[Federal Register Volume 68, Number 65 (Friday, April 4, 2003)]
[Notices]
[Pages 16523-16541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8262]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0094]


Annual Guidance Agenda

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing its 
annual guidance document agenda. FDA committed to publishing, on an 
annual basis, a list of possible topics for future guidance document 
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 September 2000 good 
guidance practices (GGPs) final rule, which sets 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 guidance.

[[Page 16524]]


DATES: Submit written or electronic 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. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: For general information regarding 
FDA's GGPs contact: Diane Sullivan-Ford, Office of Policy (HF-26), Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
827-3480. For information regarding specific topics or guidance, please 
see contact persons listed in the table in the SUPPLEMENTARY 
INFORMATION section.

SUPPLEMENTARY INFORMATION:

Background

    In the Federal Register of September 19, 2000 (65 FR 56468), FDA 
published a final rule announcing its GGPs, which set forth the 
agency's policies and procedures for the development, issuance, and use 
of guidance documents. The agency adopted the GGPs 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 
an annual guidance document agenda of possible guidance topics or 
documents for development or revision during the coming year. The 
agency also committed to soliciting public input regarding these and 
additional ideas for new topics or revisions to existing guidance 
documents (65 FR 56468 at 56477, 21 CFR 10.115(f)(5)).
    The agency is neither bound by this list of possible topics nor 
required to issue every guidance document on this list or precluded 
from issuing guidance documents not on the list set forth in this 
document.
    The following list of guidance topics or documents represents 
possible new topics or revisions to existing guidance documents that 
the agency is considering. The agency solicits comments on the topics 
listed in this document and also seeks additional ideas from the 
public.
    The guidance topic or 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 guidance in the following 
table.

------------------------------------------------------------------------
      Title/Topic of Guidance                      Contact
------------------------------------------------------------------------
         I. CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
------------------------------------------------------------------------
CATEGORY--COMPLIANCE AND INSPECTION
------------------------------------------------------------------------
Guidance for Industry:               Stephen M. Ripley, Center for
 Reprocessing, Reworking and          Biologics Evaluation and Research
 Blending of Biological Drug          (HFM-17), Food and Drug
 Substances and Drug Products         Administration, 1401 Rockville
                                      Pike, Rockville, MD 20852-1448,
                                      301-827-6210
------------------------------------------------------------------------
Guidance for Industry: Process       Same as above (Do)
 Validation Considerations for
 Biological Drug Substances and
 Biological Drug Products
------------------------------------------------------------------------
Guidance for Industry: Sterile Drug  Do
 Products Produced by Aseptic
 Processing
------------------------------------------------------------------------
Guidance for Industry: Design,       Do
 Installation and Operation of
 Heating, Ventilation and Air
 Conditioning (HVAC) Systems Used
 in the Manufacture of Products
 Regulated by the Center for
 Biologics Evaluation and Research
 and the Center for Drug Evaluation
 and Research
------------------------------------------------------------------------
Guidance for Industry: Content and   Do
 Format of the Warnings/Precautions
 Section of Labeling for Drugs and
 Biologics
------------------------------------------------------------------------
Guidance for Industry: Content and   Do
 Format of the Pregnancy and
 Lactation Sections of Labeling for
 Drugs and Biologics
------------------------------------------------------------------------
Guidance for Industry and            Do
 Reviewers: Measuring Patient
 Reported Outcomes to Support
 Medical Product Claims in Labeling
 and Advertising
------------------------------------------------------------------------
Compliance Program 7341.001          Do
 Inspections of Licensed
 Therapeutic Drug Products
------------------------------------------------------------------------
Compliance Program 7341.002--        Do
 Inspection of Tissue
 Establishments
------------------------------------------------------------------------
Compliance Program 7342.001--        Do
 Inspection of Licensed and
 Unlicensed Blood Banks, Brokers,
 Reference Laboratories, and
 Contractors
------------------------------------------------------------------------
Compliance Program 7342.002--        Do
 Inspection of Source Plasma
 Establishments
------------------------------------------------------------------------
Compliance Program 7342.006--        Do
 Inspection of Plasma Derivatives
 of Human Origin
------------------------------------------------------------------------
Compliance Program 7342.008--        Do
 Inspections of Licensed Viral
 Marker Test Kits
------------------------------------------------------------------------

[[Page 16525]]

 
Compliance Program 7345.001--        Do
 Inspection of Licensed Allergenic
 Products
------------------------------------------------------------------------
Compliance Program 7345.002--        Do
 Inspection of Licensed Vaccines
------------------------------------------------------------------------
CATEGORY--THERAPEUTICS               ...................................
------------------------------------------------------------------------
Submission of Information for the    Do
 National Xenotransplantation
 Database (NXD)
------------------------------------------------------------------------
Guidance for Reviewers:              Do
 Instructions and Template for
 Chemistry, Manufacturing, and
 Controls Reviewers of Human Gene
 Therapy Investigational New Drug
 Applications
------------------------------------------------------------------------
Guidance for Reviewers:              Do
 Instructions and Template for
 Chemistry, Manufacturing, and
 Controls Reviewers of Human
 Somatic Cell Therapy
 Investigational New Drug
 Applications
------------------------------------------------------------------------
Potency Assays for Therapeutic       Do
 Vaccines
------------------------------------------------------------------------
Good Review Practices--Track IV      Do
------------------------------------------------------------------------
Submission of Information for        ...................................
 Adverse Event and Annual Reports
 for Gene Therapy Investigational
 New Drug Applications
------------------------------------------------------------------------
Mechanisms of Regulation for         Do
 Products Used in the Manufacture
 of Cellular Products
------------------------------------------------------------------------
Submission of Chemistry,             Do
 Manufacturing, and Controls
 Information for a Therapeutic
 Recombinant DNA-Derived Product or
 a Monoclonal Antibody for In Vivo
 Use
------------------------------------------------------------------------
Submission of Chemistry,             Do
 Manufacturing, and Controls
 Information for Synthetic Peptide
 Substances
------------------------------------------------------------------------
Submission of Chemistry,             Do
 Manufacturing, and Controls
 Information and Establishment
 Description for Autologous Somatic
 Therapy Products
------------------------------------------------------------------------
CATEGORY--BLOOD AND BLOOD            ...................................
 COMPONENTS
------------------------------------------------------------------------
Blood Establishment Software         Do
------------------------------------------------------------------------
Apheresis Guidance                   Do
------------------------------------------------------------------------
Uniform Donor History Questionnaire  Do
------------------------------------------------------------------------
Quality Control of Bacterial         Do
 Contamination
------------------------------------------------------------------------
Content of Premarket Submissions     Do
 (Instruments)
------------------------------------------------------------------------
Medication Deferrals                 Do
------------------------------------------------------------------------
Validation of Computer Crossmatch    Do
------------------------------------------------------------------------
Blood Contact Materials              Do
------------------------------------------------------------------------
Red Blood Cell Repositories          Do
------------------------------------------------------------------------
Rapid Human Immunodeficiency Virus   Do
 Tests
------------------------------------------------------------------------
Submission of Chemistry,             Do
 Manufacturing, and Controls and
 Establishment Description
 Information for Human Plasma-
 Derived Biological Products,
 Animal Plasma or Serum-Derived
 Products
Blood Donor Testing for Syphilis
Format and Content of a Biologics
 License Application for Immune
 Globulin Intravenous
Recommendations for Deferral of
 Donors of Vaccinated With Smallpox
Nucleic Acid Testing for Human
 Immunodeficiency Virus and
 Hepatitis C Virus; Testing,
 Product Disposition, Donor
 Deferral and Reentry
------------------------------------------------------------------------
CATEGORY--VACCINES                   ...................................
------------------------------------------------------------------------
Guidance for Industry:               Do
 Characterization and Qualification
 of Cell Substances and Viral Seeds
 Used to Produce Viral Vaccines
------------------------------------------------------------------------

[[Page 16526]]

