[Federal Register: June 10, 1999 (Volume 64, Number 111)]
[Notices]
[Page 31228-31280]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jn99-101]

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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.

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

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

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

ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Information on where to obtain a single copy of
listed guidance documents is provided for each agency Center
individually in the specific Center's list of guidance documents.

FOR FURTHER INFORMATION CONTACT: Lisa M. Helmanis, Office of Policy
(HF-22), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3480.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 27, 1997 (62 FR 8961), FDA
published a notice announcing its GGP's, which set forth the agency's
policies and procedures for the development, issuance, and use of
guidance documents. The agency adopted the GGP's to ensure public
involvement in the development of guidance documents and to enhance
public understanding of the availability, nature, and legal effect of
such guidance.
    As part of FDA's effort to ensure meaningful interaction with the
public regarding guidance documents, the agency committed to publish an
annual comprehensive list of guidance documents and quarterly updates
that list all guidance documents that were issued and withdrawn during
that quarter, including ``Level 2'' guidance documents.
    On June 1, 1998, the President instructed all Federal agencies to
ensure the use of ``plain language'' in all new documents. As part of
this initiative,

[[Page 31229]]

FDA uses the principles of ``plain language'' set forth by the
President when writing its guidance documents. The agency seeks public
comment on the clarity of its guidances.
    The following comprehensive list of guidance documents represents
all guidances currently in effect. This comprehensive list is
maintained on the FDA World Wide Web home page. This list will be
updated and published annually in the Federal Register. The guidance
documents on this comprehensive list are organized by the issuing
Center or Office within FDA, and are further grouped by the intended
users or regulatory activities to which they pertain. Dates provided in
the following list refer to the date of issuance or, where applicable,
the date of last revision of the document. Document numbers are
provided where available.

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

----------------------------------------------------------------------------------------------------------------
                                                                                    How to Obtain a Hard Copy of
                                                             Grouped by Intended       the Document (Name and
           Name of Document              Date of Issuance     User or Regulatory    Address, Phone, FAX, E-mail
                                                                   Activity                 or Internet)
----------------------------------------------------------------------------------------------------------------
Requirements for Infrequent             August 27, 1982     FDA regulated          Office of Communication,
 Plasmapheresis Donors                                       industry               Training, and Manufacturers
                                                                                    Assistance (HFM-40), 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: http://www.fda.gov/
                                                                                    cber
Recommendations to Decrease the Risk    March 24, 1983      Do                     Do
 of Transmitting AIDS from Plasma
 Donors
Deferral of Blood Donors Who Have       February 28, 1984   Do                     Do
 Received the Drug Accutane
 (isotretinoin/Roche); 13-cis-retinoic
 acid)
Equivalent Methods for Compatibility    December 14, 1984   Do                     Do
 Testing
Plasma Derived from Therapeutic Plasma  December 14, 1984   Do                     Do
 Exchange
Reduction of the Maximum Platelet       June 2, 1986        Do                     Do
 Storage Period to 5 Days in an
 Approved Container
Deferral of Donors Who Have Received    November 25, 1987   Do                     Do
 Human Pituitary-Derived Growth
 Hormone
Recommendations for the Management of   December 2, 1987    Do                     Do
 Donors and Units That Are Initially
 Reactive for Hepatitis B Surface
 Antigen (HBsAg)
Extension of Dating Period for Storage  December 4, 1987    Do                     Do
 of Red Blood Cells, Frozen
To Licensed In-Vitro Diagnostic         December 23, 1987   Do                     Do
 Manufacturers: Handling of Human
 Blood Source Materials
Recommendations for Implementation of   April 6, 1988       Do                     Do
 Computerization in Blood
 Establishments
Control of Unsuitable Blood and Blood   April 6, 1988       Do                     Do
 Components
Discontinuance of Prelicensing          July 7, 1988        Do                     Do
 Inspection for Immunization Using
 Licensed Tetanus Toxoid and Hepatitis
 B and Rabies Vaccines
Physician Substitutes                   August 15, 1988     Do                     Do
To Licensed Manufacturers of Blood      August 26, 1988     Do                     Do
 Grouping Reagents: Criteria for
 Exemption of Lot Release
To Manufacturers of HTLV-I Antibody     October 18, 1988    Do                     Do
 Test Kits: Antibody to Human T-Cell
 Lymphotropic Virus, Type I (HTLV-I)
 Release Panel I
HTLV-1 Antibody Testing                 November 29, 1988   Do                     Do
Use of Recombigen HIV-1 LA Test         February 1, 1989    Do                     Do
Guidance for Autologous Blood and       March 15, 1989      Do                     Do
 Blood Components
HTLV-I Antibody Testing                 July 6, 1989        Do                     Do
Use of Recombigen HIV-1 Latex           August 1, 1989      Do                     Do
 Agglutination (LA) Test
Requirements for Computerization of     September 8, 1989   Do                     Do
 Blood Establishments
Abbott Laboratories' HIVAG-1 Test for   October 4, 1989     Do                     Do
 HIV-1 Antigen(s) Not Recommended for
 Requirements for Computerization of
 Blood Establishments
Autologous Blood Collection and         February 12, 1990   Do                     Do
 Processing Procedures
Use of Genetic Systems HIV-2 EIA        June 21, 1990       Do                     Do
Deficiencies Relating to the            March 20, 1991      Do                     Do
 Manufacture of Blood and Blood
 Components

[[Page 31230]]

Responsibilities of Blood               March 20, 1991      Do                     Do
 Establishments Related to Errors &
 Accidents in the Manufacture of Blood
 and Blood Components
Revision to October 26, 1989 Guideline  April 17, 1991      Do                     Do
 for Collection of Blood or Blood
 Products from Donors with Positive
 Tests for Infectious Disease Markers
 (High Risk Donors)
FDA Recommendations Concerning Testing  September 10, 1991  Do                     Do
 for Antibody to Hepatitis B Core
 Antigen (Anti-HBc)
Disposition of Blood Products Intended  September 11, 1991  Do                     Do
 for Autologous Use That Test
 Repeatedly Reactive for Anti-HCV
Clarification of FDA Recommendations    December 12, 1991   Do                     Do
 for Donor Deferral and Product
 Distribution Based on the Results of
 Syphilis Testing
Revised Recommendations for the         April 23, 1992      Do                     Do
 Prevention of Human Immunodeficiency
 Virus (HIV) Transmission by Blood and
 Blood Products
Use of Fluorognost HIV-1                April 23, 1992      Do                     Do
 Immunofluorescent Assay (IFA)
Revised Recommendations for Testing     April 23, 1992      Do                     Do
 Whole Blood, Blood Components, Source
 Plasma and Source Leukocytes for
 Antibody to Hepatitis C Virus Encoded
 Antigen (Anti-HCV)
Exemptions to Permit Persons with a     April 23, 1992      Do                     Do
 History of Viral Hepatitis Before the
 Age of Eleven Years to Serve as
 Donors of Whole Blood and Plasma;
 Alternative Procedures (21 CFR
 640.120)
Changes in Equipment for Processing     July 21, 1992       Do                     Do
 Blood Donor Samples
Nomenclature for Monoclonal Blood       August 19, 1993     Do                     Do
 Grouping Reagents
Volume Limits for Automated Collection  November 4, 1992    Do                     Do
 of Source Plasma
Revision of October 7, 1988 Memo        December 16, 1992   Do                     Do
 Concerning Red Blood Cell
 Immunization Programs
Recommendations Regarding License       July 22, 1993       Do                     Do
 Amendments and Procedures for Gamma
 Irradiation of Blood Products
Deferral of Blood and Plasma Donors     July 28, 1993       Do                     Do
 Based on Medications
Revised Recommendations for Testing     August 19, 1993     Do                     Do
 Whole Blood, Blood Components, Source
 Plasma and Source Leukocytes for
 Antibody to Hepatitis C Virus Encoded
 Antigen (Anti-HCV)
Changes in Administrative Procedures    September 9, 1993   Do                     Do
Guidance Regarding Post Donation        December 10, 1993   Do                     Do
 Information Reports
Donor Suitability Related to            December 22, 1993   Do                     Do
 Laboratory Testing for Viral
 Hepatitis and a History of Viral
 Hepatitis
Recommendations for the Invalidation    January 3, 1994     Do                     Do
 of Test Results When Using Licensed
 Viral Marker Assays to Screen Donors
Recommendations for Deferral of Donors  July 26, 1994       Do                     Do
 for Malaria Risk
Use of and FDA Cleared or Approved      August 5, 1994      Do                     Do
 Sterile Docking Device (STCD) in
 Blood Bank Practices (transmittal
 memo 8/12/94) (corrects 7/29/94 Memo)
Recommendations to Users of Medical     December 20, 1994   Do                     Do
 Devices That Test for Infectious
 Disease Markers by Enzyme Immunoassay
 (EIA) Test Systems
 Timeframe for Licensing Irradiated     February 3, 1995    Do                     Do
 Blood Products
Revision of 8/27/82 FDA Memo:           March 10, 1995      Do                     Do
 Requirements for Infrequent
 Plasmapheresis Donors
To All Establishments Performing Red    March 14, 1995      Do                     Do
 Blood Cell Immunizations: Revised
 Recommendations for Red Blood Cell
 Immunization Programs for Source
 Plasma

[[Page 31231]]

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

[[Page 31232]]

Recommended Methods for Evaluating      March 1, 1992       Do                     Do
 Potency, Specificity and Reactivity
 of Anti-Human Globulin
Methods of the Allergenic Products      October 1, 1993     Do                     Do
 Testing Laboratory
Guide to Inspections of Blood Banks,    September 1, 1994   FDA personnel          Do
 Division of Field Investigations,
 Office of Regional Operations, Office
 of Regulatory Affairs
Guide to Inspections of Infectious      June 1, 1996        Do                     Do
 Disease Marker Testing Facilities
Guide to Inspections of Source Plasma   June 1, 1997        Do                     Do
 Establishments (Division of Field
 Investigations, Office of Regional
 Operations, Office of Regulatory
 Affairs)
Notification Process for Transfusion    October 7, 1997     FDA regulated          Do
 Related Fatalities and Donation                             industry
 Related Deaths (revised telephone
 number)
Submission Requirements for Requesting  October 15, 1997    Do                     Do
 Certificates for Exporting Products
 to Foreign Countries
CBER Refusal to File (RTF) Guidance     July 12, 1993       Do                     Do
 for Product and Establishment License
 Applications
OELPS, Advertising and Promotional      August 1, 1994      Do                     Do
 Labeling Staff Procedural Guidance
 Document (Draft)
Guidance on Alternatives to Lot         October 27, 1994    Do                     Do
 Release for Licensed Biological
 Products
Content and Format of Investigational   November 1, 1995    Do                     Do
 New Drug Applications (INDs) for
 Phase 1 Studies of Drugs, Including
 Well-Characterized, Therapeutic,
 Biotechnology-Derived Products
Computer Assisted Product License       March 1, 1996       Do                     Do
 Application (CAPLA) Guidance Manual
FDA Guidance Concerning Demonstration   April 26, 1996      Do                     Do
 of Comparability of Human Biological
 Products, Including Therapeutic
 Biotechnology-Derived Products
Guidance for Industry--The Content and  May 23, 1996        Do                     Do
 Format for Pediatric Use Supplements
Guidance on Applications for Products   May 24, 1996        Do                     Do
 Comprised of Living Autologous Cells
 Manipulated Ex Vivo and Intended for
 Structural Repair of Reconstruction
Guidance for Industry for the           August 15, 1996     Do                     Do
 Submission of Chemistry,
 Manufacturing, and Controls
 Information for a Therapeutic
 Recombinant DNA-Derived Product or a
 Monoclonal Antibody Product for In
 Vivo Use
Draft Guidance for Industry:            September 20, 1996  Do                     Do
 Manufacture, Processing or Holding of
 Active Pharmaceutical Ingredients
Draft Guidance for Industry;            November 4, 1996    Do                     Do
 Submitting Application Archival
 Copies in Electronic Format
Draft Guidance for Industry;            November 4, 1996    Do                     Do
 Electronic Submission of Case Report
 Forms and Case Report Tabulations
Guidance for the Submission of          January 10, 1997    Do                     Do
 Chemistry, Manufacturing, and
 Controls Information and
 Establishment Description for
 Autologous Somatic Cell Therapy
 Products
Proposed Approach to Regulation of      February 28, 1997   Do                     Do
 Cellular and Tissue-Based Products
Tables 1 and 2 from Proposed Approach   March 4, 1997       Do                     Do
 to Regulation of Cellular and Tissue-
 Based Products
Guidance for Industry--Providing        March 13, 1997      Do                     Do
 Clinical Evidence of Effectiveness
 for Human Drug and Biological
 Products
Guidance for Industry for the           April 10, 1997      Do                     Do
 Evaluation of Combination Vaccines
 for Preventable Diseases: Production,
 Testing and Clinical Studies
Guidance for Industry--Changes to an    July 24, 1997       Do                     Do
 Approved Application: Biological
 Products
Guidance for Industry--Changes to an    July 24, 1997       Do                     Do
 Approved Application for Specified
 Biotechnology and Specified Synthetic
 Biological Products

[[Page 31233]]

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

[[Page 31234]]

FDA Regulated Industries for            October 26, 1989    Do                     Do
 Collection of Blood or Blood Products
 from Donors With Positive Tests for
 Infectious Disease Markers (``High
 Risk'' Donors)
Guideline for Determination of          January 1, 1990     Do                     Do
 Residual Moisture in Dried Biological
 Products
Guideline on the Preparation of         March 1, 1991       Do                     Do
 Investigational New Drug Products
 (Human & Animal)
Draft Guideline for the Validation of   September 28, 1993  Do                     Do
 Blood Establishment Computer Systems
Guideline for Adverse Experience        October 15, 1993    Do                     Do
 Reporting for Licensed Biological
 Products
Guideline for Quality Assurance in      July 11, 1995       Do                     Do
 Blood Establishments
To In Vitro Diagnostic Reagent          December 6, 1986    Do                     Do
 Manufacturers: Guidance On the
 Labeling of Human Blood Derived In
 Vitro Diagnostic Devices In Regard to
 Labeling for HTLV-III/LAV Antibody
 Testing
To Biologic Product Manufacturers--     May 3, 1991         Do                     Do
 Controlling Materials of Bovine or
 Ovine Origin
To Sponsors of INDs Using Retroviral    September 20, 1993  Do                     Do
 Vectors
To Manufacturers: Bovine Derived        December 17, 1993   Do                     Do
 Materials (BSE)
To Blood Establishment Computer         March 31, 1994      Do                     Do
 Software Manufacturers
To Sponsors of INDs for Human           May 23, 1994        Do                     Do
 Immunoglobulin Products
To Manufacturers of Licensed Anti-HIV   May 26, 1994        Do                     Do
 Test Kits
Letter to Manufacturers of Immune       October 3, 1994     Do                     Do
 Globulin Intravenous (Human) (IGIV),
 Aseptic Meningitis Syndrome
To Manufacturers of Immune Globulin     December 27, 1994   Do                     Do
 Products: Testing for Hepatitis C
 Virus RNA Immunoglobulin
To Blood Establishment Computer         February 10, 1995   Do                     Do
 Software Manufacturers
To Manufacturers of Intramuscular       March 3, 1995       Do                     Do
 Immune Globulin Products: HCV RNA
 Testing by PCR
To Manufacturers of Intramuscular       March 13, 1995      Do                     Do
 Immune Globulin Products: Additional
 Information Regarding HCV RNA Testing
 by PCR
To Health Professionals:                March 14, 1995      Do                     Do
 Implementation of Testing for HCV RNA
 by PCR for Immune Globulin Products
 for Intramuscular Administration
Dear Colleague: Regarding Reverse       January 4, 1996      Do                    Do
 Transcriptase Activity in Viral
 Vaccines Produced in Chicken Cells
To Manufacturers of FDA-Regulated Drug/ May 9, 1996         Do                     Do
 Biological/Device Products, Bovine
 Spongiform Encephalopathy (BSE)
To Manufacturers: Implementation of     June 13, 1996       Do                     Do
 Testing for Hepatitis C Virus RNA by
 Manufacturers: Implementation of
 Testing for Hepatitis C Virus RNA by
 Polymerase Chain Reaction (PCR) of
 Intramuscular Immune Globulin
 Preparations
To Manufacturers: HIV-1 Group O         July 31, 1996       Do                     Do
To All Plasma Derivative Manufacturers  October 7, 1996     Do                     Do
 and to ABRA: Warning Statement for
 Plasma Derivative Product Labeling
To Biologic Product Manufacturers:      December 3, 1996    Do                     Do
 Revised Procedures for Internal
 Labeling Review Number Assignment
To Plasma Fractionators--CBER's View    May 29, 1997        Do                     Do
 on Product Recalls Conducted by the
 Plasma Fractionation Industry
PTC in the Manufacture of In Vitro      June 20, 1983       Do                     Do
 Monoclonal Antibody Products Subject
 to Licensure
Draft PTC in the Production and         July 28, 1983       Do                     Do
 Testing of Interferon Intended for
 Investigational Use in Humans
 (Interferon Test Procedures)

[[Page 31235]]

Draft PTC in the Production and         April 10, 1985      Do                     Do
 Testing of New Drugs and Biologicals
 Produced by Recombinant DNA
 Technology
Draft PTC in the Manufacture and        August 8, 1989      Do                     Do
 Clinical Evaluation of In Vitro Tests
 to Detect Antibodies to Human
 Immunodeficiency Virus Type 1 (1989)
PTC in the Collection, Processing and   August 22, 1989     Do                     Do
 Testing of Ex Vivo Activated
 Mononuclear Leukocytes for
 Administration to Humans
Cytokine and Growth Factor Pre-Pivotal  April 2, 1990       Do                     Do
 Trial Information Package
PTC in the Safety Evaluation of         August 21, 1990     Do                     Do
 Hemoglobin-Based Oxygen Carriers
PTC in the Design and Implementation    March 1, 1992       Do                     Do
 of Field Trials for Blood Grouping
 Reagents and Anti-Human Globulin
PTC in the Manufacture of In Vitro      March 1, 1992       Do                     Do
 Monoclonal Antibody Products for
 Further Manufacturing into Blood
 Grouping Reagent and Anti-Human
 Globulin
Supplement to the PTC in the            April 6, 1992       Do                     Do
 Production and Testing of New Drugs
 and Biologicals Produced by
 Recombinant DNA Technology: Nucleic
 Acid Characterization and Genetic
 Stability
Draft PTC in the Characterization of    July 12, 1993       Do                     Do
 Cell Lines Used to Produce
 Biologicals
PTC in the Manufacture and Testing of   August 22, 1995     Do                     Do
 Therapeutic Products for Human Use
 Derived from Transgenic Animals
PTC on Plasmid DNA Vaccines for         December 22, 1996   Do                     Do
 Preventive Infectious Disease
 Indications
PTC in the Manufacture and Testing of   February 28, 1997   Do                     Do
 Monoclonal Antibody Products for
 Human Use
Reviewer Guidance, Computer Software    April 26, 1995      FDA Personnel          Do
 Informed Consent for Plasmapheresis/   October 1, 1995     Do                     Do
 Immunization
Draft Reviewers' Guide: Changes in      October 1, 1995     Do                     Do
 Personnel
Disease Associated Antibody Collection  October 1, 1995     Do                     Do
 Program
Reviewer Guidance for a Premarket       January 13, 1997    Do                     Do
 Notification Submission for Blood
 Establishment Computer Software
Compliance Program Guidance Manual      1994                Do                     National Technical
 (Drugs and Biologics)                                                              Information Service (NTIS),
                                                                                    5285 Port Royal Rd.,
                                                                                    Springfield, VA 22161, 703-
                                                                                    605-6050 (Publication No. 94-
                                                                                    920699)
Guidance for Industry: Industry-        November 1997       FDA regulated          Office of Communication,
 Supported Scientific and Educational                        industry               Training, and Manufacturers
 Activities                                                                         Assistance (HFM-40), 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: http://www.fda.gov/
                                                                                    cber
To Biologic Product Manufacturers--     December 11, 1997   Do                     Do
 Withdrawal 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
Draft Guidance for Industry: Promoting  December 1997       Do                     Do
 Medical Products in a Changing
 Healthcare Environment; I. Medical
 Product Promotion by Healthcare
 Organizations or Pharmacy Benefits
 Management Companies (PBMS)
Dear Doctor Letter--Difficulty in       January 28, 1998    Health care providers  Do
 Obtaining Immune Globulin Intravenous
 (Human)
Guidance for Industry: Year 2000 Date   January 1998        FDA regulated          Do
 Change for Computer Systems and                             industry
 Software Applications Used in the
 Manufacture of Blood Products

[[Page 31236]]

Draft Guidance for Industry: Efficacy   January 1998        Do                     Do
 Studies to Support Marketing of
 Fibrin Sealant Products Manufactured
 for Commercial Use
Draft Guidance for Industry: Container  January 1998        Do                     Do
 and Closure Integrity Testing in Lieu
 of Sterility Testing as a Component
 of the Stability Protocol for Sterile
 Products
Draft Guidance for Industry: Clinical   February 1998       Do                     Do
 Development of Programs for Drugs,
 Devices and Biological Products
 Intended for Treatment of
 Osteoarthritis (OA)
Draft Guidance for Industry:            March 1998          Do                     Do
 Manufacturing, Processing or Holding
 Active Pharmaceutical Ingredients
Guidance for Industry: Guidance for     March 1998          Do                     Do
 Human Somatic Cell Therapy and Gene
 Therapy
Dear Doctor Letter--Standardized Grass  May 11, 1998        Health care providers  Do
 Pollen Extracts
Draft Guidance for Industry:            May 1998            FDA regulated          Do
 Instructions for Submitting                                 industry
 Electronic Lot Release Protocols to
 the Center for Biologics Evaluation
 and Research
Draft Guidance for Industry: Pilot      May 1998            Do                     Do
 Program for Electronic
 Investigational New Drug (eIND)
 Applications for Biological Products
Draft Guidance for Industry:            May 1998            Do                     Do
 Electronic Submissions of Case Report
 Forms (CRFs), Case Report Tabulations
 (CRTs) and Data to the Center for
 Biologics Evaluation and Research
Draft Guidance for Industry:            May 1998            Do                     Do
 Electronic Submissions of a Biologics
 License Application (BLA) or Product
 License Application (PLA)/
 Establishment License Application
 (ELA) to the Center for Biologics
 Evaluation and Research
Guidance for Industry: Submitting and   May 1998            Do                     Do
 Reviewing Complete Responses to
 Clinical Holds
Guidance for Industry: Classifying      May 1998            Do                     Do
 Resubmissions in Response to Action
 Letters
Guidance for Industry:                  May 1998            Do                     Do
 Pharmacokinetics in Patients with
 Impaired Renal Function--Study
 Design, Data Analysis and Impact on
 Dosing and Labeling
Guidance for Industry: Standards for    May 1998            Do                     Do
 the Prompt Review of Efficacy
 Supplements, Including Priority
 Efficacy Supplements
Guidance for Industry: Providing        May 1998            Do                     Do
 Clinical Evidence of Effectiveness
 for Human Drugs and Biological
 Products
Draft Guidance for Industry: Stability  June 1998           Do                     Do
 Testing of Drug Substances and Drug
 Products
ICH Draft Guidance on Specifications:   June 9, 1998        Do                     Do
 Test 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    June 12, 1998       Do                     Do
 and Imports Under the FDA Export
 Reform and Enhancement Act of 1996
Guidance for Industry: Qualifying for   June 1998           Do                     Do
 Pediatric Exclusivity Under Section
 505A of the Federal Food, Drug, and
 Cosmetic Act
Guidance for Industry: Errors and       June 1998           Do                     Do
 Accidents Regarding Saline Dilution
 of Samples Used for Viral Marker
 Testing
Draft Guidance for Industry: In the     July 1998           Do                     Do
 Manufacture and Clinical Evaluation
 of In Vitro Tests to Detect Nucleic
 Acid Sequences of Human
 Immunodeficiency Virus Type 1

[[Page 31237]]

Draft Guidance for Industry: For the    July 1998           Do                     Do
 Submission of 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 FDA Form 356h
 ``Application to Market a New Drug,
 Biologic or an Antibiotic Drug for
 Human Use''
Guidance for Industry: Implementation   July 1998           Do                     Do
 of Section 126 of the Food and Drug
 Administration Modernization Act of
 1997--Elimination of Certain Labeling
 Requirements
Guidance for Industry: Environmental    July 1998           Do                     Do
 Assessment of Human Drug and
 Biologics Applications
Draft Guidance for Industry:            July 1998           Do                     Do
 Recommendations for Collecting Red
 Blood Cells by Automated Apheresis
 Methods
Dear Colleague Letter--Use of           August 12, 1998     Health care providers  Do
 Haemophilus influenzae Conjugate
 Vaccines in Combination With DTaP in
 Infants
Dear Doctor Letter--Albumin Use in      August 19, 1998     Do                     Do
 Seriously Ill Patients
Draft Guidance for Industry: Content    August 1998         FDA regulated          Do
 and Format of Chemistry,                                    industry
 Manufacturing and Controls
 Information and Establishment
 Description Information for an
 Allergenic Extract or Allergen Patch
 Test
Draft Guidance for Industry:            August 1998         Do                     Do
 Submission of Abbreviated Reports and
 Synopses in Support of Marketing
 Applications
ICH Guidance on Statistical Principles  September 16, 1998  Do                     Do
 for Clinical Trials
ICH Guidance on Quality of              September 21, 1998  Do                     Do
 Biotechnological/Biological Products:
 Derivation and Characterization of
 Cell Substrates Used for Production
 of Biotechnological/Biological
 Products
ICH Guidance on Viral Safety            September 24, 1998  Do                     Do
 Evaluation of Biotechnology Products
 Derived From Cell Lines of Human or
 Animal Origin
Change to the Guidance Entitled         September 8, 1998   Do                     Do
 ``Revised Precautionary Measures to
 Reduce the Possible Risk of
 Transmission of Creutzfeldt-Jakob
 Disease (CJD) by Blood and Blood
 Products''--Information Sheet
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:            September 1998      Do                     Do
 Submitting Debarment Certification
 Statements
Guidance for Industry: How to Complete  September 1998      Do                     Do
 the Vaccine Adverse Reporting System
 Form (VAERS-1)
Guidance for Industry: Fast Track Drug  September 1998      Do                     Do
 Development Programs--Designation,
 Development, and Application Review
CBER's Year 2000 Letter                 October 27, 1998    Do                     Do
Draft Guidance for Industry:            October 1998        Do                     Do
 Developing Medical Imaging Drugs and
 Biologics
Dear Blood Bank/Transfusion Service     November 3, 1998    Do                     Do
 Director Letter: Hepatitis C Virus
 Risk
Dear Doctor Letter--Important Drug      November 13, 1998   Health care providers  Do
 Warning: Immune Globulin Intravenous
 (Human)
Draft Guidance for Industry: Content    November 1998       FDA regulated          Do
 and Format of Chemistry,                                    industry
 Manufacturing and Controls
 Information and Establishment
 Description Information for a
 Biological In Vitro Diagnostic
 Product

