Reports and guidance documents; availability, etc.: Guidance documents; annual agenda,
[Federal Register: April 4, 2003 (Volume 68, Number 65)]
[Notices]
[Page 16523-16541]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap03-82]
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.
[[Page 16524]]
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
-
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
CATEGORY--COMPLIANCE AND INSPECTION
Guidance for Industry:
Stephen M. Ripley, Center for Reprocessing, Reworking and
Biologics Evaluation and Research Blending of Biological Drug
(HFM-17), Food and Drug Substances and Drug Products
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210
Guidance for Industry: Process Same as above (Do) Validation Considerations for Biological Drug Substances and Biological Drug Products
Guidance for Industry: Sterile Drug Do Products Produced by Aseptic Processing
Guidance for Industry: Design, Do 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
Guidance for Industry: Content and Do Format of the Warnings/Precautions Section of Labeling for Drugs and Biologics
Guidance for Industry: Content and Do Format of the Pregnancy and Lactation Sections of Labeling for Drugs and Biologics
Guidance for Industry and
Do Reviewers: Measuring Patient Reported Outcomes to Support Medical Product Claims in Labeling and Advertising
Compliance Program 7341.001
Do Inspections of Licensed Therapeutic Drug Products
Compliance Program 7341.002--
Do Inspection of Tissue Establishments
Compliance Program 7342.001--
Do Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors
Compliance Program 7342.002--
Do Inspection of Source Plasma Establishments
Compliance Program 7342.006--
Do Inspection of Plasma Derivatives of Human Origin
Compliance Program 7342.008--
Do Inspections of Licensed Viral Marker Test Kits
[[Page 16525]]
Compliance Program 7345.001--
Do Inspection of Licensed Allergenic Products
Compliance Program 7345.002--
Do Inspection of Licensed Vaccines
CATEGORY--THERAPEUTICS
...................................
Submission of Information for the Do National Xenotransplantation Database (NXD)
Guidance for Reviewers:
Do Instructions and Template for Chemistry, Manufacturing, and Controls Reviewers of Human Gene Therapy Investigational New Drug Applications
Guidance for Reviewers:
Do Instructions and Template for Chemistry, Manufacturing, and Controls Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications
Potency Assays for Therapeutic Do Vaccines
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
Do Products Used in the Manufacture of Cellular Products
Submission of Chemistry,
Do Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody for In Vivo Use
Submission of Chemistry,
Do Manufacturing, and Controls Information for Synthetic Peptide Substances
Submission of Chemistry,
Do Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Therapy Products
CATEGORY--BLOOD AND BLOOD
................................... COMPONENTS
Blood Establishment Software
Do
Apheresis Guidance
Do
Uniform Donor History Questionnaire Do
Quality Control of Bacterial
Do Contamination
Content of Premarket Submissions Do (Instruments)
Medication Deferrals
Do
Validation of Computer Crossmatch Do
Blood Contact Materials
Do
Red Blood Cell Repositories
Do
Rapid Human Immunodeficiency Virus Do Tests
Submission of Chemistry,
Do 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
CATEGORY--VACCINES
...................................
Guidance for Industry:
Do Characterization and Qualification of Cell Substances and Viral Seeds Used to Produce Viral Vaccines
[[Page 16526]]
Guidance for Industry: Preclinical Do Toxicity Studies for Prophylactic Vaccines
Guidance for Industry: Immunization Do Human Plasma Donors to Obtain Source Plasma for Preparation of Specific Immune Globulins
Guidance for Industry: Content and Do Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for a Vaccine or Related Product
Guidance for Industry on the
Do Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test
CATEGORY--OTHER
...................................