 
Guidance for Industry: Preclinical   Do
 Toxicity Studies for Prophylactic
 Vaccines
------------------------------------------------------------------------
Guidance for Industry: Immunization  Do
 Human Plasma Donors to Obtain
 Source Plasma for Preparation of
 Specific Immune Globulins
------------------------------------------------------------------------
Guidance for Industry: Content and   Do
 Format of Chemistry,
 Manufacturing, and Controls
 Information and Establishment
 Description Information for a
 Vaccine or Related Product
------------------------------------------------------------------------
Guidance for Industry on the         Do
 Content and Format of Chemistry,
 Manufacturing, and Controls
 Information and Establishment
 Description Information for an
 Allergenic Extract or Allergen
 Patch Test
------------------------------------------------------------------------
CATEGORY--OTHER                      ...................................
------------------------------------------------------------------------
Providing Regulatory Submission in   Do
 Electronic Format--Stability
------------------------------------------------------------------------
Environmental Assessment/National    Do
 Environmental Policy Act
------------------------------------------------------------------------
Requests for Engagement of           Do
 Independent Consultant
------------------------------------------------------------------------
Eligibility Determination for        Do
 Donors of Human Cells, Tissue and
 Cellular and Tissue-Based Products
 (HCT/Ps)
------------------------------------------------------------------------
Filing and Application When the      Do
 Applicant Protests a Refusal to
 File Action
------------------------------------------------------------------------
Guidance for Industry: Multi-        Do
 Product Manufacturing With Spore-
 Forming Microorganisms
------------------------------------------------------------------------
          II. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
------------------------------------------------------------------------
CATEGORY--PREMARKET REVIEW--
 PROCEDURAL
------------------------------------------------------------------------
Delegation of Investigational        Joanne R. Less, Center for Devices
 Device Exemption (Withdrawal)        and Radiological Health (HFZ-403),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-1190
------------------------------------------------------------------------
Overdue Investigational Device       Do
 Exemption Annual Progress Report
 Procedures (Withdrawal)
------------------------------------------------------------------------
Humanitarian Device Exemptions       Do
 (HDE) Regulation: Questions and
 Answers (Revised)
------------------------------------------------------------------------
Guidance for the Medical Device      Thinh Nguyen, Center for Devices
 Industry on Premarket Approval       and Radiological Health (HFZ-402),
 Application Shell Development and    Food and Drug Administration, 9200
 Modular Review (Revised)             Corporate Blvd., Rockville, MD
                                      20850, 301-594-2186
------------------------------------------------------------------------
Modifications to Devices Subject to  Do
 Premarket Approval Application--
 The Premarket Approval Application
 Supplement Decision Making Process
 (Final)
------------------------------------------------------------------------
Real-Time Review Program for         Do
 Premarket Approval Application
 (PMA) Supplements (Revised)
------------------------------------------------------------------------
Pre-Premarket Approval Application   Do
 Meetings
------------------------------------------------------------------------
A New 510(k) Paradigm--Alternate     Heather Rosecrans, Center for
 Approaches to Demonstrating          Devices and Radiological Health
 Substantial Equivalence in           (HFZ-404), Food and Drug
 Premarket Notifications (Revised)    Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      594-1190
------------------------------------------------------------------------
Frequently Asked Questions on the    Do
 New 510(k) Paradigm (Revised)
------------------------------------------------------------------------
New Section 513(f)(2)--Evaluation    Do
 of Automatic Class III Designation
 (Revised)
------------------------------------------------------------------------
Implementation of Third Party        Ronald Parr, Center for Devices and
 Programs Under the Food and Drug     Radiological Health (HFZ-220),
 Modernization Act of 1997            Food and Drug Administration, 1350
 (Revised)                            Piccard Dr., Rockville, MD 20850,
                                      301-443-6597, ext. 109
------------------------------------------------------------------------
Statistical Guidance on Reporting    Kristen Meier, Center for Devices
 Results From Studies Evaluating      and Radiological Health (HFZ-542),
 Diagnostic Tests: Draft Guidance     Food and Drug Administration, 1350
 for Industry and FDA Reviewers       Piccard Dr., Rockville, MD 20850,
                                      301-827-4369
------------------------------------------------------------------------

[[Page 16527]]

 
CATEGORY--PREMARKET REVIEW           ...................................
 ANESTHESIOLOGY, DENTAL, INFECTION
 CONTROL, AND GENERAL HOSPITAL
 DEVICES
------------------------------------------------------------------------
Biological Indicator (Final)         Chiu S. Lin, Center for Devices and
                                      Radiological Health (HFZ-480),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-443-8913
------------------------------------------------------------------------
Chemical Indicator (Draft)           Do
------------------------------------------------------------------------
Medical Sterilization Packaging      Do
 (Final)
------------------------------------------------------------------------
Antimicrobial Coated Medical         Do
 Devices (Draft)
------------------------------------------------------------------------
Surgical Masks (Final)               Do
------------------------------------------------------------------------
Surgical Drapes and Gowns (Draft)    Do
------------------------------------------------------------------------
Disinfectants to Reprocess           Do
 Hemodialyzer Machine and Water
 Treatment Systems (Draft)
------------------------------------------------------------------------
Medical Glove Expiration Dating      Do
 (Final)
------------------------------------------------------------------------
Chemotherapy Glove (Draft)           Do
------------------------------------------------------------------------
Intraoral Snoring and Sleep Apnea    Kevin Mulry, Center for Devices and
 Devices (Final)                      Radiological Health (HFZ-480),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-827-5283, ext. 185
------------------------------------------------------------------------
Sonography and Jaw Tracking (Final)  Mary S. Runner, Center for Devices
                                      and Radiological Health (HFZ-480),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-827-5283
------------------------------------------------------------------------
Precious Metal Dental Alloys         Mike Adjodha, Center for Devices
                                      and Radiological Health (HFZ-480),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-827-5283
------------------------------------------------------------------------
Base Dental Alloys                   Do
------------------------------------------------------------------------
Dental Curing Light                  Do
------------------------------------------------------------------------
Periodontal Membrane Guidance        Robert Betz, Center for Devices and
                                      Radiological Health (HFZ-480),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-827-5283
------------------------------------------------------------------------
Guidance for Bone Filling and        Pam Scott, Center for Devices and
 Augmentation Devices                 Radiological Health (HFZ-480),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-827-5283
------------------------------------------------------------------------
Cutaneous O2 and CO2 Monitors        Joanna Weitershausen, Center for
 (Final)                              Devices and Radiological Health
                                      (HFZ-480), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      443-8611
------------------------------------------------------------------------
General Anesthesia Guidance          Do
 Document
------------------------------------------------------------------------
Pulse Oximeter Guidance Document     Do
 (Revised)
------------------------------------------------------------------------
Vascular Access Flush Devices        Patricia Cricenti, Center for
                                      Devices and Radiological Health
                                      (HFZ-480), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      594-1287, ext. 169
------------------------------------------------------------------------
Needleless Injection Devices         Von Nakayama, Center for Devices
                                      and Radiological Health (HFZ-480),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-1287
------------------------------------------------------------------------
CATEGORY--PREMARKET REVIEW FOR       ...................................
 CARDIOVASCULAR DEVICES
------------------------------------------------------------------------
Intravascular Stents (Revised)       Ashley Boam, Center for Devices and
                                      Radiological Health (HFZ-450),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-443-8243
------------------------------------------------------------------------
Percutaneous Transluminal Coronary   Do
 Angioplasty Catheters, Class II
 Special Control Guidance
------------------------------------------------------------------------

[[Page 16528]]

