Devices and EMI: The FDA Perspective              January 1, 1995            OC/DOEIII                  Do                         1082
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Electromagnetic Interference Issues,                                  OC/DOEIII                  Do                         1086
 Problem Reports, Standards, and Recommendations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Safety of Electrically Powered Products: Letter to        September 18, 1996         OC/DOEIII                  Do                         1087
 Medical Device and Electronic Product Manufacturers
 From Lillian Gill and BHB Correction Memo
--------------------------------------------------------------------------------------------------------------------------------------------------------
Enforcement Priorities for Single-Use Devices             August 14, 2000            OC/DOEIII                  Do                         1168
 Reprocessed by Third Parties and Hospitals; Guidance
 for Industry and for FDA Staff
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling for Electronic Anti-Theft Systems; Guidance for  August 15, 2000            OC/DOEIII                  Do                         1170
 Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wireless Medical Telemetry Risks and Recommendations,     September 27, 2000         OC/DOEIII                  Do                         1173
 Guidance for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Policy on Warning Label Required on Sunlamp Products      June 25, 1985              OC/DOEIII                  Do                         1343
--------------------------------------------------------------------------------------------------------------------------------------------------------
Policy on Lamp Compatibility (Sunlamps)                   September 2, 1986          OC/DOEIII                  Do                         2343
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry on the Likelihood of Facilities     August 5, 1999             OC/Division of Program     Do                         1269
 Inspections When Modifying Devices Subject to Premarket                              Operations (DPO)
 Approval
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on IDE Policies and Procedures [FDAMA]; Final    January 20, 1998           Office of Device           Do                         882
                                                                                      Evaluation (ODE)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Color Additives for Medical Devices                       November 15, 1995          ODE                        Do                         575
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preamendment Class III Devices                            March 11, 1992             ODE                        Do                         584
--------------------------------------------------------------------------------------------------------------------------------------------------------
Viable Bacteriophage in CO2 Laser Plume: Aerodynamic      Date not available         ODE                        Do                         595
 Size Distribution
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Submitting Reclassification Petition         June 1, 1989               ODE                        Do                         609
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53886]]

 
Electromagnetic Compatibility for Medical Devices:        June 13, 1995              ODE                        Do                         639
 Issues and Solutions; Memorandum
--------------------------------------------------------------------------------------------------------------------------------------------------------
SMDA Changes--Premarket Notification; Regulatory          April 17, 1992             ODE                        Do                         655
 Requirements for Medical Devices [510(k)] Manual Insert
--------------------------------------------------------------------------------------------------------------------------------------------------------
``Real-Time'' Review Program for Premarket Approval       April 22, 1997             ODE                        Do                         673
 Application (PMA) Supplements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Classified Convenience Kits                               April 30, 1993             ODE                        Do                         789
--------------------------------------------------------------------------------------------------------------------------------------------------------
30-Day Notices and 135-Day PMA Supplements for            February 19, 1998          ODE                        Do                         795
 Manufacturing Method or Process Changes, Guidance for
 Industry and CDRH [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Suggested Content for Original IDE Application Cover      February 27, 1996          ODE                        Do                         797
 Letter--Version 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Device Specific Guidance Documents (List)                 May 11, 1993               ODE                        Do                         815
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Shell Development and Modular Review; Guidances for   November 6, 1998           ODE                        Do                         835
 the Medical Device Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Determination of Intended Use for 510(k) Devices--        January 30, 1998           ODE                        Do                         857
 Guidance for Industry and CDRH Staff [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Notification [510(k)] Status Request Form,      March 14, 1997             ODE                        Do                         858
 Revised
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH's 510(k)/IDE/PMA Refuse to Accept/Accept/File        June 30, 1993              ODE                        Do                         859
 Policies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Indications for Use Statement                             February 6, 1996           ODE                        Do                         879
--------------------------------------------------------------------------------------------------------------------------------------------------------
The New 510(k) Paradigm--Alternate Approaches to          March 20, 1998             ODE                        Do                         905
 Demonstrating Substantial Equivalence in Premarket
 Notifications; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preamendments Class III Strategy; SXAlpert                April 19, 1994             ODE                        Do                         611
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Industry, Powered Wheelchair/Scooter or         May 26, 1994               ODE                        Do                         883
 Accessory/Component Manufacturer From Susan Alpert,
 Ph.D., M.D.
--------------------------------------------------------------------------------------------------------------------------------------------------------
ODE Executive Secretary Guidance Manual                   August 7, 1987             ODE                        Do                         1338
--------------------------------------------------------------------------------------------------------------------------------------------------------
Modifications to Devices Subject to Premarket Approval--  August 6, 1998             ODE                        Do                         102
 The PMA Supplement Decision Making Process; Guidance
 for Industry; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH Submissions Coversheet [PMA/PDP/510k/IDE]            May 8, 1998                ODE                        Do                         147
--------------------------------------------------------------------------------------------------------------------------------------------------------
Procedures for Class II Device Exemptions from Premarket  February 19, 1998          ODE                        Do                         159
 Notification, Guidance for Industry and CDRH Staff
 [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Limulus Amebocyte Lysate; Reduction of Samples for        October 23, 1987           ODE                        Do                         178
 Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling Reusable Medical Devices for Reprocessing in     April 1, 1996              ODE                        Do                         198
 Health Care Facilities: FDA Reviewer Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Section 513(f)(2)--Evaluation of Automatic Class III  February 19, 1998          ODE                        Do                         199
 Designation; Guidance for Industry and CDRH Staff
 [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53887]]

 
Methods for Conducting Recall Effectiveness Checks        June 16, 1978              ODE                        Do                         225
--------------------------------------------------------------------------------------------------------------------------------------------------------
Suggestions for Submitting a Premarket Approval (PMA)     April 1, 1993              ODE                        Do                         228
 Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Off-the-Shelf Software Use in Medical        September 9, 1999          ODE                        Do                         1252
 Devices; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application of the Device Good Manufacturing Practice     December 1, 1983           ODE                        Do                         267
 (GMP) Regulation to the Manufacture of Sterile Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider in the Characterization of Cell Lines  June 1, 1984               ODE                        Do                         269
 Used to Produce Biological Products (From John C.
 Petricciani, M.D.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Early Collaboration Meetings Under the FDA Modernization  February 19, 1998          ODE                        Do                         310
 Act (FDAMA), Guidance for Industry and CDRH Staff
 [FDAMA]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format for IDE Progress Reports                           June 1, 1996               ODE                        Do                         311
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on PMA Interactive Procedures for Day-100        February 19, 1998          ODE                        Do                         322
 Meetings and Subsequent Deficiencies--For Use by CDRH
 and Industry [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Industry Representatives on Scientific Panels             March 27, 1987             ODE                        Do                         329
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Review Schedule [P87-1]                               March 31, 1988             ODE                        Do                         333
--------------------------------------------------------------------------------------------------------------------------------------------------------
Necessary Information for Diagnostic Ultrasound 510(k)    November 24, 1987          ODE                        Do                         335
 (Draft)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Submissions for     May 29, 1998               ODE                        Do                         337
 Software Contained in Medical Devices; Guidance for FDA
 and Reviewers and Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Master Files Part III; Guidance on Scientific and         June 1, 1987               ODE                        Do                         338
 Technical Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Quality Review Program (Blue Book Memo) (I96-1)    March 29, 1996             ODE                        Do                         344
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Policy for the Regulation of Computer Products        November 13, 1989          ODE                        Do                         351
 (Draft)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Threshold Assessment of the Impact of Requirements for    January 1, 1990            ODE                        Do                         352
 Submission of PMAs for 31 Medical Devices Marketed
 Prior to May 28, 1976
--------------------------------------------------------------------------------------------------------------------------------------------------------
4-of-A-Kind PMAs                                          October 1, 1991            ODE                        Do                         371
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supplements to Approved Applications for Class III        May 20, 1998               ODE                        Do                         380
 Medical Devices: Use Published Literature, Use of
 Previously Submitted Materials, and Priority Review
 [FDAMA]; Guidance for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Substantial Equivalence (SE) Decision Making              January 1, 1990            ODE                        Do                         390
 Documentation ATTACHED: ``SE'' Decision Making Process
 (Detailed), i.e., the Decision Making Tree
--------------------------------------------------------------------------------------------------------------------------------------------------------
Shelf Life of Medical Devices                             March 1, 1991              ODE                        Do                         415
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline on General Principles of Process Validation     May 1, 1987                ODE                        Do                         425
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline on Sterile Drug Products Produced by Aseptic    June 1, 1987               ODE                        Do                         426
 Processing
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53888]]

 
Guideline on Validation of the Limulus Amebocyte Lysate   December 1, 1987           ODE                        Do                         427
 (LAL) Test as an End-Product Endotoxin Test
--------------------------------------------------------------------------------------------------------------------------------------------------------
General/Specific Intended Use [FDAMA]; Draft Guidance     November 4, 1998           ODE                        Do                         499
 for Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Distribution and Public Availability of Premarket         October 10, 1997           ODE                        Do                         563
 Approval Application Summary of Safety and
 Effectiveness Data Packages [Blue Book Memo #P98-1];
 Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposal for Establishing Mechanisms for Setting Review   June 30, 1993              ODE                        Do                         931
 Priorities Using Risk Assessment and Allocating Review
 Resources and T93-28 dated 6/25, 1993, Device ``Fast
 Track'' Plan Announcement (Include with 926-930)
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Model Medical Device Development Process; Guidance    July 21, 1998              ODE                        Do                         1101
 for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Use of Standards in Substantial           March 12, 2000             ODE                        Do                         1131
 Equivalence Determinations; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and for FDA Reviewers;              August 9, 2000             ODE                        Do                         1135
 Interpretive Guidance on Section 216 of the Food and
 Drug Administration Modernization Act of 1997
--------------------------------------------------------------------------------------------------------------------------------------------------------
Evidence Models for the Least Burdensome Means to         September 1, 1999          ODE                        Do                         1154
 Market; Guidance for Industry and FDA Reviewers; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Questions and Answers for the FDA Reviewer Guidance:      September 3, 1996          ODE                        Do                         1198
 Labeling Reusable Medical Devices for Reprocessing in
 Health Care Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Deciding When to Submit a 510(k) for a Change to an       November 30, 2000          ODE                        Do                         1073
 Existing Wireless Telemetry Medical Device; Final
 Guidance for FDA Reviewers and Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Amended Procedures for Advisory Panel         July 22, 2000              ODE                        Do                         413
 Meetings
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Devices Containing Materials Derived From Animal  November 16, 1998          ODE                        Do                         2206
 Sources (Except for In Vitro Diagnostic Devices),
 Guidance for FDA Reviewers and Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Frequently Asked Questions on the New 510(k) Paradigm;    October 22, 1998           ODE                        Do                         2230
 Guidance for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
The Least Burdensome Provisions of the FDA Modernization  May 3, 2001                ODE                        Do                         1332
 Act of 1997: Concept and Principles; Draft Guidance for
 FDA and Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for   September 12, 1994         ODE Division of            Do                         97
 Conventional and Antimicrobial Foley Catheters                                       Reproductive, Abdominal,
                                                                                      and Radiological Devices
                                                                                      (DRARD)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Checklist for Mechanical Lithotripters and Stone          November 1, 1994           ODE/DRARD                  Do                         98
 Dislodgers Used in Gastroenterology and Urology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Convenience Kits Interim Regulatory Guidance (Include     May 20, 1997               ODE/510K                   Do                         562
 874)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53889]]

 
Announcement: Implementation of the FDA/HCFA Interagency  September 15, 1995         ODE/BlueBook               Do                         106
 Agreement Regarding Reimbursement Categorization of
 Investigational Devices, Att. A Interagency Agreement,
 Att. B Criteria for Categorization of Investigational
 Devices #D95-2 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consolidated Review of Submissions for Diagnostic         October 19, 1990           ODE/BlueBook               Do                         30
 Ultrasound Equipment, Accessories and Related
 Measurement Devices #G90-2 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consolidated Review of Submissions for Lasers and         October 19, 1990           ODE/BlueBook               Do                         31
 Accessories #G90-1 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of Final Draft Medical Device Labeling #P91-4      August 29, 1991            ODE/BlueBook               Do                         34
 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of 510(k)s for Computer Controlled Medical         August 29, 1991            ODE/BlueBook               Do                         35
 Devices #K91-1 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Use of International Standard ISO-10993, ``Biological     May 1, 1995                ODE/BlueBook               Do                         164
 Evaluation of Medical Devices Part 1: Evaluation and
 Testing'' (Replaces #G87-1 #8294) (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
ODE Regulatory Information for the Office of Compliance-- May 15, 1987               ODE/BlueBook               Do                         276
 Information Sharing Procedures #G87-2 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Panel Review of ``Me-Too'' Devices #P86-6 (Blue Book      July 1, 1986               ODE/BlueBook               Do                         280
 Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Center for Devices and Radiological       June 30, 1986              ODE/BlueBook               Do                         289
 Health's Premarket Notification Review Program #K86-3
 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Filing Decisions #P90-2 (Blue Book Memo)              May 18, 1990               ODE/BlueBook               Do                         297
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMAs--Early Review and Preparation of Summaries of        January 27, 1986           ODE/BlueBook               Do                         302
 Safety and Effectiveness #P86-1 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Criteria for Panel Review of PMA Supplements #P86-3       January 30, 1986           ODE/BlueBook               Do                         304
 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review and Approval of PMAs of Licensees #P86-4 (Blue     October 22, 1990           ODE/BlueBook               Do                         305
 Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Panel Report and Recommendations on PMA Approvals #P86-5  April 18, 1986             ODE/BlueBook               Do                         306
 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Sign-Off Procedures #K94-2 (Blue Book Memo)        June 3, 1994               ODE/BlueBook               Do                         308
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of Laser Submissions #G88-1 (Blue Book Memo)       April 15, 1988             ODE/BlueBook               Do                         330
--------------------------------------------------------------------------------------------------------------------------------------------------------
Delegation of IDE Actions #D88-1 (Blue Book Memo)         April 26, 1988             ODE/BlueBook               Do                         331
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Notification--Consistency of Reviews #K89-1     February 28, 1989          ODE/BlueBook               Do                         339
 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Telephone Communications Between ODE Staff and            January 29, 1993           ODE/BlueBook               Do                         360
 Manufacturers #I93-1 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Sterility Review Guidance--and Revision of 11/18/  February 12, 1990          ODE/BlueBook               Do                         361
 1994 #K90-1 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review of IDEs for Feasibility Studies #D89-1 (Blue Book  May 17, 1989               ODE/BlueBook               Do                         362
 Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53890]]

 
Toxicology Risk Assessment Committee #G89-1 (Blue Book    August 9, 1989             ODE/BlueBook               Do                         363
 Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Assignment of Review Documents #I90-2 (Blue Book Memo)    August 24, 1990            ODE/BlueBook               Do                         366
--------------------------------------------------------------------------------------------------------------------------------------------------------
Meetings With the Regulated Industry #I89-3 (Blue Book    November 20, 1989          ODE/BlueBook               Do                         367
 Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Policy Development and Review Procedures #I90-1 (Blue     February 15, 1990          ODE/BlueBook               Do                         368
 Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Supplements: ODE Letter to Manufacturers; Identifies  April 24, 1990             ODE/BlueBook               Do                         387
 Situations Which May Require the Submission of a PMA
 Supplement (When PMA Supplements Are Required) #P90-1
 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Refuse to Accept Procedures #K94-1 (Blue Book      May 20, 1994               ODE/BlueBook               Do                         401
 Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Refuse to File Procedures #P94-1 (Blue Book Memo)     May 20, 1994               ODE/BlueBook               Do                         402
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Approval Application (PMA) Closure #P94-2       July 8, 1994               ODE/BlueBook               Do                         403
 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA/510(k) Triage Review Procedures #G94-1 (Blue Book     May 20, 1994               ODE/BlueBook               Do                         404
 Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Goals and Initiatives for the IDE Program #D95-1 (Blue    July 12, 1995              ODE/BlueBook               Do                         405
 Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cover Letter: 510(k) Requirements During Firm-Initiated   November 21, 1995          ODE/BlueBook               Do                         406
 Recalls; Attachment A: Guidance on Recall and Premarket
 Notification Review Procedures During Firm-Initiated
 Recalls of Legally Marketed Devices (Blue Book Memo
 #K95-1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
IDE Refuse to Accept Procedures #D94-1 (Blue Book Memo)   May 20, 1994               ODE/BlueBook               Do                         410
--------------------------------------------------------------------------------------------------------------------------------------------------------
Device Labeling Guidance #G91-1 (Blue Book Memo)          March 8, 1991              ODE/BlueBook               Do                         414
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Utility and Premarket Approval #P91-1 (Blue      May 3, 1991                ODE/BlueBook               Do                         443
 Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Panel Review of Premarket Approval Applications #P91-2    May 3, 1991                ODE/BlueBook               Do                         444
 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Compliance Program #P91-3 (Blue Book Memo)            May 3, 1991                ODE/BlueBook               Do                         445
--------------------------------------------------------------------------------------------------------------------------------------------------------
Document Review Processing #I91-1 (Blue Book Memo)        February 12, 1992          ODE/BlueBook               Do                         446
--------------------------------------------------------------------------------------------------------------------------------------------------------
Integrity of Data and Information Submitted to ODE #I91-  May 29, 1991               ODE/BlueBook               Do                         447
 2 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nondisclosure of Financially Sensitive Information #I92-  March 5, 1992              ODE/BlueBook               Do                         587
 1 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Memorandum of Understanding Regarding Patient Labeling    August 9, 1996             ODE/BlueBook               Do                         806
 Review (Blue Book Memo #G96-3))
--------------------------------------------------------------------------------------------------------------------------------------------------------
Continued Access to Investigational Devices During PMA    July 15, 1996              ODE/BlueBook               Do                         872
 Preparation and Review (Blue Book Memo) (D96-1)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53891]]

