Meetings: Semiannual guidance agenda,
[Federal Register: November 15, 1999 (Volume 64, Number 219)]
[Notices]
[Page 61881-61892]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15no99-88]
[[Page 61881]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0928]
Semiannual Guidance Agenda
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is publishing the semiannual guidance document agenda. FDA committed to publishing, on a semiannual basis, possible guidance topics or documents for development or revision during the next year, and seeking public comment on additional ideas for new guidance documents or revisions of existing ones. This commitment was made in FDA's February 1997 ``Good Guidance Practices'' (GGP's), which set forth the agency's policies and procedures for the development, issuance, and use of guidance documents. This list is intended to seek public comment on possible topics for guidance documents and possible revisions to existing guidances.
DATES: Submit comments on this list and on agency guidance documents at any time.
ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: For general information regarding FDA's GGP's contact: LaJuana D. Caldwell, Office of Policy (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010. For information regarding specific topics or guidances, please see contact persons listed below. SUPPLEMENTARY INFORMATION:
-
Background
In the Federal Register of February 27, 1997 (62 FR 8961), FDA published a notice announcing its GGP's, which set forth the agency's policies and procedures for the development, issuance, and use of guidance documents. The agency adopted the GGP's to ensure public involvement in the development of guidance documents and to enhance public understanding of the availability, nature, and legal effect of such guidance. As part of FDA's effort to ensure meaningful interaction with the public regarding guidance documents, the agency committed to publishing a semiannual 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. 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. On June 1, 1998, the President instructed all Federal agencies to ensure the use of ``plain language'' in all new documents. As part of this initiative, FDA is also seeking public comment on the clarity of its guidance documents. 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 are listed for each specific area.
-
Center for Biologics Evaluation and Research (CBER)
Title/Topic of Guidance
Contact
Category--Compliance and Inspection Guidance for Reprocessing,
Stephen M. Ripley, Center for Reworking, and Blending
Biologics (HFM-17), Food and Drug Practices for Biological Bulk Administration, 1401 Rockville Substances, Final Bulk, and
Pike, Rockville, MD 20852-1448, Finished Products.
301-827-6210. Compliance Program 7342.002,
Do. Inspection of Source Plasma Establishments. Compliance Program, Inspection of Do. Licensed Vaccine and Related Product Manufacturers. Compliance Program 7341.002, Do. Inspection of Tissue Banking Establishments. Compliance Program 7341.003, Do. Examination of Blood and Blood Components Offered for Import. Compliance Program 7342.006, Do. Inspection of Plasma Derivatives of Human Origin. Compliance Program 7342.008, Do. Inspection of Licensed Viral Marker Test Kits. Guidance for the Design,
Do. Installation, and Operations of Water Systems. Guidance on Heating, Ventilation, Do. and Air Conditioning (HVAC) and the Monitoring of Environments for the Manufacture of Biological Substances and Products. Guidance for the Validation of Do. the Limulus Amebocyte Lystate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products and Medical Devices. Guidance for Process Validation Do. Considerations for Biological Drug Substances and Biological Drug Products. Guidance on Lot Release for
Do. Licensed Biological Products Distributed into Foreign Markets. Category--Therapeutics Guidance for the Chemistry,
Do. Manufacturing and Control Information on Gene Therapy Products.
[[Page 61882]]
Guidance to Industry on
Do. Xenotransplantation. Guidance in the Development of Do. Products for Chronic Cutaneous Ulcers and Acute Burn Wounds. Guidance on Recombinant Biologics Do. Produced in Plants. Guidance on the Development of Do. Products for Systemic Lupus Erythematosus. Category--Blood and Blood
Do. Components Guidance for Collection, Testing Do. and Release of Autologous Blood. Guidance for Recommendations for Do. Donor Testing By Automated Methods When Using Treponemal Based Screening Tests for Syphilis. Guidance for Reviewer Guidance Do. for a Pre-Market Notification Submission for Automated Blood Establishment Testing Instruments. Guidance for HIV Reentry
Do. Algorithms for Deferred Blood and Plasma Donors. Guidance for Precautionary
Do. Measures to Reduce the Possible Risk of Transmission of Zoonoses by Xenograft Recipients and Their Close Contacts, Through Whole Blood, Blood Components, Source Plasma, and Source Leukocytes. Guidance for Additional
Do. Recommendations for Donor Questioning Regarding Travel to Areas Endemic for Malaria. Category--Vaccines Guidance for Immunization of Do. Human Plasma Donors To Obtain Source Plasma for Preparation of Specific Immune Globulins. Guidance on Assessment of the Do. Reproductive Toxicity Potential of Preventative Vaccines for Infectious Diseases. Guidance on the U.S. Minimum Do. Standards (formerly U.S. Minimum Requirements) for Tetanus and Diphtheria Toxoid Containing Products. Category--Other Guidance on the Development and Do. Use of Comparability Protocols.
