Annual Guidance Agenda, 52125-52136 [E6-14549]

Download as PDF Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Notices complex chemistry, manufacturing, efficacy, and/or safety issues, the estimated time requirement per petition is approximately 10,000 hours. An average of one petition of this type is received on an annual basis, resulting in a burden of 10,000 hours. Under § 571.6, for a food additive petition amendment, the estimated time requirement per petition is 52125 approximately 1,300 hours. An average of four petitions of this type are received on an annual basis, resulting in a burden of 5,200 hours. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section Annual Frequency of Response Total Annual Responses Hours per Response Total Hours 571.1(c) moderate category 1 1 1 3,000 3,000 571.1(c) complex category 1 1 1 10,000 10,000 571.6 2 2 4 1,300 5,200 Total 18,200 1There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: August 28, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–14510 Filed 8–31–06; 8:45 am] BILLING CODE 4160–01–S 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 https:// 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 sroberts on PROD1PC70 with NOTICES 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) VerDate Aug<31>2005 16:21 Aug 31, 2006 Jkt 208001 PO 00000 Frm 00074 Fmt 4703 Do Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1 52126 Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Notices TITLE/TOPIC OF GUIDANCE CONTACT 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 CreutzfeldtJakob 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 sroberts on PROD1PC70 with NOTICES Changes to an Approved Application: Biological Products Do III. Center for Drug Evaluation and Research (CDER) VerDate Aug<31>2005 16:21 Aug 31, 2006 Jkt 208001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1 Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Notices TITLE/TOPIC OF GUIDANCE 52127 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 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 sroberts on PROD1PC70 with NOTICES Androgens in Aging Males Do Obesity and Weight Loss Do Oral Mucositis Do Patient Reported Outcomes (PRO) Measures Do VerDate Aug<31>2005 16:21 Aug 31, 2006 Jkt 208001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1 52128 Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Notices TITLE/TOPIC OF GUIDANCE CONTACT 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 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 sroberts on PROD1PC70 with NOTICES Content and Format of the Clinical Pharmacology Section 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 VerDate Aug<31>2005 16:21 Aug 31, 2006 Jkt 208001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1 Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Notices TITLE/TOPIC OF GUIDANCE 52129 CONTACT 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 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 sroberts on PROD1PC70 with NOTICES Class II Special Control Guidance Document: Full Field Digital Mammography (FFDM) 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. VerDate Aug<31>2005 16:21 Aug 31, 2006 Jkt 208001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1 52130 Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Notices TITLE/TOPIC OF GUIDANCE CONTACT 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 sroberts on PROD1PC70 with NOTICES Breast Implant Guidance document 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 VerDate Aug<31>2005 16:21 Aug 31, 2006 Jkt 208001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1 Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Notices TITLE/TOPIC OF GUIDANCE 52131 CONTACT 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 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 sroberts on PROD1PC70 with NOTICES Medical Device Quality System Manual: A Small Entity Compliance Guide 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 VerDate Aug<31>2005 16:21 Aug 31, 2006 Jkt 208001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1 52132 Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Notices TITLE/TOPIC OF GUIDANCE CONTACT 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 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 sroberts on PROD1PC70 with NOTICES Analyte Specific Reagents: Frequently Asked Questions 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. VerDate Aug<31>2005 16:21 Aug 31, 2006 Jkt 208001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1 Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Notices TITLE/TOPIC OF GUIDANCE 52133 CONTACT 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-toEat 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. sroberts on PROD1PC70 with NOTICES 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. VerDate Aug<31>2005 16:21 Aug 31, 2006 Jkt 208001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1 52134 Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Notices TITLE OF GUIDANCE CONTACT 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 (ι83) 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 sroberts on PROD1PC70 with NOTICES Meetings With the Office of New Animal Drug Evaluation (ONADE) 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. VerDate Aug<31>2005 16:21 Aug 31, 2006 Jkt 208001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1 Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Notices TITLE OF GUIDANCE 52135 CONTACT 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 Salmonellain 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) 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 sroberts on PROD1PC70 with NOTICES TOPIC/TITLE OF GUIDANCE 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 VerDate Aug<31>2005 16:21 Aug 31, 2006 Jkt 208001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1 52136 Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Notices TOPIC/TITLE OF GUIDANCE CONTACT Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors, Exception from Informed Consent Requirements for Emergency Research 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. sroberts on PROD1PC70 with NOTICES AGENCY: SUMMARY: The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory’s certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https://workplace.samhsa.gov and https://www.drugfreeworkplace.gov. FOR FURTHER INFORMATION CONTACT: Mrs. Giselle Hersh or Dr. Walter Vogl, Division of Workplace Programs, SAMHSA/CSAP, Room 2–1035, 1 Choke Cherry Road, Rockville, Maryland 20857; 240–276–2600 (voice), 240–276– 2610 (fax). VerDate Aug<31>2005 16:21 Aug 31, 2006 Jkt 208001 Carolyn Hommel, Office of the Commissioner (HF–34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–9105. The Mandatory Guidelines were developed in accordance with Executive Order 12564 and section 503 of Pub. L. 100– 71. Subpart C of the Mandatory Guidelines, ‘‘Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies,’’ sets strict standards that laboratories must meet in order to conduct drug and specimen validity tests on urine specimens for Federal agencies. To become certified, an applicant laboratory must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory must participate in a quarterly performance testing program plus undergo periodic, on-site inspections. Laboratories which claim to be in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A laboratory must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA) which attests that it has met minimum standards. In accordance with Subpart C of the Mandatory Guidelines dated April 13, 2004 (69 FR 19644), the following laboratories meet the minimum standards to conduct drug and specimen validity tests on urine specimens: ACL Laboratories, 8901 W. Lincoln Ave., West Allis, WI 53227, 414–328– 7840/800–877–7016 (Formerly: Bayshore Clinical Laboratory). ACM Medical Laboratory, Inc., 160 Elmgrove Park, Rochester, NY 14624, 585–429–2264. Advanced Toxicology Network, 3560 Air Center Cove, Suite 101, Memphis, TN 38118, 901–794–5770/888–290– 1150. Aegis Analytical Laboratories, Inc., 345 Hill Ave., Nashville, TN 37210, 615– 255–2400. Baptist Medical Center-Toxicology Laboratory, 9601 I–630, Exit 7, Little Rock, AR 72205–7299, 501–202–2783 (Formerly: Forensic Toxicology Laboratory Baptist Medical Center). Clinical Reference Lab, 8433 Quivira Road, Lenexa, KS 66215–2802, 800– 445–6917. Diagnostic Services, Inc., dba DSI, 12700 Westlinks Drive, Fort Myers, FL 33913, 239–561–8200/800–735– 5416. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 Doctors Laboratory, Inc., 2906 Julia Drive, Valdosta, GA 31602, 229–671– 2281. DrugScan, Inc., P.O. Box 2969, 1119 Mearns Road, Warminster, PA 18974, 215–674–9310. Dynacare Kasper Medical Laboratories *, 10150–102 St., Suite 200, Edmonton, Alberta, Canada T5J 5E2, 780–451– 3702/800–661–9876. ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655, 662– 236–2609. Gamma-Dynacare Medical Laboratories,* A Division of the Gamma-Dynacare, Laboratory Partnership, 245 Pall Mall Street, London, ONT, Canada N6A 1P4, 519– 679–1630. General Medical Laboratories, 36 South Brooks St., Madison, WI 53715, 608– 267–6225. Kroll Laboratory Specialists, Inc., 1111 Newton St., Gretna, LA 70053, 504– 361–8989/800–433–3823 (Formerly: Laboratory Specialists, Inc.). Kroll Scientific Testing Laboratories, Inc., 450 Southlake Blvd., Richmond, VA 23236, 804–378–9130 (Formerly: Scientific Testing Laboratories, Inc.). Laboratory Corporation of America Holdings, 7207 N. Gessner Road, Houston, TX 77040, 713–856–8288/ 800–800–2387. Laboratory Corporation of America Holdings, 69 First Ave., Raritan, NJ 08869, 908–526–2400/800–437–4986 (Formerly: Roche Biomedical Laboratories, Inc.). Laboratory Corporation of America Holdings, 1904 Alexander Drive, Research Triangle Park, NC 27709, 919–572–6900/800–833–3984 (Formerly: LabCorp Occupational Testing Services, Inc., CompuChem Laboratories, Inc.; CompuChem Laboratories, Inc., A Subsidiary of Roche Biomedical Laboratory; Roche CompuChem Laboratories, Inc., A Member of the Roche Group). Laboratory Corporation of America Holdings, 10788 Roselle St., San Diego, CA 92121, 800–882–7272 (Formerly: Poisonlab, Inc.). Laboratory Corporation of America Holdings, 550 17th Ave., Suite 300, Seattle, WA 98122, 206–923–7020/ 800–898–0180 (Formerly: DrugProof, Division of Dynacare/Laboratory of Pathology, LLC; Laboratory of Pathology of Seattle, Inc.; DrugProof, E:\FR\FM\01SEN1.SGM 01SEN1