Providing Regulatory Submission in Do Electronic Format--Stability
Environmental Assessment/National Do Environmental Policy Act
Requests for Engagement of
Do Independent Consultant
Eligibility Determination for
Do Donors of Human Cells, Tissue and Cellular and Tissue-Based Products (HCT/Ps)
Filing and Application When the Do Applicant Protests a Refusal to File Action
Guidance for Industry: Multi-
Do Product Manufacturing With Spore- Forming Microorganisms
-
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
CATEGORY--PREMARKET REVIEW-- PROCEDURAL
Delegation of Investigational
Joanne R. Less, Center for Devices Device Exemption (Withdrawal)
and Radiological Health (HFZ-403), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190
Overdue Investigational Device Do Exemption Annual Progress Report Procedures (Withdrawal)
Humanitarian Device Exemptions Do (HDE) Regulation: Questions and Answers (Revised)
Guidance for the Medical Device Thinh Nguyen, Center for Devices Industry on Premarket Approval and Radiological Health (HFZ-402), Application Shell Development and Food and Drug Administration, 9200 Modular Review (Revised)
Corporate Blvd., Rockville, MD 20850, 301-594-2186
Modifications to Devices Subject to Do Premarket Approval Application-- The Premarket Approval Application Supplement Decision Making Process (Final)
Real-Time Review Program for
Do Premarket Approval Application (PMA) Supplements (Revised)
Pre-Premarket Approval Application Do Meetings
A New 510(k) Paradigm--Alternate Heather Rosecrans, Center for Approaches to Demonstrating
Devices and Radiological Health Substantial Equivalence in
(HFZ-404), Food and Drug Premarket Notifications (Revised) Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301- 594-1190
Frequently Asked Questions on the Do New 510(k) Paradigm (Revised)
New Section 513(f)(2)--Evaluation Do of Automatic Class III Designation (Revised)
Implementation of Third Party
Ronald Parr, Center for Devices and Programs Under the Food and Drug Radiological Health (HFZ-220), Modernization Act of 1997
Food and Drug Administration, 1350 (Revised)
Piccard Dr., Rockville, MD 20850, 301-443-6597, ext. 109
Statistical Guidance on Reporting Kristen Meier, Center for Devices Results From Studies Evaluating and Radiological Health (HFZ-542), Diagnostic Tests: Draft Guidance Food and Drug Administration, 1350 for Industry and FDA Reviewers Piccard Dr., Rockville, MD 20850, 301-827-4369
[[Page 16527]]
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 Do (Final)
Antimicrobial Coated Medical
Do Devices (Draft)
Surgical Masks (Final)
Do
Surgical Drapes and Gowns (Draft) Do
Disinfectants to Reprocess
Do Hemodialyzer Machine and Water Treatment Systems (Draft)
Medical Glove Expiration Dating Do (Final)
Chemotherapy Glove (Draft)
Do
Intraoral Snoring and Sleep Apnea Kevin Mulry, Center for Devices and Devices (Final)
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
Pam Scott, Center for Devices and Augmentation Devices
Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283
Cutaneous O2and CO2Monitors
Joanna Weitershausen, Center for (Final)
Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301- 443-8611
General Anesthesia Guidance
Do Document
Pulse Oximeter Guidance Document Do (Revised)
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 Do Angioplasty Catheters, Class II Special Control Guidance
[[Page 16528]]
Cardiovascular Intravascular
Elisa Harvey, Center for Devices Filters (Revised)
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 Robert Gatling, Center for Devices Format and Content (Withdrawal) 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 Dina J. Fleischer, Center for Document: Extracorporeal Life
Devices and Radiological Health Support Devices (Draft)
(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 Arleen Pinkos, Center for Devices Abuse
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 Elizabeth Mansfield and Michele of Multiplex Tests for Heritable Schoonmaker, Center for Devices DNA Markers and/or Mutations
and Radiological Health (HFZ-440), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1293
Class II Special Controls Guidance Roxanne Shively, Center for Devices Document: Specific Bacteriophage, and Radiological Health (HFZ-440), Antibody Conjugates, and Antigens Food and Drug Administration, 9200 for Antibody Detection for
Corporate Blvd., Rockville, MD Bacillus anthracis and Yersinia 20850, 301-594-2096 pestis
Class II Special Controls Guidance Sally Selepak, Center for Devices Document: Antimicrobial
and Radiological Health (HFZ-440), Susceptibility Test (AST) Systems Food and Drug Administration, 9200 (Final)
Corporate Blvd., Rockville, MD 20850, 301-594-2096
Draft Guidance on In Vitro
Jean Toth-Allen, Center for Devices Diagnostic (IVD) Device Studies 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
Binita Ashar, Center for Devices Device 510(k)s; Draft Guidance for and Radiological Health (HFZ-410), Industry and FDA
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1307
Class II Exempt Special Controls Hollace Rhodes, Center for Devices Guidance for Various Orthopedic and Radiological Health (HFZ-410), Fixation Devices; Final Guidance Food and Drug Administration, 9200 for Industry
Corporate Blvd., Rockville, MD 20850, 301-594-2036
Class II Special Controls Guidance Peter Allen, Center for Devices and Document: Knee Joint
Radiological Health (HFZ-410), Patellofemorotibial and
Food and Drug Administration, 9200 Femorotibial Metal/Polymer Porous- Corporate Blvd., Rockville, MD Coated Uncemented Prostheses
20850, 301-594-2036
Class II Special Controls Guidance Anthony Watson, Center for Devices Document: Surgical Suture
and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090
Class II Special Controls Guidance Charles Durfor, Center for Devices Document: Processed Human Dura and Radiological Health (HFZ-410), Mater (Draft)
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090
Class II Special Controls Guidance Stephen Rhodes, Center for Devices Document: Vascular and
and Radiological Health (HFZ-410), Neurological Embolization Devices Food and Drug Administration, 9200 (Draft)
Corporate Blvd., Rockville, MD 20850, 301-594-3090
[[Page 16529]]
Guidance for Saline, Silicone Gel, Samie Allen, Center for Devices and and Alternative Breast Implants Radiological Health (HFZ-410), (Revised)
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090
