[Federal Register Volume 65, Number 50 (Tuesday, March 14, 2000)]
[Notices]
[Pages 13771-13785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6117]


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

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.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing an update 
of all guidance documents issued and withdrawn since we compiled the 
annual comprehensive list of guidance documents that published on June 
10, 1999. FDA committed to publishing quarterly updates in its February 
1997 ``Good Guidance Practices'' (GGP's) final rule, which set forth 
the agency's policies and procedures for developing, issuing, and using 
guidance documents. This list is intended to inform the public of the 
existence and availability of guidance documents issued since the 
annual comprehensive list was compiled.

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. For information on where to obtain single copies 
of guidance documents listed here, see the specific center's list of 
guidance documents.

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

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 27, 1997 (62 FR 8961), FDA 
published a notice announcing its ``Good Guidance Practices'' (GGP's), 
which set forth our policies and procedures for developing, issuing, 
and using 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 our guidance documents.
    As part of FDA's effort to ensure meaningful interaction with the 
public regarding guidance documents, we committed to publishing 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 that we issued or withdrew since we published the annual 
comprehensive list on June 10,1999 (64 FR 31228). The guidance 
documents are organized by the issuing center or office within FDA, and 
are further grouped by the intended users or relevant regulatory 
activities. Dates provided in the following list refer to the date of 
the guidance was issued or, where applicable, the last date the 
document was revised. We provided document numbers where available.

[[Page 13772]]

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

 
------------------------------------------------------------------------
                                                    How to Obtain a Hard
                                      Grouped by    Copy of the Document
  Name of Document       Date of     Intended User    (Name and Address,
                        Issuance     or Regulatory   Phone, FAX, E-mail
                                       Activity         or  Internet)
------------------------------------------------------------------------
Draft Guidance for    May 1999      FDA Regulated   Office of
 Industry:                           Industry        Communication,
 Monoclonal                                          Training, and
 Antibodies Used as                                  Manufacturers
 Reagents in Drug                                    Assistance (HFM-
 Manufacturing                                       40), Center for
                                                     Biologics
                                                     Evaluation and
                                                     Research (CBER),
                                                     Food and Drug
                                                     Administration,
                                                     1401 Rockville
                                                     Pike, Rockville, MD
                                                     20852-1448, 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
____________________________________
Guidance for          May 1999      Do              Do
 Industry: Container
 Closure Systems for
 Packaging Human
 Drugs and
 Biologics;
 Chemistry,
 Manufacturing, and
 Controls
 Documentation
------------------------------------------------------------------------
Draft Guidance for    June 1999     Do              Do
 Industry:
 Establishing
 Pregnancy
 Registries
------------------------------------------------------------------------
Draft Reviewer        June 1999     Do              Do
 Guidance:
 Evaluation of Human
 Pregnancy Outcome
 Data
------------------------------------------------------------------------
Draft Guidance for    June 1999     Do              Do
 Industry: Current
 Good Manufacturing
 Practice for Blood
 and Blood
 Components: (1)
 Quarantine and
 Disposition of
 Prior Collections
 from donors with
 Repeatedly Reactive
 Screening Tests for
 Hepatitis C Virus
 (HCV); (2)
 Supplemental
 Testing, and the
 Notification of
 Consignees and
 Transfusion
 Recipients of donor
 Test Results for
 Antibody to HCV
 (Anti-HCV)
------------------------------------------------------------------------
ICH Guidance on the   June 25,      Do              Do
 Duration of Chronic   1999
 Toxicity Testing in
 Animals (Rodent and
 Nonrodent Toxicity
 Testing)
------------------------------------------------------------------------
Draft Guidance for    July 1999     Do              Do
 Industry: Clinical
 Development
 Programs for Drugs,
 Devices, and
 Biological Products
 Intended for the
 Treatment of
 Osteoarthritis (OA)
------------------------------------------------------------------------
Draft Guidance for    July 1999     Do              Do
 Industry:
 Interpreting
 Sameness of
 Monoclonal Antibody
 Products Under the
 Orphan Drug
 Regulations
------------------------------------------------------------------------
Draft Guidance for    August 1999   Do              Do
 Industry:
 Cooperative
 Manufacturing
 Arrangements for
 Licensed Biologics
------------------------------------------------------------------------
Guidance for          August 1999   Do              Do
 Industry: Consumer-
 Directed Broadcast
 Advertisements
------------------------------------------------------------------------
Draft Guidance for    August 1999   Do              Do
 Industry:
 Information Request
 and Discipline
 Review Letters
 Under the
 Prescription Drug
 User Fee Act
------------------------------------------------------------------------
ICH Guidance on       August 18,    Do              Do
 Specifications:       1999
 Test Procedures and
 Acceptance Criteria
 for
 Biotechnological/
 Biological Products
------------------------------------------------------------------------
Guidance for          August 1999   Do              Do
 Industry: Possible
 Dioxin/PCB
 Contamination of
 Drug and Biological
 Products
------------------------------------------------------------------------

[[Page 13773]]

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

[[Page 13774]]

 
Draft Guidance for    January 2000  Do              Do
 Industry: Changes
 to an Approved
 Application:
 Biological
 Products: Human
 Blood and Blood
 Components Intended
 for Transfusion or
 for Further
 Manufacture
------------------------------------------------------------------------

