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71 FR 170 pgs. 52125-52136 - Annual Guidance Agenda

Type: NOTICEVolume: 71Number: 170Pages: 52125 - 52136
Docket number: [Docket No. 2004N-0234]
FR document: [FR Doc. E6-14549 Filed 8-31-06; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version:  PDF Version

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 Do
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) Do
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 Do
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 Do
Guidance for Industry, Submission of Drug Experience Reports (DER) to the Center for Veterinary Medicine, Form Form FDA 2301 Do
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 Do
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 Do

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