Class II Special Controls Guidance Nadine Sloan, Center for Devices Document: Resorbable Calcium Salt and Radiological Health (HFZ-410), Bone Void Filler Device (Final) Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1296
Class II Special Controls Guidance Robert DeLuca, Center for Devices Document: Transcutaneous
and Radiological Health (HFZ-450), Electrical Stimulator for Cosmetic Food and Drug Administration, 9200 Use (Draft)
Corporate Blvd., Rockville, MD 20850, 301-594-1296
Class II Special Controls Guidance Do Document: Cutaneous Electrode (Draft)
Class II Special Controls Guidance Do Document: Electroconductive Media (Draft)
Class II Special Controls Guidance Do Document: Powered Muscle Stimulator for Muscle Conditioning (Draft)
Class II Special Controls Guidance Do Document: Powered Muscle Stimulator for Rehabilitation (Draft)
Class II Special Controls Guidance Do Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief (Draft)
Special Control Guidance for
Kristen Bowsher, Center for Devices Premarket Notifications for
and Radiological Health (HFZ-450), Totally Implanted Spinal Cord
Food and Drug Administration, 9200 Stimulators for Pain Relief
Corporate Blvd., Rockville, MD (Withdrawal)
20850, 301-594-1296
Guidance for Technical Reporting in Do the Submission of Research and Marketing Applications for Totally Implanted Spinal Cord Stimulators (Draft)
CATEGORY--PREMARKET REVIEW FOR ................................... OPHTHALMIC AND ENT DEVICES
Class II Special Controls Guidance James F. Saviola, Center for Document: Rigid Gas Permeable
Devices and Radiological Health (RGP) by Contact Lens Finishing (HFZ-460), Food and Drug Laboratories
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301- 594-1744
Premarket Notification (510(k)) Do Guidance Document for Class II Daily Wear Contact Lenses (Revised)
Class II Special Controls Guidance Do Document: Artificial Eye Care Products
Class II Special Controls Guidance Do Document: Intraocular Gases for Retina Tamponade
Retinal Implants: Guidance for Do Investigational Device Exemptions (IDE) and Premarket Approval (PMA) Applications (Draft)
Guidance for Premarket Approval Do Applications of Class III Extended Wear Contact Lenses
Guidance for Post Approval Studies Do of Class III Extended Wear Contact Lenses Worn Beyond Seven Continuous Nights
Labeling Guidance for Ultraviolet Do Absorbing Contact Lenses
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
Do Document
Guidance Document for Keratomes and Everette T. Beers, Chief, Center Keratome Blades
for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301- 594-2018
[[Page 16530]]
Implantable Middle Ear Hearing Eric C. Mann, Center for Devices Device (Final)
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 Colin M. Pollard, Center for Technologies (ART)
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 Do Fibroid Embolization
Condoms
Do
Menstrual Tampons
Do
Devices for Vacuum Assisted
Do Delivery
Device Systems for Endometrial Do Ablation
Class II Special Controls Guidance Janine Morris, Center for Devices Document: External Penile Rigidity and Radiological Health (HFZ-470), Devices
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2194, ext. 117
Guidance for the Treatment of
Do Prostate Cancer
Guidance for Urethral Stents
Do
Class II Special Controls Guidance Do for Home Uterine Activity Monitors (Revised)
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
Do Radiological Devices
Sheaths and Covers for Ultrasound Do Transducers
Bone Sonometers (Revised)
Do
Class II Special Controls Guidance Carolyn Neuland, Center for Devices Document: Sorbent Hemoperfusion and Radiological Health (HFZ-470), Systems (Draft) Bone Sonometers Food and Drug Administration, 9200 (Revised)
Corporate Blvd., Rockville, MD 20850, 301-594-1220, ext. 131
Content of Premarket Notification Do Submissions for Conventional and High Permeability Hemodialyzers, Hemoconcentrators, Hemofilters and Hemodiafilters (Revised)
Guidance for the Content of
Do Premarket Notifications for Hemodialysis Delivery Systems
Automated Blood Cell Separators for Do Therapeutic Purposes (Draft)
Blood Access Devices for
Do Hemodialysis (Draft)
CATEGORY--COMPLIANCE AND
................................... INSPECTIONS
Impact Resistance Lenses: Questions Walter Snesko, Center for Devices and Answers
and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-6597, ext. 120
Medical Device Quality Systems Joseph Puleo, Center for Devices Manual for Small Entities (Update) and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-6597, ext. 116
[[Page 16531]]
Medical Glove Guidance Manual
Arthur Yellin, Center for Devices (Update)
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 Daniel Kassidy, Center for Devices Systems Performance Specifications 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
Casper Uldriks, Center for Devices Penalties
and Radiological Health (HFZ-300), Food and Drug Administration, 2904 Gaither Rd., Rockville, MD 20850, 301-594-4692
Draft Guidance on the Reports of Do Corrections and Removals Regulation
Draft Guidance for Field Clinical Marian Surge, Center for Devices Engineers
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 Rodney Allnutt, Center for Devices Practice (GLP) for Nonclinical and Radiological Health (HFZ-300), Laboratory Studies
Food and Drug Administration, 2904 Gaither Rd., Rockville, MD 20850, 301-594-4723, ext. 140
Draft Guidance on the Submission of Tom Jakub, Center for Devices and Abbreviated Reports on Bone
Radiological Health (HFZ-333), Densitometer Devices Utilizing Food and Drug Administration, 2904 Electronic Product Radiation
Gaither Rd., Rockville, MD 20850, 301-594-4591, ext. 151
Implementation of the Third Party Ronald Parr, Center for Devices and Domestic Quality System Program 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 Nancy Leonard, Center for Devices Update
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 Charles A. Finder, Center for Policy Guidance Help System 6
(HFZ-240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-827-0009
Modifications and Additions to the Do Policy Guidance Help System 7
Modifications and Additions to the Do Policy Guidance Help System 8
Modifications and Additions to the Do Policy Guidance Help System 9
Modifications and Additions to the Do Policy Guidance Help System 10
CATEGORY--MEDICAL DEVICE REPORTING ...................................