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

 
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                            How to Obtain a Hard Copy of the
                     Name of Document                              Date of Issuance                Group by Intended User  or Regulatory Activity       Document  (Name and Address, Phone, FAX,
                                                                                                                                                                  E-mail or  Internet)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Staff--Guidance on Medical   January 24, 2000                  Office of Compliance (OC)                                  Division of Small Manufacturers
 Device Tracking (FDAMA) (Replaces: Guidance for Industry                                                                                                Assistance, 1-800-638-2041 or 301-827-
 and FDA Staff--Guidance on Medical Device Tracking                                                                                                      0111 or
 (FDAMA) 2/12/99)                                                                                                                                       (FAX) Facts-on-Demand at 1-800-899-0381
                                                                                                                                                         or
                                                                                                                                                        Internet: http://www.fda.gov/cdrh
________________________________________________________________________________________________
Guidance for FDA Staff--Civil Money Penalty Policy         June 8, 1999                      Do                                                             Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Alternative to Certain Prescription Device Labeling        January 21, 2000                  Do                                                             Do
 Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance on Information Disclosure  October 18, 1999                  OC/Division of Enforcement I (DOEI)                            Do
 by Manufacturers to Assemblers for Diagnostic X-ray
 Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Electrosurgical Devices and the Application    November 15, 1999                 Do                                                             Do
 of the Performance Standard for Electrode Lead Wires and
 Patient Cables
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Draft Guidance on Quality System    August 3, 1999                    OC/Division of Enforcement II (DOE II)                         Do
 Regulation Information for Various Premarket Submissions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for FDA Staff--Regulating In Vitro Diagnostic     December 17, 1999                 OC/Division of Bioresearch Monitoring (DBM)                    Do
 Device (IVD) Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry on the Likelihood of Facilities      August 5, 1999                    OC/Division of Program Operations (DPO)                        Do
 Inspections When Modifying Devices Subject to Premarket
 Approval
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
The FDA Export Reform and Enhancement Act of 1996/Export   June 22, 1999                     Do                                                             Do
 Certification Package including ``Instructions for
 Requests for Certificate to Foreign Governments''
 (Replaces: The FDA Export Reform and Enhancement Act of
 1996/Export Certification 10/1/96)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Compliance Program Guidance Manual: Inspection of    August 12, 1999                   Do                                                             Do
 Medical Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Off-the-Shelf Software Use in Medical         September 9, 1999                 Office of Device Evaluation (ODE)                              Do
 Devices--Draft Guidance (Replaces: Guidance for Off-the-
 Shelf Software Use in Medical Devices--Draft Guidance
 August 17, 1998)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 13775]]

 
Guidance for Industry and FDA Reviewers on Evidence        September 1, 1999                 DO                                                             Do
 Models for the Least Burdensome Means to Market
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on the Labeling for Over-the-Counter Sample       December 21, 1999                 ODE/Division of Clinical Laboratory Devices (DCLD)             Do
 Collection Systems for Drugs of Abuse Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Labeling for Laboratory Tests                  June 24, 1999                     DO                                                             Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance on Premarket Approval Applications for      October 8, 1999                   Do                                                             Do
 Assays Pertaining to Hepatitis C Viruses (HCV) that Are
 Indicated for Diagnosis or Monitoring of HCV Infection
 or Associated Disease
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance and Format of Premarket Notification (510(k))     January 3, 2000                   ODE/Division of Dental, Infection Control and General          Do
 Submissions for Liquid Chemical Sterilants/High Level                                        Hospital Devices (DDIGD)
 Disinfectants (Replaces: Draft Guidance on the Content
 and Format of Premarket Notification (510(k)) Submission
 for Liquid Chemical Sterilants and High Level
 Disinfectants (12/18/97)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reprocessing and Reuse of Single-Use Devices--Risk         December 9, 1999                  Do                                                             Do
 Categorization Scheme
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Conducting Stability Testing To Support An    November 16, 1999                 Do                                                             Do
 Expiration Date Labeling Claim for Medical Gloves
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Cardiovascular Intravascular Filter 510(k)    November 26, 1999                 ODE/Division of Cardiovascular, Respiratory &                  Do
 Submission                                                                                   Neurological Devices (DCRND)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and for FDA Reviewers: Recommended   May 7, 1999                       Do                                                             Do
 Clinical Study Design for Ventricular Tachycardia
 Ablation
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Vascular Prostheses 510(k)           November 26, 1999                 Do                                                             Do
 Submissions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Annuloplasty Rings 510(k) Submissions         November 26, 1999                 Do                                                             Do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Cardiovascular Intravascular Filter 510(k)    November 26, 1999                 Do                                                             Do
 Submissions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Cardiopulmonary Bypass Oxygenators 510(k)     January 17, 2000                  Do                                                             Do
 Submissions
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of Research and Marketing      January 14, 2000                  Do                                                             Do
 Applications for Permanent Pacemaker Leads and for
 Pacemaker Lead Adaptor 510(k) Submissions (Replaces:
 Implantable Pacemaker Lead Testing Guidance for the
 Submission of a Section 510(k) Notification September 1,
 1989)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and/or for FDA Reviewers/Staff and/  May 7, 1999                       ODE/Division of General & Restorative Devices (DGRD)           Do
 or Compliance--Guidance for Spinal System 510(k)s
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 13776]]

