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