 
Cardiovascular Intravascular         Elisa Harvey, Center for Devices
 Filters (Revised)                    and Radiological Health (HFZ-450),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-443-8262
------------------------------------------------------------------------
Arrhythmia Detectors                 Elias Mallis, Center for Devices
                                      and Radiological Health (HFZ-450),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-443-8517
------------------------------------------------------------------------
Medical Device Labeling--Suggested   Robert Gatling, Center for Devices
 Format and Content (Withdrawal)      and Radiological Health (HFZ-402),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-1190, ext. 140
------------------------------------------------------------------------
Class II Special Control Guidance    Dina J. Fleischer, Center for
 Document: Extracorporeal Life        Devices and Radiological Health
 Support Devices (Draft)              (HFZ-450), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      443-8517, ext. 176
------------------------------------------------------------------------
CATEGORY--PREMARKET REVIEW FOR       ...................................
 CLINICAL LABORATORY DEVICES
------------------------------------------------------------------------
Over-the-Counter (OTC) Drugs of      Arleen Pinkos, Center for Devices
 Abuse                                and Radiological Health (HFZ-440),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-1243
------------------------------------------------------------------------
Glucose Test Systems                 Pat Bernhardt, Center for Devices
                                      and Radiological Health (HFZ-440),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-1243
------------------------------------------------------------------------
Automated Coagulation Devices        Valerie Dada, Center for Devices
                                      and Radiological Health (HFZ-440),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-1293
------------------------------------------------------------------------
Analytical and Clinical Validation   Elizabeth Mansfield and Michele
 of Multiplex Tests for Heritable     Schoonmaker, Center for Devices
 DNA Markers and/or Mutations         and Radiological Health (HFZ-440),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-1293
------------------------------------------------------------------------
Class II Special Controls Guidance   Roxanne Shively, Center for Devices
 Document: Specific Bacteriophage,    and Radiological Health (HFZ-440),
 Antibody Conjugates, and Antigens    Food and Drug Administration, 9200
 for Antibody Detection for           Corporate Blvd., Rockville, MD
 Bacillus anthracis and Yersinia      20850, 301-594-2096
 pestis
------------------------------------------------------------------------
Class II Special Controls Guidance   Sally Selepak, Center for Devices
 Document: Antimicrobial              and Radiological Health (HFZ-440),
 Susceptibility Test (AST) Systems    Food and Drug Administration, 9200
 (Final)                              Corporate Blvd., Rockville, MD
                                      20850, 301-594-2096
------------------------------------------------------------------------
Draft Guidance on In Vitro           Jean Toth-Allen, Center for Devices
 Diagnostic (IVD) Device Studies      and Radiological Health (HFZ-312),
                                      Food and Drug Administration, 2904
                                      Gaither Rd., Rockville, MD 20850,
                                      301-594-4723, ext. 141
------------------------------------------------------------------------
CATEGORY--PREMARKET REVIEW FOR       ...................................
 GENERAL, RESTORATIVE AND
 NEUROLOGICAL DEVICES
------------------------------------------------------------------------
Guidance for Thermal Ablation        Binita Ashar, Center for Devices
 Device 510(k)s; Draft Guidance for   and Radiological Health (HFZ-410),
 Industry and FDA                     Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-1307
------------------------------------------------------------------------
Class II Exempt Special Controls     Hollace Rhodes, Center for Devices
 Guidance for Various Orthopedic      and Radiological Health (HFZ-410),
 Fixation Devices; Final Guidance     Food and Drug Administration, 9200
 for Industry                         Corporate Blvd., Rockville, MD
                                      20850, 301-594-2036
------------------------------------------------------------------------
Class II Special Controls Guidance   Peter Allen, Center for Devices and
 Document: Knee Joint                 Radiological Health (HFZ-410),
 Patellofemorotibial and              Food and Drug Administration, 9200
 Femorotibial Metal/Polymer Porous-   Corporate Blvd., Rockville, MD
 Coated Uncemented Prostheses         20850, 301-594-2036
------------------------------------------------------------------------
Class II Special Controls Guidance   Anthony Watson, Center for Devices
 Document: Surgical Suture            and Radiological Health (HFZ-450),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-3090
------------------------------------------------------------------------
Class II Special Controls Guidance   Charles Durfor, Center for Devices
 Document: Processed Human Dura       and Radiological Health (HFZ-410),
 Mater (Draft)                        Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-3090
------------------------------------------------------------------------
Class II Special Controls Guidance   Stephen Rhodes, Center for Devices
 Document: Vascular and               and Radiological Health (HFZ-410),
 Neurological Embolization Devices    Food and Drug Administration, 9200
 (Draft)                              Corporate Blvd., Rockville, MD
                                      20850, 301-594-3090
------------------------------------------------------------------------

[[Page 16529]]

 
Guidance for Saline, Silicone Gel,   Samie Allen, Center for Devices and
 and Alternative Breast Implants      Radiological Health (HFZ-410),
 (Revised)                            Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-3090
------------------------------------------------------------------------
Class II Special Controls Guidance   Nadine Sloan, Center for Devices
 Document: Resorbable Calcium Salt    and Radiological Health (HFZ-410),
 Bone Void Filler Device (Final)      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-1296
------------------------------------------------------------------------
Class II Special Controls Guidance   Robert DeLuca, Center for Devices
 Document: Transcutaneous             and Radiological Health (HFZ-450),
 Electrical Stimulator for Cosmetic   Food and Drug Administration, 9200
 Use (Draft)                          Corporate Blvd., Rockville, MD
                                      20850, 301-594-1296
------------------------------------------------------------------------
Class II Special Controls Guidance   Do
 Document: Cutaneous Electrode
 (Draft)
------------------------------------------------------------------------
Class II Special Controls Guidance   Do
 Document: Electroconductive Media
 (Draft)
------------------------------------------------------------------------
Class II Special Controls Guidance   Do
 Document: Powered Muscle
 Stimulator for Muscle Conditioning
 (Draft)
------------------------------------------------------------------------
Class II Special Controls Guidance   Do
 Document: Powered Muscle
 Stimulator for Rehabilitation
 (Draft)
------------------------------------------------------------------------
Class II Special Controls Guidance   Do
 Document: Transcutaneous
 Electrical Nerve Stimulator for
 Pain Relief (Draft)
------------------------------------------------------------------------
Special Control Guidance for         Kristen Bowsher, Center for Devices
 Premarket Notifications for          and Radiological Health (HFZ-450),
 Totally Implanted Spinal Cord        Food and Drug Administration, 9200
 Stimulators for Pain Relief          Corporate Blvd., Rockville, MD
 (Withdrawal)                         20850, 301-594-1296
------------------------------------------------------------------------
Guidance for Technical Reporting in  Do
 the Submission of Research and
 Marketing Applications for Totally
 Implanted Spinal Cord Stimulators
 (Draft)
------------------------------------------------------------------------
CATEGORY--PREMARKET REVIEW FOR       ...................................
 OPHTHALMIC AND ENT DEVICES
------------------------------------------------------------------------
Class II Special Controls Guidance   James F. Saviola, Center for
 Document: Rigid Gas Permeable        Devices and Radiological Health
 (RGP) by Contact Lens Finishing      (HFZ-460), Food and Drug
 Laboratories                         Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      594-1744
------------------------------------------------------------------------
Premarket Notification (510(k))      Do
 Guidance Document for Class II
 Daily Wear Contact Lenses
 (Revised)
------------------------------------------------------------------------
Class II Special Controls Guidance   Do
 Document: Artificial Eye Care
 Products
------------------------------------------------------------------------
Class II Special Controls Guidance   Do
 Document: Intraocular Gases for
 Retina Tamponade
------------------------------------------------------------------------
Retinal Implants: Guidance for       Do
 Investigational Device Exemptions
 (IDE) and Premarket Approval (PMA)
 Applications (Draft)
------------------------------------------------------------------------
Guidance for Premarket Approval      Do
 Applications of Class III Extended
 Wear Contact Lenses
------------------------------------------------------------------------
Guidance for Post Approval Studies   Do
 of Class III Extended Wear Contact
 Lenses Worn Beyond Seven
 Continuous Nights
------------------------------------------------------------------------
Labeling Guidance for Ultraviolet    Do
 Absorbing Contact Lenses
------------------------------------------------------------------------
Intraocular Lens Guidance Document   Donna R. Lochner, Center for
                                      Devices and Radiological Health
                                      (HFZ-460), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      594-2053
------------------------------------------------------------------------
Refractive Implants Guidance         Do
 Document
------------------------------------------------------------------------
Guidance Document for Keratomes and  Everette T. Beers, Chief, Center
 Keratome Blades                      for Devices and Radiological
                                      Health (HFZ-460), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      594-2018
------------------------------------------------------------------------

[[Page 16530]]

