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Notice

Annual Guidance Agenda

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is publishing its annual guidance document agenda. This list is being published under FDA's good guidance practices (GGPs) regulations. It is intended to seek public comment on possible topics for future guidance document development or revisions of existing ones.

DATES:

Submit 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:

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.

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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.

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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 GuidanceContact
CATEGORY—BLOOD AND BLOOD COMPONENTSStephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210
Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for TransfusionSame as above (Do)
Assessment of Donors of Blood and Blood Components for Transfusion Transmitted Malaria RiskDo
Use 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 InfectionDo
CATEGORY—VACCINES AND ALLERGENICS
Considerations for the Development of Vaccines to Protect Against Global Infectious DiseasesDo
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Considerations for the Development of Products that Contain Whole, Live Microorganisms with an Intended Therapeutic or Preventive Effect in HumansDo
CATEGORY—CELLULAR, TISSUE, AND GENE THERAPY
Potency Tests for Cell and Gene Therapy ProductsDo
Characterization and Qualification of Cell Banks Used in the Production of Cellular and Gene Therapy ProductsDo
Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product EstablishmentsDo
Preparation of INDs for Certain Unlicensed Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Products (HPC-C)Do
Clinical Study Design for Early Phase Studies of Cellular and Gene TherapiesDo
Clinical Study Design Considerations for Cancer Vaccine DevelopmentDo
Somatic Cell Therapy for Cardiac DiseaseDo
Determination of Homologous Use DesignationDo
Devices Involved in Manufacture, Storage and Administration of Cellular Products and TissuesDo
Preparation of Investigational Device Exemptions and Investigational New Drugs for Tissue Engineered and Regenerative Medicine ProductsDo

III. Center for Drug Evaluation and Research (CDER)

Title/Topic of GuidanceContact
CATEGORY—ADVERTISING
Amendment of the Brief SummaryEmily T. Thakur, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3601
Presentation of Risk Information in Prescription Drug and Medical Device PromotionDo
CATEGORY—CHEMISTRY
Assay Development for Immunogenicity TestingDo
CMC Post-Approval Changes Reportable in an Annual ReportDo
Immunogenicity Assessment for Therapeutic Protein ProductsDo
Incorporation of Physical-chemical Indentifiers (PCID) into Solid Oral Dosage Form Drug Products for AnticounterfeitingDo
Standards RecognitionDo
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat ProcessesDo
CATEGORY—CLINICAL/MEDICAL
Adaptive Trial DesignsDo
Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and PreventionDo
Oncology Endpoints: Non-Small Cell Lunch CancerDo
Pain Management: Developing Drug and Biological ProductsDo
Risk Management of Highly Suspect or Known Human Teratogens: Pregnancy Prevention StrategiesDo
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CATEGORY—CLINICAL/PHARMACOLOGY
End of Phase 2a MeetingDo
CATEGORY—CLINICAL/STATISTICAL
Non-Inferiority TrialsDo
CATEGORY—COMBINATION PRODUCTS
Drug Diagnostic Co-DevelopmentDo
CATEGORY—COMPLIANCE
Active Pharmaceutical Ingredient (API)Do
Medical GasDo
Non-Penicillin Beta-Lactam ContaminationDo
Pharmacy Compounding of Human Drugs: Compliance Policy Guide, Section 460.200Do
Penicillins and Their DefinitionDo
PET CGMPsDo
Pre-Launch Activities Importation Request (PLAIR)Do
Process Validation: General Principles and PracticesDo
CATEGORY—DRUG SAFETY INFORMATION
Contents of a Complete Submission Package for a Proposed Proprietary Drug or Biologic NameDo
Dear Healthcare Professional LettersDo
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During Pandemic InfluenzaDo
CATEGORY—ELECTRONIC SUBMISSIONS
Providing Regulatory Submissions in Electronic Format—Analysis Datasets and DocumentationDo
CATEGORY—GENERICS
Submission of Summary Bioequivalence Data for ANDAsDo
CATEGORY—IND
Consumer Product Safety Commission—Tamper Resistant Packaging for INDsDo
Determining Whether Human Research Studies Can Be Conducted Without an INDDo
CATEGORY—LABELING
Content and Format of the Clinical Pharmacology SectionDo
Drug Names and Dosage FormsDo
Hypertension Indication: Drug Labeling for Cardiovascular Outcome ClaimsDo
Labeling Dietary Supplements for Women Who are or Could be PregnantDo
Labeling Guidance for Inclusion and Placement of Safe Handling Statements in Package Inserts for Human PharmaceuticalsDo
CATEGORY—OTC
Label Comprehension Studies for OTC Drug ProductsDo
Labeling of OTC Skin Protectant Drug ProductsDo
CATEGORY—PHARMACOLOGY/TOXICOLOGY
Biotechnology-Derived Pharmaceuticals: Nonclinical Safety EvaluationDo
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Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended ApproachesDo
Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate RouteDo
CATEGORY—PROCEDURAL
Assessment of Abuse Potential of DrugsDo
Determining Whether Human Research With a Radioactive Drug Can Be Conducted Under a Radioactive Drug Research Committee (RDRC)Do
Formal Meeting Between CDER/CBER Staff and SponsorsDo
Integrated Summary of EffectivenessDo

