Reports and guidance documents; availability, etc.: Guidance documents; annual list,
[Federal Register: September 1, 2006 (Volume 71, Number 170)]
[Notices]
[Page 52125-52136]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01se06-52]
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:
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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.
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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 Same as above (Do) 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
CATEGORY--BLOOD AND BLOOD
................................... COMPONENTS
Reentry Algorithm for Donors Who Do Are Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti- HBc)
[[Page 52126]]
Implementation of a Licensed West Do Nile Virus Nucleic Acid Test (NAT) for Whole Blood Donor Screening
Revised Preventive Measures to Do Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
Recognition and Use of a Standard Do for the Uniform Labeling of Blood and Blood Components
Use of Nucleic Acid Test (NAT) on Do Source and Recovered Plasma for Parvovirus B19
CATEGORY--VACCINES AND ALLERGENICS ...................................
Characterization and Qualification Do of Cell Substrates and Other Biological Starting Materials for the Production of Viral Vaccines
CATEGORY--CELLULAR, TISSUE, AND ................................... GENE THERAPY
Licensure of Minimally Manipulated, Do Unrelated, Allogeneic Placental/ Umbilical Cord Blood Intended For Hematopoietic Reconstitution in Patients With Hematological Malignancies
Preparation of Investigational Do Device Exemptions and Investigational New Drugs for Products Intended to Repair or Replace Knee Articular Cartilage
Initiation and Conduct of Clinical Do Trials Using Cellular Therapies for Cardiac Disease
Potency Measurements for Cell and Do Gene Therapy Products
Considerations for Allogeneic
Do Pancreatic Islet Cell Products
Current Good Tissue Practice for Do Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments
Certain Distributed and Inventoried Do Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Improperly Tested
Clinical Study Design for Early Do Phase Studies of Cellular and Gene Therapies
Devices Involved in Manufacture, Do Storage and Administration of Cellular Products and Tissues
Validation of Rapid Microbiological Do Methods for Assessing Sterility of Cellular and Gene Therapy Products
Submission of Information for the Do National Xenotransplantation Database
Registration and Listing for Human Do Cell, Tissue, and Cellular and Tissue-Based Products Establishments
Preparation of Investigational Do Device Exemptions and Investigational New Drugs for Tissue Engineered and Regenerative Medicine Products
Facilities and Controls for
Do Cellular and Gene Therapy Product Manufacturing Operations Guidance
CATEGORY--OTHER
...................................
Changes to an Approved Application: Do Biological Products
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Center for Drug Evaluation and Research (CDER)
[[Page 52127]]
Title/Topic of Guidance
Contact
CATEGORY--ADVERTISING
...................................
Presentation of Risk Information in Emily T. Thakur, Center for Drug Prescription Drug and Medical
Evaluation and Research (HFD-7), Device
Food and Drug Administration, 5515 Security Lane, Rockville, MD 20852, 301-594-2041.
CATEGORY--CHEMISTRY
...................................
Immunogenicity Assessment for
Do Follow-on Protein Products
Immunogenicity Assessment for
Do Therapeutic Protein Products
Individual Product Bioequivalence Do Recommendations
Patient Specific Drug Products Do
Quality by Design
Do
Recommendations for Determination Do of Bioequivalence of Vaginal Antifungal Products
Submission of Documentation in Do Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
CATEGORY--CLINICAL/MEDICAL
...................................