 
Implantable Middle Ear Hearing       Eric C. Mann, Center for Devices
 Device (Final)                       and Radiological Health (HFZ-460),
                                      Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-2018
------------------------------------------------------------------------
Tinnitis Masking Devices             Do
------------------------------------------------------------------------
Laryngoplastic Phonosurgery Devices  Do
------------------------------------------------------------------------
Ear Plug Devices                     Do
------------------------------------------------------------------------
CATEGORY--PREMARKET REVIEW FOR       ...................................
 REPRODUCTIVE, ABDOMINAL AND
 RADIOLOGICAL DEVICES
------------------------------------------------------------------------
Devices for Assisted Reproduction    Colin M. Pollard, Center for
 Technologies (ART)                   Devices and Radiological Health
                                      (HFZ-470), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      594-1180, ext. 115
------------------------------------------------------------------------
Embolization Agents for Uterine      Do
 Fibroid Embolization
------------------------------------------------------------------------
Condoms                              Do
------------------------------------------------------------------------
Menstrual Tampons                    Do
------------------------------------------------------------------------
Devices for Vacuum Assisted          Do
 Delivery
------------------------------------------------------------------------
Device Systems for Endometrial       Do
 Ablation
------------------------------------------------------------------------
Class II Special Controls Guidance   Janine Morris, Center for Devices
 Document: External Penile Rigidity   and Radiological Health (HFZ-470),
 Devices                              Food and Drug Administration, 9200
                                      Corporate Blvd., Rockville, MD
                                      20850, 301-594-2194, ext. 117
------------------------------------------------------------------------
Guidance for the Treatment of        Do
 Prostate Cancer
------------------------------------------------------------------------
Guidance for Urethral Stents         Do
------------------------------------------------------------------------
Class II Special Controls Guidance   Do
 for Home Uterine Activity Monitors
 (Revised)
------------------------------------------------------------------------
Ultrasound Coupling Gel              Robert A. Phillips, Center for
                                      Devices and Radiological Health
                                      (HFZ-470), Food and Drug
                                      Administration, 9200 Corporate
                                      Blvd., Rockville, MD 20850, 301-
                                      594-1212, ext. 130
------------------------------------------------------------------------
Diagnostic Ultrasound                Do
------------------------------------------------------------------------
Cleaning and Disinfection of         Do
 Radiological Devices
------------------------------------------------------------------------
Sheaths and Covers for Ultrasound    Do
 Transducers
------------------------------------------------------------------------
Bone Sonometers (Revised)            Do
------------------------------------------------------------------------
Class II Special Controls Guidance   Carolyn Neuland, Center for Devices
 Document: Sorbent Hemoperfusion      and Radiological Health (HFZ-470),
 Systems (Draft) Bone Sonometers      Food and Drug Administration, 9200
 (Revised)                            Corporate Blvd., Rockville, MD
                                      20850, 301-594-1220, ext. 131
------------------------------------------------------------------------
Content of Premarket Notification    Do
 Submissions for Conventional and
 High Permeability Hemodialyzers,
 Hemoconcentrators, Hemofilters and
 Hemodiafilters (Revised)
------------------------------------------------------------------------
Guidance for the Content of          Do
 Premarket Notifications for
 Hemodialysis Delivery Systems
------------------------------------------------------------------------
Automated Blood Cell Separators for  Do
 Therapeutic Purposes (Draft)
------------------------------------------------------------------------
Blood Access Devices for             Do
 Hemodialysis (Draft)
------------------------------------------------------------------------
CATEGORY--COMPLIANCE AND             ...................................
 INSPECTIONS
------------------------------------------------------------------------
Impact Resistance Lenses: Questions  Walter Snesko, Center for Devices
 and Answers                          and Radiological Health (HFZ-220),
                                      Food and Drug Administration, 1350
                                      Piccard Dr., Rockville, MD 20850,
                                      301-443-6597, ext. 120
------------------------------------------------------------------------
Medical Device Quality Systems       Joseph Puleo, Center for Devices
 Manual for Small Entities (Update)   and Radiological Health (HFZ-220),
                                      Food and Drug Administration, 1350
                                      Piccard Dr., Rockville, MD 20850,
                                      301-443-6597, ext. 116
------------------------------------------------------------------------

[[Page 16531]]

 
Medical Glove Guidance Manual        Arthur Yellin, Center for Devices
 (Update)                             and Radiological Health (HFZ-220),
                                      Food and Drug Administration, 1350
                                      Piccard Dr., Rockville, MD 20850,
                                      301-443-6597, ext. 146
------------------------------------------------------------------------
Draft Guidance on Cabinet X-ray      Daniel Kassidy, Center for Devices
 Systems Performance Specifications   and Radiological Health (HFZ-342),
                                      Food and Drug Administration, 2904
                                      Gaither Rd., Rockville, MD 20850,
                                      301-594-4654, ext. 141
------------------------------------------------------------------------
Final Guidance on Civil Money        Casper Uldriks, Center for Devices
 Penalties                            and Radiological Health (HFZ-300),
                                      Food and Drug Administration, 2904
                                      Gaither Rd., Rockville, MD 20850,
                                      301-594-4692
------------------------------------------------------------------------
Draft Guidance on the Reports of     Do
 Corrections and Removals
 Regulation
------------------------------------------------------------------------
Draft Guidance for Field Clinical    Marian Surge, Center for Devices
 Engineers                            and Radiological Health (HFZ-300),
                                      Food and Drug Administration, 2904
                                      Gaither Rd., Rockville, MD 20850,
                                      301-594-4720, ext. 139
------------------------------------------------------------------------
Draft Guidance on Good Laboratory    Rodney Allnutt, Center for Devices
 Practice (GLP) for Nonclinical       and Radiological Health (HFZ-300),
 Laboratory Studies                   Food and Drug Administration, 2904
                                      Gaither Rd., Rockville, MD 20850,
                                      301-594-4723, ext. 140
------------------------------------------------------------------------
Draft Guidance on the Submission of  Tom Jakub, Center for Devices and
 Abbreviated Reports on Bone          Radiological Health (HFZ-333),
 Densitometer Devices Utilizing       Food and Drug Administration, 2904
 Electronic Product Radiation         Gaither Rd., Rockville, MD 20850,
                                      301-594-4591, ext. 151
------------------------------------------------------------------------
Implementation of the Third Party    Ronald Parr, Center for Devices and
 Domestic Quality System Program      Radiological Health (HFZ-220),
                                      Food and Drug Administration, 1350
                                      Piccard Dr., Rockville, MD 20850,
                                      301-443-6597, ext. 109
------------------------------------------------------------------------
CATEGORY: CONSUMER INFORMATION
------------------------------------------------------------------------
Breast Implants: An Information      Nancy Leonard, Center for Devices
 Update                               and Radiological Health (HFZ-220),
                                      Food and Drug Administration, 1350
                                      Piccard Dr., Rockville, MD 20850,
                                      301-443-6597, ext. 141
------------------------------------------------------------------------
Modifications and Additions to the   Charles A. Finder, Center for
 Policy Guidance Help System 6                                  (HFZ-240), Food and Drug
                                      Administration, 1350 Piccard Dr.,
                                      Rockville, MD 20850, 301-827-0009
------------------------------------------------------------------------
Modifications and Additions to the   Do
 Policy Guidance Help System 7
------------------------------------------------------------------------
Modifications and Additions to the   Do
 Policy Guidance Help System 8
------------------------------------------------------------------------
Modifications and Additions to the   Do
 Policy Guidance Help System 9
------------------------------------------------------------------------
Modifications and Additions to the   Do
 Policy Guidance Help System 10
------------------------------------------------------------------------
CATEGORY--MEDICAL DEVICE REPORTING   ...................................
------------------------------------------------------------------------
Needlesticks; Medical Device         Sharon Kapsch, Center for Devices
 Reporting Guidance for User          and Radiological Health (HFZ-533),
 Facilities, Manufacturers, and       Food and Drug Administration, 1350
 Importers                            Piccard Dr., Rockville, MD 20850,
                                      301-827-2982
------------------------------------------------------------------------
CATEGORY--POSTMARKET SURVEILLANCE    ...................................
------------------------------------------------------------------------
Preparing a Postmarket Surveillance  Laura Alonge, Center for Devices
 Plan: Guidance for Manufacturers     and Radiological Health (HFZ-510),
                                      Food and Drug Administration, 1350
                                      Piccard Dr., Rockville, MD 20850,
                                      301-594-3060
------------------------------------------------------------------------
CATEGORY--OTHER                      ...................................
------------------------------------------------------------------------
Hospital Bed System Dimensional and  Jay A. Rachlin, Center for Devices
 Assessment Guidance to Reduce        and Radiological Health (HFZ-230),
 Entrapment: For Industry and         Food and Drug Administration, 1350
 Health Care Facilities               Piccard Dr., Rockville, MD 20850,
                                      301-594-3174
------------------------------------------------------------------------
           III. CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
------------------------------------------------------------------------
CATEGORY--ADVERTISING
------------------------------------------------------------------------
Advertising and Labeling of          Nancy E. Derr, Center for Drug
 Treatment Investigational New Drug   Evaluation and Research (HFD-5),
 Application Protocols                Food and Drug Administration, 1451
                                      Rockville Pike, Rockville, MD
                                      20852, 301-594-5400
------------------------------------------------------------------------