Agencies

[Federal Register Volume 71, Number 170 (Friday, September 1, 2006)]
[Notices]
[Pages 52125-52136]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14549]


-----------------------------------------------------------------------

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 https://
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    Same as above (Do)
 of Heating, Ventilation, and Air
 Conditioning (HVAC) Systems Used
 in the Manufacture of Products
 Regulated by the Center for
 Biologics Evaluation and Research
 and the Center for Drug Evaluation
 and Research
------------------------------------------------------------------------
CATEGORY--BLOOD AND BLOOD            ...................................
 COMPONENTS
========================================================================
Reentry Algorithm for Donors Who     Do
 Are Deferred Because of Reactive
 Test Results for Antibody to
 Hepatitis B Core Antigen (Anti-
 HBc)
------------------------------------------------------------------------

[[Page 52126]]

 
Implementation of a Licensed West    Do
 Nile Virus Nucleic Acid Test (NAT)
 for Whole Blood Donor Screening
------------------------------------------------------------------------
Revised Preventive Measures to       Do
 Reduce the Possible Risk of
 Transmission of Creutzfeldt-Jakob
 Disease (CJD) and Variant
 Creutzfeldt-Jakob Disease (vCJD)
 by Blood and Blood Products
------------------------------------------------------------------------
Recognition and Use of a Standard    Do
 for the Uniform Labeling of Blood
 and Blood Components
------------------------------------------------------------------------
Use of Nucleic Acid Test (NAT) on    Do
 Source and Recovered Plasma for
 Parvovirus B19
------------------------------------------------------------------------
CATEGORY--VACCINES AND ALLERGENICS   ...................................
========================================================================
Characterization and Qualification   Do
 of Cell Substrates and Other
 Biological Starting Materials for
 the Production of Viral Vaccines
------------------------------------------------------------------------
CATEGORY--CELLULAR, TISSUE, AND      ...................................
 GENE THERAPY
========================================================================
Licensure of Minimally Manipulated,  Do
 Unrelated, Allogeneic Placental/
 Umbilical Cord Blood Intended For
 Hematopoietic Reconstitution in
 Patients With Hematological
 Malignancies
------------------------------------------------------------------------
Preparation of Investigational       Do
 Device Exemptions and
 Investigational New Drugs for
 Products Intended to Repair or
 Replace Knee Articular Cartilage
------------------------------------------------------------------------
Initiation and Conduct of Clinical   Do
 Trials Using Cellular Therapies
 for Cardiac Disease
------------------------------------------------------------------------
Potency Measurements for Cell and    Do
 Gene Therapy Products
------------------------------------------------------------------------
Considerations for Allogeneic        Do
 Pancreatic Islet Cell Products
------------------------------------------------------------------------
Current Good Tissue Practice for     Do
 Human Cell, Tissue, and Cellular
 and Tissue-Based Product
 Establishments
------------------------------------------------------------------------
Certain Distributed and Inventoried  Do
 Human Cells, Tissues, and Cellular
 and Tissue-Based Products (HCT/Ps)
 Recovered From Donors Who Were
 Improperly Tested
------------------------------------------------------------------------
Clinical Study Design for Early      Do
 Phase Studies of Cellular and Gene
 Therapies
------------------------------------------------------------------------
Devices Involved in Manufacture,     Do
 Storage and Administration of
 Cellular Products and Tissues
------------------------------------------------------------------------
Validation of Rapid Microbiological  Do
 Methods for Assessing Sterility of
 Cellular and Gene Therapy Products
------------------------------------------------------------------------
Submission of Information for the    Do
 National Xenotransplantation
 Database
------------------------------------------------------------------------
Registration and Listing for Human   Do
 Cell, Tissue, and Cellular and
 Tissue-Based Products
 Establishments
------------------------------------------------------------------------
Preparation of Investigational       Do
 Device Exemptions and
 Investigational New Drugs for
 Tissue Engineered and Regenerative
 Medicine Products
------------------------------------------------------------------------
Facilities and Controls for          Do
 Cellular and Gene Therapy Product
 Manufacturing Operations Guidance
------------------------------------------------------------------------
CATEGORY--OTHER                      ...................................
========================================================================
Changes to an Approved Application:  Do
 Biological Products
------------------------------------------------------------------------

III. Center for Drug Evaluation and Research (CDER)

[[Page 52127]]



