Notices. Notice
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/register/2003/04/04/03-8262·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 03N-0094] Annual Guidance Agenda AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is publishing its annual guidance document agenda. FDA committed to publishing, on an annual basis, a list of possible topics for future guidance document development or revision during the next year, and seeking public comment on additional ideas for new guidance documents or revisions of existing ones. This commitment was made in FDA's September 2000 good guidance practices
(GGPs)final rule, which sets forth the agency's policies and procedures for the development, issuance, and use of guidance documents. This list is intended to seek public comment on possible topics for guidance documents and possible revisions to existing guidance. DATES: Submit written or electronic comments on this list and on agency guidance documents at any time. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments.* FOR FURTHER INFORMATION CONTACT: For general information regarding FDA's GGPs contact: Diane Sullivan-Ford, Office of Policy (HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480. For information regarding specific topics or guidance, please see contact persons listed in the table in the SUPPLEMENTARY INFORMATION section. SUPPLEMENTARY INFORMATION: Background In the **Federal Register** of September 19, 2000 (65 FR 56468), FDA published a final rule announcing its GGPs, which set forth the agency's policies and procedures for the development, issuance, and use of guidance documents. The agency adopted the GGPs to ensure public involvement in the development of guidance documents and to enhance public understanding of the availability, nature, and legal effect of such guidance. As part of FDA's effort to ensure meaningful interaction with the public regarding guidance documents, the agency committed to publishing an annual guidance document agenda of possible guidance topics or documents for development or revision during the coming year. The agency also committed to soliciting public input regarding these and additional ideas for new topics or revisions to existing guidance documents (65 FR 56468 at 56477, 21 CFR 10.115(f)(5)). The agency is neither bound by this list of possible topics nor required to issue every guidance document on this list or precluded from issuing guidance documents not on the list set forth in this document. The following list of guidance topics or documents represents possible new topics or revisions to existing guidance documents that the agency is considering. The agency solicits comments on the topics listed in this document and also seeks additional ideas from the public. The guidance topic or documents are organized by the issuing center or office within FDA and are further grouped by topic categories. The agency's contact persons are listed for each guidance in the following table. **Title/Topic of Guidance** **Contact** I. CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
(CBER)CATEGORY—COMPLIANCE AND INSPECTION Guidance for Industry: Reprocessing, Reworking and Blending of Biological Drug Substances and Drug Products Stephen M. Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210 Guidance for Industry: Process Validation Considerations for Biological Drug Substances and Biological Drug Products Same as above
(Do)Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing Do Guidance for Industry: Design, Installation and Operation of Heating, Ventilation and Air Conditioning
(HVAC)Systems Used in the Manufacture of Products Regulated by the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research Do Guidance for Industry: Content and Format of the Warnings/Precautions Section of Labeling for Drugs and Biologics Do Guidance for Industry: Content and Format of the Pregnancy and Lactation Sections of Labeling for Drugs and Biologics Do Guidance for Industry and Reviewers: Measuring Patient Reported Outcomes to Support Medical Product Claims in Labeling and Advertising Do Compliance Program 7341.001 Inspections of Licensed Therapeutic Drug Products Do Compliance Program 7341.002—Inspection of Tissue Establishments Do Compliance Program 7342.001—Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors Do Compliance Program 7342.002—Inspection of Source Plasma Establishments Do Compliance Program 7342.006—Inspection of Plasma Derivatives of Human Origin Do Compliance Program 7342.008—Inspections of Licensed Viral Marker Test Kits Do Compliance Program 7345.001—Inspection of Licensed Allergenic Products Do Compliance Program 7345.002—Inspection of Licensed Vaccines Do CATEGORY—THERAPEUTICS Submission of Information for the National Xenotransplantation Database
