[Federal Register Volume 64, Number 3 (Wednesday, January 6, 1999)]
[Notices]
[Pages 888-903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-155]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Quarterly List of Guidance Documents at the Food and Drug 
Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a 
quarterly update of all guidance documents issued and withdrawn since 
the compilation of the quarterly list that published on July 6, 1998. 
FDA committed to publishing quarterly updates in its February 1997 
``Good Guidance Practices'' (GGP's), which set forth the agency's 
policies and procedures for the development, issuance, and use of 
guidance documents. This list is intended to inform the public of the 
existence and availability of guidance documents issued during this 
quarter. This list also includes some guidance documents that were 
inadvertently not included on previously published lists.

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

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

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

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 27, 1997 (62 FR 8961), FDA 
published a notice announcing its ``Good Guidance Practices'' (GGP's), 
which set forth the agency's policies and procedures for the 
development, issuance, and use of guidance documents. The agency 
adopted the GGP's to ensure public involvement in the development of 
guidance documents and to enhance public understanding of the 
availability, nature, and legal effect of such guidance.
    As part of FDA's effort to ensure meaningful interaction with the 
public regarding guidance documents, the agency committed to publish an 
annual comprehensive list of guidance documents and quarterly Federal 
Register notices that list all guidance documents that were issued and 
withdrawn during that quarter, including ``Level 2'' guidance 
documents. The following list of guidance documents represents all 
guidances issued or withdrawn by FDA since the compilation of the July 
6, 1998 (63 FR 36413) quarterly list and any guidance documents 
inadvertently not included on previously published lists. The guidance 
documents are organized by the issuing Center or Office within FDA, and 
are further grouped by the intended users or regulatory activities to 
which they pertain. Dates provided in the following list refer to the 
date of issuance or, where applicable, the date of last revision of the 
document. Document numbers are provided where available.

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

[[Page 889]]



 
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                                                                                                               How to Obtain a Hard Copy of the Document
              Name of Document                    Date of Issuance           Grouped by Intended User or       (Name and Address, Phone, FAX, E-mail or
                                                                                 Regulatory Activity                           Internet)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Manufacturing,  March 1998                  FDA Regulated Industry               Office of Communication, Training, and
 Processing or Holding Active                                                                                  Manufacturers Assistance (HFM-40), Center
 Pharmaceutical Ingredients                                                                                    for Biologics Evaluation and Research
                                                                                                               (CBER), Food and Drug Administration,
                                                                                                               1401 Rockville Pike, Rockville, MD 20852-
                                                                                                               1448, 1-800-835-4709 or 301-827-1800, FAX
                                                                                                               Information System: 1-888-CBER-FAX
                                                                                                               (within U.S.)or 301-827-3844 (outside
                                                                                                               U.S. and local to Rockville, MD).
                                                                                                               Internet access: http://www.fda.gov/cber
Draft Guidance for Industry: Instructions    May 1998                    Do                                   Do
 for Submitting Electronic Lot Release
 Protocols to the Center for Biologics
 Evaluation and Research
Draft Guidance for Industry: Pilot Program   May 1998                    Do                                   Do
 for Electronic Investigational New Drug
 (eIND) Applications for Biological
 Products
Draft Guidance for Industry: Electronic      May 1998                    Do                                   Do
 Submissions of Case Report Forms (CRF's),
 Case Report Tabulations (CRT's) and Data
 to the Center for Biologics Evaluation and
 Research
Draft Guidance for Industry: Electronic      May 1998                    Do                                   Do
 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: Pharmacokinetics in   May 1998                    Do                                   Do
 Patients with Impaired Renal Function--
 Study Design, Data Analysis and Impact on
 Dosing and Labeling
Guidance for Industry: Standards for the     May 1998                    Do                                   Do
 Prompt Review of Efficacy Supplements,
 Including Priority Efficacy Supplements
Guidance for Industry: Providing Clinical    May 1998                    Do                                   Do
 Evidence of Effectiveness for Human Drugs
 and Biological Products
Draft Guidance for Industry: Stability       June 1998                   Do                                   Do
 Testing of Drug Substances and Drug
 Products
ICH Draft Guidance on Specifications: Test   June 9, 1998                Do                                   Do
 Procedures and Acceptance Criteria for
 Biotechnological/Biological Products
ICH Guidance on Ethnic Factors in the        June 10, 1998               Do                                   Do
 Acceptability of Foreign Clinical Data
Draft Guidance for Industry: Exports and     June 12, 1998               Do                                   Do
 Imports Under the FDA Export Reform and
 Enhancement Act of 1996
Draft Guidance for Industry: Content and     June 1998                   Do                                   Do
 Format of Chemistry, Manufacturing and
 Controls Information and Establishment
 Description Information for a Vaccine or
 Related Product
Guidance for Industry: Qualifying for        June 1998                   Do                                   Do
 Pediatric Exclusivity Under Section 505A
 of the Federal Food, Drug and Cosmetic Act

[[Page 890]]

 
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
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 of     July 1998                   Do                                   Do
 Section 126 of the Food and Drug
 Administration Modernization Act of 1997--
 Elimination of Certain Labeling
 Requirements
Guidance for Industry: Environmental         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
Draft Guidance for Industry: Content and     August 1998                 Do                                   Do
 Format of Chemistry, Manufacturing and
 Controls Information and Establishment
 Description Information for an Allergenic
 Extract or Allergen Patch Test
ICH Guidance on Statistical Principles for   September 16, 1998          Do                                   Do
 Clinical Trials
ICH Guidance on Quality of Biotechnological/ September 21, 1998          Do                                   Do
 Biological Products: Derivation and
 Characterization of Cell Substrates Used
 for Production of Biotechnological/
 Biological Products
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
ICH Guidance on Viral Safety Evaluation of   September 24, 1998          Do                                   Do
 Biotechnology Products Derived From Cell
 Lines of Human or Animal Origin
Guidance for Industry: Errors and Accidents  June 1998                   Do                                   Do
 Regarding Saline Dilution of Samples Used
 for Viral Marker Testing (Level 2)
Guidance for Industry: How to Complete the   September 1998              Do                                   Do
 Vaccine Adverse Reporting System Form
 (VAERS-1) (Level 2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
Withdrawn
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Supplemental Testing  September 1998              Do                                   Do
 and the Notification of Consignees of
 Donor Test Results for Antibody to
 Hepatitis C Virus (Anti-HCV)--March 1998