------------------------------------------------------------------------
      Title/Topic of Guidance                      Contact
------------------------------------------------------------------------
CATEGORY--ADVERTISING                ...................................
========================================================================
Presentation of Risk Information in  Emily T. Thakur, Center for Drug
 Prescription Drug and Medical        Evaluation and Research (HFD-7),
 Device                               Food and Drug Administration, 5515
                                      Security Lane, Rockville, MD
                                      20852, 301-594-2041.
------------------------------------------------------------------------
CATEGORY--CHEMISTRY                  ...................................
========================================================================
Immunogenicity Assessment for        Do
 Follow-on Protein Products
------------------------------------------------------------------------
Immunogenicity Assessment for        Do
 Therapeutic Protein Products
------------------------------------------------------------------------
Individual Product Bioequivalence    Do
 Recommendations
------------------------------------------------------------------------
Patient Specific Drug Products       Do
------------------------------------------------------------------------
Quality by Design                    Do
------------------------------------------------------------------------
Recommendations for Determination    Do
 of Bioequivalence of Vaginal
 Antifungal Products
------------------------------------------------------------------------
Submission of Documentation in       Do
 Applications for Parametric
 Release of Human and Veterinary
 Drug Products Terminally
 Sterilized by Moist Heat Processes
------------------------------------------------------------------------
CATEGORY--CLINICAL/MEDICAL           ...................................
========================================================================
Androgens in Aging Males             Do
------------------------------------------------------------------------
Clinical Development of Drugs for    Do
 Irritable Bowel Syndrome
------------------------------------------------------------------------
Clinical Evaluation of Agents to     Do
 Lower the Risk of Developing
 Sporadic Colorectal Adenomas
------------------------------------------------------------------------
Clinical Evaluation of Drugs for     Do
 Female Infertility
------------------------------------------------------------------------
Clinical Evaluation of Drug          Do
 Products for Inflammatory Bowel
 Disease
------------------------------------------------------------------------
Clinical Trial Design for the        Do
 Treatment of Bacterial Blepharitis
------------------------------------------------------------------------
Clinical Trial Design for the        Do
 Treatment of Bacterial
 Conjunctivitis
------------------------------------------------------------------------
Clinical Trial Design for the        Do
 Treatment of Bacterial Corneal
 Ulcers
------------------------------------------------------------------------
Clinical Trial Design for the        Do
 Treatment of Dry Eye
------------------------------------------------------------------------
Clinical Trial Design for the        Do
 Treatment of Superficial Punctate
 Keratitis (SPK)
------------------------------------------------------------------------
Conducting and Submitting Virology   Do
 Studies to the Division of
 Antiviral Drug Products
------------------------------------------------------------------------
Co-packaged Sodium Nitrite and       Do
 Sodium Thiosulfate Drug Products--
 Submitting a New Drug Application
------------------------------------------------------------------------
Developing Analgesic Products for    Do
 the Treatment of Pain
------------------------------------------------------------------------
Developing Drugs to Treat or         Do
 Prevent Smallpox (Variola)
 Injection
------------------------------------------------------------------------
Development of Drugs for Chronic     Do
 Obstructive Pulmonary Disease
 (COPD)
------------------------------------------------------------------------
Drug Development for the Treatment   Do
 of Malaria
------------------------------------------------------------------------
Evaluation of New Treatments for     Do
 Diabetes Mellitus
------------------------------------------------------------------------
Inhalational Anthrax (Symptomatic)-- Do
 Developing Therapeutic Agents that
 Target Anthrax Toxin
------------------------------------------------------------------------
Obesity and Weight Loss              Do
------------------------------------------------------------------------
Oral Mucositis                       Do
------------------------------------------------------------------------
Patient Reported Outcomes (PRO)      Do
 Measures
------------------------------------------------------------------------

[[Page 52128]]

 
Periodontitis                        Do
------------------------------------------------------------------------
Peripheral Neuropathy                Do
------------------------------------------------------------------------
Treatment of Congestive Heart        Do
 Failure
------------------------------------------------------------------------
CATEGORY--CLINICAL/PHARMACOLOGY      ...................................
========================================================================
Immediate Release to Modified        Do
 Release Dosage Forms
------------------------------------------------------------------------
In Vitro Drug Metabolism/Drug        Do
 Interaction--Guidance for
 Reviewers
------------------------------------------------------------------------
CATEGORY--COMBINATION PRODUCTS       ...................................
========================================================================
Drug Diagnostic Co-Development       Do
------------------------------------------------------------------------
CATEGORY--COMPLIANCE                 ...................................
========================================================================
Registration Requirements Under the  Do
 Public Health Security and
 Bioterrorism Preparedness and
 Response Act of 2002
------------------------------------------------------------------------
Process Validation: General          Do
 Principles and Practices
------------------------------------------------------------------------
Penicillin as Defined in the CGMP    Do
 Regulation Under 21 CFR 211 and
 Separation Requirements for
 Manufacturing
------------------------------------------------------------------------
Non-Penicillin Beta-Lactam           Do
 Contamination
------------------------------------------------------------------------
Importation of Active                Do
 Pharmaceutical Ingredients
------------------------------------------------------------------------
CATEGORY--DRUG SAFETY INFORMATION    ...................................
========================================================================
Good Naming, Labeling and Packaging  Do
 (GNLP) Practices
------------------------------------------------------------------------
Premarketing Evaluation of Drug-     Do
 Induced Liver Injury
------------------------------------------------------------------------
Risk Management of Highly Suspect    Do
 or Known Human Teratogens:
 Pregnancy Prevention Strategies
------------------------------------------------------------------------
Selecting and Submitting             Do
 Proprietary Names for Evaluation
------------------------------------------------------------------------
CATEGORY--ELECTRONIC SUBMISSIONS     ...................................
========================================================================
Providing Regulatory Submissions in  Do
 Electronic Format--Analysis
 Datasets and Documentation
------------------------------------------------------------------------
CATEGORY--GOOD REVIEW PRACTICES      ...................................
========================================================================
Good Review Management Practices     Do
 for Investigational New Drugs
------------------------------------------------------------------------
CATEGORY--INVESTIGATIONAL NEW DRUGS  ...................................
========================================================================
Consumer Product Safety Commission-- Do
 Tamper Resistant Packaging for
 Investigational New Drugs
------------------------------------------------------------------------
Guidance for Clinical                Do
 Investigators--Preparing and
 Submitting an Investigational New
 Drug Application
------------------------------------------------------------------------
CATEGORY--LABELING                   ...................................
========================================================================
Content and Format of the Clinical   Do
 Pharmacology Section
------------------------------------------------------------------------
Dosage and Administration Section    Do
 of Labeling for Human Prescription
 Drug and Biological Products--
 Content and Format
------------------------------------------------------------------------
Drug Names and Dosage Forms          Do
------------------------------------------------------------------------
Indication and Usage Section of      Do
 Labeling for Human Prescription
 Drugs and Biological Products--
 Content and Format
------------------------------------------------------------------------
Labeling Dietary Supplements for     Do
 Women Who Are or Could Be Pregnant
------------------------------------------------------------------------
Labeling for Human Prescription      Do
 Drug and Biologic Products--
 Pharmacologic Classification for
 the Highlights Section of Labeling
------------------------------------------------------------------------