Androgens in Aging Males
Do
Clinical Development of Drugs for Do Irritable Bowel Syndrome
Clinical Evaluation of Agents to Do Lower the Risk of Developing Sporadic Colorectal Adenomas
Clinical Evaluation of Drugs for Do Female Infertility
Clinical Evaluation of Drug
Do Products for Inflammatory Bowel Disease
Clinical Trial Design for the
Do Treatment of Bacterial Blepharitis
Clinical Trial Design for the
Do Treatment of Bacterial Conjunctivitis
Clinical Trial Design for the
Do Treatment of Bacterial Corneal Ulcers
Clinical Trial Design for the
Do Treatment of Dry Eye
Clinical Trial Design for the
Do Treatment of Superficial Punctate Keratitis (SPK)
Conducting and Submitting Virology Do Studies to the Division of Antiviral Drug Products
Co-packaged Sodium Nitrite and Do Sodium Thiosulfate Drug Products-- Submitting a New Drug Application
Developing Analgesic Products for Do the Treatment of Pain
Developing Drugs to Treat or
Do Prevent Smallpox (Variola) Injection
Development of Drugs for Chronic Do Obstructive Pulmonary Disease (COPD)
Drug Development for the Treatment Do of Malaria
Evaluation of New Treatments for Do Diabetes Mellitus
Inhalational Anthrax (Symptomatic)-- Do Developing Therapeutic Agents that Target Anthrax Toxin
Obesity and Weight Loss
Do
Oral Mucositis
Do
Patient Reported Outcomes (PRO) Do Measures
[[Page 52128]]
Periodontitis
Do
Peripheral Neuropathy
Do
Treatment of Congestive Heart
Do Failure
CATEGORY--CLINICAL/PHARMACOLOGY ...................................
Immediate Release to Modified
Do Release Dosage Forms
In Vitro Drug Metabolism/Drug
Do Interaction--Guidance for Reviewers
CATEGORY--COMBINATION PRODUCTS ...................................
Drug Diagnostic Co-Development Do
CATEGORY--COMPLIANCE
...................................
Registration Requirements Under the Do Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Process Validation: General
Do Principles and Practices
Penicillin as Defined in the CGMP Do Regulation Under 21 CFR 211 and Separation Requirements for Manufacturing
Non-Penicillin Beta-Lactam
Do Contamination
Importation of Active
Do Pharmaceutical Ingredients
CATEGORY--DRUG SAFETY INFORMATION ...................................
Good Naming, Labeling and Packaging Do (GNLP) Practices
Premarketing Evaluation of Drug- Do Induced Liver Injury
Risk Management of Highly Suspect Do or Known Human Teratogens: Pregnancy Prevention Strategies
Selecting and Submitting
Do Proprietary Names for Evaluation
CATEGORY--ELECTRONIC SUBMISSIONS ...................................
Providing Regulatory Submissions in Do Electronic Format--Analysis Datasets and Documentation
CATEGORY--GOOD REVIEW PRACTICES ...................................
Good Review Management Practices Do for Investigational New Drugs
CATEGORY--INVESTIGATIONAL NEW DRUGS ...................................
Consumer Product Safety Commission-- Do Tamper Resistant Packaging for Investigational New Drugs
Guidance for Clinical
Do Investigators--Preparing and Submitting an Investigational New Drug Application
CATEGORY--LABELING
...................................
Content and Format of the Clinical Do Pharmacology Section
Dosage and Administration Section Do of Labeling for Human Prescription Drug and Biological Products-- Content and Format
Drug Names and Dosage Forms
Do
Indication and Usage Section of Do Labeling for Human Prescription Drugs and Biological Products-- Content and Format
Labeling Dietary Supplements for Do Women Who Are or Could Be Pregnant
Labeling for Human Prescription Do Drug and Biologic Products-- Pharmacologic Classification for the Highlights Section of Labeling
[[Page 52129]]
Labeling for Outcome Claims for Do Drugs to Treat Hypertension
Pregnancy Labeling Revisions
Do
Use of Pharmacologic/Therapeutic Do Classification in Approved Labeling
CATEGORY--OVER-THE-COUNTER
...................................
Actual Use Trials
Do
Labeling Comprehension Studies for Do Over-the-Counter Drug Products
Labeling of Skin Protectants
Do
Topical Drug Products for Vaginal Do Yeast Infections
CATEGORY--PHARMACOLOGY/TOXICOLOGY ...................................
Nonclinical Safety Evaluation of Do Reformulated Drug Products, Including Administration by an Alternate Route
Nonclinical Studies for Anticancer Do Drugs
CATEGORY--PROCEDURAL
...................................
