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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2004-N-0056] (formerly 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 comments on this list and on any agency guidance documents at any time.
 ADDRESSES: You may submit comments, identified by Docket No. FDA-2004-N-0056, by any of the following methods: *Electronic Submissions* Submit electronic comments in the following way: Federal eRulemaking Portal:*http://www.regulations.gov*. Follow the instructions for submitting comments. *Written Submissions* Submit written submissions in the following ways: FAX: 301-827-6870.
                    Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal, as described previously, in the 
                        **ADDRESSES**
                         portion of this document under 
                        *Electronic Submissions*. *Instructions*: All submissions received must include the agency name and docket number for this notice. All comments received may be posted without change to 
                        *http://www.regulations.gov*, including any personal information provided. *Docket*: For access to the docket to read background documents or comments received, go to 
                        *http://www.regulations.gov*
                         and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
 FOR FURTHER INFORMATION CONTACT: *For general information regarding FDA's GGP policy contact*: 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 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 56468 at 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 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
ContactCATEGORY—BLOOD AND BLOOD COMPONENTS
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion
Same as above (Do)Assessment of Donors of Blood and Blood Components for Transfusion Transmitted Malaria Risk
DoUse of Serological of Tests on Samples from Donors of Whole Blood and Blood Components for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) to Reduce the Risk of Transmission of 
                            *Trypanosoma cruzi*
                             Infection
DoCATEGORY—VACCINES AND ALLERGENICSConsiderations for the Development of Vaccines to Protect Against Global Infectious Diseases
Do( print page 46009)Considerations for the Development of Products that Contain Whole, Live Microorganisms with an Intended Therapeutic or Preventive Effect in Humans
DoCATEGORY—CELLULAR, TISSUE, AND GENE THERAPYPotency Tests for Cell and Gene Therapy Products
DoCharacterization and Qualification of Cell Banks Used in the Production of Cellular and Gene Therapy Products
DoCurrent Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments
DoPreparation of INDs for Certain Unlicensed Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Products (HPC-C)
DoClinical Study Design for Early Phase Studies of Cellular and Gene Therapies
DoClinical Study Design Considerations for Cancer Vaccine Development
DoSomatic Cell Therapy for Cardiac Disease
DoDetermination of Homologous Use Designation
DoDevices Involved in Manufacture, Storage and Administration of Cellular Products and Tissues
DoPreparation of Investigational Device Exemptions and Investigational New Drugs for Tissue Engineered and Regenerative Medicine Products
Do
 III. Center for Drug Evaluation and Research (CDER) Title/Topic of Guidance
ContactCATEGORY—ADVERTISINGAmendment of the Brief Summary
Emily T. Thakur, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3601Presentation of Risk Information in Prescription Drug and Medical Device Promotion
DoCATEGORY—CHEMISTRYAssay Development for Immunogenicity Testing
DoCMC Post-Approval Changes Reportable in an Annual Report
DoImmunogenicity Assessment for Therapeutic Protein Products
DoIncorporation of Physical-chemical Indentifiers (PCID) into Solid Oral Dosage Form Drug Products for Anticounterfeiting
DoStandards Recognition
DoSubmission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
DoCATEGORY—CLINICAL/MEDICALAdaptive Trial Designs
DoDiabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention
DoOncology Endpoints: Non-Small Cell Lunch Cancer
DoPain Management: Developing Drug and Biological Products
DoRisk Management of Highly Suspect or Known Human Teratogens: Pregnancy Prevention Strategies
Do( print page 46010)CATEGORY—CLINICAL/PHARMACOLOGYEnd of Phase 2a Meeting
DoCATEGORY—CLINICAL/STATISTICALNon-Inferiority Trials
DoCATEGORY—COMBINATION PRODUCTSDrug Diagnostic Co-Development
DoCATEGORY—COMPLIANCEActive Pharmaceutical Ingredient (API)
DoMedical Gas
DoNon-Penicillin Beta-Lactam Contamination
DoPharmacy Compounding of Human Drugs: Compliance Policy Guide, Section 460.200
DoPenicillins and Their Definition
DoPET CGMPs
DoPre-Launch Activities Importation Request (PLAIR)
DoProcess Validation: General Principles and Practices
DoCATEGORY—DRUG SAFETY INFORMATIONContents of a Complete Submission Package for a Proposed Proprietary Drug or Biologic Name