(NXD)Do Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Controls Reviewers of Human Gene Therapy Investigational New Drug Applications Do Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Controls Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications Do Potency Assays for Therapeutic Vaccines Do Good Review Practices—Track IV Do Submission of Information for Adverse Event and Annual Reports for Gene Therapy Investigational New Drug Applications Mechanisms of Regulation for Products Used in the Manufacture of Cellular Products Do Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody for In Vivo Use Do Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances Do Submission of Chemistry, Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Therapy Products Do CATEGORY—BLOOD AND BLOOD COMPONENTS Blood Establishment Software Do Apheresis Guidance Do Uniform Donor History Questionnaire Do Quality Control of Bacterial Contamination Do Content of Premarket Submissions (Instruments) Do Medication Deferrals Do Validation of Computer Crossmatch Do Blood Contact Materials Do Red Blood Cell Repositories Do Rapid Human Immunodeficiency Virus Tests Do Submission of Chemistry, Manufacturing, and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products Blood Donor Testing for Syphilis Format and Content of a Biologics License Application for Immune Globulin Intravenous Recommendations for Deferral of Donors of Vaccinated With Smallpox Nucleic Acid Testing for Human Immunodeficiency Virus and Hepatitis C Virus; Testing, Product Disposition, Donor Deferral and Reentry Do CATEGORY—VACCINES Guidance for Industry: Characterization and Qualification of Cell Substances and Viral Seeds Used to Produce Viral Vaccines Do Guidance for Industry: Preclinical Toxicity Studies for Prophylactic Vaccines Do Guidance for Industry: Immunization Human Plasma Donors to Obtain Source Plasma for Preparation of Specific Immune Globulins Do Guidance for Industry: Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for a Vaccine or Related Product Do Guidance for Industry on the Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test Do CATEGORY—OTHER Providing Regulatory Submission in Electronic Format—Stability Do Environmental Assessment/National Environmental Policy Act Do Requests for Engagement of Independent Consultant Do Eligibility Determination for Donors of Human Cells, Tissue and Cellular and Tissue-Based Products (HCT/Ps) Do Filing and Application When the Applicant Protests a Refusal to File Action Do Guidance for Industry: Multi-Product Manufacturing With Spore-Forming Microorganisms Do II. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
(CDRH)CATEGORY—PREMARKET REVIEW—PROCEDURAL Delegation of Investigational Device Exemption (Withdrawal) Joanne R. Less, Center for Devices and Radiological Health (HFZ-403), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190 Overdue Investigational Device Exemption Annual Progress Report Procedures (Withdrawal) Do Humanitarian Device Exemptions
(HDE)Regulation: Questions and Answers (Revised) Do Guidance for the Medical Device Industry on Premarket Approval Application Shell Development and Modular Review (Revised) Thinh Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186 Modifications to Devices Subject to Premarket Approval Application—The Premarket Approval Application Supplement Decision Making Process (Final) Do Real-Time Review Program for Premarket Approval Application
(PMA)Supplements (Revised) Do Pre-Premarket Approval Application Meetings Do A New 510(k) Paradigm—Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications (Revised) Heather Rosecrans, Center for Devices and Radiological Health (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190 Frequently Asked Questions on the New 510(k) Paradigm (Revised) Do New Section 513(f)(2)—Evaluation of Automatic Class III Designation (Revised) Do Implementation of Third Party Programs Under the Food and Drug Modernization Act of 1997 (Revised) Ronald Parr, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-6597, ext. 109 Statistical Guidance on Reporting Results From Studies Evaluating Diagnostic Tests: Draft Guidance for Industry and FDA Reviewers Kristen Meier, Center for Devices and Radiological Health (HFZ-542), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-827-4369 CATEGORY—PREMARKET REVIEW ANESTHESIOLOGY, DENTAL, INFECTION CONTROL, AND GENERAL HOSPITAL DEVICES Biological Indicator (Final) Chiu S. Lin, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8913 Chemical Indicator (Draft) Do Medical Sterilization Packaging (Final) Do Antimicrobial Coated Medical Devices (Draft) Do Surgical Masks (Final) Do Surgical Drapes and Gowns (Draft) Do Disinfectants to Reprocess Hemodialyzer Machine and Water Treatment Systems (Draft) Do Medical Glove Expiration Dating (Final) Do Chemotherapy Glove (Draft) Do Intraoral Snoring and Sleep Apnea Devices (Final) Kevin Mulry, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283, ext. 185 Sonography and Jaw Tracking (Final) Mary S. Runner, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283 Precious Metal Dental Alloys Mike Adjodha, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283 Base Dental Alloys Do Dental Curing Light Do Periodontal Membrane Guidance Robert Betz, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283 Guidance for Bone Filling and Augmentation Devices Pam Scott, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283 Cutaneous O <sup>2</sup> and CO <sup>2</sup> Monitors (Final) Joanna Weitershausen, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8611 General Anesthesia Guidance Document Do Pulse Oximeter Guidance Document (Revised) Do Vascular Access Flush Devices Patricia Cricenti, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1287, ext. 169 Needleless Injection Devices Von Nakayama, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1287 CATEGORY—PREMARKET REVIEW FOR CARDIOVASCULAR DEVICES Intravascular Stents (Revised) Ashley Boam, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8243 Percutaneous Transluminal Coronary Angioplasty Catheters, Class II Special Control Guidance Do Cardiovascular Intravascular Filters (Revised) Elisa Harvey, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8262 Arrhythmia Detectors Elias Mallis, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8517 Medical Device Labeling—Suggested Format and Content (Withdrawal) Robert Gatling, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190, ext. 140 Class II Special Control Guidance Document: Extracorporeal Life Support Devices (Draft) Dina J. Fleischer, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8517, ext. 176 CATEGORY—PREMARKET REVIEW FOR CLINICAL LABORATORY DEVICES Over-the-Counter