 
510(k) Additional Information Procedures #K93-1 (Blue     July 23, 1993              ODE/BlueBook               Do                         886
 Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Overdue IDE Annual Progress Report Procedures #D93-1      July 23, 1993              ODE/BlueBook               Do                         887
 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Documentation and Resolution of Differences of Opinion    December 23, 1993          ODE/BlueBook               Do                         920
 on Product Evaluations #G93-1 (Blue Book Memo)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Deciding When to Submit a 510(k) for a Change to an       January 10, 1997           ODE/BlueBook               Do                         1935
 Exisiting Device; (Blue Book Memo #K97-1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interagency Agreement Between FDA and HCFA; #D95-2,       September 15, 1995         ODE/BlueBook               Do                         2106
 Attachment A
--------------------------------------------------------------------------------------------------------------------------------------------------------
Executive Secretaries Guidance Manual #G87-3              August 7, 1987             ODE/BlueBook               Do                         2326
--------------------------------------------------------------------------------------------------------------------------------------------------------
Criteria for Categorization of Investigational Devices    September 15, 1995         ODE/BlueBook               Do                         3106
 (HCFA); #D95-2, Attachment B
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Devices and Radiological Health's Premarket    June 30, 1993              ODE/BlueBook               Do                         3859
 Notification [510(k)] Refuse to Accept Policy--(Updated
 Checklist March 14, 1995)
--------------------------------------------------------------------------------------------------------------------------------------------------------
HCFA Reimbursement Categorization Determinations for FDA- October 31, 1995           ODE/BlueBook               Do                         4106
 Approved IDEs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Devices and Radiological Health's              June 30, 1993              ODE/BlueBook               Do                         4859
 Investigational Device Exemption (IDE) Refuse to Accept
 Policy
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Prescription Use Drugs of Abuse Assays       November 14, 2000          ODE Division of Clinical   Do                         152
 Premarket Notifications; Guidance for Industry and/or                                Laboratory Devices
 for FDA Reviewers/Staff and/or Compliance; Draft                                     (DCLD)
 Guidance--Not for Implementation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of In Vitro Diagnostic     August 31, 1995            ODE/DCLD                   Do                         1191
 Devices for Drugs of Abuse Assays Using Various
 Methodologies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Labeling for Over-the-Counter Sample         December 21, 1999          ODE/DCLD                   Do                         1359
 Collection Systems for Drugs of Abuse Testing; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro Diagnostic Devices for the   February 1, 1994           ODE/DCLD                   Do                         51
 Assessment of Thyroid Autoantibodies Using Indirect
 Immunofluorescence Assay (IFA), Indirect
 Hemagglutination Assay (IHA), Radioimmunoasay (RIA),
 and Enzyme Linked Immunosorbent Assay (ELISA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Blood Culture Systems                 August 12, 1991            ODE/DCLD                   Do                         82
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for Collection of Data in Support of   September 26, 1994         ODE/DCLD                   Do                         95
 In Vitro Device Submissions for 510(k) Clearance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for Portable Blood Glucose Monitoring  February 20, 1996          ODE/DCLD                   Do                         122
 Devices Intended for Bedside Use in the Neonate Nursery
--------------------------------------------------------------------------------------------------------------------------------------------------------
Criteria for Assessment of In Vitro Diagnostic Devices    August 31, 1995            ODE/DCLD                   Do                         1191
 for Drugs of Abuse Assays Using Various Methodologies;
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Rheumatoid Factor (RF)  February 21, 1997          ODE/DCLD                   Do                         165
 In Vitro Diagnostic Devices Using Enzyme-Linked
 Immunoassay (EIA), Enzyme Linked Immunosorbent Assay
 (ELISA), Particle Agglutination Tests, and Laser and
 Rate Nephelometry
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53892]]

 
Assessing the Safety/Effectiveness of Home-Use In Vitro   October 1, 1988            ODE/DCLD                   Do                         272
 Diagnostic Devices (IVDs): Points to Consider Regarding
 Labeling and Premarket Submissions; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Submission of Immunohistochemistry           June 3, 1998               ODE/DCLD                   Do                         364
 Applications to the FDA; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Cytogenetic Analysis    July 15, 1991              ODE/DCLD                   Do                         417
 Using Automated and Semi-Automated Chromosome Analyzers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Alpha-Fetoprotein       July 15, 1994              ODE/DCLD                   Do                         459
 (AFP) In Vitro Diagnostic Devices for Fetal Open Neural
 Tube Defects Using Immunological Test Methodologies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for 510(k) Submission of Lymphocyte              September 26, 1991         ODE/                       Do                         475
 Immunophenotyping IVDs using Monoclonal Antibodies;
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for Hematology Quality Control         September 30, 1997         ODE/DCLD                   Do                         512
 Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro Diagnostic Devices for       August 1, 1992             ODE/DCLD                   Do                         527
 Detection of IGM Antibodies to Viral Agents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for Review of Calibration and Quality  February 1, 1996           ODE/DCLD                   Do                         553
 Control Labeling for In Vitro Diagnostic Devices/Cover
 Letter Dated March 14, 1996
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Devices Intended for the Detection    December 30, 1991          ODE/DCLD                   Do                         554
 of Hepatitis B ``e'' Antigen and Antibody to HBe
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Criteria for Cyclosporine PMAs                   January 24, 1992           ODE/DCLD                   Do                         564
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Laboratory Tests for    September 17, 1992         ODE/DCLD                   Do                         588
 the Detection of Antibodies to Helicobacter Pylori
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Human Chorionic         September 27, 1995         ODE/DCLD                   Do                         592
 Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarketing Approval Review Criteria for Premarket       September 10, 1992         ODE/DCLD                   Do                         603
 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Portable Blood Glucose  February 14, 1996          ODE/DCLD                   Do                         604
 In Vitro Diagnostic Devices Using Glucose Oxidase,
 Dehydrogenase, or Hexokinase Methodology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for 510(k)s on Cholesterol Tests for Clinical    July 14, 1995              ODE/DCLD                   Do                         605
 Laboratory, Physicians' Office Laboratory, and Home Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Devices Assisting in the Diagnosis    May 31, 1990               ODE/DCLD                   Do                         629
 of C. Difficile Associated Diseases
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for 510(k) Submission of                September 30, 1991         ODE/DCLD                   Do                         658
 Glycohemoglobin (Glycated or Glycosylated) Hemoglobin
 for IVDs; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria For Premarket Approval of In Vitro        May 15, 1992               ODE/DCLD                   Do                         770
 Diagnostic Devices for Detection of Antibodies to
 Parvovirus B19
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53893]]

 
Guidance Document for 510(k) Submission of Fecal Occult   July 29, 1992              ODE/DCLD                   Do                         772
 Blood Tests; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of In Vitro Diagnostic     January 1, 1992            ODE/DCLD                   Do                         778
 Devices for Direct Detection of Chlamydiae in Clinical
 Specimens
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for 510(k) Submission of                September 1, 1992          ODE/DCLD                   Do                         785
 Immunoglobulins A, G, M, D and E Immunoglobulin System
 In Vitro Devices; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for the Assessment of Allergen-Specific   March 2, 1993              ODE/DCLD                   Do                         800
 Immunoglobulin E (IGE) In Vitro Diagnostic Devices
 Using Immunological Test Methodologies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for the Assessment of Anti-Nuclear        September 1, 1992          ODE/DCLD                   Do                         848
 Antibodies (ANA) In Vitro Diagnostic Devices Using
 Indirect Immunofluorescence Assay (IFA),
 Immunodiffusion (IMD) and Enzyme Linked Immunosorbant
 Assay (ELISA).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Nucleic Acid Amplification Based In   June 14, 1993              ODE/DCLD                   Do                         861
 Vitro Diagnostic Devices for Direct Detection of
 Infectious Microorganisms; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of In Vitro Diagnostic     July 6, 1993               ODE/DCLD                   Do                         862
 Devices for Direct Detection of Mycobacterium Spp.
 [Tuberculosis (TB)]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data for Commercialization of Original Equipment          June 10, 1996              ODE/DCLD                   Do                         950
 Manufacturer, Secondary and Generic Reagents for
 Automated Analyzers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Submission of Tumor Associated  September 19, 1996         ODE/DCLD                   Do                         957
 Antigen Premarket Notification [510(k)] to FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider for Cervical Cytology Devices          July 25, 1994              ODE/DCLD                   Do                         968
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for In Vitro Diagnostic Devices That      February 15, 1996          ODE/DCLD                   Do                         980
 Utilize Cytogenetic In Situ Hybridization Technology
 for the Detection of Human Genetic Mutations (Germ Line
 and Somatic)
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test       July 6, 1998               ODE/DCLD                   Do                         1102
 System; Guidance for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Chloride Test System; Guidance for    July 6, 1998               ODE/DCLD                   Do                         1103
 Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Creatinine Test System; Guidance for  July 2, 1998               ODE/DCLD                   Do                         1104
 Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Glucose Test System; Guidance for     July 6, 1998               ODE/DCLD                   Do                         1105
 Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Potassium Test System; Guidance for   July 6, 1998               ODE/DCLD                   Do                         1107
 Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Sodium Test System; Guidance for      July 6, 1998               ODE/DCLD                   Do                         1109
 Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Urea Nitrogen Test System; Guidance   July 6, 1998               ODE/DCLD                   Do                         1110
 for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Administrative Procedures for CLIA           August 14, 2000            ODE/DCLD                   Do                         1143
 Categorization; Guidance for Industry and/or for FDA
 Reviewers/Staff and/or Compliance; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53894]]

 
Guidance for Clinical Laboratory Improvement Amendments   March 1, 2001              ODE/DCLD                   Do                         1147
 of 1988 (CLIA) Criteria for Waiver; Draft Guidance for
 Industry and FDA Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Over-the-Counter (OTC) Ovulation Predictor   July 22, 2000              ODE/DCLD                   Do                         1171
 510(k)s
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Over-the-Counter (OTC) Human Chorionic       July 22, 2000              ODE/DCLD                   Do                         1172
 Gonadotropin (hCG) 510(k)s
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Review Criteria for Assessment of             March 8, 2000              ODE/DCLD                   Do                         631
 Antimicrobial Susceptibility Devices; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic C-Reactive Protein Immunological      July 20, 1998              ODE/DCLD                   Do                         1246
 Test System; Guidance for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abbreviated 510(k) Submissions for In Vitro Diagnostic    February 22, 1999          ODE/DCLD                   Do                         1247
 Calibrators; Guidance for Industry: Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Labeling for Laboratory Tests; Guidance for   June 24, 1999              ODE/DCLD                   Do                         1352
 Industry; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Approval Applications for Assays Pertaining to  October 8, 1999            ODE/DCLD                   Do                         1353
 Hepatitis C Viruses (HCV) That Are Indicated for
 Diagnosis or Monitoring of HCV Infection or Associated
 Disease; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Class II Special Control Guidance Document for Anti-      August 23, 2000            ODE/DCLD                   Do                         1183
 Saccharomyces Cerevisiae (S. Cerevisiae) Antibody
 (ASCA) Premarket Notifications; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Premarket Notifications for Automated        November 1, 2000           ODE/DCLD                   Do                         1184
 Differential Cell Counters for Immature or Abnormal
 Blood Cells; Final; Guidance for Industry and FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Antimicrobial           October 30, 1996           ODE/DCLD                   Do                         1631
 Susceptibility Test Discs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Over the Counter (OTC) Screening Tests for Drugs of       November 14, 2000          ODE/DCLD                   Do                         2209
 Abuse: Guidance for Premarket Notifications; Guidance
 for Industry; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider Guidance Document on Assayed and       February 3, 1999           ODE/DCLD                   Do                         2231
 Unassayed Quality Control Material; Guidance for
 Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Document for Special Controls for Erythropoietin Assay    April 28, 1999             ODE/DCLD                   Do                         2241
 Premarket Notifications [510(k)s]; Guidance for
 Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Fibrin Monomer Paracoagulation Test;  April 27, 1999             ODE/DCLD                   Do                         2242
 Guidance for Industry and FDA Reviewers/Staff; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Class II Special Control Guidance Document for B-Type     November 30, 2000          ODE/DCLD                   Do                         1072
 Natriuretic Peptide Premarket Notifications; Final
 Guidance for Industry and FDA Reviewers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Electrical Safety, Electromagnetic           June 28, 2000              ODE Division of            Do                         1161
 Compatibility and Mechanical Testing for Indwelling                                  Cardiovascular and
 Blood Gas Analyzer Premarket Notification Submissions                                Respiratory Devices
                                                                                      (DCRD)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Research and Marketing     November 1, 2000           ODE/DCRD                   Do                         372
 Applications for Permanent Pacemaker Leads and for
 Pacemaker Lead Adaptor 510(k) Submissions; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53895]]

 
Investigational Device Exemption (IDE) Study Enrollment   November 8, 2000           ODE/DCRD                   Do                         1199
 for Cardiac Ablation of Typical Atrial Flutter; Final
 Guidance for Industry and FDA Reviewers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Vascular Prostheses 510(k)          November 1, 2000           ODE/DCRD                   Do                         1357
 Submissions; Guidance for Industry and FDA Staff; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Annuloplasty Rings 510(k) Submissions;       January 31, 2001           ODE/DCRD                   Do                         1358
 Final Guidance for Industry and FDA Staff
--------------------------------------------------------------------------------------------------------------------------------------------------------
1-Consolidated Annual Report for a Device Product Line    July 6, 2000               ODE/DCRD                   Do                         1167
 (1-CARD); Pilot for Preparation of Annual Reports for
 Pacemaker Premarket Approval Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Excerpts Related to EMI From November 1993                November 1, 1993           ODE/DCRD                   Do                         638
 Anesthesiology and Respiratory Devices Branch
 (Including Electromagnetic Compatibility Standard for
 Medical Devices; 10/1/79)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Infant/Child Apnea Monitor 510(k)            September 22, 2000         ODE/DCRD                   Do                         1178
 Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and for FDA Reviewers: Recommended  May 7, 1999                ODE/DCRD                   Do                         2244
 Clinical Study Design for Ventricular Tachycardia
 Ablation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Electro-Optical Sensors for the    August 25, 1999            ODE/DCRD                   Do                         266
 In Vivo Detection of Cervical Cancer and its
 Precursors: Submission Guidance for an IDE/PMA; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Cardiovascular Intravascular Filter 510(k)   November 26, 1999          ODE/DCRD                   Do                         24
 Submission; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of 510(k) Premarket           February 11, 1997          ODE/DCRD                   Do                         25
 Notifications for Electrocardiograph (ECG) Electrode--
 Version 1.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of 510(k) Premarket           February 11, 1997          ODE/DCRD                   Do                         26
 Notifications for Electrocardiograph (ECG) Lead
 Switching Adapter--Version 1.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document Device: Electrocardiograph (ECG)        February 11, 1997          ODE/DCRD                   Do                         27
 Surface Electrode Tester--Version 1.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance Outline--Points to Consider for Clinical   November 30, 1993          ODE/DCRD                   Do                         100
 Studies for Vasovasostomy Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Labeling--Suggested Format and Content;    April 25, 1997             ODE/DCRD                   Do                         119
 Draft Document
--------------------------------------------------------------------------------------------------------------------------------------------------------
Non-Invasive Blood Pressure (NIBP) Monitor Guidance       March 10, 1997             ODE/DCRD                   Do                         123
--------------------------------------------------------------------------------------------------------------------------------------------------------
Policy for Expiration Dating (DCRD RB92-G)                October 30, 1992           ODE/DCRD                   Do                         137
--------------------------------------------------------------------------------------------------------------------------------------------------------
Human Heart Valve Allografts; Draft                       June 21, 1991              ODE/DCRD                   Do                         224
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Extracorporeal Blood Circuit Defoamer        February 16, 2000          ODE/DCRD                   Do                         1632
 510(k) Submissions; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Cardiopulmonary Bypass Arterial Line Blood   February 21, 2000          ODE/DCRD                   Do                         1622
 Filter 510(k) Submissions; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Balloon Valvuloplasty Guidance for the Submission of an   January 1, 1989            ODE/DCRD                   Do                         370
 IDE Application and a PMA Application
--------------------------------------------------------------------------------------------------------------------------------------------------------
Replacement Heart Valve Guidance; Draft                   October 14, 1994           ODE/DCRD                   Do                         375
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53896]]