[[Page 31238]]

Draft Guidance for Industry: In Vivo    November 1998       Do                     Do
 Drug Metabolism/Drug Interaction
 Studies--Study Design, Data Analysis
 and Recommendations for Dosing and
 Labeling
Draft Document: United States Industry  December 1997       Do                     Do
 Consensus Standard for the Uniform      (released
 Labeling of Blood and Blood             November 1998)
 Components Using ISBT 128
Draft Guidance for Industry: General    November 1998       Do                     Do
 Considerations for Pediatric
 Pharmacokinetic Studies for Drugs and
 Biological Products
To Viral Vaccine IND Sponsors--Use of   December 18, 1998   Do                     Do
 PCR-Based Reverse Transcriptase Assay
Guidance for Industry: FDA Approval of  December 1998       Do                     Do
 New Cancer Treatment Uses for
 Marketed Drug and Biological Products
Draft Guidance for Industry: Gamma      December 1998       Do                     Do
 Irradiation of Blood and Blood
 Components: A Pilot Program for
 Licensing
Draft Guidance for Industry: Content    December 1998       Do                     Do
 and Format of Geriatric Labeling
Dear Healthcare Provider: Important     January 25, 1999    Health care providers  Do
 Drug Warning: Safety Information
 Regarding the use of Abbokinase
 (Urokinase)
Guidance for Industry: Content and      January 1999        FDA regulated          Do
 Format of Chemistry, Manufacturing                          industry
 and Controls Information and
 Establishment Description Information
 for a Vaccine or Related Product
Guidance on Amended Procedures for      January 1999        Do                     Do
 Advisory Panel Meetings
Guidance for Industry: Providing        January 1999        Do                     Do
 Regulatory Submissions in Electronic
 Format--General Considerations
Guidance for Industry: Population       February 1999       Do                     Do
 Pharmacokinetics
Guidance for Industry: For the          February 1999       Do                     Do
 Submission of Chemistry,
 Manufacturing and Controls and
 Establishment Description Information
 for Human Plasma-Derived Biological
 Products, Animal Plasma or Serum-
 Derived Products
Guidance for Industry: Clinical         February 1999       Do                     Do
 Development Programs for Drugs,
 Devices and Biological Products for
 the Treatment of Rheumatoid Arthritis
 (RA)
Dear Colleague Letter: Voluntary        February 4, 1999    Health care providers  Do
 Recall of Tripedia, DTaP Vaccine
----------------------------------------------------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------
                                                                                    How to Obtain a Hard Copy of
                                                             Grouped by Intended       the Document (Name and
           Name of Document              Date of Issuance     User or Regulatory    Address, Phone, FAX, E-mail
                                                                   Activity                 or Internet)
----------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Tracking     February 19, 1998   Office of Compliance   Division of Small
 (Docket No. 98D-0132)                                       (OC)                   Manufacturers Assistance,
                                                                                    CDRH, Food and Drug
                                                                                    Administration, 1-800-638-
                                                                                    2041 or 301-827-0111 or
                                                                                    (FAX) Facts on Demand at 1-
                                                                                    800-899-0381 or Internet at
                                                                                    http://www.fda.gov/cdrh
Guidance on Lead Wires and Patient      March 9, 1998       OC                     Do
 Cables
Global Harmonization Task Force: Draft  October 28, 1998    OC                     Do
 Document on the Essentials Principles
 of Safety and Performance of Medical
 Devices on a Global Basis
 Medical Devices: Draft Global          July 16, 1998       OC                     Do
 Harmonization Task Force Study Group
 3 Process Validation Guidance (Draft)

[[Page 31239]]

Letter to Medical Device Manufacturer   February 14, 1995   OC                     Do
 on Pentium Processors
Guideline for Preparing Notices of      November 1, 1985    OC/Bioresearch         Do
 Availability of Investigational                             Monitoring (BIMO)
 Medical Devices
All Diagnostic Ultrasound               February 24, 1986   OC/Division of         Do
 Manufacturers and Importers-Exemption                       Enforcement I (DOEI)
 from Reporting Under 21 CFR 1002
General Principles of Software          June 9, 1997        OC/DOEI                Do
 Validation; Draft Guidance
Exemption from Reporting and            September 16, 1981  OC/DOEI                Do
 Recordkeeping Requirements for
 Certain Sunlamp Product Manufacturers
Clarification of Radiation Control      March 1, 1989       OC/DOEI                Do
 Regulations for Diagnostic X-ray
 Equipment (FDA 89-8221)
A Guide for the Submission of           March 1, 1996       OC/DOEI                Do
 Abbreviated Radiation 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           March 1, 1996       OC/DOEI                Do
 Abbreviated Radiation Safety Reports
 on Image Receptor Support Devices for
 Mammographic X-ray Systems
A Guide for the Submission of an        March 1, 1996       OC/DOEI                Do
 Abbreviated Radiation Safety Report
 on X-ray Tables, Cradles, Film
 Changers or Cassette Holders Intended
 for Diagnostic Use
Guide for the Submission of Initial     January 1, 1982     OC/DOEI                Do
 Reports on Diagnostic X-Ray Systems
 and their Major Components
Guideline for the Manufacture of In     January 10, 1994    OC/DOEI                Do
 Vitro Diagnostic Products
Letter to Medical Device Industry on    May 17, 1993        OC/DOEI                Do
 Endoscopy and Laparoscopy Accessories
 (Galdi)
Manufacturers/Assemblers of Diagnostic  October 13, 1993    OC/DOEI                Do
 X-ray Systems: Enforcement Policy for
 Positive-Beam Limitation (PBL)
 Requirements in 21 CFR 1020.31(g)
Retention of Records Required by 21     August 24, 1981     OC/DOEI                Do
 CFR 1002
All U.S. Condom Manufacturers,          April 7, 1987       OC/Division of         Do
 Importers and Repackagers                                   Enforcement II
                                                             (DOEII)
Letter to Ophthalmologists about        June 27, 1997       OC/DOEII               Do
 Lasers for Refractive Surgery
Manufacturers and Initial Distributors  May 23, 1996        OC/DOEII               Do
 of Hemodialyzers
Manufacturers and Users of Lasers for   October 10, 1996    OC/DOEII               Do
 Refractive Surgery
Shielded Trocars and Needles Used for   August 23, 1996     OC/DOEII               Do
 Abdominal Access During Laparoscopy
Prospective Manufacturers of Barrier    October 31, 1996    OC/DOEII               Do
 Devices Used During Oral Sex for STD
 Protection
Condoms: Inspection and Sampling at     April 8, 1987       OC/DOEII               Do
 Domestic Manufacturers and of all
 Repackers; Sampling from all
 Importers (Damaska Memo to Field on 4/
 8/87)
Guide for Preparing Product Reports     September 1, 1995   OC/DOEII               Do
 for Lasers and Products Containing
 Lasers
Hazards of Volume Ventilators and       September 15, 1993  OC/DOEII               Do
 Heated Humidifiers
Latex Labeling Letter (Johnson)         March 18, 1993      OC/DOEII               Do
Letter--Condom Manufacturers and        April 5, 1994       OC/DOEII               Do
 Distributors (included in Condom
 Packet #398)
Letter to Industry, Powered Wheelchair  May 10, 1993        OC/DOEII               Do
 Manufacturers from R. M. Johnson
Letter to Manufacturers/Repackers       April 22, 1994      OC/DOEII               Do
 Using Cotton
Manufacturers and Initial Distributors  February 3, 1994    OC/DOEII               Do
 of Sharps Containers and Destroyers
 Used by Health Care Professionals
Compliance Guide for Laser Products     September 1, 1985   OC/DOEII               Do
 (FDA 86-8260)
Dental Handpiece Sterilization (Dear    September 28, 1992  OC/DOEII               Do
 Doctor Letter)

[[Page 31240]]

Ethylene Oxide; Ethylene Chlorohydrin;  June 23, 1978       OC/DOEII               Do
 and Ethylene Glycol; Proposed Maximum
 Residue Limits and Maximum Levels of
 Exposure
Letter--Manufacturers, Distributors     February 23, 1994   OC/DOEII               Do
 and Importers of Condom Products
 (included in Condom Packet #<greek-
 K>398)
Letter--Manufacturers, Importers, and   February 13, 1989   OC/DOEII               Do
 Repackagers of Condoms for
 Contraception or Sexually-Transmitted
 Disease Prevention (Holt) (included
 in Condom Packet #398)
Regulatory Requirements for Medical     September 1, 1996   OC/DOEII               Do
 Gloves--A Workshop Manual FDA
 Publication No. 96-4257
Standard Specification for Rubber       October 28, 1983    OC/DOEII               Do
 Contraceptives (Condoms) (included in
 Condom Packet #398)
Pesticide Regulation Notice 94-4        June 30, 1994       OC/DOEII               Do
 Interim Measures for the Registration
 of Antimicrobial Products/Liquid
 Chemical Germicides with Medical
 Device Use Claims
Open Door Operation of Microwave Ovens  March 28, 1980      OC/Division of         Do
 as a Result of Oven Miswiring                               Enforcement III
                                                             (DOEIII)
Guide for Preparing Abbreviated         September 1, 1996   OC/DOEIII              Do
 Reports of Microwave and RF Emitting
 Electronic Products Intended for
 Medical Use
Final Design Control Inspectional       March 1, 1997       OC/DOEIII              Do
 Strategy
Abbreviated Reports on Radiation        August 1, 1995      OC/DOEIII              Do
 Safety for Microwave Products (Other
 Than Microwave Ovens)--E.G. Microwave
 Heating, Microwave Diathermy, RF
 Sealers, Induction, Dielectric
 Heaters, Security Systems
Design Control Guidance for Medical     March 11, 1997      OC/DOEIII              Do
 Device Manufacturers
Abbreviated Reports on Radiation        August 1, 1995      OC/DOEIII              Do
 Safety of Non-Medical Ultrasonic
 Products
Application for a Variance from 21 CFR  March 1, 1987       OC/DOEIII              Do
 1040.11(c) for a Laser Light Show,
 Display, or Device
Computerized Devices/Processes          May 1, 1992         OC/DOEIII              Do
 Guidance--Application of the Medical
 Device GMP to Computerized Devices
 and Manufacturing Processes
Guidance for the Submission of Cabinet  February 1, 1975    OC/DOEIII              Do
 X-Ray System Reports Pursuant to 21
 CFR 1020.40
Guide for Preparing Annual Reports on   October 1, 1987     OC/DOEIII              Do
 Radiation Safety Testing of
 Electronic Products (General)
Guide for Preparing Annual Reports on   September 1, 1995   OC/DOEIII              Do
 Radiation Safety Testing of Mercury
 Vapor Lamps (replaces FDA 82-8127)
Guide for Preparing Annual Reports on   September 1, 1995   OC/DOEIII              Do
 Radiation Safety Testing of Sunlamps
 and Sunlamp Products (replaces FDA 82-
 8127)
Guide for Preparing Product Reports on  September 1, 1995   OC/DOEIII              Do
 Sunlamps and Sunlamp Products (21 CFR
 1002)
Guide for Preparing Reports on          March 1, 1985       OC/DOEIII              Do
 Radiation Safety of Microwave Ovens
Guide for Submission of Information on  April 1, 1971       OC/DOEIII              Do
 Accelerators Intended to Emit X-
 Radiation Required Pursuant to 21 CFR
 1002.10
Guide for Submission of Information on  April 30, 1974      OC/DOEIII              Do
 Analytical X-Ray Equipment Required
 Pursuant to 21 CFR 1002.10
Guide for Submission of Information on  September 1, 1980   OC/DOEIII              Do
 Industrial Radiofrequency Dielectric
 Heater and Sealer Equipment Pursuant
 to 21 CFR 1002.10 and 1002.12 (FDA 81-
 8137)
Guide for Submission of Information on  March 1, 1973       OC/DOEIII              Do
 Industrial X-Ray Equipment Required
 Pursuant to 21 CFR 1002.10
Guide for the filing of Annual Reports  July 1, 1980        OC/DOEIII              Do
 for X-Ray Components and Systems
Guide for the Submission of Initial     September 1, 1984   OC/DOEIII              Do
 Reports on Computed Tomography X-Ray
 Systems

[[Page 31241]]

Impact Resistant Lenses: Questions and  September 1, 1987   OC/DOEIII              Do
 Answers (FDA 87-4002) (see shelf #
 460)
Imports Radiation-Producing Electronic  November 1, 1988    OC/DOEIII              Do
 Products (FDA 89-8008)
Information Requirements for Cookbooks  October 31, 1988    OC/DOEIII              Do
 and User and Service Manuals
Keeping Medical Devices Safe from       July 1, 1995        OC/DOEIII              Do
 Electromagnetic Interference
Keeping Up With the Microwave           March 1, 1990       OC/DOEIII              Do
 Revolution (FDA Pub No. 91-4160)
Laser Light Show Safety--Who's          May 1, 1986         OC/DOEIII              Do
 Responsibility (FDA 86-8262)
Letter to All Foreign Manufacturers     May 28, 1981        OC/DOEIII              Do
 and Importers of Electronic Products
 for Which Applicable FDA Performance
 Standards Exist
Letter to Trade Association: ReUse of   December 27, 1995   OC/DOEIII              Do
 Single-use or Disposable Medical
 Devices
Letter: Changes in Regulations          October 27, 1995    OC/DOEIII              Do
 Concerning Records and Reports on
 Radiation-Emitting Electronic
 Products
Medical Device Electromagnetic                              OC/DOEIII              Do
 Interference Issues, Problem Reports,
 Standards, and Recommendations
Medical Devices and EMI: The FDA        January 1, 1995     OC/DOEIII              Do
 Perspective
Policy on Lamp Compatibility            September 2, 1986   OC/DOEIII              Do
 (sunlamps)
Policy on Maximum Timer Interval and    August 21, 1986     OC/DOEIII              Do
 Exposure Schedule for Sunlamp
 Products
Policy on Warning Label Required on     June 25, 1985       OC/DOEIII              Do
 Sunlamp Products
Quality Assurance Guidelines for        February 1, 1991    OC/DOEIII              Do
 Hemodialysis Devices
Quality Control Guide for Sunlamp       March 1, 1988       OC/DOEIII              Do
 Products (FDA 88-8234)
Quality Control Practices for           May 1, 1980         OC/DOEIII              Do
 Compliance with the Federal Mercury
 Vapor Lamp Performance Standard
Reporting and Compliance Guide for      October 1, 1995     OC/DOEIII              Do
 Television Products including Product
 Report, Supplemental Report,
 Radiation Safety Abbreviated Report,
 Annual Report, Information and
 Guidance
Reporting Guide for Laser Light Shows   September 1, 1995   OC/DOEIII              Do
 and Displays (21 CFR 1002) (FDA 88-
 8140)
Reporting Guide for Product Reports on  September 1, 1995   OC/DOEIII              Do
 High Intensity Mercury Vapor
 Discharge Lamps (21 CFR 1002)
Reporting of New Model Numbers to       June 14, 1983       OC/DOEIII              Do
 Existing Model Families
Revised Guide for Preparing Annual      September 1, 1995   OC/DOEIII              Do
 Reports on Radiation Safety Testing
 of Laser and Laser Light Show
 Products (replaces FDA 82-8127)
Safety of Electrically Powered          September 18, 1996  OC/DOEIII              Do
 Products: Letter To Medical Device
 and Electronic Product Manufacturers
 From Lillian Gill & BHB correction
 memo
Suggested State Regulations for         January 1, 1982     OC/DOEIII              Do
 Control of Radiation--Volume II
 Nonionizing Radiation--Lasers (FDA
 Pub No. 83-8220)
Unsafe Patient Lead Wires and Cables    September 3, 1993   OC/DOEIII              Do
Guide for Preparing Annual Reports for  September 1, 1996   OC/DOEIII              Do
 Ultrasonic Therapy Products
Guide for Preparing Product Reports     September 1, 1996   OC/DOEIII              Do
 for Medical Ultrasound Products
Guide for Preparing Product Reports     August 1, 1996      OC/DOEIII              Do
 for Ultrasonic Therapy Products
 (physical therapy only)
Guide for Establishing and Maintaining  March 1, 1988       OC/DOEI & III          Do
 a Calibration Constancy
 Intercomparison System for Microwave
 Oven Compliance Survey Instruments
 (FDA 88-8264)
The FDA Export Reform and Enhancement   October 1, 1996     OC/Division of         Do
 Act of 1996/Export Certification                            Program Operations
                                                             (DPO)

[[Page 31242]]

Sec. 300.600 Commercial Distribution    September 24, 1987  OC/Office of the       Do
 with Regard to Premarket Notification                       Director (OD)
 (Section 510(k)) (CPG 7124.19)
Global Harmonization Task Force:        August 31, 1998     OC/Office of           Do
 Availability of Draft Documents on                          Surveillance and
 Adverse Event and Vigilance Reporting                       Biometrics (OSB)
 of Medical Device Events
Commercial Distribution/Exhibit Letter  April 10, 1992      OC/Other (OT)          Do
 (Use instead of Hile letter)
 (Display)
Working Draft of the Current Good       July 1, 1995        OC/OT                  Do
 Manufacturing Practice (CGMP) Final
 Rule
Guidance for the Medical Device         November 6, 1998    ODE                    Do
 Industry on PMA Shell Development and
 Modular Review
Medical Devices Containing Materials    November 6, 1998    ODE                    Do
 Derived from Animal Sources (Except
 In Vitro Diagnostic Devices),
 Guidance for FDA Reviewers and
 Industry
Frequently Asked Questions on the New   October 22, 1998    ODE                    Do
 510(k) Pardigm
Guidance to Industry Supplements to     May 20, 1998        ODE                    Do
 Approved Applications for Class III
 Medical Devices: Use of Published
 Literature, Use of Previously
 Submitted Material, and Priority
 Review
Convenience Kits Interim Regulatory     May 20, 1997        ODE                    Do
 Guidance
Kit Certification for 510(k)s           July 1997           ODE                    Do
Guidance for Industry--Contents of a    July 27, 1998       ODE                    Do
 Product Development Protocol
Guidance for the Content of Premarket   May 28, 1998        ODE                    Do
 Submissions for Software Contained in
 Medical Devices (replaces Reviewer
 Guidance for Computer-Controlled
 Medical Devices Undergoing 510(k)
 Review 8/29/91)
New Model Medical Device Development    June 3, 1998        ODE                    Do
 Process
Modifications to Devices Subject to     August 6, 1998      ODE                    Do
 Premarket Approval--the PMA
 Supplement Decision Making Process
Guidance for Off-the-Shelf Software     August 17, 1998     ODE                    Do
 Use in Medical Devices
PMA/510(k) Expedited Review--Guidance   March 20, 1998      ODE                    Do
 for Industry and CDRH Staff
Guidance on Amended Procedures for      March 30, 1998      ODE                    Do
 Advisory Panel Meetings
`Real-Time' Review Program for          April 22, 1997      ODE                    Do
 Premarket Approval Application (PMA)
 Supplements
A New 510(k) Paradigm--Alternate        March 30, 1998      ODE                    Do
 Approaches to Demonstrating
 Substantial Equivalence in Premarket
 Notifications
Freedom of Information/510(K) Process   May 15, 1997        ODE                    Do
 Changes
Guidance for Submitting                 January 1, 2000     ODE                    Do
 Reclassification Petition
Product Development Protocol            October 1, 1997     ODE                    Do
Guidance on PMA Interactive Procedures  February 19, 1998   ODE                    Do
 for Day-100 Meetings and Subsequent
 Deficiencies--for Use by CDRH and
 Industry (Docket No. 98D-0079)
Procedures for Class II Device          February 25, 1998   ODE                    Do
 Exemptions from Premarket
 Notification Guidance for Industry
 and CDRH Staff (Docket No. 98D-0083)
New section 513(f)(2)--Evaluation of    February 19, 1998   ODE                    Do
 Automatic Class III Designation:
 Guidance for Industry and CDRH Staff
 (Docket No. 98D-0082)
SMDA Changes--Premarket Notification;   April 17, 1992      ODE                    Do
 Regulatory Requirements for Medical
 Devices (510k) Manual Insert
#D95-2, Attachment A (Interagency       September 15, 1995  ODE                    Do
 Agreement between FDA & HCFA)
#D95-2, Attachment B (Criteria for      September 15, 1995  ODE                    Do
 Categorization of Investigational
 Devices (HCFA)
30-Day Notices and 135-Day PMA          February 19, 1998   ODE                    Do
 Supplements for Manufacturing Method
 or Process Changes, Guidance for
 Industry and CDRH (Docket No. 98D-
 0080)
510(k) Quality Review Program (blue     March 29, 1996      ODE                    Do
 book memo)

[[Page 31243]]

Distribution and Public Availability    October 10, 1997    ODE                    Do
 of PMA Summary of Safety and
 Effectiveness Data Packages
Document Review by the Office of the    June 6, 1996        ODE                    Do
 Chief Counsel (Blue Book Memo G96-1))
HCFA Reimbursement Categorization       September 15, 1995  ODE                    Do
 Determinations for FDA-approved IDEs
ODE Executive Secretary Guidance        August 7, 1987      ODE                    Do
 Manual
Determination of Intended Use for       February 19, 1998   ODE                    Do
 510(k) Devices: Final Document
 (Docket No. 98D-0081)
Letter--Vascular Graft Industry         November 22, 1995   ODE                    Do
 (Philip Phillips)
Letter to Industry, Powered Wheelchair/ May 26, 1994        ODE                    Do
 Scooter or Accessory/Component
 Manufacturer from Susan Alpert,
 Ph.D., M.D.
Preamendments Class III Strategy;       April 19, 1994      ODE                    Do
 SXAlpert
4-of-A-Kind PMA's                       October 1, 1991     ODE                    Do
Application of the Device Good          December 1, 1983    ODE                    Do
 Manufacturing Practice (GMP)
 Regulation to the Manufacture of
 Sterile Devices
CDRH's 510(k)/IDE/PMA Refuse to Accept/ June 30, 1993       ODE                    Do
 Accept/File Policies (see #D94-1,
 #K94-1, & #P94-1)
Classified Convenience Kits             April 30, 1993      ODE                    Do
Color Additive Petitions (p. II-19 of   June 1, 1987        ODE                    Do
 PMA Manual)
Color Additive Status List (Inspection  February 1, 1989    ODE                    Do
 Operations Manual)
Early Collaboration Meetings Under the  February 19, 1998   ODE                    Do
 FDA Modernization Act (FDAMA),
 Guidance for Industry and CDRH Staff,
 Final Document (Docket No. 98D-0078)
Color Additives for Medical Devices     November 15, 1995   ODE                    Do
 (Snesko)
Deciding When to Submit a 510(k) for a  January 10, 1997    ODE                    Do
 Change to an Existing Device (see
 CDRH F-O-D #1935)
Device Specific Guidance Documents      May 11, 1993        ODE                    Do
 (List)
FDA Clinical Investigator Information   May 1, 1989         ODE                    Do
 Sheets
FDA Guide for Validation of Biological  January 1, 1986     ODE                    Do
 Indicator Incubation Time (Source:
 Sterilization Committee; through
 Virginia Ross; HFZ-332)
FDA Policy For The Regulation Of        November 13, 1989   ODE                    Do
 Computer Products (DRAFT) (See 2099)
Format for IDE Progress Reports         January 1, 2000     ODE                    Do
Guidance for Preparation of PMA         August 1, 1992      ODE                    Do
 Manufacturing Information
Guideline for the Monitoring of         January 1, 1988     OC/BIMO                Do
 Clinical Investigations
Guideline on General Principles of      May 1, 1987         ODE                    Do
 Process Validation
Guideline on Sterile Drug Products      June 1, 1987        ODE                    Do
 Produced by Aseptic Processing
Guideline on Validation of the Limulus  December 1, 1987    ODE                    Do
 Amebocyte Lysate (LAL) Test as an End-
 Product Endotoxin Test
Indications for Use Statement           January 2, 1996     ODE                    Do
Industry Representatives on Scientific  March 27, 1987      ODE                    Do
 Panels
Labeling Reusable Medical Devices for   April 1, 1996       ODE                    Do
 Reprocessing in Health Care
 Facilities: FDA Reviewer Guidance
 (see 1198)
Limulus Amebocute Lysate; Reduction of  October 23, 1987    ODE                    Do
 Samples for Testing
Master Files Part III; Guidance on      June 1, 1987        ODE                    Do
 Scientific and Technical Information
Memorandum: Electromagnetic             June 13, 1995       ODE                    Do
 Compatibility for Medical Devices:
 Issues and Solutions
Methods for Conducting Recall           June 16, 1978       ODE                    Do
 Effectiveness Checks
Necessary Information for Diagnostic    November 24, 1987   ODE                    Do
 Ultrasound 510(k) (Draft)
Perspectives on Clinical Studies for    January 1, 2000     ODE                    Do
 Medical Device Submissions
 (Statistical)
PMA Review Statistical Checklist        January 1, 2000     ODE                    Do