[[Page 16532]]

 
Patient Reported Outcomes            Do
------------------------------------------------------------------------
Promotion of Combination Oral        Do
 Contraceptive Products
------------------------------------------------------------------------
CATEGORY--BIOPHARMACEUTICS           ...................................
------------------------------------------------------------------------
Clozapine Tablets--In Vivo           Do
 Bioequivalence and In Vitro
 Dissolution Testing
------------------------------------------------------------------------
CATEGORY--CHEMISTRY                  ...................................
------------------------------------------------------------------------
Documentation for Antibiotics and    Do
 Other Cellular Metabolites
 Produced by Microorganisms
 Modified Using Recombinant DNA
 Technology
------------------------------------------------------------------------
Drug Products: Chemistry,            Do
 Manufacturing, and Control
 Documentation
------------------------------------------------------------------------
Drug Substance: Chemistry,           Do
 Manufacturing, and Control
 Documentation
------------------------------------------------------------------------
CATEGORY--CLINICAL/MEDICAL           ...................................
------------------------------------------------------------------------
Acne Vulgaris                        Do
------------------------------------------------------------------------
Analgesics                           Do
------------------------------------------------------------------------
Clinical Development Programs for    Do
 Metered Dose Inhaler and Dry
 Powder Inhalers Products--Revised
------------------------------------------------------------------------
Clinical Evaluation of Drugs for     Do
 the Treatment of Acute Coronary
 Syndrome
------------------------------------------------------------------------
Clinical Evaluation of Combination   Do
 Estrogen/Progestin-Containing Drug
 Products Used for Hormone
 Replacement Therapy in
 Postmenopausal Women--Revised
------------------------------------------------------------------------
Clinical Evaluation of Drugs for     Do
 Neuropathic Pain
------------------------------------------------------------------------
Clinical Evaluation of Drugs for     Do
 the Treatment of Heart Failure
------------------------------------------------------------------------
Collection and Use of Race and       Do
 Ethnicity Data in Clinical Trials
 for FDA Regulated Products
------------------------------------------------------------------------
Development of New Opiate            Do
 Formulations
------------------------------------------------------------------------
Developing Antiviral Drug for the    Do
 Mitigation of Complication
 Associated Vaccine Immunization
------------------------------------------------------------------------
Developing Antiviral Drugs for the   Do
 Treatment of Smallpox
------------------------------------------------------------------------
Drug-Coated Cardiovascular Stents    Do
------------------------------------------------------------------------
Evaluation of New Treatments for     Do
 Diabetes Mellitus
------------------------------------------------------------------------
Gingivitis                           Do
------------------------------------------------------------------------
Safety Review of Clinical Data       Do
------------------------------------------------------------------------
CATEGORY--CLINICAL/PHARMACOLOGY      Do
------------------------------------------------------------------------
Content and Format of the Clinical   Do
 Pharmacology Section
------------------------------------------------------------------------
Content and Format of the Warnings   Do
 and Precautions, Contradictions
 and Boxed Warning Sections of
 Prescription Drugs
------------------------------------------------------------------------
Immediate Release to Modified        Do
 Release Dosage Forms
------------------------------------------------------------------------
In Vitro Drug Metabolism/Drug        Do
 Interaction--Guidance for
 Reviewers
------------------------------------------------------------------------
CATEGORY--COMPLIANCE                 ...................................
------------------------------------------------------------------------
Current Good Manufacturing           Do
 Practices for Compressed Medical
 Gases--Revised
------------------------------------------------------------------------
Maintaining Adequate and Accurate    Do
 Records During Clinical
 Investigations
------------------------------------------------------------------------

[[Page 16533]]

 
National Drug Code Number and Drug   Do
 Product Labels
------------------------------------------------------------------------
Describing How Positron Emission     Do
 Tomography Drug Products May
 Comply With New Current Good
 Manufacturing Process
 Requirements--Revised
------------------------------------------------------------------------
Sterile Drug Products Produced by    Do
 Aseptic Processing
------------------------------------------------------------------------
CATEGORY--ELECTRONIC SUBMISSIONS     ...................................
------------------------------------------------------------------------
Providing Electronic Submissions to  Do
 the Division of Drug Marketing,
 Advertising, and Communications
------------------------------------------------------------------------
Providing Electronic Submissions in  ...................................
 Electronic Format: Marketing
 Applications and Related
 Submissions
------------------------------------------------------------------------
Providing Regulatory Submissions in  Do
 Electronic Format--Annual Reports
 for Approved New Drug Applications
------------------------------------------------------------------------
Providing Regulatory Submissions in  Do
 Electronic Format--General
 Considerations
------------------------------------------------------------------------
Providing Regulatory Submissions in  Do
 Electronic Format: Postmarketing
 Periodic Adverse Drug Experience
 Report
------------------------------------------------------------------------
Scope and Implementation of 21 CFR   Do
 Part 11: Archiving
------------------------------------------------------------------------
Scope and Implementation of 21 CFR   Do
 Part 11: Audit Trails
------------------------------------------------------------------------
Standards for Clinical Data          Do
 Submissions
------------------------------------------------------------------------
CATEGORY--GENERICS                   ...................................
------------------------------------------------------------------------
Bioequivalence Studies With          Do
 Clinical Endpoints for Vaginal
 Antifungal Drug Products
------------------------------------------------------------------------
Chemistry, Manufacturing, and        Do
 Controls Documentation Unique to
 Radiopharmaceuticals Submitted in
 Abbreviated New Drug Applications
------------------------------------------------------------------------
Generic Drug Labeling When           Do
 Pediatric Labeling Information Has
 Been Added to the Innovator
 Labeling
------------------------------------------------------------------------
CATEGORY--GOOD REVIEW PRACTICES      ...................................
------------------------------------------------------------------------
General Clinical Review Template     Do
------------------------------------------------------------------------
CATEGORY--INVESTIGATIONAL NEW DRUG   ...................................
 APPLICATIONS
------------------------------------------------------------------------
Consumer Product Safety Commission-- Do
 Tamper Resistant Packaging for
 Investigational New Drug
 Applications
------------------------------------------------------------------------
Pediatric Safety and Efficacy Data   Do
 in Investigational New Drug
 Applications
------------------------------------------------------------------------
CATEGORY--LABELING                   ...................................
------------------------------------------------------------------------
Drug Names and Dosage Forms          Do
------------------------------------------------------------------------
Pregnancy Labeling Revisions         Do
------------------------------------------------------------------------
Submitting Proprietary Names for     Do
 Evaluation
------------------------------------------------------------------------
CATEGORY-OVER-THE-COUNTER            ...................................
------------------------------------------------------------------------
Actual Use Trials                    Do
------------------------------------------------------------------------
Labeling Comprehension Studies for   Do
 Over-the-Counter Drug Products
------------------------------------------------------------------------
Labeling for Over-the-Counter Human  Do
 Drug Products
------------------------------------------------------------------------
Labeling Over-the-Counter Human      Do
 Drug Products; Questions and
 Answers
------------------------------------------------------------------------
Time and Extent Applications         Do
------------------------------------------------------------------------

[[Page 16534]]