(OTC)Drugs of Abuse Arleen Pinkos, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1243 Glucose Test Systems Pat Bernhardt, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1243 Automated Coagulation Devices Valerie Dada, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1293 Analytical and Clinical Validation of Multiplex Tests for Heritable DNA Markers and/or Mutations Elizabeth Mansfield and Michele Schoonmaker, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1293 Class II Special Controls Guidance Document: Specific Bacteriophage, Antibody Conjugates, and Antigens for Antibody Detection for *Bacillus anthracis* and *Yersinia pestis* Roxanne Shively, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2096 Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test
(AST)Systems (Final) Sally Selepak, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2096 Draft Guidance on In Vitro Diagnostic
(IVD)Device Studies Jean Toth-Allen, Center for Devices and Radiological Health (HFZ-312), Food and Drug Administration, 2904 Gaither Rd., Rockville, MD 20850, 301-594-4723, ext. 141 CATEGORY—PREMARKET REVIEW FOR GENERAL, RESTORATIVE AND NEUROLOGICAL DEVICES Guidance for Thermal Ablation Device 510(k)s; Draft Guidance for Industry and FDA Binita Ashar, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1307 Class II Exempt Special Controls Guidance for Various Orthopedic Fixation Devices; Final Guidance for Industry Hollace Rhodes, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2036 Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses Peter Allen, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2036 Class II Special Controls Guidance Document: Surgical Suture Anthony Watson, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090 Class II Special Controls Guidance Document: Processed Human Dura Mater (Draft) Charles Durfor, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090 Class II Special Controls Guidance Document: Vascular and Neurological Embolization Devices (Draft) Stephen Rhodes, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090 Guidance for Saline, Silicone Gel, and Alternative Breast Implants (Revised) Samie Allen, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090 Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device (Final) Nadine Sloan, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1296 Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator for Cosmetic Use (Draft) Robert DeLuca, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1296 Class II Special Controls Guidance Document: Cutaneous Electrode (Draft) Do Class II Special Controls Guidance Document: Electroconductive Media (Draft) Do Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning (Draft) Do Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation (Draft) Do Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief (Draft) Do Special Control Guidance for Premarket Notifications for Totally Implanted Spinal Cord Stimulators for Pain Relief (Withdrawal) Kristen Bowsher, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1296 Guidance for Technical Reporting in the Submission of Research and Marketing Applications for Totally Implanted Spinal Cord Stimulators (Draft) Do CATEGORY—PREMARKET REVIEW FOR OPHTHALMIC AND ENT DEVICES Class II Special Controls Guidance Document: Rigid Gas Permeable
(RGP)by Contact Lens Finishing Laboratories James F. Saviola, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1744 Premarket Notification (510(k)) Guidance Document for Class II Daily Wear Contact Lenses (Revised) Do Class II Special Controls Guidance Document: Artificial Eye Care Products Do Class II Special Controls Guidance Document: Intraocular Gases for Retina Tamponade Do Retinal Implants: Guidance for Investigational Device Exemptions
(IDE)and Premarket Approval
(PMA)Applications (Draft) Do Guidance for Premarket Approval Applications of Class III Extended Wear Contact Lenses Do Guidance for Post Approval Studies of Class III Extended Wear Contact Lenses Worn Beyond Seven Continuous Nights Do Labeling Guidance for Ultraviolet Absorbing Contact Lenses Do Intraocular Lens Guidance Document Donna R. Lochner, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2053 Refractive Implants Guidance Document Do Guidance Document for Keratomes and Keratome Blades Everette T. Beers, Chief, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2018 Implantable Middle Ear Hearing Device (Final) Eric C. Mann, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2018 Tinnitis Masking Devices Do Laryngoplastic Phonosurgery Devices Do Ear Plug Devices Do CATEGORY—PREMARKET REVIEW FOR REPRODUCTIVE, ABDOMINAL AND RADIOLOGICAL DEVICES Devices for Assisted Reproduction Technologies