[[Page 891]]

 
Memorandum: Revised Precautionary Measures   September 1998              Do                                   Do
 to Reduce the Possible Risk of
 Transmission of Creutzfeldt-Jakob Disease
 (CJD) by Blood and Blood Products--
 December 11, 1996 (Partial Withdrawal)
 (Withdrawal of recommendations pertaining
 to retrieval, quarantine, destruction, and
 notification for plasma derivatives)
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               How to Obtain a Hard Copy of the Document
              Name of Document                    Date of Issuance           Grouped by Intended User or       (Name and Address, Phone, FAX, E-mail or
                                                                                 Regulatory Activity                           Internet)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Devices: Draft Global Harmonization  July 16, 1998               Office of Compliance (OC)            Division of Small Manufacturers
 Task Force Study Group 3 Process                                                                              Assistance, 1-800-638-2041 or 301-827-
 Validation Guidance (Draft)                                                                                   0111 or (FAX) Facts-on-Demand at 1-800-
                                                                                                               899-0381 or Internet at http://
www.fda.gov/cdrh
Global Harmonization Task Force: Draft       October 28, 1998            Do                                   Do
 Document on the Essential Principles of
 Safety and Performance of Medical Devices
 on a Global Basis
Global Harmonization Task Force:             August 31, 1998             OC/Office of Surveillance and        Do
 Availability of Draft Documents on Adverse                               Biometrics (OSB)
 Event and Vigilance Reporting of Medical
 Device Events
Guidance for Industry--Contents of a PDP     April 25, 1998              Office of Device Evaluation (ODE)
Medical Device Labeling--Suggested Format    May 9, 1997                 Do                                   Do
 and Content
Guidance for the Content of Premarket        May 28, 1998                Do                                   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                Do                                   Do
 Process
Modifications to Devices Subject to          August 6, 1998              Do                                   Do
 Premarket Approval the PMA Supplement
 Decision Making Process
Guidance for Off-the Shelf Software Use in   August 17, 1998             Do                                   Do
 Medical Devices
Convenience Kits Interim Regulatory          May 20, 1997                Do                                   Do
 Guidance
Kit Certification for 510(k)s                July 1997                   Do                                   Do
Guidance to Industry Supplements to          May 20, 1998                Do                                   Do
 Approved Applications for Class III
 Medical Devices: Use of Published
 Literature, Use of Previously Submitted
 Materials, and Priority Review
30-Day Notices and 135-Day PMA Supplements   February 19, 1998           Do                                   Do
 for Manufacturing Method or Process
 Changes, Guidance for Industry and CDRH
Procedures for Class II Device Exemptions    February 19, 1998           Do                                   Do
 from Premarket Notification, Guidance for
 Industry and CDRH Staff
Guidance for Submission of                   June 6, 1998                ODE/Division of Clinical Laboratory  Do
 Immunohistochemistry Applications to the                                 Devices (DCLD)
 FDA

[[Page 892]]

 
In Vitro Diagnostic Creatinine Test System   July 2, 1998                Do                                   Do
In Vitro Diagnostic Bicarbonate/Carbon       July 6, 1998                Do                                   Do
 Dioxide Test System
In Vitro Diagnostic Chloride Test System     July 6, 1998                Do                                   Do
In Vitro Diagnostic Glucose Test System      July 6, 1998                Do                                   Do
In Vitro Diagnostic Potassium Test System    July 6, 1998                Do                                   Do
In Vitro Diagnostic Sodium Test System       July 6, 1998                Do                                   Do
In Vitro Diagnostic Urea Nitrogen Test       July 6, 1998                Do                                   Do
 System
In Vitro Diagnostic C-Reactive               July 20, 1998               Do                                   Do
 Immunological Test System
In Vitro Diagnostic Calibrators              July 20, 1998               Do                                   Do
Points To Consider For Hematology Quality    September 30, 1997          Do                                   Do
 Control Materials
Points to Consider for Approval of Home      September 16, 1997          Do                                   Do
 Drugs of Abuse Test Kits Draft
Review Criteria for Assessment of            November 6, 1996            Do                                   Do
 Professional Use Human Chorionic
 Gonadotropin (hCG) in Vitro Diagnostic
 Devices (IVD's)
Letter to IVD Manufacturers on Streamlined   December 22, 1997           Do                                   Do
 PMA
Reviewer Guidance for Premarket              July 19, 1995               ODE/Division of Cardiovascular,      Do
 Notification (510(k)) Submissions--                                      Respiratory, and Neurological
 Labeling, Performance and Environmental                                  Devices (DCRND)
 Testing for Electronic Devices
Draft Guidance for Format and Content for    July 19, 1995               Do                                   Do
 Premarket Notification 510(k)
Guidance on the Content and Format of        December 18, 1997           ODE/Division of Dental, Infection    Do
 Premarket Notifications [510(k)]                                         Control, and General Hospital
 Submissions for Liquid Chemical Sterilants                               Devices (DDIGD)
 and High Level Disinfectants
Guidance on the Content and Format of        January 16, 1998            Do                                   Do
 Premarket Notification [510(k)]
 Submissions for Surgical Masks
Guidance on the Content and Format of        February 13, 1998           Do                                   Do
 Premarket Notification [510(k)]
 Submissions for Testing for Skin
 Sensitization to Chemicals in Latex
 Products
CDRH Regulatory Guidance Document for        April 27, 1998              Do                                   Do
 Preamendments Unclassified Washers and
 Washer-Disinfectors Intended for
 Processing Reusable Medical Devices
Guidance on the Content and Format of        August 4, 1998              Do                                   Do
 Premarket Notification [510(k)]
 Submissions of Washers and Washer-
 Disinfectors
Devices for the Treatment and/or Diagnosis   June 10, 1998               Do                                   Do
 of Temporomandibular Joint Dysfunction and/
 or Orofacial Pain
Dental Impression Materials Premarket        August 17, 1998             Do                                   Do
 Notification
OTC Denture Cushions, Pads, Reliners,        August 18, 1998             Do                                   Do
 Repair Kits, and Partially Fabricated
 Denture Kits
Dental Cements Premarket Notification        August 18, 1998             Do                                   Do
Further Information on the Regulation of     August 18, 1997             Do                                   Do
 Liquid Chemical Sterilants and High Level
 Disinfectants
Letter to Orthopedic Surgical Manufacturers  November 26, 1997           ODE/Division of General and          Do
 Association                                                              Restorative Devices (DGRD)
Letter to the Health Industry Manufacturers  November 26, 1997           Do                                   Do
 Association