 
CATEGORY--PRESCRIPTION DRUG USER     ...................................
 FEE AMENDMENTS OF 2002
------------------------------------------------------------------------
Continuous Marketing Application:    Do
 Pilot 1--Reviewable Units for Fast
 Track Products Under the
 Prescription Drug User Fee
 Amendments of 2002
------------------------------------------------------------------------
Continuous Marketing Application:    Do
 Pilot 2--Scientific Feedback and
 Interactions During Drug
 Development of Fast Track Products
 Under the Prescription Drug User
 Fee Amendments of 2002
------------------------------------------------------------------------
First Cycle Review Performance:      Do
 Good Review Management Principles
------------------------------------------------------------------------
CATEGORY--PHARMACOLOGY/TOXICOLOGY    ...................................
------------------------------------------------------------------------
Drug-Induced Vasculitis in           Do
 Nonclinical Studies
------------------------------------------------------------------------
Estimating the Safe Starting Dose    Do
 for Clinical Trials of
 Therapeutics in Adult Healthy
 Volunteers
------------------------------------------------------------------------
Immunotoxicology Evaluation of       Do
 Investigational New Drug
 Applications
------------------------------------------------------------------------
Nonclinical Safety Evaluation of     Do
 Pediatric Drug Products
------------------------------------------------------------------------
CATEGORY--PROCEDURAL                 ...................................
------------------------------------------------------------------------
Assessment of Abuse Potential of     Do
 Drugs
------------------------------------------------------------------------
Dispute Resolution Involving         Do
 Pediatric Labeling
------------------------------------------------------------------------
Exocrine Pancreatic Insufficiency    Do
 Drug Products--New Drug
 Application Requirements
------------------------------------------------------------------------
Process for Contracts and Written    Do
 Requests Under the Best
 Pharmaceuticals for Children Act
------------------------------------------------------------------------
Qualifying for Pediatric             Do
 Exclusivity Under Section 505a of
 the Federal Food, Drug, and
 Cosmetic Act
------------------------------------------------------------------------
Reports on the Status of             Do
 Postmarketing Studies--
 Implementation of Section 130 of
 the Food and Drug Administration
 Modernization Act of 1997
------------------------------------------------------------------------
          IV. CENTER FOOD SAFETY AND APPLIED NUTRITION (CFSAN)
------------------------------------------------------------------------
CATEGORY: OFFICE OF PLANTS, DAIRY
 FOODS, AND BEVERAGES
------------------------------------------------------------------------
Final Guidance on Juice Transport    Amy Green, Center for Food Safety
                                      and Applied Nutrition (HFS-306),
                                      Food and Drug Administration, 5100
                                      Paint Branch Pkwy., College Park,
                                      MD 20740, 301-436-2025
------------------------------------------------------------------------
Draft Guidance on Use of Food        Jennifer Burnham, Center for Food
 Allergen Test Kits                   Safety and Applied Nutrition (HFS-
                                      306), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-2030
------------------------------------------------------------------------
Draft Guidance to Harmonize U.S.     Lauren Posnick, Center for Food
 Aflatoxin Levels in Peanuts With     Safety and Applied Nutrition (HFS-
 Codex Levels                         306), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-1639
------------------------------------------------------------------------
Compliance Policy Guide for Lead     Do
 Levels in Food Based on Levels
 Adopted by Codex
------------------------------------------------------------------------
Additional Questions and Answers on  Samir Assar, Center for Food Safety
 Juice Hazard Analysis and Critical   and Applied Nutrition (HFS-235),
 Control Point                        Food and Drug Administration, 5100
                                      Paint Branch Pkwy., College Park,
                                      MD 20740, 301-436-1636
------------------------------------------------------------------------
Update the Pesticide Compliance      Mike Kashtock, Center for Food
 Policy Guide to Bring It in Line     Safety and Applied Nutrition (HFS-
 With the Food Quality Protection     305), Food and Drug
 Act of 1996 and Changes in           Administration, 5100 Paint Branch
 Pesticide Programs and Policy Over   Pkwy., College Park, MD 20740, 301-
 the Past Few Years                   436-2022
------------------------------------------------------------------------
Guidance for Industry: Standardized  Do
 Training Curriculum for
 Application of Hazard Analysis and
 Critical Control Point Principles
 to Juice Processing
------------------------------------------------------------------------

[[Page 16535]]

 
Listeria monocytogenes Draft         Andreas Keller, Center for Food
 Guidance                             Safety and Applied Nutrition (HFS-
                                      306), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-2029
------------------------------------------------------------------------
Fresh-Cut Produce Draft Guidance     Julie Schrimpf, Center for Food
                                      Safety and Applied Nutrition (HFS-
                                      306), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740. 301-
                                      436-2031
------------------------------------------------------------------------
Small Entities Guide for the Juice   Amy Green, Center for Food Safety
 Hazard Analysis and Critical         and Applied Nutrition (HFS-306),
 Control Point Regulations            Food and Drug Administration, 5100
                                      Paint Branch Pkwy., College Park,
                                      MD 20740, 301-436-2025
------------------------------------------------------------------------
Juice Hazard Analysis and Critical   Dale Wohlers, Center for Food
 Control Point Compliance Program     Safety and Applied Nutrition (HFS-
                                      306), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-2029
------------------------------------------------------------------------
Final Compliance Policy Guide        Douglas Park, Center for Food
 555.600 Filth From Insects,          Safety and Applied Nutrition (HFS-
 Rodents, and Other Pests in Food     345), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-2401
------------------------------------------------------------------------
Draft Compliance Policy Guide        Do
 555.525--Fly Infestations
------------------------------------------------------------------------
Draft Compliance Policy Guide        Do
 555.500--Classification of
 Establishment Inspection Report
------------------------------------------------------------------------
Draft Compliance Policy Guide        Do
 580.100--Pest Infestations
------------------------------------------------------------------------
Rescind Compliance Policy Guide      Esther Lazar, Center for Food
 527.600 Use of Dichlorvos Strips     Safety and Applied Nutrition (HFS-
 in Milk Houses and Milk Rooms        306), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-1485
------------------------------------------------------------------------
Rescind Compliance Policy Guide      Do
 527.450 Milk and Milk Products
 Containing Penicillin
------------------------------------------------------------------------
Update Compliance Policy Guide       Do
 527.400 Whole Milk, Low Fat Milk,
 Skim Milk--Aflatoxin M1
------------------------------------------------------------------------
Update Compliance Policy Guide       Do
 527.300 Pathogens in Dairy
 Products
------------------------------------------------------------------------
Update Compliance Policy Guide       Do
 527.200 Cheese and Cheese
 Products--Adulteration With Filth
------------------------------------------------------------------------
New Compliance Policy Guide on       Monica Metz, Center for Food Safety
 Vitamins A and D in Milk Products    and Applied Nutrition (HFS-306),
                                      Food and Drug Administration, 5100
                                      Paint Branch Pkwy., College Park,
                                      MD 20740, 301-436-2041
------------------------------------------------------------------------
New Compliance Policy Guide on Vat   Do
 Pasteurization
------------------------------------------------------------------------
New Compliance Policy Guide on High  Do
 Temperature/Short Time
 Pasteurization
------------------------------------------------------------------------
New Compliance Policy Guide on Soft  Do
 Cheeses
------------------------------------------------------------------------
 
------------------------------------------------------------------------
We may either update or rescind the  Do
 following:
------------------------------------------------------------------------
Compliance Policy Guide 527.250      To be determined (TBD)
 Cheese Misbranding Due to Moisture
 and Fat
------------------------------------------------------------------------
Compliance Policy Guide 527.500      TBD
 Malted Milk
------------------------------------------------------------------------
Compliance Policy Guide 527.100      TBD
 Butter--Adulteration Involving
 Insufficient Fat Content
------------------------------------------------------------------------
Compliance Policy Guide 527.250      TBD
 Cheese and Cheese Products:
 Misbranding Involving Net Weights
------------------------------------------------------------------------
CATEGORY: OFFICE OF FIELD PROGRAMS   ...................................
------------------------------------------------------------------------
Allergen Questions and Answers       Donald Kautter, Center for Food
                                      Safety and Applied Nutrition (HFS-
                                      615), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-1629
------------------------------------------------------------------------