-
Center for Devices and Radiololgical Health (CDRH)
Title/Topic of Document
Contact
Preparation of IDE's for Spinal Systems.
Samie N. Allen, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-3090. Preclinical and Clinical Data and Labeling for Breast Do. Prostheses. Ultra High Molecular Weight Polyethylene (UHMWPE) John S. Goode, Center for Devices and Radiological Guidance.
Health (HFZ-410), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2036. Bone Cement Guidance.
Hany W. Demian, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2036. Adhesion Prevention Guidance.
Dave B. Berkowitz, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-3090. Neuroembolization Guidance.
Keith E. Foy, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-3090. Dura Substitutes Guidance.
Ann H. Costello, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1184. Guidance on Labeling for Laboratory Tests.
Steve I. Gutman, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1905. Over the Counter Luteunizing Hormone Assays.
Jean M. Cooper, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1243. Over the Counter Human Chorionic Gonadotropin Assays Do. (Revision). Quality Control Guidance (Revision).
Do. Point of Care In Vitro Diagnostics.
Do. Guidance for Premarket Submissions for Kits for
Do. Screening Drugs of Abuse to Be Used By The Consumer (Revision).
[[Page 61883]]
Review Criteria for Assessment of Portable Blood Do. Glucose In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology (Revision). Criteria for a Streamline PMA for Early Detection of Peter E. Maxim, Center for Devices and Radiological PSA.
Health (HFZ-440), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1293. Abbreviated 510(k) Submission for In Vitro Diagnostic Do. Antinuclear Antibody (ANA) Immunological Test Systems. Points to Consider for Cervical Cytology Devices Do. (Revision). Draft Guidance for 510(k) Submission of Lymphocyte Do. Immunophenotyping IVD's using Monoclonal Antibodies (Revision). Review Criteria for Assessment of Antimicrobial
Woody Dubois, Center for Devices and Radiological Susceptibility Devices (Special Control).
Health (HFZ-440), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2096. Premarket Approval Applications for In Vitro
Do. Diagnostics Devices Pertaining to Hepatitis C Viruses (HCV): Assays Intended for Diagnosis, Prognosis, or Monitoring of HCV Infection, Hepatitis C, or Other HCV-associated Disease. Oral Appliance For Snoring And Sleep Apnea.
Sandy L. Shire, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5283. General Hospital IV Administration Sets.
Pat M. Cricenti, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-8879. IV flushes.
Do. Infrared Thermometers.
Do. Jet Injectors.
Do. Infection Control Expiration Dating of Medical Glove. Chiu C. Lin, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-8913. Biological Indicators.
Do. Chemical Indicators.
Do. Renal Dialyzer Reprocessing.
Do. Liquid Sterilizers and High Level Disinfectants. Do. General Purpose Washers/Disinfectants.
Do. Heart Valve Guidance (Revision).
Thomas J. Callahan, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-8252. Cardiac Ablation: Atrial Fibrillation Clinical Study Dina J. Fleischer, Center for Devices and Radiological Design.
Health (HFZ-450), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-8517. Cardiac Ablation: Pre-clinical Testing.
Barbara A. Zimmerman, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-8517. Cardiac Ablation: SVT Clinical Study Design.
Stuart M. Portnoy, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-8517. Cardiac Ablation: Atrial Flutter Clinical Study
Jennifer L. Goode, Center for Devices and Radiological Design.
Health (HFZ-450), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-8517. Percutaneous Transluminal Angioplasty (PTA)
Christopher M. Sloan, Center for Devices and Catheters.
Radiological Health (HFZ-450), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-8243. Applications for Permanent Pacemaker Leads.
Lynette A. Gabriel, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-8243. Implantable Defibrillator Guidance Document.
Doris J. Terry, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-8609. Replacement Rechargeable Batteries 510(k)s.
Charles S. Ho, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-8609. Extracorporeal Membrane Oxygenators (ECMO).
Thinh Nguyen, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-8252. Compressible Limb Sleeves.
Do. Telemetry Guidance.
Do. Electromagnetic Compatibility Guidance (Revision). Do. Roller Pump Special Control.
Do. Arrhythmia Detector and Alarm including ST Segment Carole C. Carey, Center for Devices and Radiological Monitor and Alarm (Revision).
Health (HFZ-450), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-8252.
[[Page 61884]]
External Cardiac Defibrillators (including AED's). Do. Multifunction Electrodes (a subset of the External Do. Defibrillators). 510k Biopsy Devices Guidance (Revision).
Mary Beth Abt, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2194. 510(k) Irrigation Set Checklist (Revision).