[[Page 893]]

 
Guidance Document for Industry and CDRH      March 18, 1998              Do                                   Do
 Staff for the Preparation of
 Investigational Device Exemptions and
 Premarket Approval Applications for Bone
 Growth Stimulator Devices (Replaces:
 Guidance Document for the Preparation of
 Investigational Device Exemptions and
 Premarket Approval Applications for Bone
 Growth Stimulator Devices 8/12/88)
Guidance for Content of Premarket            April 28, 1998              Do                                   Do
 Notifications for Esophageal and Tracheal
 Prostheses
Guidance Document for Surgical Lamp 510ks    July 13, 1998               Do                                   Do
Retinoscope Guidance                         July 8, 1998                ODE/Division of Opthalmic Devices    Do
                                                                          (DOD)
Opthalmoscope Guidance                       July 8, 1998                Do                                   Do
Slit Lamp Guidance                           July 8, 1998                Do                                   Do
Revised Procedures for Adding Lens           August 11, 1998             Do                                   Do
 Finishing Laboratories to Approved
 Premarket Approval Applications for Class
 III Rigid Gas Permeable Contact Lens for
 Extended Wear
Third Party Review Guidance for Vitreous     January 31, 1997            Do                                   Do
 Aspiration and Cutting Device Premarket
 Notification (510K)
Third Party Review Guidance for              January 31, 1997            Do                                   Do
 Phacofragmentation System Device Premarket
 Notification (510K)
Dear Sponsor Letter Concerning the           May 20, 1997                Do                                   Do
 Revocation of 21 CFR part 813 IOL IDE
 Regulations
Guidance for the Content of Premarket        August 7, 1998              ODE/Division of Reproductive         Do
 Notification for Conventional and High                                   Abdominal, ENT, and Radiological
 Permeability Hemodialyzers (replaces:                                    Devices (DRAERD)
 Guidelines for Premarket Testing of New
 Conventional Hemodialyers, High
 Premeability Hemodialyzers and
 Hemofilters)
Uniform Contraceptive Labeling               July 23, 1998               Do                                   Do
Guidance for the Content of Premarket        August 7, 1998              Do                                   Do
 Notifications for Conventional and High
 Permeability Hemodialyzers
Guidance for Industry and CDRH Reviewers on  August 7, 1998              Do                                   Do
 the Content of Premarket Notifications for
 Hemodialysis Delivery Systems
Devices Used for In Vitro Fertilization and  September 10, 1998          Do                                   Do
 Related Assisted Reproduction Procedures
Letter to Manufacturers of Falloposcopes     September 5, 1996           Do                                   Do
Letter to Manufacturers of Prescription      September 6, 1996           Do                                   Do
 Home Monitors for Non-Stress Tests
Continuing Education Credits for Reading/    April 17, 1998              Office of Health and Industry        Do
 Writing Articles/Papers and Presenting                                   Programs (OHIP)/Division of
 Courses/Lectures                                                         Mammography Quality and Radiation
                                                                          Programs (DMQRP)
Accidental Radioactive Contamination of      August 13, 1998             Do                                   Do
 Human Food and Animal Feeds:
 Recommendations for State and Local
 Agencies
Additional Mammography Review Policy         March 26, 1998              Do                                   Do
Guidance For Review of Cases of Possible     March 26, 1998              Do                                   Do
 Suspension or Revocation of Mammography
 Facility Certificates Under the
 Mammography Quality Standards Act, 42.
 U.S.C. section 263b

[[Page 894]]

 
Guidance for Review of Requests for          March 26, 1998              Do                                   Do
 Reconsideration of Adverse Decisions on
 Accreditation of Mammography Facilities
 Under the Mammography Quality Standards
 Act, 42. U.S.C. section 263b
Guidance for Submission of Requests for      March 26, 1998              Do                                   Do
 Reconsideration of Adverse Decisions on
 Accreditation of Mammography Facilities
 Under the Mammography Quality Standards
 Act, 42. U.S.C. section 263b
Supplement to ``The Physician's Continuing   April 9, 1998               Do                                   Do
 Experience Requirement''
Requalification for Interpreting             May 28, 1998                Do                                   Do
 Physician's Continuing Experience
MQSA Policy Statements in a Question and     June 2, 1998                Do                                   Do
 Answer
Compliance Guidance: The Mammography         July 8, 1998                Do                                   Do
 Quality Standards Act Final Regulations
MQSA Policy Statements for the Interim       August 6, 1998              Do                                   Do
 Regulations
Policy for Facilities Changing               April 15, 1998              Do                                   Do
 Accreditation Bodies
Guidance on FDA's Expectations of Medical    May 15, 1998                Office of Science and Technology     Do
 Device Manufacturers Concerning the Year                                 (OST)/ Division of Electronics and
 2000 Date                                                                Computer Science (DESC)
Immunotoxicity Testing                       1996                        OST/Division of Life Sciences (DLS)  Do
Guidance on the Recognition and Use of       February 19, 1998           OST/Office of the Director (OD)      Do
 Consensus Standards
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
Deletions
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Biotechnology and FDA Regulation of          January 1, 1986             ODE                                  Do
 Hybridoma In-Vitro Diagnostic Products:
 List of Current Devices and Guidelines for
 Manufacturers
DCRND--Draft Guidance for Format and         July 19, 1995               ODE/DCRND                            Do
 Content for Premarket Notification 510(k)
 [replaces 908] [cardiovascular,
 respiratory, neurological]
Guidance for Safety and Effectiveness Data   March 1, 1983               Do                                   Do
 Required in Premarket Notification
 (510(k)) Applications for Blood
 Oxygenators
Automated Defibrillators: Operator's Shift   August 8, 1991              Do                                   Do
 Checklist and Manual Defibrillators:
 Operator's Shift Checklist
Guidance for the Preparation and Content of  December 4, 1987            Do                                   Do
 Applications to the Food and Drug
 Administration for Ventricular Assist
 Devices and Total Artificial Hearts
 (draft)
Guidance Document for the Preparation of     August 12, 1988             ODE/DGRD/ORDB                        Do
 IDE and PMA Applications for Bone Growth
 Stimulator Devices
Reviewer Guidance for Computer Controlled    August 29, 1991             ODE                                  Do
 Medical Devices Undergoing 510(k) Review
Guidelines for Premarket Testing of New      March 1, 1982               ODE/DRAERD/GRDB                      Do
 Conventional Hemodialyzers, High
 Permeability Hemodialyzers, and
 Hemofilters
Frequently Asked Questions on Recognition    February 19, 1998           OST                                  Do
 of Consensus Standards
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
Corrections
 
