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Notice

Annual Guidance Agenda

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Information about this document as published in the Federal Register.

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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.

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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.

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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 GuidanceContact
CATEGORY—COMPLIANCE AND INSPECTIONStephen 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 ResearchSame 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
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Implementation of a Licensed West Nile Virus Nucleic Acid Test (NAT) for Whole Blood Donor ScreeningDo
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 ProductsDo
Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood ComponentsDo
Use of Nucleic Acid Test (NAT) on Source and Recovered Plasma for Parvovirus B19Do
CATEGORY—VACCINES AND ALLERGENICS
Characterization and Qualification of Cell Substrates and Other Biological Starting Materials for the Production of Viral VaccinesDo
CATEGORY—CELLULAR, TISSUE, AND GENE THERAPY
Licensure of Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended For Hematopoietic Reconstitution in Patients With Hematological MalignanciesDo
Preparation of Investigational Device Exemptions and Investigational New Drugs for Products Intended to Repair or Replace Knee Articular CartilageDo
Initiation and Conduct of Clinical Trials Using Cellular Therapies for Cardiac DiseaseDo
Potency Measurements for Cell and Gene Therapy ProductsDo
Considerations for Allogeneic Pancreatic Islet Cell ProductsDo
Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product EstablishmentsDo
Certain Distributed and Inventoried Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Improperly TestedDo
Clinical Study Design for Early Phase Studies of Cellular and Gene TherapiesDo
Devices Involved in Manufacture, Storage and Administration of Cellular Products and TissuesDo
Validation of Rapid Microbiological Methods for Assessing Sterility of Cellular and Gene Therapy ProductsDo
Submission of Information for the National Xenotransplantation DatabaseDo
Registration and Listing for Human Cell, Tissue, and Cellular and Tissue-Based Products EstablishmentsDo
Preparation of Investigational Device Exemptions and Investigational New Drugs for Tissue Engineered and Regenerative Medicine ProductsDo
Facilities and Controls for Cellular and Gene Therapy Product Manufacturing Operations GuidanceDo
CATEGORY—OTHER
Changes to an Approved Application: Biological ProductsDo