[[Page 31244]]

Points to Consider in the               June 1, 1984        ODE                    Do
 Characterization of Cell Lines Used
 to Produce Biological Products (from
 John C. Petricciani, M.D.)
Preamendment Class III Devices          March 11, 1992      ODE                    Do
Premarket Notification [510(k)] Status  March 7, 1994       ODE                    Do
 Request Form, revised
Premarket Submission Coversheet,        January 19, 1995    ODE                    Do
 Instructions, and Survey
Preproduction Quality Assurance         September 1, 1989   ODE                    Do
 Planning: Recommendations for Medical
 Device Manufacturers (FDA 90-4236)
Proposal for Establishing Mechanisms    June 30, 1993       ODE                    Do
 for Setting Review Priorities Using
 Risk Assessment and Allocating Review
 Resources (include with 926-930)
Questions and Answers for the FDA       September 3, 1996   ODE                    Do
 Reviewer Guidance: Labeling Reusable
 Medical Devices for Reprocessing in
 Health Care Facilities (see 198)
Shelf Life of Medical Devices           March 1, 1991       ODE                    Do
Substantial Equivalence (SE) Decision   January 1, 1990     ODE                    Do
 Making Documentation ATTACHED: `SE'
 Decision Making Process (Detailed)
 i.e. the decision making tree
Suggested Content for Original IDE      February 27, 1996   ODE                    Do
 Application Cover Letter--Version 4
Suggestions for Submitting a Premarket  April 1, 1993        ODE                   Do
 Approval (PMA) Application
Threshold Assessment of the Impact of   January 1, 1990     ODE                    Do
 Requirements for Submission of PMAs
 for 31 Medical Devices Marketed Prior
 to May 28, 1976
Guidance on IDE Policies and            January 20, 1998    ODE                    Do
 Procedures
Viable Bacteriophage in Co2 Laser       January 1, 2000     ODE                    Do
 Plume: Aerodynamic Size Distribution
Deciding When to Submit a 510(k) for a  January 10, 1997    ODE/blue               Do
 Change to an Existing Device (blue
 book memo #K97-1) (see CDRH F-O-D
 #935)
Memorandum of Understanding Regarding   August 9, 1996      ODE/blue               Do
 Patient Labeling Review (blue book
 memo #G96-3))
Continued Access to Investigational     July 15, 1996       ODE/blue               Do
 Devices During PMA Preparation and
 Review (blue book memo)
510(k) Additional Information           July 23, 1993       ODE/blue/510k          Do
 Procedures (blue book memo #K93-1)
510(k) Refuse to Accept Procedures      May 20, 1994        ODE/blue/510k          Do
 (blue book memo #K94-1)
510(k) Sign-Off Procedures (blue book   June 3, 1994        ODE/blue/510k          Do
 memo #K94-2)
510(k) Sterility Review Guidance and    February 12, 1990   ODE/blue/510k          Do
 Revision of 11/18/1994 (blue book
 memo #K90-1)
Cover Letter: 510(k) Requirements       November 21, 1995   ODE/blue/510k          Do
 During Firm-Initiated Recalls;
 Attachment A: Guidance on Recall and
 Premarket Notification Review
 Procedures During Firm-Initiated
 Recalls of Legally Marketed Devices
 (blue book memo #<greek-K>95-1)
Guidance on the Center for Devices and  June 30, 1986       ODE/blue/510k          Do
 Radiological Health's Premarket
 Notification Review Program (blue
 book memo #K86-3)
Premarket Notification--Consistency of  February 28, 1989   ODE/blue/510k          Do
 Reviews (blue book memo #K89-1)
Review of 510(k)s for Computer          August 29, 1991     ODE/blue/510k          Do
 Controlled Medical Devices (blue book
 memo #K91-1)
Executive Secretaries Guidance Manual   August 7, 1987      ODE/blue/gnrl          Do
 <greek-i>G87-3
Consolidated Review of Submissions for  October 19, 1990    ODE/blue/gnrl          Do
 Diagnostic Ultrasound Equipment,
 Accessories and Related Measurement
 Devices (blue book memo #G90-2)
Consolidated Review of Submissions for  October 19, 1990    ODE/blue/gnrl          Do
 Lasers and Accessories (blue book
 memo #G90-1)
Device Labeling Guidance (blue book     March 8, 1991       ODE/blue/gnrl          Do
 memo <greek-G>91-1 )
 Documentation and Resolution of        December 23, 1993   ODE/blue/gnrl          Do
 Differences of Opinion on Product
 Evaluations (blue book memo #G93-1)

[[Page 31245]]

ODE Regulatory Information for the      May 15, 1987        ODE/blue/gnrl          Do
 Office of Compliance--Information
 Sharing Procedures (blue book memo
 #G87-2)
PMA/510(k) Expedited Review (blue book  May 20, 1994        ODE/blue/gnrl          Do
 memoG94-2)
PMA/510(k) Triage Review Procedures     May 20, 1994        ODE/blue/gnrl          Do
 (blue book memo #G94-1)
Review of Laser Submissions (blue book  April 15, 1988      ODE/blue/gnrl          Do
 memo #G88-1)
Toxicology Risk Assessment Committee    August 9, 1989      ODE/blue/gnrl          Do
 (blue book memo #G89-1)
Use of International Standard ISO-      May 1, 1995         ODE/blue/gnrl          Do
 10993, 'Biological Evaluation of
 Medical Devices Part 1: Evaluation
 and Testing' (blue book memo)
 (Replaces #G87-1 #8294)
Delegation of IDE Actions (blue book    April 26, 1988      ODE/blue/ide           Do
 memo #D88-1)
 Goals and Initiatives for the IDE      July 12, 1995       ODE/blue/ide           Do
 Program (blue book memo #D95-1)
IDE Refuse to Accept Procedures (blue   May 20, 1994        ODE/blue/ide           Do
 book memo #D94-1)
Implementation of the FDA/HCFA          September 15, 1995  ODE/blue/ide           Do
 Interagency Agreement Regarding
 Reimbursement Categorization of
 Investigational Devices, Att. A
 Interagency Agreement, Att. B
 Criteria for Catergorization of
 Investigational Devices, & Att. C-
 List (blue book memo #D95-2)
Overdue IDE Annual Progress Report      July 23, 1993       ODE/blue/ide           Do
 Procedures (blue book memo) #D93-1
Review of IDEs for Feasibility Studies  May 17, 1989        ODE/blue/ide           Do
 (blue book memo #D89-1)
Assignment of Review Documents (blue    August 24, 1990     ODE/blue/integ         Do
 book memo #I90-2)
Document Review Processing (blue book   February 12, 1992   ODE/blue/integ         Do
 memo #I91-1)
Integrity of Data and Information       May 29, 1991        ODE/blue/integ         Do
 Submitted to ODE (blue book memo #I91-
 2)
Meetings with the Regulated Industry    November 20, 1989   ODE/blue/integ         Do
 (blue book memo #I89-3)
Nondisclosure of Financially Sensitive  March 5, 1992       ODE/blue/integ         Do
 Information (blue book memo #I92-1)
Policy Development and Review           February 15, 1990   ODE/blue/integ         Do
 Procedures (blue book memo #I90-1)
Telephone Communications Between ODE    January 29, 1993    ODE/blue/integ         Do
 Staff and Manufacturers (blue book
 memo #I93-1)
Clinical Utility and Premarket          May 3, 1991         ODE/blue/pma           Do
 Approval (blue book memo #P91-1)
Criteria for Panel Review of PMA        January 30, 1986    ODE/blue/pma           Do
 Supplements (blue book memo #P86-3)
Panel Report and Recommendations on     April 18, 1986      ODE/blue/pma           Do
 PMA Approvals (blue book memo #P86-5)
 Panel Review of 'Me-Too' Devices       July 1, 1986        ODE/blue/pma           Do
 (blue book memo #P86-6)
Panel Review of Premarket Approval      May 3, 1991         ODE/blue/pma           Do
 Applications (blue book memo #P91-2)
PMA Compliance Program (blue book memo  May 3, 1991         ODE/blue/pma           Do
 #P91-3)
PMA Filing Decisions (blue book memo    May 18, 1990        ODE/blue/pma           Do
 #P90-2)
PMA Refuse to File Procedures (blue     May 20, 1994        ODE/blue/pma           Do
 book memo #P94-1)
PMA Supplements: ODE's letter to        April 24, 1990      ODE/blue/pma           Do
 manufacturers; identifies situations
 which may require the submission of a
 PMA supplement (when PMA Supplements
 are required) (blue book memo) #P90-1
PMAs Early Review and Preparation of    January 27, 1986    ODE/blue/pma           Do
 Summaries of Safety and Effectiveness
 (blue book memo #P86-1)
Premarket Approval Application (PMA)    July 8, 1994        ODE/blue/pma           Do
 Closure (blue book memo #P94-1)

[[Page 31246]]

Review and Approval of PMAs of          October 22, 1990    ODE/blue/pma           Do
 Licensees (blue book memo #P86-4)
Review of Final Draft Medical Device    August 29, 1991     ODE/blue/pma           Do
 Labeling (blue book memo #P91-4)
Distribution and Public Availability    October 10, 1997    ODE/blue/pma           Do
 of Premarket Approval Application
 Summary of Safety and Effectiveness
 Data Packages (P98-1)
PMA Summaries of Safety and             June 11, 1993       ODE/blue/pma           Do
 Effectiveness and Federal Register
 Notices of PMA Approvals--Review by
 the Office of General Counsel
 (Revised) (P98-1)
PMA Review Schedules (P87-1)            March 31, 1988      ODE/blue/pma           Do
Points to Consider Guidance Document    February 3, 1999    ODE/Division of        Do
 on Assayed and Unassayed Quality                            Clinical Laboratory
 Control Material                                            Devices (DCLD)
Review Criteria for Assessment of       October 30, 1996    ODE/DCLD               Do
 Antimicrobial Susceptibility Test
 Discs
Guidance for Submission of              June 3, 1998        ODE/DCLD               Do
 Immunohistochemistry Applications to
 the FDA
In Vitro Diagnostic Creatinine Test     July 2, 1998        ODE/DCLD               Do
 System
In Vitro Diagnostic Bicarbonate/Carbon  July 6, 1998        ODE/DCLD               Do
 Dioxide Test System
In Vitro Diagnostic Chloride Test       July 6, 1998        ODE/DCLD               Do
 System
In Vitro Diagnostic Glucose Test        July 6, 1998        ODE/DCLD               Do
 System
In Vitro Diagnostic Potassium Test      July 6, 1998        ODE/DCLD               Do
 System
In Vitro Diagnostic Sodium Test System  July 6, 1998        ODE/DCLD               Do
In Vitro Diagnostic Urea Nitrogen Test  July 6, 1998        ODE/DCLD               Do
 System
In Vitro Diagnostic C-Reactive          July 20, 1998       ODE/DCLD               Do
 Immunological Test System
In Vitro Diagnostic Calibrators         July 20, 1998       ODE/DCLD               Do
Points To Consider For Hematology       September 30, 1997  ODE/DCLD               Do
 Quality Control Materials
Guidance for Premarket Submissions for  December 30, 1998   ODE/DCLD               Do
 Kits for Screening Drugs of Abuse to
 be Used by the Consumer
Review Criteria for Assessment of       November 6, 1996    ODE/DCLD               Do
 Professional Use Human Chorionic
 Gonadotropin (hCG) in Vitro
 Diagnostic Devices (IVDs)
Letter to IVD Manufacturers on          December 22, 1997   ODE/DCLD               Do
 Streamlined PMA
Guidance Document for the Submission    September 19, 1996  ODE/DCLD               Do
 of Tumor Associated Antigen Premarket
 Notification [510(k)] to FDA
Review Criteria for Assessment of       February 21, 1997   ODE/DCLD               Do
 Rheumatoid Factor (RF) In Vitro
 Diagnostic Devices Using Enzyme-
 Linked Immunoassay (EIA), Enzyme
 Linked Immunosorbent Assay (ELISA),
 Particle Agglutination Tests, and
 Laser and Rate Nephgelometry
Guidance for 510(k)s on Cholesterol     July 14, 1995       ODE/DCLD               Do
 Tests for Clinical Laboratory,
 Physicians' Office Laboratory, and
 Home Use
Assessing the Safety/Effectiveness of   October 1, 1988     ODE/DCLD               Do
 Home-use In Vitro Diagnostic Devices
 (IVDs): Draft Points to Consider
 Regarding Labeling and Premarket
 Submissions
Data for Commercialization of Original  June 10, 1996       ODE/DCLD               Do
 Equipment Manufacturer, Secondary and
 Generic Reagents for Automated
 Analyzers
DCLD Tier/Triage lists (include 931)    May 31, 1996        ODE/DCLD               Do
Draft Criteria for Assessment of In     August 31, 1995     ODE/DCLD               Do
 Vitro Diagnostic Devices for Drugs of
 Abuse Assays Using Various
 Methodologies
Draft Guidance Document for 510(k)      July 29, 1992       ODE/DCLD               Do
 Submission of Fecal Occult Blood
 Tests
Draft Guidance Document for 510(k)      September 30, 1991  ODE/DCLD               Do
 Submission of Glycohemoglobin
 (Glycated or Glycosylated) Hemoglobin
 for IVDs
Draft Guidance Document for 510(k)      September 1, 1992   ODE/DCLD               Do
 Submission of Immunoglobulins A, G,
 M, D and E Immunoglobulin System In
 Vitro Devices

[[Page 31247]]

Draft Guidance for 510(k) Submission    September 26, 1991  ODE/DCLD               Do
 of Lymphocyte Immunophenotyping IVDs
 using Monoclonal Antibodies
Draft Review Criteria for Nucleic Acid  June 14, 1993       ODE/DCLD                Do
 Amplification Based In Vitro
 Diagnostic Devices for Direct
 Detection of Infectious
 Microorganisms
Guidance Criteria for Cyclosporine      January 24, 1992    ODE/DCLD               Do
 PMAs
Draft: Premarketing Approval Review     September 10, 1992  ODE/DCLD               Do
 Criteria for Premarket Approval of
 Estrogen (ER) or Progesterone (PGR)
 Receptors In Vitro Diagnostic Devices
 Using Steroid Hormone
Points to Consider for Cervical         July 25, 1994       ODE/DCLD               Do
 Cytology Devices
Points to Consider for Collection of    September 26, 1994  ODE/DCLD               Do
 Data in Support of In-Vitro Device
 Submissions for 510(k) Clearance
Points to Consider for Portable Blood   February 20, 1996   ODE/DCLD                Do
 Glucose Monitoring Devices Intended
 for Bedside Use in the Neonate
 Nursery
Points to Consider for Review of        February 1, 1996    ODE/DCLD               Do
 Calibration and Quality Control
 Labeling for In Vitro Diagnostic
 Devices/Cover Letter dated 3/14/1996
Review Criteria for In Vitro            February 1, 1994    ODE/DCLD               Do
 Diagnostic Devices for the Assessment
 of Thyroid Autoantibodies Using
 Indirect Immunofluorescence Assay
 (IFA), Indirect Hemagglutination
 Assay (IHA), Radioimmunoasay (RIA),
 and Enzyme Linked Immunosorbent Assay
 (ELISA)
Review Criteria for Assessment of       July 15, 1994       ODE/DCLD               Do
 Alpha-Fetoprotein (AFP) In Vitro
 Diagnostic Devices for Fetal Open
 Neural Tube Defects Using
 Immunological Test Methodologies
Review Criteria for Assessment of       May 31, 1991        ODE/DCLD               Do
 Antimicrobial Susceptibility Devices
Review Criteria for Assessment of       July 15, 1991       ODE/DCLD               Do
 Cytogenetic Analysis Using Automated
 and Semi-Automated Chromosome
 Analyzers
Review Criteria for Assessment of       September 27, 1995  ODE/DCLD               Do
 Human Chorionic Gonadotropin (hCG) In
 Vitro Diagnostic Devices (IVDs)
Review Criteria for Assessment of In    January 1, 1992     ODE/DCLD               Do
 Vitro Diagnostic Devices for Direct
 Detection of Chlamydiae in Clinical
 Specimens
Review Criteria for Assessment of In    July 6, 1993        ODE/DCLD               Do
 Vitro Diagnostic Devices for Direct
 Detection of Mycobacterium Spp.
 (Tuberculosis (TB))
Review Criteria for Assessment of       September 17, 1992  ODE/DCLD               Do
 Laboratory Tests for the Detection of
 Antibodies to Helicobacter pylori
Review Criteria for Assessment of       February 14, 1996   ODE/DCLD               Do
 Portable Blood Glucose In Vitro
 Diagnostic Devices Using Glucose
 Oxidase, Dehydrogenase, or Hexokinase
 Methodology
Review Criteria for Blood Culture       August 12, 1991     ODE/DCLD               Do
 Systems
Review Criteria for Devices Assisting   May 31, 1990         ODE/DCLD              Do
 in the Diagnosis of C. Difficile
 Associated Diseases
Review Criteria for Devices Intended    December 30, 1991   ODE/DCLD               Do
 for the Detection of Hepatitis B 'e'
 Antigen and Antibody to HBe
Review Criteria for In Vitro            August 1, 1992      ODE/DCLD               Do
 Diagnostic Devices for Detection of
 IGM Antibodies to Viral Agents
Review Criteria for In Vitro            February 15, 1996   ODE/DCLD               Do
 Diagnostic Devices that Utilize
 Cytogenetic In Situ Hybridization
 Technology for the Detection of Human
 Genetic Mutations (Germ Line and
 Somatic)
Review Criteria For Premarket Approval  May 15, 1992        ODE/DCLD               Do
 of In Vitro Diagnostic Devices for
 Detection of Antibodies to Parvovirus
 B19
Review Criteria for the Assessment of   March 2, 1993       ODE/DCLD               Do
 Allergen-Specific Immunoglobulin E
 (IGE) In-Vitro Diagnostic Devices
 Using Immunological Test
 Methodologies

[[Page 31248]]

Review Criteria for the Assessment of   September 1, 1992   ODE/DCLD               Do
 Anti-nuclear Antibodies (ANA) In-
 Vitro Diagnostic Devices Using
 Indirect Immunofluorescence Assay
 (IFA), Immunodiffusion (IMD) and
 Enzyme Linked Immunosorbant Assay
 (ELISA)
Non-Automated Sphygmomanometer (Blood   November 19, 1998   ODE/DCRND              Do
 Pressure Cuff) Guidance
Cardiac Monitor Guidance (including     November 5, 1998    ODE/Division of        Do
 Cardiotachometer and Rate Alarm)                            Cardiovascular,
                                                             Respiratory and
                                                             Neurological Devices
                                                             (DCRND)
Diagnostic ECG Guidance (Including Non- November 5, 1998    ODE/DCRND              Do
 Alarming ST Segment measurement)
Carotid Stent--Suggestions for Content  October 26, 1996    ODE/DCRND              Do
 of Submissions to the Food and Drug
 Administration in Support of
 Investigational Devices Exemption
 (IDE) Applications
Non-Invasive Blood Pressure (NIBP)      March 10, 1997      ODE/DCRND              Do
 Monitor Guidance
 Guidance for Off-the-Shelf Software    June 4, 1997        ODE/DCRND              Do
 Use in Medical Devices; Draft
 Document
Draft Percutaneous Transluminal         February 7, 1995    ODE/DCRND              Do
 Coronary Angioplasty Package Insert
 Template
Medical Device Labeling--Suggested      August 12, 1997     ODE/DCRND              Do
 Format and Content; Draft Document
Draft Intravascular Brachytherapy--     May 24, 1996        ODE/DCRND              Do
 Guidance for Data to be Submitted to
 the Food and Drug Administration in
 Support of Investigational Device
 Exemption (IDE) Applications
510(k) Reviewer Guidelines--            January 1, 2000     ODE/DCRND              Do
 Tracheostomy Tubes 868.5800
Balloon Valvuloplasty Guidance For The  January 1, 1989     ODE/DCRND              Do
 Submission Of an IDE Application and
 a PMA Application
Rechargeable Battery Preliminary        July 12, 1993       ODE/DCRND              Do
 Guidance for Data to be Submitted to
 FDA in Support of Premarket
 Notification Applications
Review Guidance for Anesthesia          May 15, 1991        ODE/DCRND              Do
 Conduction Catheter
Coronary and Cerebrovascular Guidewire  January 1, 1995     ODE/DCRND              Do
 Guidance
Draft Guidance: Human Heart Valve       June 21, 1991       ODE/DCRND              Do
 Allografts
Draft Replacement Heart Valve Guidance  October 14, 1994    ODE/DCRND              Do
Draft Reviewer Guidance for             July 1, 1995        ODE/DCRND              Do
 Ventilators
Draft Reviewer Guidance on Face Masks   March 16, 1996      ODE/DCRND              Do
 and Shield for CPR
Draft Version Cardiac Ablation          March 1, 1995       ODE/DCRND              Do
 Preliminary Guidance (Data to be
 Submitted to FDA in Support
 Investigation Device Exemption
 Application
Draft Version Electrode Recording       March 1, 1995       ODE/DCRND              Do
 Catheter Preliminary Guidance (Data
 to be Submitted to FDA in Support of
 Premarket Notifications
Excerpts Related to EMI from November   November 1, 1993    ODE/DCRND              Do
 1993 Anesthesiology and Respiratory
 Devices Branch (to be used with EMI
 standard)
General Guidance Document: Non-         September 7, 1992   ODE/DCRND              Do
 Invasive Pulse Oximeter
Guidance for Oxygen Conserving Device   February 1, 1989    ODE/DCRND              Do
 510(k) Review 73 BZD 868.5905 Non-
 continuous Ventilator Class II
Reviewer Guidance for Premarket         July 19, 1995       ODE/DCRND              Do
 Notification (510(k)) Submissions--
 Labeling, Performance and
 Environmental Testing for Electronic
 Devices
Guidance for Peak Flow Meters for Over- June 1, 1993        ODE/DCRND              Do
 the-Counter Sale
Guidance for the Preparation of the     April 1, 1990       ODE/DCRND              Do
 Annual Report to the PMA Approved
 Heart Valve Prostheses
Heated Humidifier Review Guidance       August 30, 1991     ODE/DCRND              Do
Implantable Pacemaker Lead Testing      September 1, 1989   ODE/DCRND              Do
 Guidance For The Submission of a
 Section 510(k) Notification
Implantable Pacemaker Testing Guidance  January 12, 1990    ODE/DCRND              Do
Policy for Expiration Dating (DCRND     October 30, 1992    ODE/DCRND              Do
 RB92-G)

[[Page 31249]]

Review Guidelines for Oxygen            Undated             ODE/DCRND              Do
 Generators and Oxygen Equipment
Reviewer Guidance for Nebulizers,       November 9, 1990    ODE/DCRND              Do
 Metered Dose Inhalers, Spacers and
 Actuators
Reviewer's Guidance for Oxygen          August 30, 1991     ODE/DCRND              Do
 Concentrator
Electrocardiograph (ECG) Electrode      February 11, 1997   ODE/DCRND              Do
Electrocardiograph (ECG) Lead           February 11, 1997   ODE/DCRND              Do
 Switching Adapter
Electrocardiograph (ECG) Surface        February 11, 1997   ODE/DCRND              Do
 Electrode Tester
Guidance on the Content of Premarket    December 1, 1995    ODE/Division of        Do
 Notification [510(k)] Submissions for                       Dental Infection
 Protective Restraints                                       Control and General
                                                             Hospital Devices
                                                             (DDIGD)
Guidance for the Preparation of         November 27, 1998   ODE/DDIGD              Do
 Premarket Notifications for Dental
 Composites
Neonatal and Neonatal Transport         September 18, 1998  ODE/DDIGD              Do
 Incubators Premarket Notifications
Reexamination of the Evaluation         May 19, 1997        ODE/DDIGD              Do
 Process for Liquid Chemical Sterilant
 and High Level Disinfectants
Further Information on the Regulation   August 5, 1997      ODE/DDIGD              Do
 of Liquid Chemical Sterilants and
 High Level Disinfectants
Guidance on the Content and Format of   December 18, 1997   ODE/DDIGD              Do
 Premarket Notifications [510(k)]
 Submissions for Liquid Chemical
 Sterilants and High Level
 Disinfectants
Guidance on the Content and Format of   January 16, 1998    ODE/DDIGD              Do
 Premarket Notification [510(k)]
 Submissions for Surgical Masks
Premarket Notification [510(k)]         January 13, 1999    ODE/DDIGD              Do
 Submissions for Testing for Skin
 Sensitization to Chemicals in Natural
 Rubber Products (Replaces: Guidance
 on the Content and Format of
 Premarket Notifications [510(k)]
 Submissions for Testing for Skin
 Sensitization to Chemicals in Natural
 Rubber Products--2/13/98)
Guidance on the Content and Format of   August 4, 1998      ODE/DDIGD              Do
 Premarket Notification [510(k)]
 Submissions of Washers and Washer-
 Disinfectors
Devices for the Treatment and/or        June 10, 1998       ODE/DDIGD              Do
 Diagnosis of Temporomandibular Joint
 Dysfunction and/or Orofacial Pain
Dental Impression Materials--Premarket  August 17, 1998     ODE/DDIGD              Do
 Notification
OTC Denture Cushions, Pads, Reliners,   August 18, 1998     ODE/DDIGD              Do
 Repair Kits, and Partially Fabricated
 Denture Kits
Dental Cements--Premarket Notification  August 18, 1998     ODE/DDIGD              Do
Groups Capable of Testing for Latex     July 28, 1997       ODE/DDIGD              Do
 Skin Sensitization (Addendum to #944)
Addendum to: Guidance on Premarket      September 19, 1995  ODE/DDIGD              Do
 Notification [510(k)] Submissions for
 Sterilizers Intended for Use in
 Health Care Facilities
Guidance Document on Dental Handpieces  July 1, 1995        ODE/DDIGD/Dental       Do
                                                             Devices Branch (DDB)
510(k) Guidance for Screw Type          August 11, 1992     ODE/DDIGD/DDB          Do
 Endosseous Implants for Prosthetic
 Attachment
510(k) Information Needed for           July 6, 1993        ODE/DDIGD/DDB          Do
 Hydroxyapatite Coated Titanium
 Endosseous Implants
510(k) Information Needed for           August 12, 1993     ODE/DDIGD/DDB          Do
 Metallurgical Endosseous Implants
510(k) Information Needed for Ti-       July 13, 1993       ODE/DDIGD/DDB          Do
 Powder Coated Titanium Endosseous
 Implants
Draft Guidance Document for the         March 3, 1997       ODE/DDIGD/DDB          Do
 Preparation of Premarket Notification
 [510(k)'s] for Dental Alloys
Guidance Document for the Preparation   January 23, 1995    ODE/DDIGD/DDB          Do
 of Premarket Notifications (510(k)'s)
 for Temporomandibular Joint Implants
Guidance for the Arrangement and        May 16, 1989        ODE/DDIGD/DDB          Do
 Content of a Premarket Approval (PMA)
 Application For An Endosseous Implant
 For Prosthetic Attachment
Guidance for the Preparation of         January 1, 2000     ODE/DDIGD/DDB          Do
 Premarket Notification [510(k)] for
 Resorbable Periodontal Barriers