[[Page 52129]]

 
Labeling for Outcome Claims for      Do
 Drugs to Treat Hypertension
------------------------------------------------------------------------
Pregnancy Labeling Revisions         Do
------------------------------------------------------------------------
Use of Pharmacologic/Therapeutic     Do
 Classification in Approved
 Labeling
------------------------------------------------------------------------
CATEGORY--OVER-THE-COUNTER           ...................................
========================================================================
Actual Use Trials                    Do
------------------------------------------------------------------------
Labeling Comprehension Studies for   Do
 Over-the-Counter Drug Products
------------------------------------------------------------------------
Labeling of Skin Protectants         Do
------------------------------------------------------------------------
Topical Drug Products for Vaginal    Do
 Yeast Infections
------------------------------------------------------------------------
CATEGORY--PHARMACOLOGY/TOXICOLOGY    ...................................
========================================================================
Nonclinical Safety Evaluation of     Do
 Reformulated Drug Products,
 Including Administration by an
 Alternate Route
------------------------------------------------------------------------
Nonclinical Studies for Anticancer   Do
 Drugs
------------------------------------------------------------------------
CATEGORY--PROCEDURAL                 ...................................
========================================================================
Assessment of Abuse Potential of     Do
 Drugs
------------------------------------------------------------------------
Clinical Source Data                 Do
------------------------------------------------------------------------
Determining Whether Human Research   Do
 With a Radioactive Drug Can be
 Conducted Under a Radioactive Drug
 Research Committee
------------------------------------------------------------------------
Good Meeting Management Guidance     Do
------------------------------------------------------------------------
Nonclinical Evaluation of Late       Do
 Radiation Toxicity of Therapeutic
 Radiopharmaceuticals
------------------------------------------------------------------------
Process for Contracts and Written    Do
 Requests Under the Best
 Pharmaceutical for Children Act
------------------------------------------------------------------------
Qualifying for Pediatric             Do
 Exclusivity Under Section 505a of
 the Federal Food, Drug, and
 Cosmetic Act
------------------------------------------------------------------------
Target Product Profile--A Strategic  Do
 Development Process Tool
------------------------------------------------------------------------

IV. Center for Devices and Radiological Health (CDRH)

------------------------------------------------------------------------
      Title/Topic of Guidance                      Contact
------------------------------------------------------------------------
Class II Special Control Guidance    Robert A. Phillips, Center for
 Document: Full Field Digital         Devices and Radiological Health
 Mammography (FFDM)                   (HFZ-470), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      594-1212, ext. 130.
------------------------------------------------------------------------
Format Guidance (Table of Contents)  Heather S. Rosecrans, Center for
 for Special 510(k)s                  Devices and Radiological Health
                                      (HFZ-404), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      594-1190.
------------------------------------------------------------------------
Updated 510(k) Sterility Review      Sheila A. Murphey, Center for
 Guidance K90-1; Final Guidance for   Devices and Radiological Health
 Industry and FDA                     (HFZ-480), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      443-8913.
------------------------------------------------------------------------
Antimicrobials; Draft                Do
------------------------------------------------------------------------
510(k) Paradigm Guidance             Heather S. Rosecrans, Center for
                                      Devices and Radiological Health
                                      (HFZ-404), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      594-1190.
------------------------------------------------------------------------
Replacement Heart Valve Premarket    Matthew Hillebrenner, Center for
 Approval Applications                Devices and Radiological Health
                                      (HFZ-450), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      443-8517.
------------------------------------------------------------------------

[[Page 52130]]

 
Breast Implant Guidance document     Stephen P. Rhodes, Center for
                                      Devices and Radiological Health
                                      (HFZ-410), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      594-3090.
------------------------------------------------------------------------
Class II Special Control Guidance    Ashley B. Boam, Center for Devices
 Document: Percutaneous               and Radiological Health (HFZ-450),
 Transluminal Coronary Angioplasty    Food and Drug Administration, 9200
 (PTCA) Catheters                     Corporate Blvd., Rockville, MD
                                      20850, 240-276-4222.
------------------------------------------------------------------------
Pulse Oximeter Premarket             Ann A. Graham, Center for Devices
 Notification [510(k)] Submissions    and Radiological Health (HFZ-480),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-827-4479.
------------------------------------------------------------------------
Keratome and Keratome Blade 510ks    Everette T. Beers, Center for
                                      Devices and Radiological Health
                                      (HFZ-460), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      594-2018, ext. 136.
------------------------------------------------------------------------
Coronary Drug Eluting Stents         Ashley B. Boam, Center for Devices
 Guidance Document                    and Radiological Health (HFZ-450),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 240-276-4222.
------------------------------------------------------------------------
Metal Tracheal Stents                Stephen P. Rhodes, Center for
                                      Devices and Radiological Health
                                      (HFZ-410), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      594-3090.
------------------------------------------------------------------------
Class II Special Control Guidance    Do
 Document: Absorbable Hemostatic
 Agent
------------------------------------------------------------------------
Preparation of Investigational       Jonette Foy, Center for Devices and
 Device Exemptions and                Radiological Health (HFZ-450),
 Investigational New Drugs for        Food and Drug Administration, 9200
 Products Intended to Repair or       Corporate Blvd., Rockville, MD
 Replace Articular Cartilage          20850, 301-443-8262.
------------------------------------------------------------------------
Premarket Approval Application       Thinh X. Nguyen, Center for Devices
 Modifications                        and Radiological Health (HFZ-402),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-2186, ext. 152.
------------------------------------------------------------------------
Medical Device User Fee              Ginette Y. Michaud, Center for
 Modernization Act of 2002            Devices and Radiological Health
 Validation Data in Premarket         (HFZ-480), Food and Drug
 Notification (510(k)) Submissions    Administration, 9200 Corporate
 for Reprocessed Single-Use Medical   Blvd., Rockville, MD 20850, 301-
 Devices                              443-8879, ext. 143.
------------------------------------------------------------------------
Premarket Approval Application       Thinh X. Nguyen, Center for Devices
 Performance Goals and Review Clock   and Radiological Health (HFZ-402),
 Guidance                             Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-2186, ext. 152.
------------------------------------------------------------------------
Humanitarian Device Exemption Q and  Elisa D. Harvey, Center for Devices
 A Guidance                           and Radiological Health (HFZ-403),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-1190.
------------------------------------------------------------------------
Premarket Approval Application       Thinh X. Nguyen, Center for Devices
 Annual Reports                       and Radiological Health (HFZ-402),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-2186, ext. 152.
------------------------------------------------------------------------
Class II Special Control Guidance    Theodore R. Stevens, Center for
 Document: Cutaneous Electrode        Devices and Radiological Health
                                      (HFZ-410), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      594-1296.
------------------------------------------------------------------------
Class II Special Control Guidance    Do
 Document: Electroconductive Media
------------------------------------------------------------------------
Class II Special Control Guidance    Do
 Document: Powered Muscle
 Stimulators for Muscle
 Conditioning
------------------------------------------------------------------------
Class II Special Control Guidance    Do
 Document: Powered Muscle
 Stimulators with Limited Output
 for Muscle Conditioning
------------------------------------------------------------------------
Class II Special Control Guidance    Do
 Document: Powered Muscle
 Stimulators for Rehabilitation
------------------------------------------------------------------------
Class II Special Control Guidance    Do
 Document: Powered Muscle
 Stimulators With Limited Output
 for Rehabilitation
------------------------------------------------------------------------
Class II Special Control Guidance    Do
 Document: Transcutaneous
 Electrical Nerve Stimulators for
 Pain Relief
------------------------------------------------------------------------
Class II Special Control Guidance    Do
 Document: Transcutaneous
 Electrical Nerve Stimulators With
 Limited Output for Pain Relief
------------------------------------------------------------------------