Do. Testicular Implant Guidance Document (Revision). John H. Baxley, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2194. Inflatable Penile Implant Guidance Document
Do. (Revision). Content of PMA Application for Testicular Implants Do. (Revised). Content of PMN for Extracorpreal Shock Wave
Do. (Revised). Lithrotriptor indicated for the fragmentation of Do. kidney and ureteral calculi. 510(k) Enuresis Alarm Checklist (Revision).
Do. 510(k) Antimicrobial Foley Guidance (Revision).
Laura J. Byrd, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2194. 510(k) Electrical Surgical Unit Checklist (Revision). Do. 510(k) Non-implantable Electrical Stim. Checklist Do. (Revision). Vesicoureteral Reflux Guidance Doc. (New).
Hector H. Herrera, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2194. 510(k) Urodynamic Systems Guidance Document
Do. (Revision). BPH Guidance Document (Revision).
Mil J. Jevtich, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2194. Urethral Bulking Agent Guidance (Revision).
Rao Nimmagadda, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2194. 510(k) Condom Catheter Checklist (Revision).
Do. External Penile Rigidity Device Guidance (New).
Jim Seiler, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2194. 510(k) Urine Drainage Bag Guidance (Revision).
Do. Urethral Stent Guidance Document (Revision).
Do. Artificial Urinary Sphincter Guidance (Revision). Nicole L. Wolanski, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2194. 510(k) Balloon Catheter Guidance Document (Revision). Do. 510(k) Mechanical Lithrotriptor/Stone Dislodger
Do. (Revision). 510(k) Light Sources checklist (Revision).
Do. 510(k) Endoscope Guidance (Revision).
Mary Jo Cornelius, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2194. Thermal Endometrial Ablation Devices Submission
Veronica A. Price, Center for Devices and Radiological Guidance for an IDE (Revision).
Health (HFZ-470), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1180. Guidance for Content of Premarket Notification for Carolyn Y. Neuland, Center for Devices and Radiological Conventional and High Permeability hemodialysers Health (HFZ-470), Food and Drug Administration, 5600 (Revision).
Fishers Lane, Rockville, MD 20857, 301-594-1220. Guidance for Premarket Notification for Hemodialysis Do. Delivery System (Revision). Guidance for Industry and CDRH Rev. of Content of Do. Premarket Notification for Perioneo-Venous Shunts (Revision). Guidance for Content of Premarket Notification of Do. Body Composition Analyzers (Revision). Guidance of Content of Investigational Device
Do. Exemption (IDE) for Solutions for hypothermic flushing, transport and storage of organs and transplantation (Revision). Guidance on Devices in Invitro Fertilization and Elisa D. Harvey, Center for Devices and Radiological other Assisted Reproduction procedures (Revision). Health (HFZ-470), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1220. Guidance for Submission of Bone Sonometer Premarket Robert A. Phillips, Center for Devices and Radiological Applications (PMS's) (Revision).
Health (HFZ-470), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1212. Guidance for Brachytherapy Source 510(k)s (Revision). Do. Guidance for Radiation Therapy Systems Software
Do. Testing (Revision). Diagnostic Ultrasound Guidance (Revision).
Do.
[[Page 61885]]
Guidance for Manufacturing of Digital Mammography William M. Sacks, Center for Devices and Radiological Devices (Revision).
Health (HFZ-470), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1212. Guidance for Manufacturers of Bone Ultrasound Devices Do. for Osteoporosis (Revision). Guidance for Preparation of Bone Sonometer PMA
Joe Arnaudo, Center for Devices and Radiological Health Submissions (Revision).
(HFZ-470), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1212. Guidance for Review of Bone Densitometer 510(k)
Do. Submissions (Revision). Extended Wear Contact Lens Guidance, Including
Karen Warburton, Center for Devices and Radiological Clinical Studies.
Health (HFZ-460), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1744. Guidance on Post Market Studies for Extended Wear Do. Contact Lenses. Orthokeratology Contact Lens Clinical Study Guidance. Eleanor M. Felton, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1744. Labeling Guidance for UV Absorbing Contact Lenses. Do. 510k Guidance Document for Daily Wear Contacts
Do. (Revision). Guidance for the Arrangement and Content of a
Teri Cygnarowicz, Center for Devices and Radiological Premarket Approval (PMA) Application for an
Health (HFZ-460), Food and Drug Administration, 5600 Implantable Middle Ear Hearing Device.
Fishers Lane, Rockville, MD 20857, 301-594-2080. Guidance for the Arrangement and Content of a
Do. Premarket Approval (PMA) Application for a Cochlear Implant for Children (Revision). Guidance for the Arrangement and Content of a
Do. Premarket Approval (PMA) Application for a Cochlear Implant for Adults (Revision). Guidance for the Development of a Premarket
Karen H. Baker, Center for Devices and Radiological Notification for a Disposable Sterile Ear, Nose and Health (HFZ-460), Food and Drug Administration, 5600 Throat Endoscope Sheath with Protective Barrier
Fishers Lane, Rockville, MD 20857, 301-594-2080. Claims (Revision). Guidance for the Development of a Premarket
Do. Notification for Vocal Cord Medialization Devices. Scanning Laser Ophthalmoscopes.