Needlesticks; Medical Device
Sharon Kapsch, Center for Devices Reporting Guidance for User
and Radiological Health (HFZ-533), Facilities, Manufacturers, and Food and Drug Administration, 1350 Importers
Piccard Dr., Rockville, MD 20850, 301-827-2982
CATEGORY--POSTMARKET SURVEILLANCE ...................................
Preparing a Postmarket Surveillance Laura Alonge, Center for Devices Plan: Guidance for Manufacturers 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 Jay A. Rachlin, Center for Devices Assessment Guidance to Reduce
and Radiological Health (HFZ-230), Entrapment: For Industry and
Food and Drug Administration, 1350 Health Care Facilities
Piccard Dr., Rockville, MD 20850, 301-594-3174
-
CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
CATEGORY--ADVERTISING
Advertising and Labeling of
Nancy E. Derr, Center for Drug Treatment Investigational New Drug Evaluation and Research (HFD-5), Application Protocols
Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, 301-594-5400
[[Page 16532]]
Patient Reported Outcomes
Do
Promotion of Combination Oral
Do Contraceptive Products
CATEGORY--BIOPHARMACEUTICS
...................................
Clozapine Tablets--In Vivo
Do Bioequivalence and In Vitro Dissolution Testing
CATEGORY--CHEMISTRY
...................................
Documentation for Antibiotics and Do Other Cellular Metabolites Produced by Microorganisms Modified Using Recombinant DNA Technology
Drug Products: Chemistry,
Do Manufacturing, and Control Documentation
Drug Substance: Chemistry,
Do Manufacturing, and Control Documentation
CATEGORY--CLINICAL/MEDICAL
...................................
Acne Vulgaris
Do
Analgesics
Do
Clinical Development Programs for Do Metered Dose Inhaler and Dry Powder Inhalers Products--Revised
Clinical Evaluation of Drugs for Do the Treatment of Acute Coronary Syndrome
Clinical Evaluation of Combination Do Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy in Postmenopausal Women--Revised
Clinical Evaluation of Drugs for Do Neuropathic Pain
Clinical Evaluation of Drugs for Do the Treatment of Heart Failure
Collection and Use of Race and Do Ethnicity Data in Clinical Trials for FDA Regulated Products
Development of New Opiate
Do Formulations
Developing Antiviral Drug for the Do Mitigation of Complication Associated Vaccine Immunization
Developing Antiviral Drugs for the Do Treatment of Smallpox
Drug-Coated Cardiovascular Stents Do
Evaluation of New Treatments for Do Diabetes Mellitus
Gingivitis
Do
Safety Review of Clinical Data Do
CATEGORY--CLINICAL/PHARMACOLOGY Do
Content and Format of the Clinical Do Pharmacology Section
Content and Format of the Warnings Do and Precautions, Contradictions and Boxed Warning Sections of Prescription Drugs
Immediate Release to Modified
Do Release Dosage Forms
In Vitro Drug Metabolism/Drug
Do Interaction--Guidance for Reviewers
CATEGORY--COMPLIANCE
...................................
Current Good Manufacturing
Do Practices for Compressed Medical Gases--Revised
Maintaining Adequate and Accurate Do Records During Clinical Investigations
[[Page 16533]]
National Drug Code Number and Drug Do Product Labels
Describing How Positron Emission Do Tomography Drug Products May Comply With New Current Good Manufacturing Process Requirements--Revised
Sterile Drug Products Produced by Do Aseptic Processing
CATEGORY--ELECTRONIC SUBMISSIONS ...................................
Providing Electronic Submissions to Do the Division of Drug Marketing, Advertising, and Communications
Providing Electronic Submissions in ................................... Electronic Format: Marketing Applications and Related Submissions
Providing Regulatory Submissions in Do Electronic Format--Annual Reports for Approved New Drug Applications
Providing Regulatory Submissions in Do Electronic Format--General Considerations
Providing Regulatory Submissions in Do Electronic Format: Postmarketing Periodic Adverse Drug Experience Report
Scope and Implementation of 21 CFR Do Part 11: Archiving
Scope and Implementation of 21 CFR Do Part 11: Audit Trails
Standards for Clinical Data
Do Submissions
CATEGORY--GENERICS
...................................
Bioequivalence Studies With
Do Clinical Endpoints for Vaginal Antifungal Drug Products
Chemistry, Manufacturing, and
Do Controls Documentation Unique to Radiopharmaceuticals Submitted in Abbreviated New Drug Applications
Generic Drug Labeling When
Do Pediatric Labeling Information Has Been Added to the Innovator Labeling
CATEGORY--GOOD REVIEW PRACTICES ...................................