 
Implantable Pacemaker Testing Guidance                    January 12, 1990           ODE/DCRD                   Do                         383
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter/Guidance: Vascular Graft Manufacturer, Developer,  May 11, 1990               ODE/DCRD                   Do                         391
 or Representative
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance for Ventilators; Draft                  July 1, 1995               ODE/DCRD                   Do                         500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Urological Irrigation System   August 1, 1995             ODE/DCRD                   Do                         515
 and Tubing Set
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance to Firms on Biliary Lithotripsy Studies    August 2, 1990             ODE/DCRD                   Do                         522
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Clinical Investigations of Devices     November 11, 1994          ODE/DCRD                   Do                         533
 Used for the Treatment of Benign Prostatic Hyperplasia
 (BPH)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter: Notice to Manufacturers of Bone Mineral           September 25, 1997         ODE/DCRD                   Do                         552
 Densitometers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information for Manufacturers Seeking Marketing           September 30, 1997         ODE/DCRD                   Do                         560
 Clearance of Diagnostic Ultrasound Systems and
 Transducers: Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of Premarket               January 24, 1992           ODE/DCRD                   Do                         567
 Notifications for Urological Balloon Dilatation
 Catheters
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for the Arrangement and Content of a Premarket  May 1, 1990                ODE/DCRD                   Do                         577
 Approval (PMA) Application for a Cochlear Implant in
 Adults at Least 18 Years of Age
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of the Annual Report to the  April 1, 1990              ODE/DCRD                   Do                         582
 PMA Approved Heart Valve Prostheses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Version: Electrode Recording Catheter Preliminary   March 1, 1995              ODE/DCRD                   Do                         602
 Guidance (Data to Be Sumitted to the FDA in Support of
 Premarket Notifications [510(k)s])
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cardiac Ablation Preliminary Guidance (Data to Be         March 1, 1995              ODE/DCRD                   Do                         619
 Submitted to the FDA in Support Investigation Device
 Exemption Application; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Testing Guidelines for Falloposcopes            November 20, 1992          ODE/DCRD                   Do                         621
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Evaluation of Non-Drug IUDs                September 28, 1976         ODE/DCRD                   Do                         641
--------------------------------------------------------------------------------------------------------------------------------------------------------
Simplified 510(k) procedures for certain radiology        December 21, 1993          ODE/DCRD                   Do                         708
 devices: 12/21, 1993, letter from L Yin, ODE/ODE/DRARD,
 to NEMA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Endoscopic Electrosurgical     August 16, 1995            ODE/DCRD                   Do                         768
 Unit (ESU) and Accessories Used in Gastroenterology and
 Urology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Heated Humidifier Review Guidance                         August 30, 1991            ODE/DCRD                   Do                         780
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance for Nebulizers, Metered Dose Inhalers,  October 1, 1993            ODE/DCRD                   Do                         784
 Spacers and Actuators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer Guidance for Automatic X-Ray Film Processor      February 1, 1990           ODE/DCRD                   Do                         788
 510(k)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Technical Content of a Premarket         April 1, 1990              ODE/DCRD                   Do                         791
 Approval (PMA) Application for an Endolymphatic Shunt
 Tube With Valve
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Magnetic Resonance Diagnostic Devices--      September 29, 1997         ODE/DCRD                   Do                         793
 Criteria for Significant Risk Investigations
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53897]]

 
Draft Guidance for Preparation of PMA Applications for    March 16, 1993             ODE/DCRD                   Do                         809
 Testicular Prostheses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA Applications for    March 16, 1993             ODE/DCRD                   Do                         810
 Penile Inflatable Implants
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of Premarket               May 30, 1997               ODE/DCRD                   Do                         842
 Notifications for Water Purification Components and
 Systems for Hemodialysis
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Research and Marketing     May 1, 1995                ODE/DCRD                   Do                         846
 Applications for Interventional Cardiology Devices:
 PTCA Catheters, Atherectomy Catheters, Lasers,
 Intravascular Stents; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Preclinical and Clinical               November 29, 1995          ODE/DCRD                   Do                         850
 Investigations of Urethral Bulking Agents Used in the
 Treatment of Urinary Incontinence
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Review of Bone Densitometer 510(k)     November 9, 1992           ODE/DCRD                   Do                         866
 Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Battery Guidance                                          July 12, 1993              ODE/DCRD                   Do                         873
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of Research and Marketing    August 1, 1993             ODE/DCRD                   Do                         885
 Applications for Vascular Graft Prostheses; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Checklist for Sterile Lubricating Jelly Used With  September 19, 1994         ODE/DCRD                   Do                         892
 Transurethral Surgical Instruments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Hemodialyzer Reuse Labeling            October 6, 1995            ODE/DCRD                   Do                         899
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hysteroscopes and Gynecology Laparoscopes--Submission     March 27, 1996             ODE/DCRD                   Do                         907
 Guidance for a 510(k)--Includes 00192
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of Premarket               July 29, 1991              ODE/DCRD                   Do                         953
 Notifications for Loop and Rollerball Electrodes for
 GYN Electrosurgical Excisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intravascular Brachytherapy--Guidance for Data to be      May 24, 1996               ODE/DCRD                   Do                         955
 Submitted to the Food and Drug Administration in
 Support of Investigational Device Exemption (IDE)
 Applications; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percutaneous Transluminal Coronary Angioplasty Package    February 7, 1995           ODE/DCRD                   Do                         959
 Insert Template; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Coronary and Cerebrovascular Guidewire Guidance           January 1, 1995            ODE/DCRD                   Do                         964
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Implantable Cardioverter-Defibrillators;     June 24, 1996              ODE/DCRD                   Do                         965
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carotid Stent--Suggestions for Content of Submissions to  October 26, 1996           ODE/DCRD                   Do                         974
 the Food and Drug Administration in Support of
 Investigational Devices Exemption (IDE) Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Emergency Resuscitator Guidance; Draft                    April 14, 1993             ODE/DCRD                   Do                         985
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Guidelines for Oxygen Generators and Oxygen        April 14, 1993             ODE/DCRD                   Do                         986
 Equipment; Draft Document
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Condom Catheters               February 23, 1995          ODE/DCRD                   Do                         991
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH Interim Regulatory Policy for External Penile        September 10, 1997         ODE/DCRD                   Do                         992
 Rigidity Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53898]]

 
Reviewer Guidance on Face Masks and Shield for CPR;       March 16, 1994             ODE/DCRD                   Do                         996
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Guidance Document: Non-Invasive Pulse Oximeter    September 7, 1992          ODE/DCRD                   Do                         997
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Peak Flow Meters for Over-the-Counter Sale   June 23, 1992              ODE/DCRD                   Do                         998
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(K) Submission Requirements for Peak Flow Meters;      January 13, 1994           ODE/DCRD                   Do                         999
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA; Guidance for Indwelling    February 21, 2000          ODE/DCRD                   Do                         1126
 Blood Gas Analyzer 510(k) Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Premarket Notification Submission   January 24, 2000           ODE/DCRD                   Do                         1157
 for Nitric Oxide Delivery Apparatus, Nitric Oxide
 Analyzer and Nitrogen Dioxide Analyzer; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Latex Condoms for Men--Information for 510(k) Premarket   July 23, 1998              ODE/DCRD                   Do                         1250
 Notifications: Use of Consensus Standards for
 Abbreviated Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Uniform Contraceptive Labeling;    July 23, 1998              ODE/DCRD                   Do                         1251
 Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Cardiopulmonary Bypass Oxygenators 510(k)    January 17, 2000           ODE/DCRD                   Do                         1361
 Submissions; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for   January 16, 2000           ODE/DCRD                   Do                         177
 Penile Rigidity Implants; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federal Register Notice; Devices Used for In Vitro        September 10, 1998         ODE/DCRD                   Do                         1620
 Fertilization and Related Assisted Reproduction
 Procedures: Submission Guidance for a 510(k); Draft;
 Availability
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hysteroscopic and Laparoscopic Insufflators: Submission   August 1, 1995             ODE/DCRD                   Do                         1907
 Guidance for a 510(k)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and CDRH Reviewers--Guidance for    August 7, 1998             ODE/DCRD                   Do                         2202
 the Content of Premarket Notifications for Hemodialysis
 Delivery Systems; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Noise Claims in Hearing Aid Labeling; Final               October 21, 1998           ODE/DCRD                   Do                         2210
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Diagnostic ECG Guidance            November 5, 1998           ODE/DCRD                   Do                         2232
 (Including Non-Alarming ST Segment Measurement); Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Cardiac Monitor Guidance           November 5, 1998           ODE/DCRD                   Do                         2233
 (including Cardiotachometer and Rate Alarm); Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Harmonic Imaging With/Without      November 16, 1998          ODE/DCRD                   Do                         2234
 Contrast--Premarket Notification; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance for the Content of        November 30, 1998          ODE/DCRD                   Do                         2235
 Premarket Notifications for Intracorporeal
 Lithotripters; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance for the Submission of     November 20, 1998          ODE/DCRD                   Do                         2238
 Premarket Notifications for Radionuclide Dose
 Calibrators; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Non-Automated Sphygmomanometer     November 19, 1998          ODE/DCRD                   Do                         2239
 (Blood Pressure Cuff) Guidance; Version 1; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53899]]

 
Guidance for Industry--Guidance for the Submission of     December 3, 1998           ODE/DCRD                   Do                         2240
 Premarket Notifications for Emission Computed
 Tomography Devices and Accessories (SPECT and PET) and
 Nuclear Tomography Systems; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for   February 5, 1998           ODE/DCRD                   Do                         2243
 Metal Expandable Biliary Stents; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of 510(k)'s for Solid State   August 6, 1999             ODE/DCRD                   Do                         644
 X-Ray Imaging Devices; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Class II Special Control Guidance Document for Acute      July 30, 2000              ODE/DCRD                   Do                         1138
 Upper Airway Obstruction Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Conducting Stability Testing to Support an   November 16, 1999          ODE Division of Dental,    Do                         1355
 Expiration Date Labeling Claim for Medical Gloves;                                   Infection Control and
 Draft                                                                                General Hospital Devices
                                                                                      (DDIGD)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reprocessing and Reuse of Single-Use Devices: Review      February 8, 2000           ODE/DDIGD                  Do                         1156
 Prioritization Scheme; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Approval Applications (PMA) for Sharps Needle   March 2, 2001              ODE/DDIGD                  Do                         891
 Destruction Devices; Final Guidance for Industry and
 FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket           June 2, 1998               ODE/DDIGD                  Do                         4
 Notification 510(k) Submissions of Washers and Washer-
 Disinfectors
--------------------------------------------------------------------------------------------------------------------------------------------------------
Overview of Information Necessary for Premarket           April 21, 1999             ODE/DDIGD                  Do                         86
 Notification Submissions for Endosseous Implants; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Arrangement and Content of a Premarket   May 16, 1989               ODE/DDIGD                  Do                         353
 Approval (PMA) Application for an Endosseous Implant
 for Prosthetic Attachment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on 510(k) Submissions for Implanted Infusion     October 1, 1990            ODE/DDIGD                  Do                         392
 Ports
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification         April 1, 1993              ODE/DDIGD                  Do                         450
 [510(K)] Submissions for Hypodermic Single Lumen
 Needles
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document on Dental Handpieces                    July 1, 1995               ODE/DDIGD                  Do                         556
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket           December 6, 1996           ODE/DDIGD                  Do                         576
 Notification 510(k) Submissions for Liquid Chemical
 Germicides
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification         April 1, 1993              ODE/DDIGD                  Do                         821
 [510(K)] Submissions for Piston Syringes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification         March 1, 1993              ODE/DDIGD                  Do                         822
 [510(K)] Submissions for Clinical Electronic
 Thermometers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification         March 1, 1993              ODE/DDIGD                  Do                         823
 [510(k)] Submissions for External Infusion Pumps
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification [510(K)] Submissions   March 16, 1995             ODE/DDIGD                  Do                         824
 for Short-Term and Long-Term Intravascular Catheters
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification [510(k)] Submissions   March 1, 1993              ODE/DDIGD                  Do                         833
 for Sterilizers Intended for Use in Health Care
 Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53900]]

 
Guidance on Premarket Notification [510(k)] Submissions   August 1, 1993             ODE/DDIGD                  Do                         881
 for Automated Endoscope Washers, Washer/Disinfectors,
 and Disinfectors Intended for Use in Health Care
 Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification [510(k)] Submissions   August 1, 1993             ODE/DDIGD                  Do                         888
 for Surgical Gowns and Surgical Drapes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket           October 1, 1993            ODE/DDIGD                  Do                         895
 Notification [510(k)] Submissions for Sharps Containers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Supplementary Guidance on the Content of Premarket  March 1, 1995              ODE/DDIGD                  Do                         934
 Notification [510(k)] Submissions for Medical Devices
 With Sharps Injury Prevention Features (Antistick)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Reviewers/Staff--Premarket  January 13, 1999           ODE/DDIGD                  Do                         944
 Notification [510(k)] Submissions for Testing for Skin
 Sensitization to Chemicals in Natural Latex Products
 [Draize Testing]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information Necessary for Premarket Notification          December 9, 1996           ODE/DDIGD                  Do                         948
 Submissions for Screw-Type Endossesous Implants
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance Document for the Preparation of Premarket  March 3, 1997              ODE/DDIGD                  Do                         984
 Notification [510(k)'s] for Dental Alloys
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content of Premarket Notification         December 1, 1995           ODE/DDIGD                  Do                         993
 [510(k)] Submissions for Protective Restraints
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notifications for Intravascular     October 12, 2000           ODE/DDIGD                  Do                         1189
 Administration Sets; Guidance for Industry and FDA
 Review Staff; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Addendum to: Guidance on Premarket Notification [510(k)]  September 19, 1995         ODE/DDIGD                  Do                         1833
 Submissions for Sterilizers Intended for Use in Health
 Care Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Groups Capable of Testing for Latex Skin Sensitization    July 28, 1997              ODE/DDIGD                  Do                         1944
 (Addendum to #944)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Reviewers; Neonatal and     September 18, 1998         ODE/DDIGD                  Do                         2201
 Neonatal Transport Incubators--Premarket Notifications;
 Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dental Impression Materials--Premarket Notification;      August 17, 1998            ODE/DDIGD                  Do                         2203
 Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dental Cements Premarket Notification; Final              August 18, 1998            ODE/DDIGD                  Do                         2204
--------------------------------------------------------------------------------------------------------------------------------------------------------
OTC Denture Cushions, Pads, Reliners, Repair Kits and     August 18, 1998            ODE/DDIGD                  Do                         2205
 Partially Fabricated Denture Kits; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a Premarket Notification  November 27, 1998          ODE/DDIGD                  Do                         642
 [510(k)] for Direct Filling Dental Composites
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance and Format of Premarket Notification [510(k)]    January 3, 2000            ODE/DDIGD                  Do                         397
 Submissions for Liquid Chemical Sterilants/High Level
 Disinfectants; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Class II Special Control Guidance Document: Pharmacy      March 12, 2001             ODE/DDIGD                  Do                         1326
 Compounding Devices; Final Guidance for Industry and
 FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Guidance for the Content of        April 28, 1998             ODE Division of General,   Do                         6
 Premarket Notifications for Esophageal and Tracheal                                  Restorative and
 Prostheses; Final                                                                    Neurological Devices
                                                                                      (DGRND)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53901]]