[[Page 31250]]

Information Necessary for Premarket     December 9, 1996    ODE/DDIGD/DDB          Do
 Notification Submissions for Screw-
 Type Endossesous Implants
Outline of Recommended Procedures for   January 1, 2000     ODE/DDIGD/DDB          Do
 a Clinical Investigation of
 Endosseous Implants Under a 510(k)
Outline of Recommended Procedures for   January 1, 2000     ODE/DDIGD/DDB          Do
 Animal Laboratory Studies of
 Endosseous Implants
Guidance on the Content of Premarket    April 1, 1993       ODE/DDIGD/General      Do
 Notification [510(k)] Submissions for                       Hospital Devices
 Piston Syringes                                             Branch (GHDB)
Draft Supplementary Guidance on the     March 1, 1995       ODE/DDIGD/GHDB         Do
 Content of Premarket Notification
 [510(k)] Submissions for Medical
 Devices with Sharps Injury Prevention
 Features (Antistick)
Guidance on 510(k) Submissions for      October 1, 1990     ODE/DDIGD/GHDB         Do
 Implanted Infusion Ports
Guidance on Premarket Notification      March 16, 1995      ODE/DDIGD/GHDB         Do
 [510(k)] Submissions for Short-Term
 and Long-Term Intravascular Catheters
Guidance on the Content of Premarket    March 1, 1993       ODE/DDIGD/GHDB         Do
 Notification [510(k)] Submissions for
 Clinical Electronic Thermometers
Guidance on the Content of Premarket    March 1, 1993       ODE/DDIGD/GHDB         Do
 Notification [510(k)] Submissions for
 External Infusion Pumps
Guidance on the Content of Premarket    April 1, 1993       ODE/DDIGD/GHDB         Do
 Notification [510(k)] Submissions for
 Hypodermic Single Lumen Needles
Guidance on Premarket Notification      August 1, 1993      ODE/DDIGD/Infection    Do
 [510(k)] Submissions for Automated                          Control Devices
 Endoscope Washers, Washer/                                  Branch (ICDB)
 Disinfectors, and Disinfectors
 Intended for Use in Health Care
 Facilities
Guidance on Premarket Notification      August 1, 1993      ODE/DDIGD/ICDB         Do
 [510(k)] Submissions for Surgical
 Gowns and Surgical Drapes
Guidance on the Content and Format of   December 6, 1996    ODE/DDIG/ICDB          Do
 Premarket Notification 510(k)
 Submissions for Liquid Chemical
 Germicides
Guidance on the Content and Format of   October 1, 1993     ODE/DDIGD/ICDB         Do
 Premarket Notification [510(k)]
 Submissions for General Purpose
 Disinfectants (and 3/9/94 Addendum)
Guidance on the Content and Format of   October 1, 1993     ODE/DDIGD/ICDB         Do
 Premarket Notification [510(k)]
 Submissions for Sharps Containers
Addendum to Guidance on the Content     March 9, 1994       ODE/DDIGD/ICDB         Do
 and Format of Premarket Notification
 [510(k)] Submissions for General
 Purpose Disinfectants
Guidance on Premarket Notification      March 3, 1993       ODE/Division of        Do
 510(k) for Sterilizers Intended for                         General and
 Use in Health Care Facilities                               Restorative Devices
                                                             (DGRD)
Guidance Document for Powered Suction   September 30, 1998  ODE/DGRD               Do
 Pump 510(k)s
Guidance Document for Industry and      March 18, 1998      ODE/DGRD               Do
 CDRH Staff for the Preparation of
 Investigational Device Exemptions and
 Premarket Approval Applications for
 Bone Growth Stimulator Devices
 (Replaces: Guidance Document for the
 Preparation of Investigatinal Device
 Exemptions and Premarket Approval
 Applications for Bone Growth
 Stimulator Devices--8/12/88)
Guidance for Content of Premarket       April 28, 1998      ODE/DGRD               Do
 Notifications for Esophageal and
 Tracheal Prostheses
Guidance Document for Surgical Lamp     July 13, 1998       ODE/DGRD               Do
 510ks
Protocol for Dermal Toxicity Testing    January 1, 2000     ODE/DGRD               Do
 for Devices in Contact with Skin
 (Draft)
Guide for 510(k) Review of Processed    June 26, 1990       ODE/DGRD               Do
 Human Dura Mater
Guide for TENS 510(k) Content (Draft)   August 1, 1994      ODE/DGRD               Do
Guidelines for Reviewing Premarket      January 1, 2000     ODE/DGRD               Do
 Notifications that Claim Substantial
 Equivalence to Evoked Response
 Stimulators

[[Page 31251]]

Guidance for Studies for Pain Therapy   May 12, 1988        ODE/DGRD               Do
 Devices--General Considerations in
 the Design of Clinical Studies for
 Pain-Alleviating Devices
Galvanic Skin Response Measurement      August 23, 1994     ODE/DGRD               Do
 Devices--Draft Guidance for 510(k)
 Content
Draft Version Guide for Cortical        August 10, 1992     ODE/DGRD               Do
 Electrode 510(k) Content
Draft Version Neuro Endoscope Guidance  July 7, 1994        ODE/DGRD               Do
Draft Version Guidance for Clinical     August 20, 1992     ODE/DGRD               Do
 Data to be Submitted for Premarket
 Approval Application for Cranial
 Electrotherapy Stimulators
Draft Version 1--Biofeedback Devices--  August 1, 1994      ODE/DGRD               Do
 Draft Guidance for 510(k) Content
Draft Version--Guidance on              September 12, 1994  ODE/DGRD               Do
 Biocompatibility Requirements for
 Long Term Neurological Implants: Part
 3--Implant Model
Draft Premarket Notification Review     June 1, 1994        ODE/DGRD               Do
 Guidance for Evoked Response
 Somatosensory Stimulators
Draft Version Cranial Perforator        July 13, 1994       ODE/DGRD               Do
 Guidance
ORDB 510(k) Sterility Review Guidance   July 3, 1997        ODE/DGRD               Do
Draft Guidance for Testing MR           May 22, 1996        ODE/DGRD               Do
 Interaction with Aneurysm Clips
Draft 510(k) Guideline for General      May 10, 1995        ODE/DGRD/General       Do
 Surgical Electrosurgical Devices                            Surgery Devices
                                                             Brancch (GSDB)
Draft Guidance for Arthroscope and      May 1994            ODE/DGRD/GSDB          Do
 Accessory 510(k)s
Guidance for the Preparation of a       August 30, 1994     ODE/DGRD/GSDB          Do
 Premarket Notification for Extended
 Laparoscopy Devices
Guidance on the Content and             June 1, 1995        ODE/DGRD/GSDB          Do
 Organization of a Premarket
 Notification for a Medical Laser
Guidance Document for Testing Bone      April 20, 1996      ODE/DGRD/Orthopedic    Do
 Anchor Devices                                              Devices Branch
                                                             (ORDB)
510(k) Information Needed for           February 20, 1997   ODE/DGRD/ORDB          Do
 Hydroxyapatite Coated Orthopedic
 Implants
Calcium Phosphate (Ca-P) Coating Draft  February 21, 1997   ODE/DGRD/ORDB          Do
 Guidance for Preparation of FDA
 Submissions for Orthopedic and Dental
 Endosseous Implants
Draft Data Requirements for Ultrahigh   March 28, 1995      ODE/DGRD/ORDB          Do
 Molecular Weight Polyethylene
 (Uhmupe) Used in Orthopedic Devices
Draft Guidance Document for Femoral     August 1, 1995      ODE/DGRD/ORDB          Do
 Stem Prostheses
Draft Guidance Document for Testing     May 1, 1995         ODE/DGRD/ORDB          Do
 Acetabular Cup Prostheses
Draft Guidance Document for the         July 16, 1997       ODE/DGRD/ORDB          Do
 Preparation of Premarket Notification
 [510(k)] Applications for Orthopedic
 Devices-The Basic Elements
Draft Guidance for the Preparation of   April 1, 1993       ODE/DGRD/ORDB          Do
 Premarket Notifications [510(k)s] for
 Cemented, Semi-Constrained Total Knee
 Prostheses
Draft Guideline for Reviewing Spinal    January 9, 1997     ODE/DGRD/ORDB          Do
 Fixation Device Systems
Draft of Guidance Document for Testing  October 25, 1995    ODE/DGRD/ORDB          Do
 of Orthopedic Implants with Metallic
 Plasma Sprayed Porous Coatings
 Subject to Required Post Market
 Surveillance
Draft Outline for a Guidance Document   November 1, 1993    ODE/DGRD/ORDB          Do
 for Testing Orthopedic Bone Cement,
 request for comments by December 10,
 1993
Guidance Document for Testing           April 20, 1996      ODE/DGRD/ORDB          Do
 Biodegradable Polymer Implant Devices
Guidance Document for Testing Non-      May 1, 1995         ODE/DGRD/ORDB          Do
 Articulating, ``Mechanically
 Locked'', Modular Implant Components
Guidance Document for Testing           April 28, 1994      ODE/DGRD/ORDB          Do
 Orthopedic Implants with Modified
 Metallic Surfaces Apposing Bone or
 Bone Cement

[[Page 31252]]

Guidance Document for the Preparation   February 18, 1993   ODE/DGRD/ORDB          Do
 of IDE and PMA Applications for Intra-
 Articular Prosthetic Knee Ligament
 Devices
Guidance Document for the Preparation   January 10, 1995    ODE/DGRD/ORDB          Do
 of Premarket Notification for Ceramic
 Ball Hip Systems
Reviewers Guidance Checklist for        February 21, 1997   ODE/DGRD/ORDB          Do
 Intramedullary Rods
Reviewers Guidance Checklist for        February 21, 1997   ODE/DGRD/ORDB          Do
 Orthopedic External Fixation Devices
Electroencephalograph Device Draft      June 25, 1997       ODE/DGRD/Plastic and   Do
 Guidance for 510(k) Content                                 Reconstructive
                                                             Surgery Devices
                                                             Branch (PRSB)
Alternate Suture Labeling Resulting     January 11, 1993    ODE/DGRD/PRSB          Do
 from the January 11, 1993, Meeting
 with HIMA
Copy of October 9, 1992 Letter and                          ODE/DGRD/PRSB          Do
 Original Suture Labeling Guidance
Draft Guidance for Preparation of PMA   January 18, 1995    ODE/DGRD/PRSB          Do
 Applications for Silicone Inflatable
 (Saline) Breast Prostheses
Draft Guidance for Preparations of FDA  May 11, 1992        ODE/DGRD/PRSB          Do
 Submissions of Silicone Gel-Filled
 Breast Prostheses
Draft Guidance for Testing of           September 1, 1994   ODE/DGRD/PRSB          Do
 Alternative Breast Prostheses
 (nonsilicone gel-filled)
Draft Guidance for the Preparation of   March 31, 1995      ODE/DGRD/PRSB          Do
 a Premarket Notification for a Non-
 Interactive Wound and Burn Dressing
 [510(k)]
Draft Guidance for the Preparation of   April 1, 1995       ODE/DGRD/PRSB          Do
 IDE Submission for Interactive Wound
 and Burn Dressing
Letter: Core Study for Silicone Breast  January 11, 1996    ODE/DGRD/PRSB          Do
 Implants
Electrical Muscle Stimulator (EMS)      July 11, 1985       ODE/DGRD/Restorative   Do
 Labeling Indications,                                       Devices Branch
 Contraindications, Warnings, etc.                           (REDB)
Technological Reporting for Powered     January 1, 1992     ODE/DGRD/REDB          Do
 Muscle Stimulator 510k Submissions
Guidance Document for the Preparation   July 26, 1995       ODE/DGRD/REDB          Do
 of Notification (510(k)) Applications
 for Therapeutic Massagers and
 Vibrators
Guidance Document for the Preparation   July 26, 1995       ODE/DGRD/REDB          Do
 of Premarket Notification [510(k)]
 Applications for Beds
Guidance Document for the Preparation   July 26, 1995       ODE/DGRD/REDB          Do
 of Premarket Notification [510(k)]
 Applications for Communications
 Systems (Powered and Non-Powered) and
 Powered Environmental Control Systems
Guidance Document for the Preparation   July 26, 1995       ODE/DGRD/REDB          Do
 of Premarket Notification [510(k)]
 Applications for Electromyograph
 Needle Electrodes
Guidance Document for the Preparation   July 26, 1995       ODE/DGRD/REDB          Do
 of Premarket Notification [510(k)]
 Applications for Exercise Equipment
Guidance Document for the Preparation   July 26, 1995       ODE/DGRD/REDB          Do
 of Premarket Notification [510(k)]
 Applications for Heating and Cooling
 Devices
Guidance Document for the Preparation   July 26, 1995       ODE/DGRD/REDB          Do
 of Premarket Notification [510(k)]
 Applications for Immersion
 Hyudrobaths
Guidance Document for the Preparation   July 26, 1995       ODE/DGRD/REDB          Do
 of Premarket Notification [510(k)]
 Applications for Powered Muscle
 Stimulators, and Ultrasound Diathermy
 and Muscle Stimulators
Guidance Document for the Preparation   July 26, 1995       ODE/DGRD/REDB          Do
 of Premarket Notification [510(k)]
 Applications for Powered Tables and
 Multifunctional Physical Therapy
 Tables
Guidance Document for the Preparation   July 26, 1995       ODE/DGRD/REDB          Do
 of Premarket Notification [510(k)]
 Applications for Submerged
 (Underwater) Exercise Equipment

[[Page 31253]]

 Guidance Document for the Preparation  July 26, 1995       ODE/DGRD/REDB          Do
 of Premarket Notification [510k)]
 Applications for Mechanical and
 Powered Wheelchairs, and Motorized
 Three-Wheeled Vehicles
Aqueous Shunts--510(k) Submissions      November 16, 1998   ODE/Division of        Do
                                                             Opthalmics Devices
                                                             (DOD)
Guidance for Industry--Guidance         October 9, 1998     ODE/DOD                Do
 Document for Nonprescription
 Sunglasses
Third Party Review Guidance for         January 31, 1997    ODE/DOD                Do
 Vitreous Aspiration and Cutting
 Device Premarket Notification (510k)
Dear Sponsor Letter Concerning the      May 20, 1997        ODE/DOD                Do
 Revocation of 21 CFR Part 813 IOL IDE
 Regulations
Retinoscope Guidance                    July 8, 1998        ODE/DOD                Do
Opthalmoscope Guidance                  July 8, 1998        ODE/DOD                Do
Slit Lamp Guidance                      July 8, 1998        ODE/DOD                Do
Revised Procedures for Adding Lens      August 11, 1998     ODE/DOD                Do
 Finishing Laboratories to Approved
 Premarket Approval Applications for
 Class III Rigid Gas Permeable Contact
 Lens for Extended Wear
Announcement by Dr. Alpert at 7/26/96   August 26, 1996     ODE/DOD                Do
 Ophthalmic Panel Meeting Concerning
 Manufacturers & Users of Lasers for
 Refractive Surgery [excimer
Announcement: Information for           September 22, 1997  ODE/DOD                Do
 Manufacturers & Users of Lasers for
 Refractive Surgery [excimer]
Intraocular Lens (IOL) Guidance         October 10, 1997    ODE/DOD                Do
 Document
FDA Guidelines for Multifocal           May 29, 1997        ODE/DOD                Do
 Intraocular Lens IDE Studies and PMAs
 Premarket Notification [510(k)]        May 12, 1994        ODE/DOD                Do
 Guidance Document for Class II Daily
 Wear Contact Lenses
Contact Lenses: The Better the Care     April 1, 1991       ODE/DOD                Do
 the Safer the Wear--FDA Publication
 No. (FDA) (91-4220)
An FDA Survey of U.S. Contact Lens      July 1, 1987        ODE/DOD                Do
 Wearers (Carol L. Herman) Reprinted
 from Contact Lens Spectrum
Facts for Consumers from the Federal    April 1, 1986       ODE/DOD                Do
 Trade Commission--Eyeglasses
Important Information About Rophae      August 20, 1992     ODE/DOD                Do
 Intraocular Lenses
Checklist of Information Usually        October 10, 1996    ODE/DOD                Do
 Submitted in an Investigational
 Device Exemption (IDE) Application
 for Refractive Surgery Lasers
 [excimer]
Ophthalmic Device Triage List           March 19, 1998      ODE/DOD                Do
Discussion Points for Expansion of the  September 5, 1997   ODE/DOD                Do
 'Checklist of Information Usually
 Submitted in an Investigational
 Device Exemption (IDE) Application
 for Refractive Surgery Lasers' Draft
 Document
Letter to Manufacturers and Users of    October 10, 1996    ODE/DOD                Do
 Lasers for Refractive Surgery
 [excimer]
Owners Certification of Lasers as PMA   September 26, 1996  ODE/DOD                Do
 Approved Devices [excimer]
Update on Excimer Lasers for            May 20, 1996        ODE/DOD                Do
 Nearsightedness
Amendment 1: Premarket Notification     June 28, 1994       ODE/DOD                Do
 [510(k)] Guidance Document for Class
 II Daily Wear Contact Lenses
Certification Statement for the Impact  February 3, 1995    ODE/DOD                Do
 Resistance Test
Premarket Notification 510(k) Guidance  May 1, 1997         ODE/DOD                Do
 for Contact Lens Care Products
Eye Valve Implant (and all glaucoma     November 16, 1995   ODE/DOD                Do
 drainage devices) manufacturers
 letter from N. C. Brogdon
New FDA Recommendations & Results of    May 30, 1989        ODE/DOD                Do
 Contact Lens Study (7-day letter)
Sunglass Letter including 510(k)        October 8, 1996     ODE/DOD                Do
 format
Sunglass Package                        February 3, 1995    ODE/DOD                Do
Guidance for Industry; Noise Claims in  October 21, 1998    ODE/Division of        Do
 Hearing Aid Labeling                                        Reproductive,
                                                             Abdominal, ENT, and
                                                             Radiological Devices
                                                             (DRAERD)

[[Page 31254]]

Guidance for the Submission of          November 14, 1998   ODE/DRAERD             Do
 Premarket Notification for Magnetic
 Resonance Diagnostic Devices
Guidance for the Content of Premarket   November 30, 1998   ODE/DRAERD             Do
 Notifications for Intracorporeal
 Lithotripters
Guidance for the Submission of          November 20, 1998   ODE/DRAERD             Do
 Premarket Notifications for
 Radionuclide Dose Calibrators
Guidance for the Submission of          December 3, 1998    ODE/DRAERD             Do
 Premarket Notifications for Emission
 Computed Tomography Devices and
 Accessories (SPECT and PET) and
 Nuclear Tomography Systems
Information for Manufacturers Seeking   February 4, 1999    ODE/-DRAERD            Do
 Marketing Clearance of Digital
 Mammography Systems
Harmonic Imaging with/without           November 16, 1998   ODE/DRAERD             Do
 Contrast--Premarket Notification
 Requirements
Guidance for the Content of Premarket   February 5, 1998    ODE/DRAERD             Do
 Notifications for Metal Expandable
 Biliary Stents
Guidance for the Submission of 510(k)   February 11, 1997   ODE/DRAERD             Do
 Premarket Notifications for
 Cardiovascular Intravascular Filters
Tympanostomy Tubes, Submission          January 14, 1998    ODE/DRAERD             Do
 Guidance for a 510(k) Premarket
 Notification
Letter to Manufacturers of              September 5, 1996   ODE/DRAERD             Do
 Falloposcopes
Letter to Manufacturers of              September 6, 1996   ODE/DRAERD             Do
 Prescription Home Monitors for Non-
 Stress Tests
Latex Condoms for Men--Information for  July 23, 1998       ODE/DRAERD             Do
 510(k) Premarket Notifications: Use
 of Consensus Standards for
 Abbreviated Submissions
Uniform Contraceptive Labeling          July 23, 1998       ODE/DRAERD             Do
Guidance to Industry and CDRH           August 7, 1998      ODE/DRAERD             Do
 Reviewers--Guidance for the Content
 of Premarket Notifications for
 Conventional and Permeability
 Hemodialyzers (Replaces: Guidelines
 for Premarket Testing of New
 Conventional Hemodialyers, High
 Premeability Hemodialyzers and
 Hemofilters)
Devices Used for In Vitro               September 10, 1998  ODE/DRAERD             Do
 Fertilization and Related Assisted
 Reproduction Procedures
Guidance for the Technical Content of   April 1, 1990       ODE/DRAERD             Do
 a Premarket Approval (PMA)
 Application for an Endolymphatic
 Shunt Tube with Valve
Letter: Notice to Manufacturers of      September 25, 1997  ODE/DRAERD             Do
 Bone Mineral Densitometers
Draft Guidance to Hearing Aid           August 5, 1994      ODE/DRAERD/Ear, Nose,  Do
 Manufacturers for Substantiation of                         and Throat Devices
 Claims                                                      Branch (ENTB)
Guidance for Submission of a 510(k)     April 1, 1991       ODE/DRAERD/ENTB        Do
 Premarket Notification for an Air
 Conduction Hearing Aid
Guidance For The Arrangement and        May 1, 1990         ODE/DRAERD/ENTB        Do
 Content of a Premarket Approval (PMA)
 Application For a Cochlear Implant in
 Children Ages 2 through to 17 Years
Guidance for the Content of Premarket   October 21, 1996    ODE/DRAERD/ENTB        Do
 Notification for Disposable, Sterile,
 Ear, Nose and Throat Endoscope
 Sheaths with Protective Barrier
 Claims
Guideline for the Arrangement and       May 1, 1990         ODE/DRAERD/ENTB        Do
 Content of a Premarket Approval (PMA)
 Application for a Cochlear Implant in
 Adults at Least 18 Years of Age
Draft Guidance for Hemodialyzer Reuse   October 6, 1995     ODE/DRAERD/            Do
 Labeling                                                    Gastroenterology and
                                                             Renal Devices Branch
                                                             (GRDB)
Draft Guidance for the Content of       May 30, 1997        ODE/DRAERD/GRDB        Do
 Premarket Notifications for Water
 Purification Components and Systems
 for Hemodialysis
Condom Packet: 4/13/94 R. J. Rivera     April 13, 1994      ODE/DRAERD/Obstetrics/ Do
 Letter, Condom Guidance & 7 Tabs,                           Gynecology Devices
 General Guidance for Modifying Condom                       Branch (OGDB)
 Labeling to Include Shelf Life

[[Page 31255]]