(ART)Colin M. Pollard, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180, ext. 115 Embolization Agents for Uterine Fibroid Embolization Do Condoms Do Menstrual Tampons Do Devices for Vacuum Assisted Delivery Do Device Systems for Endometrial Ablation Do Class II Special Controls Guidance Document: External Penile Rigidity Devices Janine Morris, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2194, ext. 117 Guidance for the Treatment of Prostate Cancer Do Guidance for Urethral Stents Do Class II Special Controls Guidance for Home Uterine Activity Monitors (Revised) Do Ultrasound Coupling Gel Robert A. Phillips, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1212, ext. 130 Diagnostic Ultrasound Do Cleaning and Disinfection of Radiological Devices Do Sheaths and Covers for Ultrasound Transducers Do Bone Sonometers (Revised) Do Class II Special Controls Guidance Document: Sorbent Hemoperfusion Systems (Draft) Bone Sonometers (Revised) Carolyn Neuland, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1220, ext. 131 Content of Premarket Notification Submissions for Conventional and High Permeability Hemodialyzers, Hemoconcentrators, Hemofilters and Hemodiafilters (Revised) Do Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems Do Automated Blood Cell Separators for Therapeutic Purposes (Draft) Do Blood Access Devices for Hemodialysis (Draft) Do CATEGORY—COMPLIANCE AND INSPECTIONS Impact Resistance Lenses: Questions and Answers Walter Snesko, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-6597, ext. 120 Medical Device Quality Systems Manual for Small Entities (Update) Joseph Puleo, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-6597, ext. 116 Medical Glove Guidance Manual (Update) Arthur Yellin, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-6597, ext. 146 Draft Guidance on Cabinet X-ray Systems Performance Specifications Daniel Kassidy, Center for Devices and Radiological Health (HFZ-342), Food and Drug Administration, 2904 Gaither Rd., Rockville, MD 20850, 301-594-4654, ext. 141 Final Guidance on Civil Money Penalties Casper Uldriks, Center for Devices and Radiological Health (HFZ-300), Food and Drug Administration, 2904 Gaither Rd., Rockville, MD 20850, 301-594-4692 Draft Guidance on the Reports of Corrections and Removals Regulation Do Draft Guidance for Field Clinical Engineers Marian Surge, Center for Devices and Radiological Health (HFZ-300), Food and Drug Administration, 2904 Gaither Rd., Rockville, MD 20850, 301-594-4720, ext. 139 Draft Guidance on Good Laboratory Practice
(GLP)for Nonclinical Laboratory Studies Rodney Allnutt, Center for Devices and Radiological Health (HFZ-300), Food and Drug Administration, 2904 Gaither Rd., Rockville, MD 20850, 301-594-4723, ext. 140 Draft Guidance on the Submission of Abbreviated Reports on Bone Densitometer Devices Utilizing Electronic Product Radiation Tom Jakub, Center for Devices and Radiological Health (HFZ-333), Food and Drug Administration, 2904 Gaither Rd., Rockville, MD 20850, 301-594-4591, ext. 151 Implementation of the Third Party Domestic Quality System Program Ronald Parr, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-6597, ext. 109 CATEGORY: CONSUMER INFORMATION Breast Implants: An Information Update Nancy Leonard, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-6597, ext. 141 Modifications and Additions to the Policy Guidance Help System #6 Charles A. Finder, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-827-0009 Modifications and Additions to the Policy Guidance Help System #7 Do Modifications and Additions to the Policy Guidance Help System #8 Do Modifications and Additions to the Policy Guidance Help System #9 Do Modifications and Additions to the Policy Guidance Help System #10 Do CATEGORY—MEDICAL DEVICE REPORTING Needlesticks; Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers Sharon Kapsch, Center for Devices and Radiological Health (HFZ-533), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-827-2982 CATEGORY—POSTMARKET SURVEILLANCE Preparing a Postmarket Surveillance Plan: Guidance for Manufacturers Laura Alonge, Center for Devices and Radiological Health (HFZ-510), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3060 CATEGORY—OTHER Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment: For Industry and Health Care Facilities Jay A. Rachlin, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3174 III. CENTER FOR DRUG EVALUATION AND RESEARCH
(CDER)CATEGORY—ADVERTISING Advertising and Labeling of Treatment Investigational New Drug Application Protocols Nancy E. Derr, Center for Drug Evaluation and Research (HFD-5), Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, 301-594-5400 Patient Reported Outcomes Do Promotion of Combination Oral Contraceptive Products Do CATEGORY—BIOPHARMACEUTICS Clozapine Tablets—In Vivo Bioequivalence and In Vitro Dissolution Testing Do CATEGORY—CHEMISTRY Documentation for Antibiotics and Other Cellular Metabolites Produced by Microorganisms Modified Using Recombinant DNA Technology Do Drug Products: Chemistry, Manufacturing, and Control Documentation Do Drug Substance: Chemistry, Manufacturing, and Control Documentation Do CATEGORY—CLINICAL/MEDICAL Acne Vulgaris Do Analgesics Do Clinical Development Programs for Metered Dose Inhaler and Dry Powder Inhalers Products—Revised Do Clinical Evaluation of Drugs for the Treatment of Acute Coronary Syndrome Do Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy in Postmenopausal Women—Revised Do Clinical Evaluation of Drugs for Neuropathic Pain Do Clinical Evaluation of Drugs for the Treatment of Heart Failure Do Collection and Use of Race and Ethnicity Data in Clinical Trials for FDA Regulated Products Do Development of New Opiate Formulations Do Developing Antiviral Drug for the Mitigation of Complication Associated Vaccine Immunization Do Developing Antiviral Drugs for the Treatment of Smallpox Do