 
Calcium Phosphate (Ca-P) Coating Draft Guidance for       February 21, 1997          ODE/DGRND                  Do                         33
 Preparation of FDA Submissions for Orthopedic and
 Dental Endosseous Implants
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Information Needed for Hydroxyapatite Coated       February 20, 1997          ODE/DGRND                  Do                         47
 Orthopedic Implants
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter: Core Study for Silicone Breast Implants           January 11, 1996           ODE/DGRND                  Do                         107
--------------------------------------------------------------------------------------------------------------------------------------------------------
Protocol for Dermal Toxicity Testing for Devices in       January 1, 1985            ODE/DGRND                  Do                         124
 Contact With Skin (Draft)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Version 1--Biofeedback Devices--Draft Guidance for  August 1, 1994             ODE/DGRND                  Do                         143
 510(k) Content
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Data Requirements for Ultrahigh Molecular Weight    March 28, 1995             ODE/DGRND                  Do                         180
 Polyethylene (Uhmupe) Used in Orthopedic Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance Document for Femoral Stem Prostheses       August 1, 1995             ODE/DGRND                  Do                         187
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Premarket Notification Review Guidance for Evoked   June 1, 1994               ODE/DGRND                  Do                         207
 Response Somatosensory Stimulators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Version Guide for Cortical Electrode 510(k)         August 10, 1992            ODE/DGRND                  Do                         208
 Content
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Version Guidance for Clinical Data to be Submitted  August 20, 1992            ODE/DGRND                  Do                         209
 for Premarket Approval Application for Cranial
 Electrotherapy Stimulators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Version Cranial Perforator Guidance                 July 13, 1994              ODE/DGRND                  Do                         212
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Version Neuro Endoscope Guidance                    July 7, 1994               ODE/DGRND                  Do                         214
--------------------------------------------------------------------------------------------------------------------------------------------------------
Galvanic Skin Response Measurement Devices--Draft         August 1, 1994             ODE/DGRND                  Do                         215
 Guidance for 510(k) Content
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of IDE and PMA      February 18, 1993          ODE/DGRND                  Do                         233
 Applications for Intra-Articular Prosthetic Knee
 Ligament Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry, FDA Reviewers/Staff and            June 9, 1999               ODE/DGRND                  Do                         2246
 Compliance Guidance Document for Powered Muscle
 Stimulator 510(k)s; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance for the Preparation of a  August 30, 1999            ODE/DGRND                  Do                         54
 Premarket Notification Application for Processed Human
 Dura Mater; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for TENS 510(k) Content (Draft)                     August 1, 1994             ODE/DGRND                  Do                         300
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket        July 26, 1995              ODE/DGRND                  Do                         307
 Notification [510(k)] Applications for Submerged
 (Underwater) Exercise Equipment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket        July 26, 1995              ODE/DGRND                  Do                         325
 Notification [510(k)] Applications for Electromyograph
 Needle Electrodes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket        July 26, 1995              ODE/DGRND                  Do                         326
 Notification [510(k)] Applications for Exercise
 Equipment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket        July 26, 1995              ODE/DGRND                  Do                         346
 Notification [510k)] Applications for Mechanical and
 Powered Wheelchairs, and Motorized Three-Wheeled
 Vehicles
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53902]]

 
Guidance Document for the Preparation of Premarket        January 10, 1995           ODE/DGRND                  Do                         355
 Notification for Ceramic Ball Hip Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Organization of a Premarket   June 1, 1995               ODE/DGRND                  Do                         386
 Notification for a Medical Laser
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance Document for Testing Acetabular Cup        May 1, 1995                ODE/DGRND                  Do                         453
 Prostheses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Industry and CDRH Staff for the     March 18, 1998             ODE/DGRND                  Do                         487
 Preparation of Investigational Device Exemptions and
 Premarket Approval Applications for Bone Growth
 Stimulator Devices; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copy of October 9, 1992, Letter and Original Suture       October 9, 1992            ODE/DGRND                  Do                         502
 Labeling Guidance (Reformatted 12/17/1997)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alternate Suture Labeling Resulting From the January 11,  January 11, 1993           ODE/DGRND                  Do                         503
 1993, Meeting With HIMA (Reformatted 12/17/1997)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Reviewing Premarket Notifications that     February 1, 1997           ODE/DGRND                  Do                         593
 Claim Substantial Equivalence to Evoked Response
 Stimulators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Version--Guidance on Biocompatibility Requirements  September 12, 1994         ODE/DGRND                  Do                         627
 for Long Term Neurological Implants: Part 3--Implant
 Model
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Studies for Pain Therapy Devices--General    May 12, 1988               ODE/DGRND                  Do                         640
 Considerations in the Design of Clinical Studies for
 Pain-Alleviating Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
ORDB 510(k) Sterility Review Guidance                     July 3, 1997               ODE/DGRND                  Do                         659
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of a Premarket         August 30, 1994            ODE/DGRND                  Do                         667
 Notification for Extended Laparoscopy Devices (ELD)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Outline for a Guidance Document for Testing         November 1, 1993           ODE/DGRND                  Do                         668
 Orthopedic Bone Cement, Request for Comments by
 December 10, 1993
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket        July 26, 1995              ODE/DGRND                  Do                         689
 Notification [510(k)] Applications for Beds
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket        July 26, 1995              ODE/DGRND                  Do                         729
 Notification [510(k)] Applications for Immersion
 Hydrobaths
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket        July 26, 1995              ODE/DGRND                  Do                         735
 Notification [510(k)] Applications for Powered Tables
 and Multifunctional Physical Therapy Tables
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket        July 26, 1995              ODE/DGRND                  Do                         762
 Notification [510(k)] Applications for Communications
 Systems (Powered and Non-Powered) and Powered
 Environmental Control Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electroencephalograph Devices Guidance for 510(k)         November 3, 1997           ODE/DGRND                  Do                         767
 Content; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket        July 26, 1995              ODE/DGRND                  Do                         818
 Notification [510(k)] Applications for Therapeutic
 Massagers and Vibrators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Orthopedic Implants With    April 28, 1994             ODE/DGRND                  Do                         827
 Modified Metallic Surfaces Apposing Bone or Bone Cement
 (Replaces 8623 and 8093)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53903]]

 
Guidance Document for the Preparation of Premarket        July 26, 1995              ODE/DGRND                  Do                         828
 Notification [510(k)] Applications for Heating and
 Cooling Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewers Guidance Checklist for Orthopedic External      February 21, 1997          ODE/DGRND                  Do                         829
 Fixation Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of Premarket           April 1, 1993              ODE/DGRND                  Do                         830
 Notifications [510(k)]s for Cemented, Semi-Constrained
 Total Knee Prostheses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance Document for the Preparation of Premarket  July 16, 1997              ODE/DGRND                  Do                         832
 Notification [510(k)] Applications for Orthopedic
 Devices--The Basic Elements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft 510(k) Guideline for General Surgical               May 10, 1995               ODE/DGRND                  Do                         904
 Electrosurgical Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Arthroscopes and Accessory 510(k)s     May 1, 1994                ODE/DGRND                  Do                         909
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Biodegradable Polymer       April 20, 1996             ODE/DGRND                  Do                         914
 Implant Devices; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Bone Anchor Devices; Draft  April 20, 1996             ODE/DGRND                  Do                         915
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Testing Non-Articulating,           May 1, 1995                ODE/DGRND                  Do                         916
 ``Mechanically Locked'', Modular Implant Components;
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewers Guidance Checklist for Intramedullary Rods      February 21, 1997          ODE/DGRND                  Do                         956
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Testing MR Interaction With Aneurysm   May 22, 1996               ODE/DGRND                  Do                         958
 Clips
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance Document for Dura         August 13, 1999            ODE/DGRND                  Do                         1152
 Substitute Devices; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Surgical Lamp 510Ks; Final          July 13, 1998              ODE/DGRND                  Do                         1244
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance on Preclinical and        October 5, 1999            ODE/DGRND                  Do                         1354
 Clinical Data and Labeling for Breast Prostheses; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of IDEs for Spinal  January 13, 2000           ODE/DGRND                  Do                         2250
 Systems; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of an IDE Submission   April 4, 1995              ODE/DGRND                  Do                         1817
 for a Interactive Wound and Burn Dressing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and/or for FDA Reviewers/Staff and/ October 30, 1998           ODE/DGRND                  Do                         2207
 or Compliance--Guidance Document for Powered Suction
 Pump 510(k)s
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of a Premarket Notification  March 2, 1999              ODE/DGRND                  Do                         2247
 Application for a Surgical Mesh; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Shoulder Joint Metal/  October 31, 2000           ODE/DGRND                  Do                         1193
 Polymer/Metal Nonconstrained or Semi-Constrained Porous-
 Coated Uncemented Prosthesis; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Dermabrasion Devices; Final                  March 2, 1999              ODE/DGRND                  Do                         2248
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Preparation of a Premarket         May 31, 1995               ODE/DGRND                  Do                         2817
 Notification for a Non-Interactive Wound and Burn
 Dressing [510(k)]
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53904]]

 
Guidance for Resorbable Adhesion Barrier Devices for Use  December 16, 1999          ODE/DGRND                  Do                         1356
 in Abdominal and/or Pelvic Surgery; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Special Control Guidance for Premarket Notifications for  September 6, 2000          ODE/DGRND                  Do                         1179
 Totally Implanted Spinal Cord Stimulators for Pain
 Relief; Guidance for Industry; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Surgical Suture 510(k)s; Guidance for        August 10, 2000            ODE/DGRND                  Do                         1180
 Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Neurological Embolization Devices; Guidance  November 1, 2000           ODE/DGRND                  Do                         1151
 for Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Spinal System 510(k)s                        September 27, 2000         ODE/DGRND                  Do                         636
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Guidelines for Multifocal Intraocular Lens IDE        May 29, 1997               ODE Division of            Do                         55
 Studies and PMAs                                                                     Ophthalmic and Ear,
                                                                                      Nose, and Throat Devices
                                                                                      (DOED)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Announcement: Information for Manufacturers and Users of  September 22, 1997         ODE/DOED                   Do                         93
 Lasers for Refractive Surgery [Excimer]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket           January 16, 1998           ODE/DOED                   Do                         94
 Notification [510(k)] Submissions for Surgical Mask--
 Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
New FDA Recommendations and Results of Contact Lens       May 30, 1989               ODE/DOED                   Do                         265
 Study (7-Day Letter)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Premarket Notification 510(k) Guidance for Contact  May 1, 1997                ODE/DOED                   Do                         674
 Lens Care Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
Important Information About Rophae Intraocular Lenses     August 20, 1992            ODE/DOED                   Do                         811
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Premarket Notification [510(k)] Guidance Document   May 12, 1994               ODE/DOED                   Do                         896
 for Class II Daily Wear Contact Lenses and 6/28, 1994,
 Corrections to Pages 18 and 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Retinoscope Guidance; Final                               July 8, 1998               ODE/DOED                   Do                         1240
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Ophthalmoscope Guidance (Direct    July 8, 1998               ODE/DOED                   Do                         1241
 and Indirect)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Slit Lamp Guidance; Final                                 July 13, 1998              ODE/DOED                   Do                         1242
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Staff--Revised Procedures   August 11, 1998            ODE/DOED                   Do                         1249
 for Adding Lens Finishing Laboratories to Approved
 Premarket Approval (PMA) Applications for Class III
 Rigid Gas Permeable Contact Lenses for Extended Wear;
 Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Accountability Analysis for Clinical Studies for          August 4, 1999             ODE/DOED                   Do                         1350
 Ophthalmic Devices; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on 510(k) Submissions for Keratoprostheses;      March 3, 1999              ODE/DOED                   Do                         1351
 Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amendment 1: Draft Premarket Notification [510(k)]        June 28, 1994              ODE/DOED                   Do                         1896
 Guidance Document for Class II Daily Wear Contact
 Lenses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Checklist of Information Usually Submitted in an          October 10, 1996           ODE/DOED                   Do                         2093
 Investigational Device Exemptions (IDE) Application for
 Refractive Surgery Lasers [Excimer]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Third Party Review Guidance for Vitreous Aspiration and   January 31, 1997           ODE/DOED                   Do                         2196
 Cutting Device Premarket Notification [510(k)]
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53905]]

 
Guidance Document for Nonprescription Sunglasses; Final   October 9, 1998            ODE/DOED                   Do                         2208
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aqueous Shunts--510(k) Submissions; Final                 November 16, 1998          ODE/DOED                   Do                         2236
--------------------------------------------------------------------------------------------------------------------------------------------------------
Discussion Points for Expansion of the ``Checklist of     September 5, 1997          ODE/DOED                   Do                         7093
 Information Usually Submitted in an Investigational
 Device Exemption (IDE) Application for Refractive
 Surgery Lasers'' Draft Document
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intraocular Lens (IOL) Guidance Document; Draft           October 14, 1999           ODE/DOED                   Do                         834
--------------------------------------------------------------------------------------------------------------------------------------------------------
Refractive Implants: Guidance for Investigational Device  August 1, 2000             ODE/DOED                   Do                         1145
 Exemptions (IDE) and Premarket Approval (PMA)
 Applications
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Submissions of Orthokeratology      April 10, 2000             ODE/DOED                   Do                         1134
 Rigid Gas Permeable Contact Lenses; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Manufacturers Seeking Marketing Clearance    March 12, 2000             ODE/DOED                   Do                         954
 of Ear, Nose, and Throat Endoscope Sheaths Used as
 Protective Barriers; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Information for a Latex Condom 510(k) Submission for      April 13, 1994             ODE Division of            Do                         398
 Obstetrics-Gynecology Devices Branch--Draft                                          Reproductive, Abdominal,
                                                                                      and Radiological Devices
                                                                                      (DRARD)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for   June 7, 1994               ODE/DRARD                  Do                         96
 Urine Drainage Bags
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft--510(k) Checklist for Conditioned Response          November 23, 1994          ODE/DRARD                  Do                         99
 Enuresis Alarms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA Applications for    May 1, 1995                ODE/DRARD                  Do                         161
 the Implanted Mechanical/Hydraulic Urinary Continence
 Device (Artificial Urinary Sphincter)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of Premarket               March 17, 1995             ODE/DRARD                  Do                         162
 Notifications for Endoscopes Used in Gastroenterology
 and Urology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Content of Premarket               May 25, 1995               ODE/DRARD                  Do                         166
 Notifications for Menstrual Tampons
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Non-Implanted Electrical       June 6, 1995               ODE/DRARD                  Do                         189
 Stimulators Used for the Treatment of Urinary
 Incontinence
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft 510(k) Checklist for Endoscopic Light Sources Used  June 22, 1995              ODE/DRARD                  Do                         190
 in Gastroenterology and Urology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for Evaluation of Laparoscopic  May 1, 1978                ODE/DRARD                  Do                         232
 Bipolar and Thermal Coagulators (and Accessories)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for Evaluation of Fetal Clip    March 8, 1977              ODE/DRARD                  Do                         244
 Electrode
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for Evaluation of Tubal         November 22, 1977          ODE/DRARD                  Do                         245
 Occlusion Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance (``Guidelines'') for Evaluation of               May 10, 1978               ODE/DRARD                  Do                         248
 Hysteroscopic Sterilization Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intrapartum Continuous Monitors for Fetal Oxygen          June 14, 1997              ODE/DRARD                  Do                         298
 Saturation and Fetal pH; Submission Guidance for a PMA;
 Draft Document
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53906]]