Everette T. Beers, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2018. Electrosurgical Devices.
Do. Microkeratomes.
Do. Refractive Lasers (Revision).
Do. Interocular Lenses Guidance Document (Revision). Donna R. Lochner, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2053. Refractive Implants Guidance Document.
Ashley A. Boulware, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2053. Draft Guidance for Industry on the Custom Device Casper Uldrik, Office of Compliance, Center for Devices Exemption of the Federal Food, Drug, and Cosmetic and Radiological Health (HFZ-300), Food and Drug Act (Level 1).
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-4692. Draft Guidance for Industry on the Likelihood of Do. Facilities Inspections When Modifying Devices Subject to PMA Approval (Level 1). Draft Guidance for Industry on Quality System
Do. Regulation Information Required for Various Premarket Submissions. (Level 1). Draft Compliance Program Guidance Manual: Inspection Do. of Medical Device Manufacturers (Level 1). Guidance to Industry on the information to be
Do. provided under 21 CFR 1020.30(g). (Level 1) This will be effective immediately based on the public health exemption, per Linda Kahan and Dr. Jacobson. Guidance to Industry on the alternative use of the Do. statement ``Rx only.'' (Level 1). Compliance Guidance: The Mammography Quality
Charles A. Finder, Center for Devices and Radiological Standards Act Final Regulations Document #2 (Final). Health (HFZ-240), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-3332. Compliance Guidance: The Mammography Quality
Do. Standards Act Final Regulations Document #4. Compliance Guidance: The Mammography Quality
Do. Standards Act Final Regulations Document #5. Compliance Guidance: The Mammography Quality
Do. Standards Act Final Regulations Document #6. Compliance Guidance: The Mammography Quality
Do. Standards Act Final Regulations Document #7.
[[Page 61886]]
Mammography Quality Standards Act (MQSA) Inspections Walid G. Mourad, Center for Devices and Radiological of Mobile Facilities Under the Final Regulations. Health (HFZ-240), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-3332. MQSA Inspections of Digital Mammography Systems Under Do. the Final Regulations. Bayesian Statistics.
Laura Alonge, Office of Surveillance and Biometrics, Center for Devices and Radiological Health (HFZ-500), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2812. Discrepant Resolution.
Do. Diagnostic Devices (statistics).
Do. Medical Device Reporting (MDR) Regulations: Reporting Do. Adverse Events Associated with Medical Device Reprocessing or Medical Device Reuse. MDR Guidance for Importers.
Do. Non-diagnostic Devices (statistics) (Revision).
Do. MDR Reporting for Endosseous Implants (Revision). Do. Guidance for Manufacturers for Preparation of
Do. Postmarket Surveillance Plans Required Under Section 522 of the Federal Food, Drug, and Cosmetic Act (Revision).
-
Center for Drugs Evaluation and Research (CDER)
Title/Topic of Document
Contact
Category--Advertising Accelerated Approval Products: Submission of
Nancy E. Derr, Center for Drug Evaluation and Research Promotional Materials.
(HFD-5), Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, 301-594-5400. Advertising and Labeling of Treatment IND Protocols. Do. Anti-Infective Human Drug and Biological Products Do. Advertising and Promotional Labeling. Comparative Claims in Advertising and Labeling.
Do. Continuing Medical Education.
Do. Fair Balance.
Do. Health Related Quality of Life Claims.
Do. Informercials.
Do. Promotion of Investigational Products.
Do. Promotion of Medical Products on the Internet.
Do. Promotion at International Meetings.
Do. Proprietary (Brand) Name & Established (Generic) Name Do. Placement, Size, & Prominence in Advertising and Promotional Labeling. Providing Electronic Submissions to the Division of Do. Drug Marketing, Advertising, and Communications. Category--Biopharmaceutics Food-Effect Bioavailability and Bioequivalence
Do. Studies. Oral Inhalation Drug Products; In Vivo
Do. Bioavailability and Bioequivalence. Pharmacokinetics Metrics for Bioavailability/
Do. Bioequivalence. Category--Chemistry BAC PAC II--Bulk Actives Postapproval Changes (Re: Do. Postapproval Changes from the Final Intermediate to the Drug Substance). Comparability Protocol for Making Changes to
Do. Chemistry, Manufacturing, and Controls for Drug and Biological Products. Drug Master Files; General Content and Format.
