Annual Guidance Agenda
Federal RegisterSep 1, 2006
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Annual Guidance Agenda
[Docket No. 2004N-0234]
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is publishing its annual guidance document agenda. This list is being published under FDA's good guidance practices (GGPs) regulations. It is intended to seek public comment on possible topics for future guidance document development or revisions of existing ones.
DATES:
Submit written or electronic comments on this list and on any agency guidance documents at any time.
ADDRESSES:
Submit written comments to the Division of Dockets Management (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 GGP policy
: Lisa Helmanis, Office of Policy (HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480.
For information regarding specific topics or guidances
: Please see contact persons listed in the table in the
SUPPLEMENTARY INFORMATION
section.
SUPPLEMENTARY INFORMATION:
I. Background
In the
Federal Register
of September 19, 2000 (65 FR 56468), FDA's issued its final rule on GGPs (21 CFR 10.115). GGPs are intended to ensure involvement of the public in the development of guidance documents and to enhance understanding of the availability, nature, and legal effect of such guidance documents.
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 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 documents are organized by the issuing Center or Office within FDA, and, in some cases, are further grouped by topic categories. The agency's contact persons for each specific area are listed in the tables that follow.
II. Center for Biologics Evaluation and Research (CBER)
Title/Topic of Guidance
Contact
CATEGORY—COMPLIANCE AND INSPECTION
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.
Design, Operation, and Validation 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
Same as above (Do)
CATEGORY—BLOOD AND BLOOD COMPONENTS
Reentry Algorithm for Donors Who Are Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)
Do
Implementation of a Licensed West Nile Virus Nucleic Acid Test (NAT) for Whole Blood Donor Screening
Do
Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
Do
Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components
Do
Use of Nucleic Acid Test (NAT) on Source and Recovered Plasma for Parvovirus B19
Do
CATEGORY—VACCINES AND ALLERGENICS
Characterization and Qualification of Cell Substrates and Other Biological Starting Materials for the Production of Viral Vaccines
Do
CATEGORY—CELLULAR, TISSUE, AND GENE THERAPY
Licensure of Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended For Hematopoietic Reconstitution in Patients With Hematological Malignancies
Do
Preparation of Investigational Device Exemptions and Investigational New Drugs for Products Intended to Repair or Replace Knee Articular Cartilage
Do
Initiation and Conduct of Clinical Trials Using Cellular Therapies for Cardiac Disease
Do
Potency Measurements for Cell and Gene Therapy Products
Do
Considerations for Allogeneic Pancreatic Islet Cell Products
Do
Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments
Do
Certain Distributed and Inventoried Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Improperly Tested
Do
Clinical Study Design for Early Phase Studies of Cellular and Gene Therapies
Do
Devices Involved in Manufacture, Storage and Administration of Cellular Products and Tissues
Do
Validation of Rapid Microbiological Methods for Assessing Sterility of Cellular and Gene Therapy Products
Do
Submission of Information for the National Xenotransplantation Database
Do
Registration and Listing for Human Cell, Tissue, and Cellular and Tissue-Based Products Establishments
Do
Preparation of Investigational Device Exemptions and Investigational New Drugs for Tissue Engineered and Regenerative Medicine Products
Do
Facilities and Controls for Cellular and Gene Therapy Product Manufacturing Operations Guidance
Do
CATEGORY—OTHER
Changes to an Approved Application: Biological Products
Do
III. Center for Drug Evaluation and Research (CDER)
Title/Topic of Guidance
Contact
CATEGORY—ADVERTISING
Presentation of Risk Information in Prescription Drug and Medical Device
Emily T. Thakur, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5515 Security Lane, Rockville, MD 20852, 301-594-2041.