Draft Guidance for the Content of       July 29, 1991       ODE/DRAERD/OGDB        Do
 Premarket Notifications for Loop and
 Rollerball Electrodes for GYN
 Electrosurgical Excisions
Draft Guidance for the Content of       May 25, 1995        ODE/DRAERD/OGDB        Do
 Premarket Notifications for Menstrual
 Tampons
Draft Thermal Endometrial Ablation      March 14, 1996      ODE/DRAERD/OGDB        Do
 Devices (Submission Guidance for an
 IDE)
Guidance (`Guidelines') for Evaluation  March 8, 1977       ODE/DRAERD/OGDB        Do
 of Fetal Clip Electrode
Guidance (`Guidelines') for Evaluation  May 10, 1978        ODE/DRAERD/OGDB        Do
 of Hysteroscopic Sterilization
 Devices
Guidance (`Guidelines') for Evaluation  January 1, 2000     ODE/DRAERD/OGDB        Do
 of Laparoscopic Bipolar and Thermal
 Coagulators (and Accessories)
Guidance (`Guidelines') for Evaluation  November 22, 1977   ODE/DRAERD/OGDB        Do
 of Tubal Occlusion Devices
Guidelines for Evaluation of Non-Drug   September 28, 1976  ODE/DRAERD/OGDB        Do
 IUDs
Hysteroscopes and Gynecology            March 27, 1996      ODE/DRAERD/OGDB        Do
 Laparoscopes--Submission Guidance for
 a 510(k) --includes 00192
Hysteroscopes and Laparoscopic          August 1, 1995      ODE/DRAERD/OGDB        Do
 Insufflators: Submission Guidance for
 a 510(k)
In-vivo Devices for the Detection of    June 14, 1997       ODE/DRAERD/OGDB        Do
 Cervical Cancer and its Precursors:
 Submission Guidance for an IDE Draft
 Document
Intrapartum Continuous Monitors for     June 14, 1997       ODE/DRAERD/OGDB        Do
 Fetal Oxygen Saturation and Fetal pH;
 Submission Guidance for a PMA; Draft
 Document
Premarket Testing Guidelines for        November 20, 1992   ODE/DRAERD/OGDB        Do
 Falloposcopes
Premarket Testing Guidelines for        April 4, 1990       ODE/DRAERD/OGDB        Do
 Female Barrier Contraceptive Devices
 also Intended to Prevent Sexually
 Transmitted Diseases
Premarket Testing Guidelines for Home   March 31, 1993      ODE/DRAERD/OGDB        Do
 Uterine Activity Monitors
Information for a Latex Condom 510(k)   March 1994          ODE/DRAERD/OGDB        Do
 Submission for Obstetrics-Gynecology
 Branch (draft)
Testing Guidance for Male Condoms Made  June 29, 1995       ODE/DRAERD/OGDB        Do
 from New Material (Non-Latex)
Draft Guidance for Review of Bone       November 9, 1992    ODE/DRAERD/Radiology   Do
 Densitometer 510(k) Submissions                             Devices Branch (RDB)
Guidance for Content and Review of a    August 2, 1988      ODE/DRAERD/RDB         Do
 Magnetic Resonance Diagnostic Device
 510(k) Application and 10/11/95 MRI
 Guidance Update for dB/dt
Guidance for Magnetic Resonance         September 29, 1997  ODE/DRAERD/RDB         Do
 Diagnostic Devices--Criteria for
 Significant Risk Investigations
Guidance for the Comment and Review of  August 1, 1993      ODE/DRAERD/RDB         Do
 510(k) Notifications for Picture
 Archiving and Communications Systems
 (PACS) and Related Devices [See 2099]
Guidance for the Submission of 510(k)s  June 1, 1997        ODE/DRAERD/RDB         Do
 for Solid State X-ray Imaging Devices
Information for Manufacturers Seeking   September 30, 1997  ODE/DRAERD/RDB         Do
 Marketing Clearance of Diagnostic
 Ultrasound Systems and Transducers
Information for Manufacturers Seeking   June 19, 1996       ODE/DRAERD/RDB         Do
 Marketing Clearance of Digital
 Mammography Systems
Reviewer Guidance for Automatic X-Ray   February 1, 1990    ODE/DRAERD/RDB         Do
 Film Processor 510(k)
Simplified 510(k) procedures for        December 21, 1993   ODE/DRAERD/RDB         Do
 certain radiology devices: 12/21/93
 letter from L. Yin, ODE/DRAERD, to
 NEMA
510(k) Checklist for Sterile            September 19, 1994  ODE/DRAERD/Urology     Do
 Lubricating Jelly Used With                                 and Lithrotripsy
 Transurethral Surgical Instruments                          Devices Branch
                                                             (ULDB)
Draft Guidance to Firms on Biliary      August 2, 1990      ODE/DRAERD/ULDB        Do
 Lithotripsy Studies
CDRH Interim Regulatory Policy for      September 10, 1997  ODE/DRAERD/ULDB        Do
 External Penile Rigidity Devices
Checklist for Mechanical Lithotripters  November 1, 1994    ODE/DRAERD/ULDB        Do
 and Stone Dislodgers Used in
 Gastroenterology and Urology

[[Page 31256]]

Draft--510(k) Checklist for             November 23, 1994   ODE/DRAERD/ULDB        Do
 Conditioned Response Enuresis Alarms
 Draft 510(k) Checklist for Condom      February 23, 1995   ODE/DRAERD/ULDB        Do
 Catheters
Draft 510(k) Checklist for Endoscopic   August 16, 1995     ODE/DRAERD/ULDB        Do
 Electrosurgical Unit (ESU) and
 Accessories Used in Gastroenterology
 and Urology
Draft 510(k) Checklist for Endoscopic   June 22, 1995       ODE/DRAERD/ULDB        Do
 Light Sources Used in
 Gastroenterology and Urology
Draft 510(k) Checklist for Non-         June 6, 1995        ODE/DRAERD/ULDB        Do
 Implanted Electrical Stimulators Used
 for the Treatment of Urinary
 Incontinence
Draft 510(k) Checklist for Urological   August 1, 1995      ODE/DRAERD/ULDB        Do
 Irrigation System and Tubing Set
Draft Guidance for Clinical             November 11, 1994   ODE/DRAERD/ULDB        Do
 Investigations of Devices Used for
 the Treatment of Benign Prostatic
 Hyperplasia (BPH)
Draft Guidance for Information on       February 5, 1992    ODE/DRAERD/ULDB        Do
 Clinical Safety and Effectiveness
 Data for Extracorporeal Shock Wave
 Lithotripsy of Upper Urinary Tract
 (Renal Pelvis, Renal Calyx and Upper
 Ureteral) Calculi
Draft Guidance for Preclinical and      November 29, 1995   ODE/DRAERD/ULDB        Do
 Clinical Investigations of Urethral
 Bulking Agents Used in the Treatment
 of Urinary Incontinence
Draft Guidance for Preparation of PMA   March 16, 1993      OD/DRAERD/ULDB         Do
 Applications for Penile Inflatable
 Implants
Draft Guidance for Preparation of PMA   March 16, 1993      ODE/DRAERD/ULDB        Do
 Applications for Testicular
 Prostheses
Draft Guidance for Preparation of PMA   May 1, 1995         ODE/DRAERD/ULDB        Do
 Applications for the Implanted
 Mechanical/Hydraulic Urinary
 Continence Device (Artificial Urinary
 Sphincter)
Draft Guidance for the Clinical         November 2, 1995    ODE/DRAERD/ULDB        Do
 Investigation of Urethral Stents
Draft Guidance for the Content of       March 17, 1995      ODE/DRAERD/ULDB        Do
 Premarket Notifications for
 Endoscopes Used in Gastroenterology
 and Urology
Draft Guidance for the Content of       May 30, 1995        ODE/DRAERD/ULDB        Do
 Premarket Notifications for Penile
 Rigidity Implants
Draft Guidance for the Content of       January 24, 1992    ODE/DRAERD/ULDB        Do
 Premarket Notifications for
 Urological Balloon Dilatation
 Catheters
Draft Guidance Outline--Points to       November 30, 1993   ODE/DRAERD/ULDB        Do
 Consider for Clinical Studies for
 Vasovasostomy Devices
Draft of Suggested Information for      January 18, 1991    ODE/DRAERD/ULDB        Do
 Reporting Extracorporeal Shock Wave
 Lithotripsy Device Shock Wave
 Measurements
Guidance for the Content of Premarket   February 10, 1993   ODE/DRAERD/ULDBDo
 Notifications for Biopsy Devices Used
 in Gastroenterology and Urology
Guidance for the Content of Premarket   September 12, 1994  ODE/DRAERD/ULDB        Do
 Notifications for Conventional and
 Antimicrobial Foley Catheters
Guidance for the Content of Premarket   February 10, 1993   ODE/DRAERD/ULDB        Do
 Notifications for Ureteral Stents
Guidance for the Content of Premarket   June 7, 1994        ODE/DRAERD/ULDB        Do
 Notifications for Urine Drainage Bags
Guidance for the Content of Premarket   July 29, 1994       ODE/DRAERD/ULDB        Do
 Notifications for Urodynamic/
 Uroflowmetry Systems
Guidance to Manufacturers on the        January 1, 2000     ODE/DRAERD/ULDB        Do
 Development of Required Postapproval
 Epidemiologic Study Protocols for
 Testicular Implants
Center for Devices and Radiological     June 30, 1993       ODE/IDE/blue/          Do
 Health's Investigational Device
 Exemption (IDE) Refuse to Accept
 Policy
Center for Devices and Radiological     June 30, 1993       ODE/510k/blue/         Do
 Health's Premarket Notification
 [510(k)] Refuse to Accept Policy--
 (updated Checklist 3/14/95)

[[Page 31257]]

Guidance For Request and Issuance of    October 21, 1998    Office of Health and   Do
 Interim Notice Letters for                                  Industry Programs
 Mammography Facilities Under the MQSA                       (OHIP)/Division of
                                                             Mammography Quality
                                                             and Radiation
                                                             Programs (DMQRP)
Continuing Education Credits for        March 17, 1998      OHIP/DMQRP             Do
 Reading/ Writing Articles/Papers and
 Presenting Courses/Lectures
Accidental Radioactive Contamination    August 13, 1998     OHIP/DMQRP             Do
 of Human Food and Animal Feeds:
 Recommendations for State and Local
 Agencies
Additional Mammography Review Policy    March 26, 1998      OHIP/DMQRP             Do
Guidance For Review of Cases of         March 26, 1998      OHIP/DMQRP             Do
 Possible Suspension or Revocation of
 Mammography Facility Certificates
 Under the Mammography Quality
 Standards Act (42 U.S.C. 263(b))
Guidance for Review of Requests for     March 26, 1998      OHIP/DMQRP             Do
 Reconsideration of Adverse Decisions
 on Accreditation of Mammography
 Facilities Under the Mammography
 Quality Standards Act (42 U.S.C.
 263(b))
Guidance for Submission of Requests     March 26, 1998      OHIP/DMQRP             Do
 for Reconsideration of Adverse
 Decisions on Accreditation of
 Mammography Facilities Under the
 Mammography Quality Standards Act, 42
 U.S.C. 263(b)
Supplement to The Physician's           April 9, 1998       OHIP/DMQRP             Do
 Continuing Experience Requirement
Requalification for Interpreting        May 28, 1998        OHIP/DMQRP             Do
 Physician's Continuing Experience
MQSA Policy Statements in a Question    June 2, 1998        OHIP/DMQRP             Do
 and Answer
Compliance Guidance: The Mammography    August 27, 1998     OHIP/DMQRP             Do
 Quality Standards Act Final
 Regulations
MQSA Policy Statements for the Interim  August 6, 1998      OHIP/DMQRP             Do
 Regulations
Policy for Facilities Changing          April 15, 1998      OHIP/DMQRP             Do
 Accreditation Bodies
Addendum to What a Mammography          July 31, 1996       OHIP/DMQRP             Do
 Facility Should do to Prepare for an
 MQSA Inspection
Handbook of Selected Tissue Doses for   September 1, 1995   OHIP/DMQRP             Do
 Fluoroscopic and Cineangiographic
 Examination of the Coronary Arteries
 (in SI Units) FDA 95-8289, (Units of
 milliray (mmmGy) tissue dose and gray
 (Gy) air kerma)
What a Mammography Facility Should Do   June 30, 1995       OHIP/DMQRP             Do
 to Prepare for an MQSA Inspection
Policy Notebook in a Q/A Format         January 23, 1998    OHIP/DMQRP             Do
 (update to existing document)
Guidance for Staff, Industry, and       October 30, 1998    OHIP/Division of       Do
 Third Parties Implementation of Third                       Small Manufacturer's
 Party Programs Under the FDA                                Assistance (DSMA)
 Modernization Act of 1997
Pages 39.html Exporting Medical         June 30, 1998       OHIP/DSMA              Do
 Devices and 391.html Foreign Liaison
 List
Guidance for Staff, Industry and Third  January 6, 1999     OHIP/DSMA              Do
 Parties: Third Party Programs Under
 the Sectoral Annex on Medical Devices
 to the Agreement on Mutual
 Recognition Between the United States
 of America and the European Community
 (MRA)
A Pocket Guide to Device GMP            November 1, 1991    OHIP/DSMA              Do
 Inspections--Inspections of Medical
 Device Manufacturers and GMP
 Regulation Requirements
Medical Device Reporting for            March 1997          OHIP/DSMA              Do
 Manufacturers
Regulatory Requirement for Devices for  August 1, 1987      OHIP/DSMA              Do
 the Handicapped (FDA 87-4221)
Comparison Chart: 1996 Quality System   January 1, 2000     OHIP/DSMA              Do
 Reg vs. 1978 Good Manufacturing
 Practices Reg vs. ANSI/ISO/ASQC Q9001
 and ISO/DI 13485:1996 (include 126)
Small Business Guide to FDA (FDA 96-    January 1, 1996     OHIP/DSMA              Do
 1092)
Investigational Device Exemptions       July 1, 1996        OHIP/DSMA              Do
 [IDE] Manual (FDA 96-4159)/DSMA
An Introduction to Medical Device       January 1, 1992     OHIP/DSMA              Do
 Regulations (FDA 92-4222)

[[Page 31258]]

In Vitro Diagnostic Devices: Guidance   January 1, 1997     OHIP/DSMA              Do
 for the Preparation of 510(k)
 Submissions (supersedes FDA 87-4224)
Instructions for Completion of Medical  July 1, 1997        OHIP/DSMA              Do
 Device Registration and Listing Forms
 FDA 2891, 2891a and 2892
Additional Guidance for Testing         September 1, 1993   OHIP/DSMA              Do
 Immunity to Radiated Electromagnetic
 Fields--Infant Apnea Monitor Standard
Classification Names for Medical        March 1, 1995       OHIP/DSMA              Do
 Devices and In Vitro Diagnostic
 Products (FDA Pub No. 95-4246)
Labeling--Regulatory Requirements for   September 1, 1989   OHIP/DSMA              Do
 Medical Devices (FDA 89-4203)
List of Current CDRH Addresses for      July 30, 1996       OHIP/DSMA              Do
 Report Submission and Ordering of
 CDRH Forms
Obtaining CDRH Guidance Documents       May 13, 1998        OHIP/DSMA              Do
Premarket Approval (PMA) Manual (FDA    July 1, 1997        OHIP/DSMA              Do
 97-4214)
Premarket Notification: 510(k)--        August 1, 1995      OHIP/DSMA              Do
 Regulatory Requirements for Medical
 Devices (FDA 95-4158)
Procedures for Laboratory Compliance    May 1, 1986         OHIP/DSMA              Do
 Testing of Television Receivers--Part
 of TV Packet
Regulation of Medical Devices           May 1, 1996         OHIP/DSMA              Do
 Background Information for Foreign
 Officials
MDR Documents Access Information        May 10, 1996        OHIP/DSMA              Do
MDR Documents Access Information for    February 29, 1996   OHIP/DSMA              Do
 CDRH Electronic Docket (ED)
MDR Documents Access Information for    February 29, 1996   OHIP/DSMA              Do
 CDRH Facts-On-Demand (FOD)
MDR Documents Access Information for    May 8, 1996         OHIP/DSMA              Do
 Industry Organizations
MDR Documents Access Information for    May 10, 1996        OHIP/DSMA              Do
 National Technical Information
 Service (NTIS)
MDR Documents Access Information for    February 29, 1996   OHIP/DSMA              Do
 World Wide Web (WWW)
Medical Device Quality Systems Manual:  December 1, 1996    OHIP/DSMA              Do
 A Small Entity Compliance Guide
Overview of FDA Modernization Act of    February 19, 1998   OHIP/DSMA              Do
 1997, Medical Device Provisions
Medical Device Appeals and Complaints-- February 1, 1998    OHIP/DSMA/Office of    Do
 Guidance on Dispute Resolutions                             the Center Director
                                                             (OCD)
Medical Device Reporting for User       April 1996          OHIP/Division of       Do
 Facilities                                                  Device User Programs
                                                             and Systems Analysis
                                                             (DUPSA)
Human Factors Points to Consider for    January 17, 1997    OHIP/DUPSA             Do
 IDE Devices
Human Factors Principles for Medical    September 1, 1993   OHIP/DUPSA             Do
 Device Labeling
Write it Right                          August 1, 1993      OHIP/DUPSA             Do
Do It By Design--An Introduction to     December 1, 1996    OHIP/DUPSA             Do
 Human Factors in Medical Devices
FDA Modernization Act of 1997:          February 6, 1998    OHIP/Regs              Do
 Guidance for the Device Industry on
 Implementation of Highest Priority
 Provisions: Availability
Statistical Aspects of Submissions to   June 1, 1984        OSB/Division of        Do
 FDA: A Medical Device Perspective                           Biostatistics (DB)
 (also includes as Appendix the
 Article Observed Uses and Abuses of
 Statistical Procedures in Medical
 Device Submissions
Statistical Guidance for Clinical       January 1, 1996     OSB/DB                 Do
 Trials of Non Diagnostic Medical
 Devices (Replaces Clincal Study
 Guidance, formerly 891)
Amendment to Guidance on Discretionary  March 30, 1994      OSB/Division of        Do
 Postmarket Surveillance on Pacemaker                        Postmarket
 Leads                                                       Surveillance (DPS)
Guidance on Procedures to Determine     February 19, 1998   OSB/DPS                Do
 Application of Postmarket
 Surveillance Strategies
Guidance on Procedures for Review of    February 19, 1998   OSB/DPS                Do
 Postmarket Surveillance Submissions
SMDA to FDAMA: Guidance on FDA's        February 19, 1998   OSB/DPS                Do
 Transition Plan for Existing
 Postmarket Surveillance

[[Page 31259]]

Proposed Draft Guidance to Sponsors     October 7, 1994     OSB/DPS                Do
 Regarding Required Postmarket
 Surveillance Studies of Plasma-
 Sprayed Porous-Coated Hip Prostheses
Guidance to Sponsors on the             June 9, 1993        OSB/DPS                Do
 Development of a Discretionary
 Postmarket Surveillance Study for
 Permanent Implantable Cardiac
 Pacemaker Electrodes (Leads)
Medical Device Reporting for            April 1996          OSB/Division of        Do
 Distributors                                                Surveillance Systems
                                                             (DSS)
Medical Device Reporting: An Overview   April 1996          OSB/DSS                Do
MDR Internet List Server (listserv)     August 29, 1996     OSB/DSS                Do
 Instruction Sheet
MEDWATCH FDA Form 3500A For Use By      June 1, 1993        OSB/DSS                Do
 User Facilities, Distributors and
 Manufacturers for Mandatory Reporting
Instructions for Completing FDA Form    December 15, 1995   OSB/DSS                Do
 3500A with Coding Manual for Form
 3500A (MEDWATCH)
MDR Policy/Guidance for Endosseus       December 1992       OSB/DSS                Do
 Implant Devices
MDR Guidance--Blood Loss Policy         December 1995       OSB/DSS                Do
Summary Reporting Approval for Adverse  July 31, 1997       OSB/DSS                Do
 Events
Common Problems: Baseline Reports and                       OSB/DSS                Do
 MedWatch Form 3500A (letter to
 manufacturer--undated)
MDR Guidance Document: Remedial Action  July 30, 1996       OSB/DSS                Do
 Exemption--E1996001
Variance from Manufacturer Report       July 16, 1996       OSB/DSS                Do
 Number Format [MDR letter]
Instructions for Completing Form 3417:  March 31, 1997      OSB/DSS                Do
 Medical Device Reporting Baseline
 Report [MDR]
MDR Guidance Document No. 1--IOL--      August 7, 1996      OSB/DSS                Do
 E1996004
MDR Guidance Document No. 3--           August 9, 1996      OSB/DSS                Do
 Needlestick & Blood Exposure--
 E1996003
MDR Reporting Guidance For Breast       August 7, 1996      OSB/DSS                Do
 Implants--E1996002
Instructions for Completing Semi-       September 24, 1996  OSB/DSS                Do
 Annual Report, Form 3419 (MDR)
Guidance on FDA's Expectations of       May 15, 1998        Office of Standards    Do
 Medical Device Manufacturers                                and Technology (OST)/
 Concerning the Year 2000 Date                               Division of
                                                             Electronics and
                                                             Computer Science
                                                             (DECS)
Draft Document--A Primer on Medical     February 7, 1997    OST/Division of        Do
 Device Interactions with Magnetic                           Postmarket
 Resonance Imaging Systems                                   Surveillance (DPS)
Frequently Asked Questions on           February 19, 1998   OST/OD                 Do
 Recognition of Consensus Standards
Guidance on the Recognition and Use of  February 19, 1998   OST/OD                 Do
 Consensus Standards
----------------------------------------------------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------
                                                                                    How to Obtain a Hard Copy of
                                                             Grouped by Intended       the Document (Name and
           Name of Document              Date of Issuance     User or Regulatory    Address, Phone, FAX, E-mail,
                                                                   Activity                 or Internet)
----------------------------------------------------------------------------------------------------------------
Aerosol Steroid Product Safety          January 12, 1998    Advertising            Drug Information Branch (HFD-
 Information in Prescription Drug                                                   210), CDER, Food and Drug
 Advertising and Promotional Labeling                                               Administration, 5600 Fishers
                                                                                    Lane, Rockville, MD 20857,
                                                                                    301-827-4573, or via
                                                                                    Internet at http://
                                                                                    www.fda.gov/cder/guidance/
                                                                                    index.htm
Dissemination of Reprints of Certain    October 8, 1996     Do                     Do
 Published, Original Data
Funded Dissemination of Reference       October 8, 1996     Do                     Do
 Texts

[[Page 31260]]

Consumer-Directed Broadcast             August 12, 1997     Advertising draft      Do
 Advertisements
Promoting Medical Products in a         January 5, 1998     Do                     Do
 Changing Healthcare Environment;
 Medical Product Promotion by
 Healthcare Organizations or Pharmacy
 Benefits Management Companies (PBMs)
Alprazolam Tablets In Vivo              November 27, 1992   Biopharmaceutic        Do
 Bioequivalence and In Vitro
 Dissolution Testing
Bioavailability Policies and                                Do                     Do
 Guidelines
Bumetanide Tablets In Vivo              April 23, 1993      Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Buspirone Hydrochloride Tablets In      May 15, 1998        Do                     Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
Captopril Tablets In Vivo               May 13, 1993        Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Carbidopa and Levodopa Tablets In Vivo  June 19, 1992       Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Cefactor Capsules and Suspension In     April 23, 1993      Do                     Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
Cholestyramine Powder In Vitro          July 15, 1993       Do                     Do
 Bioequivalence
Cimetidine Tablets In Vivo              June 12, 1992       Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Clozapine (Tablets) In Vivo             November 15, 1996   Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Corticosteroids, Dermatologic           June 2, 1995        Do                     Do
 (topical) In Vivo
Diclofenac Sodium (tablets) In Vivo     October 6, 1994     Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Diflunisal Tablets In Vivo              May 16, 1992        Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Diltiazen Hydrochloride Tablets In      May 16, 1992        Do                     Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
Dissolution Testing of Immediate        August 25, 1997     Do                     Do
 Release Solid Oral Dosage Forms
Extended Release Oral Dosage Forms:     September 26, 1997  Do                     Do
 Development, Evaluation, and
 Application of In Vitro/In Vivo
 Correlations
Flurbiprofen (tablets) In Vivo          June 8, 1995        Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Gemfibrozil Capsules or Tablets In      June 15, 1992       Do                     Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
Glipizide (Tablets) In Vivo             April 23, 1993      Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Guanabenz Acetate Tablets In Vivo       April 23, 1993      Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Hydroxchloroquine Sulfate (tablets) In  December 28, 1995   Do                     Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
Indapamide (tablets) In Vivo            April 23, 1993      Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Ketoprofen (capsules) In Vivo           April 23, 1993      Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Leucovorin Calcium (tablets) In Vivo    August 4, 1988      Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Medroxyprogesterone Acetate (tablets)   September 17, 1987  Do                     Do
 In Vivo Bioequivalence and In Vitro
 Dissolution Testing
Metaproferenol Sulfate and Albuterol    June 27, 1989       Do                     Do
 Metered Dose Inhalers In Vitro
Metoprolol Tartrate (tablets) In Vivo   June 12, 1992       Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Nadolol (tablets) In Vivo               May 16, 1992        Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Naproxen (tablets) In Vivo              June 8, 1995        Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Nortriptyline Hydrochloride (capsules)  June 12, 1992       Do                     Do
 In Vivo Bioequivalence and In Vitro
 Dissolution Testing
Oral Extended (controlled) Release In   September 9, 1993   Do                     Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
Pentoxifyline (extended-release         December 22, 1995   Do                     Do
 tablets) In Vivo Bioequivalence and
 In Vitro Dissolution Testing
Phenytoin/Phenytoin Sodium (capsules,   March 4, 1994       Do                     Do
 tablets, suspension) In Vivo
 Bioequivalence and In Vitro
 Dissolution Testing

[[Page 31261]]