[[Page 52131]]

 
Class II Special Control Guidance    Do
 Document: Transcutaneous
 Electrical Stimulators for
 Aesthetic Purposed
------------------------------------------------------------------------
Class II Special Control Guidance    Do
 Document: Transcutaneous
 Electrical Stimulators With
 Limited Output for Aesthetic
 Purposes
------------------------------------------------------------------------
Office of Science and Engineering    ...................................
 Laboratories
========================================================================
Application of IEC 60601 Third       Jean M. Olson, Center for Devices
 Edition in Premarket Applications;   and Radiological Health (HFZ-84),
 Draft Guidance for Industry and      Food and Drug Administration, 9200
 FDA Staff                            Corporate Blvd., Rockville, MD
                                      20850, 301-827-0952.
------------------------------------------------------------------------
Establishing the Compatibility of    Do
 Medical Devices in Magnetic
 Resonance Imaging Systems; Draft
 Guidance for Industry and FDA
 Staff
------------------------------------------------------------------------
Stereotactic Devices; Draft          Do
 Guidance for Industry and FDA
 Staff
------------------------------------------------------------------------
Medical Device Electromagnetic       Do
 Compatibility Guidance
------------------------------------------------------------------------
Diagnostic Spectroscopy for          Do
 Detection of Cervical Disease
 Guidance
------------------------------------------------------------------------
Criteria for Establishing Labeling   Do
 of Continuous Peripheral
 Anesthesia Devices for Austere
 Conditions
------------------------------------------------------------------------
Office of Compliance                 ...................................
========================================================================
Site Change Supplements and Express  Christy Foreman Center for Devices
 Premarket Approval Application       and Radiological Health (HFZ-340),
 Supplements                          Food and Drug Administration, 4
                                      Oak Grove , Rockville, MD 20850,
                                      240-276-0120.
------------------------------------------------------------------------
Consumer Directed Broadcast          Deborah Wolf, Center for Devices
 Advertising                          and Radiological Health (HFZ-302),
                                      Food and Drug Administration, 4
                                      Oak Grove, Rockville, MD 20850,
                                      240-276-0100.
------------------------------------------------------------------------
 Decorative, Non-corrective Contact  Casper Uldriks, Center for Devices
 Lenses                               and Radiological Health (HFZ-300),
                                      Food and Drug Administration, 4
                                      Oak Grove, Rockville, MD 20850,
                                      240-276-0100.
------------------------------------------------------------------------
Good Manufacturing Practice          Tim Ulatowski, Center for Devices
 Inspectional Information (Medical    and Radiological Health (HFZ-300),
 Device User Fee Modernization Act    Food and Drug Administration, 4
 of 2002)                             Oak Grove, Rockville, MD 20850,
                                      240-276-0100.
------------------------------------------------------------------------
Bioresearch Monitoring Program       Matt Tarosky, Center for Devices
 Inspectional Information (Medical    and Radiological Health (HFZ-310),
 Device User Fee Modernization Act    Food and Drug Administration, 4
 of 2002)                             Oak Grove, Rockville, MD 20850,
                                      240-276-0243.
------------------------------------------------------------------------
Office of Surveillance and           ...................................
 Biometrics
========================================================================
Instructions for Completing FDA      Howard A. Press, Center for Devices
 Form 3500A With Coding Manual for    and Radiological Health (HFZ-530),
 Form 3500A                           Food and Drug Administration, 1350
                                      Piccard Drive, Rockville, MD
                                      20850, 240-276-3457.
------------------------------------------------------------------------
Electronic Medical Device Adverse    Do
 Event Reporting
------------------------------------------------------------------------
Office of Communication, Education,  ...................................
 and Radiation Programs
========================================================================
Medical Device Quality System        John Stigi, Center for Devices and
 Manual: A Small Entity Compliance    Radiological Health (HFZ-220),
 Guide                                Food and Drug Administration, 1350
                                      Piccard Dr., Rockville, MD 20850,
                                      301-443-0806.
------------------------------------------------------------------------
Medical Device Reporting for         Do
 Manufacturers
------------------------------------------------------------------------
Revision to Compliance Program       Sean Boyd, Center for Devices and
 7386.001 Inspection of               Radiological Health (HFZ-240),
 Manufacturers of Laser Products      Food and Drug Administration, 1350
                                      Piccard Dr., Rockville, MD 20850,
                                      240-276-3287.
------------------------------------------------------------------------
Revision to Compliance Program       Do
 7386.002 Field Implementation of
 the Sunlamp and Sunlamp Products
 Performance Standard as Amended
------------------------------------------------------------------------
Revision to Compliance Program       Do
 7386.004 Field Compliance Testing
 of Cabinet X-Ray Equipment
------------------------------------------------------------------------

[[Page 52132]]