III. Center for Drug Evaluation and Research (CDER)Start Printed Page 52127

Title/Topic of GuidanceContact
CATEGORY—ADVERTISING
Presentation of Risk Information in Prescription Drug and Medical DeviceEmily 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 ProductsDo
Immunogenicity Assessment for Therapeutic Protein ProductsDo
Individual Product Bioequivalence RecommendationsDo
Patient Specific Drug ProductsDo
Quality by DesignDo
Recommendations for Determination of Bioequivalence of Vaginal Antifungal ProductsDo
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat ProcessesDo
CATEGORY—CLINICAL/MEDICAL
Androgens in Aging MalesDo
Clinical Development of Drugs for Irritable Bowel SyndromeDo
Clinical Evaluation of Agents to Lower the Risk of Developing Sporadic Colorectal AdenomasDo
Clinical Evaluation of Drugs for Female InfertilityDo
Clinical Evaluation of Drug Products for Inflammatory Bowel DiseaseDo
Clinical Trial Design for the Treatment of Bacterial BlepharitisDo
Clinical Trial Design for the Treatment of Bacterial ConjunctivitisDo
Clinical Trial Design for the Treatment of Bacterial Corneal UlcersDo
Clinical Trial Design for the Treatment of Dry EyeDo
Clinical Trial Design for the Treatment of Superficial Punctate Keratitis (SPK)Do
Conducting and Submitting Virology Studies to the Division of Antiviral Drug ProductsDo
Co-packaged Sodium Nitrite and Sodium Thiosulfate Drug Products—Submitting a New Drug ApplicationDo
Developing Analgesic Products for the Treatment of PainDo
Developing Drugs to Treat or Prevent Smallpox (Variola) InjectionDo
Development of Drugs for Chronic Obstructive Pulmonary Disease (COPD)Do
Drug Development for the Treatment of MalariaDo
Evaluation of New Treatments for Diabetes MellitusDo
Inhalational Anthrax (Symptomatic)—Developing Therapeutic Agents that Target Anthrax ToxinDo
Obesity and Weight LossDo
Oral MucositisDo
Patient Reported Outcomes (PRO) MeasuresDo
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PeriodontitisDo
Peripheral NeuropathyDo
Treatment of Congestive Heart FailureDo
CATEGORY—CLINICAL/PHARMACOLOGY
Immediate Release to Modified Release Dosage FormsDo
In Vitro Drug Metabolism/Drug Interaction—Guidance for ReviewersDo
CATEGORY—COMBINATION PRODUCTS
Drug Diagnostic Co-DevelopmentDo
CATEGORY—COMPLIANCE
Registration Requirements Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002Do
Process Validation: General Principles and PracticesDo
Penicillin as Defined in the CGMP Regulation Under 21 CFR 211 and Separation Requirements for ManufacturingDo
Non-Penicillin Beta-Lactam ContaminationDo
Importation of Active Pharmaceutical IngredientsDo
CATEGORY—DRUG SAFETY INFORMATION
Good Naming, Labeling and Packaging (GNLP) PracticesDo
Premarketing Evaluation of Drug-Induced Liver InjuryDo
Risk Management of Highly Suspect or Known Human Teratogens: Pregnancy Prevention StrategiesDo
Selecting and Submitting Proprietary Names for EvaluationDo
CATEGORY—ELECTRONIC SUBMISSIONS
Providing Regulatory Submissions in Electronic Format—Analysis Datasets and DocumentationDo
CATEGORY—GOOD REVIEW PRACTICES
Good Review Management Practices for Investigational New DrugsDo
CATEGORY—INVESTIGATIONAL NEW DRUGS
Consumer Product Safety Commission—Tamper Resistant Packaging for Investigational New DrugsDo
Guidance for Clinical Investigators—Preparing and Submitting an Investigational New Drug ApplicationDo
CATEGORY—LABELING
Content and Format of the Clinical Pharmacology SectionDo
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and FormatDo
Drug Names and Dosage FormsDo
Indication and Usage Section of Labeling for Human Prescription Drugs and Biological Products—Content and FormatDo
Labeling Dietary Supplements for Women Who Are or Could Be PregnantDo
Labeling for Human Prescription Drug and Biologic Products—Pharmacologic Classification for the Highlights Section of LabelingDo
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Labeling for Outcome Claims for Drugs to Treat HypertensionDo
Pregnancy Labeling RevisionsDo
Use of Pharmacologic/Therapeutic Classification in Approved LabelingDo
CATEGORY—OVER-THE-COUNTER
Actual Use TrialsDo
Labeling Comprehension Studies for Over-the-Counter Drug ProductsDo
Labeling of Skin ProtectantsDo
Topical Drug Products for Vaginal Yeast InfectionsDo
CATEGORY—PHARMACOLOGY/TOXICOLOGY
Nonclinical Safety Evaluation of Reformulated Drug Products, Including Administration by an Alternate RouteDo
Nonclinical Studies for Anticancer DrugsDo
CATEGORY—PROCEDURAL
Assessment of Abuse Potential of DrugsDo
Clinical Source DataDo
Determining Whether Human Research With a Radioactive Drug Can be Conducted Under a Radioactive Drug Research CommitteeDo
Good Meeting Management GuidanceDo
Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic RadiopharmaceuticalsDo
Process for Contracts and Written Requests Under the Best Pharmaceutical for Children ActDo
Qualifying for Pediatric Exclusivity Under Section 505a of the Federal Food, Drug, and Cosmetic ActDo
Target Product Profile—A Strategic Development Process ToolDo