 
Guidance for the Arrangement and Content of a Premarket   May 1, 1990                ODE/DRARD                  Do                         327
 Approval (PMA) Application For A Cochlear Implant in
 Children Ages 2 Through to 17 Years
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance for the Submission of     November 14, 1998          ODE/DRARD                  Do                         340
 Premarket Notifications for Magnetic Resonance
 Diagnostic Devices; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Testing Guidelines for Female Barrier           April 4, 1990              ODE/DRARD                  Do                         384
 Contraceptive Devices Also Intended to Prevent Sexually
 Transmitted Diseases
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft of Suggested Information for Reporting              January 18, 1991           ODE/DRARD                  Do                         418
 Extracorporeal Shock Wave Lithotripsy Device Shock Wave
 Measurements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for   August 7, 1998             ODE/DRARD                  Do                         421
 Conventional and Permeability Hemodialyzers; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for   February 10, 1993          ODE/DRARD                  Do                         431
 Urethral Stents
--------------------------------------------------------------------------------------------------------------------------------------------------------
Testing Guidance for Male Condoms Made From New Material  June 29, 1995              ODE/DRARD                  Do                         455
 (Non-Latex)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for   February 10, 1993          ODE/DRARD                  Do                         482
 Biopsy Devices Used in Gastroenterology and Urology
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for   July 29, 1994              ODE/DRARD                  Do                         490
 Urodynamic/Uroflowmetry Systems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Investigational Device Exemptions for        January 16, 2001           ODE/DRARD                  Do                         1164
 Solutions for Hypothermic Flushing, Transport, and
 Storage of Organs for Transplantation; Final Guidance
 for Industry and FDA Reviewers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Premarket Notifications    July 27, 2000              ODE/DRARD                  Do                         416
 for Medical Image Management Devices; Guidance for
 Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications       August 9, 2000             ODE/DRARD                  Do                         1226
 (510(k)s) for Extracorporeal Shock Wave Lithotripters
 Indicated for the Fragmentation of Kidney and Ureteral
 Calculi; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Premarket Notifications    August 2, 2000             ODE/DRARD                  Do                         1177
 for Photon-Emitting Brachytherapy Sources; Guidance for
 Industry; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Applications for Digital Mammography Systems;   February 16, 2001          ODE/DRARD                  Do                         983
 Final Guidance for Industry and FDA
--------------------------------------------------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance for Home Uterine       March 9, 2001              ODE/DRARD                  Do                         820
 Activity Monitors; Final Guidance for Industry and FDA
 Reviewers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Class II Special Controls Guidance Document for Clitoral  July 3, 2000               ODE/DRARD                  Do                         1144
 Engorgement Devices; Guidance for Industry and FDA
 Reviewers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Thermal Endometrial Ablation Devices (Submission          March 14, 1996             ODE/DRARD                  Do                         547
 Guidance for an IDE); Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for the Clinical Investigation of          November 2, 1995           ODE/DRARD                  Do                         573
 Urethral Stents
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53907]]

 
Tympanostomy Tubes Submission Guidance for a 510(k)       January 14, 1998           ODE/DRARD                  Do                         930
 Premarket Notification; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Early Collaboration Meetings Under the FDA Modernization  February 28, 2001          ODE Program Operations     Do                         310
 Act (FDAMA); Final Guidance for Industry and for CDRH                                Staff (POS)
 Staff
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA/510(k) Expedited Review #G98-4 (Blue Book Memo)       March 20, 1998             ODE/POS                    Do                         7
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA/510(k) Expedited Review--Guidance for Industry and    March 20, 1998             ODE/POS                    Do                         108
 CDRH Staff [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Deciding When to Submit a 510(k) for a Change to an       January 10, 1997           ODE/POS                    Do                         935
 Existing Device
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Suggested Approach to Resolving Least Burdensome        September 11, 2000         ODE/POS                    Do                         1188
 Issues
--------------------------------------------------------------------------------------------------------------------------------------------------------
Suggested Format for Developing and Responding to         November 2, 2000           ODE/POS                    Do                         1195
 Deficiencies in Accordance with the Least Burdensome
 Provisions of FDAMA; Final; Guidance for Industry and
 FDA Staff
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Modernization Act of 1997 Guidance for the Device     February 6, 1998           Office of Health and       Do                         434
 Industry on Implementation of Highest Priority                                       Industry Programs (OHIP)
 Provisions [FDAMA]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Accidental Radioactive Contamination of Human Food and    August 13, 1998            OHIP                       Do                         1071
 Animal Feeds: Recommendations to State and Local
 Agencies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance--The Mammography Quality Standards    May 5, 1999                OHIP Division of           Do                         6400
 Act Final Regulations--Preparing for MQSA Inspections                                Mammography Quality and
                                                                                      Radiation Programs
                                                                                      (DMQRP)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Submission of Request for Reconsideration    March 26, 1998             OHIP/DMQRP                 Do                         69
 of Adverse Decisions on Accreditation of Mammography
 Facilities Under the Mammography Quality Standards
 Acts, 42 U.S.C. 263(b)/4/8, 1998
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Review of Requests for Reconsideration of    March 26, 1998             OHIP/DMQRP                 Do                         83
 Adverse Decisions on Accreditation of Mammography
 Facilities Under the Mammography Quality Standards Act,
 42 U.S.C. 263(b)/4/8, 1998
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance; The Mammography Quality Standards    September 13, 2000         OHIP/DMQRP                 Do                         1159
 Act Final Regulations Document #4; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
The Mammography Quality Standards Act Final Regulations;  January 24, 2001           OHIP/DMQRP                 Do                         1317
 Modifications and Additions to Policy Guidance Help
 System #2; Final Guidance for Industry and FDA
 (Incorporated into PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance: The Mammography Quality Standards    December 8, 1999           OHIP/DMQRP                 Do                         1496
 Act Final Regulations Document #3 (Incorporated into
 PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance: The Mammography Quality Standards Act Final     March 4, 1999              OHIP/DMQRP                 Do                         1499
 Regulations Document #1 (Incorporated into PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Policy and Standard Operating Procedures When             April 15, 1998             OHIP/DMQRP                 Do                         1186
 Mammography Facilities in States That Have
 Accreditation Bodies Intend to Change Accreditation
 Bodies
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53908]]

 
Guidance for Request and Issuance of Interim Notice       May 4, 1999                OHIP/DMQRP                 Do                         2217
 Letters for Mammography Facilities Under the
 Mammography Quality Standards Act, 42 U.S.C. Section
 263(b)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Continuing Education Credit for Reading/Writing Articles/ March 17, 1998             OHIP/DMQRP                 Do                         66206
 Papers and Presenting Courses/Lectures (Incorporated
 into PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Requalification for Interpreting   May 28, 1998               OHIP/DMQRP                 Do                         66301
 Physician's Continuing Experience Requirement
 (Incorporated into PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance: The Mammography Quality Standards    March 23, 1999             OHIP/DMQRP                 Do                         2256
 Act Final Regulations Motion of Tube-Image Receptor
 Assembly (Incorporated into PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance: The Mammography Quality Standards    December 7, 1999           OHIP/DMQRP                 Do                         1194
 Act Final Regulations Quality Assurance Documentation
 (Incorporated into PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance: The Mammography Quality Standards    February 25, 2000          OHIP/DMQRP                 Do                         1498
 Act Final Regulations Document #2 (Incorporated into
 PGHS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance--Mammography Facility Survey,         November 6, 2000           OHIP/DMQRP                 Do                         6409
 Equipment Evaluation and Medical Physicist
 Qualification Requirements Under MQSA; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Glove Guidance Manual Draft FDA 99-4257           August 12, 1999            OHIP Division of Small     Do                         852
                                                                                      Manufacturers Assistance
                                                                                      (DSMA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for Completion of Medical Device             July 1, 1997               OHIP/DSMA                  Do                         12
 Registration and Listing Forms FDA 2891, 2891a and 2892
--------------------------------------------------------------------------------------------------------------------------------------------------------
An Introduction to Medical Device Regulations (FDA 92-    January 1, 1992            OHIP/DSMA                  Do                         18
 4222)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Requirements for Devices for the Handicapped   August 1, 1987             OHIP/DSMA                  Do                         22
 (FDA 87-4221)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Impact Resistant Lenses: Questions and Answers (FDA 87-   September 1, 1987          OHIP/DSMA                  Do                         23
 4002)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Comparison Chart: 1996 Quality System Reg vs. 1978 Good   November 29, 1996          OHIP/DSMA                  Do                         133
 Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and
 ISO/DI 13485:1996 (Include 126)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Appeals and Complaints: A Guidance on      February 19, 1998          OHIP/DSMA                  Do                         396
 Dispute Resolution
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Notification: 510(k)--Regulatory Requirements   August 1, 1995             OHIP/DSMA                  Do                         469
 for Medical Devices (FDA 95-4158) [Available on Disk]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling--Regulatory Requirements for Medical Devices     September 1, 1989          OHIP/DSMA                  Do                         470
 (FDA 89-4203)
--------------------------------------------------------------------------------------------------------------------------------------------------------
In Vitro Diagnostic Devices: Guidance for the             January 1, 1997            OHIP/DSMA                  Do                         471
 Preparation of 510(k) Submissions (FDA 97-4224)
 [Available on Disk]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Investigational Device Exemptions [IDE] Manual (FDA 96-   June 1, 1996               OHIP/DSMA                  Do                         472
 4159) DSMA [Available on Disk]
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53909]]

 
Regulation of Medical Devices; Background Information     April 14, 1999             OHIP/DSMA                  Do                         610
 for International Officials (Entire Document Available
 on Disk)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Reporting for Manufacturers [Available on  March 1, 1997              OHIP/DSMA                  Do                         987
 Disk]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Approval (PMA) Manual                           January 1, 1998            OHIP/DSMA                  Do                         1051
--------------------------------------------------------------------------------------------------------------------------------------------------------
Overview of FDA Modernization Act of 1997 Medical Device  February 19, 1998          OHIP/DSMA                  Do                         1174
 Provisions [FDAMA]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mutual Recognition Agreement Between the European Union   June 29, 2000              OHIP/DSMA                  Do                         1175
 and the United States of America: Confidence Building
 Programme: Overview and Procedure; Medical Device
 Annex, Version 7, June 29, 2000; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implementation of Third Party Programs Under the FDA      February 2, 2001           OHIP/DSMA                  Do                         1160
 Modernization Act of 1997; Final Guidance for Staff,
 Industry and Third Parties
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH Manual for the Good Guidance Practices (GGP)         February 9, 2001           OHIP Division of Device    Do                         1323
 Regulations; Final Guidance for FDA Staff                                            User Programs and
                                                                                      Systems Analysis (DUPSA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Human Factors Principles for Medical Device Labeling      September 1, 1993          OHIP/DUPSA                 Do                         227
--------------------------------------------------------------------------------------------------------------------------------------------------------
Human Factors Points to Consider for IDE Devices          January 17, 1997           OHIP/DUPSA                 Do                         839
--------------------------------------------------------------------------------------------------------------------------------------------------------
Write It Right                                            August 1, 1993             OHIP/DUPSA                 Do                         897
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Reporting for User Facilities              April 1, 1996              OHIP/DUPSA                 Do                         989
--------------------------------------------------------------------------------------------------------------------------------------------------------
Do It By Design--An Introduction to Human Factors in      December 1, 1996           OHIP/DUPSA                 Do                         995
 Medical Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Use--Safety: Incorporating Human Factors   July 18, 2000              OHIP/DUPSA                 Do                         1497
 Engineering into Risk Management; Guidance for Industry
 and FDA Premarket and Design Control Reviewers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Patient Labeling; Final        April 19, 2001             OHIP/DUPSA                 Do                         1128
 Guidance for Industry and FDA Reviewers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Perspectives on Clinical Studies for Medical Device                                  Office of Surveillance     Do                         78
 Submissions (Statistical)                                                            and Biometrics (OSB)
                                                                                      Division of
                                                                                      Biostatistics (DB)
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Review Statistical Checklist                          (no date available)        OSB/DB                     Do                         84
--------------------------------------------------------------------------------------------------------------------------------------------------------
Statistical Aspects of Submissions to FDA: A Medical      June 1, 1984               OSB/DB                     Do                         537
 Device Perspective (Also Includes as Appendix the
 Article Observed Uses and Abuses of Statistical
 Procedures in Medical Device Submissions
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Guidance Document: Remedial Action Exemption--        July 30, 1996              OSB/DSS                    Do                         188
 E1996001; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Adverse Event Reporting for Hospitals That    April 24, 2001             OSB/DSS                    Do                         1334
 Reprocess Devices Intended by the Originial Equipment
 Manufacturer for Single Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Guidance Document No. 1-IOL-E1996004; Final           August 7, 1996             OSB/DSS                    Do                         216
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Guidance Document No. 3--Needlestick and Blood        August 9, 1996             OSB/DSS                    Do                         250
 Exposure--E1996003; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53910]]

 
Common Problems: Baseline Reports and Medwatch Form       January 1, 1997            OSB/DSS                    Do                         379
 3500A
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Reporting Guidance for Breast Implants--E1996002;     August 7, 1996             OSB/DSS                    Do                         452
 Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Reporting: An Overview; Final              April 1, 1996              OSB/DSS                    Do                         509
--------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for Completing FDA Form 3500A With Coding    December 15, 1995          OSB/DSS                    Do                         853
 Manual for Form 3500A (MEDWATCH)(MDR); Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
MEDWATCH FDA Form 3500A for Use by User Facilities,       June 1, 1993               OSB/DSS                    Do                         854
 Distributors and Manufacturers for Mandatory Reporting
 (MDR); Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Variance From Manufacturer Report Number Format [MDR      July 16, 1996              OSB/DSS                    Do                         1059
 Letter]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for Completing Form 3417: Medical Device     March 31, 1997             OSB/DSS                    Do                         1061
 Reporting Baseline Report [MDR]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Internet List Server (listserv) Instruction Sheet;    August 29, 1996            OSB/DSS                    Do                         1094
 Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Reporting-Alternative Summary Reporting    October 19, 2000           OSB/DSS                    Do                         315
 (ASR) Program; Guidance for Industry
--------------------------------------------------------------------------------------------------------------------------------------------------------
Addendum to the Instructions for Completing FDA Form      June 9, 1999               OSB/DSS                    Do                         1853
 3500A With Coding Manual (MEDWATCH) (MDR); Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance to Sponsors on the Development of a              June 9, 1993               OSB Issues Management      Do                         206
 Discretionary Postmarket Surveillance Study for                                      Staff (IMS)
 Permanent Implantable Cardiac Pacemaker Electrodes
 (Leads)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Criteria and Approaches for Postmarket        November 2, 1998           OSB/IMS                    Do                         9
 Surveillance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Procedures to Determine Application of        February 19, 1998          OSB/IMS                    Do                         316
 Postmarket Surveillance Strategies [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Procedures for Review of Postmarket           February 19, 1998          OSB/IMS                    Do                         317
 Surveillance Submissions [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Staff--SMDA to FDAMA:       November 2, 1998           OSB/IMS                    Do                         318
 Guidance on FDA's Transition Plan for Existing
 Postmarket Surveillance Protocols [FDAMA]; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amendment to Guidance on Discretionary Postmarket         March 30, 1994             OSB/IMS                    Do                         374
 Surveillance on Pacemaker Leads; Final
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry on the Testing of Metallic Plasma   February 2, 2000           OSB/IMS                    Do                         946
 Sprayed Coatings on Orthopedic Implants to Support
 Reconsideration of Postmarket
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Frequently Asked Questions on Recognition of  December 21, 1998          Office of Science and      Do                         109
 Consensus Standards [FDAMA]                                                          Technology (OST)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Recognition and Use of Consensus          February 19, 1998          OST                        Do                         321
 Standards/Appendix A [FDAMA]
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Primer on Medical Device Interactions With Magnetic     February 7, 1997           OST                        Do                         952
 Resonance Imaging Systems; Draft
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH Standard Operating Procedures for the                August 6, 1999             OST                        Do                         616
 Identification and Evaluation of Candidate Consensus
 Standard for Recognition
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53911]]