 
Revision to Compliance Program       Do
 7386.006 Compliance Testing of
 Electronic Products at Winchester
 Engineering and Analytical Center
------------------------------------------------------------------------
Revision to Compliance Program       Do
 7386.007 Imported Electronic
 Products
------------------------------------------------------------------------
Revision to Compliance Program       Do
 7386.007A Imported Non-certified
 Radiation-Emitting Electronic
 Products (Special Exemption for
 Television Receivers, Microwave
 Ovens, and Certain Class I Laser
 Products) Amending or Revoking as
 Appropriate Based on Guidance
 Published in Fiscal Year 2006 on
 Low Risk Product Reporting
 Exemptions
------------------------------------------------------------------------
Revision to Compliance Program       Do
 7386.008 Medical Device and
 Radiological Health Use Control
 and Policy Implementation
------------------------------------------------------------------------
Guidance to Allow Alternate Means    Do
 of Labeling Certain Laser
 Products: Granting Approval to
 Include Labels for Small Laser
 Products in Packaging or in
 Product Literature, Rather Than on
 Product Itself, to Eliminate
 Burden on FDA and Industry
------------------------------------------------------------------------
Guidance to Exempt Laser Light Show  Do
 Manufacturers From Variance
 Application Requirements Under
 Certain Conditions: Granting Light
 Show Variances by Guidance to
 Reduce Burden on FDA and Industry
------------------------------------------------------------------------
Guidance Regarding Risk Messaging    Margaret Tolbert, Center for
 for Implantable Cardioverter         Devices and Radiological Health
 Defibrillator Dear Doctor Letters    (HFZ-230), Food and Drug
 to Include Flow, Order of            Administration, 1350 Piccard Dr.,
 Presentation, Required Elements of   Rockville, MD 20850, 240-276-3240.
 Content, and Language
------------------------------------------------------------------------
Device Use Safety: Incorporating     Ron Kaye, Center for Devices and
 Human Factors into Risk Management   Radiological Health (HFZ-230),
                                      Food and Drug Administration, 1350
                                      Piccard Dr., Rockville, MD 20850,
                                      240-276-3244.
------------------------------------------------------------------------
Office of In Vitro Diagnostic        ...................................
 Device Evaluation and Safety
========================================================================
Analyte Specific Reagents:           Courtney Harper, Center for Devices
 Frequently Asked Questions           and Radiological Health (HFZ-440),
                                      Food and Drug Administration, 8
                                      Oak Grove , Rockville, MD 20850,
                                      240-276-0443.
------------------------------------------------------------------------
Class II Special Controls Guidance   Sally Hojvat, Center for Devices
 Document: Herpes Simplex Virus       and Radiological Health (HFZ-440),
 Types 1 and 2 Serological Assays     Food and Drug Administration, 8
                                      Oak Grove, Rockville, MD 20850,
                                      240-276-0496.
------------------------------------------------------------------------
Draft guidance--Class II Special     Roxanne Shively, Center for Devices
 Controls Guidance Document:          and Radiological Health (HFZ-440),
 Bacillus spp. Serological Reagents   Food and Drug Administration, 8
                                      Oak Grove , Rockville, MD 20850,
                                      240-276-0496.
------------------------------------------------------------------------
Draft guidance--Tumor Marker Assays  Maria Chan, Center for Devices and
                                      Radiological Health (HFZ-440),
                                      Food and Drug Administration, 8
                                      Oak Grove , Rockville, MD 20850,
                                      240-276-0493.
------------------------------------------------------------------------
Recommendations for Gene Expression  Zivana Tezak, Center for Devices
                                      and Radiological Health (HFZ-440),
                                      Food and Drug Administration, 8
                                      Oak Grove , Rockville, MD 20850,
                                      240-276-0496.
------------------------------------------------------------------------
Guidance for Administrative          Carol Benson, Center for Devices
 Procedures for Clinical Laboratory   and Radiological Health (HFZ-440),
 Improvement Amendments of 1988       Food and Drug Administration, 8
 Categorization                       Oak Grove , Rockville, MD 20850,
                                      240-276-0496.
------------------------------------------------------------------------
Guidance for Over-the-Counter        Veronica Calvin, Center for Devices
 Ovulation Tests                      and Radiological Health (HFZ-440),
                                      Food and Drug Administration, 8
                                      Oak Grove , Rockville, MD 20850,
                                      240-276-0496.
------------------------------------------------------------------------
In Vitro Diagnostic Product Devices  Sally Hojvat, Center for Devices
 Under Development: Frequently        and Radiological Health (HFZ-440),
 Asked Questions                      Food and Drug Administration, 8
                                      Oak Grove , Rockville, MD 20850,
                                      240-276-0496.
------------------------------------------------------------------------
Medical Device Reporting for Self-   Claudia Gaffey, Center for Devices
 Monitoring Blood Glucose Devices     and Radiological Health (HFZ-440),
                                      Food and Drug Administration, 8
                                      Oak Grove , Rockville, MD 20850,
                                      240-276-0496.
------------------------------------------------------------------------

[[Page 52133]]

 
Migration Studies for Assays With    Sally Hojvat, Center for Devices
 Multiple Instrumentation Systems     and Radiological Health (HFZ-440),
                                      Food and Drug Administration, 8
                                      Oak Grove , Rockville, MD 20850,
                                      240-276-0496.
------------------------------------------------------------------------
Nucleic Acid Based In Vitro          Roxanne Shively, Center for Devices
 Diagnostic Devices for Detection     and Radiological Health (HFZ-440),
 of Microbial Pathogens               Food and Drug Administration, 8
                                      Oak Grove , Rockville, MD 20850,
                                      240-276-0496.
------------------------------------------------------------------------
Pharmacogenetic Tests and Genetic    Kathleen Simon, Center for Devices
 Tests for Heritable Markers          and Radiological Health (HFZ-440),
                                      Food and Drug Administration, 8
                                      Oak Grove , Rockville, MD 20850,
                                      240-276-0496.
------------------------------------------------------------------------
Points to Consider on Assayed and    Carol Benson, Center for Devices
 Unassayed Quality Control Material   and Radiological Health (HFZ-440),
                                      Food and Drug Administration, 8
                                      Oak Grove , Rockville, MD 20850,
                                      240-276-0496
------------------------------------------------------------------------
Recommendations for Therapeutic      Avis Danishefsky, Center for
 Drug Monitoring Assays               Devices and Radiological Health
                                      (HFZ-440), Food and Drug
                                      Administration, 8 Oak Grove ,
                                      Rockville, MD 20850, 240-276-0496.
------------------------------------------------------------------------
Recommendations for Clinical         Carol Benson, Center for Devices
 Laboratory Improvement Amendments    and Radiological Health (HFZ-440),
 of 1988 (CLIA) Waiver Applications   Food and Drug Administration, 8
                                      Oak Grove , Rockville, MD 20850,
                                      240-276-0496.
------------------------------------------------------------------------
Serologic Assays for the Detection   Sally Hojvat, Center for Devices
 of Antibodies to Viral Agents        and Radiological Health (HFZ-440),
                                      Food and Drug Administration, 8
                                      Oak Grove , Rockville, MD 20850,
                                      240-276-0496.
------------------------------------------------------------------------
Total Product Life Cycle for         Carol Benson, Center for Devices
 Portable Invasive Blood Glucose      and Radiological Health (HFZ-440),
 Monitoring Systems                   Food and Drug Administration, 8
                                      Oak Grove , Rockville, MD 20850,
                                      240-276-0496.
------------------------------------------------------------------------