DoDear Healthcare Professional Letters
DoPostmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During Pandemic Influenza
DoCATEGORY—ELECTRONIC SUBMISSIONSProviding Regulatory Submissions in Electronic Format—Analysis Datasets and Documentation
DoCATEGORY—GENERICSSubmission of Summary Bioequivalence Data for ANDAs
DoCATEGORY—INDConsumer Product Safety Commission—Tamper Resistant Packaging for INDs
DoDetermining Whether Human Research Studies Can Be Conducted Without an IND
DoCATEGORY—LABELINGContent and Format of the Clinical Pharmacology Section
DoDrug Names and Dosage Forms
DoHypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
DoLabeling Dietary Supplements for Women Who are or Could be Pregnant
DoLabeling Guidance for Inclusion and Placement of Safe Handling Statements in Package Inserts for Human Pharmaceuticals
DoCATEGORY—OTCLabel Comprehension Studies for OTC Drug Products
DoLabeling of OTC Skin Protectant Drug Products
DoCATEGORY—PHARMACOLOGY/TOXICOLOGYBiotechnology-Derived Pharmaceuticals: Nonclinical Safety Evaluation
Do( print page 46011)Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches
DoNonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route
DoCATEGORY—PROCEDURALAssessment of Abuse Potential of Drugs
DoDetermining Whether Human Research With a Radioactive Drug Can Be Conducted Under a Radioactive Drug Research Committee (RDRC)
DoFormal Meeting Between CDER/CBER Staff and Sponsors
DoIntegrated Summary of Effectiveness
Do
 IV. Center for Devices and Radiological Health (CDRH) Title
Contact PersonOffice of ComplianceImplementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007 (FDAAA)
Tim Ulatowski, Center for Devices and Radiological Health (HFZ-300), 2094 Gaither Rd., Rockville, MD 20850, 240-276-0100Surveillance and Detention Without Physical Examination of Condoms
DoSurveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves
DoMedical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)
DoManufacturing Site Change Supplements: Content and Inspectional Considerations
DoUsing the Global Harmonization Task Force (GHTF) Clinical Evaluation Guidance (SG5/N2R8:2007) for Medical Devices
DoUsing the Global Harmonization Task Force (GHTF) Quality Management System—Process Validation SG3/N99-10:2004 for Medical Devices
DoGuidance on the Third Party Inspection Program for Medical Devices (FDAAA)
DoGuidance on Submitting International Standards Organization (ISO) 13485 Audits to FDA for Medical Devices Under the Food and Drug Administration Amendments Act of 2007 (FDAAA)
Do30-Day Notices and 135-Day PMA Supplements (FDAAA)
DoRegulatory Requirements for Foreign and Domestic Dental Laboratories
DoUsing the Global Harmonization Task Force (GHTF) SG1/N041:2005 Essential Principles of Safety & Performance for Medical Devices
DoUsing the Global Harmonization Task Force (GHTF) SG1 PD/N0011 Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles for Medical Devices
DoUsing the Global Harmonization Task Force (GHTF) SG3N17 (Proposed) Quality Management System Medical Devices management of procured products, outsourced processes and their suppliers
DoUsing the Global Harmonization Task Force (GHTF) SG3 (Proposed) Criteria for Characterizing the Significance of Quality Management System Deficiencies for Medical Devices
DoUsing the Global Harmonization Task Force (GHTF) SG1 (Proposed) Multi-site Audits and Audits of Suppliers (Suppl 1. to Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers—Part 2: Regulatory Auditing Strategy)
DoOffice of Communication, Education, and Radiation Programs (OCER)( print page 46012)Guidance Regarding Hand-Held X-Ray Equipment
Sean Boyd, Center for Devices and Radiological Health (HFZ-240), 1350 Piccard Dr., Rockville, MD 20850, 240-276-3287Impact Resistant Lenses Q&A
John Stigi, Center for Devices and Radiological Health (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, 240-276-3150Office of Science and Engineering Laboratories (OSEL)Medical Device Electromagnetic Compatibility Guidance
Joel Myklebust, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 301-796-2491Bone Sonometers
Keith Wear, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 240-796-2538Risk Management Information in Premarket Submissions
William Midgette, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 301-796-2583Application of IEC 60601-1 Third Edition in Premarket Applications
Alford Taylor, Jr. Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 301-796-2583Premarket Clearance of Diagnostic Ultrasound Imaging Systems
Larry Grossman, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 301-796-2502Guidance on the use of the IEC standard(s) for ultrasound therapy systems in lieu of older BRH mandatory standard
DoStereotactic Devices
Alford Taylor, Jr., Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 301-796-2583Electroconvulsive Therapy Device Class III Premarket Notification (510k) and Investigational Device Exemption Submissions