 
Guidance for Industry--Guidance for the Preparation of a   August 30, 1999                   Do                                                             Do
 Premarket Notification Application for Processed Human
 Dura Mater (Replaces: Guidance for Industry--Guidance
 for the Preparation of a Premarket Notification
 Application for Processed Human Dura Mater July 31,
 1999)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance Document for Neurological  August 13, 1999                   Do                                                             Do
 Embolization Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance Document for Dura          August 13, 1999                   DO                                                             Do
 Substitute Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance on Preclinical and         October 5, 1999                   Do                                                             Do
 Clinical Data and Labeling for Breast Prostheses
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry, FDA Reviewers/Staff and             June 9, 1999                      Do                                                             Do
 Compliance--Guidance Document for Powered Muscle
 Stimulator 510(k)s
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Resorbable Adhesion Barrier Devices for Use   December 16, 1999                 Do                                                             Do
 in Abdominal and/or Pelvic Surgery
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Intraocular Lens (IOL) Guidance Document; Draft (Replaces  October 14, 1999                  ODE/Division of Ophthalmic Devices (DOD)                       Do
 Intraocular Lens (IOL) Guidance Document Draft,
 September 10, 1997)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and for FDA Reviewers--              August 4, 1999                    Do                                                             Do
 Accountability for Clinical Studies for Ophthalmic
 Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and for FDA Reviewers/Staff--              --                          ODE/DOD                                                        Do
 Guidance on 510(k) Submissions for Keratoprostheses
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Home Uterine Activity Monitors: Guidance for the           July 30, 1999                     ODE/Division of Reproductive, Abdominal, ENT &                 Do
 Submission of 510(k) Premarket Notifications (Replaces:                                      Radiological Devices (DRAERD)
 Premarket Testing Guidelines for Home Uterine Activity
 Monitors March 31, 1993)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of 510(k)s for Solid State X-  August 6, 1999                    Do                                                             Do
 ray Imaging Devices
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry: Electro-optical Sensors for the In  August 25, 1999                   Do                                                             Do
 Vivo Detection of Cervical Cancer and its Precursors:
 Submission Guidance for an IDE/PMA; Draft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Announcement for FOD: Guidance for Industry and FDA--      August 12, 1999                   Office of Health and Industry Programs (OHIP)/Division of      Do
 Medical Glove Guidance Manual; Draft FDA 99-4257                                             Small Manufacturers Assistance (DSMA)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Device Use Safety: Incorporating    August 3, 1999                    OHIP/Division of Device User Programs and Systems              Do
 Human Factors in Risk Management                                                             Analysis (DUPSA)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance: The Mammography Quality Standards     January 14, 2000                  OHIP/Division of Mammography Quality and Radiation
 Act Final Regulations Document #2                                                            Programs (DMQRP)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 13777]]

 
Compliance Guidance: The Mammography Quality Standards     December 8, 1999                  Do                                                             Do
 Act Final Regulations Document #3
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance--Mammography Facility Survey and       May 5, 1999                       Do                                                             Do
 Medical Physicist Qualification Requirements Under MQSA
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance--The Mammography Quality Standards     May 5, 1999                       Do                                                             Do
 Act Final Regulations--Preparing for MQSA Inspections
 (Replaces: Compliance Guidance--Preparing for MQSA
 Inspections 6/30/95)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Request and Issuance of Interim Notice        May 4, 1999                       Do                                                             Do
 Letters for Mammography Facilities Under the mammography
 Quality Standards Act, 42 U.S.C. Section 263(b)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Addendum to the Instructions for Completing FDA Form       June 9, 1999                      Office of Surveillance and Biometrics (OSB)                    Do
 3500A with Coding Manual (MEDWATCH) (MDR)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Reviewers: Guidance on       May 6, 1999                       Office of Science and Technology (OST)/Division of Life        Do
 Immunotoxicity Testing                                                                       Science (DLS)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--CDRH Standard Operating Procedures  August 6, 1999                    OST/ODE                                                        Do
 for the Identification and Evaluation of Candidate
 Consensus Standard for Recognition
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry on the Testing of Metallic Plasma    February 22, 1999                 OSB/Division of Postmarket Surveillance (DPS)                  Do
 Sprayed Coatings on Orthopedic Implants to Support
 Reconsideration of Postmarket (Replaces: Guidance for
 Industry on the Testing of Metallic Plasma Sprayed
 Coatings on Orthopedic Implants to Support
 Reconsideration of Postmarket--No Date Available)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


 
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Withdrawals
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                     Name of Document                              Date of Issuance                Group by Intended User or Regulatory Activity                     Date Withdrawn
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance on Premarket Notification 510(k) for Sterilizers  March 3, 1993                     OC                                                         June 29, 1999
 Intended for Use in Health Care Facilities March 3, 1993
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Global Harmonization Task Force Study Group 3--Draft       1998                              Do                                                         June 22, 1999
 Process Validation Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Staff--Guidance on Medical   February 12, 1999                 Do                                                         January 24, 2000
 Device Tracking (FDAMA) (Replaced by: Guidance for
 Industry and FDA Staff--Guidance on Medical Device
 Tracking (FDAMA) January 24, 2000)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Regulatory Requirements for Medical Gloves--A Workshop     September 1, 1996                 OC/DOEII                                                   July 7, 1999
 Manual FDA Publication No 96.4257
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 13778]]

