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Annual Guidance Agenda

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Information about this document as published in the Federal Register.

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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.

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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.

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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.

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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 GuidanceContact
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 ProductsStephen 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 ProductsSame as above (Do)
Guidance for Industry: Sterile Drug Products Produced by Aseptic ProcessingDo
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 ResearchDo
Guidance for Industry: Content and Format of the Warnings/Precautions Section of Labeling for Drugs and BiologicsDo
Guidance for Industry: Content and Format of the Pregnancy and Lactation Sections of Labeling for Drugs and BiologicsDo
Guidance for Industry and Reviewers: Measuring Patient Reported Outcomes to Support Medical Product Claims in Labeling and AdvertisingDo
Compliance Program 7341.001 Inspections of Licensed Therapeutic Drug ProductsDo
Compliance Program 7341.002—Inspection of Tissue EstablishmentsDo
Compliance Program 7342.001—Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and ContractorsDo
Compliance Program 7342.002—Inspection of Source Plasma EstablishmentsDo
Compliance Program 7342.006—Inspection of Plasma Derivatives of Human OriginDo
Compliance Program 7342.008—Inspections of Licensed Viral Marker Test KitsDo
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Compliance Program 7345.001—Inspection of Licensed Allergenic ProductsDo
Compliance Program 7345.002—Inspection of Licensed VaccinesDo
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 ApplicationsDo
Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Controls Reviewers of Human Somatic Cell Therapy Investigational New Drug ApplicationsDo
Potency Assays for Therapeutic VaccinesDo
Good Review Practices—Track IVDo
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 ProductsDo
Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody for In Vivo UseDo
Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide SubstancesDo
Submission of Chemistry, Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Therapy ProductsDo
CATEGORY—BLOOD AND BLOOD COMPONENTS
Blood Establishment SoftwareDo
Apheresis GuidanceDo
Uniform Donor History QuestionnaireDo
Quality Control of Bacterial ContaminationDo
Content of Premarket Submissions (Instruments)Do
Medication DeferralsDo
Validation of Computer CrossmatchDo
Blood Contact MaterialsDo
Red Blood Cell RepositoriesDo
Rapid Human Immunodeficiency Virus TestsDo
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 ReentryDo
CATEGORY—VACCINES
Guidance for Industry: Characterization and Qualification of Cell Substances and Viral Seeds Used to Produce Viral VaccinesDo
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Guidance for Industry: Preclinical Toxicity Studies for Prophylactic VaccinesDo
Guidance for Industry: Immunization Human Plasma Donors to Obtain Source Plasma for Preparation of Specific Immune GlobulinsDo
Guidance for Industry: Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for a Vaccine or Related ProductDo
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 TestDo
CATEGORY—OTHER
Providing Regulatory Submission in Electronic Format—StabilityDo
Environmental Assessment/National Environmental Policy ActDo
Requests for Engagement of Independent ConsultantDo
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 ActionDo
Guidance for Industry: Multi-Product Manufacturing With Spore-Forming MicroorganismsDo
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 MeetingsDo
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 ReviewersKristen Meier, Center for Devices and Radiological Health (HFZ-542), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-827-4369
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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 AlloysMike Adjodha, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283
Base Dental AlloysDo
Dental Curing LightDo
Periodontal Membrane GuidanceRobert 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 DevicesPam Scott, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283
Cutaneous O2 and CO2 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 DocumentDo
Pulse Oximeter Guidance Document (Revised)Do
Vascular Access Flush DevicesPatricia 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 DevicesVon 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 GuidanceDo
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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 DetectorsElias 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 AbuseArleen Pinkos, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1243
