# Annual Guidance Agenda > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3AE6-14549 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** September 1, 2006 - **Citation:** 71 FR 52125 ## Text 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 --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3AE6-14549. Public record. Not legal advice.