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 895]]

 
Determining Equivalence of Intraaortic       December 8, 1993            ODE/DCRND                            Do
 Balloon Catheters Under the 510(k)
 Regulations
Guidance for the Preparation of the Annual   September 1, 1990           Do                                   Do
 Report to the PMA Approved Heart Valve
 Prostheses
Electrocardiograph (ECG) Electrode           February 11, 1997           Do                                   Do
Electrocardiograph (ECG) Lead Switching      February 11, 1997           Do                                   Do
 Adapter
Electrocardiograph (ECG) Surface Electrode   February 11, 1997           Do                                   Do
 Tester
Reviewer Guidance for Nebulizers, Metered    October 1, 1993             Do                                   Do
 Dose Inhalers, Spacers and Actuators
Reexamination of the Evaluation Process for  May 19, 1997                ODE/DDIGD                            Do
 Liquid Chemical Sterilant and Height Level
 Disinfectants
FDA Guidelines for Multifocal Intraocular    May 29, 1997                ODE/DOD                              Do
 Lens IDE Studies and PMAs
Information for Manufacturers Seeking        September 30, 1997          ODE/DRAERD/RDB                       Do
 Marketing Clearance of Diagnostic
 Ultrasound Systems and Transducers
Tympanostomy Tubes, Submission Guidance for  January 14, 1998            ODE/DRAERD                           Do
 a 510(k) Premarket Notification
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               How to Obtain a Hard Copy of the Document
              Name of Document                    Date of Issuance           Grouped by Intended User or       (Name and Address, Phone, FAX, E-mail or
                                                                                 Regulatory Activity                           Internet)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Topical Dermatological Drug Product NDA's     June 18, 1998              Biopharmaceutic                      Office of Training and Communication, Drug
 and ANDA's--In Vivo Bioavailability,                                                                          Information Branch, Food and Drug
 Bioequivalence, In Vitro Release and                                                                          Administration, 5600 Fishers Lane,
 Associated Studies, Draft                                                                                     Rockville, MD 20857. Internet access:
                                                                                                               http://www.fda.gov/cder/guidance/
index.htm
Buspirone Hydrochloride Tablets In Vivo      May 15, 1998                Do                                   Do
 Bioequivalence and In Vitro Dissolution
 Testing
SUPAC IR/MR: Immediate Release and Modified  April 28, 1998              Chemistry                            Do
 Release Solid Oral Dosage Forms
 Manufacturing Equipment Addendum, Draft
Stability Testing of Drug Substances and     June 8, 1998                Do                                   Do
 Drug Products, Draft
PAC-ATLS: Postapproval Changes- Analytical   April 28, 1998              Do                                   Do
 Testing Laboratory Sites
Environmental Assessment of Human Drugs and  July 27, 1998               Do                                   Do
 Biologics Applications
Uncomplicated and Complicated Skin and Skin  July 22, 1998               Clinical Antimicrobial Guidances     Do
 Structure Infections; Developing
 Antimicrobial Drugs for Treatment, Draft
Acute Bacterial Meningitis; Developing       July 22, 1998               Do                                   Do
 Antimicrobial Drugs for Treatment, Draft
Uncomplicated Gonorrhea--Cervical,           July 22, 1998               Do                                   Do
 Urethral, Rectal, and/or Pharyngeal;
 Developing Antimicrobial Drugs for
 Treatment, Draft
Complicated Urinary Tract Infections and     July 22, 1998               Do                                   Do
 Pylonephritis; Developing Antimicrobial
 Drugs for Treatment, Draft

[[Page 896]]