Joel Myklebust, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 301-796-2491Office of Surveillance and BiometricsBayesean Statistics
Gerry Grey, Center for Devices and Radiological Health (HFZ-530), 1350 Piccard Dr., Rockville, MD 20850, 240-276-3451Electronic Premarket Statistical Data Submission
DoElectronic Medical Device Reporting
Howard Press, Center for Devices and Radiological Health (HFZ-530), 1350 Piccard Dr., Rockville, MD 20850, 240-276-3457CDRH Postmarket Problem Codes
Do( print page 46013)Global Harmonization Task Force (GHTF) Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices
DoFDA's Use of Global Harmonization Task Force (GHTF) Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form for Medical Devices
DoOffice of In Vitro Diagnostic Device Evaluation and Safety (OIVD)Invasive Portable Blood Glucose Monitoring System
Pat Bernhardt, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0397Class II Special Control Guidance Document: Human Metapneumovirus (hMPV) Nucleic Acid Assays
Sally Hojvat, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0711Class II Special Control Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay
DoClass II Special Controls Guidance Document: Nucleic Acid Assay for Detection and Differentiation of Influenza A Virus Subtypes
DoSpecial Controls Guidance Document: Bacillus spp. Serological Reagents; Guidance for Industry and FDA
DoAdverse Event Reporting for IVD's (with appendix on glucose meters)
Claudia Gaffey, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0718Class II Special Control Guidance Document: Enterovirus Nucleic Acid Assays
Uwe Scherf, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0725Therapeutic Drug Monitoring Assays: Zonisamide and Lamotrigine
Avis Danishefsky, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0687Assay Migration Studies for IVD's
Sally Hojvat, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0711Administrative Procedures for CLIA Categorization Procedures
Carol Benson, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0396Class II Special Control Guidance Document: Plasmodium Species Antigen Detection Assays
Freddie Poole, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0712IVD Multivariate Index Assays
Courtney Harper, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0694Office of Device Evaluation (ODE)Pediatric HDEs—Guidance for IRBs
Stephen Rhodes, Center for Devices and Radiological Health (HFZ-403), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4036( print page 46014)Sex Differences in Clinical Evaluation of Cardiovascular Devices
Bram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4038Condom Labeling, Special Controls
Nancy Brogdon, Center for Devices and Radiological Health (HFZ-470), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3650ECG Electrodes SCGD
Bram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4038Dental Amalgam
Susan Runner, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3776Antimicrobial Agent Devices; Premarket Notification Submissions
Chiu Lin, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3742Absorbable Hemostatic Devices
Mark Melkerson, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3737FDA and Industry Actions on Premarket Notification Submissions
Samie Niver Allen, Center for Devices and Radiological Health (HFZ-402), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4013Annual Reports for PMAs
DoMDUFMA: Disputes Concerning Payment or Refund of Medical Device User Fees
Les Weinstein, Center for Devices and Radiological Health (HFZ-5), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3962Topical Oxygen Chamber for Extremities
Mark Melkerson, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3737MDUFMA: User Fees and Refunds for Premarket Notification Submissions
Heather Rosecrans, Center for Devices and Radiological Health (HFZ-404), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4021Pulse Oximeters; Submissions
Chiu Lin, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3742Tracking Pediatric Device Approvals Sec. 302 FDAAA
Barbara Buch, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4000( print page 46015)Trial Considerations for Hip Joint Replacement Systems
Mark Melkerson, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3737Replacement Heart Valves; IDE & PMA Applications
Bram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4038Retina Prostheses; Preclinical & Clinical Recommendations
Malvina Eydelman, Center for Devices and Radiological Health (HFZ-400), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3783Bone Graft SCGD Adding Intra-Oral Barrier Membrane Indication
Chiu Lin, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3742Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities
DoPacing Leads Guidance
Bram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3783Powered Wheelchairs
Mark Melkerson, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3737Tissue Adhesive for the Topical Approximation of Skin