[[Page 16536]]

 
Allergen Recall Classification       Do
 Guidance
------------------------------------------------------------------------
Juice Hazard Analysis and Critical   Do
 Control Point Regulator Guide and
 Training
------------------------------------------------------------------------
Spice Reconditioning Inspection      Do
 Guidance
------------------------------------------------------------------------
Spice Reconditioning Industry        Do
 Guidance
------------------------------------------------------------------------
Interstate Travel Handbooks on       Do (pending Office of Field
 Sanitation of:                       Programs reorganization)
[sbull] Railroad Servicing Areas
[sbull] Vessels in Operation
[sbull] Vessel Construction
[sbull] Vessel Watering Points
[sbull] Buses
[sbull] Airlines
Railroad Passenger Cars
------------------------------------------------------------------------
International Travel Program--Guide  Do
 to Inspections of Interstate
 Carriers and Support Facilities
------------------------------------------------------------------------
Compliance Programs for Milk,        Faye Feldstein, Center for Food
 Retail Food, and Molluscan           Safety and Applied Nutrition (HFS-
 Shellfish                            615), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-1564
------------------------------------------------------------------------
Electronic Inspection System With    Do
 Model Code Database, Model
 Inspection Form, Users' Manual
------------------------------------------------------------------------
Food Recovery Guidelines             Do
------------------------------------------------------------------------
Permanent Outdoor Cooking            Do
 Guidelines
------------------------------------------------------------------------
Temporary Food Establishments        Do
 Guidance
------------------------------------------------------------------------
Voluntary National Retail            Do
 Regulatory Program Standards and
 Annexes
------------------------------------------------------------------------
Program Standards Clearinghouse      Do
 Questions and Answers
------------------------------------------------------------------------
Conference Position Papers           Do
 (Shellfish and Milk for 2003)
------------------------------------------------------------------------
Food Code Supplements                Do
------------------------------------------------------------------------
Center for Food Safety and Applied   Do
 Nutrition Response to Conference
 for Food Protection
 Recommendations
------------------------------------------------------------------------
Food Code Interpretations;           Do
 Questions and Answers
------------------------------------------------------------------------
Opinion Letters in Response to       Do
 Correspondence
------------------------------------------------------------------------
Backgrounders                        Do
------------------------------------------------------------------------
Program Information Manual           Do
 Additions and Revised
------------------------------------------------------------------------
Letters to Industry Alerting Them    Do
 to a Commodity Problem, Emerging
 Situations, and How to Respond
------------------------------------------------------------------------
Managing Food Safety: A Regulator's  Do
 Guide for Applying Hazard Analysis
 and Critical Control Point
 Principles to Risk-Based Retail
 and Food Service Inspections
------------------------------------------------------------------------
Managing Food Safety: A Guide for    Do
 the Voluntary Use of Hazard
 Analysis and Critical Control
 Point Principles for Operators of
 Food Service and Retail
 Establishments
------------------------------------------------------------------------
Combined Pasteurized Milk and Dry    Do
 Milk Ordinance
------------------------------------------------------------------------
Annual Report Regarding State        Do
 Program Evaluations (Milk and
 Shellfish)
------------------------------------------------------------------------
Rescind Guidance Regarding Blending  Office of Plant and Dairy Foods and
 of Milk Products (Compliance         Beverages
 Policy Guide?)
------------------------------------------------------------------------
Compliance Policy Guide--Criteria    Do
 for Refusal for Entry of Food
 Products From Firms That Refuse to
 Allow Inspections
------------------------------------------------------------------------

[[Page 16537]]

 
Listeria Action Plan                 Donald Kautter, Center for Food
                                      Safety and Applied Nutrition (HFS-
                                      615), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-1629
------------------------------------------------------------------------
Food Registration Implementation     Do
------------------------------------------------------------------------
Molluscan Shellfish:                 Faye Feldstein, Center for Food
Guide for the Control of Molluscan    Safety and Applied Nutrition (HFS-
 Shellfish                            615), Food and Drug
[sbull] Model Ordinance               Administration, 5100 Paint Branch
[sbull] Public Health Reasons and     Pkwy., College Park, MD 20740, 301-
 Program Requirements for State       436-1564
 Administrative Procedures;
 Laboratory Procedures; Growing
 Area Survey and Classification;
 Controlled Relaying; Patrol of
 Shellfish Harvesting Areas;
 Control of Harvesting;
 Aquaculture; Harvesting, Handling
 and Shipping Shellfish; Shellfish
 Processing
[sbull] Guidance Documents on
 Growing Areas, Harvesting,
 Processing, and Distribution
[sbull] Suggested Forms
[sbull] Manual of FDA
 Interpretations of Model Ordinance
 Requirements
------------------------------------------------------------------------
Program No. 7303.003: Import         TBD
 Acidified and Low Acid Canned
 Foods Program
------------------------------------------------------------------------
Program No. 7303.037: Domestic and   TBD
 Imported Cheese and Cheese
 Products
------------------------------------------------------------------------
Program No. 7303.039: National Drug  TBD
 Residue Milk Monitoring Program
------------------------------------------------------------------------
Program No. 7303.803: Domestic Food  TBD
 Safety
------------------------------------------------------------------------
Program No. 7303.803A: Domestic      TBD
 Acidified and Low-Acid Canned
 Foods
------------------------------------------------------------------------
Program No. 7303.819: Import Foods-- TBD
 General Program
------------------------------------------------------------------------
Program No. 7303.842: Domestic Fish  TBD
 and Fishery Products Inspection
 Program (Fiscal Years 2001 and
 2002)
------------------------------------------------------------------------
Program No. 7303.844: Import         TBD
 Seafood Products
------------------------------------------------------------------------
Program No. 7304.004: Pesticides     TBD
 and Industrial Chemicals in
 Domestic Foods
------------------------------------------------------------------------
Program No. 7304.016: Pesticides     TBD
 and Industrial Chemicals in
 Imported Foods
------------------------------------------------------------------------
Program No. 7304.018:                TBD
 Chemotherapeutic in Seafood
 Compliance Program
------------------------------------------------------------------------
Program No. 7304.019: Toxic          TBD
 Elements in Foods and Foodware
 Import and Domestic
------------------------------------------------------------------------
Program No. 7304.839: Total Diet     TBD
 Study
------------------------------------------------------------------------
Program No. 7304.803: Domestic Food  TBD
 Safety Program--Primary Project
 Filed in Chapter 3
------------------------------------------------------------------------
Program No. 7307.001: Mycotoxins in  TBD
 Domestic Foods
------------------------------------------------------------------------
Program No. 7307.002: Mycotoxins in  TBD
 Imported Foods
------------------------------------------------------------------------
Program No.7309.006: Imported Foods  TBD
 and Color Additives
------------------------------------------------------------------------
Program No. 7309.803: Domestic Food  TBD
 Safety Program--Primary Project
 Filed in Chapter 3)
------------------------------------------------------------------------
Program No. 7309.808: Good           TBD
 Laboratory Practice (Nonclinical
 Laboratories)--Primary Project
 Filed in Chapter 48
------------------------------------------------------------------------
Program No. 7309.809: Institutional  TBD
 Review Board Program--Primary
 Project Filed in Chapter 48
------------------------------------------------------------------------

[[Page 16538]]