IV. Center for Devices and Radiological Health (CDRH)

Title/Topic of GuidanceContact
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)sHeather 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 FDASheila A. Murphey, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8913.
Antimicrobials; DraftDo
510(k) Paradigm GuidanceHeather 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 ApplicationsMatthew Hillebrenner, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8517.
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Breast Implant Guidance documentStephen 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) CathetersAshley 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)] SubmissionsAnn 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 510ksEverette 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 DocumentAshley 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 StentsStephen 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 AgentDo
Preparation of Investigational Device Exemptions and Investigational New Drugs for Products Intended to Repair or Replace Articular CartilageJonette 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 ModificationsThinh 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 DevicesGinette 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 GuidanceThinh 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 GuidanceElisa 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 ReportsThinh 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 ElectrodeTheodore 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 MediaDo
Class II Special Control Guidance Document: Powered Muscle Stimulators for Muscle ConditioningDo
Class II Special Control Guidance Document: Powered Muscle Stimulators with Limited Output for Muscle ConditioningDo
Class II Special Control Guidance Document: Powered Muscle Stimulators for RehabilitationDo
Class II Special Control Guidance Document: Powered Muscle Stimulators With Limited Output for RehabilitationDo
Class II Special Control Guidance Document: Transcutaneous Electrical Nerve Stimulators for Pain ReliefDo
Class II Special Control Guidance Document: Transcutaneous Electrical Nerve Stimulators With Limited Output for Pain ReliefDo
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Class II Special Control Guidance Document: Transcutaneous Electrical Stimulators for Aesthetic PurposedDo
Class II Special Control Guidance Document: Transcutaneous Electrical Stimulators With Limited Output for Aesthetic PurposesDo
Office of Science and Engineering Laboratories
Application of IEC 60601 Third Edition in Premarket Applications; Draft Guidance for Industry and FDA StaffJean 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 StaffDo
Stereotactic Devices; Draft Guidance for Industry and FDA StaffDo
Medical Device Electromagnetic Compatibility GuidanceDo
Diagnostic Spectroscopy for Detection of Cervical Disease GuidanceDo
Criteria for Establishing Labeling of Continuous Peripheral Anesthesia Devices for Austere ConditionsDo
Office of Compliance
Site Change Supplements and Express Premarket Approval Application SupplementsChristy 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 AdvertisingDeborah 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 LensesCasper 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 3500AHoward 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 ReportingDo
Office of Communication, Education, and Radiation Programs
Medical Device Quality System Manual: A Small Entity Compliance GuideJohn 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 ManufacturersDo
Revision to Compliance Program 7386.001 Inspection of Manufacturers of Laser ProductsSean 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 AmendedDo
Revision to Compliance Program 7386.004 Field Compliance Testing of Cabinet X-Ray EquipmentDo
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Revision to Compliance Program 7386.006 Compliance Testing of Electronic Products at Winchester Engineering and Analytical CenterDo
Revision to Compliance Program 7386.007 Imported Electronic ProductsDo
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 ExemptionsDo
Revision to Compliance Program 7386.008 Medical Device and Radiological Health Use Control and Policy ImplementationDo
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 IndustryDo
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 IndustryDo
Guidance Regarding Risk Messaging for Implantable Cardioverter Defibrillator Dear Doctor Letters to Include Flow, Order of Presentation, Required Elements of Content, and LanguageMargaret 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 ManagementRon 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 QuestionsCourtney 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 AssaysSally 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 ReagentsRoxanne 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 AssaysMaria 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 ExpressionZivana 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 CategorizationCarol 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 TestsVeronica 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 QuestionsSally 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 DevicesClaudia Gaffey, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 8 Oak Grove , Rockville, MD 20850, 240-276-0496.
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Migration Studies for Assays With Multiple Instrumentation SystemsSally 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 PathogensRoxanne 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 MarkersKathleen 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 MaterialCarol 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 AssaysAvis 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 ApplicationsCarol 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 AgentsSally 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 SystemsCarol 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 GuidanceContact
New Dietary Ingredient NotificationsLinda 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 GuidanceRobert 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 FoodsNega 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 StatementsKathy 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 SubmissionsPaul 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 GuidanceContact
Key Elements in Labeling of Prescription Antimicrobial Drug ProductsMelanie 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.
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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 LabelsDragan 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 GuideNeal 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 GuideGloria 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 AnimalsGloria 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 GuideHenry 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 FeedDragan 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 SubstancesDennis 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 ProductsDo
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 ReductionsDave 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 ReportsLynn 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.
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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 ReportsDo
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 TermsDo
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 DataDo
Guidance for Industry, Submission of Drug Experience Reports (DER) to the Center for Veterinary Medicine, Form Form FDA 2301Do
Guidance for Industry, Submission of Veterinary Adverse Drug Event Reports to the Center for Veterinary Medicine, Form FDA 1932Do
Salmonella in Pet Turtles Compliance Policy GuideJoseph 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 GuideMark 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 GuidanceContact
21 CFR Part 58: Closure of Nonclinical LaboratoriesDirector, Office of Regulatory Affairs (HFC-230), Food and Drug Administration, 15800 Crabbs Branch Way, Rockville, MD 20855, 240-632-6860.
Disqualification of Clinical InvestigatorsDo
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 FactsDirector, Office of Regulatory Affairs (HFC-230), Food and Drug Administration, 15800 Crabbs Branch Way, Rockville, MD 20855, 240-632-6860.
Application Integrity PolicyDo

VIII. Office of the Commissioner (OC)

Topic/Title of GuidanceContact
Information Sheet Guidances for Institutional Review Boards, Clinical Investigators, and SponsorsDavid 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 TrialsPatricia 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 InvestigatorsDo
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Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors, Exception from Informed Consent Requirements for Emergency ResearchCarolyn Hommel, Office of the Commissioner (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-9105.
Start Signature

Dated: August 23, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. E6-14549 Filed 8-31-06; 8:45 am]

BILLING CODE 4160-01-S