 
The FDA Export Reform and Enhancement Act of 1996/Export   October 1, 1996                   OC/DPO                                                     September 29, 1999
 Certification
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for Abbreviated 510(k) Submissions for   1998                              ODE                                                        June 29, 1999
 In Vitro Diagnostic Calibrators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Freedom of Information/510(K) Process Changes              May 15, 1997                      Do                                                         May 26, 1999
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Off-the-Shelf Software Use in Medical         August 17, 1998                   Do                                                         October 5, 1999
 Devices--Draft Guidance
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Reexamination of the Evaluation Process for Liquid         May 19, 1997                      Do                                                         January 11, 2000
 Chemical Sterilants and High Level Disinfectants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PMA Summaries of Safety and Effectiveness--Review by the   July 25, 1986                     ODE/BlueBook                                               May 26, 1999
 Office of General Counsel (blue book memo #P85-1)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Submission of 510(k) Premarket            February 11, 1997                 ODE/DCRND                                                  December 13, 1999
 Notifications for Cardiovascular Intravascular Filters--
 Version 1.0
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance For The Submission of      June 1, 1998                      Do                                                         October 18, 1999
 Research and Marketing Applications for Permanent
 Pacemaker Leads
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Outline of Recommended Procedures for a Clinical           1998                              ODE/Division of Dental, Infection Control and General      May 5, 1999
 Investigation of Endosseous Implants Under a 510(k)                                          Hospital Devices (DDIGD)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Outline of Recommended Procedures for Animal Laboratory    1998                              Do                                                         May 5, 1999
 Studies of Endosseous Implants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Information Needed for Hydroxyapatite Coated        July 6, 1993                      Do                                                             Do
 Titanium Endosseous Implants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Information Needed for Ti-Powder Coated Titanium    July 13, 1993                     Do                                                             Do
 Endosseous Implants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Information Needed for Metallurgical Endosseous     August 12, 1993                   Do                                                             Do
 Implants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket         January 23, 1995                  Do                                                             Do
 Notifications [510(k)s] for Temporomandibular Joint
 Implants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance on the Content and Format of Premarket      December 18, 1997                 Do                                                         January 11, 2000
 Notification (510(k)) Submission for Liquid Chemical
 Sterilants and High Level Disinfectants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guideline for Reviewing Spinal Fixation Device       January 9, 1997                   ODE/DGRD                                                   June 1, 1999
 Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guide for 510(k) Review of Processed Human Dura Mater      June 26, 1990                     Do                                                         August 9, 1999
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Preparation of PMA Applications for     January 18, 1995                  Do                                                         August 16, 1999
 Silicone Inflatable (Saline) Breast Prostheses
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Guidance for Testing of Alternative Breast           September 1, 1994                 Do                                                         September 1, 1994
 Prostheses (nonsilicone gel-filled)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 13779]]

 
Draft Guidance for Preparation of FDA Submissions of       May 11, 1992                      Do                                                         August 16, 1999
 Silicone Gel-Filled Breast Prostheses
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Guidance for the Preparation of a   July 31, 1999                     Do                                                         September 7, 1999
 Premarket Notification Application for Processed Human
 Dura Mater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Technological Reporting For Powered Muscle Stimulator      January 1, 1993                   DO                                                         June 29, 1999
 510(k) (EMS)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance Document for the Preparation of Premarket         July 26, 1995                     Do                                                         June 29, 1999
 Notification [510(k)] Applications for Powered Muscle
 Stimulators, and Ultrasound Diathermy and Muscle
 Stimulators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Electrical Muscle Stimulator (EMS) Labeling Indications;   July 11, 1985                     Do                                                         June 29, 1999
 Contraindications; Warnings; etc.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Draft Intraocular Lens (IOL) Guidance Document             October 10, 1997                  ODE/DOD                                                    July 21, 1999
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for the Content of Premarket Notifications for    February 5, 1998                  ODE/DRAERD                                                 June 29, 1999
 Metal Expandable Biliary Stents
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
In-vivo Devices for the Detection of Cervical Cancer and   June 14, 1997                     Do                                                         May 26, 1999
 its Precursors: Submission Guidance for an IDE Draft
 Document
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket Testing Guidelines for Home Uterine Activity     March 31, 1993                    Do                                                         June 2, 1999
 Monitors
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Information for Manufacturers Seeking Marketing Clearance  June 19, 1996                     Do                                                         June 29, 1999
 of Digital Mammography Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Obtaining CDRH Guidance Documents                          March 29, 1999                    OHIP/DSMA                                                  May 11, 1999
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
List of Current CDRH Addresses for Report Submission and   July 30, 1996                     OHIP/DUPSA                                                 October 20, 1999
 Ordering of CDRH Forms
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Addendum to What a Mammography Facility Should do to       July 31, 1996                     OHIP/DMQRP                                                 May 12, 1999
 Prepare for an MQSA Inspection
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Guidance--Preparing for MQSA Inspections        June 30, 1995                     Do                                                         May 13, 1999
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for completing Semi-Annual Report, Form 3419  September 24, 1996                OSB                                                        May 21, 1999
 (MDR)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry on the Testing of Metallic Plasma    No date available                 OSB/Division of Postmarket Surveillance (DPS)              January 7, 2000
 Sprayed Coatings on Orthopedic Implants to Support
 Reconsideration of Postmarket
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 13780]]