DoFDA and Industry Actions on Premarket Approval Application
Samie Niver Allen, Center for Devices and Radiological Health (HFZ-402), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4013Pacemaker Lead Adaptor 510(k) Submissions
Bram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4038510(k) Paradigm
Heather Rosecrans, Center for Devices and Radiological Health (HFZ-404), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4021Urinary Incontinence Devices; Clinical Recommendations
Nancy Brogdon, Center for Devices and Radiological Health (HFZ-470), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3650Guidance on Dental Mouthguards
Chiu Lin, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3742Tissue Expander
Mark Melkerson, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3737( print page 46016)PTCA Devices
Bram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4038TENS, Muscle Stimulator, and Conductive Gel Guidances
Mark Melkerson, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3737Sterile Devices in Premarket Notification (510(k)) Submissions
Chiu Lin, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3742Full Field Digital Mammography
Nancy Brogdon, Center for Devices and Radiological Health (HFZ-470), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3650Coronary Drug Eluting Stents Guidance Document
Ashley Boam, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4222Modifications to PMA Devices
Samie Niver Allen, Center for Devices and Radiological Health (HFZ-402), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4013
 V. Center for Safety and Applied Nutrition (CFSAN) Title/Topic of Guidance
ContactNew Dietary Ingredient Notifications Guidance
Linda Pellicore, CFSAN (HFS-810), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1448, 
                            *linda.pellicore@fda.hhs.gov*Fish and Fishery Products Hazards and Control Guidance (Edition 4)
Robert Samuels, CFSAN (HFS-325), 5100 Paint Branch Pkwy., College Park, MD 20740 301-436-1418, 
                            *robert.samuels@fda.hhs.gov*Dietary Guidance Statements
Kathy Ellwood, CFSAN (HFS-830), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1450, 
                            *kathy.ellwood@fda.hhs.gov*Providing Regulatory Submissions in Electronic Format—Food Additive Petitions, Color Additive Petitions, Food Contact Notifications, Food Master Files, GRAS Notices, Biotechnology Consultations, and New Protein Consultations
Berhane Girmay, CFSAN (HFS-205), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1194, 
                            *berhane.girmay@fda.hhs.gov*Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5)
Rhonda Kane, CFSAN (HFS-820), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1803, 
                            *rhonda.Kane@fda.hhs.gov*( print page 46017)The Seafood List—FDA's Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce
Spring Randolph, CFSAN (HFS-325), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1421, 
                            *spring.randolph@fda.hhs.gov*Small Entity Compliance Guide: “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements”
Vasilios Frankos, CFSAN (HFS-810), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1850, 
                            *vasilios.frankos@fda.hhs.gov*Pathogens in Diary Products Draft CPG
Bob Childers, CFSAN (HFS-316), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1494, 
                            *bob.childers@fda.hhs.gov*Prior Notice CPG
May Nelson, CFSAN (HFS-024), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1722, 
                            *may.nelson@fda.hhs.gov*
 VI. Center for Veterinary Medicine Title of Guidance
ContactRegulation of Genetically Engineered (GE) Animals Containing Heritable nDNA Constructs
Larisa Rudenko, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8245, e-mail: 
                            *larisa.rudenko@fda.hhs.gov*Labeling and Marketing of Nutritional Products for Dogs and Cats Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases—Compliance Policy Guide—Final
William J. Burkholder, Center for Veterinary Medicine (HFV-228), Food and Drug Administration, 7519 Standish Pl., MPN-4, rm. 2642, Rockville, MD 20855, 
                            *william.burkholder@fda.hhs.gov*Veterinary Drug Compounding Compliance Policy Guide
Neal Bataller, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., MPN-4, rm. 143, Rockville, MD 20855, 240-276-9201, 
                            *neal.bataller@fda.hhs.gov*Voluntary Self Inspection of Medicated Feed Manufacturing Facilities—Compliance Policy Guide
Paul Bachman, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., MPN-4, rm. 128, Rockville, MD 20855, 240-276-9225, 
                            *paul.bachman@fda.hhs.gov*Salmonella Contamination of Feeds Compliance Policy Guide
Xin Li, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7519 Standish Pl., MPN-4, rm. 221, Rockville, MD 20855, 240-453-6863, 