CATEGORY—CHEMISTRY
Immunogenicity Assessment for Follow-on Protein Products
Do
Immunogenicity Assessment for Therapeutic Protein Products
Do
Individual Product Bioequivalence Recommendations
Do
Patient Specific Drug Products
Do
Quality by Design
Do
Recommendations for Determination of Bioequivalence of Vaginal Antifungal Products
Do
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
Do
CATEGORY—CLINICAL/MEDICAL
Androgens in Aging Males
Do
Clinical Development of Drugs for Irritable Bowel Syndrome
Do
Clinical Evaluation of Agents to Lower the Risk of Developing Sporadic Colorectal Adenomas
Do
Clinical Evaluation of Drugs for Female Infertility
Do
Clinical Evaluation of Drug Products for Inflammatory Bowel Disease
Do
Clinical Trial Design for the Treatment of Bacterial Blepharitis
Do
Clinical Trial Design for the Treatment of Bacterial Conjunctivitis
Do
Clinical Trial Design for the Treatment of Bacterial Corneal Ulcers
Do
Clinical Trial Design for the Treatment of Dry Eye
Do
Clinical Trial Design for the Treatment of Superficial Punctate Keratitis (SPK)
Do
Conducting and Submitting Virology Studies to the Division of Antiviral Drug Products
Do
Co-packaged Sodium Nitrite and Sodium Thiosulfate Drug Products—Submitting a New Drug Application
Do
Developing Analgesic Products for the Treatment of Pain
Do
Developing Drugs to Treat or Prevent Smallpox (Variola) Injection
Do
Development of Drugs for Chronic Obstructive Pulmonary Disease (COPD)
Do
Drug Development for the Treatment of Malaria
Do
Evaluation of New Treatments for Diabetes Mellitus
Do
Inhalational Anthrax (Symptomatic)—Developing Therapeutic Agents that Target Anthrax Toxin
Do
Obesity and Weight Loss
Do
Oral Mucositis
Do
Patient Reported Outcomes (PRO) Measures
Do
Periodontitis
Do
Peripheral Neuropathy
Do
Treatment of Congestive Heart Failure
Do
CATEGORY—CLINICAL/PHARMACOLOGY
Immediate Release to Modified Release Dosage Forms
Do
In Vitro Drug Metabolism/Drug Interaction—Guidance for Reviewers
Do
CATEGORY—COMBINATION PRODUCTS
Drug Diagnostic Co-Development
Do
CATEGORY—COMPLIANCE
Registration Requirements Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Do
Process Validation: General Principles and Practices
Do
Penicillin as Defined in the CGMP Regulation Under 21 CFR 211 and Separation Requirements for Manufacturing
Do
Non-Penicillin Beta-Lactam Contamination
Do
Importation of Active Pharmaceutical Ingredients
Do
CATEGORY—DRUG SAFETY INFORMATION
Good Naming, Labeling and Packaging (GNLP) Practices
Do
Premarketing Evaluation of Drug-Induced Liver Injury
Do
Risk Management of Highly Suspect or Known Human Teratogens: Pregnancy Prevention Strategies
Do
Selecting and Submitting Proprietary Names for Evaluation
Do
CATEGORY—ELECTRONIC SUBMISSIONS
Providing Regulatory Submissions in Electronic Format—Analysis Datasets and Documentation
Do
CATEGORY—GOOD REVIEW PRACTICES
Good Review Management Practices for Investigational New Drugs
Do
CATEGORY—INVESTIGATIONAL NEW DRUGS
Consumer Product Safety Commission—Tamper Resistant Packaging for Investigational New Drugs
Do
Guidance for Clinical Investigators—Preparing and Submitting an Investigational New Drug Application
Do
CATEGORY—LABELING
Content and Format of the Clinical Pharmacology Section
Do
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format
Do
Drug Names and Dosage Forms
Do
Indication and Usage Section of Labeling for Human Prescription Drugs and Biological Products—Content and Format
Do
Labeling Dietary Supplements for Women Who Are or Could Be Pregnant
Do
Labeling for Human Prescription Drug and Biologic Products—Pharmacologic Classification for the Highlights Section of Labeling
Do
Labeling for Outcome Claims for Drugs to Treat Hypertension
Do
Pregnancy Labeling Revisions
Do
Use of Pharmacologic/Therapeutic Classification in Approved Labeling
Do
CATEGORY—OVER-THE-COUNTER
Actual Use Trials
Do
Labeling Comprehension Studies for Over-the-Counter Drug Products
Do
Labeling of Skin Protectants
Do
Topical Drug Products for Vaginal Yeast Infections
Do
CATEGORY—PHARMACOLOGY/TOXICOLOGY
Nonclinical Safety Evaluation of Reformulated Drug Products, Including Administration by an Alternate Route
Do
Nonclinical Studies for Anticancer Drugs
Do
CATEGORY—PROCEDURAL
Assessment of Abuse Potential of Drugs
Do
Clinical Source Data
Do
Determining Whether Human Research With a Radioactive Drug Can be Conducted Under a Radioactive Drug Research Committee
Do
Good Meeting Management Guidance
Do
Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals
Do
Process for Contracts and Written Requests Under the Best Pharmaceutical for Children Act
Do
Qualifying for Pediatric Exclusivity Under Section 505a of the Federal Food, Drug, and Cosmetic Act
Do
Target Product Profile—A Strategic Development Process Tool
Do
IV. Center for Devices and Radiological Health (CDRH)
Title/Topic of Guidance
Contact
Class II Special Control Guidance Document: Full Field Digital Mammography (FFDM)
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.