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

 
----------------------------------------------------------------------------------------------------------------
                                                                                           How to Obtain a Hard
                                                                    Grouped by Intended    Copy of the  Document
            Name of Document                 Date of Issuance       User or Regulatory      (Name and Address,
                                                                         Activity         Phone,  FAX, E-mail or
                                                                                                 Internet)
----------------------------------------------------------------------------------------------------------------
ANDAs: Blend Uniformity Analysis          August 26, 1999         Generic Drug Draft      Office of Training and
                                                                                           Communication, Drug
                                                                                           Information Branch,
                                                                                           Food and Drug
                                                                                           Administration, 5600
                                                                                           Fishers Lane,
                                                                                           Rockville, Md 20857,
                                                                                          Internet: http://
www.fda.gov/cder/
guidance/index.htm
________________________________________________________
ANDAs: Impurities in Drug Substances      December 3, 1999        Generic Drug            Do
----------------------------------------------------------------------------------------------------------------
Applications Covered by Section           December 8, 1999        Procedural Draft        Do
 505(b)(2)
----------------------------------------------------------------------------------------------------------------
Average, Population, and Individual       August 27, 1999         Biopharmaceutic Draft   Do
 Approaches to Establishing
 Bioequivalence
----------------------------------------------------------------------------------------------------------------
BA and BE Studies for Orally              August 27, 1999         Do                      Do
 Administered Drug Products
----------------------------------------------------------------------------------------------------------------
Bioavailability and Bioequivalence        June 2, 1999            Do                      Do
 Studies for Nasal Aerosols and Nasal
 Sprays for Local Action
----------------------------------------------------------------------------------------------------------------
Catheter-Related Bloodstream Infections - October 18, 99          Clinical Antimicrobial  Do
  Developing Antimicrobial Drugs for                               Draft
 Treatment
----------------------------------------------------------------------------------------------------------------
Changes to an Approved NDA or ANDA        November 23, 1999       Chemistry               Do
----------------------------------------------------------------------------------------------------------------
Clinical Considerations for Accelerated   September 1, 1999       Clinical Medical Draft  Do
 and Traditional Approval of
 Antiretroviral Drugs Using Plasma HIV
 RNA Measurements
----------------------------------------------------------------------------------------------------------------
Clinical Development Programs for Drugs,  July 15, 1999           Do                      Do
 Devices, and Biological Products
 Intended for the Treatment of
 Osteoarthritis (OA)
----------------------------------------------------------------------------------------------------------------
Computerized Systems Used in Clinical     May 10, 1999            Compliance              Do
 Trials
----------------------------------------------------------------------------------------------------------------
Consumer-Directed Broadcast               August 9, 1999          Advertising             Do
 Advertisements
----------------------------------------------------------------------------------------------------------------
Disclosure of Materials Provided to       November 30, 1999       Procedural              Do
 Advisory Committees in Connection with
 Open Advisory Committee Meetings
 Convened by the Center for Drug
 Evaluation and Research
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry on            December 22, 1999       Procedural Draft        Do
 Disclosing Information Provided to
 Advisory Committees in Connection with
 Open Advisory Committee Meetings
 Related to the Testing or Approval of
 New Drugs and Convened by CDER,
 Beginning January 1, 2000; Availability
----------------------------------------------------------------------------------------------------------------
Drug Master Files for Bulk Antibiotic     November 29, 1999       Chemistry               Do
 Drug Substances: Availability
----------------------------------------------------------------------------------------------------------------
E10 - Choice of Control Group in          September 24, 1999      ICH Draft - Efficacy    Do
 Clinical Trials
----------------------------------------------------------------------------------------------------------------
Establishing Pregnancy Registries         June 4, 1999            Clinical Medical Draft  Do
----------------------------------------------------------------------------------------------------------------
Evaluation of Human Pregnancy Outcome     June 4, 1999            Do                      Do
 Data
----------------------------------------------------------------------------------------------------------------
In Vivo Metabolism/Drug Interaction       November 24, 1999       Clinical Pharmacology   Do
 Studies - Study Design, Data Analysis,
 and Recommendations for Dosing and
 Labeling
----------------------------------------------------------------------------------------------------------------

[[Page 13781]]