 
Guidance on FDA's Expectations of Medical Device          May 15, 1998               OST                        Do                         2000
 Manufacturers Concerning the Year 2000 Date Problems
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Reviewers: Guidance on      May 6, 1999                OST Division of Life       Do                         635
 Immunotoxicity Testing                                                               Sciences (DLS)
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                       Withdrawals
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Intended User or
                    Name of Document                           Date of Issuance         Regulatory Activity         Date of Withdrawal        FOD No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and for FDA Staff: Enforcement      February 8, 2000           OC                         August 8, 2000             801029
 Priorities for Single-Use Devices Reprocessed by Third
 Parties and Hospitals, Draft Guidance--Not for
 Implementation (Replaced by Enforcement Priorities for
 Single-Use Devices Reprocessed by Third Parties and
 Hospitals; Guidance for Industry and for FDA Staff 8/14/
 00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Information Disclosure by Manufacturers to    October 18, 1999           OC/DOEI                    March 30, 2001             802619
 Assemblers for Diagnostic X-Ray Systems; Guidance for
 Industry (Replaced by Information Disclosure by
 Manufacturers to Assemblers for Diagnostic X-Ray
 Systems; Final Guidance for Industry and FDA 4/2/01)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Final Design Control Report and Guidance (No              June 1, 1998               OC/DOEIII                  July 24, 2000              800949
 Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Working Draft of the Current Good Manufacturing Practice  July 1, 1995               OC/OT                      April 24, 2000             800303
 (CGMP) Final Rule (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Amended Procedures for Advisory Panel         January 26, 1999           ODE                        August 4, 2000             800413
 Meetings [FDAMA]; Final (Replaced by Guidance on
 Amended Procedures for Advisory Panel Meetings, 7/22/
 00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Review Criteria for Assessment of Antimicrobial           May 31, 1991               ODE/DCLD                   June 16, 2000              800631
 Susceptibility Devices (Replaced by Guidance on Review
 Criteria for Assessment of Antimicrobial Susceptibility
 Devices, 3/8/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Premarket Submissions for Kits for           December 30, 1998          ODE/DCLD                   October 30, 2000           802209
 Screening Drugs of Abuse to Be Used by the Consumer;
 Guidance for Industry; Draft (Replaced by Over-the-
 Counter (OTC) Screening Tests for Drugs of Abuse:
 Guidance for Premarket Notifications; Guidance for
 Industry; Draft 11/14/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Vascular Prostheses 510(k)          November 1, 2000           ODE/DCRD                   January 16, 2000           801357
 Submission; Final (Replaced by Guidance Document for
 Vascular Prostheses 510(k) Submissions; Guidance for
 Industry and FDA Staff; Final 11/1/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance to Manufacturers on the Development of Required  Date not available         ODE/DCRD                   June 15, 2000              800202
 Postapproval Epidemiological Study Protocols for
 Testicular Implants (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Reviewer Guidelines--Tracheostomy Tubes 868.5800   Date not available         ODE/DCRD                   June 15, 2000              800550
 (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53912]]

 
Guidance for the Comment and Review of 510(k)             August 1, 1993             ODE/DCRD                   August 8, 2000             800416
 Notifications for Picture Archiving and Communications
 Systems (PACS) and Related Devices (Replaced by
 Guidance for the Submission of Premarket Notifications
 for Medical Image Management Devices; Guidance for
 Industry; Final 7/27/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance for the Content of        February 8, 1999           ODE/DCRD                   August 10, 2000            801226
 Premarket Notifications [510(k)s] for Extracorporeal
 Shock Wave Lithotripters Indicated for the
 Fragmentation of Kidney and Ureteral Calculi (Replaced
 by Guidance for the Content of Premarket Notifications
 (510(k)s) for Extracorporeal Shock Wave Lithotripters
 Indicated for the Fragmentation of Kidney and Ureteral
 Calculi; Final 8/9/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Oxygen Conserving Device 510(k) Review 73    February 1, 1989           ODE/DCRD                   August 30, 2000            800583
 BZD 868.5905 Non-continuous Ventilator Class II (No
 Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reviewer's Guidance for Oxygen Concentrator (No           August 30, 1991            ODE/DCRD                   August 30, 2000            800781
 Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Vascular Prostheses 510(k)          November 26, 1999          ODE/DCRD                   November 16, 2000          801357
 Submission; Final (Replaced by Guidance Document for
 Vascular Prostheses 510(k) Submissions; Guidance for
 Industry and FDA Staff; Final 11/1/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Research and Marketing     January 14, 2000           ODE/DCRD                   January 21, 2000           800372
 Applications for Permanent Pacemaker Leads and for
 Pacemaker Lead Adaptor 510(k) Submissions; Final
 (Replaced by Guidance for the Submission of Research
 and Marketing Applications for Permanent Pacemaker
 Leads and for Pacemaker Lead Adaptor 510(k)
 Submissions; Final 11/1/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Information on Clinical Safety and     February 5, 1992           ODE/DCRD                   January 10, 2001           800864
 Effectiveness Data for Extracorporeal Shock Wave
 Lithotripsy of Upper Urinary Tract (Renal Pelvis, Renal
 Calyx and Upper Ureteral) Calculi (Replaced by Guidance
 for the Content of Premarket Notifications (510(k)s)
 for Extracorporeal Shock Wave Lithotripters Indicated
 for the Fragmentation of Kidney and Ureteral Calculi;
 Final 8/9/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Annuloplasty Rings 510(k) Submissions;       November 26, 1999          ODE/DCRD                   February 12, 2001          801358
 Final (Replaced by Guidance for Annuloplasty Rings
 510(k) Submissions; Final Guidance for Industry and FDA
 Staff 1/31/01)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Home Uterine Activity Monitors: Guidance for the          July 30, 1999              ODE/DCRD                   March 2001                 800820
 Submission of 510(k) Premarket Notifications (Replaced
 by Class II Special Controls Guidance for Home Uterine
 Activity Monitors; Final Guidance for Industry and FDA
 Reviewers, 3/9/01)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Status Update--Information for Manufacturers Seeking      February 4, 1999           ODE/DCRD                   February 27, 2001          800983
 Marketing Clearance of Digital Mammography Systems
 (Replaced by Premarket Applications for Digital
 Mammography Systems; Final Guidance for Industry and
 FDA 2/16/01)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Content and Format of Premarket           October 1, 1993            ODE/DDIGD                  August 10, 2000            800902
 Notification [510(k)] Submissions for General Purpose
 Disinfectants (includes Addendum of 3/9, 1994) (No
 Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Preparation of Premarket Notification    April 1, 1991              ODE/DDIGD                  September 1, 2000          800028
 [510(k)] for Resorbable Periodontal Barriers (No
 Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53913]]

 
Guidance for Spinal System 510(k); Final (Replaced by     May 7, 1999                ODE/DGRND                  October 2, 2000            800636
 Guidance for Spinal System 510(k)s 9/27/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance Document for              August 13, 1999            ODE/DGRND                  November 7, 2000           801151
 Neurological Embolization Devices; Final (Replaced by
 Guidance for Neurological Embolization Devices;
 Guidance for Industry; Final 11/1/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ophthalmic Device Triage (No Replacement)                 March 19, 1998             ODE/DOED                   June 20, 2000              800160
--------------------------------------------------------------------------------------------------------------------------------------------------------
Announcement by Dr Alpert at 7/26, 1996, Ophthalmic       August 26, 1996            ODE/DOED                   July 17, 2000              803093
 Panel Meeting Concerning Manufacturers and Users of
 Lasers for Refractive Surgery [Excimer] (No
 Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Owners Certification of Lasers as PMA Approved Devices    September 26, 1996         ODE/DOED                   July 17, 2000              804093
 [Excimer] (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance--Mammography Facility Survey and      May 5, 1999                OHIP/DMORP                 April 8, 2000              806409
 Medical Physicist Qualification Requirements Under MQSA
 (Replaced by Compliance Guidance--Mammography Facility
 Survey and Medical Physicist Qualification Requirements
 Under MQSA; Final 11/6/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
A Pocket Guide to Device GMP Inspections--Inspections of  November 1, 1991           OHIP/DSMA                  June 28, 2000              800508
 Medical Device Manufacturers and GMP Regulation
 Requirements (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Staff, Industry, and Third Parties           June 12, 2000              OHIP/DSMA                  February 2, 2001           801160
 Implementation of Third Party Programs Under the FDA
 Modernization Act of 1997--June 2000; Draft (Replaced
 by Implementation of Third Party Programs Under the FDA
 Modernization Act of 1997; Final Guidance for Staff,
 Industry and Third Parties 2/2/01)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Device Use Safety: Incorporating   August 3, 1999             OHIP/DUPSA                 July 20, 2000              801497
 Human Factors in Risk Management (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Patient Labeling; Final        March 3, 2000              OHIP/DUPSA                 April 9, 2001              801128
 Guidance for Industry (Replaced by Guidance on Medical
 Device Patient Labeling; Final Guidance for Industry
 and FDA Reviewers 4/19/01)
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Documents Access Information for National Technical   May 10, 1996               OSB                        June 28, 2000              803799
 Information Service (NTIS) (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed Draft Guidance to Sponsors Regarding Required    October 7, 1994            OSB/DPS                    June 16, 2000              800323
 Postmarket Surveillance Studies of Plasma-Sprayed
 Porous-Coated Hip Prostheses (Archived by OSB--Replaced
 by Guidance Testing Metallic Plasma Sprayed Orthopedic
 Implants, 2/2/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letter to Manufacturers: Summary Reporting Approval for   July 31, 1997              OSB/DSS                    October 30, 2000           800315
 Adverse Events; Final (Replaced by Medical Device
 Reporting--Alternative Summary Reporting (ASR) Program;
 Guidance for Industry 10/19/00)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Thermal Endometrial Ablation Devices (Submission    March 14, 1996             ODE/DCRD                   March 1996                 800547
 Guidance for an IDE) (Replaced by Thermal Endometrial
 Ablation Devices (Submission Guidance for an IDE);
 Final 3/14/96))
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Review of Cases of Possible Suspension or    March 26, 1998             OHIP/DMORP                 May 23, 2001               800080
 Revocation of Mammography Facility Certificates Under
 the Mammography Quality Standards Act, 42 U.S.C. 263(b)/
 4/8, 1998 (No Replacement)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53914]]

 
Compliance Guidance--Mammography Facility Survey and      May 5, 1999                OHIP/DMORP                 November 8, 2000           806409
 Medical Physicist Qualification Requirements Under MQSA
 , Draft (replaced by Compliance Guidance--Mammography
 Facility Survey and Medical Physicist Qualification
 Requirements Under MQSA; Final 11/6/00
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                    V. Guidance Documents Issued by the Center for Food Safety and Applied Nutrition (CFSAN)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    How to Obtain A Hard Copy of the Document (Name and Address,
                   Name of Document                             Date of Issuance            Intended User or Regulatory Activity                   Phone, 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, NTIS Order No. PB96-
                                                                                                                                     920500
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Programs Guidance Manual                    1995                               FDA Regulated Industries                  Do (NTIS Order No. 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, (NTIS Order No. PB-95-
                                                                                                                                     913399)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual                           August 1995                        FDA Regulated Industries                  Do (NTIS Order No. PB95-265534)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Requirements of Laws and Regulations Enforced by the   1997                               FDA Regulated Industries                  Superintendent of Documents, Government Printing Office,
 U.S. Food and Drug Administration ``Blue Book''                                                                                     Washington, DC 20402
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Action Levels for Poisonous or Deleterious Substances  1995                               Food and Animal Feed Industries           Industry Activities Staff (HFS-565), Center for Food Safety
 in Human Food and Animal Feed                                                                                                       and Applied Nutrition, FDA, 200 C St. SW., Washington, DC
                                                                                                                                     20204, (NTIS Order No. PB96-920500)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Pesticides Analytical Manual                           1996                               Food Industry                             National Technical Information Service (NTIS), 5285 Port
                                                                                                                                     Royal Rd., Springfield, VA 22161, (NTIS Order No. PB94-
                                                                                                                                     911899)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 FDA Advisory for Deoxynivanol (DON) in Finished       September 16, 1993                 Food and Animal Feed Industries           Office of Plant and Dairy Foods and Beverages, Food and Drug
 Wheat Products Intended for Human Consumption and in                                                                                Administration (HFS-306), 200 C St. SW., Washington, DC
 Grain and Grain By-Products for Animal Feed                                                                                         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 Plant      May 29, 1992                        Developers of New Plant Food Varieties   Office of Premarket Approval, Food and Drug Administration
 Varieties: Notice                                                                                                                   (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
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Model Small Business Food Labeling Exemption Notice    1998                               Food Industry                             Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Food Labeling: Questions and Answers                   August 1994                        Food Industry                             Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53915]]

 
Food Labeling: Questions and Answers: Volume II        February 1996                      Food Industry                             Superintendent of Documents, 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, (NTIS Order
                                                                                                                                     No. 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 and      1985                               Food Industry                             Industry Activities Staff (HFS-565), Center for Food Safety
 Acidified Foods                                                                                                                     and Applied Nutrition, FDA, 200 C St. SW., Washington, DC
                                                                                                                                     20204, 202-205-5251
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Evaluation of Milk Laboratories                        1995                               States                                    Milk Safety Branch (HFS-626), Center for Food Safety and
                                                                                                                                     Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-
                                                                                                                                     205-9175
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Methods of Making Sanitation Ratings of Milk Supplies  1999                               States                                     Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Dry Milk Ordinance                                     1995                               States                                    Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Procedures Governing the Cooperative State-Public      1999                               Dairy Industry                            Do
 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                             1999                               States                                    Milk Safety Branch (HFS-626), Center for Food Safety and
                                                                                                                                     Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-
                                                                                                                                     205-9175
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for Determining Metric Equivalents of       October 1, 1993                    Food Industry                             Office of Nutritional Products, Labeling, and Dietary
 Household Measures                                                                                                                  Supplements, Food and Drug Administration (HFS-800), 200 C
                                                                                                                                     St. SW., Washington, DC 20204, 202-205-4561
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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 Substances  1995                               Food and Animal Feed Industries           Do
 in Human Food and Feed (Also Found in CPGs)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Food Code                                          1999                               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 Sanitation     1992                               States                                    Office of Seafood (HFS-407), Shellfish Sanitation Branch,
                                                                                                                                     200 C St. SW., Washington, DC 20204, 202-418-3150
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53916]]

 
Fish and Fisheries Product Hazards and Control Guide   1996                               Seafood Industry                          Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Submitting Requests Under 21 CFR 170.39,  1996                               Food Packaging Industry                   Office of Premarket Approval, Food and Drug Administration
 Threshold of Regulation for Substances Used in Food                                                                                 (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-
 Articles                                                                                                                            3100
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for the Preparation of Petition             1996                               Food Ingredient or Packaging Industry     Do
 Submissions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for Approval of Color Additives in Contact   1996                               Color or Contact Lens Industry            Do
 Lenses Intended as Colors
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Recommendations for Submission of Chemical and     February 1993                      Color Additives Industry                  Do
 Technological Data on Color Additives for Food,
 Drugs or Cosmetics Use
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 Points to Consider for the Use of Recycled Plastics   December 1992                      Food Packaging Industry                   Do
 in Food Packaging: Chemistry Considerations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 Recommendations for Submission of Chemical and        May 1993                           Food Packaging Industry                   Do
 Technological Data for Direct Food Additive and GRAS
 Food Ingredient Petitions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Recommendations for Chemistry Data for Indirect Food   June 1995                          Food Packaging Industry                   Do
 Additive Petitions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Enzyme Preparations: Chemistry Recommendations for     January 1993                       Food Enzyme Industry                      Do
 Food Additive and GRAS Affirmation Petitions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Estimating Exposure to Direct Food Additive and        September 1995                     Food and Food Ingredient Industry         Do
 Chemical Contaminants in the Diet
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Toxicological Principles for the Safety Assessment of  1982                               Petitioners for Food or Color Additives   National Technical Information Service (NTIS), 5285 Port
 Direct Food Additives and Color Additives Used in                                                                                   Royal Rd., Springfield, VA 2216, (NT IS Order No. PR-83-
 Food (also known as Redbook I)                                                                                                      170696
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Environmental Assessment Technical Handbook            March 1987                         Petitioners for Food or Color Additives   Do (NTIS Order No. PB87175345-AS, A-01)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Color Additive Petitions Information and Guidance      1996                               Petitioners for Color Additives           Office of Premarket Approval, Food 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 Additives   Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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 Foods;   June 10, 1996                      Food Industry                             Do
 Notice to Manufacturers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Labeling of Foods That Need Refrigeration  February 24, 1997                  Food Industry                             Do
 by Consumers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines Concerning Notification and Testing of      1985                               Infant Formula Manufacturers              Do
 Infant Formula
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53917]]