Format Guidance (Table of Contents) for Special 510(k)s
Heather S. Rosecrans, Center for Devices and Radiological Health (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190.
Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA
Sheila A. Murphey, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8913.
Antimicrobials; Draft
Do
510(k) Paradigm Guidance
Heather S. Rosecrans, Center for Devices and Radiological Health (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190.
Replacement Heart Valve Premarket Approval Applications
Matthew Hillebrenner, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8517.
Breast Implant Guidance document
Stephen P. Rhodes, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090.
Class II Special Control Guidance Document: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters
Ashley B. Boam, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4222.
Pulse Oximeter Premarket Notification [510(k)] Submissions
Ann A. Graham, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-4479.
Keratome and Keratome Blade 510ks
Everette T. Beers, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2018, ext. 136.
Coronary Drug Eluting Stents Guidance Document
Ashley B. Boam, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4222.
Metal Tracheal Stents
Stephen P. Rhodes, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090.
Class II Special Control Guidance Document:
Absorbable Hemostatic Agent
Do
Preparation of Investigational Device Exemptions and Investigational New Drugs for Products Intended to Repair or Replace Articular Cartilage
Jonette Foy, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8262.
Premarket Approval Application Modifications
Thinh X. Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186, ext. 152.
Medical Device User Fee Modernization Act of 2002 Validation Data in Premarket Notification (510(k)) Submissions for Reprocessed Single-Use Medical Devices
Ginette Y. Michaud, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8879, ext. 143.
Premarket Approval Application Performance Goals and Review Clock Guidance
Thinh X. Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186, ext. 152.
Humanitarian Device Exemption Q and A Guidance
Elisa D. Harvey, Center for Devices and Radiological Health (HFZ-403), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190.
Premarket Approval Application Annual Reports
Thinh X. Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186, ext. 152.
Class II Special Control Guidance Document: Cutaneous Electrode
Theodore R. Stevens, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1296.
Class II Special Control Guidance Document: Electroconductive Media
Do
Class II Special Control Guidance Document: Powered Muscle Stimulators for Muscle Conditioning
Do
Class II Special Control Guidance Document: Powered Muscle Stimulators with Limited Output for Muscle Conditioning
Do
Class II Special Control Guidance Document: Powered Muscle Stimulators for Rehabilitation
Do
Class II Special Control Guidance Document: Powered Muscle Stimulators With Limited Output for Rehabilitation
Do
Class II Special Control Guidance Document: Transcutaneous Electrical Nerve Stimulators for Pain Relief
Do
Class II Special Control Guidance Document: Transcutaneous Electrical Nerve Stimulators With Limited Output for Pain Relief
Do
Class II Special Control Guidance Document: Transcutaneous Electrical Stimulators for Aesthetic Purposed
Do
Class II Special Control Guidance Document: Transcutaneous Electrical Stimulators With Limited Output for Aesthetic Purposes
Do
Office of Science and Engineering Laboratories
Application of IEC 60601 Third Edition in Premarket Applications; Draft Guidance for Industry and FDA Staff
Jean M. Olson, Center for Devices and Radiological Health (HFZ-84), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-0952.