General Clinical Review Template Do
CATEGORY--INVESTIGATIONAL NEW DRUG ................................... APPLICATIONS
Consumer Product Safety Commission-- Do Tamper Resistant Packaging for Investigational New Drug Applications
Pediatric Safety and Efficacy Data Do in Investigational New Drug Applications
CATEGORY--LABELING
...................................
Drug Names and Dosage Forms
Do
Pregnancy Labeling Revisions
Do
Submitting Proprietary Names for Do Evaluation
CATEGORY-OVER-THE-COUNTER
...................................
Actual Use Trials
Do
Labeling Comprehension Studies for Do Over-the-Counter Drug Products
Labeling for Over-the-Counter Human Do Drug Products
Labeling Over-the-Counter Human Do Drug Products; Questions and Answers
Time and Extent Applications
Do
[[Page 16534]]
CATEGORY--PRESCRIPTION DRUG USER ................................... FEE AMENDMENTS OF 2002
Continuous Marketing Application: Do Pilot 1--Reviewable Units for Fast Track Products Under the Prescription Drug User Fee Amendments of 2002
Continuous Marketing Application: Do Pilot 2--Scientific Feedback and Interactions During Drug Development of Fast Track Products Under the Prescription Drug User Fee Amendments of 2002
First Cycle Review Performance: Do Good Review Management Principles
CATEGORY--PHARMACOLOGY/TOXICOLOGY ...................................
Drug-Induced Vasculitis in
Do Nonclinical Studies
Estimating the Safe Starting Dose Do for Clinical Trials of Therapeutics in Adult Healthy Volunteers
Immunotoxicology Evaluation of Do Investigational New Drug Applications
Nonclinical Safety Evaluation of Do Pediatric Drug Products
CATEGORY--PROCEDURAL
...................................
Assessment of Abuse Potential of Do Drugs
Dispute Resolution Involving
Do Pediatric Labeling
Exocrine Pancreatic Insufficiency Do Drug Products--New Drug Application Requirements
Process for Contracts and Written Do Requests Under the Best Pharmaceuticals for Children Act
Qualifying for Pediatric
Do Exclusivity Under Section 505a of the Federal Food, Drug, and Cosmetic Act
Reports on the Status of
Do Postmarketing Studies-- Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997
-
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
Jennifer Burnham, Center for Food Allergen Test Kits
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. Lauren Posnick, Center for Food Aflatoxin Levels in Peanuts With Safety and Applied Nutrition (HFS- Codex Levels
306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301- 436-1639
Compliance Policy Guide for Lead Do Levels in Food Based on Levels Adopted by Codex
Additional Questions and Answers on Samir Assar, Center for Food Safety Juice Hazard Analysis and Critical and Applied Nutrition (HFS-235), Control Point
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1636
Update the Pesticide Compliance Mike Kashtock, Center for Food Policy Guide to Bring It in Line Safety and Applied Nutrition (HFS- With the Food Quality Protection 305), Food and Drug Act of 1996 and Changes in
Administration, 5100 Paint Branch Pesticide Programs and Policy Over Pkwy., College Park, MD 20740, 301- the Past Few Years
436-2022
Guidance for Industry: Standardized Do Training Curriculum for Application of Hazard Analysis and Critical Control Point Principles to Juice Processing
[[Page 16535]]
Listeria monocytogenes Draft
Andreas Keller, Center for Food Guidance
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 Amy Green, Center for Food Safety Hazard Analysis and Critical
and Applied Nutrition (HFS-306), Control Point Regulations
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2025
Juice Hazard Analysis and Critical Dale Wohlers, Center for Food Control Point Compliance Program 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
Douglas Park, Center for Food 555.600 Filth From Insects,
Safety and Applied Nutrition (HFS- Rodents, and Other Pests in Food 345), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301- 436-2401
Draft Compliance Policy Guide
Do 555.525--Fly Infestations
Draft Compliance Policy Guide
Do 555.500--Classification of Establishment Inspection Report
Draft Compliance Policy Guide
Do 580.100--Pest Infestations
Rescind Compliance Policy Guide Esther Lazar, Center for Food 527.600 Use of Dichlorvos Strips Safety and Applied Nutrition (HFS- in Milk Houses and Milk Rooms
306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301- 436-1485
Rescind Compliance Policy Guide Do 527.450 Milk and Milk Products Containing Penicillin
Update Compliance Policy Guide Do 527.400 Whole Milk, Low Fat Milk, Skim Milk--Aflatoxin M1
Update Compliance Policy Guide Do 527.300 Pathogens in Dairy Products
Update Compliance Policy Guide Do 527.200 Cheese and Cheese Products--Adulteration With Filth
New Compliance Policy Guide on Monica Metz, Center for Food Safety Vitamins A and D in Milk Products 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 Do Pasteurization
New Compliance Policy Guide on High Do Temperature/Short Time Pasteurization
New Compliance Policy Guide on Soft Do Cheeses