Assessment of Abuse Potential of Do Drugs
Clinical Source Data
Do
Determining Whether Human Research Do With a Radioactive Drug Can be Conducted Under a Radioactive Drug Research Committee
Good Meeting Management Guidance Do
Nonclinical Evaluation of Late Do Radiation Toxicity of Therapeutic Radiopharmaceuticals
Process for Contracts and Written Do Requests Under the Best Pharmaceutical for Children Act
Qualifying for Pediatric
Do Exclusivity Under Section 505a of the Federal Food, Drug, and Cosmetic Act
Target Product Profile--A Strategic Do Development Process Tool
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Center for Devices and Radiological Health (CDRH)
Title/Topic of Guidance
Contact
Class II Special Control Guidance Robert A. Phillips, Center for Document: Full Field Digital
Devices and Radiological Health Mammography (FFDM)
(HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301- 594-1212, ext. 130.
Format Guidance (Table of Contents) Heather S. Rosecrans, Center for for Special 510(k)s
Devices and Radiological Health (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301- 594-1190.
Updated 510(k) Sterility Review Sheila A. Murphey, Center for Guidance K90-1; Final Guidance for Devices and Radiological Health Industry and FDA
(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 Matthew Hillebrenner, Center for Approval Applications
Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301- 443-8517.
[[Page 52130]]
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 Ashley B. Boam, Center for Devices Document: Percutaneous
and Radiological Health (HFZ-450), Transluminal Coronary Angioplasty Food and Drug Administration, 9200 (PTCA) Catheters
Corporate Blvd., Rockville, MD 20850, 240-276-4222.
Pulse Oximeter Premarket
Ann A. Graham, Center for Devices Notification [510(k)] Submissions 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
Ashley B. Boam, Center for Devices Guidance Document
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 Do Document: Absorbable Hemostatic Agent
Preparation of Investigational Jonette Foy, Center for Devices and Device Exemptions and
Radiological Health (HFZ-450), Investigational New Drugs for
Food and Drug Administration, 9200 Products Intended to Repair or Corporate Blvd., Rockville, MD Replace Articular Cartilage
20850, 301-443-8262.
Premarket Approval Application Thinh X. Nguyen, Center for Devices Modifications
and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186, ext. 152.
Medical Device User Fee
Ginette Y. Michaud, Center for Modernization Act of 2002
Devices and Radiological Health Validation Data in Premarket
(HFZ-480), Food and Drug Notification (510(k)) Submissions Administration, 9200 Corporate for Reprocessed Single-Use Medical Blvd., Rockville, MD 20850, 301- Devices
443-8879, ext. 143.
Premarket Approval Application Thinh X. Nguyen, Center for Devices Performance Goals and Review Clock and Radiological Health (HFZ-402), Guidance
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186, ext. 152.
Humanitarian Device Exemption Q and Elisa D. Harvey, Center for Devices A Guidance
and Radiological Health (HFZ-403), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190.
Premarket Approval Application Thinh X. Nguyen, Center for Devices Annual Reports
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 Theodore R. Stevens, Center for Document: Cutaneous Electrode
Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301- 594-1296.
Class II Special Control Guidance Do Document: Electroconductive Media
Class II Special Control Guidance Do Document: Powered Muscle Stimulators for Muscle Conditioning
Class II Special Control Guidance Do Document: Powered Muscle Stimulators with Limited Output for Muscle Conditioning
Class II Special Control Guidance Do Document: Powered Muscle Stimulators for Rehabilitation
Class II Special Control Guidance Do Document: Powered Muscle Stimulators With Limited Output for Rehabilitation
Class II Special Control Guidance Do Document: Transcutaneous Electrical Nerve Stimulators for Pain Relief
Class II Special Control Guidance Do Document: Transcutaneous Electrical Nerve Stimulators With Limited Output for Pain Relief
[[Page 52131]]
Class II Special Control Guidance Do Document: Transcutaneous Electrical Stimulators for Aesthetic Purposed
Class II Special Control Guidance Do Document: Transcutaneous Electrical Stimulators With Limited Output for Aesthetic Purposes
Office of Science and Engineering ................................... Laboratories
Application of IEC 60601 Third Jean M. Olson, Center for Devices Edition in Premarket Applications; and Radiological Health (HFZ-84), Draft Guidance for Industry and Food and Drug Administration, 9200 FDA Staff
Corporate Blvd., Rockville, MD 20850, 301-827-0952.