Drug-Coated Cardiovascular Stents Do Evaluation of New Treatments for Diabetes Mellitus Do Gingivitis Do Safety Review of Clinical Data Do CATEGORY—CLINICAL/PHARMACOLOGY Do Content and Format of the Clinical Pharmacology Section Do Content and Format of the Warnings and Precautions, Contradictions and Boxed Warning Sections of Prescription Drugs Do Immediate Release to Modified Release Dosage Forms Do In Vitro Drug Metabolism/Drug Interaction—Guidance for Reviewers Do CATEGORY—COMPLIANCE Current Good Manufacturing Practices for Compressed Medical Gases—Revised Do Maintaining Adequate and Accurate Records During Clinical Investigations Do National Drug Code Number and Drug Product Labels Do Describing How Positron Emission Tomography Drug Products May Comply With New Current Good Manufacturing Process Requirements—Revised Do Sterile Drug Products Produced by Aseptic Processing Do CATEGORY—ELECTRONIC SUBMISSIONS Providing Electronic Submissions to the Division of Drug Marketing, Advertising, and Communications Do Providing Electronic Submissions in Electronic Format: Marketing Applications and Related Submissions Providing Regulatory Submissions in Electronic Format—Annual Reports for Approved New Drug Applications Do Providing Regulatory Submissions in Electronic Format—General Considerations Do Providing Regulatory Submissions in Electronic Format: Postmarketing Periodic Adverse Drug Experience Report Do Scope and Implementation of 21 CFR Part 11: Archiving Do Scope and Implementation of 21 CFR Part 11: Audit Trails Do Standards for Clinical Data Submissions Do CATEGORY—GENERICS Bioequivalence Studies With Clinical Endpoints for Vaginal Antifungal Drug Products Do Chemistry, Manufacturing, and Controls Documentation Unique to Radiopharmaceuticals Submitted in Abbreviated New Drug Applications Do Generic Drug Labeling When Pediatric Labeling Information Has Been Added to the Innovator Labeling Do CATEGORY—GOOD REVIEW PRACTICES General Clinical Review Template Do CATEGORY—INVESTIGATIONAL NEW DRUG APPLICATIONS Consumer Product Safety Commission—Tamper Resistant Packaging for Investigational New Drug Applications Do Pediatric Safety and Efficacy Data in Investigational New Drug Applications Do CATEGORY—LABELING Drug Names and Dosage Forms Do Pregnancy Labeling Revisions Do Submitting Proprietary Names for Evaluation Do CATEGORY-OVER-THE-COUNTER Actual Use Trials Do Labeling Comprehension Studies for Over-the-Counter Drug Products Do Labeling for Over-the-Counter Human Drug Products Do Labeling Over-the-Counter Human Drug Products; Questions and Answers Do Time and Extent Applications Do CATEGORY—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2002 Continuous Marketing Application: Pilot 1—Reviewable Units for Fast Track Products Under the Prescription Drug User Fee Amendments of 2002 Do Continuous Marketing Application: Pilot 2—Scientific Feedback and Interactions During Drug Development of Fast Track Products Under the Prescription Drug User Fee Amendments of 2002 Do First Cycle Review Performance: Good Review Management Principles Do CATEGORY—PHARMACOLOGY/TOXICOLOGY Drug-Induced Vasculitis in Nonclinical Studies Do Estimating the Safe Starting Dose for Clinical Trials of Therapeutics in Adult Healthy Volunteers Do Immunotoxicology Evaluation of Investigational New Drug Applications Do Nonclinical Safety Evaluation of Pediatric Drug Products Do CATEGORY—PROCEDURAL Assessment of Abuse Potential of Drugs Do Dispute Resolution Involving Pediatric Labeling Do Exocrine Pancreatic Insufficiency Drug Products—New Drug Application Requirements Do Process for Contracts and Written Requests Under the Best Pharmaceuticals for Children Act Do Qualifying for Pediatric Exclusivity Under Section 505a of the Federal Food, Drug, and Cosmetic Act Do Reports on the Status of Postmarketing Studies—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 Do IV. CENTER FOOD SAFETY AND APPLIED NUTRITION (CFSAN) CATEGORY: OFFICE OF PLANTS, DAIRY FOODS, AND BEVERAGES Final Guidance on Juice Transport Amy Green, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2025 Draft Guidance on Use of Food Allergen Test Kits Jennifer Burnham, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2030 Draft Guidance to Harmonize U.S. Aflatoxin Levels in Peanuts With Codex Levels Lauren Posnick, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1639 Compliance Policy Guide for Lead Levels in Food Based on Levels Adopted by Codex Do Additional Questions and Answers on Juice Hazard Analysis and Critical Control Point Samir Assar, Center for Food Safety and Applied Nutrition (HFS-235), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1636 Update the Pesticide Compliance Policy Guide to Bring It in Line With the Food Quality Protection Act of 1996 and Changes in Pesticide Programs and Policy Over the Past Few Years Mike Kashtock, Center for Food Safety and Applied Nutrition (HFS-305), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2022 Guidance for Industry: Standardized Training Curriculum for Application of Hazard Analysis and Critical Control Point Principles to Juice Processing Do *Listeria monocytogenes* Draft Guidance Andreas Keller, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2029 Fresh-Cut Produce Draft Guidance Julie Schrimpf, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. 