Establishing the Compatibility of Medical Devices in Magnetic Resonance Imaging Systems; Draft Guidance for Industry and FDA Staff
Do
Stereotactic Devices; Draft Guidance for Industry and FDA Staff
Do
Medical Device Electromagnetic Compatibility Guidance
Do
Diagnostic Spectroscopy for Detection of Cervical Disease Guidance
Do
Criteria for Establishing Labeling of Continuous Peripheral Anesthesia Devices for Austere Conditions
Do
Office of Compliance
Site Change Supplements and Express Premarket Approval Application Supplements
Christy Foreman Center for Devices and Radiological Health (HFZ-340), Food and Drug Administration, 4 Oak Grove , Rockville, MD 20850, 240-276-0120.
Consumer Directed Broadcast Advertising
Deborah Wolf, Center for Devices and Radiological Health (HFZ-302), Food and Drug Administration, 4 Oak Grove, Rockville, MD 20850, 240-276-0100.
Decorative, Non-corrective Contact Lenses
Casper Uldriks, Center for Devices and Radiological Health (HFZ-300), Food and Drug Administration, 4 Oak Grove, Rockville, MD 20850, 240-276-0100.
Good Manufacturing Practice Inspectional Information (Medical Device User Fee Modernization Act of 2002)
Tim Ulatowski, Center for Devices and Radiological Health (HFZ-300), Food and Drug Administration, 4 Oak Grove, Rockville, MD 20850, 240-276-0100.
Bioresearch Monitoring Program Inspectional Information (Medical Device User Fee Modernization Act of 2002)
Matt Tarosky, Center for Devices and Radiological Health (HFZ-310), Food and Drug Administration, 4 Oak Grove, Rockville, MD 20850, 240-276-0243.
Office of Surveillance and Biometrics
Instructions for Completing FDA Form 3500A With Coding Manual for Form 3500A
Howard A. Press, Center for Devices and Radiological Health (HFZ-530), Food and Drug Administration, 1350 Piccard Drive, Rockville, MD 20850, 240-276-3457.
Electronic Medical Device Adverse Event Reporting
Do
Office of Communication, Education, and Radiation Programs
Medical Device Quality System Manual: A Small Entity Compliance Guide
John Stigi, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-0806.
Medical Device Reporting for Manufacturers
Do
Revision to Compliance Program 7386.001 Inspection of Manufacturers of Laser Products
Sean Boyd, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3287.
Revision to Compliance Program 7386.002 Field Implementation of the Sunlamp and Sunlamp Products Performance Standard as Amended
Do
Revision to Compliance Program 7386.004 Field Compliance Testing of Cabinet X-Ray Equipment
Do
Revision to Compliance Program 7386.006 Compliance Testing of Electronic Products at Winchester Engineering and Analytical Center
Do
Revision to Compliance Program 7386.007 Imported Electronic Products
Do
Revision to Compliance Program 7386.007A Imported Non-certified Radiation-Emitting Electronic Products (Special Exemption for Television Receivers, Microwave Ovens, and Certain Class I Laser Products) Amending or Revoking as Appropriate Based on Guidance Published in Fiscal Year 2006 on Low Risk Product Reporting Exemptions
Do
Revision to Compliance Program 7386.008 Medical Device and Radiological Health Use Control and Policy Implementation
Do
Guidance to Allow Alternate Means of Labeling Certain Laser Products: Granting Approval to Include Labels for Small Laser Products in Packaging or in Product Literature, Rather Than on Product Itself, to Eliminate Burden on FDA and Industry
Do
Guidance to Exempt Laser Light Show Manufacturers From Variance Application Requirements Under Certain Conditions: Granting Light Show Variances by Guidance to Reduce Burden on FDA and Industry
Do
Guidance Regarding Risk Messaging for Implantable Cardioverter Defibrillator Dear Doctor Letters to Include Flow, Order of Presentation, Required Elements of Content, and Language
Margaret Tolbert, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3240.
Device Use Safety: Incorporating Human Factors into Risk Management
Ron Kaye, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3244.
Office of In Vitro Diagnostic Device Evaluation and Safety
Analyte Specific Reagents: Frequently Asked Questions
Courtney Harper, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0443.
Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
Sally Hojvat, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove, Rockville, MD 20850, 240-276-0496.
Draft guidance—Class II Special Controls Guidance Document: Bacillus spp. Serological Reagents
Roxanne Shively, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Draft guidance—Tumor Marker Assays
Maria Chan, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0493.