Do. Drug Master Files for Bulk Antibiotic Drug
Do. Substances. Formal Meetings Between CDER/CBER and Sponsors on Do. Chemistry, Manufacturing and Controls Information for IND Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products. ISPE for SUPAC TDS.
Do. ISPE for SUPAC SS.
Do. Methods Validation for the Assay of Drugs And/or Do. Metabolites in Human Biological Matrices. Post Approval Changes for Sterile Aqueous Solutions. Do. Proprietary Drug Names.
Do. Provides Recommendation Regarding Submission of
Do. Information for Drug Products Containing Cyclodextrin. Recombinant DNA Growth Hormone Drug Products.
Do.
[[Page 61887]]
Recombinant DNA Human Insulin Drug Products.
Do. Revision to the SUPAC IR Guidance Document That
Do. Published in November 1995. Submission of Documentation for Antibiotics and Other Do. Cellular Metabolites Produced by Microorganisms Modified by the Use of Recombinant DNA Technology. Submission of CMC Information for Synthetic Peptide Do. Substances. Submission of CMC and Biopharm Information for
Do. Liposomal and Lipid-Complexed Drug Products. Submission of Chemistry, Manufacturing, and Controls Do. Documentation for Inhalation Drug Products: MDI's and DPI's. Submission of CMC Information on Chiral Drugs.
Do. Submitting Manufacturing and Quality Control
Do. Information with INDs, NDAs, ANDA's, and AADA's. SUPAC TDS.
Do. Category--Clinical/Antimicrobial Acute Bacterial Arthritis; Developing Antimicrobials Do. for Treatment. Agents to Treat Opportunistic Infections Related to Do. AIDS; Developing Antimicrobials for Treatment. Agents Used in Surgical Prophylaxis, Developing
Do. Antimicrobials for Treatment. Agents to Treat Sepsis/Septic Shock; Developing
Do. Antimicrobials for Treatment. Antifungal Agents; Developing Antimicrobials for Do. Treatment. Antimycobacterial Agents; Developing Antimicrobials Do. for Treatment. Antiparasitic Agents; Developing Antimicrobials for Do. Treatment. Antiviral Agents; Developing Antimicrobials for
Do. Treatment. Catheter-Related Infections.
Do. Complicated Intra-Abdominal Infections; Developing Do. Antimicrobials for Treatment. Clinical Considerations for Accelerated and
Do. Traditional Approval of Antiretroviral Drugs Using Plasma HIV RNA Measurements. Dermatologic Surgical Scrubs, Etc., Developing
Do. Antimicrobials for Treatment. Endocarditis; Developing Antimicrobials for
Do. Treatment. Gynecologic Infections (Except Sexually Transmitted Do. Disease and Pelvic Inflammatory Disease); Developing Antimicrobials for Treatment. Helicobacter Pylori Infections; Developing
Do. Antimicrobials for Treatment. Immunologic/Transplant Agents; Developing
Do. Antimicrobials for Treatment. Nongonoccocal Urethritis/Cervicitis; Developing
Do. Antimicrobials for Treatment. Osteomyelitis (Acute and Chronic); Developing
Do. Antimicrobials for Treatment. Pelvic Inflammatory Disease; Developing
Do. Antimicrobials for Treatment. Uncomplicated Intra-Abdominal Infections; Developing Do. Antimicrobials for Treatment. Category--Clinical/Medical Clinical Development for Drugs to Treat Urinary
Do. Incontinence. Clinical Development Programs for MDI and DPI Drug Do. Products Revised. Clinical Evaluation of Drugs for the Treatment of Do. Acute Coronary Syndrome. Clinical Evaluation of Drugs for the Treatment of Do. Heart Failure. Clinical Development Programs for Drugs, Devices, and Do. Biological Products Intended for the Treatment of Osteoarthritis. Clinical Development of Drugs for the Treatment of Do. Allergic Rhinitis Revised. Clinical Evaluation of Drugs for Ulcerative Colitis. Do. Clinical Evaluation of Weight-Control Drugs Revised. Do. Clinical Development of Products for the Treatment of Do. Chronic Cutaneous Ulcers and Acute Burn Wounds. Clinical Evaluation of Lipid-Altering Agents Revised. Do. Clinical Evaluation of Estrogen--and Estrogen/
Do. Progestin-Containing Drug Products Used for Hormone Replacement Therapy in Postmenopausal Women. Clinical Evaluation of Motility Modifying Drugs. Do. Clinical Evaluation of Drugs for Crohn's Disease. Do.