 
Streptococcal Pharyngitis and Tonsillitis;   July 22, 1998               Do                                   Do
 Developing Antimicrobial Drugs for
 Treatment, Draft
Secondary Bacterial Infections of Acute      July 22, 1998               Do                                   Do
 Bronchitis; Developing Antimicrobial Drugs
 for Treatment, Draft
Uncomplicated Urinary Tract Infections;      July 22, 1998               Do                                   Do
 Developing Antimicrobial Drugs for
 Treatment, Draft
Nosocomial Pneumonia; Developing             July 22, 1998               Do                                   Do
 Antimicrobial Drugs for Treatment, Draft
Vulvovaginal Candidiasis; Developing         July 22, 1998               Do                                   Do
 Antimicrobial Drugs for Treatment, Draft
Lyme Disease; Developing Antimicrobial       July 22, 1998               Do                                   Do
 Drugs for Treatment, Draft
Empiric Therapy of Febrile Neutropenia;      July 22, 1998               Do                                   Do
 Developing Antimicrobial Drugs for
 Treatment, Draft
Community Acquired Pneumonia; Developing     July 22, 1998               Do                                   Do
 Antimicrobial Drugs for Treatment, Draft
Bacterial Vaginosis; Developing              July 22, 1998               Do                                   Do
 Antimicrobial Drugs for Treatment, Draft
Acute Otitis Media; Developing               July 22, 1998               Do                                   Do
 Antimicrobial Drugs for Treatment, Draft
Acute Bacterial Sinusitis; Developing        July 22, 1998               Do                                   Do
 Antimicrobial Drugs for Treatment, Draft
Acute Bacterial Exacerbation of Chronic      July 22, 1998               Do                                   Do
 Bronchitis; Developing Antimicrobial Drugs
 for Treatment, Draft
General Considerations for Clinical Trials;  July 22, 1998               Do                                   Do
 Developing Antimicrobial Drugs for
 Treatment, Draft
Acute or Chronic Bacterial Prostatitis;      July 22, 1998               Do                                   Do
 Developing Antimicrobial Drugs for
 Treatment, Draft
Submission of Abbreviated Reports and        September 21, 1998          Clinical Medical                     Do
 Synopses in Support of Marketing
 Applications; Draft
Developing Medical Imaging Drugs and         October 13, 1998            Do                                   Do
 Biologics
Providing Clinical Evidence of               May 15, 1998                Do                                   Do
 Effectiveness for Human Drug and
 Biological Products
Pharmacokinetics and Pharmacodynamics in     May 15, 1998                Clinical Pharmacology                Do
 Patients with Impaired Renal Function:
 Study Design, Data Analysis, and Impact on
 Dosing and Labeling
Manufacture, Processing or Holding of        April 17, 1998              Compliance                           Do
 Active Pharmaceutical Ingredients, Draft
Investigating Out of Specification (OOS)     September 30, 1998          Do                                   Do
 Test Results for Pharmaceutical Production
ANDA's: Impurities in Drug Substances,       July 24, 1998               Generic Drug                         Do
 Draft
E5 Ethnic Factors in the Acceptability of    June 10, 1998               ICH Efficacy                         Do
 Foreign Clinical Data, Draft
E9 Statistical Principles for Clinical       September 16, 1998          Do                                   Do
 Trials
Q6B Specifications: Test Procedures and      June 9, 1998                ICH Quality                          Do
 Acceptance Criteria for Biotechnological/
 Biological Products, Draft
Q5D Quality of Biotechnological/Biological   September 21, 1998          Do                                   Do
 Products: Derivation and Characterization
 of Cell Substrates Used for Production of
 Biotechnological/Biological Products
Q5A Biotechnological/Biological              September 24, 1998          Do                                   Do
 Pharmaceutical Products; Viral Safety
 Evaluation

[[Page 897]]

 
OTC Topical Drug Products for the Treatment  July 16, 1998               Labeling                             Do
 of Vaginal Yeast Infections (Vulvovaginal
 Candidiasis), Draft
Dipirefrin Hydrochloride Opthalmic Solution  October 1, 1998             Do                                   Do
 USP
Non-Contraceptive Estrogen Class Labeling    October 15, 1998            Do                                   Do
Submitting Debarment Certification           October 2, 1998             Procedural Guidances                 Do
 Statements, Draft
National Uniformity for Nonprescription      April 9, 1998               Do                                   Do
 Drugs Ingredient Labeling for OTC Drugs
Standards for the Prompt Review of Efficacy  May 15, 1998                Do                                   Do
 Supplements, Including Priority Efficacy
 Supplements
Repeal of Section 507 of the Federal Food,   June 15, 1998               Do                                   Do
 Drug, and Cosmetic Act
Qualifying for Pediatric Exclusivity Under   June 29, 1998               Do                                   Do
 Section 505A of the Federal Food, Drug,
 and Cosmetic Act
180-Day Generic Drug Exclusivity Under the   July 14, 1998               Do                                   Do
 Hatch-Waxman Amendments to the Federal
 Food, Drug, and Cosmetic Act
Implementation of Section 126, Elimination   July 21, 1998               Do                                   Do
 of Certain Labeling Requirements of the
 FDA Modernization Act of 1997
Advisory Committees: Implementing Section    November 2, 1998            Do                                   Do
 120 of the FDA Modernization Act of 1997
Submitting and Reviewing Complete Responses  May 14, 1998                User Fee                             Do
 to Clinical Holds
Classifying Resubmissions in Response to     May 14, 1998                Do                                   Do
 Action Letters
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
Withdrawn
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pharmacokinetic Considerations in Drug                                   Biopharmaceutic
 Studies
Carbamazepine (tablets) In Vivo              January 20, 1988            Do
 Bioequivalence and In Vitro Dissolution
 Testing
Evaluation of Controlled Release Drug        April 18, 1984              Do
 Products; Division Guidelines
Approaches to Statistical Data Analysis of   November 11, 1985           Do
 Bioavailability/Bioequivalence Studies
Controlled Release Dosage Forms: Issues and  September 10, 1985          Do
 Controversies (Conference Report)
Submission of Data for Bioequivalence                                    Do
 Studies in Computer Format
Albuterol Inhalation Aerosols (Metered Dose  January 27, 1994            Do
 Inhalers) In Vivo Bioequivalence and In
 Vitro Dissolution Testing
Albuterol Sulfate (tablets) In Vivo          May 29, 1987                Do
 Bioequivalence and In Vitro Dissolution
 Testing
Amoxapine (tablets) In Vivo Bioequivalence   August 5, 1988              Do
 and In Vitro Dissolution Testing
Atenolol (tablets) In Vivo Bioequivalence    October 6, 1988             Do
 and In Vitro Dissolution Testing
Clindamycin Hydrochloride (capsules) In      May 31, 1988                Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
Diazepam In Vivo Bioequivalence Study        July 8, 1985                Do
Dipyridamole Drug Products Bioavailability   September 25, 1987          Do
Disopyramide Phosphate (Capsules)            July 9, 1985                Do
Doxepin Hydrochloride Drug Products In Vivo  October 9, 1986             Do
 Bioequivalence Study
Doxycycline Hyclate In Vivo Studies and In   April 11, 1988              Do
 Vitro Dissolution Testing