We may either update or rescind the Do following:
Compliance Policy Guide 527.250 To be determined (TBD) Cheese Misbranding Due to Moisture and Fat
Compliance Policy Guide 527.500 TBD Malted Milk
Compliance Policy Guide 527.100 TBD Butter--Adulteration Involving Insufficient Fat Content
Compliance Policy Guide 527.250 TBD Cheese and Cheese Products: Misbranding Involving Net Weights
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
[[Page 16536]]
Allergen Recall Classification Do Guidance
Juice Hazard Analysis and Critical Do Control Point Regulator Guide and Training
Spice Reconditioning Inspection Do Guidance
Spice Reconditioning Industry
Do Guidance
Interstate Travel Handbooks on Do (pending Office of Field Sanitation of:
Programs reorganization)
[sbull] Railroad Servicing Areas
[sbull] Vessels in Operation
[sbull] Vessel Construction
[sbull] Vessel Watering Points
[sbull] Buses
[sbull] Airlines Railroad Passenger Cars
International Travel Program--Guide Do to Inspections of Interstate Carriers and Support Facilities
Compliance Programs for Milk,
Faye Feldstein, Center for Food Retail Food, and Molluscan
Safety and Applied Nutrition (HFS- Shellfish
615), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301- 436-1564
Electronic Inspection System With Do Model Code Database, Model Inspection Form, Users' Manual
Food Recovery Guidelines
Do
Permanent Outdoor Cooking
Do Guidelines
Temporary Food Establishments
Do Guidance
Voluntary National Retail
Do Regulatory Program Standards and Annexes
Program Standards Clearinghouse Do Questions and Answers
Conference Position Papers
Do (Shellfish and Milk for 2003)
Food Code Supplements
Do
Center for Food Safety and Applied Do Nutrition Response to Conference for Food Protection Recommendations
Food Code Interpretations;
Do Questions and Answers
Opinion Letters in Response to Do Correspondence
Backgrounders
Do
Program Information Manual
Do Additions and Revised
Letters to Industry Alerting Them Do to a Commodity Problem, Emerging Situations, and How to Respond
Managing Food Safety: A Regulator's Do Guide for Applying Hazard Analysis and Critical Control Point Principles to Risk-Based Retail and Food Service Inspections
Managing Food Safety: A Guide for Do the Voluntary Use of Hazard Analysis and Critical Control Point Principles for Operators of Food Service and Retail Establishments
Combined Pasteurized Milk and Dry Do Milk Ordinance
Annual Report Regarding State
Do Program Evaluations (Milk and Shellfish)
Rescind Guidance Regarding Blending Office of Plant and Dairy Foods and of Milk Products (Compliance
Beverages Policy Guide?)
Compliance Policy Guide--Criteria Do for Refusal for Entry of Food Products From Firms That Refuse to Allow Inspections
[[Page 16537]]
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 Guide for the Control of Molluscan Safety and Applied Nutrition (HFS- Shellfish
615), Food and Drug
[sbull] Model Ordinance
Administration, 5100 Paint Branch
[sbull] Public Health Reasons and Pkwy., College Park, MD 20740, 301- Program Requirements for State 436-1564 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
[sbull] Guidance Documents on Growing Areas, Harvesting, Processing, and Distribution
[sbull] Suggested Forms
[sbull] Manual of FDA Interpretations of Model Ordinance Requirements
Program No. 7303.003: Import
TBD Acidified and Low Acid Canned Foods Program
Program No. 7303.037: Domestic and TBD Imported Cheese and Cheese Products
Program No. 7303.039: National Drug TBD Residue Milk Monitoring Program
Program No. 7303.803: Domestic Food TBD Safety
Program No. 7303.803A: Domestic TBD Acidified and Low-Acid Canned Foods
Program No. 7303.819: Import Foods-- TBD General Program
Program No. 7303.842: Domestic Fish TBD and Fishery Products Inspection Program (Fiscal Years 2001 and 2002)
Program No. 7303.844: Import
TBD Seafood Products
Program No. 7304.004: Pesticides TBD and Industrial Chemicals in Domestic Foods
Program No. 7304.016: Pesticides TBD and Industrial Chemicals in Imported Foods
Program No. 7304.018:
TBD Chemotherapeutic in Seafood Compliance Program
Program No. 7304.019: Toxic
TBD Elements in Foods and Foodware Import and Domestic
Program No. 7304.839: Total Diet TBD Study
Program No. 7304.803: Domestic Food TBD Safety Program--Primary Project Filed in Chapter 3
Program No. 7307.001: Mycotoxins in TBD Domestic Foods
Program No. 7307.002: Mycotoxins in TBD Imported Foods
Program No.7309.006: Imported Foods TBD and Color Additives
Program No. 7309.803: Domestic Food TBD Safety Program--Primary Project Filed in Chapter 3)
Program No. 7309.808: Good
TBD Laboratory Practice (Nonclinical Laboratories)--Primary Project Filed in Chapter 48
Program No. 7309.809: Institutional TBD Review Board Program--Primary Project Filed in Chapter 48
[[Page 16538]]
Program No. 7309.810: Sponsors, TBD Contract Research Organizations and Monitors--Compliance With Regulations--Primary Project Filed in Chapter 48
Program No. 7309.811: Clinical TBD Investigators--Primary Project Filed in Chapter 48