Establishing the Compatibility of Do Medical Devices in Magnetic Resonance Imaging Systems; Draft Guidance for Industry and FDA Staff
Stereotactic Devices; Draft
Do Guidance for Industry and FDA Staff
Medical Device Electromagnetic Do Compatibility Guidance
Diagnostic Spectroscopy for
Do Detection of Cervical Disease Guidance
Criteria for Establishing Labeling Do of Continuous Peripheral Anesthesia Devices for Austere Conditions
Office of Compliance
...................................
Site Change Supplements and Express Christy Foreman Center for Devices Premarket Approval Application and Radiological Health (HFZ-340), Supplements
Food and Drug Administration, 4 Oak Grove , Rockville, MD 20850, 240-276-0120.
Consumer Directed Broadcast
Deborah Wolf, Center for Devices Advertising
and Radiological Health (HFZ-302), Food and Drug Administration, 4 Oak Grove, Rockville, MD 20850, 240-276-0100.
Decorative, Non-corrective Contact Casper Uldriks, Center for Devices Lenses
and Radiological Health (HFZ-300), Food and Drug Administration, 4 Oak Grove, Rockville, MD 20850, 240-276-0100.
Good Manufacturing Practice
Tim Ulatowski, Center for Devices Inspectional Information (Medical and Radiological Health (HFZ-300), Device User Fee Modernization Act Food and Drug Administration, 4 of 2002)
Oak Grove, Rockville, MD 20850, 240-276-0100.
Bioresearch Monitoring Program Matt Tarosky, Center for Devices Inspectional Information (Medical and Radiological Health (HFZ-310), Device User Fee Modernization Act Food and Drug Administration, 4 of 2002)
Oak Grove, Rockville, MD 20850, 240-276-0243.
Office of Surveillance and
................................... Biometrics
Instructions for Completing FDA Howard A. Press, Center for Devices Form 3500A With Coding Manual for and Radiological Health (HFZ-530), Form 3500A
Food and Drug Administration, 1350 Piccard Drive, Rockville, MD 20850, 240-276-3457.
Electronic Medical Device Adverse Do Event Reporting
Office of Communication, Education, ................................... and Radiation Programs
Medical Device Quality System
John Stigi, Center for Devices and Manual: A Small Entity Compliance Radiological Health (HFZ-220), Guide
Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-0806.
Medical Device Reporting for
Do Manufacturers
Revision to Compliance Program Sean Boyd, Center for Devices and 7386.001 Inspection of
Radiological Health (HFZ-240), Manufacturers of Laser Products Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3287.
Revision to Compliance Program Do 7386.002 Field Implementation of the Sunlamp and Sunlamp Products Performance Standard as Amended
Revision to Compliance Program Do 7386.004 Field Compliance Testing of Cabinet X-Ray Equipment
[[Page 52132]]
Revision to Compliance Program Do 7386.006 Compliance Testing of Electronic Products at Winchester Engineering and Analytical Center
Revision to Compliance Program Do 7386.007 Imported Electronic Products
Revision to Compliance Program Do 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
Revision to Compliance Program Do 7386.008 Medical Device and Radiological Health Use Control and Policy Implementation
Guidance to Allow Alternate Means Do 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
Guidance to Exempt Laser Light Show Do Manufacturers From Variance Application Requirements Under Certain Conditions: Granting Light Show Variances by Guidance to Reduce Burden on FDA and Industry
Guidance Regarding Risk Messaging Margaret Tolbert, Center for for Implantable Cardioverter
Devices and Radiological Health Defibrillator Dear Doctor Letters (HFZ-230), Food and Drug to Include Flow, Order of
Administration, 1350 Piccard Dr., Presentation, Required Elements of Rockville, MD 20850, 240-276-3240. Content, and Language
Device Use Safety: Incorporating Ron Kaye, Center for Devices and Human Factors into Risk Management 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:
Courtney Harper, Center for Devices Frequently Asked Questions
and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0443.