[[Page 61888]]
Clinical Development of Drugs for the Treatment of Do. Chronic Sinusitis (Other than Antimicrobials). Clinical Evaluation of Potential ECG Effects of New Do. Antihistamines Revised. Content and Format of the Clinical Studies Section of Do. Labeling for Human Drugs and Biologics. Content and Format for Submission of Carcinogenicity Do. Protocols for Evaluation. Content and Format of the Adverse Reactions Section Do. of the Labeling. Data Monitoring and Interim Analysis of Clinical Do. Studies Performed Under an IND. Design and Endpoint Issues Related to Treatment
Do. Trials for Female Sexual Disfunction. Developing Clinical Programs for Developing Drugs, Do. Devices and Biological Products for the Treatment of Systemic Lupus Erythematosus. Evaluation of New Treatments for Diabetes Mellitus. Do. Evaluation of Growth Effects of Orally Inhaled and Do. Intranasal Corticosteroids in Asthma and Allergic Rhinitis. H.Pylori Ulcer.
Do. NSAID Ulcer.
Do. Performance of Clinical Trials for Gastroduodenal Do. Ulcer Disease. Postmarketing Adverse Experience Reporting for Human Do. Drug and Licensed Biological Products. Preclinical and Clinical Evaluation of Agents Used in Do. the Prevention or Treatment of Postmenopausal Osteoporosis Revised. Preclinical Development of Inhalation Drugs for
Do. Indications in Children 2 Years of Age or Less. Psoriasis Therapies.
Do. Safety Review of Clinical Data; Reviewer Guidance. Do. Ulcers Not Due to H.Pylori or NSAID.
Do. Ulcers Without Consideration of Pathogenesis.
Do. Vaginal Contraceptive Drug Development Revised.
Do. Category--Clinical/Pharmacology Clinical Pharmacology and Biopharmaceutic Data for Do. Human Drug Products. Failed Bioequivalence.
Do. Format and Content of the Clinical Pharmacology
Do. Section of Prescription Drug Product Labeling. General Considerations for Pediatric Pharmacokinetic Do. Studies. Immediate Release to Modified Release Dosage Forms. Do. In Vitro Drug Metabolism/Drug Interaction.
Do. Pharmacokinetics in Patients with Impaired Hepatic Do. Function: Study Design, Data Analysis, and Impact on Dosing and Labeling. Pharmacokinetics and Pharmacodynamics.
Do. Special Initiative: Narrow Therapeutic Index (Range). Do. Submission of Expanded Synopses for Clinical
Do. Pharmacology and Biopharmaceutics Studies. Category--Compliance Civil Money Penalty Cases Under PDMA.
Do. Development, Implementation, and Maintenance of a Do. Sample Security and Audit System under the Prescription Drug and Marketing Act of 1987. First Party Audit.
Do. Information Required for Pre-Approval GMP
Do. Inspections. Maintaining Adequate and Accurate Records During Do. Clinical Investigations. National Drug Code Number and Drug Product Labels. Do. Sterile Drug Products Produced by Aseptic Processing Do. Revised. Submission to an IND of Investigator Information for Do. Non-US Studies. Waiver of Informed Consent Requirements for Emergency Do. Care Research. Category--Electronic Submissions Electronic Submission of Adverse Reaction Data via Do. Physical Media. Preparing Data for Electronic Submissions of ANDA's. Do. Standards for Electronic Safety Data Submissions. Do. Category--Generics Botanical Drug Products.
Do. Changes in Labeling of ANDA's Subsequent to Revisions Do. in the RLD Labeling.
[[Page 61889]]
Clindamycin Intravenous Labeling.
Do. OGD's Policy on Inactive Ingredients.
Do. Submitting Documentation to Abbreviated Drug
Do. Applications for Degredation Products in Drug Products. Variation in Drug Product That May Be Included in a Do. Single Application. Category--Labeling Content and Format for ``Geriatric Use'' Supplemental Do. Applications. Labeling Guidance for Combined Oral Contraceptives-- Do. Physician Labeling and Instructions for Use Revised. Topical Corticosteroid Class Labeling.
Do. Category--OTC Eye Allergy Relief/Allergic Conjunctivitis.
Do. Labeling of OTC Human Drug Products.
Do. Labeling Comprehension Studies for OTC Drug Products. Do. Manufacturing Issues/Policy for Ophthalmic Drug
Do. Products. Points to Consider--OTC Actual Use Studies.
Do. Post Cataract Inflammation Studies.
Do. Removal of a Preservative to Create a ``Preservative Do. Free'' Ophthalmic Solution. The Small Entity Compliance Guidance On: Regulations Do. for the Labeling of Over-the-counter Human Drugs. Uveitis Studies.
Do. Category--Pharmacology/Toxicology Evaluation of Preclinical Reproductive Toxicology Do. Data. Immunotoxicology.
Do. Photo Safety Testing.
Do. Statistical Aspects of Design, Analysis, and
Do. Interpretation of Animal Carcinogenicity Studies. Testing for Photocarcinogenesis.
Do. Category--Procedural Available Therapy Guidance (As Defined by CDER and Do. CBER). Appeal of Center Regulatory and Scientific Decisions. Do. Applications Pursuant to 505 (B)(2).