IV. Center for Devices and Radiological Health (CDRH)

TitleContact Person
Office of Compliance
Implementation 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, 240-276-0100
Surveillance and Detention Without Physical Examination of CondomsDo
Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination GlovesDo
Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)Do
Manufacturing Site Change Supplements: Content and Inspectional ConsiderationsDo
Using the Global Harmonization Task Force (GHTF) Clinical Evaluation Guidance (SG5/N2R8:2007) for Medical DevicesDo
Using the Global Harmonization Task Force (GHTF) Quality Management System—Process Validation SG3/N99-10:2004 for Medical DevicesDo
Guidance on the Third Party Inspection Program for Medical Devices (FDAAA)Do
Guidance on Submitting International Standards Organization (ISO) 13485 Audits to FDA for Medical Devices Under the Food and Drug Administration Amendments Act of 2007 (FDAAA)Do
30-Day Notices and 135-Day PMA Supplements (FDAAA)Do
Regulatory Requirements for Foreign and Domestic Dental LaboratoriesDo
Using the Global Harmonization Task Force (GHTF) SG1/N041:2005 Essential Principles of Safety & Performance for Medical DevicesDo
Using the Global Harmonization Task Force (GHTF) SG1 PD/N0011 Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles for Medical DevicesDo
Using the Global Harmonization Task Force (GHTF) SG3N17 (Proposed) Quality Management System Medical Devices management of procured products, outsourced processes and their suppliersDo
Using the Global Harmonization Task Force (GHTF) SG3 (Proposed) Criteria for Characterizing the Significance of Quality Management System Deficiencies for Medical DevicesDo
Using 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)Do
Office of Communication, Education, and Radiation Programs (OCER)
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Guidance Regarding Hand-Held X-Ray EquipmentSean Boyd, Center for Devices and Radiological Health (HFZ-240), 1350 Piccard Dr., Rockville, MD 20850, 240-276-3287
Impact Resistant Lenses Q&AJohn Stigi, Center for Devices and Radiological Health (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, 240-276-3150
Office of Science and Engineering Laboratories (OSEL)
Medical Device Electromagnetic Compatibility GuidanceJoel Myklebust, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 301-796-2491
Bone SonometersKeith Wear, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 240-796-2538
Risk Management Information in Premarket SubmissionsWilliam Midgette, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 301-796-2583
Application of IEC 60601-1 Third Edition in Premarket ApplicationsAlford Taylor, Jr. Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 301-796-2583
Premarket Clearance of Diagnostic Ultrasound Imaging SystemsLarry Grossman, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 301-796-2502
Guidance on the use of the IEC standard(s) for ultrasound therapy systems in lieu of older BRH mandatory standardDo
Stereotactic DevicesAlford Taylor, Jr., Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 301-796-2583
Electroconvulsive Therapy Device Class III Premarket Notification (510k) and Investigational Device Exemption SubmissionsJoel Myklebust, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 301-796-2491
Office of Surveillance and Biometrics
Bayesean StatisticsGerry Grey, Center for Devices and Radiological Health (HFZ-530), 1350 Piccard Dr., Rockville, MD 20850, 240-276-3451
Electronic Premarket Statistical Data SubmissionDo
Electronic Medical Device ReportingHoward Press, Center for Devices and Radiological Health (HFZ-530), 1350 Piccard Dr., Rockville, MD 20850, 240-276-3457
CDRH Postmarket Problem CodesDo
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Global Harmonization Task Force (GHTF) Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical DevicesDo
FDA's Use of Global Harmonization Task Force (GHTF) Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form for Medical DevicesDo
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Invasive Portable Blood Glucose Monitoring SystemPat Bernhardt, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0397
Class II Special Control Guidance Document: Human Metapneumovirus (hMPV) Nucleic Acid AssaysSally Hojvat, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0711
Class II Special Control Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid AssayDo
Class II Special Controls Guidance Document: Nucleic Acid Assay for Detection and Differentiation of Influenza A Virus SubtypesDo
Special Controls Guidance Document: Bacillus spp. Serological Reagents; Guidance for Industry and FDADo
Adverse 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, 240-276-0718
Class II Special Control Guidance Document: Enterovirus Nucleic Acid AssaysUwe Scherf, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0725
Therapeutic Drug Monitoring Assays: Zonisamide and LamotrigineAvis Danishefsky, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0687
Assay Migration Studies for IVD'sSally Hojvat, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0711
Administrative Procedures for CLIA Categorization ProceduresCarol Benson, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0396
Class II Special Control Guidance Document: Plasmodium Species Antigen Detection AssaysFreddie Poole, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0712
IVD Multivariate Index AssaysCourtney Harper, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0694
Office of Device Evaluation (ODE)
Pediatric HDEs—Guidance for IRBsStephen Rhodes, Center for Devices and Radiological Health (HFZ-403), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4036
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Sex Differences in Clinical Evaluation of Cardiovascular DevicesBram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4038
Condom Labeling, Special ControlsNancy Brogdon, Center for Devices and Radiological Health (HFZ-470), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3650
ECG Electrodes SCGDBram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4038
Dental AmalgamSusan Runner, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3776
Antimicrobial Agent Devices; Premarket Notification SubmissionsChiu Lin, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3742
Absorbable Hemostatic DevicesMark Melkerson, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3737
FDA and Industry Actions on Premarket Notification SubmissionsSamie Niver Allen, Center for Devices and Radiological Health (HFZ-402), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4013