 
In Vivo Pharmacokinetics and              June 10, 1999           Clinical Medical Draft  Do
 Bioavailability Studies and In Vitro
 Dissolution Testing for Levothyroxine
 Sodium Tablets
----------------------------------------------------------------------------------------------------------------
Information Request and Discipline        August 17, 1999         Procedural Draft        Do
 Review Letters Under the Prescription
 Drug User Fee Act
----------------------------------------------------------------------------------------------------------------
Labeling OTC Human Drug Products Using a  December 1, 1999        OTC Draft               Do
 Column Format
----------------------------------------------------------------------------------------------------------------
Levothyroxine Sodium                      August 18, 1999         Clinical Medical Draft  Do
----------------------------------------------------------------------------------------------------------------
Major, Minor, Facsimile, and Telephone    August 11,1999          Generic Drug            Do
 Amendments to Original Abbreviated New
 Drug Applications
----------------------------------------------------------------------------------------------------------------
Monoclonal Antibodies Used as Reagents    June 24, 1999           Chemistry Draft         Do
 in Drug Manufacturing
----------------------------------------------------------------------------------------------------------------
Nasal Spray and Inhalation Solution,      June 2, 1999            Do                      Do
 Suspension, and Spray Drug Products
----------------------------------------------------------------------------------------------------------------
Noncontraceptive Estrogen Class Labeling  September 27, 1999      Labeling Draft          Do
----------------------------------------------------------------------------------------------------------------
Pharmacokinetics in Patients With         December 7, 1999        Clinical Pharmacology   Do
 Impaired Hepatic Function: Study
 Design, Data Analysis, and Impact on
 Dosing and Labeling
----------------------------------------------------------------------------------------------------------------
Photosafety Testing                       January 10, 2000        Pharmacology/           Do
                                                                   Toxicology
----------------------------------------------------------------------------------------------------------------
Possible Dioxin/PCB Contamination of      August 23, 1999         Compliance              Do
 Drug and Biological Products
----------------------------------------------------------------------------------------------------------------
Preparing Data for Electronic Submission  September 21, 1999      Generic Drug            Do
 in ANDAs
----------------------------------------------------------------------------------------------------------------
Q6B-Test Procedures and Acceptance        August 18, 1999         ICH-Quality             Do
 Criteria for Biotechnological/
 Biological Products
----------------------------------------------------------------------------------------------------------------
Qualifying for Pediatric Exclusivity      October 1, 1999         Procedural              Do
 Under Section 505A of the Federal Food,
 Drug, and Cosmetic Act-Revised
----------------------------------------------------------------------------------------------------------------
S4A Duration of Chronic Toxicity Testing  June 25, 1999           ICH-Safety              Do
 in Animals (Rodent and Nonrodent
 Toxicity Testing)
----------------------------------------------------------------------------------------------------------------
Submission of Abbreviated Reports and     September 13, 1999      Clinical Medical        Do
 Synopses in Support of Marketing
 Applications
----------------------------------------------------------------------------------------------------------------
Submission of Documentation in Drug       July 7, 1999            Chemistry               Do
 Applications for Container Closure
 Systems Used for the Packaging of Human
 Drugs and Biologics
----------------------------------------------------------------------------------------------------------------


 
----------------------------------------------------------------------------------------------------------------
                                                   Withdrawals
-----------------------------------------------------------------------------------------------------------------
                                                                    Grouped by Intended
            Name of Document                 Date of Issuance       User or Regulatory        Date Withdrawn
                                                                         Activity
----------------------------------------------------------------------------------------------------------------
Alprazolam Tablets In Vivo                November 27, 1992       Biopharmaceutic         July 8, 1999
 Bioequivalence and In Vitro Dissolution
 Testing
----------------------------------------------------------------------------------------------------------------
Bumetanide Tablets In Vivo                April 23, 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
----------------------------------------------------------------------------------------------------------------
Cefaclor Capsules and Suspension In Vivo  April 23, 1993          Do                      Do
 Bioequivalence and In Vitro Dissolution
 Testing
----------------------------------------------------------------------------------------------------------------

[[Page 13782]]

 
Diflunisal Tablets In Vivo                May 16, 1992            Do                      Do
 Bioequivalence and In Vitro Dissolution
 Testing
----------------------------------------------------------------------------------------------------------------
Diltiazem Hydrochloride Tablets In Vivo   May 16, 1992            Do                      Do
 Bioequivalence and In Vitro Dissolution
 Testing
----------------------------------------------------------------------------------------------------------------
Flurbiprofen (tablets) In Vivo            June 8, 1995            Do                      Do
 Bioequivalence and In Vitro Dissolution
 Testing
----------------------------------------------------------------------------------------------------------------
Gemfibrozil Capsules or Tablets In Vivo   June 16, 1992           Do                      Do
 Bioequivalence and In Vitro Dissolution
 Testing
----------------------------------------------------------------------------------------------------------------
Guanabenz Acetate Tablets In Vivo         April 23, 1993          Do                      Do
 Bioequivalence and In Vitro Dissolution
 Testing
----------------------------------------------------------------------------------------------------------------
Hydroxychloroquine 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                      July 8, 1999
 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) In  September 17, 1987      Do                      Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
----------------------------------------------------------------------------------------------------------------
Metoprolol Tartrate (tablets) In Vivo     June 12, 1992           Do                      Do
 Bioequivalence and In Vitro Dissolution
 Testing
----------------------------------------------------------------------------------------------------------------
Nadolol (tablets) In Vivo Bioequivalence  May 16, 1992            Do                      Do
 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
----------------------------------------------------------------------------------------------------------------
Pentoxifylline (extended-release          December 22, 1995       Do                      Do
 tablets) In Vivo Bioequivalence and In
 Vitro Dissolution Testing
----------------------------------------------------------------------------------------------------------------
Pindolol (tablets) In Vivo                April 23, 1993          Do                      Do
 Bioequivalence and In Vitro Dissolution
 Testing
----------------------------------------------------------------------------------------------------------------
Piroxicam (capsules) In Vivo              June 15, 1999           Do                      Do
 Bioequivalence and In Vitro Dissolution
 Testing
----------------------------------------------------------------------------------------------------------------
Ranitidine Hydrochloride (tablets) In     April 23, 1993          Do                      Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
----------------------------------------------------------------------------------------------------------------
Trazodone Hydrochloride (tablets) In      April 30, 1988          Do                      Do
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
----------------------------------------------------------------------------------------------------------------
Waiver Policy                             March 29, 1993          Biopharmaceutic Draft   Do
----------------------------------------------------------------------------------------------------------------
Bioavailability Policies and Guidelines   N/A                     Biopharmaceutic Draft   Do
----------------------------------------------------------------------------------------------------------------
SUPAC-IR: Immediate Release and Solid     October 21, 1997        Chemistry Draft         February 26, 1999
 Oral Dosage Forms; Manufacturing
 Equipment Addendum
----------------------------------------------------------------------------------------------------------------
Selegiline Hydrochloride (tablets) In     December 22, 1995       Biopharmaceutic         December 27, 1999
 Vivo Bioequivalence and In Vitro
 Dissolution Testing
----------------------------------------------------------------------------------------------------------------