Class II Special Controls Guidance Sally Hojvat, Center for Devices Document: Herpes Simplex Virus and Radiological Health (HFZ-440), Types 1 and 2 Serological Assays Food and Drug Administration, 8 Oak Grove, Rockville, MD 20850, 240-276-0496.
Draft guidance--Class II Special Roxanne Shively, Center for Devices Controls Guidance Document:
and Radiological Health (HFZ-440), Bacillus spp. Serological Reagents 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
Carol Benson, Center for Devices Procedures for Clinical Laboratory and Radiological Health (HFZ-440), Improvement Amendments of 1988 Food and Drug Administration, 8 Categorization
Oak Grove , Rockville, MD 20850, 240-276-0496.
Guidance for Over-the-Counter
Veronica Calvin, Center for Devices Ovulation Tests
and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
In Vitro Diagnostic Product Devices Sally Hojvat, Center for Devices Under Development: Frequently
and Radiological Health (HFZ-440), Asked Questions
Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Medical Device Reporting for Self- Claudia Gaffey, Center for Devices Monitoring Blood Glucose Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
[[Page 52133]]
Migration Studies for Assays With Sally Hojvat, Center for Devices Multiple Instrumentation Systems and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Nucleic Acid Based In Vitro
Roxanne Shively, Center for Devices Diagnostic Devices for Detection and Radiological Health (HFZ-440), of Microbial Pathogens
Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Pharmacogenetic Tests and Genetic Kathleen Simon, Center for Devices Tests for Heritable Markers
and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Points to Consider on Assayed and Carol Benson, Center for Devices Unassayed Quality Control Material and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496
Recommendations for Therapeutic Avis Danishefsky, Center for Drug Monitoring Assays
Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Recommendations for Clinical
Carol Benson, Center for Devices Laboratory Improvement Amendments and Radiological Health (HFZ-440), of 1988 (CLIA) Waiver Applications Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Serologic Assays for the Detection Sally Hojvat, Center for Devices of Antibodies to Viral Agents
and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
Total Product Life Cycle for
Carol Benson, Center for Devices Portable Invasive Blood Glucose and Radiological Health (HFZ-440), Monitoring Systems
Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
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Center for Food Safety and Applied Nutrition (CFSAN)
Title/Topic of Guidance
Contact
New Dietary Ingredient
Linda Pellicore, Center for Food Notifications
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 Kathy Ellwood, Center for Food System for Health Claims
Safety and Applied Nutrition (HFS- (Including Qualified Health
830), Food and Drug Claims)
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301- 436-1450.
Fish and Fishery Products Hazards Robert Samuels, Kathy Ellwood, and Control Guidance
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
Nega Beru, Kathy Ellwood, Center Monocytogenes Contamination in for Food Safety and Applied Ready-to-Eat Foods
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 Paul DeLeo, Center for Food Safety Antimicrobial Food Additive
and Applied Nutrition (HFS-265), Submissions
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1302.
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Center for Veterinary Medicine (CVM)
Title of Guidance
Contact
Key Elements in Labeling of
Melanie Berson, Center for Prescription Antimicrobial Drug Veterinary Medicine (HFV-110), Products
Food and Drug Administration, 7500 Standish Pl., MPN-2, Rockville, MD 20855, 301-827-7540, e-mail: melanie.berson@fda.hhs.gov.
[[Page 52134]]
Meetings With the Office of New Gail Schmerfeld, Center for Animal Drug Evaluation (ONADE) 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
Dennis Bensley, Center for Control Changes to an Approved Veterinary Medicine (HFV-143), NADA or ANADA (83)
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 Rebecca Owen, Center for Veterinary Type C Medicated Feeds (137)
Administration, 7500 Standish Pl., MPN-2, Rockville, MD 20855, 240- 276-9842, e-mail: rebecca.owen@fda.hhs.gov.