[[Page 898]]

 
Erythromycin Capsules (Enteric Coated        September 21, 1988          Do
 Pellets) In Vivo Bioequivalence Study and
 In Vitro Dissolution Testing
Fenoprofen (capsules and tablets) In Vivo    February 3, 1988            Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Haloperidol (tablets) In Vivo                April 30, 1987              Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Hydroxyzine Pamoate (capsules) In Vivo       September 28, 1987          Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Isosorbide Dinitrate (chewable tablets,      September 22, 1987          Do
 oral tablets, and sublingual tablets) In
 Vivo Bioequivalence Study and In Vitro
 Dissolution Testing
Isosorbide Dinitrate (Controlled Release)    November 6, 1985            Do
 In Vivo Bioavailability Studies
Lorazepam (tablets) In Vivo Bioequivalence   September 16, 1987          Do
 Study and In Vitro Dissolution Testing
Megestrol Acetate (tablets) In Vivo          August 17, 1987             Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Methylprednisolone (tablets) In Vivo         June 12, 1986               Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Minoxidil (tablets)                          June 12, 1986               Do
Nafcillin Sodium (Capsules and Tablets) In   September 10, 1987          Do
 Vivo Bioequivalence Study and In Vitro
 Dissolution Testing
Norethindrone and Ethinyl Estradiol          March 18, 1988              Do
 (tablets) In Vivo Bioequivalence Study and
 In Vitro Dissolution Testing
Norethindrone and Mestranol (tablets) In     May 13, 1988                Do
 Vivo Bioequivalence Study and In Vitro
 Dissolution Testing
Orphenadrine Citrate (tablets) In Vivo       July 22, 1983               Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Procainamide In Vivo Bioavailability         September 28, 1987          Do
 Studies
Rifampin (capsules) In Vivo Bioequivalence   September 8, 1988           Do
 Study and In Vitro Dissolution Testing
Silver Sulfadiazine (cream)                  May 7, 1987                 Do
Spironolactone In Vivo Single Dose Studies   January 1, 1986             Do
 and In Vitro Dissolution Testing
Sulfasalazine (tablets) In Vivo              October 8, 1987             Do
 Bioequivalence and In Vitro Dissolution
 Testing
Sulindac (tablets) In Vivo Bioequivalence    July 18, 1988               Do
 and In Vitro Dissolution Testing
Theophylline (conventional dosage form) In   September 1, 1984           Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
Timolol Maleate (tablets) In Vivo            August 9, 1988              Do
 Bioequivalence and In Vitro Dissolution
 Testing
Tolmetin Sodium (tablets and capsules) In    October 6, 1994             Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
Triazolam (tablets) In Vivo Bioequivalence   December 24, 1992           Do
 and In Vitro Dissolution Testing
Acetohexamide (tablets) In Vivo              August 1, 1988              Do
 Bioequivalence and In Vitro Dissolution
 Testing
Allopurinol (tablets) In Vivo                July 15, 1985               Do
 Bioequivalence and In Vitro Dissolution
 Testing

[[Page 899]]

 
Amiloride Hydrochloride (tablets) In Vivo    March 29, 1985              Do
 Bioequivalence and In Vitro Dissolution
 Testing
Aminophylline (suppositories) In Vivo        July 5, 1983                Do
 Bioequivalence and In Vitro Dissolution
 Testing
Amitriptyline Hydrochloride (tablets) In     July 5, 1983                Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
Amoxicillin (capsules, tablets, and          July 10, 1988               Do
 suspensions) In Vivo Bioequivalence and In
 Vitro Dissolution Testing
Baclofen (tablets) In Vivo Bioequivalence    May 5, 1988                 Do
 and In Vitro Dissolution Testing
Cefadroxil (capsules, tablets, and           October 7, 1988             Do
 suspension) In Vivo Bioequivalence and In
 Vitro Dissolution Testing
Cephalexin (tablets and capsules) In Vivo    March 19, 1987              Do
 Bioequivalence and In Vitro Dissolution
 Testing
Cephradine (capsule and suspension) In Vivo  September 10, 1986          Do
 Bioequivalence Studies
Chlordiazepoxide and Chlordiazepoxide HCI    July 5, 1983                Do
 Bioavailability and Dissolution Studies
Chlorpropamide In Vivo Bioavailability       July 5, 1983                Do
 Studies
Chlorthalidone (tablets)                     July 5, 1983                Do
Clofibrate In Vivo Bioavailability Studies   April 7, 1986               Do
Clonidine Hydrochloride Drug Products In     December 5, 1984            Do
 Vivo Bioequivalence Study and In Vitro
 Dissolution Testing
Clorazepate In Vivo Bioequivalence Study     February 17, 1987           Do
 and In Vitro Dissolution Testing
Cyclobenzaprine Hydrochloride (tablets) In   January 25, 1988            Do
 Vivo Bioequivalence Study and In Vitro
 Dissolution Testing
Desipramine Hydrochloride (tablets) In Vivo  September 22, 1987          Do
 Bioequivalence Studies
Dicyclomine Hydrochloride Drug Products In   August 10, 1984             Do
 Vivo Bioequivalence
Dissolution Testing (General)                April 1, 1978               Do
Estopipate Tablets In Vivo Bioequivalence    August 26, 1992             Do
 Study and In Vitro Dissolution Testing
Flurazepam Hydrochloride (capsules) In Vivo  October 15, 1985            Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Hydrochlorothiazide (tablets) In Vivo        September 28, 1987          Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Hydroxyzine Hydrochloride (tablets)          March 4, 1986               Do
 (dissolution only)
Indomethacin (capsules) In Vivo              January 27, 1988            Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Isopropamide Iodide (tablets) In Vivo        May 12, 1982                Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Loxapine Succinate (capsules) In Vivo        September 10, 1987          Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Maprotiline Hydrochloride (tablets) In Vivo  August 27, 1987             Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Meclofenamate Sodium (capsules) In Vivo      November 12, 1986           Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Metaproterenol Sulfate (tablets) In Vivo     March 18, 1986              Do
 Bioequivalence Study and In Vitro
 Dissolution Testing