[[Page 13783]]

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

 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                              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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Antimicrobial Food Additives--Guidance       July 1999                   Industry and Center for Food Safety  Mark Hepp, Ph.D., (HFS-215)
                                                                          and Applied Nutrition Staff           OPA/CFSAN/FDA
                                                                                                                200 C Street. S.W.
                                                                                                                Washington, DC 20204
                                                                                                                202-418-3098
                                                                                                              Internet: http://vm.cfsan.fda.gov/
                                                                                                               dms/opa-antg.html
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Preparation of        Sept. 1999                  Regulated Industry                   Mitch Cheeseman, Ph.D., (HFS-215)
 Premarket Notifications for Food Contact                                                                       OPA/CFSAN/FDA
 Substances--Chemistry Recommendations                                                                          200 C Street. S.W.
                                                                                                                Washington, DC 20204
                                                                                                                202-418-3083
                                                                                                              Internet: http://vm.cfsan.fda.gov/
                                                                                                               dms/opa-pmnc.html
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guidance for Industry--Preparation of        Sept. 1999                  Regulated Industry                   Mitch Cheeseman, Ph.D., (HFS-215)
 Premarket Notifications for Food Contact                                                                       OPA/CFSAN/FDA
 Substances--Toxicology Recommendations                                                                         200 C Street. S.W.
                                                                                                                Washington, DC 20204
                                                                                                                202-418-3083
                                                                                                                Internet: http://vm.cfsan.fda.gov/
                                                                                                               dms/
                                                                                                                opa-pmnt.html
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

 
------------------------------------------------------------------------
                                                         How to Obtain a
                                                        Hard Copy of the
                                         Grouped by       Document (Name
 Name of Document   Date of Issuance  Intended User or    and Address,
                                         Regulatory      Phone, FAX, E-
                                          Activity           mail or
                                                            Internet)
------------------------------------------------------------------------
Guidance for       June 1999          Animal Drug       Communications
 Industry:                             Industry          Staff (HFV-12),
 Chemistry,                                              FDA/CVM, 7500
 Manufacturing                                           Standish Pl.,
 and Controls                                            Rockville, MD
 Changes to an                                           20855, 301-594-
 Approved NADA or                                        1755,
 ANADA: Draft                                           FAX 301-594-1831
 Guidance                                               Internet: http://
www.fda.gov/cvm
____________________________________
Draft Guidance     July 1999          Do                Do
 for Industry:
 Good Clinical
 Practices
------------------------------------------------------------------------
Guidance for       July 1999          Do                Do
 Industry:
 Efficacy of
 Anthelmintics:
 General Recom-
 mendations:
 Draft Guidance
------------------------------------------------------------------------
Guidance for       July 1999          Do                Do
 Industry:
 Stability
 Testing for
 Medicated
 Premixes Draft
 Guidance
------------------------------------------------------------------------
Guidance for       July 1999          Do                Do
 Industry:
 Impurities in
 New Veterinary
 Drug Substances
 Draft Guidance
------------------------------------------------------------------------
Guidance for       July 1999          Do                Do
 Industry:
 Impurities in
 New Veterinary
 Medical Products
 Draft Guidance
------------------------------------------------------------------------
Guidance for       July 1999          Do                Do
 Industry:
 Efficacy of
 Anthelmintics:
 Specific
 Recommendations
 for Bovines:
 Draft Guidance
------------------------------------------------------------------------
Guidance for       July 1999          Do                Do
 Industry:
 Efficacy of
 Anthelmintics:
 Specific
 Recommendations
 for Ovines:
 Draft Guidance
------------------------------------------------------------------------

[[Page 13784]]