Glucose Test SystemsPat Bernhardt, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1243
Automated Coagulation DevicesValerie 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 MutationsElizabeth 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 pestisRoxanne 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 StudiesJean 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 FDABinita 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 IndustryHollace 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 ProsthesesPeter 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 SutureAnthony 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
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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 LaboratoriesJames 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 ProductsDo
Class II Special Controls Guidance Document: Intraocular Gases for Retina TamponadeDo
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 LensesDo
Guidance for Post Approval Studies of Class III Extended Wear Contact Lenses Worn Beyond Seven Continuous NightsDo
Labeling Guidance for Ultraviolet Absorbing Contact LensesDo
Intraocular Lens Guidance DocumentDonna 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 DocumentDo
Guidance Document for Keratomes and Keratome BladesEverette T. Beers, Chief, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2018
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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 DevicesDo
Laryngoplastic Phonosurgery DevicesDo
Ear Plug DevicesDo
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 EmbolizationDo
CondomsDo
Menstrual TamponsDo
Devices for Vacuum Assisted DeliveryDo
Device Systems for Endometrial AblationDo
Class II Special Controls Guidance Document: External Penile Rigidity DevicesJanine 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 CancerDo
Guidance for Urethral StentsDo
Class II Special Controls Guidance for Home Uterine Activity Monitors (Revised)Do
Ultrasound Coupling GelRobert 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 UltrasoundDo
Cleaning and Disinfection of Radiological DevicesDo
Sheaths and Covers for Ultrasound TransducersDo
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 SystemsDo
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 AnswersWalter 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
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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 SpecificationsDaniel 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 PenaltiesCasper 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 RegulationDo
Draft Guidance for Field Clinical EngineersMarian 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 StudiesRodney 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 RadiationTom 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 ProgramRonald 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 UpdateNancy 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 #6Charles 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 #7Do
Modifications and Additions to the Policy Guidance Help System #8Do
Modifications and Additions to the Policy Guidance Help System #9Do
Modifications and Additions to the Policy Guidance Help System #10Do
CATEGORY—MEDICAL DEVICE REPORTING
Needlesticks; Medical Device Reporting Guidance for User Facilities, Manufacturers, and ImportersSharon 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 ManufacturersLaura 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 FacilitiesJay 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 ProtocolsNancy E. Derr, Center for Drug Evaluation and Research (HFD-5), Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, 301-594-5400
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Patient Reported OutcomesDo
Promotion of Combination Oral Contraceptive ProductsDo
CATEGORY—BIOPHARMACEUTICS
Clozapine Tablets—In Vivo Bioequivalence and In Vitro Dissolution TestingDo
CATEGORY—CHEMISTRY
Documentation for Antibiotics and Other Cellular Metabolites Produced by Microorganisms Modified Using Recombinant DNA TechnologyDo
Drug Products: Chemistry, Manufacturing, and Control DocumentationDo
Drug Substance: Chemistry, Manufacturing, and Control DocumentationDo
CATEGORY—CLINICAL/MEDICAL
Acne VulgarisDo
AnalgesicsDo
Clinical Development Programs for Metered Dose Inhaler and Dry Powder Inhalers Products—RevisedDo
Clinical Evaluation of Drugs for the Treatment of Acute Coronary SyndromeDo
Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy in Postmenopausal Women—RevisedDo
Clinical Evaluation of Drugs for Neuropathic PainDo
Clinical Evaluation of Drugs for the Treatment of Heart FailureDo
Collection and Use of Race and Ethnicity Data in Clinical Trials for FDA Regulated ProductsDo
Development of New Opiate FormulationsDo
Developing Antiviral Drug for the Mitigation of Complication Associated Vaccine ImmunizationDo
Developing Antiviral Drugs for the Treatment of SmallpoxDo
