73 FR 153 pgs. 46008-46020 - Annual Guidance Agenda
Type: NOTICEVolume: 73Number: 153Pages: 46008 - 46020
Docket number: [Docket No. FDA-2004-N-0056] (formerly Docket No. 2004N-0234)
FR document: [FR Doc. E8-18126 Filed 8-6-08; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0056] (formerly Docket No. 2004N-0234)
Annual Guidance Agenda
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 | Contact |
|---|---|
| CATEGORY-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, 301-827-6210 |
| Pre-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 | Do |
| 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 Infection | Do |
| CATEGORY-VACCINES AND ALLERGENICS | |
| Considerations for the Development of Vaccines to Protect Against Global Infectious Diseases | Do |
| Considerations for the Development of Products that Contain Whole, Live Microorganisms with an Intended Therapeutic or Preventive Effect in Humans | Do |
| CATEGORY-CELLULAR, TISSUE, AND GENE THERAPY | |
| Potency Tests for Cell and Gene Therapy Products | Do |
| Characterization and Qualification of Cell Banks Used in the Production of Cellular and Gene Therapy Products | Do |
| Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments | Do |
| 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 Therapies | Do |
| Clinical Study Design Considerations for Cancer Vaccine Development | Do |
| Somatic Cell Therapy for Cardiac Disease | Do |
| Determination of Homologous Use Designation | Do |
| Devices Involved in Manufacture, Storage and Administration of Cellular Products and Tissues | Do |
| Preparation 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 | Contact |
|---|---|
| CATEGORY-ADVERTISING | |
| Amendment 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, 301-796-3601 |
| Presentation of Risk Information in Prescription Drug and Medical Device Promotion | Do |
| CATEGORY-CHEMISTRY | |
| Assay Development for Immunogenicity Testing | Do |
| CMC Post-Approval Changes Reportable in an Annual Report | Do |
| Immunogenicity Assessment for Therapeutic Protein Products | Do |
| Incorporation of Physical-chemical Indentifiers (PCID) into Solid Oral Dosage Form Drug Products for Anticounterfeiting | Do |
| Standards Recognition | 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 | |
| Adaptive Trial Designs | Do |
| Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention | Do |
| Oncology Endpoints: Non-Small Cell Lunch Cancer | Do |
| Pain Management: Developing Drug and Biological Products | Do |
| Risk Management of Highly Suspect or Known Human Teratogens: Pregnancy Prevention Strategies | Do |
| CATEGORY-CLINICAL/PHARMACOLOGY | |
| End of Phase 2a Meeting | Do |
| CATEGORY-CLINICAL/STATISTICAL | |
| Non-Inferiority Trials | Do |
| CATEGORY-COMBINATION PRODUCTS | |
| Drug Diagnostic Co-Development | Do |
| CATEGORY-COMPLIANCE | |
| Active Pharmaceutical Ingredient (API) | Do |
| Medical Gas | Do |
| Non-Penicillin Beta-Lactam Contamination | Do |
| Pharmacy Compounding of Human Drugs: Compliance Policy Guide, Section 460.200 | Do |
| Penicillins and Their Definition | Do |
| PET CGMPs | Do |
| Pre-Launch Activities Importation Request (PLAIR) | Do |
| Process Validation: General Principles and Practices | Do |
| CATEGORY-DRUG SAFETY INFORMATION | |
| Contents of a Complete Submission Package for a Proposed Proprietary Drug or Biologic Name | Do |
| Dear Healthcare Professional Letters | Do |
| Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During Pandemic Influenza | Do |
| CATEGORY-ELECTRONIC SUBMISSIONS | |
| Providing Regulatory Submissions in Electronic Format-Analysis Datasets and Documentation | Do |
| CATEGORY-GENERICS | |
| Submission of Summary Bioequivalence Data for ANDAs | Do |
| CATEGORY-IND | |
| Consumer Product Safety Commission-Tamper Resistant Packaging for INDs | Do |
| Determining Whether Human Research Studies Can Be Conducted Without an IND | Do |
| CATEGORY-LABELING | |
| Content and Format of the Clinical Pharmacology Section | Do |
| Drug Names and Dosage Forms | Do |
| Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims | Do |
| Labeling Dietary Supplements for Women Who are or Could be Pregnant | Do |
| Labeling Guidance for Inclusion and Placement of Safe Handling Statements in Package Inserts for Human Pharmaceuticals | Do |
| CATEGORY-OTC | |
| Label Comprehension Studies for OTC Drug Products | Do |
| Labeling of OTC Skin Protectant Drug Products | Do |
| CATEGORY-PHARMACOLOGY/TOXICOLOGY | |
| Biotechnology-Derived Pharmaceuticals: Nonclinical Safety Evaluation | Do |
| Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches | Do |
| Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route | Do |
| CATEGORY-PROCEDURAL | |
| Assessment of Abuse Potential of Drugs | Do |
| 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 Sponsors | Do |
| Integrated Summary of Effectiveness | Do |
IV. Center for Devices and Radiological Health (CDRH)
| Title | Contact 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 Condoms | Do |
| Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves | Do |
| Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) | Do |
| Manufacturing Site Change Supplements: Content and Inspectional Considerations | Do |
| Using the Global Harmonization Task Force (GHTF) Clinical Evaluation Guidance (SG5/N2R8:2007) for Medical Devices | Do |
| Using the Global Harmonization Task Force (GHTF) Quality Management System-Process Validation SG3/N99-10:2004 for Medical Devices | Do |
| 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 Laboratories | Do |
| Using the Global Harmonization Task Force (GHTF) SG1/N041:2005 Essential Principles of Safety Performance for Medical Devices | Do |
| Using the Global Harmonization Task Force (GHTF) SG1 PD/N0011 Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles for Medical Devices | Do |
| Using the Global Harmonization Task Force (GHTF) SG3N17 (Proposed) Quality Management System Medical Devices management of procured products, outsourced processes and their suppliers | Do |
| Using the Global Harmonization Task Force (GHTF) SG3 (Proposed) Criteria for Characterizing the Significance of Quality Management System Deficiencies for Medical Devices | Do |
| 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) | |
| Guidance Regarding Hand-Held X-Ray Equipment | Sean Boyd, Center for Devices and Radiological Health (HFZ-240), 1350 Piccard Dr., Rockville, MD 20850, 240-276-3287 |
| Impact Resistant Lenses QA | John 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 Guidance | Joel Myklebust, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 301-796-2491 |
| Bone Sonometers | Keith Wear, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 240-796-2538 |
| Risk Management Information in Premarket Submissions | William 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 Applications | Alford 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 Systems | Larry 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 standard | Do |
| Stereotactic Devices | Alford 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 Submissions | Joel Myklebust, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20933, 301-796-2491 |
| Office of Surveillance and Biometrics | |
| Bayesean Statistics | Gerry Grey, Center for Devices and Radiological Health (HFZ-530), 1350 Piccard Dr., Rockville, MD 20850, 240-276-3451 |
| Electronic Premarket Statistical Data Submission | Do |
| Electronic Medical Device Reporting | Howard Press, Center for Devices and Radiological Health (HFZ-530), 1350 Piccard Dr., Rockville, MD 20850, 240-276-3457 |
| CDRH Postmarket Problem Codes | Do |
| Global Harmonization Task Force (GHTF) Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices | Do |
| 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 Devices | Do |
| Office 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, 240-276-0397 |
| Class 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, 240-276-0711 |
| Class II Special Control Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay | Do |
| Class II Special Controls Guidance Document: Nucleic Acid Assay for Detection and Differentiation of Influenza A Virus Subtypes | Do |
| Special Controls Guidance Document: Bacillus spp. Serological Reagents; Guidance for Industry and FDA | Do |
| 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 Assays | Uwe Scherf, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0725 |
| Therapeutic Drug Monitoring Assays: Zonisamide and Lamotrigine | Avis Danishefsky, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0687 |
| Assay Migration Studies for IVD's | Sally Hojvat, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0711 |
| Administrative Procedures for CLIA Categorization Procedures | Carol 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 Assays | Freddie Poole, Center for Devices and Radiological Health (HFZ-440), 2098 Gaither Rd., Rockville MD 20850, 240-276-0712 |
| IVD Multivariate Index Assays | Courtney 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 IRBs | Stephen Rhodes, Center for Devices and Radiological Health (HFZ-403), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4036 |
| Sex Differences in Clinical Evaluation of Cardiovascular Devices | Bram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4038 |