Veterinary Drug Compounding
Neal Bataller, Center for Compliance Policy Guide
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
Gloria Dunnavan, Center for Medicated Feed Manufacturing
Veterinary Medicine (HFV-230), Facilities Compliance Policy Guide 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
Michelle L. Stull, Center for Evaluation of Effectiveness
Veterinary Medicine (HFV-133), Studies for Swine Respiratory
Food and Drug Administration, 7500 Disease Claims (178)
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 Henry Ekperigin, Center for Compliance Policy Guide
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 Dragan Momcilovic, Center for Detection of Animal Proteins
Veterinary Medicine (HFV-220), Prohibited in Ruminant Feed
7519 Standish Pl., MPN-4, Rockville, MD 20855, 240-453-6856, e-mail: dragan.momcilovic@fda.hhs.gov.
International Cooperation on
Dennis Bensley, Center for Harmonisation of Technical
Veterinary Medicine (HFV-143), Requirements for Registration of Food and Drug Administration, 7500 Veterinary Medicinal Products
Standish Pl., MPN-2, Rockville, MD (VICH)GL-39 Specifications: Test 20855, 301-827-6956, e-mail: Procedures and Acceptance Criteria dennis.bensley@fda.hhs.gov. for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances
International Cooperation on
Do 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
International Cooperation on
Do 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)
International Cooperation on
Do 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)
Animal Drug User Fees: Fees Exceed Dave Newkirk, Center for Veterinary Costs Waivers and Reductions
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
Lynn Post, Center for Veterinary Harmonisation of Technical
Medicine (HFV-210), Food and Drug Requirements for Registration of Administration, 7519 Standish Pl., Veterinary Medicinal Products
MPN-4, Rockville, MD 20855, 240- (VICH) GL-24 Pharmacovigilance of 276-9062, e-mail: Veterinary Medicinal Products: Lynn.Post@fda.hhs.gov. Management of Adverse Event Reports
[[Page 52135]]
International Cooperation on
Do 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
International Cooperation on
Do 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)
International Cooperation on
Do Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) GL-30 Pharmacovigilance of Veterinary Medicinal Products: Controlled Lists of Terms
International Cooperation on
Do Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) GL-35 Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data
Guidance for Industry, Submission Do of Drug Experience Reports (DER) to the Center for Veterinary Medicine, Form Form FDA 2301
Guidance for Industry, Submission Do of Veterinary Adverse Drug Event Reports to the Center for Veterinary Medicine, Form FDA 1932
Salmonellain Pet Turtles Compliance Joseph Paige, Center for Veterinary Policy Guide
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 Mark Hackman, Center for Veterinary Products Compliance Policy Guide 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.
-
Office of Regulatory Affairs (ORA)
Title/Topic of Guidance
Contact
21 CFR Part 58: Closure of
Director, Office of Regulatory Nonclinical Laboratories
Affairs (HFC-230), Food and Drug Administration, 15800 Crabbs Branch Way, Rockville, MD 20855, 240-632-6860.
Disqualification of Clinical
Do Investigators
Compliance Policy Guide, Section Jeffrey B. Governale, Office of 310.210, Blood Pressure
Regulatory Affairs (HFC-230), Food Measurement Devices
and Drug Administration, 5600 (Sphygmomanometers)--Accuracy (CPG Fishers Lane, Rockville, MD 20857, 7124.23)
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
Do
-
Office of the Commissioner (OC)
Topic/Title of Guidance
Contact
Information Sheet Guidances for David Lepay, Office of the Institutional Review Boards,
Commissioner (HF-34), Food and Clinical Investigators, and
Drug Administration, 5600 Fishers Sponsors
Lane, Rockville, MD 20857, 301-827- 3340.
Guidance for Industry Computerized Patricia M. Beers Block, Office of Systems Used in Clinical Trials the Commissioner (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 6473.
Guidance for FDA Staff Compliance Do Program 7348.811, Inspection of Clinical Investigators and Sponsor Investigators
[[Page 52136]]
Guidance for Institutional Review Carolyn Hommel, Office of the Boards, Clinical Investigators, Commissioner (HF-34), Food and and Sponsors, Exception from
Drug Administration, 5600 Fishers Informed Consent Requirements for Lane, Rockville, MD 20857, 301-827- Emergency Research
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