Do. Clarify Requirements for Submission of Supplements. Do. Formal Meetings Between CDER and Sponsors and
Do. Applicants for PDUFA Products. Health Care Economic Information.
Do. Meetings Between CDER and External Constituents on Do. Non-PDUFA Products. New Drug Evaluation: Refusal to File.
Do. Qualifying for Pediatric Exclusivity Revised.
Do. Reports on the Status of Postmarketing Studies-- Do. Implementation of Section 130 of FDAMA. Special Protocols for the Content and Review of
Do. Applications. Submission of Debarment Certification Statements and Do. Other Information under the Generic Drug Enforcement Act of 1992. Submitting Requests for Waiver or Deferral under the Do. Pediatric Study Requirements. Category--User Fees Assessment of Product, Establishment, and Application Do. Fees. User Fee Waivers and Reductions.
Do.
-
Center for Food Safety and Applied Nutrition (CFSAN)
Title/Topic of Document
Contact
Category--Environmental Preparing a Claim of Categorical Exclusion or an Buzz L. Hoffman, Office of Premarket Approval (HFS- Environmental Assessment for Submission to the
246), Food and Drug Administration, 200 C St. SW., Center for Food Safety and Applied Nutrition.
Washington, DC 20204, 202-418-3012. Category--Antimicrobial Food Additives Antimicrobial Food Additives.
Mark A. Hepp, Office of Premarket Approval (HFS-215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3098 Category--Premarket Notification for Food Contact Substances
[[Page 61890]]
Draft Guidance for Preparing a Premarket Notification Mitch A. Cheeseman, Office of Premarket Approval (HFS- for Food Contact Substances.
215), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3083 Category--Dietary Supplements Dietary Supplements: Questions and Answers.
Ellen M. Anderson, Office of Food Labeling (HFS-165), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-5562 Dietary Supplements: Identity Testing Guidelines. Karen F. Strauss, Office of Special Nutritionals (HFS- 456), Food and Drug Administration, 200 C St., SW., Washington, DC 20204, 202-205-4168
-
Center for Veterinary Medicine (CVM)
Title/Topic of Document
Contact
Category--Food Additives Data Requirements for Demonstrating a Food Additive George Graber, Center for Veterinary Medicine (HFV- Can Contro Salmonella in Feed.
220), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6651. Data Requirements for Demonstrating a Food Additive Do. Binds Mycotoxins. Category--Microbial Products in Feeds Compliance Policy Guide about Microbial Products. Do. Category--Human Food Safety Disposition of Animals Used in Research and in the Linda R. Tollefson, Center for Veterinary Medicine (HFV- Manufacture of Biomedical Products.
200), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6644. Threshold Assessment Guidance.
Devaraya R. Jagannath, Center for Veterinary Medicine (HFV-153), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6982. Tolerance Guidance.
Steven Brynes, Center for Veterinary Medicine (HFV- 151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6975. Risk Analysis Guidance.
Kevin J. Greenlees, Center for Veterinary Medicine (HFV- 153), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6977. Animal Drug Availability Act Import Tolerance Policy. Do. Microbiological Testing of Antimicrobial Drug
Do. Residues in Food Guidance. Category--Substantial Evidence One v. Multiple Adequate and Well-controlled Studies/ Claire M. Lathers, Center for Veterinary Medicine (HFV- Field Studies.
100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1620. Use of Published Studies.
Do. Dose or Dose Range Characterization.
Do. Category--Manufacturing Chemistry Stability Guidance.
William G. Marnane, Center for Veterinary Medicine (HFV- 140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6966. Guidance on Chemistry and Manufacturing Changes and Do. Good Manufacturing Practices Requirements for Minor Use/Minor Species Drug Products. Guidance on Chemistry and Manufacturing and Controls Dennis M. Bensley, Center for Veterinary Medicine (HFV- Changes to an Approved NADA or ANADA.
143), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6956. Stability Testing of New Drug Substances and Products William G. Marnane, Center for Veterinary Medicine (HFV- in the Veterinary Field.
140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6966. Stability Testing of New Dosage Forms in the
Do. Veterinary Field. Stability Testing for Medicated Premixes.
Do. Stability Testing: Photostability Testing of New Drug Do. Substances and Products in the Veterinary Field. Guidance for Industry, BACPAC I: Intermediates in David R. Newkirk, Center for Veterinary Medicine (HFV- Drug Substance Synthesis - Bulk Actives Postapproval 140), Food and Drug Administration, 7500 Standish Pl., Changes: Chemistry, Manufacturing and Controls
Rockville, MD 20855, 301-827-6967. Documentation. Category--Target Animal Safety and Effectiveness Studies for Production Drugs
[[Page 61891]]
Anticoccidials in Poultry Guidance.