| Condom Labeling, Special Controls | Nancy Brogdon, Center for Devices and Radiological Health (HFZ-470), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3650 |
| ECG Electrodes SCGD | Bram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4038 |
| Dental Amalgam | Susan Runner, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3776 |
| Antimicrobial Agent Devices; Premarket Notification Submissions | Chiu Lin, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3742 |
| Absorbable Hemostatic Devices | Mark 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 Submissions | Samie Niver Allen, Center for Devices and Radiological Health (HFZ-402), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4013 |
| Annual Reports for PMAs | Do |
| MDUFMA: 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, 240-276-3962 |
| Topical Oxygen Chamber for Extremities | Mark 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 Submissions | Heather Rosecrans, Center for Devices and Radiological Health (HFZ-404), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4021 |
| Pulse Oximeters; Submissions | Chiu Lin, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3742 |
| Tracking 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 |
| Trial Considerations for Hip Joint Replacement Systems | Mark Melkerson, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3737 |
| Replacement Heart Valves; IDE PMA Applications | Bram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4038 |
| Retina Prostheses; Preclinical Clinical Recommendations | Malvina 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 Indication | Chiu 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 Facilities | Do |
| Pacing Leads Guidance | Bram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3783 |
| Powered Wheelchairs | Mark 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 Skin | Do |
| FDA and Industry Actions on Premarket Approval Application | Samie Niver Allen, Center for Devices and Radiological Health (HFZ-402), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4013 |
| Pacemaker Lead Adaptor 510(k) Submissions | Bram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4038 |
| 510(k) Paradigm | Heather Rosecrans, Center for Devices and Radiological Health (HFZ-404), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4021 |
| Urinary Incontinence Devices; Clinical Recommendations | Nancy Brogdon, Center for Devices and Radiological Health (HFZ-470), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3650 |
| Guidance on Dental Mouthguards | Chiu Lin, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3742 |
| Tissue Expander | Mark Melkerson, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3737 |
| PTCA Devices | Bram Zuckerman, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4038 |
| TENS, Muscle Stimulator, and Conductive Gel Guidances | Mark 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)) Submissions | Chiu Lin, Center for Devices and Radiological Health (HFZ-480), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3742 |
| Full Field Digital Mammography | Nancy Brogdon, Center for Devices and Radiological Health (HFZ-470), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3650 |
| Coronary Drug Eluting Stents Guidance Document | Ashley Boam, Center for Devices and Radiological Health (HFZ-450), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4222 |
| Modifications 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 | Contact |
|---|---|
| New 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 |
| 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 | Contact |
|---|---|
| Regulation 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 |
| 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 |
| 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 | Contact |
|---|---|
| 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 Trials | Sara Goldkind, Office of the Commissioner (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340, FAX: 301-827-1169 |
| Guidance 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: 301-827-1169 |
| Guidance 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: 301-827-1169 |
| 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 2007 | Jarilyn Dupont, Office of Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360 |
| Final Guidance on Good Reprint Practices | Do |
| Guidance on Good Importer Practices | Sharon Mayl, Office of Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360 |
| Guidance 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