 
Guidance for       July 1999          Do                Do
 Industry--Valida
 tion of
 Analytical
 Procedures:
 Definition and
 Terminology
------------------------------------------------------------------------
Guidance for       July 1999          Do                Do
 Industry--Valida
 tion of
 Analytical
 Procedures:
 Methodology:
 Final Guidance
------------------------------------------------------------------------
Guidance for       July 1999          Do                Do
 Industry:
 Efficacy of
 Anthelmintics:
 Specific
 Recommendations
 for Caprines:
 Draft Guidance
------------------------------------------------------------------------
Guidance for       August 1999        Do                Do
 Industry:
 Manufacture and
 Distribution of
 Unapproved
 Piperazine
 Products
------------------------------------------------------------------------
Guidance for       August 1999        Do                Do
 Industry:
 Possible Dioxin/
 PCB
 Contamination of
 Drug and
 Biological
 Products
------------------------------------------------------------------------
Guidance for       August 1999        Do                Do
 Industry--Consum
 er-Directed
 Broadcast
 Advertisements:
 Final Guidance
------------------------------------------------------------------------
Guidance for       September 1999     Do                Do
 Industry:
 Stability
 Testing of New
 Veterinary
 Dosage Forms
 VICH GL4: Final
 Guidance
------------------------------------------------------------------------
Guidance for       September 1999     Do                Do
 Industry:
 Stability
 Testing of New
 Veterinary Drug
 Substances and
 Medicinal
 Products VICH
 GL3: Final
 Guidance
------------------------------------------------------------------------
Guidance for       September 1999     Do                Do
 Industry:
 Environmental
 Impact
 Assessments
 (EIA's) for
 Veterinary
 Medicinal
 Products
 (VMP's)--Phase
 I: Draft
 Guidance
------------------------------------------------------------------------
Guidance for       September 1999     Do                Do
 Industry:
 Quality of
 Biotechnological
 Products in the
 Veterinary
 Field: Stability
 Testing of
 Biotechnological/
  Biological
 Products VICH GL
 17: Draft
 Guidance
------------------------------------------------------------------------
Guidance for       September 1999     Do                Do
 Industry:
 Impurities:
 Residual
 Solvents VICH GL
 18: Draft
 Guidance
------------------------------------------------------------------------
Guidance for       September 1999     Do                Do
 Industry--Conten
 t and Format of
 Effectiveness
 and Target
 Animal Safety
 Technical
 Sections and
 Final Study
 Reports for
 Submission to
 the Division of
 Therapeutic
 Drugs for Non-
 Food Animals
------------------------------------------------------------------------
Guidance for       September 1999     Do                Do
 Industry:
 Stability
 Testing:
 Photostability
 Testing of New
 Veterinary Drug
 Substances and
 Medicinal
 Products: Final
 Guidance
------------------------------------------------------------------------
Computerized       October 1999       Do                Do
 Systems Used in
 Clinical Trials
------------------------------------------------------------------------

[[Page 13785]]

 
Dioxin in Anti-    October 1999       Do                Do
 Caking Agents
 Used in Animal
 Feed and Feed
 Ingredients
------------------------------------------------------------------------
Guidance for       December 1999      Do                Do
 Industry--Evalua
 tion of the
 Human Health
 Impact of the
 Microbial
 Effects of
 Antimicrobial
 New Animal Drugs
 Intended for Use
 in Food-
 Producing
 Animals
------------------------------------------------------------------------

VII. Guidance Documents Issued by Office of Regulatory Affairs

 
----------------------------------------------------------------------------------------------------------------
                                                                                       How to obtain a Hard Copy
                                                           Grouped by Intended User    of the Document (Name and
      Name of Document             Date of Issuance         of Regulatory Activity      Address, Phone, FAX, E-
                                                                                           mail or Internet)
----------------------------------------------------------------------------------------------------------------
Guide to Inspections of      August 1999                  FDA Personnel               Division of Emergency and
 Quality Systems                                                                       Investigational
                                                                                       Operations (HFC-130),
                                                                                       Office of Regional
                                                                                       Operations, Food and Drug
                                                                                       Administration, 5600
                                                                                       Fishers Lane, Rockville,
                                                                                       MD 20857, 301-827-5636
                                                                                      Internet: http://
www.fda.gov/ora/inspect_
ref/igs/qsit/
QSITGUIDE.PDF
________________________________________________________
Import Alerts                Continuously                 FDA Personnel               Freedom of Information
                                                                                       Staff (HFI-35), Food and
                                                                                       Drug Administration, 5600
                                                                                       Fishers Lane, Rockville,
                                                                                       MD
                                                                                      Internet: http://
www.fda.gov/ora/fiars/
ora_import_alerts.html
----------------------------------------------------------------------------------------------------------------


 
------------------------------------------------------------------------
                                         Grouped by
                                      Intended User or
   Withdrawals      Date of Issuance     Regulatory      Date Withdrawn
                                          Activity
------------------------------------------------------------------------
Compliance Policy                     FDA Personnel     December 23,
 Guide (CPG),                                            1999
 Chapter 3, Sec.
 305.100,
 Accupuncture
 Devices and
 Accessories (CPG
 7124.11)
 Revoked:
 December 23,
 1999.
------------------------------------------------------------------------


    Dated: March 7, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-6117 Filed 3-13-00; 8:45 am]
BILLING CODE 4160-01-F