[Federal Register: March 14, 2000 (Volume 65, Number 50)] [Notices] [Page 13771-13785] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr14mr00-81] ----------------------------------------------------------------------- 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SUMMARY: The Food and Drug Administration (FDA) is publishing an update of all guidance documents issued and withdrawn since we compiled the annual comprehensive list of guidance documents that published on June 10, 1999.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list of guidance documents and quarterly Federal Register notices that list all guidance documents that were issued and withdrawn during that quarter, including ``Level 2'' guidance documents.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