Pindolol (tablets) In Vivo              April 23, 1993      Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Piroxicam (capsules) In Vivo            June 15, 1992       Do                     Do
 Bioequivalence and In Vitro
 Dissolution Testing
Potassium Chloride (slow-release        June 6, 1994        Do                     Do
 tablets and capsules) In Vivo
 Bioequivalence and In Vitro
 Dissolution Testing
Rantidine Hydrochloride (tablets) In    April 23, 1993      Do                     Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
Selegiline Hydrochloride (tablets) In   December 22, 1995   Do                     Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
Statistical Procedure for               July 1, 1992        Do                     Do
 Bioequivalence Studies Using a
 Standard Two-Treatment Crossover
 Design
Trazodone Hydrochloride (tablets) In    April 30, 1988      Do                     Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
Antifungal (topical)                    February 24, 1990   Biopharmaceutic draft  Do
Antifungal (vaginal)                    February 24, 1990   Do                     Do
Bioanalytical Methods Validations for   January 5, 1999     Do                     Do
 Human Studies
Food-Effect Bioavailability and         December 30, 1997   Do                     Do
 Bioequivalence Studies
In Vivo Bioequivalence Studies Based    December 30, 1997   Do                     Do
 on Population and Individual
 Bioequivalence Approaches
Topical Dermatological Drug Product     June 18, 1998       Do                     Do
 NDAs and ANDAs--In Vivo
 Bioavailability, Bioequivalence, In
 Vitro Release and Associated Studies
Waiver Policy                           March 29, 1993      Do                     Do
Glyburide Tablets In Vivo               April 23, 1993      Biopharmaceutic        Do
 Bioequivalence and In Vitro                                 testing
 Dissolution Testing
Drug Master Files                       September 1, 1989   Chemistry              Do
Environmental Assessment of Human       July 27, 1998       Do                     Do
 Drugs and Biologics Applications
FDA's Policy Statement for the          May 1, 1992         Do                     Do
 Development of New Stereoisomeric
 Drugs
Format and Content for the CMC Section  September 1, 1994   Do                     Do
 of an Annual Report
Format and Content of the Chemistry,    February 1, 1987    Do                     Do
 Manufacturing and Controls Section of
 an Application
Format and Content of the Microbiology  February 1, 1987    Do                     Do
 Section of an Application
PAC-ALTS: Postapproval Changes--        April 28, 1998      Do                     Do
 Analytical Testing Laboratory Sites
Reviewer Guidance: Validation of        November 1, 1994    Do                     Do
 Chromatographic Methods
Submission of Chemistry, Manufacturing  November 1, 1994    Do                     Do
 and Controls Information for
 Synthetic Peptide Substances
Submission of Documentation for         November 1, 1994    Do                     Do
 Sterilization Process Validation
 Applications for Human and Veterinary
 Drug Products
Submitting Documentation for Packaging  February 1, 1987    Do                     Do
 for Human Drugs and Biologics
Submitting Documentation for the        February 1, 1987    Do                     Do
 Manufacturing of and Controls for
 Drug Products
Submitting Documentation for the        February 1, 1987    Do                     Do
 Stability of Human Drugs and
 Biologics
Submitting Supporting Documentation in  February 1, 1987    Do                     Do
 Testing Drug Applications for the
 Manufacture of Drug Substances
Submitting Samples and Analytical Data  February 1, 1987    Do                     Do
 for Methods Validation
SUPAC-IR--Immediate-Release Solid Oral  November 30, 1995   Do                     Do
 Dosage Forms: Scale-Up and Post-
 Approval Changes: Chemistry,
 Manufacturing and Controls, In Vitro
 Dissolution Testing and In Vivo
 Bioequivalence Documentation
SUPAC-IR: Immediate Release Solid Oral  October 21, 1997    Do                     Do
 Dosage Forms; Manufacturing Equipment
 Addendum
SUPAC-IR Questions and Answers          February 18, 1997   Do                     Do

[[Page 31262]]

SUPAC-MR: Modified Release Solid Oral   October 6, 1997     Do                     Do
 Dosage Forms: Scale-Up and
 Postapproval Changes: Chemistry,
 Manufacturing, and Controls, In Vitro
 Dissolution Testing, and In Vivo
 Bioequivalence Documentation
SUPAC-SS--Nonsterile Semisolid Dosage   June 13, 1997       Do                     Do
 Forms; Scale-Up and Postapproval
 Changes: Chemistry, Manufacturing,
 and Controls; In Vitro Release
 Testing and In Vivo Bioequivalence
 Documentation
BACPAC I: Intermediates in Drug         November 30, 1998   Chemistry draft        Do
 Substance Synthesis (Bulk Actives
 Postapproval Changes: Chemistry,
 Manufacturing, and Controls
 Documentation)
Content and Format of Investigational   December 10, 1997   Do                     Do
 New Drug Applications (INDs) for
 Phases 2 and 3 Studies of Drugs,
 Including Specific Therapeutic
 Biotechnology-Derived Products--
 Preliminary Draft
Metered Dose Inhalers (MDI) and Dry     November 19, 1998   Do                     Do
 Powder Inhalers (DPI) Drug Products;
 Chemistry, Manufacturing, and
 Controls Documentation
NDAs: Impurities in Drug Substances     January 21, 1999    Do                     Do
Stability Testing of Drug Substances    June 8, 1998        Do                     Do
 and Drug Products
Submission of Documentation in Drug     July 15, 1997       Do                     Do
 Applications for Container Closure
 Systems Used for the Packaging of
 Human Drugs and Biologics
Submitting Supporting Chemistry         November 1, 1991    Do                     Do
 Documentation in Radiopharmaceutical
 Drug Applications
SUPAC-IR/MR: Immediate Release and      April 28, 1998      Do                     Do
 Modified Release Solid Oral Dosage
 Forms, Manufacturing Equipment
 Addendum
SUPAC-SS: Nonsterile Semisolid Dosage   January 5, 1999     Do                     Do
 Forms
Tracking of NDA and ANDA                                    Do                     Do
 Reformulations for Solid, Oral,
 Immediate Release Drug Products
Acute Bacterial Exacerbation of         July 22, 1998       Clinical               Do
 Chronic Bronchitis; Developing                              antimicrobial draft
 Antimicrobial Drugs for Treatment
Acute Bacterial Meningitis; Developing  July 22, 1998       Do                     Do
 Antimicrobial Drugs for Treatment
Acute Bacterial Sinusitis; Developing   July 22, 1998       Do                     Do
 Antimicrobial Drugs for Treatment
Acute or Chronic Bacterial              July 22, 1998       Do                     Do
 Prostatitis; Developing Antimicrobial
 Drugs for Treatment
Acute Otitis Media; Developing          July 22, 1998       Do                     Do
 Antimicrobial Drugs for Treatment
Bacterial Vaginosis; Developing         July 22, 1998       Do                     Do
 Antimicrobial Drugs for Treatment
Community Acquired Pneumonia;           July 22, 1998       Do                     Do
 Developing Antimicrobial Drugs for
 Treatment
Complicated Urinary Tract Infections    July 22, 1998       Do                     Do
 and Pylonephritis; Developing
 Antimicrobial Drugs for Treatment
Empiric Therapy of Febrile              July 22, 1998       Do                     Do
 Neutropenia; Developing Antimicrobial
 Drugs for Treatment
General Considerations for Clinical     July 22, 1998       Do                     Do
 Trials; Developing Antimicrobial
 Drugs for Treatment
Lyme Disease; Developing Antimicrobial  July 22, 1998       Do                     Do
 Drugs for Treatment
Nosocomial Pneumonia; Developing        July 22, 1998       Do                     Do
 Antimicrobial Drugs for Treatment
Secondary Bacterial Infections of       July 22, 1998       Do                     Do
 Acute Bronchitis; Developing
 Antimicrobial Drugs for Treatment
Streptococcal Pharyngitis and           July 22, 1998       Do                     Do
 Tonsillitis; Developing Antimicrobial
 Drugs for Treatment
Uncomplicated Gonorrhea--Cervical,      July 22, 1998       Do                     Do
 Urethral, Rectal, and/or Pharyngeal;
 Developing Antimicrobial Drugs for
 Treatment
Uncomplicated Urinary Tract             July 22, 1998       Do                     Do
 Infections; Developing Antimicrobial
 Drugs for Treatment

[[Page 31263]]

Uncomplicated and Complicated Skin and  July 22, 1998       Do                     Do
 Skin Structure Infections; Developing
 Antimicrobial Drugs for Treatment
Vuvlovaginal Candidiasis; Developing    July 22, 1998       Do                     Do
 Antimicrobial Drugs for Treatment
Clinical Evaluation of Antidepressant   September 1, 1977   Clinical medical       Do
 Drugs
Clinical Evaluation of Antidiarrheal    September 1, 1977   Do                     Do
 Drugs
Clinical Evaluation of Antiepileptic    January 1, 1981     Do                     Do
 Drugs (adults and children)
Clinical Evaluation of Combination      March 20, 1995      Do                     Do
 Estrogen/Progestin-Containing Drug
 Products Used for Hormone Replacement
 Therapy of Postmenopausal Women
Clinical Evaluation of                  October 1, 1981     Do                     Do
 Radiopharmaceutical Drugs
Clinical Evaluation of Analgesic Drugs  December 1, 1992    Do                     Do
Clinical Evaluation of Antacid Drugs    April 1, 1978       Do                     Do
Clinical Evaluation of Anti-            April 1, 1988       Do                     Do
 Inflammatory and Antirheumatic Drugs
 (adults and children)
Clinical Evaluation of Anti-Anxiety     September 1, 1977   Do                     Do
 Drugs
Clinical Evaluation of Anti-Infective   September 1, 1977   Do                     Do
 Drugs (Systemic)
Clinical Evaluation of Drugs to         November 1, 1978    Do                     Do
 Prevent, Control and/or Treat
 Periodontal Disease
Clinical Evaluation of Gastric          September 1, 1977   Do                     Do
 Secretory Depressant (GSD) Drugs
Clinical Evaluation of General          May 1, 1982         Do                     Do
 Anesthetics
Clinical Evaluation of Hypnotic Drugs   September 1, 1977   Do                     Do
Clinical Evaluation of Laxative Drugs   April 1, 1978       Do                     Do
Clinical Evaluation of Local            May 1, 1982         Do                     Do
 Anesthetics
Clinical Evaluation of Psychoactive     July 1, 1979        Do                     Do
 Drugs in Infants and Children
Content and Format for Pediatric Use    May 24, 1996        Do                     Do
 Supplements
Content and Format of Investigational   November 20, 1995   Do                     Do
 New Drug Applications (INDs) for
 Phase 1 Studies of Drugs, Including
 Well-Characterized, Therapeutic,
 Biotechnology-Derived Products
Development of Vaginal Contraceptive    April 19, 1995      Do                     Do
 Drugs (NDA)
FDA Approval of New Cancer Treatment    February 2, 1999    Do                     Do
 Uses for Marketed Drug and Biological
 Products
FDA Requirements for Approval of Drugs  June 20, 1989       Do                     Do
 to Treat Superficial Bladder Cancer
FDA Requirements for Approval of Drugs  January 29, 1991    Do                     Do
 to Treat Non-Small Cell Lung 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   February 1, 1987    Do                     Do
 New Drug and Antibiotic Applications
Formatting, Assembling and Submitting   February 1, 1987    Do                     Do
 New Drug and Antibiotic Applications
General Considerations for the          September 1, 1977   Do                     Do
 Clinical Evaluation of Drugs in
 Infants and Children
General Considerations for the          December 1, 1978    Do                     Do
 Clinical Evaluation of Drugs
Oncologic Drugs Advisory Committee      April 13, 1988      Do                     Do
 Discussion on FDA Requirements for
 Approval of New Drugs for Treatment
 of Ovarian Cancer
Oncologic Drugs Advisory Committee      April 19, 1988      Do                     Do
 Discussion on FDA Requirements for
 Approval of New Drugs for Treatment
 of Colon and Rectal Cancer
OTC Treatment of Hypercholesterolemia   October 27, 1997    Do                     Do
Points to Consider: Clinical            September 19, 1994  Do                     Do
 Development Programs for MDI and DPI
 Drug Products
Points to Consider in the Clinical      October 26, 1992    Do                     Do
 Development and Labeling of Anti-
 Infective Drug Products
Points to Consider in the Preclinical   May 1, 1993         Do                     Do
 Development of Immunomodulatory Drugs
 for the Treatment of HIV Infection
 and Associated Disorders
Points to Consider in the Preclinical   November 1, 1990    Do                     Do
 Development of Antiviral Drugs

[[Page 31264]]

Postmarketing Adverse Experience        August 27, 1997     Do                     Do
 Reporting for Human Drugs and
 Licensed Biological Products;
 Clarification of What to Report
Postmarketing Reporting of Adverse      March 1, 1992       Do                     Do
 Drug Experiences
Preparation of Investigational New      November 1, 1992    Do                     Do
 Drug Products (Human and Animal)
Providing Clinical Evidence of          May 15, 1998        Do                     Do
 Effectiveness for Human Drug and
 Biological Products
Study and Evaluation of Gender          July 22, 1993       Do                     Do
 Differences in the Clinical
 Evaluation of Drugs
Study of Drugs Likely to be Used in     November 1, 1989    Do                     Do
 the Elderly
Abuse Liability Assessment              July 1, 1990        Clinical medical       Do
                                                             draft
Clinical Development Programs for       February 18, 1998   Do                     Do
 Drugs, Devices, and Biological
 Products Intended for the Treatment
 of Osteoarthritis (OA)
Clinical Development Programs for       March 18, 1998      Do                     Do
 Drugs, Devices, and Biological
 Products for the Treatment of
 Rheumatoid Arthritis (RA)
Clinical Evaluation of                  May 1, 1988         Do                     Do
 Antihypertensive Drugs
Clinical Evaluation of Anti-Anginal     January 1, 1989     Do                     Do
 Drugs
Clinical Evaluation of Anti-Arrhythmic  July 1, 1985        Do                     Do
 Drugs
Clinical Evaluation of Drugs for the    December 1, 1987    Do                     Do
 Treatment of Congestive Heart Failure
Clinical Evaluation of Drugs for                            Do                     Do
 Ulcerative Colitis (3rd draft)
Clinical Evaluation of Lipid-Altering   September 1, 1990   Do                     Do
 Agents in Adults and Children
Clinical Evaluation of Motility-                            Do                     Do
 Modifying Drugs
Clinical Evaluation of Weight-Control   October 1, 1997     Do                     Do
 Drugs
Conducting a Clinical Safety Review of  November 22, 1996   Do                     Do
 a New Product Application and
 Preparing a Report on the Review
Developing Medical Imaging Drugs and    October 13, 1998    Do                     Do
 Biologics
Development and Evaluation of Drugs     February 12, 1992   Do                     Do
 for the Treatment of Psychoactive
 Substance Use Disorders
Evaluating Clinical Studies of          February 18, 1997   Do                     Do
 Antimicrobials in the Division of
 Anti-Infective Drug Products
Points to Consider for System                               Do                     Do
 Inflammatory Response Syndrome (SIRS)
 1st Draft
Points to Consider in the Preparation   September 1, 1991   Do                     Do
 of IND Applications for New Drugs
 Intended for the Treatment of HIV-
 Infected Individuals
Preclinical and Clinical Evaluation of  April 1, 1994       Do                     Do
 Agents Used in the Prevention or
 Treatment of Postmenopausal
 Osteoporosis
Submission of Abbreviated Reports and   September 21, 1998  Do                     Do
 Synopses in Support of Marketing
 Applications
Drug Metabolism/Drug Interaction        April 7, 1997       Clinical pharmacology  Do
 Studies in the Drug Development
 Process: Studies In Vitro
Format and Content of the Human         February 1, 1987    Do                     Do
 Pharmacokinetics and Bioavailability
 Section of an Application
Pharmacokinetics and Pharmacodynamics   May 15, 1998        Do                     Do
 in Patients with Impaired Renal
 Function: Study Design, Data
 Analysis, and Impact on Dosing and
 Labeling
Population Pharmacokinetics             February 10, 1999   Do                     Do
General Considerations for Pediatric    November 30, 1998   Clinical pharmacology  o
 Pharmacokinetic Studies for Drugs and                       draft
 Biological Products
In Vivo Metabolism/Drug Interaction     November 19, 1998   Do                     Do
 Studies--Study Design, Data Analysis,
 and Recommendations for Dosing and
 Labeling
A Review of FDA's Implementation of                         Compliance             Do
 the Drug Export Amendments of 1986
Compressed Medical Gases                December 1, 1989    Do                     Do
Expiration Dating and Stability         June 27, 1997       Do                     Do
 Testing of Solid Oral Dosage Form
 Drugs Containing Iron
General Principles of Process           May 1, 1987         Do                     Do
 Validation

[[Page 31265]]

Good Laboratory Practice Regulations                        Do                     Do
 Questions and Answers
Monitoring of Clinical Investigations   January 1, 1988     Do                     Do
Nuclear Pharmacy Guideline Criteria     May 1, 1984         Do                     Do
 for Determining When to Register as a
 Drug Establishment
Sterile Drug Products Produced by       May 1, 1987         Do                     Do
 Aseptic Processing
Validation of Limulus Amebocyte Lysate  December 1, 1987    Do                     Do
 Test as an End-Product Endotoxin Test
 for Human and Animal Parenteral
 Drugs, Biological Products, and
 Medical Devices
Computerized Systems Used in Clinical   June 18, 1997       Compliance draft       Do
 Trials
Investigating Out of Specification      September 30, 1998  Do                     Do
 (OOS) Test Results for Pharmaceutical
 Production
Manufacture, Processing or Holding of   April 17, 1998      Do                     Do
 Active Pharmaceutical Ingredients
Repackaging of Solid Oral Dosage Form   February 1, 1992    Do                     Do
 Drug Products
ANDAs: Impurities in Drug Products      January 5, 1999     Generic drug draft     Do
ANDAs: Impurities in Drug Substances    July 24, 1998       Do                     Do
Content and Format of an Abbreviated    April 18, 1997      Do                     Do
 New Drug Application (ANDA)--Positron
 Emission Tomography (PET) Drug
 Products--With Specific Information
 for ANDAs for Fludeoxyglucose F18
 Injection
Letter announcing that the OGD will     August 18, 1995     Generic drug           Do
 now accept the ICH long-term storage
 conditions as well as the stability
 studies conducted in the past
Letter describing efforts of CDER &     October 14, 1994    Do                     Do
 ORA to clarify the responsibilities
 of CDER chemistry review scientists
 and ORA field investigators in the
 new and abbreviated drug approval
 process in order to reduce
 duplication or redundancy in the
 process
Letter on incomplete Abbreviated        April 8, 1994       Do                     Do
 Applications, Convictions under GDEA,
 Multiple Supplements, Annual Reports
 for Bulk Antibiotics, Batch Size for
 Transdermal Drugs, Bioequivalence
 Protocols, Research, Deviations from
 OGD Policy
Letter on the request for cooperation   November 8, 1991    Do                     Do
 of regulated industry to improve the
 efficiency and effectiveness of the
 generic drug review process, by
 assuring the completeness and
 accuracy of required information and
 data submissions
Letter on the provision of new          July 1, 1992        Do                     Do
 information pertaining to new
 bioequivalence guidelines and refuse-
 to-file letters
Letter on the provision of new          March 15, 1989      Do                     Do
 procedures and policies affecting the
 generic drug review process
Letter on the response to 12/20/84      March 26, 1985      Do                     Do
 letter from the Pharmaceutical
 Manufacturers Association about the
 Drug Price Competition and Patent
 Term Restoration Act
Letter to all ANDA and AADA applicants  January 15, 1993    Do                     Do
 about the Generic Drug Enforcement
 Act of 1992 (GDEA), and the Office of
 Generic Drugs intention to refuse-to-
 file incomplete submissions as
 required by the new law
Letter to regulated industry notifying  August 4, 1993      Do                     Do
 interested parties about important
 detailed information regarding
 labeling scale-up, packaging, minor/
 major amendment criteria, and
 bioequivalence requirements
Organization of an Abbreviated New      April 7, 1997       Do                     Do
 Drug Application and an Abbreviated
 Antibiotic Application
Variations in Drug Products that May    January 27, 1999    Do                     Do
 Be Included in a Single ANDA
E5 Ethnic Factors in the Acceptability  June 10, 1998       ICH draft guidances    Do
 of Foreign Clinical Data                                    efficacy

[[Page 31266]]

Q6A Specifications: Test Procedures     November 25, 1997   ICH draft guidances--  Do
 and Acceptance Criteria for New Drug                        quality
 Substances and New Drug Products:
 Chemical Substances
Q6B Specifications: Test Procedures     June 9, 1998        Do                     Do
 and Acceptance Criteria for
 Biotechnological/Biological Products
S4A Duration of Chronic Toxicity        November 18, 1997   ICH draft guidances    Do
 Testing in Animals (Rodent and                              safety
 Nonrodent Toxicity Testing)
E1A The Extent of Population Exposure   March 1, 1995       ICH guidances--        Do
 to Assess Clinical Safety: for Drugs                        efficacy
 Intended for Long-Term Treatment of
 Non-Life-Threatening Conditions
E2A Clinical Safety Data Management:    March 1, 1995       Do                     Do
 Definitions and Standards for
 Expedited Reporting
E2B Data Elements for Transmission of   January 15, 1998    Do                     Do
 Individual Case Reports
E2C Clinical Safety Data Management:    May 19, 1997        Do                     Do
 Periodic Safety Update Reports for
 Marketed Drugs
E4 Dose-Response Information to         November 9, 1994    Do                     Do
 Support Drug Registration
E6 Good Clinical Practice:              May 9, 1997         Do                     Do
 Consolidated Guideline
E7 Studies in Support of Special        August 2, 1994      Do                     Do
 Populations: Geriatrics
E8 General Considerations for Clinical  December 24, 1997   Do                     Do
 Trials
E9 Statistical Principles for Clinical  September 16, 1998  Do                     Do
 Trials
M3 Nonclinical Safety Studies for the   November 25, 1997   ICH guidances--joint   Do
 Conduct of Human Clinical Trials for                        safety/efficacy
 Pharmaceuticals                                             (multidisciplinary)
Q1A Stability Testing of New Drug       September 22, 1994  ICH guidances--        Do
 Substances and Products                                     quality
Q1B Photostability Testing of New Drug  May 16, 1997        Do                     Do
 Substances and Products
Q1C Stability Testing for New Dosage    May 9, 1997         Do                     Do
 Forms
Q2A Text on Validation of Analytical    March 1, 1995       Do                     Do
 Procedures
Q2B Validation of Analytical            May 19, 1997        Do                     Do
 Procedures: Methodology
Q3A Impurities in New Drug Substances   January 4, 1996     Do                     Do
Q3B Impurities in New Drug Products     May 19, 1997        Do                     Do
Q3C Impurities: Residual Solvents       December 24, 1997   Do                     Do
Q5A Biotechnological/Biological         September 24, 1998  Do                     Do
 Pharmaceutical Products, Viral Safety
 Evaluation
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
Q5C Quality of Biotechnological         July 10, 1996       Do                     Do
 Products: Stability Testing of
 Biotechnology/Biological Products
Q5D Quality of Biotechnological/        September 21, 1998  Do                     Do
 Biological Products: Derivation and
 Characterization of Cell Substrates
 Used for Production of
 Biotechnological/Biological Products
S1A The Need for Long-Term Rodent       March 1, 1996       ICH guidances--safety  Do
 Carcinogenicity Studies of
 Pharmaceuticals
S1B Testing for Carcinogenicity in      February 23, 1998   Do                     Do
 Pharmaceuticals
S1C Dose Selection for Carcinogenicity  March 1, 1995       Do                     Do
 Studies of Pharmaceuticals
S1C(R) Dose Selection for               December 4, 1997    Do                     Do
 Carcinogenicity 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      November 21, 1997   Do                     Do
 Testing
S3A Toxicokinetics: The Assessment of   March 1, 1995       Do                     Do
 Systemic Exposure in Toxicity Studies
S3B Pharmacokinetics: Guidance for      March 1, 1995       Do                     Do
 Repeated Dose Tissue Distribution
 Studies
S5A Detection of Toxicity to            September 22, 1994  Do                     Do
 Reproduction for Medicinal Products
S5B Detection of Toxicity to            April 5, 1996       Do                     Do
 Reproduction for Medicinal Products:
 Addendum on Toxicity to Male
 Fertility

[[Page 31267]]

S6 Preclinical Safety Evaluation of     November 18, 1997   Do                     Do
 Biotechnology-Derived Pharmaceuticals
E3 Structure and Content of Clinical    July 17, 1996       IHC guidances--        Do
 Study Reports                                               efficacy
A Revision in Sample Collection Under   July 15, 1996       Industry letters       Do
 the Compliance Program Pertaining to
 Pre-Approval Inspections
Certification Requirements for          July 27, 1992       Do                     Do
 Debarred Individuals in Drug
 Applications
Continuation of a series of letters     June 1, 1990        Do                     Do
 communicating interim and informal
 generic drug policy and guidance.
 Availability of Policy and Procedure
 Guides, and further operational
 changes to the generic drug review
 program
Fifth of a series of letters providing  April 10, 1987      Do                     Do
 informal notice about the Act,
 discussing the statutory mechanisms
 by which ANDA applicants may make
 modifications in approved drugs where
 clinical data is required
Fourth of a series of letters           October 31, 1986    Do                     Do
 providing informal notice to all
 affected parties about policy
 developments and interpretations
 regarding the Act. Three year
 exclusivity provisions of Title I
Implementation of the Drug Price        October 11, 1984    Do                     Do
 Competition and Patent Term
 Restoration Act. Preliminary Guidance
Implementation Plan USP injection       October 2, 1995     Do                     Do
 nomenclature
Instructions for Filing Supplements     April 11, 1996      Do                     Do
 Under the Provisions of SUPAC-IR
Seventh of a series of letters about    July 29, 1988       Do                     Do
 the act providing guidance on the
 ``180-day exclusivity'' provision of
 section 505(j)(4)(B)(iv) of the FD&C
 Act
Sixth of a series of informal notice    April 28, 1988      Do                     Do
 letters about the Act discussing the
 3- and 5-year exclusivity provisions
 of sections 505(c)(3)(d) and
 505(j)(4)(D) of the FD&C Act
Streamlining Initiatives                December 24, 1996   Do                     Do
Supplement to 10/11/84 letter about     November 16, 1984   Do                     Do
 policies, procedures and
 implementation of the Act (Q & A
 format)
Third of a series of letters regarding  May 1, 1985         Do                     Do
 the implementation of the Act
Regulatory Submissions in Electronic    January 28, 1999    Information            Do
 Format; General Considerations                              technology
Regulatory Submissions in Electronic    January 28, 1999    Do                     Do
 Format; New Drug Applications
Acetaminophen, Aspirin and Codeine      December 1, 1993    Labeling               Do
 Phosphate Tablets/Capsules
Acetaminophen and Codeine Phosphate     December 1, 1993    Do                     Do
 Oral Solution/Suspension
Acetaminophen and Codeine Phosphate     December 1, 1993    Do                     Do
 Tablets/Capsules
Alprazolam Tablets USP                  August 1, 1996      Do                     Do
Amiloride Hydrochloride and             September 1, 1997   Do                     Do
 Hydrochlorothiazide 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
Barbituate, Single Entity-Class         March 1, 1981       Do                     Do
 Labeling
Butalbital, Acetaminophen, Caffeine     September 21, 1997  Do                     Do
 and Hydocodone Bitartrate Tablets
Butalbital, Acetaminophen and Caffeine  September 1, 1997   Do                     Do
 Capsules/Tablets USP
Butorphanol Tartrate Injection USP      October 1, 1992     Do                     Do
Captopril and Hydrochlorothiazide       April 1, 1995       Do                     Do
 Tablets USP
Captopril Tablets                       February 1, 1995    Do                     Do
Carbidopa and Levodopa Tablets USP      February 1, 1992    Do                     Do
Chlordiazepoxide Hydrochloride          January 1, 1988     Do                     Do
 Capsules
Cimetidine Hydrochloride Injection      September 1, 1995   Do                     Do
Cimetidine Tablets                      September 1, 1995   Do                     Do
Cisapride Oral Suspension               September 1, 1997   Do                     Do