301-436-2031 Small Entities Guide for the Juice Hazard Analysis and Critical Control Point Regulations Amy Green, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2025 Juice Hazard Analysis and Critical Control Point Compliance Program Dale Wohlers, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2029 Final Compliance Policy Guide 555.600 Filth From Insects, Rodents, and Other Pests in Food Douglas Park, Center for Food Safety and Applied Nutrition (HFS-345), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2401 Draft Compliance Policy Guide 555.525—Fly Infestations Do Draft Compliance Policy Guide 555.500—Classification of Establishment Inspection Report Do Draft Compliance Policy Guide 580.100—Pest Infestations Do Rescind Compliance Policy Guide 527.600 Use of Dichlorvos Strips in Milk Houses and Milk Rooms Esther Lazar, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1485 Rescind Compliance Policy Guide 527.450 Milk and Milk Products Containing Penicillin Do Update Compliance Policy Guide 527.400 Whole Milk, Low Fat Milk, Skim Milk—Aflatoxin M1 Do Update Compliance Policy Guide 527.300 Pathogens in Dairy Products Do Update Compliance Policy Guide 527.200 Cheese and Cheese Products—Adulteration With Filth Do New Compliance Policy Guide on Vitamins A and D in Milk Products Monica Metz, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2041 New Compliance Policy Guide on Vat Pasteurization Do New Compliance Policy Guide on High Temperature/Short Time Pasteurization Do New Compliance Policy Guide on Soft Cheeses Do We may either update or rescind the following: Do Compliance Policy Guide 527.250 Cheese Misbranding Due to Moisture and Fat To be determined
(TBD)Compliance Policy Guide 527.500 Malted Milk TBD Compliance Policy Guide 527.100 Butter—Adulteration Involving Insufficient Fat Content TBD Compliance Policy Guide 527.250 Cheese and Cheese Products: Misbranding Involving Net Weights TBD CATEGORY: OFFICE OF FIELD PROGRAMS Allergen Questions and Answers Donald Kautter, Center for Food Safety and Applied Nutrition (HFS-615), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1629 Allergen Recall Classification Guidance Do Juice Hazard Analysis and Critical Control Point Regulator Guide and Training Do Spice Reconditioning Inspection Guidance Do Spice Reconditioning Industry Guidance Do Interstate Travel Handbooks on Sanitation of: • Railroad Servicing Areas • Vessels in Operation • Vessel Construction • Vessel Watering Points • Buses • Airlines Railroad Passenger Cars Do (pending Office of Field Programs reorganization) International Travel Program—Guide to Inspections of Interstate Carriers and Support Facilities Do Compliance Programs for Milk, Retail Food, and Molluscan Shellfish Faye Feldstein, Center for Food Safety and Applied Nutrition (HFS-615), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1564 Electronic Inspection System With Model Code Database, Model Inspection Form, Users' Manual Do Food Recovery Guidelines Do Permanent Outdoor Cooking Guidelines Do Temporary Food Establishments Guidance Do Voluntary National Retail Regulatory Program Standards and Annexes Do Program Standards Clearinghouse Questions and Answers Do Conference Position Papers (Shellfish and Milk for 2003) Do Food Code Supplements Do Center for Food Safety and Applied Nutrition Response to Conference for Food Protection Recommendations Do Food Code Interpretations; Questions and Answers Do Opinion Letters in Response to Correspondence Do Backgrounders Do Program Information Manual Additions and Revised Do Letters to Industry Alerting Them to a Commodity Problem, Emerging Situations, and How to Respond Do Managing Food Safety: A Regulator's Guide for Applying Hazard Analysis and Critical Control Point Principles to Risk-Based Retail and Food Service Inspections Do Managing Food Safety: A Guide for the Voluntary Use of Hazard Analysis and Critical Control Point Principles for Operators of Food Service and Retail Establishments Do Combined Pasteurized Milk and Dry Milk Ordinance Do Annual Report Regarding State Program Evaluations (Milk and Shellfish) Do Rescind Guidance Regarding Blending of Milk Products (Compliance Policy Guide?) Office of Plant and Dairy Foods and Beverages Compliance Policy Guide—Criteria for Refusal for Entry of Food Products From Firms That Refuse to Allow Inspections Do Listeria Action Plan Donald Kautter, Center for Food Safety and Applied Nutrition (HFS-615), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1629 Food Registration Implementation Do Molluscan Shellfish: Guide for the Control of Molluscan Shellfish • Model Ordinance • Public Health Reasons and Program Requirements for State Administrative Procedures; Laboratory Procedures; Growing Area Survey and Classification; Controlled Relaying; Patrol of Shellfish Harvesting Areas; Control of Harvesting; Aquaculture; Harvesting, Handling and Shipping Shellfish; Shellfish Processing • Guidance Documents on Growing Areas, Harvesting, Processing, and Distribution • Suggested Forms • Manual of FDA Interpretations of Model Ordinance Requirements Faye Feldstein, Center for Food Safety and Applied Nutrition (HFS-615), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1564 Program No. 7303.003: Import Acidified and Low Acid Canned Foods Program TBD Program No. 7303.037: Domestic and Imported Cheese and Cheese Products TBD Program No. 7303.039: National Drug Residue Milk Monitoring Program TBD Program No. 7303.803: Domestic Food Safety TBD Program No. 7303.803A: Domestic Acidified and Low-Acid Canned Foods TBD Program No. 7303.819: Import Foods—General Program TBD Program No. 7303.842: Domestic Fish and Fishery Products Inspection Program (Fiscal Years 2001 and 2002) TBD Program No. 7303.844: Import