Program No. 7318.002: Retail Food TBD Protection--State
Program No. 7318.003: Milk Safety TBD Program
Program No. 7318.004: Molluscan TBD Shellfish Evaluation
Program No. 7318.029: Interstate TBD Travel Program
Program No. 7321.002: Medical
TBD Foods--Import and Domestic
Program No. 7321.005: Domestic TBD Nutrition Labeling and Education Act of 1990, Nutrient Sample Analysis, General Food Labeling Program
Program No. 7321.006: Infant
TBD Formula Program--Import and Domestic
Program No. 7321.007: Nutrition TBD Labeling and Education Act of 1990 and Enforcement--Imports
Program No. 7321.008: Dietary
TBD Supplements--Imports and Domestic
Program No. 7329.001: Domestic TBD Cosmetics Program
Program No. 7329.002: Imported TBD Cosmetics Compliance Program
CATEGORY: OFFICE OF NUTRITION, ................................... PRODUCTS, LABELING AND DIETARY SUPPLEMENTS
Soy Formulas and Preterm Infants-- Shawne Suggs-Anderson, Center for Draft Guidance
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 Loretta Carey, Center for Food Labeling of Foods That Have Been Safety and Applied Nutrition (HFS- Treated With Irradiation--Final 822), Food and Drug Guidance published October 7, 2002 Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301- 436-2371
Voluntary Labeling Indicating
Cataline Ferre-Hockensmith, Center Whether Foods Have or Have Not for Food Safety and Applied Been Developed Using
Nutrition (HFS-822), Food and Drug Bioengineering--Final Guidance 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 Robert Moore, Center for Food for Dietary Supplements
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 Kristina Paquette, Center for Food Recycled Plastics in Food
Safety and Applied Nutrition (HFS- Packaging: Chemistry
275), Food and Drug Considerations
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 202- 436-3020
Guidance for Industry: Testing Do Protocols for Determining Exposure to Radiolysis Products From Packaging Materials Irradiated in Contact With Food
Revised of Four Chapters of
Carolyn Young, Center for Food ``Toxicological Principles for the Safety and Applied Nutrition (HFS- Safety Assessment of Direct Food 275), Food and Drug Additives and Color Additives Used Administration, 5100 Paint Branch in Food'' (Redbook 2000)
Pkwy., College Park, MD 20740- 3835, 202-418-3059
[[Page 16539]]
Guidance to Industry: Evaluation of Kathleen Jones, Center for Food Allergenicity of Proteins
Safety and Applied Nutrition (HFS- Introduced into Bioengineered
013), Food and Drug Foods
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 Judy Kidwell, Center for Food for Submission to the Center for Safety and Applied Nutrition (HFS- Food Safety and Applied Nutrition 265), Food and Drug for Color Additives Used in or on Administration, 5100 Paint Branch Contact Lenses
Pkwy., College Park, MD 20740- 3835, 202-418-3354
Compliance Policy Guideline on Do Chloropropanols in Soy Sauces and Hydrolyzed Vegetable Protein
Guidance for Preparing a Claim of Layla Batarseh, Center for Food Categorical Exclusion or an
Safety and Applied Nutrition (HFS- Environmental Assessment for
245), Food and Drug Submissions to the Center for Food Administration, 5100 Paint Branch Safety and Applied Nutrition
Pkwy., College Park, MD 20740- 3835, 202-418-3016
Guidance for Preparing a Claim of Do Categorical Exclusion or an Environmental Assessment for Submissions to the Center for Food Safety and Applied Nutrition (Appendix D)
Guidance for Industry: Submission Ken McAdams, Center for Food Safety of Food Contact Notifications in and Applied Nutrition (HFS-205), Electronic Format
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3392
Submission of Premarket
Linda Kahl, Center for Food Safety Biotechnology Notices (PBNs) to and Applied Nutrition (HFS-255) FDA's Office of Food Addictive Food and Drug Administration, 5100 Safety--Electronic Copies in
Paint Branch Pkwy., College Park, Portable Document Format (PDF) MD 20740-3835, 202-418-3101
Submission of Premarket
Do Biotechnology Notices (PBNs) to FDA's Office of Food Addictive Safety--Electronic Copies in Hypertest Markup Language (HTML)
Providing Food and Color Additive Do Petitions in Electronic Format
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 Julie Barrows, Center for Food Cosmetic Products Containing Alpha Safety and Applied Nutrition (HFS- Hydroxy Acids as Ingredients-- 105), Food and Drug Draft Guidance
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 202- 418-3407
Cosmetics Handbook for Industry-- Beth Meyers, Center for Food Safety Draft Guidance
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 Do 740.10: Required Warning Statement for Cosmetics With Insufficient Data to Substantiate Safety--Draft Guidance
-
CENTER FOR VETERINARY MEDICINE (CVM)
CATEGORY--HUMAN FOOD SAFETY
Evaluating the Safety of
William Flynn, Center for Antimicrobial New Animal Drugs Veterinary Medicine (HFV-2), Food With Regard to Their
and Drug Administration, 7519 Microbiological Effects on