[[Page 900]]

 
Metoclopramide Hydrochloride (tablets) In    December 27, 1984           Do
 Vivo Bioequivalence Study and In Vitro
 Dissolution Testing
Nalidixic Acid In Vivo Bioequivalence Study  August 19, 1987             Do
 and In Vitro Dissolution Testing
Nitrofurantion Macrocrystalline (capsules)   January 10, 1986            Do
 In Vivo Bioequivalence Study and In Vitro
 Dissolution Testing
Nitroglycerin Ointment In Vivo               December 17, 1986           Do
 Bioequivalence Studies
Perphenazine (tablets) In Vivo               August 27, 1987             Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Perphenazine/Amitriptyline (tablets) In      August 27, 1987             Do
 Vivo Bioequivalence Study and In Vitro
 Dissolution Testing
Phenylbutazone Oxyphenbutazone (capsules     September 28, 1987          Do
 and tablets) In Vivo Bioequivalence Study
 and In Vitro Dissolution Testing
Prazepam (capsules and tablets) In Vivo      July 26, 1988               Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Prednisone (tablets) (dissolution only)      July 10, 1985               Do
Probenecid Drug Products Bioavailability     July 26, 1983               Do
 Study
Propoxyphene Napsylate with Acetaminphen     March 26, 1980              Do
 (tablets)
Propranolol Hydrochloride (tablets) In Vivo  August 1, 1984              Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Propylthiouracil (tablets) In Vivo           August 13, 1986             Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Quinidine Gluconate (tablets, controlled     September 22, 1987          Do
 release) In Vivo Bioequivalence Study and
 In Vitro Dissolution Testing
Ritodrine Hydrochloride (tablets) In Vivo    August 27, 1987             Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Sulfinpyrazone (Capsules and Tablets)        September 25, 1987          Do
Sulfones (tablets) In Vivo Bioequivalence    November 7, 1986            Do
 Study and In Vitro Dissolution Testing
Temazepam In Vivo Bioequivalence Study and   August 8, 1985              Do
 In Vitro Dissolution Testing
Tolazamide (tablets) In Vivo Bioequivalence  May 30, 1986                Do
 Study and In Vitro Dissolution Testing
Tolbutamide (tablets) In Vivo                December 1, 1983            Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Trimipramine Maleate (capsules) In Vivo      August 18, 1987             Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Verapamil Hydrochloride (tablets) In Vivo    July 18, 1985               Do
 Bioequivalence Study and In Vitro
 Dissolution Testing
Clinical Evaluation of Drugs for the                                     Clinical
 Treatment of Peripheral Vascular Disease
Clinical Evaluation of Bronchodilator Drugs  November 1, 1978            Clinical/Medical
Topical Corticosteriod Class Labeling                                    Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

[[Page 901]]



 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               How to Obtain a Hard Copy of the Document
              Name of Document                    Date of Issuance           Grouped by Intended User or       (Name and Address, Phone, FAX, E-mail or
                                                                                 Regulatory Activity                           Internet)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Level I Guidances
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Working Guide to Minimize Microbial    1998                        Farmers and Food Packers             Lou Carson (HFS-3), Food and Drug
 Hazards for Fresh Fruits and Vegetables                                                                       Administration, 200 C. St. SW.,
                                                                                                               Washington, DC 20204 or
                                                                                                               [email protected]
Notification of a Health Claim or Nutrient   1998                        Regulated Industry                   Office of Food Labeling (HFS-150), Food
 Content Claim Based on an Authoritative                                                                       and Drug Administration, 200 C. St. NW.,
 Statement of a Scientific Body                                                                                Washington, DC 20204
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               How to Obtain a Hard Copy of the Document
              Name of Document                    Date of Issuance           Grouped by Intended User or       (Name and Address, Phone, FAX, E-mail or
                                                                                 Regulatory Activity                           Internet)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Use of Human          April 1998                  FDA Regulated Industry               CVM Internet Home Page at http://
 Chorionic Gonadotropin (HCG) as a Spawning                                                                    www.fda.gov/cvm, or from CVM's
 Aid for Fish                                                                                                  Communications Staff (HFV-12), Food and
                                                                                                               Drug Administration, 7500 Standish Pl.,
                                                                                                               Rockville, MD 20855, 301-594-1755, fax
                                                                                                               301-594-1831
Guidance for Industry: GMP's For Medicated   May 1998                    Do                                   Do
 Feed Manufacturers Not Required to
 Register and Be Licensed With FDA
VICH Draft Guidance for Industry: Stability  July 1998                   Do                                   Do
 Testing of New Animal Drug Substances and
 Products
VICH Draft Guidance for Industry: Stability  July 1998                   Do                                   Do
 Testing for New Dosage Forms of New Animal
 Drugs: Draft Guidance
VICH Draft Guidance for Industry: Stability  July 1998                   Do                                   Do
 Testing: Photostability Testing of New
 Animal Drug Substances and Products
Guidance for Industry: Questions and         July 1998                   Do                                   Do
 Answers; BSE Feed Regulations
Guidance for Industry: Interpretation of On- August 1998                 Do                                   Do
 Farm Feed Manufacturing and Mixing
 Operations; Draft
Tolerances Established for Tetracyclines in  August 11, 1998 (Updated)   Do                                   Do
 Milk
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
Withdrawn
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Points to Consider Guideline: Development    1993                        Do
 of a Pharmacokinetic Guideline Enabling
 Flexible Labeling of Therapeutic
 Antimicrobials
--------------------------------------------------------------------------------------------------------------------------------------------------------

VII. Guidance Documents Issued by the Office of Regulatory Affairs

[[Page 902]]