Seafood Products TBD Program No. 7304.004: Pesticides and Industrial Chemicals in Domestic Foods TBD Program No. 7304.016: Pesticides and Industrial Chemicals in Imported Foods TBD Program No. 7304.018: Chemotherapeutic in Seafood Compliance Program TBD Program No. 7304.019: Toxic Elements in Foods and Foodware Import and Domestic TBD Program No. 7304.839: Total Diet Study TBD Program No. 7304.803: Domestic Food Safety Program—Primary Project Filed in Chapter 3 TBD Program No. 7307.001: Mycotoxins in Domestic Foods TBD Program No. 7307.002: Mycotoxins in Imported Foods TBD Program No.7309.006: Imported Foods and Color Additives TBD Program No. 7309.803: Domestic Food Safety Program—Primary Project Filed in Chapter 3) TBD Program No. 7309.808: Good Laboratory Practice (Nonclinical Laboratories)—Primary Project Filed in Chapter 48 TBD Program No. 7309.809: Institutional Review Board Program—Primary Project Filed in Chapter 48 TBD Program No. 7309.810: Sponsors, Contract Research Organizations and Monitors—Compliance With Regulations—Primary Project Filed in Chapter 48 TBD Program No. 7309.811: Clinical Investigators—Primary Project Filed in Chapter 48 TBD Program No. 7318.002: Retail Food Protection—State TBD Program No. 7318.003: Milk Safety Program TBD Program No. 7318.004: Molluscan Shellfish Evaluation TBD Program No. 7318.029: Interstate Travel Program TBD Program No. 7321.002: Medical Foods—Import and Domestic TBD Program No. 7321.005: Domestic Nutrition Labeling and Education Act of 1990, Nutrient Sample Analysis, General Food Labeling Program TBD Program No. 7321.006: Infant Formula Program—Import and Domestic TBD Program No. 7321.007: Nutrition Labeling and Education Act of 1990 and Enforcement—Imports TBD Program No. 7321.008: Dietary Supplements—Imports and Domestic TBD Program No. 7329.001: Domestic Cosmetics Program TBD Program No. 7329.002: Imported Cosmetics Compliance Program TBD CATEGORY: OFFICE OF NUTRITION, PRODUCTS, LABELING AND DIETARY SUPPLEMENTS Soy Formulas and Preterm Infants—Draft Guidance Shawne Suggs-Anderson, Center for Food Safety and Applied Nutrition (HFS-831), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1783 Petition Process for Requesting Labeling of Foods That Have Been Treated With Irradiation—Final Guidance published October 7, 2002 Loretta Carey, Center for Food Safety and Applied Nutrition (HFS-822), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371 Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering—Final Guidance Cataline Ferre-Hockensmith, Center for Food Safety and Applied Nutrition (HFS-822), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371 Compliance Programs John Foret, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1761 Summary of Regulatory Requirements for Dietary Supplements Robert Moore, Center for Food Safety and Applied Nutrition (HFS-811), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1441 Dietary Supplement Labeling Guide Do CATEGORY: OFFICE FOOD ADDITIVE AND SAFETY Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry Considerations Kristina Paquette, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 202-436-3020 Guidance for Industry: Testing Protocols for Determining Exposure to Radiolysis Products From Packaging Materials Irradiated in Contact With Food Do Revised of Four Chapters of “Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food” (Redbook 2000) Carolyn Young, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3059 Guidance to Industry: Evaluation of Allergenicity of Proteins Introduced into Bioengineered Foods Kathleen Jones, Center for Food Safety and Applied Nutrition (HFS-013), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1856. Guidance document reassigned with Kathleen Jones Office of Regulation and Policy (HFS-013) Preparing a Color Additive Petition for Submission to the Center for Food Safety and Applied Nutrition for Color Additives Used in or on Contact Lenses Judy Kidwell, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3354 Compliance Policy Guideline on Chloropropanols in Soy Sauces and Hydrolyzed Vegetable Protein Do Guidance for Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submissions to the Center for Food Safety and Applied Nutrition Layla Batarseh, Center for Food Safety and Applied Nutrition (HFS-245), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3016 Guidance for Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submissions to the Center for Food Safety and Applied Nutrition (Appendix D) Do Guidance for Industry: Submission of Food Contact Notifications in Electronic Format Ken McAdams, Center for Food Safety and Applied Nutrition (HFS-205), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3392 Submission of Premarket Biotechnology Notices
(PBNs)to FDA's Office of Food Addictive Safety—Electronic Copies in Portable Document Format
(PDF)Linda Kahl, Center for Food Safety and Applied Nutrition (HFS-255) Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3101 Submission of Premarket Biotechnology Notices
(PBNs)to FDA's Office of Food Addictive Safety—Electronic Copies in Hypertest Markup Language
(HTML)Do Providing Food and Color Additive Petitions in Electronic Format Do Guidances Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Title III, Subtitle A CATEGORY: OFFICE OF COSMETICS AND COLORS Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients—Draft Guidance Julie Barrows, Center for Food Safety and Applied Nutrition (HFS-105), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 202-418-3407 Cosmetics Handbook for Industry—Draft Guidance Beth Meyers, Center for Food Safety and Applied Nutrition (HFS-105), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 202-418-3174 Strategy for Enforcement of 21 CFR 740.10: Required Warning Statement for Cosmetics With Insufficient Data to Substantiate Safety—Draft Guidance Do V. CENTER FOR VETERINARY MEDICINE