V. Center for Food Safety and Applied Nutrition (CFSAN)

------------------------------------------------------------------------
      Title/Topic of Guidance                      Contact
------------------------------------------------------------------------
New Dietary Ingredient               Linda Pellicore, Center for Food
 Notifications                        Safety and Applied Nutrition (HFS-
                                      810), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-1448.
------------------------------------------------------------------------
Evidence-Based Scientific Review     Kathy Ellwood, Center for Food
 System for Health Claims             Safety and Applied Nutrition (HFS-
 (Including Qualified Health          830), Food and Drug
 Claims)                              Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-1450.
------------------------------------------------------------------------
Fish and Fishery Products Hazards    Robert Samuels, Kathy Ellwood,
 and Control Guidance                 Center for Food Safety and Applied
                                      Nutrition (HFS-417), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-1418.
------------------------------------------------------------------------
Steps to Reduce Listeria             Nega Beru, Kathy Ellwood, Center
 Monocytogenes Contamination in       for Food Safety and Applied
 Ready-to-Eat Foods                   Nutrition (HFS-300), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-1700.
------------------------------------------------------------------------
Dietary Guidance Statements          Kathy Ellwood, Center for Food
                                      Safety and Applied Nutrition (HFS-
                                      830), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-1450.
------------------------------------------------------------------------
Microbiological Considerations for   Paul DeLeo, Center for Food Safety
 Antimicrobial Food Additive          and Applied Nutrition (HFS-265),
 Submissions                          Food and Drug Administration, 5100
                                      Paint Branch Pkwy., College Park,
                                      MD 20740, 301-436-1302.
------------------------------------------------------------------------

VI. Center for Veterinary Medicine (CVM)

------------------------------------------------------------------------
         Title of Guidance                         Contact
------------------------------------------------------------------------
Key Elements in Labeling of          Melanie Berson, Center for
 Prescription Antimicrobial Drug      Veterinary Medicine (HFV-110),
 Products                             Food and Drug Administration, 7500
                                      Standish Pl., MPN-2, Rockville, MD
                                      20855, 301-827-7540, e-mail:
                                      melanie.berson@fda.hhs.gov.
------------------------------------------------------------------------

[[Page 52134]]

 
Meetings With the Office of New      Gail Schmerfeld, Center for
 Animal Drug Evaluation (ONADE)       Veterinary Medicine (HFV-100),
                                      Food and Drug Administration, 7500
                                      Standish Pl., MPN-2, Rockville, MD
                                      20855, 301-827-1796, e-mail:
                                      gail.schmerfeld@fda.hhs.gov.
------------------------------------------------------------------------
Blue Bird Medicated Feed Labels      Dragan Momcilovic, Center for
                                      Veterinary Medicine (HFV-220),
                                      7519 Standish Pl., MPN-4,
                                      Rockville, MD 20855, 240-453-6856,
                                      e-mail:
                                      dragan.momcilovic@fda.hhs.gov.
------------------------------------------------------------------------
Chemistry, Manufacturing, and        Dennis Bensley, Center for
 Control Changes to an Approved       Veterinary Medicine (HFV-143),
 NADA or ANADA (83)          Food and Drug Administration, 7500
                                      Standish Pl., MPN-2, Rockville, MD
                                      20855, 301-827-6956, e-mail:
                                      dennis.bensley@.fda.hhs.gov.
------------------------------------------------------------------------
Analytical Methods Description for   Rebecca Owen, Center for Veterinary
 Type C Medicated Feeds (137)                               Administration, 7500 Standish Pl.,
                                      MPN-2, Rockville, MD 20855, 240-
                                      276-9842, e-mail:
                                      rebecca.owen@fda.hhs.gov.
------------------------------------------------------------------------
Veterinary Drug Compounding          Neal Bataller, Center for
 Compliance Policy Guide              Veterinary Medicine (HFV-235),
                                      Food and Drug Administration, 7519
                                      Standish Pl., MPN-4, Rockville, MD
                                      20855, 240-276-9202, e-mail:
                                      neal.bataller@fda.hhs.gov.
------------------------------------------------------------------------
Voluntary Self Inspection of         Gloria Dunnavan, Center for
 Medicated Feed Manufacturing         Veterinary Medicine (HFV-230),
 Facilities Compliance Policy Guide   Food and Drug Administration, 7519
                                      Standish Pl., MPN-4, Rockville, MD
                                      20855, 240-276-9200, e-mail:
                                      gloria.dunnavan@fda.hhs.gov.
------------------------------------------------------------------------
Recommended Study Design and         Michelle L. Stull, Center for
 Evaluation of Effectiveness          Veterinary Medicine (HFV-133),
 Studies for Swine Respiratory        Food and Drug Administration, 7500
 Disease Claims (178)        Standish Pl., MPN-2, Rockville, MD
                                      20855, 301-827-5058, e-mail:
                                      michelle.stull@fda.hhs.gov.
------------------------------------------------------------------------
Extra-label Use of Drugs in Animals  Gloria Dunnavan, Center for
                                      Veterinary Medicine (HFV-230),
                                      Food and Drug Administration, 7519
                                      Standish Pl., MPN-4, Rockville, MD
                                      20855, 240-276-9200, e-mail:
                                      gloria.dunnavan@fda.hhs.gov.
------------------------------------------------------------------------
Salmonella Contamination of Feeds    Henry Ekperigin, Center for
 Compliance Policy Guide              Veterinary Medicine (HFV-222),
                                      Food and Drug Administration, 7500
                                      Standish Pl., MPN-4, Rockville, MD
                                      20855, 240-453-6868, e-mail:
                                      henry.ekperigin@fda.hhs.gov.
------------------------------------------------------------------------
Criteria for Evaluating Tests for    Dragan Momcilovic, Center for
 Detection of Animal Proteins         Veterinary Medicine (HFV-220),
 Prohibited in Ruminant Feed          7519 Standish Pl., MPN-4,
                                      Rockville, MD 20855, 240-453-6856,
                                      e-mail:
                                      dragan.momcilovic@fda.hhs.gov.
------------------------------------------------------------------------
International Cooperation on         Dennis Bensley, Center for
 Harmonisation of Technical           Veterinary Medicine (HFV-143),
 Requirements for Registration of     Food and Drug Administration, 7500
 Veterinary Medicinal Products        Standish Pl., MPN-2, Rockville, MD
 (VICH)GL-39 Specifications: Test     20855, 301-827-6956, e-mail:
 Procedures and Acceptance Criteria   dennis.bensley@fda.hhs.gov.
 for New Veterinary Drug Substances
 and New Medicinal Products:
 Chemical Substances
------------------------------------------------------------------------
International Cooperation on         Do
 Harmonisation of Technical
 Requirements for Registration of
 Veterinary Medicinal Products
 (VICH) GL-40 Specifications: Test
 Procedures and Acceptance Criteria
 for New Biotechnological/
 Biological Veterinary Medicinal
 Products
------------------------------------------------------------------------
International Cooperation on         Do
 Harmonisation of Technical
 Requirements for Registration of
 Veterinary Medicinal Products
 (VICH); Draft Revised Guidance for
 Industry on Impurities in New
 Veterinary Drug Substances
 (Revision) VICH GL10(R)
------------------------------------------------------------------------
International Cooperation on         Do
 Harmonisation of Technical
 Requirements for Registration of
 Veterinary Medicinal Products
 (VICH); Draft Revised Guidance for
 Industry on Impurities in New
 Veterinary Medicinal Products
 (Revision) VICH GL11(R)
------------------------------------------------------------------------
Animal Drug User Fees: Fees Exceed   Dave Newkirk, Center for Veterinary
 Costs Waivers and Reductions         Medicine (HFV-100) , Food and Drug
                                      Administration, 7500 Standish Pl.,
                                      MPN-2, Rockville, MD 20855, 301-
                                      827-6967, e-mail:
                                      David.Newkirk@fda.hhs.gov.
------------------------------------------------------------------------
International Cooperation on         Lynn Post, Center for Veterinary
 Harmonisation of Technical           Medicine (HFV-210), Food and Drug
 Requirements for Registration of     Administration, 7519 Standish Pl.,
 Veterinary Medicinal Products        MPN-4, Rockville, MD 20855, 240-
 (VICH) GL-24 Pharmacovigilance of    276-9062, e-mail:
 Veterinary Medicinal Products:       Lynn.Post@fda.hhs.gov.
 Management of Adverse Event
 Reports
------------------------------------------------------------------------