 
Guidelines for the Evaluation of Safety and            1988                               Infant Formula Manufacturers              Do
 Suitability of New Infant Formulas for Feeding
 Preterm Infants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Testing of Infant Formulas With Respect to    1988                               Infant Formula Manufacturers              Do
 Nutritional Suitability for Term Infants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidelines for the Evaluation of the Safety and        1990                               Infant Formula Manufacturers              Do
 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 in       January 1993                       States                                    Office of Seafood, Food and Drug Administration (HFS-400),
 Seafood)                                                                                                                            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 in       January 1993                       States                                    Do
 Seafood)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Chromium (Trace Elements in      January 1993                       States                                    Do
 Seafood)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Lead (Trace Elements in          August 1993                        States                                    Do
 Seafood)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Nickel (Trace Elements in        January 1993                       States                                    Do
 Seafood)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Consultation Procedures for Foods Derived  October 1997                       Regulated Industry                        Office of Premarket Approval (HFS-200), 200 C St. SW.,
 From New Plant Varieties                                                                                                            Washington, DC 20204, 202-418-3100, Internet: FDA Home Page
                                                                                                                                     Http://vm.cfsan.fda.gov
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA's Policy for Foods Developed by Biotechnology      1995                               Food Industry                             Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bovine Spongiform Encephalopathy (BSE) in Products     1997                               Food Industry                             Office of Plant and Dairy Foods and Beverages (HFS-302),
 for Human Use                                                                                                                       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 Milk     February 1994                      Regulated Industry                        Office of Nutritional Products, Labeling, and Dietary
 and Milk Products That Have Not Been Treated With                                                                                   Supplements (HFS-800), Food and Drug Administration, 200 C
 Recombinant Bovine Somatropin                                                                                                       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 Fruits   1998                               Farmers and Food Packers                  Food Safety Initiative (HFS-32), Center for Food Safety and
 and Vegetables (Available in English, Spanish,                                                                                      Applied Nutrition, 200 C St. SW., Washington, DC 20204, or
 Portuguese, and French)                                                                                                             [email protected]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53918]]

 
Iron-Containing Supplements and Drugs: Label Warning   1997                               Dietary Supplement Manufacturers: Small   Office of Nutritional Products, Labeling, and Dietary
 and Unit Dose Packaging; Small Entity Compliance                                          Entities                                  Supplements (HFS-450), Center for Food Safety and Applied
 Guide                                                                                                                               Nutrition, 200 C St. SW., Washington, DC 20204
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Partial List of Enzyme Preparations That Are Used in   1998                               FDA Regulated Industry                    Office of Premarket Approval (HFS-200), Center for Food
 Foods                                                                                                                               Safety and Applied Nutrition, 200 C St. SW., Washington, DC
                                                                                                                                     20204
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Partial List of Microorganisms and Microbial-Derived   1998                               FDA Regulated Industry                    Do
 Ingredients That Are Used in Food
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Fish and Fishery Products Hazards and Controls Guide,  January 1998                       FDA Regulated Industry                    Office of Seafood (HFS-400), Center for Food Safety and
 2d Edition                                                                                                                          Applied Nutrition, 200 C St. SW., Washington, DC 20204
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
HACCP Regulations for Fish and Fishery Products:       1998                               FDA Regulated Industry                    Do
 Questions and Answers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of a Health Claim or Nutrient Content     1998                               FDA Regulated Industry                    Office of Nutritional Products, Labeling, and Dietary
 Claim Based on an Authoritative Statement of a                                                                                      Supplements (HFS-150), Center for Food Safety and Applied
 Scientific Body                                                                                                                     Nutrition, 200 C St. SW., Washington, DC 20204
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Nutrition Labeling Manual, A Guide for Developing  March 1998                         FDA Regulated Industry                    Do
 and Using Data Bases
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
HACCP Regulation for Fish and Fishery Products:        January 1999                       Seafood Processors                        Office of Seafood (HFS-400), Center for Food Safety and
 Questions and Answers, Issue Three, Revised January                                                                                 Nutrition, 200 C St. SW., Washington, DC 20204, Ellen
 1999                                                                                                                                Nesheim, 202-418-3150
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Foods--Adulteration Involving Hard or Sharp Foreign    February 1999                      FDA Field Offices                         Office of Plant and Dairy Foods and Beverages (HFS-300),
 Objects (CPG)                                                                                                                       Center for Food Safety and Applied Nutrition, 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/CFSAN/FDA, 200 C St. SW.,
                                                                                           Food Safety and Applied Nutrition Staff   Washington, DC 20204, 202-418-3074, [email protected]
                                                                                                                                     or http://vm.cfsan.fda.gov/6dms/opa-expe.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Use of Antibiotic Resistance Marker Genes in           September 1998                     Guidance for Industry                     Nega Beru (HFS-206), OPA/CFSAN/FDA, 200 C St. SW.,
 Transgenic Plants                                                                                                                   Washington, DC 20204, 202-418-3097, [email protected]
                                                                                                                                     or http://vm.cfsan.fda.gov//6dms/opa-armg.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance: Channels of Trade Policy for Commodities     December 2000                      Regulated Industry                        Office of Plant and Dairy Foods and Beverages, Center for
 With Methyl Parathion Residues                                                                                                      Food Safety and Applied Nutrition (HFS-300), FDA, 200 C St.
                                                                                                                                     SW., Washington, DC 20204, http://vm.cfsan.fda.gov/`dms
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance: Fumonisin Levels in Human Foods and    June 2000                          Regulated Industry                        Do
 Animal Feeds
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Statement of Identity, Nutrition Labeling, and         January 1999                       Small Business Entities                   Industry Activities Staff (HFS-565), Center for Food Safety
 Ingredient Labeling of Dietary Supplements Small                                                                                    and Applied Nutrition, FDA, 200 C St. SW., Washington, DC
 Entity Compliance Guide                                                                                                             20204, 202-205-5251
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Significant Scientific Agreement in the Review of      December 1999                      Regulated Industry                        Office of Nutritional Products, Labeling, and Dietary
 Health Claims for Conventional Foods and Dietary                                                                                    Supplements, Center for Food Safety and Applied Nutrition,
 Supplements (December 1999)                                                                                                         FDA, 200 C St. SW., Washington, DC 20204, 202-205-4561
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53919]]

 
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 Food        November 1999                      Regulated Industry                        Do
 Contact Substances: Chemistry Recommendations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Preparation of Premarket Notifications for Food        November 1999                      Regulated Industry                        Do
 Contact Substances: Toxicology Recommendations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Small Businesses: Submission of Comments  October 1999                       Small Business Entities                   Division of Market Studies (HFS-726), Center for Food Safety
 for CFSAN Rulemaking                                                                                                                and Applied Nutrition, Food and Drug Administration,
                                                                                                                                     Washington, DC 20204, 202-401-4590
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Warning and Notice Statement: Labeling of Juice        September 1998                     Regulated Industry                        Office of Nutritional Products, Labeling, and Dietary
 Products Small Entity Compliance Guide                                                                                              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 Sprouted    October 1999                       Regulated Industry                        Office of Plant and Dairy Foods and Beverages, Center for
 Seeds                                                                                                                               Food Safety and Applied Nutrition, FDA, 200 C St. SW.,
                                                                                                                                     Washington, DC 20204, 202-205-4064
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sampling and Microbial Testing of Spent Irrigation     October 1999                       Regulated Industry                        Do
 Water During Sprout Production
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Seafood HACCP Transition Policy                        December 1999                      Regulated Industry                        Office of Seafood (HFS-400), Food and Drug Administration,
                                                                                                                                     200 C St. SW., Washington, DC 20204, 202-205-3150
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Recommendations for Sampling and Testing Yellow    January 19, 2001                   Regulated Industry                        Office of Plant and Dairy Foods and Beverages, Center for
 Corn Shipments for Cry9C Protein Residues                                                                                           Food Safety and Applied Nutrition, FDA, 200 C St. SW.,
                                                                                                                                     Washington, DC 20204, 202-205-4064
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance: Voluntary Labeling Indicating Whether  January 2001                       Regulated Industry                        Office of Premarket Approval (HFS-200), Center for Food
 Foods Have or Have Not Been Developed Using                                                                                         Safety and Applied Nutrition, FDA, 200 C St. SW.,
 Bioengineering                                                                                                                      Washington, DC 20204, 202-418-3100
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bacteriological Analytical Manual                      2001                               Regulated Industry                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Importation of PMO Defined Dairy Products              April 11, 2000                     Dairy Industry                            Milk Safety Branch (HFS-626), Center for Food Safety and
                                                                                                                                     Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-
                                                                                                                                     205-9175
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance: Apple Juice, Apple Juice               June 2000                          Juice Industry                            Office of Plant and Dairy Foods and Beverages, Center for
 Concentrates, and Apple Juice Products--Adulteration                                                                                Food Safety and Applied Nutrition, FDA, 200 C St. SW.,
 with Patulin                                                                                                                        Washington, DC 20204, 202-205-4064
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry on Refusal of Inspection   November 2000                      Seafood Industry                          Office of Seafood (HFS-400), Food and Drug Administration,
 or Access to HACCP Records Pertaining to the Safe                                                                                   200 C St. SW., Washington, DC 20204, 202-205-3150
 and Sanitary Processing of Fish and Fishery Products
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 53920]]


                                                                                           Withdrawals
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    How to Obtain A Hard Copy of the Document (Name and Address,
                   Name of Document                     Date of Issuance/Date Withdrawn     Intended User or Regulatory Activity                   Phone, Fax, E-Mail or Internet)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Nutrition Labeling Manual: A Guide for Developing  1993/June 2001                     Food Industry                             Office of Nutritional Products, Labeling, and Dietary
 and Using Databases (Replaced by 1998 update with                                                                                   Supplements, Food and Drug Administration (HFS-800), 200 C
 the same title.)                                                                                                                    St. SW., Washington, DC 20204, 202-205-4561
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Fabrication of Single Service Containers and Closures  1995/June 2001                     States                                    Milk Safety Branch, Center for Food Safety and Applied
 for Milk and Milk Products (Incorporated into                                                                                       Nutrition, Food and Drug Administration, 200 C St. SW.,
 Pasteurized Milk Ordinance as an appendix.)                                                                                         Washington, DC 20204, 202-205-9175
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


                                                            VI. Guidance Documents Issued by the Center for Veterinary Medicine (CVM)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                   Name of Document                             Date of Issuance            Intended User or Regulatory Activity              How to Obtain a Hard Copy of the Document
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Effectiveness of                September 2000                     Animal Drug Industry                      Internet via: http://www.fda.gov/cvm Communications Staff
 Anthelmintics: Specific Recommendations for Equine                                                                                  (HFV-12), FDA/CVM, 7500 Standish Pl., Rockville, MD 20855,
 (VICH GL15)--Draft                                                                                                                  301-827-4582, FAX 301-594-1831
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Effectiveness of                September 2000                     Do                                        Do
 Anthelmintics: Specific Recommendations for Porcine
 (VICH GL16)--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Effectiveness of                September 2000                     Do                                        Do
 Anthelmintics: Specific Recommendations for Canine
 (VICH GL19)--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Effectiveness of                December 2000                      Do                                        Do
 Anthelmintics: Specific Recommendations for Feline
 (VICH GL20)--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Effectiveness of                December 2000                      Do                                        Do
 Anthelmintics: Specific Recommendations for Poultry
 (VICH GL21)--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Safety Studies for Veterinary   December 2000                      Do                                        Do
 Drug Residues in Human Food: Reproduction Studies
 (VICH GL22)--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Safety Studies for Veterinary   December 2000                      Do                                        Do
 Drug Residues in Human Food: Genotoxicity Studies
 (VICH GL23)--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Pharmacovigilance of            December 2000                      Do                                        Do
 Veterinary Medicinal Products: Management of Adverse
 Event Reports (AERs)(VICH GL24)--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Efficacy of Anthelmintics:      March 2000                         Do                                        Do
 General Recommendations (VICH GL7)--Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Efficacy of Anthelmintics:      March 2000                         Do                                        Do
 Specific Recommendations for Bovines (VICH GL12)--
 Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Efficacy of Anthelmintics:      March 2000                         Do                                        Do
 Specific Recommendations for Ovines (VICH GL13)--
 Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Efficacy of Anthelmintics:      March 2000                         Do                                        Do
 Specific Recommendations for Caprines (VICH GL14)--
 Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53921]]

 
Guidance for Industry: Environmental Impact            March 2000                         Do                                        Do
 Assessments (EIAs) for Veterinary Medicinal Products
 (VMPs)--Phase I (VICH GL6)--Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Stability Testing of New        March 2000                         Do                                        Do
 Biotechnological/Biological Veterinary Medicinal
 Products (VICH GL17)--Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Good Clinical Practices (VICH   May 2000                           Do                                        Do
 GL9)--Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Impurities: Residual Solvents   May 2000                           Do                                        Do
 in New Veterinary Medicinal Products, Active
 Substances and Excipients (VICH GL18)--Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: How to Use E-Mail to Submit a   February 2000                      Do                                        Do
 Notice of Final Disposition of Animals Not Intended
 for Immediate Slaughter (NFDAs)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: How to Use E-Mail to Submit a   February 2000                      Do                                        Do
 Notice of Intent to Slaughter for Human Food
 Purposes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: How to Use E-Mail to Submit a   February 2000                      Do                                        Do
 Request for a Meeting or Teleconference to the
 Office of New Animal Drug Evaluation
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
How to Use E-Mail to Submit Information to the Center  February 2000                      Do                                        Do
 for Veterinary Medicine--Final
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Dioxin in Anti-Caking Agents Used in Animal Feed and   Revised April 2000                 Do                                        Do
 Feed Ingredients
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Fumonisin Levels in Human       June 2000                          Do                                        Do
 Foods and Animal Feeds--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
The Use of Published Literature in Support of New      November 2000                      Do                                        Do
 Animal Drug Approval
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Bioequivalence Guidance         Revised October 2000               Do                                        Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry #124: Voluntary Labeling         January 2001                       Do                                        Do
 Indicating Whether Foods Have or Have Not Been
 Developed Using Bioengineering--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry #126: BACPAC I: Intermediates    February 2001                      Do                                        Do
 in Drug Substance Synthesis Bulk Actives
 Postapproval Changes: Chemistry, Manufacturing, and
 Controls Documentation, February 2001
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry #120: Veterinary Feed Directive  March 2001                         Do                                        Do
 Regulation
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry #121: Expedited Review for New   March 2001                         Do                                        Do
 Animal Drug Applications for Human Pathogen
 Reduction Claims
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53922]]

 
Guidance for Industry and Reviewers: How the Center    March 2001                         Do                                        Do
 for Veterinary Medicine Intends to Handle Deficient
 Submissions Filed During the Investigation of a New
 Animal Drug--Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                   VII. Guidance Documents Issued by the Office of Policy (OP)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                   Name of Document                             Date of Issuance            Intended User or Regulatory Activity              How to Obtain a Hard Copy of the Document
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry; Exports and Imports       June 12, 1998                      Regulated Industry                        Internet via www.fda.gov/opacom/fedregister/frexport.html or
 Under the FDA Export Reform and Enhancement Act of                                                                                  63 FR 32219, June 12, 1998, or Office of Policy, 301-827-
 1996                                                                                                                                3360
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Direct Final Rule Guidance                             November 21, 1997                  FDA Personnel                             Internet via www.fda.gov/opacom/morechoices/industry/guidance.htm or 62 FR 62467, November 21, 1997, or Office
                                                                                                                                     of Policy, 301-827-3480
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
International Harmonization; Policy on Standards       October 1995                       FDA Personnel and Regulated Industry      60 FR 53078, October 11, 1995, or Office of Policy, 301-827-
                                                                                                                                     3360
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                                           Withdrawals
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                   Name of Document                             Date of Issuance            Intended User or Regulatory Activity                           Date Withdrawn
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
FDA's Development, Issuance and Use of Guidance        February 27, 1997                  FDA Personnel and Regulated Industry      September 19, 2000
 Documents
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Small Entities Compliance Guide On: Regulations To     February 1997                      Regulated Industry                        March 31, 2000
 Restrict the Sale and Distribution of Cigarettes and
 Smokeless Tobacco in Order to Protect Children and
 Adolescents (21 CFR Part 897)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Children and Tobacco--Frequently Asked Questions       July 1997                          Regulated Industry                        March 31, 2000
 About the New Regulations (Draft)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Children and Tobacco--A Retailers Guide to the New     October 1997                       Regulated Industry                        March 31, 2000
 Federal Regulations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Children and Tobacco--A Guide to the New Federal       October 1997                       Regulated Industry                        March 31, 2000
 Regulations
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