Jeffrey M. Gilbert, Center for Veterinary Medicine (HFV- 128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0233. Category--Target Animal Safety and Effectiveness Studies for Therapeutic Drug Uses Non-Steroidal Anti-inflammatory Drug Guidance.
Elizabeth Reese, Center for Veterinary Medicine (HFV- 114), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0132. Competitive Exclusion Guidance.
Steven D. Vaughn, Center for Veterinary Medicine (HFV- 130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7580. Minor Species Simulated Pharmacokinetic Submissions. Marilyn Martinez, Center for Veterinary Medicine (HFV- 130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7577. Category--Other Pre-Marketing Bioequivalence of Continual Release Drugs Such as Marilyn Martinez, Center for Veterinary Medicine (HFV- Implant Drugs.
130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7577. Correlation of In-vitro Dissolution and In-vivo
Do. Bioavailability. FOI Summary Guidance.
Steven Vaughn, Center for Veterinary Medicine (HFV- 130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7580. Category--Statistics Add Log C I Guidance to Bioequivalence Guidance. Anna Nevius, Center for Veterinary Medicine (HFV-124), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855,301-827-0218. Principles of Statistical Analysis relevant to
Do. Regulatory Studies. Category--Electronic Submissions Submitting a Notice of Final Animal Disposition of Janis R. Messenheimer, Center for Veterinary Medicine Animals not Intended for Slaughter in Electronic (HFV-135), Food and Drug Administration, 7500 Standish Format to the CVM via E-Mail.
Pl., Rockville, MD 20855, 301-827-7578. Submitting a Notice of Intent to Slaughter for Human Do. Purposes in Electronic Format to the CVM and USDA via E-Mail. Submitting a Request for Meeting or Teleconference in Do. Electronic Format to the CVM via E-Mail. Submitting a Protocol in Electronic Format to the CVM Do. via E-Mail. Category--Analytical Methods Guidance Document on the Validation of Analytical Mary Leadbetter, Center for Veterinary Medicine (HFV- Procedures for Medicated Feeds.
143), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6964. Guidance Document on Analytical Method Documents for Do. Medicated Feeds. Guidance Document on Protocols for Conduct of Method Do. Transfer Trials for Medicated Feed Assays.
-
Office of Regulatory Affairs (ORA)
Title/Topic of Document
Contact
Category--Compliance Policy Guides Compliance Policy Guide, Chapter 5, Sec.540.400, MaryLynn A. Datoc, Division of Compliance Policy (HFC- Shrimp--Fresh or Frozen, Raw, Headless, Peeled or 230), Office of Enforcement, Food and Drug Breaded--Adulteration Involving Decomposition (CPG Administration, 5600 Fishers Lane, Rockville, MD 7108.11).
20857, 301-827-0413. Compliance Policy Guide, Chapter 5, 540.650, Sale-- Do. Cured, Air-Dried, Uneviscerated Fish (e.g.,``Kapchunka'')(CPG 7108.17). Compliance Policy Guide (NEW) Regulation of Somatic JoAnne C. Marrone, Division of Compliance Policy (HFC- Cell and Tissue-Based Products.
230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1242. Category--Compliance Programs: Bioresearch Monitoring Food Laboratory Practice Program (Nonclinical
James F. McCormack, Division of Compliance Policy (HFC- Laboratories) 7348.808A: EPA Data Audit Inspections. 230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0425. Compliance Program7348.809: Bioresearch Monitoring; Do. Institutional Review Board. Exception for Informed Consent Requirements for
Do. Emergency Research. Category--Inspection Guides
[[Page 61892]]
Guide to Inspections of Source Plasma Establishments. Elizabeth A. Waltrip, Division of Emergency and Investigational Operations (HFC-132), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-5662. Guide to Inspections of Aseptic Processing and
Jody Robinson, Division of Emergency and Packaging (Food).
Investigational Operations (HFC-132), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7691. Category--Regulatory Procedures Manual Regulatory Procedures Manual (Revision), Chapter 10, Sharon Sheehan, Division of Compliance Policy (HFC- Subchapter: Application Integrity Policy.
230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0412. Category--Laboratory Procedures Manual Chapter 1, Sample Accountability.
Jim Yager, Division of Field Science (HFC-140), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1025. Chapter 2, Sample Analysis.
Do. Chapter 3, Laboratory Reporting.
Do. Chapter 4, Sample Disposition.
Do. Chapter 21, Guidance on the Review of Analytical Data Leonard Valenti, Division of Field Science (HFC-140), Generated by Private Laboratories.
Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-7103.
Dated: November 4, 1999. Margaret M. Dotzel, Acting Associate Commissioner for Policy.
[FR Doc. 99-29699Filed11-12-99; 8:45 am]
BILLING CODE 4160-01-F