Recommendations for Gene Expression
Zivana Tezak, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Guidance for Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization
Carol Benson, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Guidance for Over-the-Counter Ovulation Tests
Veronica Calvin, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
In Vitro Diagnostic Product Devices Under Development: Frequently Asked Questions
Sally Hojvat, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Medical Device Reporting for Self-Monitoring Blood Glucose Devices
Claudia Gaffey, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Migration Studies for Assays With Multiple Instrumentation Systems
Sally Hojvat, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens
Roxanne Shively, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Pharmacogenetic Tests and Genetic Tests for Heritable Markers
Kathleen Simon, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Points to Consider on Assayed and Unassayed Quality Control Material
Carol Benson, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496
Recommendations for Therapeutic Drug Monitoring Assays
Avis Danishefsky, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications
Carol Benson, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Serologic Assays for the Detection of Antibodies to Viral Agents
Sally Hojvat, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems
Carol Benson, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
V. Center for Food Safety and Applied Nutrition (CFSAN)
Title/Topic of Guidance
Contact
New Dietary Ingredient Notifications
Linda Pellicore, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1448.
Evidence-Based Scientific Review System for Health Claims (Including Qualified Health Claims)
Kathy Ellwood, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1450.
Fish and Fishery Products Hazards and Control Guidance
Robert Samuels, Kathy Ellwood, Center for Food Safety and Applied Nutrition (HFS-417), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1418.
Steps to Reduce
Listeria Monocytogenes
Contamination in Ready-to-Eat Foods
Nega Beru, Kathy Ellwood, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1700.
Dietary Guidance Statements
Kathy Ellwood, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1450.
Microbiological Considerations for Antimicrobial Food Additive Submissions
Paul DeLeo, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1302.
VI. Center for Veterinary Medicine (CVM)
Title of Guidance
Contact
Key Elements in Labeling of Prescription Antimicrobial Drug Products
Melanie Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., MPN-2, Rockville, MD 20855, 301-827-7540, e-mail:
melanie.berson@fda.hhs.gov
.
Meetings With the Office of New Animal Drug Evaluation (ONADE)
Gail Schmerfeld, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., MPN-2, Rockville, MD 20855, 301-827-1796, e-mail:
gail.schmerfeld@fda.hhs.gov
.
Blue Bird Medicated Feed Labels
Dragan Momcilovic, Center for Veterinary Medicine (HFV-220), 7519 Standish Pl., MPN-4, Rockville, MD 20855, 240-453-6856, e-mail:
dragan.momcilovic@fda.hhs.gov
.
Chemistry, Manufacturing, and Control Changes to an Approved NADA or ANADA (#83)
Dennis Bensley, Center for Veterinary Medicine (HFV-143), Food and Drug Administration, 7500 Standish Pl., MPN-2, Rockville, MD 20855, 301-827-6956, e-mail:
dennis.bensley@.fda.hhs.gov
.
Analytical Methods Description for Type C Medicated Feeds (#137)
Rebecca Owen, Center for Veterinary Medicine (HFV- 141), Food and Drug Administration, 7500 Standish Pl., MPN-2, Rockville, MD 20855, 240-276-9842, e-mail:
rebecca.owen@fda.hhs.gov
.
Veterinary Drug Compounding Compliance Policy Guide
Neal Bataller, Center for Veterinary Medicine (HFV-235), Food and Drug Administration, 7519 Standish Pl., MPN-4, Rockville, MD 20855, 240-276-9202, e-mail:
neal.bataller@fda.hhs.gov
.
Voluntary Self Inspection of Medicated Feed Manufacturing Facilities Compliance Policy Guide
Gloria Dunnavan, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., MPN-4, Rockville, MD 20855, 240-276-9200, e-mail:
gloria.dunnavan@fda.hhs.gov
.
Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims (#178)
Michelle L. Stull, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., MPN-2, Rockville, MD 20855, 301-827-5058, e-mail:
michelle.stull@fda.hhs.gov
.
Extra-label Use of Drugs in Animals
Gloria Dunnavan, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., MPN-4, Rockville, MD 20855, 240-276-9200, e-mail:
gloria.dunnavan@fda.hhs.gov
.