Drug-Coated Cardiovascular StentsDo
Evaluation of New Treatments for Diabetes MellitusDo
GingivitisDo
Safety Review of Clinical DataDo
CATEGORY—CLINICAL/PHARMACOLOGYDo
Content and Format of the Clinical Pharmacology SectionDo
Content and Format of the Warnings and Precautions, Contradictions and Boxed Warning Sections of Prescription DrugsDo
Immediate Release to Modified Release Dosage FormsDo
In Vitro Drug Metabolism/Drug Interaction—Guidance for ReviewersDo
CATEGORY—COMPLIANCE
Current Good Manufacturing Practices for Compressed Medical Gases—RevisedDo
Maintaining Adequate and Accurate Records During Clinical InvestigationsDo
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National Drug Code Number and Drug Product LabelsDo
Describing How Positron Emission Tomography Drug Products May Comply With New Current Good Manufacturing Process Requirements—RevisedDo
Sterile Drug Products Produced by Aseptic ProcessingDo
CATEGORY—ELECTRONIC SUBMISSIONS
Providing Electronic Submissions to the Division of Drug Marketing, Advertising, and CommunicationsDo
Providing Electronic Submissions in Electronic Format: Marketing Applications and Related Submissions
Providing Regulatory Submissions in Electronic Format—Annual Reports for Approved New Drug ApplicationsDo
Providing Regulatory Submissions in Electronic Format—General ConsiderationsDo
Providing Regulatory Submissions in Electronic Format: Postmarketing Periodic Adverse Drug Experience ReportDo
Scope and Implementation of 21 CFR Part 11: ArchivingDo
Scope and Implementation of 21 CFR Part 11: Audit TrailsDo
Standards for Clinical Data SubmissionsDo
CATEGORY—GENERICS
Bioequivalence Studies With Clinical Endpoints for Vaginal Antifungal Drug ProductsDo
Chemistry, Manufacturing, and Controls Documentation Unique to Radiopharmaceuticals Submitted in Abbreviated New Drug ApplicationsDo
Generic Drug Labeling When Pediatric Labeling Information Has Been Added to the Innovator LabelingDo
CATEGORY—GOOD REVIEW PRACTICES
General Clinical Review TemplateDo
CATEGORY—INVESTIGATIONAL NEW DRUG APPLICATIONS
Consumer Product Safety Commission—Tamper Resistant Packaging for Investigational New Drug ApplicationsDo
Pediatric Safety and Efficacy Data in Investigational New Drug ApplicationsDo
CATEGORY—LABELING
Drug Names and Dosage FormsDo
Pregnancy Labeling RevisionsDo
Submitting Proprietary Names for EvaluationDo
CATEGORY-OVER-THE-COUNTER
Actual Use TrialsDo
Labeling Comprehension Studies for Over-the-Counter Drug ProductsDo
Labeling for Over-the-Counter Human Drug ProductsDo
Labeling Over-the-Counter Human Drug Products; Questions and AnswersDo
Time and Extent ApplicationsDo
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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 2002Do
Continuous Marketing Application: Pilot 2—Scientific Feedback and Interactions During Drug Development of Fast Track Products Under the Prescription Drug User Fee Amendments of 2002Do
First Cycle Review Performance: Good Review Management PrinciplesDo
CATEGORY—PHARMACOLOGY/TOXICOLOGY
Drug-Induced Vasculitis in Nonclinical StudiesDo
Estimating the Safe Starting Dose for Clinical Trials of Therapeutics in Adult Healthy VolunteersDo
Immunotoxicology Evaluation of Investigational New Drug ApplicationsDo
Nonclinical Safety Evaluation of Pediatric Drug ProductsDo
CATEGORY—PROCEDURAL
Assessment of Abuse Potential of DrugsDo
Dispute Resolution Involving Pediatric LabelingDo
Exocrine Pancreatic Insufficiency Drug Products—New Drug Application RequirementsDo
Process for Contracts and Written Requests Under the Best Pharmaceuticals for Children ActDo
Qualifying for Pediatric Exclusivity Under Section 505a of the Federal Food, Drug, and Cosmetic ActDo
Reports on the Status of Postmarketing Studies—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997Do
IV. CENTER FOOD SAFETY AND APPLIED NUTRITION (CFSAN)
CATEGORY: OFFICE OF PLANTS, DAIRY FOODS, AND BEVERAGES
Final Guidance on Juice TransportAmy 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 KitsJennifer 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 LevelsLauren 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 CodexDo
Additional Questions and Answers on Juice Hazard Analysis and Critical Control PointSamir 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 YearsMike 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 ProcessingDo
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Listeria monocytogenes Draft GuidanceAndreas 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 GuidanceJulie 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 RegulationsAmy 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 ProgramDale 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 FoodDouglas 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 InfestationsDo
Draft Compliance Policy Guide 555.500—Classification of Establishment Inspection ReportDo
Draft Compliance Policy Guide 580.100—Pest InfestationsDo
Rescind Compliance Policy Guide 527.600 Use of Dichlorvos Strips in Milk Houses and Milk RoomsEsther 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 PenicillinDo