Standish Pl., Rockville, MD 20855, Bacteria of Human Health Concern 301-827-4514
Mass Spectroscopy Spectrometry for David Heller, Center for Veterinary Confirmation of the Identity of Medicine (HFV-511), Food and Drug Drug Residues
Administration, 8401 Muirkirk Rd., Beltsville, MD 20855, 301-827-8156
Assessment of the Effects of
Haydee Fernandez, Center for Antimicrobial Drug Residues From Veterinary Medicine (HFV-153), Food of Animal Origin on the Human Food and Drug Administration, 7500 Intestinal Flora
Standish Pl., Rockville, MD 20855, 301-827-6981
Studies to Evaluate the Utility of Henry Ekperigin, Center for Anti-Salmonella Chemical Food
Veterinary Medicine (HFV-222), Additives in Feed
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0174
CATEGORY--NEW ANIMAL DRUG
................................... APPLICATIONS
[[Page 16540]]
Development of Supplemental
Marilyn Martinez, Center for Applications for Approved New
Veterinary Medicine (HFV-130), Animal Drugs (Section 403(b) of Food and Drug Administration, 7500 the Food and Drug Administration Standish Pl., Rockville, MD 20855, Modernization Act of 1997)
301-827-7577
Administrative New Animal Drug Gail Schmerfeld, Center for Application Process
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0205
CATEGORY--LABELING
...................................
Manufacture and Labeling of Raw William Burkholder, Center for Meat Diets for Consumption by
Veterinary Medicine (HFV-228), Dogs, Cats, and Captive Non-
Food and Drug Administration, 7500 Companion Animal Carnivores and Standish Pl., Rockville, MD 20855, Omnivores
301-827-0179
Labeling and Professional Flexible Douglass Oeller, Center for Labeling
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 Gail Schmerfeld, Center for Characterization
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0205
Use of Field Studies to Demonstrate Steven Vaughn and Gail Schmerfeld, the Effectiveness of a New Animal Center for Veterinary Medicine Drug
(HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7584
CATEGORY--STATUTORY REQUIREMENTS ...................................
Dispute Resolution--Food and Drug Marcia Larkins, Center for Administration Modernization Act Veterinary Medicine (HFV-1), Food of 1997
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-4535
CATEGORY--INTERNATIONAL
................................... HARMONIZATION
Guidance GL27 International
William Flynn, Center for Cooperation on Harmonization of Veterinary Medicine (HFV-2), Food Technical Requirements for
and Drug Administration, 7519 Registration of Veterinary
Standish Pl., Rockville, MD 20855, Medicinal Products
301-827-4514
-
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
Bonnie M. Lee, Office of the Institutional Review Board's
Commissioner, Office for Good Review of Research
Clinical Practice (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340
Institutional Review Board's Review Do of Research Conducted at Other Sites
Continuing Review After Study
Do Approval
Dates of Continuing Review
Do
Interactions Among FDA, Sponsor, Do Investigator, and Institutional Review Board
Acceptance of Clinical Studies Do Conducted Outside the United States
Charging for Investigational
Do Products
Recruiting Study Subjects
Do
Payment to Research Subjects
Do
Screening Tests Prior to Study Do Enrollment
A Guide to Informed Consent
Do
Use of Investigational Products Do When Subjects Enter a Second Institution
[[Page 16541]]
Personal Importation of and Use of Do Drug Products Not Approved in the United States
Investigational Use of Marketed Do Drugs, Biologics, and Medical Devices
Emergency Use: Exceptions From the Do Requirements for Institutional Review Board (IRB) Review and Informed Consent
Emergency Use of an Investigational Do Drug or Biologic Under 21 CFR Part 312
Expanded Access of Investigational Do Drugs
Waiver of Institutional Review Do Board Requirements for Drug and Biologic Studies
Drug Study Designs
Do
Evaluation of Gender Differences in Do Clinical Investigations
Medical Devices 21 CFR Part 812 Do
Significant Risk and Nonsignificant Do Risk Medical Device Studies
Emergency Use of Unapproved Medical Do Devices
FDA Institutional Review Board Do Inspections
Clinical Investigator Regulatory Do Sanctions
Recordkeeping in Clinical
Do Investigations
Significant Differences in FDA's Do and the Department of Health and Human Services' Regulations
A Self-Evaluation Checklist for Do Institutional Review Boards
-
OFFICE OF REGULATORY AFFAIRS (ORA)
INSPECTION GUIDES
Techniques for Detecting False Data Gerald Miller, Division of Field During Bioresearch Monitoring
Investigations (HFC-130), Food and Inspections
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 5655
Guide to Inspections of Bulk
Do Pharmaceutical Chemicals
Guide to International Inspections Rebecca Hackett, Division of Field and Travel
Investigations, (HFC-130), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857, 301-827-3777
Guide to Produce Farm
Ellen Morrison, Emergency Investigations
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