(CVM)CATEGORY—HUMAN FOOD SAFETY Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern William Flynn, Center for Veterinary Medicine (HFV-2), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-4514 Mass Spectroscopy Spectrometry for Confirmation of the Identity of Drug Residues David Heller, Center for Veterinary Medicine (HFV-511), Food and Drug Administration, 8401 Muirkirk Rd., Beltsville, MD 20855, 301-827-8156 Assessment of the Effects of Antimicrobial Drug Residues From Food of Animal Origin on the Human Intestinal Flora Haydee Fernandez, Center for Veterinary Medicine (HFV-153), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6981 Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feed Henry Ekperigin, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0174 CATEGORY—NEW ANIMAL DRUG APPLICATIONS Development of Supplemental Applications for Approved New Animal Drugs (Section 403(b) of the Food and Drug Administration Modernization Act of 1997) Marilyn Martinez, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7577 Administrative New Animal Drug Application Process Gail Schmerfeld, Center for Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0205 CATEGORY—LABELING Manufacture and Labeling of Raw Meat Diets for Consumption by Dogs, Cats, and Captive Non-Companion Animal Carnivores and Omnivores William Burkholder, Center for Veterinary Medicine (HFV-228), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0179 Labeling and Professional Flexible Labeling Douglass Oeller, Center for Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0131 CATEGORY—TARGET ANIMAL SAFETY New Drug Dosage or Dosage Range Characterization Gail Schmerfeld, Center for Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0205 Use of Field Studies to Demonstrate the Effectiveness of a New Animal Drug Steven Vaughn and Gail Schmerfeld, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7584 CATEGORY—STATUTORY REQUIREMENTS Dispute Resolution—Food and Drug Administration Modernization Act of 1997 Marcia Larkins, Center for Veterinary Medicine (HFV-1), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-4535 CATEGORY—INTERNATIONAL HARMONIZATION Guidance GL27 International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products William Flynn, Center for Veterinary Medicine (HFV-2), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-4514 VI. OFFICE OF THE COMMISSIONER, OFFICE FOR GOOD CLINICAL PRACTICE
(OGCP)CATEGORY—GOOD CLINICAL PRACTICE; GUIDANCE FOR INSTITUTIONAL REVIEW BOARDS AND CLINICAL INVESTIGATORS Cooperative Arrangements for Institutional Review Board's Review of Research Bonnie M. Lee, Office of the Commissioner, Office for Good Clinical Practice (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340 Institutional Review Board's Review of Research Conducted at Other Sites Do Continuing Review After Study Approval Do Dates of Continuing Review Do Interactions Among FDA, Sponsor, Investigator, and Institutional Review Board Do Acceptance of Clinical Studies Conducted Outside the United States Do Charging for Investigational Products Do Recruiting Study Subjects Do Payment to Research Subjects Do Screening Tests Prior to Study Enrollment Do A Guide to Informed Consent Do Use of Investigational Products When Subjects Enter a Second Institution Do Personal Importation of and Use of Drug Products Not Approved in the United States Do Investigational Use of Marketed Drugs, Biologics, and Medical Devices Do Emergency Use: Exceptions From the Requirements for Institutional Review Board
(IRB)Review and Informed Consent Do Emergency Use of an Investigational Drug or Biologic Under 21 CFR Part 312 Do Expanded Access of Investigational Drugs Do Waiver of Institutional Review Board Requirements for Drug and Biologic Studies Do Drug Study Designs Do Evaluation of Gender Differences in Clinical Investigations Do Medical Devices 21 CFR Part 812 Do Significant Risk and Nonsignificant Risk Medical Device Studies Do Emergency Use of Unapproved Medical Devices Do FDA Institutional Review Board Inspections Do Clinical Investigator Regulatory Sanctions Do Recordkeeping in Clinical Investigations Do Significant Differences in FDA's and the Department of Health and Human Services' Regulations Do A Self-Evaluation Checklist for Institutional Review Boards Do VII. OFFICE OF REGULATORY AFFAIRS
(ORA)INSPECTION GUIDES Techniques for Detecting False Data During Bioresearch Monitoring Inspections Gerald Miller, Division of Field Investigations (HFC-130), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5655 Guide to Inspections of Bulk Pharmaceutical Chemicals Do Guide to International Inspections and Travel Rebecca Hackett, Division of Field Investigations, (HFC-130), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857, 301-827-3777 Guide to Produce Farm Investigations Ellen Morrison, Emergency Operations (HFC-160), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5660 Dated: March 28, 2003. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 03-8262 Filed 4-3-03; 8:45 am]
Connectionstraces to 2
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- 21 CFR 11
- 21 CFR 312
- 21 CFR 812
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