Update Compliance Policy Guide 527.400 Whole Milk, Low Fat Milk, Skim Milk—Aflatoxin M1Do
Update Compliance Policy Guide 527.300 Pathogens in Dairy ProductsDo
Update Compliance Policy Guide 527.200 Cheese and Cheese Products—Adulteration With FilthDo
New Compliance Policy Guide on Vitamins A and D in Milk ProductsMonica 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 PasteurizationDo
New Compliance Policy Guide on High Temperature/Short Time PasteurizationDo
New Compliance Policy Guide on Soft CheesesDo
We may either update or rescind the following:Do
Compliance Policy Guide 527.250 Cheese Misbranding Due to Moisture and FatTo be determined (TBD)
Compliance Policy Guide 527.500 Malted MilkTBD
Compliance Policy Guide 527.100 Butter—Adulteration Involving Insufficient Fat ContentTBD
Compliance Policy Guide 527.250 Cheese and Cheese Products: Misbranding Involving Net WeightsTBD
CATEGORY: OFFICE OF FIELD PROGRAMS
Allergen Questions and AnswersDonald 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
Start Printed Page 16536
Allergen Recall Classification GuidanceDo
Juice Hazard Analysis and Critical Control Point Regulator Guide and TrainingDo
Spice Reconditioning Inspection GuidanceDo
Spice Reconditioning Industry GuidanceDo
Interstate Travel Handbooks on Sanitation of: • Railroad Servicing Areas • Vessels in Operation • Vessel Construction • Vessel Watering Points • Buses • Airlines Railroad Passenger CarsDo (pending Office of Field Programs reorganization)
International Travel Program—Guide to Inspections of Interstate Carriers and Support FacilitiesDo
Compliance Programs for Milk, Retail Food, and Molluscan ShellfishFaye 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' ManualDo
Food Recovery GuidelinesDo
Permanent Outdoor Cooking GuidelinesDo
Temporary Food Establishments GuidanceDo
Voluntary National Retail Regulatory Program Standards and AnnexesDo
Program Standards Clearinghouse Questions and AnswersDo
Conference Position Papers (Shellfish and Milk for 2003)Do
Food Code SupplementsDo
Center for Food Safety and Applied Nutrition Response to Conference for Food Protection RecommendationsDo
Food Code Interpretations; Questions and AnswersDo
Opinion Letters in Response to CorrespondenceDo
BackgroundersDo
Program Information Manual Additions and RevisedDo
Letters to Industry Alerting Them to a Commodity Problem, Emerging Situations, and How to RespondDo
Managing Food Safety: A Regulator's Guide for Applying Hazard Analysis and Critical Control Point Principles to Risk-Based Retail and Food Service InspectionsDo
Managing Food Safety: A Guide for the Voluntary Use of Hazard Analysis and Critical Control Point Principles for Operators of Food Service and Retail EstablishmentsDo
Combined Pasteurized Milk and Dry Milk OrdinanceDo
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 InspectionsDo
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Listeria Action PlanDonald 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 ImplementationDo
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 RequirementsFaye 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 ProgramTBD
Program No. 7303.037: Domestic and Imported Cheese and Cheese ProductsTBD
Program No. 7303.039: National Drug Residue Milk Monitoring ProgramTBD
Program No. 7303.803: Domestic Food SafetyTBD
Program No. 7303.803A: Domestic Acidified and Low-Acid Canned FoodsTBD
Program No. 7303.819: Import Foods—General ProgramTBD
Program No. 7303.842: Domestic Fish and Fishery Products Inspection Program (Fiscal Years 2001 and 2002)TBD
Program No. 7303.844: Import Seafood ProductsTBD
Program No. 7304.004: Pesticides and Industrial Chemicals in Domestic FoodsTBD
Program No. 7304.016: Pesticides and Industrial Chemicals in Imported FoodsTBD
Program No. 7304.018: Chemotherapeutic in Seafood Compliance ProgramTBD
Program No. 7304.019: Toxic Elements in Foods and Foodware Import and DomesticTBD
Program No. 7304.839: Total Diet StudyTBD
Program No. 7304.803: Domestic Food Safety Program—Primary Project Filed in Chapter 3TBD
Program No. 7307.001: Mycotoxins in Domestic FoodsTBD
Program No. 7307.002: Mycotoxins in Imported FoodsTBD
Program No.7309.006: Imported Foods and Color AdditivesTBD
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 48TBD
Program No. 7309.809: Institutional Review Board Program—Primary Project Filed in Chapter 48TBD
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Program No. 7309.810: Sponsors, Contract Research Organizations and Monitors—Compliance With Regulations—Primary Project Filed in Chapter 48TBD
Program No. 7309.811: Clinical Investigators—Primary Project Filed in Chapter 48TBD
Program No. 7318.002: Retail Food Protection—StateTBD
Program No. 7318.003: Milk Safety ProgramTBD
Program No. 7318.004: Molluscan Shellfish EvaluationTBD
Program No. 7318.029: Interstate Travel ProgramTBD
Program No. 7321.002: Medical Foods—Import and DomesticTBD
Program No. 7321.005: Domestic Nutrition Labeling and Education Act of 1990, Nutrient Sample Analysis, General Food Labeling ProgramTBD
