[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:

 I. 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.

 II. 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.
------------------------------------------------------------------------

III. 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).
----------------------------------------------------------------------------------------------------------------

IV. 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.
----------------------------------------------------------------------------------------------------------------

V. 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
----------------------------------------------------------------------------------------------------------------

VI. 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.
----------------------------------------------------------------------------------------------------------------

VII. 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. 99-29699 Filed 11-12-99; 8:45 am]
BILLING CODE 4160-01-F