[[Page 52135]]

 
International Cooperation on         Do
 Harmonisation of Technical
 Requirements for Registration of
 Veterinary Medicinal Products
 (VICH) GL-42 Pharmacovigilance of
 Veterinary Medicinal Products:
 Data Elements for Submission of
 Adverse Event Reports
------------------------------------------------------------------------
International Cooperation on         Do
 Harmonisation of Technical
 Requirements for Registration of
 Veterinary Medicinal Products
 (VICH) GL-29 Pharmacovigilance of
 Veterinary Medicinal Products:
 Management of Periodic Summary
 Update Reports (PSUs)
------------------------------------------------------------------------
International Cooperation on         Do
 Harmonisation of Technical
 Requirements for Registration of
 Veterinary Medicinal Products
 (VICH) GL-30 Pharmacovigilance of
 Veterinary Medicinal Products:
 Controlled Lists of Terms
------------------------------------------------------------------------
International Cooperation on         Do
 Harmonisation of Technical
 Requirements for Registration of
 Veterinary Medicinal Products
 (VICH) GL-35 Pharmacovigilance of
 Veterinary Medicinal Products:
 Electronic Standards for Transfer
 of Data
------------------------------------------------------------------------
Guidance for Industry, Submission    Do
 of Drug Experience Reports (DER)
 to the Center for Veterinary
 Medicine, Form Form FDA 2301
------------------------------------------------------------------------
Guidance for Industry, Submission    Do
 of Veterinary Adverse Drug Event
 Reports to the Center for
 Veterinary Medicine, Form FDA 1932
------------------------------------------------------------------------
Salmonellain Pet Turtles Compliance  Joseph Paige, Center for Veterinary
 Policy Guide                         Medicine (HFV-230), Food and Drug
                                      Administration, 7519 Standish Pl.,
                                      MPN-4, Rockville, MD 20855, 240-
                                      276-9210, e-mail:
                                      joseph.paige@fda.hhs.gov.
------------------------------------------------------------------------
Glucosamine/Chondroitin Animal       Mark Hackman, Center for Veterinary
 Products Compliance Policy Guide     Medicine (HFV-232), Food and Drug
                                      Administration, 7519 Standish Pl.,
                                      MPN-4, Rockville, MD 20855, 240-
                                      276-9215, e-mail:
                                      mark.hackman@fda.hhs.gov.
------------------------------------------------------------------------

VII. Office of Regulatory Affairs (ORA)

------------------------------------------------------------------------
      Title/Topic of Guidance                      Contact
------------------------------------------------------------------------
21 CFR Part 58: Closure of           Director, Office of Regulatory
 Nonclinical Laboratories             Affairs (HFC-230), Food and Drug
                                      Administration, 15800 Crabbs
                                      Branch Way, Rockville, MD 20855,
                                      240-632-6860.
------------------------------------------------------------------------
Disqualification of Clinical         Do
 Investigators
------------------------------------------------------------------------
Compliance Policy Guide, Section     Jeffrey B. Governale, Office of
 310.210, Blood Pressure              Regulatory Affairs (HFC-230), Food
 Measurement Devices                  and Drug Administration, 5600
 (Sphygmomanometers)--Accuracy (CPG   Fishers Lane, Rockville, MD 20857,
 7124.23)                             240-632-6851.
------------------------------------------------------------------------
Untrue Statements of Material Facts  Director, Office of Regulatory
                                      Affairs (HFC-230), Food and Drug
                                      Administration, 15800 Crabbs
                                      Branch Way, Rockville, MD 20855,
                                      240-632-6860.
------------------------------------------------------------------------
Application Integrity Policy         Do
------------------------------------------------------------------------

VIII. Office of the Commissioner (OC)

------------------------------------------------------------------------
      Topic/Title of Guidance                      Contact
------------------------------------------------------------------------
Information Sheet Guidances for      David Lepay, Office of the
 Institutional Review Boards,         Commissioner (HF-34), Food and
 Clinical Investigators, and          Drug Administration, 5600 Fishers
 Sponsors                             Lane, Rockville, MD 20857, 301-827-
                                      3340.
------------------------------------------------------------------------
Guidance for Industry Computerized   Patricia M. Beers Block, Office of
 Systems Used in Clinical Trials      the Commissioner (HF-34), Food and
                                      Drug Administration, 5600 Fishers
                                      Lane, Rockville, MD 20857, 301-827-
                                      6473.
------------------------------------------------------------------------
Guidance for FDA Staff Compliance    Do
 Program 7348.811, Inspection of
 Clinical Investigators and Sponsor
 Investigators
------------------------------------------------------------------------

[[Page 52136]]

 
Guidance for Institutional Review    Carolyn Hommel, Office of the
 Boards, Clinical Investigators,      Commissioner (HF-34), Food and
 and Sponsors, Exception from         Drug Administration, 5600 F

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