Program No. 7321.006: Infant Formula Program—Import and DomesticTBD
Program No. 7321.007: Nutrition Labeling and Education Act of 1990 and Enforcement—ImportsTBD
Program No. 7321.008: Dietary Supplements—Imports and DomesticTBD
Program No. 7329.001: Domestic Cosmetics ProgramTBD
Program No. 7329.002: Imported Cosmetics Compliance ProgramTBD
CATEGORY: OFFICE OF NUTRITION, PRODUCTS, LABELING AND DIETARY SUPPLEMENTS
Soy Formulas and Preterm Infants—Draft GuidanceShawne 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, 2002Loretta 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 GuidanceCataline 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 ProgramsJohn 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 SupplementsRobert 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 GuideDo
CATEGORY: OFFICE FOOD ADDITIVE AND SAFETY
Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry ConsiderationsKristina 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 FoodDo
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
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Guidance to Industry: Evaluation of Allergenicity of Proteins Introduced into Bioengineered FoodsKathleen 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 LensesJudy 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 ProteinDo
Guidance for Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submissions to the Center for Food Safety and Applied NutritionLayla 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 FormatKen 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 FormatDo
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 GuidanceJulie 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 GuidanceBeth 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 GuidanceDo
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 ConcernWilliam 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 ResiduesDavid 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 FloraHaydee 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 FeedHenry 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
Start Printed Page 16540
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 ProcessGail 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 OmnivoresWilliam Burkholder, Center for Veterinary Medicine (HFV-228), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0179
Labeling and Professional Flexible LabelingDouglass 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 CharacterizationGail 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 DrugSteven 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 1997Marcia 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 ProductsWilliam 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 ResearchBonnie 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 SitesDo
Continuing Review After Study ApprovalDo
Dates of Continuing ReviewDo
Interactions Among FDA, Sponsor, Investigator, and Institutional Review BoardDo
Acceptance of Clinical Studies Conducted Outside the United StatesDo
Charging for Investigational ProductsDo
Recruiting Study SubjectsDo
Payment to Research SubjectsDo
Screening Tests Prior to Study EnrollmentDo
A Guide to Informed ConsentDo
Use of Investigational Products When Subjects Enter a Second InstitutionDo
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Personal Importation of and Use of Drug Products Not Approved in the United StatesDo
Investigational Use of Marketed Drugs, Biologics, and Medical DevicesDo
Emergency Use: Exceptions From the Requirements for Institutional Review Board (IRB) Review and Informed ConsentDo
Emergency Use of an Investigational Drug or Biologic Under 21 CFR Part 312Do
Expanded Access of Investigational DrugsDo
Waiver of Institutional Review Board Requirements for Drug and Biologic StudiesDo
Drug Study DesignsDo
Evaluation of Gender Differences in Clinical InvestigationsDo
Medical Devices 21 CFR Part 812Do
Significant Risk and Nonsignificant Risk Medical Device StudiesDo
Emergency Use of Unapproved Medical DevicesDo
FDA Institutional Review Board InspectionsDo
Clinical Investigator Regulatory SanctionsDo
Recordkeeping in Clinical InvestigationsDo
Significant Differences in FDA's and the Department of Health and Human Services' RegulationsDo
A Self-Evaluation Checklist for Institutional Review BoardsDo
VII. OFFICE OF REGULATORY AFFAIRS (ORA)
INSPECTION GUIDES
Techniques for Detecting False Data During Bioresearch Monitoring InspectionsGerald 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 ChemicalsDo
Guide to International Inspections and TravelRebecca Hackett, Division of Field Investigations, (HFC-130), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857, 301-827-3777
Guide to Produce Farm InvestigationsEllen Morrison, Emergency Operations (HFC-160), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5660
Start Signature

Dated: March 28, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 03-8262 Filed 4-3-03; 8:45 am]

BILLING CODE 4160-01-S