Salmonella
Contamination of Feeds Compliance Policy Guide
Henry Ekperigin, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7500 Standish Pl., MPN-4, Rockville, MD 20855, 240-453-6868, e-mail:
henry.ekperigin@fda.hhs.gov
.
Criteria for Evaluating Tests for Detection of Animal Proteins Prohibited in Ruminant Feed
Dragan Momcilovic, Center for Veterinary Medicine (HFV-220), 7519 Standish Pl., MPN-4, Rockville, MD 20855, 240-453-6856, e-mail:
dragan.momcilovic@fda.hhs.gov
.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)GL-39 Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances
Dennis Bensley, Center for Veterinary Medicine (HFV-143), Food and Drug Administration, 7500 Standish Pl., MPN-2, Rockville, MD 20855, 301-827-6956, e-mail:
dennis.bensley@fda.hhs.gov
.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) GL-40 Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products
Do
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Revised Guidance for Industry on Impurities in New Veterinary Drug Substances (Revision) VICH GL10(R)
Do
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Revised Guidance for Industry on Impurities in New Veterinary Medicinal Products (Revision) VICH GL11(R)
Do
Animal Drug User Fees: Fees Exceed Costs Waivers and Reductions
Dave Newkirk, Center for Veterinary Medicine (HFV-100) , Food and Drug Administration, 7500 Standish Pl., MPN-2, Rockville, MD 20855, 301-827-6967, e-mail:
David.Newkirk@fda.hhs.gov
.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) GL-24 Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports
Lynn Post, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7519 Standish Pl., MPN-4, Rockville, MD 20855, 240-276-9062, e-mail:
Lynn.Post@fda.hhs.gov
.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) GL-42 Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports
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International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) GL-29 Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)
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International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) GL-30 Pharmacovigilance of Veterinary Medicinal Products: Controlled Lists of Terms
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International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) GL-35 Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data
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Guidance for Industry, Submission of Drug Experience Reports (DER) to the Center for Veterinary Medicine, Form Form FDA 2301
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Guidance for Industry, Submission of Veterinary Adverse Drug Event Reports to the Center for Veterinary Medicine, Form FDA 1932
Do
Salmonella
in Pet Turtles Compliance Policy Guide
Joseph Paige, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., MPN-4, Rockville, MD 20855, 240-276-9210, e-mail:
joseph.paige@fda.hhs.gov
.
Glucosamine/Chondroitin Animal Products Compliance Policy Guide
Mark Hackman, Center for Veterinary Medicine (HFV-232), Food and Drug Administration, 7519 Standish Pl., MPN-4, Rockville, MD 20855, 240-276-9215, e-mail:
mark.hackman@fda.hhs.gov
.
VII. Office of Regulatory Affairs (ORA)
Title/Topic of Guidance
Contact
21 CFR Part 58: Closure of Nonclinical Laboratories
Director, Office of Regulatory Affairs (HFC-230), Food and Drug Administration, 15800 Crabbs Branch Way, Rockville, MD 20855, 240-632-6860.
Disqualification of Clinical Investigators
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Compliance Policy Guide, Section 310.210, Blood Pressure Measurement Devices (Sphygmomanometers)—Accuracy (CPG 7124.23)
Jeffrey B. Governale, Office of Regulatory Affairs (HFC-230), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240-632-6851.
Untrue Statements of Material Facts
Director, Office of Regulatory Affairs (HFC-230), Food and Drug Administration, 15800 Crabbs Branch Way, Rockville, MD 20855, 240-632-6860.
Application Integrity Policy
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VIII. Office of the Commissioner (OC)
Topic/Title of Guidance
Contact
Information Sheet Guidances for Institutional Review Boards, Clinical Investigators, and Sponsors
David Lepay, Office of the Commissioner (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340.
Guidance for Industry Computerized Systems Used in Clinical Trials
Patricia M. Beers Block, Office of the Commissioner (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-6473.
Guidance for FDA Staff Compliance Program 7348.811, Inspection of Clinical Investigators and Sponsor Investigators
Do
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors, Exception from Informed Consent Requirements for Emergency Research
Carolyn Hommel, Office of the Commissioner (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-9105.
Dated: August 23, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14549 Filed 8-31-06; 8:45 am]
BILLING CODE 4160-01-S
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