[[Page 31268]]

Cisapride Tablets                       September 1, 1997   Do                     Do
Clindamycin Phosphate Injection USP     September 1, 1998   Do                     Do
Clorazepate Dipotassium Capsules/       March 1, 1993       Do                     Do
 Tablets
Combination Oral Contraceptives--       January 1, 1994     Do                     Do
 Physician and Patient Labeling
Cyproheptadine Hydrochloride Tablets/   December 1, 1986    Do                     Do
 Syrup
Diclofenac Sodium Delayed-Release       January 1, 1997     Do                     Do
 Tablets
Diltiazem Hydrochloride Extended-       September 1, 1995   Do                     Do
 Release Capsules
Diphenoxylate Hydrochloride and         April 1, 1995       Do                     Do
 Atropine Sulphate Tablets USP
Diphenoxylate Hydrochloride and         April 1, 1995       Do                     Do
 Atropine Sulfate Oral Solution USP
Dipivefrin Hydrochloride Ophthalmic     October 1, 1998     Do                     Do
 Solution USP
Dipivefrin Hydrochloride Ophthalmic     November 2, 1998    Do                     Do
 Solution, 0.1%
Ergoloid Mesylates Tablets              January 1, 1988     Do                     Do
Fludeoxyglucose F18 Injection           January 1, 1997     Do                     Do
Flurbiprofen Tablets USP                January 1, 1994     Do                     Do
Fluvoxamine Maleate Tablets             September 1, 1997   Do                     Do
Gentamicin Sulfate Ophthalmic Ointment  April 1, 1992       Do                     Do
 and Solution USP
Heparin Sodium Injection USP            March 1, 1991       Do                     Do
Hydrocodone Bitartrate and              April 1, 1994       Do                     Do
 Acetaminophen Tablets USP
Hydroxyzine Hydrochloride Injection     December 1, 1989    Do                     Do
Hypoglycemic Oral Agents--Federal       April 1, 1984       Do                     Do
 Register
Indomethacin Capsules USP               September 1, 1995   Do                     Do
Informal Labeling Guidance Texts for    August 1, 1992      Do                     Do
 Estrogen Drug Products--Patient
 Labeling
Informal Labeling Guidance Texts for    August 1, 1992      Do                     Do
 Estrogen Drug Products--Professional
 Labeling
Isoetharine Inhalation Solution         March 1, 1989       Do                     Do
Itraconazole Capsules, USP              September 1, 1998   Do                     Do
Leucovorin Calcium for Injection        July 1, 1996        Do                     Do
Leucovorin Calcium Tablets, USP         July 1, 1996        Do                     Do
Local Anesthetics--Class Labeling       September 1, 1982   Do                     Do
Meclofenamate Sodium Capsules           July 1, 1992        Do                     Do
Medroxyprogesterone Acetate Tablets,    September 1, 1998   Do                     Do
 USP
Metaproterenol Sulfate Inhalation       May 1, 1992         Do                     Do
 Solution USP
Metaproterenol Sulfate Syrup, USP       May 1, 1992         Do                     Do
Metaproterenol Sulfate Tablets          May 1, 1992         Do                     Do
Metoclopramide Tablets/ Oral Solution,  February 1, 1995    Do                     Do
 USP
Naphazoline Hydrochloride Ophthalmic    March 1, 1989       Do                     Do
 Solution
Naproxen Sodium Tablets, USP            September 1, 1997   Do                     Do
Naproxen Tablets, USP                   September 1, 1997   Do                     Do
Niacin Tablets                          July 1, 1992        Do                     Do
Paclitaxel Injection                    September 1, 1997   Do                     Do
Phendimetrazine Tartrate Capsules/      February 1, 1991    Do                     Do
 Tablets, and Extended-Release
 Capsules
Phentermine Hydrochloride Capsules/     August 1, 1988      Do                     Do
 Tablets
Promethazine Hydrochloride Tablets      March 1, 1990       Do                     Do
Propantheline Bromide Tablets           August 1, 1988      Do                     Do
Pyridoxine Hydrochloride Injection      June 1, 1984        Do                     Do
Quinidine Sulfate Tablets/Capsules USP  October 1, 1995     Do                     Do
Ranitidine Tablets                      November 1, 1993    Do                     Do
Risperidone Oral Solution               September 1, 1997   Do                     Do
Risperidone Tablets                     September 1, 1997   Do                     Do
Sulfacetamide Sodium Ophthalmic         August 1, 1992      Do                     Do
 Solution/Ointment
Sulfacetamide Sodium and Prednisolone   January 1, 1995     Do                     Do
 Acetate Ophthalmic Suspension and
 Ointment
Sulfamethoxazole and Phenazopyridine    February 1, 1992    Do                     Do
 Hydrochloride Tablets
Sulfamethoxazole and Trimethoprim       August 1, 1993      Do                     Do
 Tablets and Oral Suspension
Theophylline Immediate-Release Dosage   February 1, 1995    Do                     Do
 Forms
Theophylline Intravenous Dosage Forms   September 1, 1995   Do                     Do
Thiamine Hydrochloride Injection        February 1, 1988    Do                     Do
Tobramycin Sulfate Injection USP        May 1, 1993         Do                     Do
Venlafaxine Hydrochloride Tablets       October 1, 1997     Do                     Do

[[Page 31269]]

Verapamil Hydrochloride Tablets         October 1, 1991     Do                     Do
Vitamin A Capsules                      February 1, 1992    Do                     Do
Zolpidem Tartrate Tablets               September 1, 1997   Do                     Do
Content and Format for Geriatric        January 21, 1999    Labeling draft         Do
 Labeling
Non-Contraceptive Estrogen Class        October 15, 1998    Do                     Do
 Labeling
Non-Contraceptive Estrogen Drug         January 8, 1999     Do                     Do
 Products--Physician and Patient
 Labeling
OTC Topical Drug Products for the       July 16, 1998       Do                     Do
 Treatment of Vaginal Yeast Infections
 (Vulvovaginal Candidiasis)
Therapeutic Equivalence Code Placement  January 28, 1999    Do                     Do
 on Prescription Drug Labels and
 Labeling
Enforcement Policy on Marketing OTC                         OTC                    Do
 Combination Products
General Guidelines for OTC Combination                      Do                     Do
 Products
Upgrading Category III Antiperspirants                      Do                     Do
 to Category I
OTC Nicotine Substitutes                March 1, 1994       OTC draft              Do
Points to Consider for OTC Actual Use   July 22, 1994       Do                     Do
 Studies
Format and Content of the Nonclinical   February 1, 1987    Pharmacology/          Do
 Pharmacology/Toxicology Section of an                       toxicology
 Application
Points to Consider in the Nonclinical                       Do                     Do
 Pharmacology/Toxicology Development
 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     February 1, 1989    Do                     Do
 Toxicity Studies of Antiviral Drugs
 Indicated for the Treatment of Non-
 Life Threatening Disease: Evaluation
 of Drug Toxicity Prior to Phase I
 Clinical Studies
Single Dose Acute Toxicity Testing for  August 26, 1996     Do                     Do
 Pharmaceuticals
180-Day Generic Drug Exclusivity Under  July 14, 1998       Procedural             Do
 the Hatch-Waxman Amendments to the
 Federal Food, Drug, and Cosmetic Act
Advisory Committees: Implementing       November 2, 1998    Do                     Do
 Section 120 of the Food and Drug
 Modernization Act of 1997
Enforcement Policy During               November 23, 1998   Do                     Do
 Implementation of 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
Implementation of Section 126,          July 21, 1998       Do                     Do
 Elimination of Certain Labeling
 Requirements, of the FDA
 Modernization Act of 1997
National Uniformity for                 April 9, 1998       Do                     Do
 Nonprescription Drugs Ingredient
 Labeling for OTC Drugs
Qualifying for Pediatric Exclusivity    June 29, 1998       Do                     Do
 Under Section 505A of the Federal
 Food, Drug, and Cosmetic Act
Repeal of Section 507 of the Federal    June 15, 1998       Do                     Do
 Food, Drug, and Cosmetic Act
Standards for the Prompt Review of      May 15, 1998        Do                     Do
 Efficacy Supplements, Including
 Priority Efficacy Supplements
Submitting Debarment Certification      October 2, 1998     Procedural draft       Do
 Statements
Classifying Resubmissions in Response   May 14, 1998        User fee               Do
 to Action Letters
Submitting and Reviewing Complete       May 14, 1998        Do                     Do
 Responses to Clinical Holds
----------------------------------------------------------------------------------------------------------------

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

[[Page 31270]]

----------------------------------------------------------------------------------------------------------------
                                                                                    How to Obtain a Hard Copy of
                                                             Grouped by Intended       the Document (Name and
           Name of Document              Date of Issuance     User or Regulatory    Address, Phone, FAX, E-mail
                                                                   Activity                 or Internet)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guides Manual         1996                FDA regulated          National Technical
                                                             industries             Information Service (NTIS),
                                                                                    5285 Port Royal Rd.,
                                                                                    Springfield, VA 22161 (Order
                                                                                    No. PB96-920500)
Compliance Programs Guidance Manual     1995                Do                     NTIS (Order No. PB95-915499)
Inspection Operations Manual            October 1994        Do                     NTIS (Order No. PB95-913399)
Regulatory Procedures Manual            August 1995         Do                     NTIS (Order No. PB95-265534)
Requirements of Laws and Regulations    1997                Do                     Superintendent of Documents,
 Enforced by the U.S. Food and Drug                                                 Government Printing Office,
 Administration ``Blue Book''                                                       Washington, DC 20402
FDA Recall Policy                       1995                Do                     Industry Activities Staff
                                                                                    (HFS-565), CFSAN, Food and
                                                                                    Drug Administration, 200 C
                                                                                    St. SW., Washington, DC
                                                                                    20204
Action Levels for Poisonous or          1995                Food and animal feed   Do
 Deleterious Substances in Human Food                        industries
 and Animal Feed
Pesticides Analytical Manual            1994                Food Industry          NTIS (Order No. PB94-911899)
FDA Advisory for Deoxynivanol (DON) in  September 16, 1993  Food and animal feed   Office of Plant & Dairy Foods
 Finished Wheat Products Intended for                        industries             & Beverages (HFS-306),
 Human Consumption and in Grain and                                                 CFSAN, Food and Drug
 Grain By-Products for Animal Feed                                                  Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-205-4681
FDA's Cosmetic Labeling Manual          October 1991        Cosmetic industry      Office of Colors and
                                                                                    Cosmetics (HFS-105), Food
                                                                                    and Drug Administration, 200
                                                                                    C St. SW., Washington, DC
                                                                                    20204, 202-205-4493
Statement of Policy: Foods Derived      May 29, 1992        Developers of new      Office of Premarket Approval
 from New Plant Varieties                                    plant food varieties   (HFS-200), Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-418-3100
A Food Labeling Guide                   September 1994      Food industry          Superintendent of Documents,
                                                                                    Government Printing Office,
                                                                                    Washington, DC 20402, 202-
                                                                                    512-1800
Appendix I--Model Small Business Food   August 7, 1993      Do                     Industry Activities Staff
 Labeling Exemption Notice                                                          (HFS-565), CFSAN, Food and
                                                                                    Drug Administration, 200 C
                                                                                    St. SW., Washington, DC
                                                                                    20204, 202-205-5251
Food Labeling: Questions and Answers    August 1993         Do                     Do
Food Labeling: Questions and Answers:   August 1995         Do                     Superintendent of Documents,
 Volume II                                                                          Government Printing Office,
                                                                                    Washington, DC 20420, 202-
                                                                                    512-1800
Fair Packaging and Labeling Act         June 1978           Do                     NTIS (Order No. PB83-222117)
 Requirements and Interpretations
Bacteriological Analytical Manual 7th   1992                FDA regulated          AOAC International, 481 North
 Edition                                                     industries             Frederick Ave., suite 500,
                                                                                    Gaithersburg, MD 20877-2417,
                                                                                    301-924-7077
FDA Food Importer's Guide for Low-Acid  1995                Food industry          Industry Activities Staff
 Canned and Acidified Foods                                                         (HFS-565), CFSAN, Food and
                                                                                    Drug Administration, 200 C
                                                                                    St. SW., Washington, DC
                                                                                    20204, 202-205-5251
Fabrication of Single Service           1995                States                 Milk Safety Branch (HFS-626),
 Containers and Closures for Milk and                                               CFSAN, Food and Drug
 Milk Products                                                                      Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-205-9175
Evaluation of Milk Laboratories         1995                Do                     Do
Methods of Making Sanitation Ratings    1995                Do                     Do
 Of Milk Supplies
Dry Milk Ordinance                      1995                Do                     Do
Procedures Governing the Cooperative    1995                Dairy industry         Do
 State-Public Health Service/Food and
 Drug Administration Program for
 Certification of Interstate Milk
 Shippers
Frozen Dessert Processing Guidelines    1989                Do                     Office of Plant and Dairy
                                                                                    Foods and Beverages (HFS-
                                                                                    302), CFSAN, Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-205-9175
Pasteurized Milk Ordinance              1995                States                 Milk Safety Branch (HFS-626),
                                                                                    CFSAN, Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-205-9175

[[Page 31271]]

FDA Nutrition Labeling Manual: A Guide  1993                Food industry          Office of Food Labeling (HFS-
 for Developing and Using Databases                                                 150), Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-205-4561
Guidelines for Determining Metric       October 1, 1993     Do                     Do
 Equivalents of Household Measures
List of Food Defect Action Levels       1995                Food and Animal Feed
 (DALS)                                                      Industries Industry
                                                             Activities Staff
                                                             (HFS-565), CFSAN,
                                                             Food and Drug
                                                             Administration, 200
                                                             C St. SW.,
                                                             Washington, DC
                                                             20204, 202-205-5251
Action Levels for Poisonous or          1995                Do                     Do
 Deleterious Substances in Human Food
 and Feed (Also Found in CPG's)
1997 FDA Food Code                      1997                States                 NTIS
Seafood List                            1993                Seafood industry       Superintendent of Documents,
                                                                                    Government Printing Office,
                                                                                    Washington, DC 20402, 202-
                                                                                    512-1800
Manual of Operations National           1992                States                  Office of Seafood (HFS-407),
 Shellfish Sanitation                                                               Shellfish Sanitation Branch,
                                                                                    Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-418-3150
Fish and Fisheries Products Hazards     1996                Seafood industry       Office of Seafood (HFS-400),
 and Controls Guide                                                                 Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-418-3150
Guidance for Submitting Requests Under  1996                Food packaging         Office of Premarket Approval
 21 CFR 170.39, Threshold of                                 industry               (HFS-200), Food and Drug
 Regulation for Substances Used in                                                  Administration, 200 C St.
 Food Articles                                                                      SW., Washington, DC 20204,
                                                                                    202-418-3100
Guidelines for the Preparation of       1996                Do                     Do
 Petition Submissions
Guidelines for Approval of Color        1996                Color or contact lens  Do
 Additives in Contact Lenses Intended                        industry
 as Colors
Recommendations for Submission of       February 1993       Color additives        Do
 Chemical and Technological Data on                          industry
 Color Additives for Food, Drugs or
 Cosmetics Use
Points to Consider for the Use of       December 1992       Food packaging         Do
 Recycled Plastics in Food Packaging:                        industry
 Chemistry Considerations
Recommendations for Submission of       May 1993            Do                     Do
 Chemical and Technological Data for
 Direct Food Additive and GRAS Food
 Ingredient Petitions
Recommendations for Chemistry Data for  June 1995           Do                     Do
 Indirect Food Additive Petitions
Enzyme Preparations: Chemistry          January 1993        Food enzyme industry   Do
 Recommendations for Food Additive and
 GRAS Affirmation Petitions
Estimating Exposure to Direct Food      September 1995      Food and food          Do
 Additive and Chemical Contaminants in                       ingredient industry
 the Diet
Toxicological Principles for the        1982                Petitioners for food   NTIS (Order No. PR-83-170696)
 Safety Assessment of Direct Food                            or color additives
 Additives and Color Additives Used in
 Food (also known as Redbook I)
Environmental Assessment Technical      March 1987          Do                     NTIS (Order No. PB87-175345-
 Handbook                                                                           AS, A-01)
Preparing Environmental Assessments:    August 1990         Do                     Office of Premarket Approval
 General Suggestions                                                                (HFS-200), Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW, Washington, DC 20204,
                                                                                    202-418-3100
Step-by-Step Guidance for Preparing     March 1987          Do                     Do
 Environmental Assessments
Environmental Assessment of Food-       February 1994       Do                     Do
 Packaging Materials with Enhanced
 Degradation Characteristics
Color Additive Petitions Information    1996                Do                     Do
 and Guidance
Toxological Testing of Food Additives   1983                Do                     Do

[[Page 31272]]

List of Products for Each Product       October 8, 1992     Food industry          Office of Food Labeling (HFS-
 Category                                                                           150), Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-205-4561
Label Declaration of Allergenic         June 10, 1996       Do                     Do
 Substances in Foods; Notice to
 Manufacturers
Guidance on Labeling of Foods that      February 24, 1997   Do                     Do
 Need Refrigeration by Consumers
Interim Guidance on the Voluntary       February 10, 1994   Do                     Do
 Labeling of Milk and Milk Products
 that Have Not Been Treated With
 Recombinant Bovine Somatropin
Guidelines Concerning Notification and  1985                Infant formula         Office of Special
 Testing of Infant Formula                                   manufacturers          Nutritionals (HFS-450), Food
                                                                                    and Drug Administration, 200
                                                                                    C St. SW, Washington, DC
                                                                                    20204 202-205-4168
Clinical Testing of Infant Formulas     1985                Do                     Do
 with Respect to Nutritional
 Suitability for Term Infants
Guidelines for the Evaluation of the    Infants with        1988                   Do
 Safety and Suitability of New Infant    Allergic Diseases
 Formulas for Feeding
Guidelines for the Evaluation of the    1990                Do                     Do
 Safety and Suitability of Infant
 Formulas for Feeding Infants with
 Allergic Diseases
Guidelines for the Clinical Evaluation  1987                Do                     Do
 of New Products Used in the Dietary
 Management of Infants, Children and
 Pregnant Women with Metabolic
 Disorders
Guidance Document for Arsenic (Trace    January 1993        States                 Office of Seafood (HFS-400),
 Elements in Seafood)                                                               Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-418-3150 or via
                                                                                    Internet: FDA Home Page
                                                                                    http://vm.cfsan.fda.gov/
                                                                                    list.html
Guidance Document for Cadmium (Trace    January 1993        Do                     Do
 Elements in Seafood)
Guidance Document for Chromium (Trace   January 1993        Do                     Do
 Elements in Seafood)
Guidance Document for Lead (Trace       August 1993         Do                     Do
 Elements in Seafood)
Guidance Document for Nickel (Trace     January 1993        Do                     Do
 Elements in Seafood)
FDA's Policy for Foods Developed by     1995                Food industry          Internet: FDA Home Page http:/
 Biotechnology                                                                      /vm.cfsan.fda.gov
Bovine Spongiform Encephalopathy (BSE)  1997                Do                     Office of Plant and Dairy
 In Products for Human Use                                                          Foods and Beverages (HFS-
                                                                                    302), CFSAN, Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-205-9175 or via
                                                                                    Internet: FDA Home Page
                                                                                    http://www.fda.gov/opacom/
                                                                                    morechoices/industry/
                                                                                    guidance/gelguide.htm
Shellfish Sanitation Model Ordinance    1995                States                 Shellfish Program
                                                                                    Implementation Branch,
                                                                                    Office of Field Programs
                                                                                    (HFS-628), Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-205-8137
Draft Working Guide to Minimize         1998                Farmers and food       Food Safety Initiative (HFS-
 Microbial Hazards for Fresh Fruits                          packers                3), Food and Drug
 and Vegetables                                                                     Administration, 200 C. St.
                                                                                    SW, Washington, DC 20204 or
                                                                                    jsaltsman@bangate.fda.gov
Iron-Containing Supplements and Drugs:  1997                Dietary supplement     Office of Special
 Label Warning and Unit Dose                                 manufacturers: small   Nutritionals (HFS-450), Food
 Packaging; Small Entity Compliance                          entities               and Drug Administration, 200
 Guide                                                                              C St. SW., Washington, DC
                                                                                    20204
Partial List of Enzyme Preparations     1998                FDA regulated          Office of Premarket Approval
 That are Used in Foods                                      industry               (HFS-200), Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204
Partial List of Microorganisms and      1998                Do                     Do
 Microbial-Derived Ingredients That
 Are Used in Food

[[Page 31273]]

Fish and Fishery Products Hazards and   January 1998        Do                     Office of Seafood (HFS-400),
 Controls Guide, 2nd Edition                                                        Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204
HACCP Regulations for Fish and Fishery  1997                Do                     Do
 Products: Questions and Answers
Notification of a Health Claim or       1998                Do                     Office of Food Labeling (HFS-
 Nutrient Content Claim Based on an                                                 150), Food and Drug
 Authoritative Statement of a                                                       Administration, 200 C St.
 Scientific Body                                                                    SW., Washington, DC 20204,
                                                                                    202-205-5099
Small Business Juice Labeling:          1998                Do                     Do
 Questions and Answers
FDA Nutrition Labeling Manual, A Guide  March 1998          Do                     Do
 for Developing and Using Data Bases
HACCP Regulation for Fish and Fishery   January 1999        Seafood processors     Office of Seafood (HFS-400),
 Products: Questions and Answers,                                                   Food and Drug
 Issue Three, Revised                                                               Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-418-3150
Foods--Adulteration Involving Hard or   February 1999       FDA field offices      Office of Plant and Dairy
 Sharp Foreign Objects (CPG)                                                        Foods and Beverages (HFS-
                                                                                    300), Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204
Food Additive Petition Expedited        January 1999        FDA personnel and      Office of Premarket Approval,
 Review                                                      regulated industry     Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-418-3074,
                                                                                    premarkt@cfsan.fda.gov OR
                                                                                    http://vm.cfsan.fda.gov/dms/
                                                                                    opa-expe.html
Use of Antibiotic Resistance Marker     September 1998      FDA regulated          Do--premarkt@cfsan.fda.gov OR
 Genes in Transgenic Plants                                  industry               http://vm.cfsan.fda.gov//dms/
                                                                                    opa-armg.html
Changes to the ``Pesticides and         December 30, 1998   FDA districts          FOI/Domestic Programs Branch
 Industrial Chemicals in Domestic                                                   (HFS-636), Office of Field
 Foods'' Compliance Program for FY 99                                               Programs, Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-205-4771
FY 99 Mycotoxin Collection and Sample   November 13, 1998   Do                     Do
 Analysis Schedule
Revisions to the EHEC Method            November 23, 1998   Do                     Do
Vibrio Vulnificus and Vibrio            June 17, 1998       Do                     Do
 parahaemolyticus in Retail Shell
 Oysters CFSAN Assignment 98-7
Revisions to Att F ``Special Survey     September 30, 1998  Do                     Do
 Obligations--Dioxins and Furans in
 Food'' of the Pesticides and
 Industrial Chemicals Domestic Food
 Compliance Program for FY99
Collection and Analyses of Physical     November 30, 1998   Do                     Do
 Sample to Support Undeclared Allergen
 Cases: NLEA and General Labeling
 Requirements; Domestic Compliance
 Program
Assignment to Assure Unpasteurized      September 21, 1998  Do                     Do
 Juice Manufacturers and Imported
 Juice Products Provide Required Label
 Warnings, Placards, and/or meet the 5
 log Pathogen Reduction Requirement
Assignment to Assure Unpasteurized      November 3, 1998    Do                     Do
 Juice Manufacturers and Imported
 Juice Products Provide Required Label
 Warnings, Placards, and/or meet the 5
 log Pathogen Reduction Requirement
Pesticides in Imported Ginseng (Field   September 17, 1998  FDA districts          FOI/Imports Branch (HFS-606),
 Assignment)                                                                        Office of Field Programs,
                                                                                    Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204
Radionuclides in Foods                  October 2, 1998     Do                     Do
Letters to Manufacturers of Prepared    August 21, 1998     Manufacturers of       Office of Field Programs (HFS-
 Sandwiches                                                  prepared sandwiches    600), Food and Drug
                                                                                    Administration, 200 C St.
                                                                                    SW., Washington, DC 20204,
                                                                                    202-205-5194 or
                                                                                    JohnThomas@OFP@FDA.CFSAN,
                                                                                    FAX 292-260-0133
----------------------------------------------------------------------------------------------------------------