                            *Xin.Lin@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, rm. 227, Rockville, MD 20855, 240-453-6856, 
                            *dragan.momcilovic@fda.hhs.gov*( print page 46018)Glucosamine/Chondroitin Animal Products Compliance Policy Guide
Paul Bachman, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., MPN-4, rm. 128, Rockville, MD 20855, 240-276-9225, 
                            *paul.bachman@fda.hhs.gov*International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Final Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products GL-43
Laura Hungerford, Center for Veterinary Medicine (HFV-143), Food and Drug Administration, 7500 Standish Pl., MPN-2, rm. E375, Rockville, MD 20855, 240-276-8232, 
                            *laura.hungerford@fda.hhs.gov*Guidance for Industry, Submission of Veterinary Adverse Drug Event Reports to the Center for Veterinary Medicine, Form FDA 1932
Lynn Post, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7519 Standish Pl., MPN-4, rm. 2612, Rockville, MD 20855, 240-276-9062, 
                            *lynn.post@fda.hhs.gov*Guidance for Industry, Submission of Drug Experience Reports (DER) to the Center for Veterinary Medicine, Form FDA 2301
Lynn Post, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7519 Standish Pl., MPN-4, rm. 2612, Rockville, MD 20855, 240-276-9062, 
                            *lynn.post@fda.hhs.gov*Draft Guidance for Industry—Documenting Statistical Analyses
Bob Abugov, Center for Veterinary Medicine (HFV-105), Food and Drug Administration, 7500 Standish Pl., MPN-2, rm. N416, Rockville, MD 20855, 240-276-8168, 
                            *robert.abugov@fda.hhs.gov*Draft Guidance for Industry—Changes to Approved NADAs—New NADA or Supplemental NADA
Suzanne Sechen, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., MPN-2, rm. N448, Rockville, MD 20855, 240-276-8108, 
                            *suzanne.sechen@fda.hhs.gov*Draft Guidance for Industry—Anesthetics for Companion Animals
Germaine Connolly, Center for Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 Standish Pl., MPN-2, rm. N331, Rockville, MD 20855, 240-276-8331, 
                            *germaine.connolly@fda.hhs.gov*Draft Guidance for Industry: Drug Residues Resulting From the Extralabel Use of Approved New Animal Drugs #186
Deborah Cera, Center for Veterinary Medicine (HFV-235), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9209, 
                            *deborah.cera@fda.hhs.gov*Common or Usual Names for Animal Feed Ingredients and Their Use in Animal Feed (CPG 7126.08); Draft Compliance Policy Guide
Sharon Benz, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., rm. 2648, Rockville, MD 20855, 240-453-6864, 
                            *esharon.benz@fda.hhs.gov*Importation of New Animal Drugs by Licensed Veterinarians; Draft Compliance Policy Guide
Nadine Steinberg, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, MPN4, rm. 2658, Rockville, MD 20855, 240-453-6846 
                            *nadine.steinberg@fda.hhs.gov*( print page 46019)Marketed Unapproved New Animal Drugs; Draft Compliance Policy Guide
Nadine Steinberg, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, MPN4, rm. 2658, Rockville, MD 20855, 240-453-6846 
                            *nadine.steinberg@fda.hhs.gov*
 VII. Office of the Commissioner Title/Topic of Guidance
ContactGuidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions—Statement of Investigator (Form FDA 1572)
Patricia Beers Block, Office of the Commissioner (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340, FAX: 301-827-1169Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Voluntarily Withdraw from FDA-Regulated Clinical Trials
Sara Goldkind, Office of the Commissioner (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340, FAX: 301-827-1169Guidance for Sponsors, Clinical Investigators, and IRBs; A Guide to Informed Consent
Marsha Melvin, Office of the Commissioner (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340, FAX: 301-827-1169Guidance for Sponsors, Clinical Investigators, and IRBs; IRBs Continuing Review After Study Approval
Carolyn Hommel, Office of the Commissioner (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340, FAX: 301-827-1169Final Guidance for Sponsors, Industry, Researchers, Investigators, and FDA Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance With Section 402(j) of the Public Health Service Act, Added by Title VII of the Food and Drug Administration Amendments Act of 2007
Jarilyn Dupont, Office of Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360Final Guidance on Good Reprint Practices
DoGuidance on Good Importer Practices
Sharon Mayl, Office of Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360Guidance on Private Labs
Phil Chao, Office of Policy (HF-23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360
 Dated: July 30, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning.


[FR Doc. E8-18126 Filed 8-6-08; 8:45 am] BILLING CODE 4160-01-S