Annual Reports for PMAsDo
MDUFMA: Disputes Concerning Payment or Refund of Medical Device User FeesLes Weinstein, Center for Devices and Radiological Health (HFZ-5), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3962
Topical Oxygen Chamber for ExtremitiesMark Melkerson, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3737
MDUFMA: User Fees and Refunds for Premarket Notification SubmissionsHeather Rosecrans, Center for Devices and Radiological Health (HFZ-404), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4021
Pulse Oximeters; SubmissionsChiu Lin, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3742
Tracking Pediatric Device Approvals Sec. 302 FDAAABarbara Buch, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4000
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Trial Considerations for Hip Joint Replacement SystemsMark Melkerson, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3737
Replacement Heart Valves; IDE & PMA ApplicationsBram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4038
Retina Prostheses; Preclinical & Clinical RecommendationsMalvina Eydelman, Center for Devices and Radiological Health (HFZ-400), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3783
Bone Graft SCGD Adding Intra-Oral Barrier Membrane IndicationChiu Lin, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3742
Labeling Reusable Medical Devices for Reprocessing in Health Care FacilitiesDo
Pacing Leads GuidanceBram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3783
Powered WheelchairsMark Melkerson, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3737
Tissue Adhesive for the Topical Approximation of SkinDo
FDA and Industry Actions on Premarket Approval ApplicationSamie Niver Allen, Center for Devices and Radiological Health (HFZ-402), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4013
Pacemaker Lead Adaptor 510(k) SubmissionsBram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4038
510(k) ParadigmHeather Rosecrans, Center for Devices and Radiological Health (HFZ-404), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4021
Urinary Incontinence Devices; Clinical RecommendationsNancy Brogdon, Center for Devices and Radiological Health (HFZ-470), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3650
Guidance on Dental MouthguardsChiu Lin, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3742
Tissue ExpanderMark Melkerson, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3737
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PTCA DevicesBram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4038
TENS, Muscle Stimulator, and Conductive Gel GuidancesMark Melkerson, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3737
Sterile Devices in Premarket Notification (510(k)) SubmissionsChiu Lin, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3742
Full Field Digital MammographyNancy Brogdon, Center for Devices and Radiological Health (HFZ-470), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3650
Coronary Drug Eluting Stents Guidance DocumentAshley Boam, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4222
Modifications to PMA DevicesSamie 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 GuidanceContact
New Dietary Ingredient Notifications GuidanceLinda 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 StatementsKathy 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 ConsultationsBerhane 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
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The Seafood List—FDA's Guide to Acceptable Market Names for Seafood Sold in Interstate CommerceSpring 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 CPGBob Childers, CFSAN (HFS-316), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1494, bob.childers@fda.hhs.gov
Prior Notice CPGMay 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 GuidanceContact
Regulation of Genetically Engineered (GE) Animals Containing Heritable nDNA ConstructsLarisa 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—FinalWilliam 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 GuideNeal 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 GuidePaul 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 GuideXin 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 FeedDragan 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
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Glucosamine/Chondroitin Animal Products Compliance Policy GuidePaul 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-43Laura 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 1932Lynn 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 2301Lynn 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 AnalysesBob 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 NADASuzanne 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 AnimalsGermaine 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 #186Deborah 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 GuideSharon 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 GuideNadine 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
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Marketed Unapproved New Animal Drugs; Draft Compliance Policy GuideNadine 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 GuidanceContact
Guidance 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: 301-827-1169
Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Voluntarily Withdraw from FDA-Regulated Clinical TrialsSara Goldkind, Office of the Commissioner (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340, FAX: 301-827-1169
Guidance for Sponsors, Clinical Investigators, and IRBs; A Guide to Informed ConsentMarsha Melvin, Office of the Commissioner (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340, FAX: 301-827-1169
Guidance for Sponsors, Clinical Investigators, and IRBs; IRBs Continuing Review After Study ApprovalCarolyn Hommel, Office of the Commissioner (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340, FAX: 301-827-1169
Final 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 2007Jarilyn Dupont, Office of Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360
Final Guidance on Good Reprint PracticesDo
Guidance on Good Importer PracticesSharon Mayl, Office of Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360
Guidance on Private LabsPhil Chao, Office of Policy (HF-23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360
Start Signature
Start Printed Page 46020

Dated: July 30, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

End Signature End Supplemental Information

[FR Doc. E8-18126 Filed 8-6-08; 8:45 am]

BILLING CODE 4160-01-S