 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               How to Obtain a Hard Copy of the Document
              Name of Document                    Date of Issuance           Grouped by Intended User or       (Name and Address, Phone, FAX, E-mail or
                                                                                 Regulatory Activity                           Internet)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide Medical Device       August 27, 1998             FDA Staff Personnel                  Division of Compliance Policy (HFC-230),
 Warning Letter Draft Pilot                                                                                    Office of Enforcement, Food and Drug
                                                                                                               Administration, 5600 Fishers Lane,
                                                                                                               Rockville, MD 20857, 301-827-0420 or via
                                                                                                               Internet at www.fda.gov/ora/compliance--
                                                                                                               ref/dev--pl.pdf
Compliance Policy Guide 675.400 (CPG         November 13, 1998           Do                                   Do--Internet at www.fda.gov/ora/
7126.24): REVISION Rendered Animal Feed                                                                       compliance--ref/cpg/cpgvet/
 Ingredients                                                                                                   cpg675.400.html
Regulatory Procedures Manual: UPDATE/        June 1998                   Do                                   Do--Internet at www.fda.gov/ora/
 REVISION Subchapter/Seizure                                                                                   compliance--ref/rpm--new2/ch6.html
Regulatory Procedures Manual: UPDATE/        June 1998                   Do                                   Do--Internet at www.fda.gov/ora/
 REVISION Subchapter/Supervisory Charges                                                                       compliance--ref/rpm--new2/ch9chgs.html
Regulatory Procedures Manual: NEW            July 1998                   Do                                   Do--Internet at www.fda.gov/ora/
 Subchapter/Civil Penalties--Electronic                                                                        compliance--ref/ch6civpen.html
 Product Radiation Control
Guide to Traceback of Fresh Fruits and       August 1998                 Do                                   Division of Emergency and Investigational
 Vegetables Implicated in Epidemiological                                                                      Operations (HFC-130), Office of Regional
 Investigations                                                                                                Operations, Food and Drug Administration,
                                                                                                               5600 Fishers Lane, Rockville, MD 20857
                                                                                                               301-443-3276
Guide to Inspections of Computerized         August 1998                 Do                                   Do--Internet at www.fda.gov/ora/inspect--
 Systems in the Food Processing Industry                                                                       ref/igf/iglist.html
Import Alerts                                Continuously                Do                                   Freedom of Information Staff (HFI-35),
                                                                                                               Food and Drug Administration, 5600
                                                                                                               Fishers Lane, Rockville, MD 20857, or via
                                                                                                               Internet at www.fda.gov/ora/fiars/ora--
                                                                                                               import--alerts.html
Investigations Operations Manual-REVISION;   July 1998                   Do                                   Division of Emergency and Investigational
 Chapter 4--Sampling                                                                                           Operations (HFC-130), Office of Regional
                                                                                                               Operations, Food and Drug Administration,
                                                                                                               5600 Fishers Lane, Rockville, MD 20857
                                                                                                               301-443-3276 or via internet at
                                                                                                               www.fda.gov/ora/inspect--ref/iom/
                                                                                                               iomtc.html
Investigations Operations Manual-REVISION;   July 1998                   Do                                   Do
 Chapter 5--Establishment Inspection
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
Documents Not Included on Previously Published Lists
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide--DRAFT               January 5, 1998             Do                                   Division of Compliance Policy (HFC-230),
 Commercialization of In Vitro Diagnostic                                                                      Office of Enforcement, Food and Drug
 Devices (IVD's) Labeled for Research Use                                                                      Administration, 5600 Fishers Lane,
 Only or Investigational Use Only                                                                              Rockville, MD 301-827-0420 or via
                                                                                                               internet at www.fda.gov/cdrh/comp/
ivddrfg.html
Compliance Policy Guide--DRAFT Distributor   August 28, 1998             Do                                   Do or via internet at www.fda/gov/ora/
 Medical Device Reporting                                                                                      compliance--ref/cpg--mdr3.txt
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
Withdrawn
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Policy Guide 530.400 (CPG         September 23, 1997          Do
 7121.02) Vitamin Products for Human Use--
 Low Potency
Compliance Policy Guide 210.150 ( CPG
 7134.09)Importation of Licensed Biological
 Products for Human Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
Corrections to July 6, 1998 Quarterly List
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guideline for the Monitoring of Clinical     Revised November 1998       FDA Regulated Industry               Division of Compliance Policy (HFC-230),
 Investigators                                                                                                 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 Should be identified as a DRAFT

[[Page 903]]

 
ComplianceProgram 7348.808, Bioresearch      Revised August 17, 1998     FDA Staff Personnel                  Do--Internet http://www.fda.gov/ora/
 Monitoring; Good Laboratory Practices                                                                         compliance--ref/bimo/default.html
 (Nonclinical)
Compliance Program 7348.810; Sponsors,       Revised October 30, 1998    Do                                   Do--Internet http://www.fda.gov/ora/
 Contract Research Organizations and                                                                           compliance--ref/bimo/default.html
 Monitors
Compliance Program 7348.811; Bioresearch     Revised September 2, 1998   Do                                   Do--Internet http://www.fda.gov/ora/
 Monitoring; Clinical Investigations                                                                           compliance--ref/bimo/default.html
The following documents are not available    October 1, 1991             Do                                   Do
 via the internet: Food Laboratory Practice
 Program (Nonclinical Laboratories)
 7348.808A; EPA Data Audit Inspections
Compliance Program 7348.809; Bioresearch     August 18, 1994
 Monitoring; Institutional Review Board
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

 
----------------------------------------------------------------------------------------------------------------
                                                                               How to Obtain a Hard Copy of the
          Name of Document             Date of   Grouped by Intended User or  Document (Name and Address, Phone,
                                      Issuance       Regulatory Activity           FAX, E-mail or Internet)
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry;         June 1998   FDA Regulated Industry       Via Internet at http://www.fda.gov/
 Exports and Imports under the FDA                                             opacom/fedregister/frexport.html
 Export Review and Enhancement Act
 of 1996
Policy & Guidance Handbook for FDA   1994        FDA Staff Personnel          National Technical Information
 Advisory Committees                                                           Service (NTIS), 5285 Port Royal
                                                                               Rd., Springfield, VA 22161, 703-
                                                                               487-4650 (Order No. PB94-158854)
----------------------------------------------------------------------------------------------------------------


    Dated: December 28, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-155 Filed 1-5-99; 8:45 am]
BILLING CODE 4160-01-F