# 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.
| | |
| --- | --- |
| 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 | 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
and CO
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
and | 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 |
| 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: | 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: | 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.