[[Page 31274]]

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

----------------------------------------------------------------------------------------------------------------
                                                                                    How to Obtain a Hard Copy of
                                                             Grouped by Intended       the Document (Name and
           Name of Document              Date of Issuance     User or Regulatory    Address, Phone, FAX, E-mail
                                                                   Activity                 or Internet)
----------------------------------------------------------------------------------------------------------------
Guideline 3--General Principles for     July 1994           Animal drug industry   Internet via: http://
 Evaluating the Safety of Compounds                                                 www.fda.gov/cvm or
 Used in Food-Producing Animals                                                     Communications Staff (HFV-
                                                                                    12), CVM, Food and Drug
                                                                                    Administration, 7500
                                                                                    Standish Pl., Rockville, MD
                                                                                    20855, 301-594-1755, FAX 301-
                                                                                    594-1831
Guideline 4--Guidelines for Efficacy                        Do                     Do
 Studies for Systemic Sustained
 Release Sulfonamide Boluses for
 Cattle
Guideline 5--Stability Guidelines       December 1990       Do                     Do
Guideline 6--Guidelines for Submitting                      Do                     Do
 NADA's for Generic Drugs Reviewed by
 NAS/NRC
Guideline 9--Preclearance Guidelines    October 1975        Do                     Do
 for Production Drugs
Guideline 10--Amendment of Section      October 1975        Do                     Do
 II(G)(1)(b)(4) of the Preclearance
 Guidelines
Guideline 13--Guidelines for            January 1985        Do                     Do
 Evaluation of Effectiveness of New
 Animal Drugs for Use in Free-Choice
 Feeds
Guideline 14--Guideline and Format for                      Do                     Do
 Reporting the Details of Clinical
 Trials Using An Investigational New
 Animal Drug in FOOD Producing Animals
Guideline 15--Guideline and Format for  February 1977       Do                     Do
 Reporting the Details of Clinical
 Trials Using An Investigational New
 Animal Drug in NON-FOOD Producing
 Animals
Guideline 16--FOI Summary Guideline     May 1985            Do                     Do
Guideline 18--Antibacterial Drugs in                        Do                     Do
 Animal Feeds: Human Health Safety
 Criteria
Guideline 19--Antibacterial Drugs in                        Do                     Do
 Animal Feeds: Animal Health Safety
 Criteria
Guideline 20--Antibacterial Drugs in                        Do                     Do
 Animal Feeds: Antibacterial
 Effectiveness Criteria
Guideline 22--Guideline Labeling of                         Do                     Do
 Arecoline Base Drugs Intended for
 Animal Use
Guideline 23--Medicated Free Choice     July 1985           Do                     Do
 Feeds--Manufacturing Control
Guideline 24--Guidelines for Drug       October 1983        Do                     Do
 Combinations for Use in Animals
Guideline 25--Guidelines for the        January 1979        Do                     Do
 Efficacy Evaluation of Equine
 Anthelmintics
Guideline 29--Guidelines for the        September 1980      Do                     Do
 Effectiveness Evaluation of Swine
 Anthelmintics
Guideline 31--Guidelines for the        July 1981           Do                     Do
 Evaluation of Bovine Anthelmintics
Guideline 33--Target Animal Safety      June 1989           Do                     Do
 Guidelines for New Animal Drugs
Guideline 35--Bioequivalence            1996                Do                     Do
 Guideline--Final
Guideline 36--Guidelines for Efficacy   July 1985           Do                     Do
 Evaluation of Canine/Feline
 Anthelmintics
Guideline 37--Guidelines for            March 1984          Do                     Do
 Evaluation of Effectiveness of New
 Animal Drugs for Use in Poultry Feed
 for Pigmentation
Guideline 38--Guideline for             August 1984         Do                     Do
 Effectiveness Evaluation of Topical/
 Otic Animal Drugs
Guideline 40--Draft Guideline for the   April 1992          Do                     Do
 Evaluation of the Efficacy of
 Anticoccidial Drugs and Anticoccidial
 Drug Combinations in Poultry
Guideline 41--Draft Guideline:          June 1992           Do                     Do
 Formatting, Assembling, and
 Submitting New Animal Drug
 Applications
Guideline 42--Animal Drug               1994                Do                     Do
 Manufacturing Guidelines, 1994
Guideline 43--Guidance on Generic       October 1995        Do                     Do
 Animal Drug Products Containing
 Fermentation-Derived Drug Substances

[[Page 31275]]

Guideline 45--Guideline for Uniform     August 1993         Do                     Do
 Labeling of Drugs for Dairy and Beef
 Cattle
Guideline 48--Guidance for Industry     November 1994       Do                     Do
 for the Submission of Documentation
 for Sterilization Process Validation
 in Applications for Human and
 Veterinary Drug Products
Guideline 49--Guidance Document for     April 1996          Do                     Do
 Target Animal Safety and Drug
 Effectiveness Studies for Anti-
 Microbial Bovine Mastitis Products
Guideline 50--Draft Guideline for       February 1993       Do                     Do
 Target Animal and Human Food Safety,
 Drug Efficacy, Environmental and
 Manufacturing Studies for Teat
 Antiseptic Products
Guideline 52--Guidance--                January 1996        Do                     Do
 Microbiological Testing of
 Antimicrobial Drug Residues in Food
Guideline 53--Guideline for the         May 1994            Do                     Do
 Evaluation of the Utility of Food
 Additives in Diets Fed to Aquatic
 Animals
Guideline 54--Draft Guideline for       June 1994           Do                     Do
 Utility Studies for Anti-Salmonella
 Chemical Food Additives in Animal
 Feeds
Guideline 55--Supportive Data for Cat   June 1994           Do                     Do
 Food Labels Bearing ``Reduces Urinary
 pH Claims: Guideline in Protocol
 Development''
Guideline 56--Protocol Development      November 1994       Do                     Do
 Guideline for Clinical Effectiveness
 and Target Animal Safety Trials
Guideline 57--Master Files--Guidance    July 1995           Do                     Do
 for Industry for the Preparation and
 Submission of Veterinary Master Files
Guideline 58--Guidance for Industry     May 1997            Do                     Do
 for Good Target Animal Study
 Practices: Clinical Investigators and
 Monitors
Guideline 59--Guidance for Industry:    January 1999        Do                     Do
 Submitting a Notice of Claimed
 Investigational Exemption in
 Electronic Format to CVM via E-Mail
Guidance 61--Guidance for Industry--    January 1999        Do                     Do
 FDA Approval of Animal Drugs for
 Minor Uses and for Minor Species
Guideline 62--Guidance for Industry--   August 1997         Do                     Do
 Consumer-Directed Broadcast
 Advertisements
Guideline 63--Guidance for Industry--   December 1997       Do                     Do
 Validation of Analytical Procedures:
 Definition and Terminology--Draft
 Guidance
Guideline 64--Guidance for Industry--   December 1997       Do                     Do
 Validation of Analytical Procedures:
 Methodology--Draft Guidance
Guideline 65--Guidance for Industry--   November 1997       Do                     Do
 Industry-Supported Scientific and
 Educational Activities
Guideline 66--Guidance for Industry--   January 1998        Do                     Do
 Professional Flexible Labeling of
 Antimicrobial Drugs--Draft Guidance
Guideline 67--Guidance for Industry--   February 1998       Do                     Do
 Small Entities Compliance Guide for
 Renderers
Guideline 68--Guidance for Industry--   February 1998       Do                     Do
 Small Entities Compliance Guide for
 Protein Blenders, Feed Manufacturers,
 and Distributors
Guideline 69--Guidance for Industry--   February 1998       Do                     Do
 Small Entities Compliance Guide for
 Feeders of Ruminant Animals With On-
 Farm Feed Mixing Operations
Guideline 70--Guidance for Industry--   February 1998       Do                     Do
 Small Entities Compliance Guide for
 Feeders of Ruminant Animals Without
 On-Farm Feed Mixing Operations
Guideline 71--Guidance for Industry--   April 1998          Do                     Do
 Use of Human Chorionic Gonadotropic
 (HCG) as a Spawning Aid for Fish
Guideline 72--Guidance for Industry--   May 1998            Do                     Do
 GMP's for Medicated Feed
 Manufacturers Not Required to
 Register and Be Licensed With FDA

[[Page 31276]]

Guideline 73--Draft Guidance for        July 1998           Do                     Do
 Industry--Stability Testing of New
 Animal Drug Substances and Products
Guideline 74--Draft Guidance for        July 1998           Do                     Do
 Industry--Stability Testing for New
 Dosage Forms of New Animal Drugs
Guideline 75--Guidance for Industry--   July 1998           Do                     Do
 Stability Testing: Photostability
 Testing of New Animal Drug Substances
 and Products: Draft Guidance
Guideline 76--Guidance for Industry--   July 1998           Do                     Do
 Questions and Answers--BSE Feed
 Regulation
Guideline 77--Guidance for Industry--   August 1998         Do                     Do
 Interpretation of On-Farm Feed
 Manufacturing and Mixing Operations--
 Draft Guidance
Guideline 78--Guidance for Industry--   November 1998       Do                     Do
 Evaluation of the Human Health Impact
 of the Microbial Effects of
 Antimicrobial New Animal Drugs
 Intended for Use in Food-Producing
 Animals--Draft Guidance
----------------------------------------------------------------------------------------------------------------

VII. Guidance Documents Issued by the Office of Regulatory Affairs

----------------------------------------------------------------------------------------------------------------
                                                                                    How To Obtain A Hard Copy of
                                                             Grouped by Intended       The Document (Name and
           Name of Document              Date of Issuance     User or Regulatory    Address, Phone, FAX, E-mail,
                                                                   Activity                 or Internet)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guides Manual         August 1996         FDA staff personnel    National Technical
                                                                                    Information Service (NTIS),
                                                                                    5285 Port Royal Rd.,
                                                                                    Springfield, VA 22161 (Order
                                                                                    No. PB96-915499) or via
                                                                                    Internet www.fda.gov/ora/
                                                                                    compliance--ref/cpg/
                                                                                    cpgtc.html
Compliance Policy Guide Medical Device  August 27, 1998     Do                     Division of Compliance Policy
 Warning Letter Draft Pilot                                                         (HFC-230), Office of
                                                                                    Enforcement, Food and Drug
                                                                                    Administration, 5600 Fishers
                                                                                    Lane, Rockville, MD 20857,
                                                                                    301-827-0420 or via Internet
                                                                                    www.fda.gov/ora/compliance--
                                                                                    ref/dev--pl.pdf
Compliance Policy Guide-DRAFT           January 5, 1998     Do                     Division of Compliance Policy
 Commercialization of In Vitro                                                      or via Internet at
 Diagnostic Devices (IVD's) Labeled                                                 www.fda.gov/cdrh/comp/
 for Research Use Only or                                                           ivddrfg.html
 Investigational Use Only
Compliance Policy Guide 675.400 (CPG    November 13, 1998   Do                     Division of Compliance Policy
 7126.24) REVISION Rendered Animal                                                  or via Internet at
 Feed Ingredients                                                                   www.fda.gov/ora/compliance--
                                                                                    ref/cpg/cpgvet/
                                                                                    cpg675.400.html
Compliance Policy Guide--DRAFT          August 28, 1998     Do                     Division of Compliance Policy
 Distributor Medical Device Reporting                                               or via Internet at
                                                                                    www.fda.gov/ora/compliance--
                                                                                    ref/cpg--mdr3.txt
Compliance Policy Guide 257.100 NEW     December 21, 1998   Do                     Division of Compliance Policy
 Deferral of Source Plasma Donors Due                                               or via Internet at
 to Red Cell Loss During Collection of                                              www.fda.gov/ora/compliance--
 Source Plasma by Automated                                                         ref/cpg/default.html
 Plasmapheresis
FDA/ORA International Inspection        May 1997            Do                     Division of Emergency &
 Manual and Travel Guide                                                            Investigational Operations
                                                                                    (HFC-130), Food and Drug
                                                                                    Administration, 5600 Fishers
                                                                                    Lane, Rockville, MD 29857 or
                                                                                    via Internet www.fda.gov/ora/
                                                                                    inspect--ref/itob/itob.html
Glossary of Computerized System and     August 1995         Do                     NTIS (Order No. PB96-127352)
 Software Development Terminology                                                   or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html

[[Page 31277]]

Import Alerts                           continuously        Do                     Freedom of Information Staff
                                                                                    (HFI-35), Food and Drug
                                                                                    Administration, 5600 Fishers
                                                                                    Lane, Rockville, MD 20857 or
                                                                                    via Internet www.fda.gov/ora/
                                                                                    fiars/ora--import--
                                                                                    alerts.html
Investigations Operations Manual        January 1999        Do                     Division of Emergency and
                                                                                    Investigational Operations
                                                                                    (HFC-130), Office of
                                                                                    Regional Operations, Food
                                                                                    and Drug Administration,
                                                                                    5600 Fishers Lane,
                                                                                    Rockville, MD 20857, 301-443-
                                                                                    3276 or via Internet
                                                                                    www.fda.gov/ora/inspect--ref/
                                                                                    iom/iomtc.html
Investigations Operations Manual-       July 1998           Do                     Do
 REVISION: Chapter 4--Sampling
Investigations Operations Manual-       July 1998           Do                     Do
 REVISION: Chapter 5--Establishment
 Inspection
Laboratory Procedures Manual            June 1994           Do                     Division of Field Science
                                                                                    (HFC-141), Food and Drug
                                                                                    Administration, 5600 Fishers
                                                                                    Lane, rm. 12-41, Rockville,
                                                                                    MD 20857, ATTN: Donna Porter
                                                                                    or via Internet www.fda.gov/
                                                                                    ora/science--ref/lpm/
                                                                                    lpmtc.html
Regulatory Procedures Manual            August 1997         Do                     NTIS (Order No. PB97-196182)
                                                                                    or via Internet www.fda.gov/
                                                                                    ora/compliance--ref/rpm/
                                                                                    rpmtc.html
Regulatory Procedures Manual: UPDATE/   March 1998          Do                     Division of Compliance
 New Subchapter/ Application Integrity                                              Policy, or via Internet
 Policy                                                                             www.fda.gov/ora/compliance--
                                                                                    ref/rpm/rpmtc.html
Regulatory Procedures Manual: UPDATE    March 1998          Do                     Do
 Subchapter/Warning Letters
Regulatory Procedures Manual: UPDATE/   April 1998          Do                     Do
 REVISION Subchapter/Import Procedures
Regulatory Procedures Manual; UPDATE/   April 1998          Do                     Do
 REVISION Subchapter/Priority
 Enforcement Strategy for Problem
 Importers
Regulatory Procedures Manual: UPDATE/   April 1998          Do                     Do
 REVISION Subchapter/Import Procedures
Regulatory Procedures Manual: UPDATE/   April 1998          Do                     Do
 REVISION Subchapter/Notice of
 Sampling
Regulatory Procedures Manual: UPDATE/   May 1998            Do                     Do
 NEW Subchapter/Granting and Denying
 Transportation and Exportation (T&E)
 Entries
Regulatory Procedures Manual: UPDATE/   June 1998           Do                     Division of Compliance Policy
 REVISION Subchapter/Seizure                                                        or via Internet at
                                                                                    www.fda.gov/ora/compliance--
                                                                                    ref/rpm--new2/ch6.html
Regulatory Procedures Manual: UPDATE/   June 1998           Do                     Division of Compliance Policy
 REVISION Subchapter/Supervisory                                                    or via Internet at
 Charges                                                                            www.fda.gov/ora/compliance--
                                                                                    ref/rpm--new2/ch9chgs.html
Regulatory Procedures Manual: NEW       July 1998           Do                     Division of Compliance Policy
 Subchapter/Civil Penalties--                                                       or via Internet at
 Electronic Product Radiation Control                                               www.fda.gov/ora/compliance--
                                                                                    ref/ch6civpen.html
Guide to Inspections of Bulk            May 1994            Do                     NTIS (Order No. PB96-127154)
 Pharmaceutical Chemicals                                                           or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Pharmaceutical  July 1993           Do                     NTIS (Order No. PB96-127279)
 Quality Control Laboratories                                                       or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of                 July 1993           Do                     NTIS (Order No. PB96-127287)
 Microbiological Pharmaceutical                                                     or via Internet www.fda.gov/
 Quality Control Laboratories                                                       ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Validation of   July 1993           Do                     NTIS (Order No. PB96-127246)
 Cleaning Processes                                                                 or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Lyophilization  July 1993           Do                     NTIS (Order No. PB96-127253)
 of Parenterals                                                                     or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of High Purity     July 1993           Do                     NTIS (Order No. PB96-127261)
 Water Systems                                                                      or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html

[[Page 31278]]

Guide to Inspections of Dosage Form     October 1993        Do                     NTIS (Order No. PB96-127212)
 Drug Manufacturers-CGMPs                                                           or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Oral Solid      January 1994        Do                     NTIS (Order No. PB96-127345)
 Dosage Forms Pre/Post Approval Issues                                              or via Internet www.fda.gov/
 for Development and Validation                                                     ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Topical Drug    July 1994           Do                     NTIS (Order No. PB96-127394)
 Products                                                                           or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Sterile Drug    July 1994           Do                     NTIS (Order No. PB96-127295)
 Substance Manufacturers                                                            or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Oral Solutions  August 1994         Do                     NTIS (Order No. PB96-127147)
 and Suspensions                                                                    or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Nutritional     February 1995       Do                     NTIS (Order No. PB96-127378)
 Labeling and Education Act (NLEA)                                                  or via Internet www.fda.gov/
 Requirements                                                                       ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Interstate      April 1995          Do                     NTIS (Order No. PB96-127386)
 Carriers and Support Facilities                                                    or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Dairy Product   April 1995          Do                     NTIS (Order No. PB96-127329)
 Manufacturers                                                                      or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Miscellaneous   May 1995            Do                     NTIS (Order No. PB96-127220)
 Foods Vol. I                                                                       or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Miscellaneous   September 1996      Do                     NTIS (Order No. PB97-196133)
 Foods Vol. II                                                                      or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Low Acid        November 1996       Do                     NTIS (Order No. PB97-196141)
 Canned Foods Manufacturers, Part 1 -                                               or via Internet www.fda.gov/
 Administrative Procedures/Scheduled                                                ora/inspect--ref/igs/
 Processes                                                                          iglist.html
Guide to Inspections of Low Acid        April 1997          Do                     NTIS (Order No. PB97-196158)
 Canned Foods Manufacturers, Part 2-                                                or via Internet www.fda.gov/
 Processes/Procedures                                                               ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Cosmetic        February 1995       Do                     NTIS (Order No. PB96-127238)
 Product Manufacturers                                                              or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Blood Banks     September 1994      Do                     NTIS (Order No. PB96-127303)
                                                                                    or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Source Plasma   December 1994       Do                     NTIS (Order No. PB96-127360)
 Establishments                                                                     or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Infectious      June 1996           Do                     NTIS (Order No. PB96-199476)
 Disease Marker Testing Facilities                                                  or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Biotechnology Inspections Guide         November 1991       Do                     NTIS (Order No. PB96-127402)
                                                                                    or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Computerized    February 1983       Do                     NTIS (Order No. PB96-127337)
 Systems in Drug Processing                                                         or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Foreign         September 1995      Do                     NTIS (Order No. PB96-127311)
 Medical Device Manufacturers                                                       or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of Foreign         May 1996            Do                     NTIS (Order No. PB96-199468)
 Pharmaceutical Manufacturers                                                       or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Mammography Quality Standards Act       January 1998        Do                     NTIS (Order No. PB98-127178)
 (MQSA) Auditors Guide                                                              or via Internet www.fda.gov/
                                                                                    ora/inspect--ref/igs/
                                                                                    iglist.html
Guide to Inspections of                 December 1997       Do                     NTIS (Order No. PB98-127152)
 Electromagnetic Compatibility Aspects                                              or via Internet www.fda.gov/
 of Medical Device Quality Systems                                                  ora/inspect--ref/igs/
                                                                                    iglist.html

[[Page 31279]]

Guide to Inspections of Grain Product   March 1998          Do                     Division of Emergency and
 Manufacturers                                                                      Investigational Operations
                                                                                    (HFC-130), Office of
                                                                                    Regional Operations, Food
                                                                                    and Drug Administration,
                                                                                    5600 Fishers Lane,
                                                                                    Rockville, MD 20857, 301-443-
                                                                                    3276
Guide to Bioresearch Monitoring         February 1998       Do                     Do
 Inspections of In Vitro Devices
Guide to Inspections of Viral           March 1998          Do                     Do
 Clearance Processes for Plasma
 Derivatives
Guide to Traceback of Fresh Fruits and  August 1998         Do                     Do
 Vegetables Implicated in
 Epidemiological Investigations
Guide to Inspections of Computerized    August 1998         Do                     Do--Internet at www.fda.gov/
 Systems in the Food Processing                                                     ora/inspect--ref/igf/
 Industry                                                                           iglist.html
Guideline for the Monitoring of         January 1988        FDA regulated          Division of Compliance Policy
 Clinical Investigators                                      industry               (HFC-230), Office of
                                                                                    Enforcement, Food and Drug
                                                                                    Administration, 5600 Fishers
                                                                                    Lane, Rockville, MD 20857,
                                                                                    301-827-0420
Computerized Systems Used in Clinical   June 18, 1997       Do                     Do
 Trials-DRAFT
Compliance Program 7348.808:            Revised August 17,  FDA staff personnel    Do--Internet http://
 Bioresearch Monitoring; Good            1998                                       www.fda.gov/ora/compliance--
 Laboratory Practices (Nonclinical)                                                 ref/bimo/default.html
Compliance Program 7348.810: Sponsors,  Revised October     Do                     Do
 Contract Research Organizations and     30, 1998
 Monitors
Compliance Program 7348.811:            Revised September   Do                     Do
 Bioresearch Monitoring; Clinical        2, 1998
 Investigations
Food Laboratory Practice Program        October 1, 1991     Do                     Division of Compliance Policy
 (Nonclinical Laboratories) 7348.808A;
 EPA Data Audit Inspections
Compliance Program 7348.809;            August 18, 1994     Do                     Do
 Bioresearch Monitoring; Institutional
 Review Board
Good Laboratory Practice Regulations    August 1979         Do                     Do--Internet at www.fda.gov/
 Management Briefings                                                               ora/compliance--ref/bimo/
                                                                                    default.html
----------------------------------------------------------------------------------------------------------------

VIII. Guidance Documents Issued by the Office of the Commissioner
and Office of Policy

----------------------------------------------------------------------------------------------------------------
                                                                                    How to Obtain a Hard Copy of
                                                             Grouped by Intended       the Document (Name and
           Name of Document              Date of Issuance     User or Regulatory    Address, Phone, Fax, E-mail
                                                                   Activity                 or Internet
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry; Exports    June 1998           Regulated industry     Internet via www.fda.gov/
 and Imports under the FDA Export                                                   opacom/fedregister/
 Reform and Enhancement Act of 1996                                                 frexport.html
FDA's Development, Issuance and Use of  February 1997       FDA personnel and      Internet via www.fda.gov/
 Guidance Documents                                          regulated industry     opacom/morechoices/
                                                                                    moreindu.html or Office of
                                                                                    Policy (301-827-3360)
Industry Supported Scientific and       December 1997       Regulated industry     Internet via www.fda.gov/cder/
 Educational Activities                                                             guidance/index.htm or Office
                                                                                    of Policy (301-827-3360)
Draft Guidance on Broadcast             February 1997       Do                     Do
 Advertisements
Direct Final Rule Guidance              November 1997       FDA personnel          Internet via www.fda.gov/
                                                                                    opacom/morechoices/industry/
                                                                                    guidedc.htm or Lisa Helmanis
                                                                                    (301-443-3480)
Small Entities Compliance Guide:        February 1997       Regulated industry     Internet via www.fda.gov/
 Regulations to Restrict the Sale and                                               opacom/campaigns/tobacco/
 Distribution of Cigarettes and                                                     tobret.htm or 1-888-FDA-
 Smokeless Tobacco in Order to Protect                                              4KIDS
 Children and Adolescents (21 CFR Part
 897)
Children & Tobacco--Frequently Asked    July 1997           Do                     Do
 Questions about the New Regulations
 (Draft)
Children & Tobacco--A Retailer's Guide  October 1997        Do                     Do
 to the New Federal Regulations
Children & Tobacco--A Guide to the the  October 1997        Do                     Do
 New Federal Regulations

[[Page 31280]]

FDA's Standards Policy                  October 1995        FDA personnel and      60 FR 53078, October 11, 1995
                                                             regulated industry     or Office of Policy (301-827-
                                                                                    3360)
Policy & Guidance Handbook for FDA      1994                FDA personnel          National Technical
 Advisory Committees                                                                Information Service (NTIS),
                                                                                    5285 Port Royal Rd.,
                                                                                    Springfield, VA 22161, 703-
                                                                                    487-4650 (Order No. PB94-
                                                                                    158854)
----------------------------------------------------------------------------------------------------------------

    Dated: June 4, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-14752 Filed 6-9-99; 8:45 am]
BILLING CODE 4160-01-F