                                                            VIII. Guidance Documents Issued by the Office of Regulatory Affairs (ORA)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                   Name of Document                             Date of Issuance            Intended User or Regulatory Activity              How to Obtain a Hard Copy of the Document
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide Manual--Compliance Policy      August 2000                        FDA Staff                                 National Technical Information Service (NTIS) 5285 Port
 Guidance for FDA Staff (Replaces Compliance Policy                                                                                  Royal Rd., Springfield, VA 22161 or Internet at:
 Guide--January 1996)                                                                                                                www.fda.gov/ora/cpgm/default.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, New Sec. 615.115 Extra-Label  April 2001                         Do                                        Division of Compliance Policy (HFC-230), Office of
 Use of Medicated Feeds for Minor Species                                                                                            Enforcement, Food and Drug Administration, 5600 Fishers
                                                                                                                                     Lane, Rockville, MD 20857, 301-827-0420 or via Internet at:
                                                                                                                                     www.fda.gov/ora/compliance--;ref/rpm/rpmtc.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53923]]

 
Compliance Policy Guide, New Sec. 555.250 Statement    April 2001                         Do                                        Do
 of Policy for Labeling and Preventing Cross-Contact
 of Common Food Allergens
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Reformat Sec. 220.100         March 2001                         Do                                        Do
 Interstate Shipment of Biological Products for Use
 in Medical Emergencies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Reformat Sec. 270.100 Final   March 2001                         Do                                        Do
 Container Labels--Allergenic Extracts Containing
 Glycerin; Reporting Changes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Draft Sec. 230.150, Blood     December 2000                      Do                                        Do
 Donor Incentives
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide, Draft Distributor Medical     August 28, 1997                    FDA Staff Personnel and Regulated         Do Internet at: www.fda.gov/ora/compliance--;ref/cpg--
 Reporting                                                                                 Industry                                  ;mdr3.txt
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide Sec. 7150.09 Fraud,            July 1991                          FDA Staff and Regulated Industry           Do Internet at: www.fda.gov/ora/compliance--;ref/aip--
 Statements of Material Facts, Bribery, and Illegal                                                                                  ;page.html
 Gratuities
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Warning Letter Pilot                    March 8, 1999                      FDA Staff and Regulated Industry          Do Internet at: www.fda.gov/ohrms/Dockets/98fr/030899e.pdf
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Glossary of Computerized System and Software           August 1995                        Do                                        National Technical Information Service (NTIS) 5285 Port
 Development Terminology                                                                                                             Royal Rd., Springfield, VA 22161 (NTIS 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                                 Division of Import Operations and Policy (HFC-170), Office
 Electronic Devices                                                                                                                  of Regional Operations, Food and Drug Administration, 5600
                                                                                                                                     Fishers Lane, Rockville, MD 20857, 301-594-1218
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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, or Internet at: www.fda.gov/ora/science--;ref/lpm/
                                                                                                                                     lpmtc.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Laboratory Procedures Manual Chapter X, New: Method    May 1999                           Do                                        Do
 Validation Samples
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Memorandum: ORA Investigational Strategy on Gamma-     May 15, 2000                       Do                                        Division of Emergency and Investigational Operations (HFC-
 Butyrolactone (GBL) and Related Products                                                                                            130), Office of Regional Operations, Food and Drug
                                                                                                                                     Administration, 5600 Fishers Lane, Rockville, MD 20857, Not
                                                                                                                                     Available on the Internet
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Investigations Operations Manual                       January 2001                       Do                                        National Technical Information Service (NTIS) 5285 Port
                                                                                                                                     Royal Rd., Springfield, VA 22161 (NTIS Order No. PB2001-
                                                                                                                                     913399 and Internet at www.fda.gov/ora/inspect--;ref/iom/
                                                                                                                                     default.htm)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Devices: Draft Guidance entitled ``Guidance    Released for Comment June 8, 1999  FDA Staff                                 Division of Compliance Policy (HFC-230), Office of
 for FDA Staff on Civil Money Penalty Policy''                                                                                       Enforcement, Food and Drug Administration, 5600 Fishers
                                                                                                                                     Lane, Rockville, MD 20857, 301-827-0420, or Internet at:
                                                                                                                                     http://www.fda.gov/ohrms/dockets/98fr/060899e.pdf
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53924]]

 
Regulatory Procedures Manual Update/New Subchapter 5   April 19, 2001                     Do                                        Do Internet at: www.fda.gov/ora/compliance--;ref/rpm/
 Civil Money Penalty Reduction Policy for Small                                                                                      rpmtc.html
 Entities
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual New RPM Subchapter:       January 2001                       Do                                        Do Internet at: www.fda.gov/ora/compliance--;ref/rpm/
 Communication Concerning Assessment of Civil                                                                                        rpmtc.html
 Monetary Penalties by U.S. Customs Service in Cases
 Involving Imported Food
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: Update, New Subchapter   March 1998                         Do                                        Division of Compliance Policy (HFC-230), Office of
 Application Integrity Policy                                                                                                        Enforcement, Food and Drug Administration, 5600 Fishers
                                                                                                                                     Lane, Rockville, MD 20857, 301-827-0420 or via Internet at:
                                                                                                                                     www.fda.gov/ora/compliance--;ref/rpm/rpmtc.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: Update/Revision          April 1998                         Do                                        Do
 Subchapter/Priority Enforcement Strategy for Problem
 Importers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: Update/Revision          April 1998                         Do                                        Do
 Subchapter/Import Procedures
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: Update/Revision          April 1998                         FDA Staff                                 Do
 Subchapter/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          June 1998                          Do                                        Do Internet at: www.fda.gov/ora/compliance--;ref/rpm--;new2/
 Subchapter/Seizure                                                                                                                  ch6.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: Update/Revision          June 1998                          Do                                        Do Internet at: www.fda.gov/ora/compliance--;ref/new2/
 Subchapter/Supervisory Charges                                                                                                      ch9chgs.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: New Subchapter: Civil    July 1998                          Do                                        Do Internet at: www.fda.gov/ora/compliance--;ref/
 Penalties--Electronic Product Radiation Control                                                                                     ch6civpen.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual: Update/Revision,         March 21, 2000                     Do                                        Do Internet at: www.fda.gov/ora/compliance--;ref/rpm--;new2/
 Chapter 4, Subchapter/Warning Letters                                                                                               ch4.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual New Chapter 9,            January 2001                       Do                                        Do Internet at: www.fda.gov/ora/compliance--;ref/rpm--;new2/
 Communication Concerning Assessment of Civil                                                                                        ch9civmonpen.html
 Monetary Penalties by U.S. Customs in Cases
 Involving Imported Food
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Procedures Manual New Chapter 9, Secured    January 2001                       Do                                        Do Internet at: www.fda.gov/ora/compliance--;ref/rpm--;new2/
 Storage                                                                                                                             ch9securedstorage.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Bulk Pharmaceutical Chemicals  May 1994                           Do                                        National Technical Information Service (NTIS), 5285 Port
                                                                                                                                     Royal Rd., Springfield, VA 22161, (NTIS Order No. PB96-
                                                                                                                                     127154) or via Internet at: www.fda.gov/ora/inspect)--;ref/
                                                                                                                                     igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Pharmaceutical Quality         July 1993                          Do                                        Do (NTIS Order No. PB96-127279) or via Internet at:
 Control Laboratories                                                                                                                www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53925]]

 
Guide to Inspections of Microbiological                July 1993                          Do                                        Do (NTIS Order No. PB96-127287) or via Internet at:
 Pharmaceutical Quality Control Laboratories                                                                                         www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Validation of Cleaning         July 1993                          Do                                        Do (NTIS Order No. PB96-127246) or via Internet at:
 Processes                                                                                                                           www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Lyophilization of Parenterals  July 1993                          Do                                        Do (NTIS Order No. PB96-127253) or via Internet at:
                                                                                                                                     www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of High Purity Water Systems      July 1993                          Do                                        Do (NTIS Order No. PB96-127261) or via Internet at:
                                                                                                                                     www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Dosage Form Drug               October 1993                       Do                                        Do (NTIS Order No. PB96-127212) or via Internet at:
 Manufacturers--CGMPs                                                                                                                www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Oral Solid Dosage Forms Pre/   January 1994                       Do                                        Do (NTIS Order No. PB96-127345) or via Internet at:
 Post Approval Issues for Development and Vaccination                                                                                www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Topical Drug Products          July 1994                          Do                                        Do (NTIS Order No. PB96-127394) or via Internet at:
                                                                                                                                     www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Sterile Drug Substance         July 1994                          Do                                        Do (NTIS Order No. PB96-127295) or via Internet at:
 Manufacturers                                                                                                                       www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Oral Solutions and             August 1994                        Do                                        Do (NTIS Order No. PB96-127147) or via Internet at:
 Suspensions                                                                                                                         www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Nutritional Labeling and       February 1995                      Do                                        Do (NTIS Order No. PB96-127378) or via Internet at:
 Education Act (NLEA) Requirements                                                                                                   www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Interstate Carriers and        April 1995                         Do                                        Do (NTIS Order No. PB96-127386) or via Internet at:
 Support Facilities                                                                                                                  www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Dairy Product Manufacturers    April 1995                         Do                                        Do (NTIS Order No. PB96-127329) or via Internet at:
                                                                                                                                     www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Miscellaneous Foods Vol. 1     May 1995                           Do                                        Do (NTIS Order No. PB97-127220) or via Internet at:
                                                                                                                                     www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Miscellaneous Foods Vol. 11    September 1996                     Do                                        Do (NTIS Order No. PB97-196133) or via Internet at:
                                                                                                                                     www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Low Acid Canned Foods          November 1996                      Do                                        Do (NTIS Order No. PB97-196141) or via Internet at:
 Manufacturers, Part 1--Administrative Procedures/                                                                                   www.fda.gov/ora/inspect--;ref/igs/iglist.html
 Scheduled Processes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Cosmetic Product               February 1995                      Do                                        Do (NTIS Order No. PB96-127238) or via Internet at:
 Manufacturers                                                                                                                       www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Low Acid Canned Foods          April 1997                         Do                                        Do (NTIS Order No. PB97-196158) or via Internet at:
 Manufacturers, Part 2--Processes/ Procedures                                                                                        www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53926]]

 
Guide to Inspections of Low Acid Canned Foods          July 2001                          FDA Staff                                 Do (NTIS Order No. PB00-133795)
 Manufacturers, Part 3--Container Closurers
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Blood Banks                    September 1994                     Do                                        Do (NTIS Order No. PB96-127303) or via Internet at:
                                                                                                                                     www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Source Plasma Establishments   December 1994                      Do                                        Do (NTIS Order No. PB96-127360) or via Internet at:
                                                                                                                                     www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Infectious Disease Marker      June 1996                          Do                                        Do (NTIS Order No. PB96-199476) or via Internet at:
 Testing Facilities                                                                                                                  www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Biotechnology Inspections Guide                        November 1991                      Do                                        Do (NTIS Order No. PB96-127402) or via Internet at:
                                                                                                                                     www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Computerized Systems in Drug   February 1983                      Do                                        Do (NTIS Order No. PB96-127337) or via Internet at:
 Processing                                                                                                                          www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Foreign Medical Device         September 1995                     Do                                        Do (NTIS Order No. PB96-127311) or via Internet at:
 Manufacturers                                                                                                                       www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Foreign Pharmaceutical         May 1996                           Do                                        Do (NTIS Order No. PB96-199468) or via Internet at:
 Manufacturers                                                                                                                       www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Mammography Quality Standards Act (MQSA) Auditors      January 1998                       Do                                        Do (NTIS Order No. PB98-127178) or via Internet at:
 Guide                                                                                                                               www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Electromagnetic Compatibility  December 1997                      Do                                        Do (NTIS Order No. PB98-127152) or via Internet at:
 Aspects of Medical Device Quality Systems                                                                                           www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Acidified Food Manufacturers   May 1998                           Do                                        http://www.fda.gov/ora/inspect--;ref/igs/acidfgde.htm
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspection of Aseptic Processing and          February 2001                      Do                                        Division of Emergency and Investigational Operations (HFC-
 Packaging for the Food Industry                                                                                                     130), Office of Regional Operations, Food and Drug
                                                                                                                                     Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
                                                                                                                                     443-1240
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Grain Product Manufacturers    March 1998                         Do                                        (NTIS Order No. PB-98-137128) or via Internet at:
                                                                                                                                     www.fda.gov/ora/inspect--;ref/igs/iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Bioresearch Monitoring Inspections of In      February 1998                      Do                                        Do Internet at: www.fda.gov/ora/inspect--;ref/igs/
 Vitro Devices                                                                                                                       iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Viral Clearance Processes for  March 1998                         Do                                        Do Internet at: www.fda.gov/ora/inspect--;ref/igs/
 Plasma Derivatives                                                                                                                  iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Trace Back of Fresh Fruits and Vegetables     April 2001                         Do                                        Do Internet at: www.fda.gov/ora/inspect--;ref/igs/
 Implicated in Epidemiological Investigations                                                                                        iglist.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspections of Computerized Systems in the    August 1998                        Do                                        Do Internet at: www.fda.gov/ora/inspect--;ref/igf/
 Food Processing Industry                                                                                                            foodcomp.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to International Inspections and Travel,         July 1999                          Do                                        Do Revision not available on Internet
 Revision (Formerly, FDA/ORA International Inspection
 Manual and Travel Guide)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 53927]]

 
Guide to Inspections of Quality Systems                August 1999                        Do                                        Do Internet at: www.fda.gov/ora/inspect--;ref/igs/qsit/
                                                                                                                                     QSITGUIDE.PDF
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide to Inspection of Firms Producing Food Products   April 2001                         Do                                        Do Internet at: http://www.fda.gov/ora/inspect--;ref/igs/
 Susceptible to Contamination with Allergenic                                                                                        iglist.html
 Ingredients
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Computerized Systems Used in Clinical Trials           April 1999                         Do                                        Do Internet at: www.fda.gov/ora/compliance--;ref/bimo/
                                                                                                                                     ffinalact.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Program 7348.001: Bioresearch Monitoring,   October 1, 1999                    D0                                        Do Internet at: www.fda.gov/ora/compliance--;ref/Bimo/7348--
 Human Drugs, In Vivo Bioequivalence                                                                                                 ;001/default.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Good Laboratory Practice Program (Nonclinical          October 1, 1991                    Do                                        Division of Compliance Policy (HFC-230), Office of
 Laboratories) 7348.808A; EPA Data Audit Inspections                                                                                 Enforcement, Food and Drug Administration, 5600 Fishers
                                                                                                                                     Lane, Rockville, MD 20857, 301-827-0420
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for the Monitoring of Clinical               January 1988                       FDA Regulated Industry                    Division of Compliance Policy (HFC-230), Office of
 Investigators                                                                                                                       Enforcement, Food and Drug Administration, 5600 Fishers
                                                                                                                                     Lane, Rockville, MD 20857, 301-827-0420
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Small Business Guide to FDA (FDA 96-1092)              January 1, 1996                    Do                                        Federal-State Relations (HFC-150), Office of Regulatory
                                                                                                                                     Affairs, Food and Drug Administration, 5600 Fishers Lane,
                                                                                                                                     Rockville, MD 20857, 301-827-2905 Internet at: www.fda.gov/ora/indust--;assit/default.htm
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Program 7348.808 Bioresearch Monitoring:    Revised August 17, 1998            FDA Staff                                 Do Internet at: www.fda.gov/ora/compliance--;ref/bimo/
 Good Laboratory Practices (Nonclinical)                                                                                             default.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Program 7348.809 Bioresearch Monitoring:    August 18, 1994                    Do                                        Do
 Institutional Review Board
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Program 7348.810: Sponsors, Contract        Revised October 30, 1998           Do                                        Do
 Research Organizations and Monitors
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Good Laboratory Practice Regulations Management        August 1979                        Do                                        Do Internet at: www.fda.gov/ora/compliance--;ref/bimo/
 Briefings                                                                                                                           default.html
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft: Guidance for Institutional Review Boards,       March 31, 2000                     FDA Regulated Industry                    Do
 Clinical Investigators, and Sponsors: Exception from
 Informed Consent Requirements for Emergency Research
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: October 9, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-26650 Filed 10-23-01; 8:45 am]
BILLING CODE 4160-01-S