 
Program No. 7309.810: Sponsors,      TBD
 Contract Research Organizations
 and Monitors--Compliance With
 Regulations--Primary Project Filed
 in Chapter 48
------------------------------------------------------------------------
Program No. 7309.811: Clinical       TBD
 Investigators--Primary Project
 Filed in Chapter 48
------------------------------------------------------------------------
Program No. 7318.002: Retail Food    TBD
 Protection--State
------------------------------------------------------------------------
Program No. 7318.003: Milk Safety    TBD
 Program
------------------------------------------------------------------------
Program No. 7318.004: Molluscan      TBD
 Shellfish Evaluation
------------------------------------------------------------------------
Program No. 7318.029: Interstate     TBD
 Travel Program
------------------------------------------------------------------------
Program No. 7321.002: Medical        TBD
 Foods--Import and Domestic
------------------------------------------------------------------------
Program No. 7321.005: Domestic       TBD
 Nutrition Labeling and Education
 Act of 1990, Nutrient Sample
 Analysis, General Food Labeling
 Program
------------------------------------------------------------------------
Program No. 7321.006: Infant         TBD
 Formula Program--Import and
 Domestic
------------------------------------------------------------------------
Program No. 7321.007: Nutrition      TBD
 Labeling and Education Act of 1990
 and Enforcement--Imports
------------------------------------------------------------------------
Program No. 7321.008: Dietary        TBD
 Supplements--Imports and Domestic
------------------------------------------------------------------------
Program No. 7329.001: Domestic       TBD
 Cosmetics Program
------------------------------------------------------------------------
Program No. 7329.002: Imported       TBD
 Cosmetics Compliance Program
------------------------------------------------------------------------
CATEGORY: OFFICE OF NUTRITION,       ...................................
 PRODUCTS, LABELING AND DIETARY
 SUPPLEMENTS
------------------------------------------------------------------------
Soy Formulas and Preterm Infants--   Shawne Suggs-Anderson, Center for
 Draft Guidance                       Food Safety and Applied Nutrition
                                      (HFS-831), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-1783
------------------------------------------------------------------------
Petition Process for Requesting      Loretta Carey, Center for Food
 Labeling of Foods That Have Been     Safety and Applied Nutrition (HFS-
 Treated With Irradiation--Final      822), Food and Drug
 Guidance published October 7, 2002   Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-2371
------------------------------------------------------------------------
Voluntary Labeling Indicating        Cataline Ferre-Hockensmith, Center
 Whether Foods Have or Have Not       for Food Safety and Applied
 Been Developed Using                 Nutrition (HFS-822), Food and Drug
 Bioengineering--Final Guidance       Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-2371
------------------------------------------------------------------------
Compliance Programs                  John Foret, Center for Food Safety
                                      and Applied Nutrition (HFS-810),
                                      Food and Drug Administration, 5100
                                      Paint Branch Pkwy., College Park,
                                      MD 20740, 301-436-1761
------------------------------------------------------------------------
Summary of Regulatory Requirements   Robert Moore, Center for Food
 for Dietary Supplements              Safety and Applied Nutrition (HFS-
                                      811), Food and Drug
                                      Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 301-
                                      436-1441
------------------------------------------------------------------------
Dietary Supplement Labeling Guide    Do
------------------------------------------------------------------------
CATEGORY: OFFICE FOOD ADDITIVE AND   ...................................
 SAFETY
------------------------------------------------------------------------
Points to Consider for the Use of    Kristina Paquette, Center for Food
 Recycled Plastics in Food            Safety and Applied Nutrition (HFS-
 Packaging: Chemistry                 275), Food and Drug
 Considerations                       Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 202-
                                      436-3020
------------------------------------------------------------------------
Guidance for Industry: Testing       Do
 Protocols for Determining Exposure
 to Radiolysis Products From
 Packaging Materials Irradiated in
 Contact With Food
------------------------------------------------------------------------
Revised of Four Chapters of          Carolyn Young, Center for Food
 ``Toxicological Principles for the   Safety and Applied Nutrition (HFS-
 Safety Assessment of Direct Food     275), Food and Drug
 Additives and Color Additives Used   Administration, 5100 Paint Branch
 in Food'' (Redbook 2000)             Pkwy., College Park, MD 20740-
                                      3835, 202-418-3059
------------------------------------------------------------------------

[[Page 16539]]

 
Guidance to Industry: Evaluation of  Kathleen Jones, Center for Food
 Allergenicity of Proteins            Safety and Applied Nutrition (HFS-
 Introduced into Bioengineered        013), Food and Drug
 Foods                                Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740-
                                      3835, 301-436-1856. Guidance
                                      document reassigned with Kathleen
                                      Jones Office of Regulation and
                                      Policy (HFS-013)
------------------------------------------------------------------------
Preparing a Color Additive Petition  Judy Kidwell, Center for Food
 for Submission to the Center for     Safety and Applied Nutrition (HFS-
 Food Safety and Applied Nutrition    265), Food and Drug
 for Color Additives Used in or on    Administration, 5100 Paint Branch
 Contact Lenses                       Pkwy., College Park, MD 20740-
                                      3835, 202-418-3354
------------------------------------------------------------------------
Compliance Policy Guideline on       Do
 Chloropropanols in Soy Sauces and
 Hydrolyzed Vegetable Protein
------------------------------------------------------------------------
Guidance for Preparing a Claim of    Layla Batarseh, Center for Food
 Categorical Exclusion or an          Safety and Applied Nutrition (HFS-
 Environmental Assessment for         245), Food and Drug
 Submissions to the Center for Food   Administration, 5100 Paint Branch
 Safety and Applied Nutrition         Pkwy., College Park, MD 20740-
                                      3835, 202-418-3016
------------------------------------------------------------------------
Guidance for Preparing a Claim of    Do
 Categorical Exclusion or an
 Environmental Assessment for
 Submissions to the Center for Food
 Safety and Applied Nutrition
 (Appendix D)
------------------------------------------------------------------------
Guidance for Industry: Submission    Ken McAdams, Center for Food Safety
 of Food Contact Notifications in     and Applied Nutrition (HFS-205),
 Electronic Format                    Food and Drug Administration, 5100
                                      Paint Branch Pkwy., College Park,
                                      MD 20740-3835, 202-418-3392
------------------------------------------------------------------------
Submission of Premarket              Linda Kahl, Center for Food Safety
 Biotechnology Notices (PBNs) to      and Applied Nutrition (HFS-255)
 FDA's Office of Food Addictive       Food and Drug Administration, 5100
 Safety--Electronic Copies in         Paint Branch Pkwy., College Park,
 Portable Document Format (PDF)       MD 20740-3835, 202-418-3101
------------------------------------------------------------------------
Submission of Premarket              Do
 Biotechnology Notices (PBNs) to
 FDA's Office of Food Addictive
 Safety--Electronic Copies in
 Hypertest Markup Language (HTML)
------------------------------------------------------------------------
Providing Food and Color Additive    Do
 Petitions in Electronic Format
------------------------------------------------------------------------
Guidances Under the Public Health    ...................................
 Security and Bioterrorism
 Preparedness and Response Act of
 2002, Title III, Subtitle A
------------------------------------------------------------------------
CATEGORY: OFFICE OF COSMETICS AND    ...................................
 COLORS
------------------------------------------------------------------------
Labeling for Topically Applied       Julie Barrows, Center for Food
 Cosmetic Products Containing Alpha   Safety and Applied Nutrition (HFS-
 Hydroxy Acids as Ingredients--       105), Food and Drug
 Draft Guidance                       Administration, 5100 Paint Branch
                                      Pkwy., College Park, MD 20740, 202-
                                      418-3407
------------------------------------------------------------------------
Cosmetics Handbook for Industry--    Beth Meyers, Center for Food Safety
 Draft Guidance                       and Applied Nutrition (HFS-105),
                                      Food and Drug Administration, 5100
                                      Paint Branch Pkwy., College Park,
                                      MD 20740, 202-418-3174
------------------------------------------------------------------------
Strategy for Enforcement of 21 CFR   Do
 740.10: Required Warning Statement
 for Cosmetics With Insufficient
 Data to Substantiate Safety--Draft
 Guidance
------------------------------------------------------------------------
                 V. CENTER FOR VETERINARY MEDICINE (CVM)
------------------------------------------------------------------------
CATEGORY--HUMAN FOOD SAFETY
------------------------------------------------------------------------
Evaluating the Safety of             William Flynn, Center for
 Antimicrobial New Animal Drugs       Veterinary Medicine (HFV-2), Food
 With Regard to Their                 and Drug Administration, 7519
 Microbiological Effects on           Standish Pl., Rockville, MD 20855,
 Bacteria of Human Health Concern     301-827-4514
------------------------------------------------------------------------
Mass Spectroscopy Spectrometry for   David Heller, Center for Veterinary
 Confirmation of the Identity of      Medicine (HFV-511), Food and Drug
 Drug Residues                        Administration, 8401 Muirkirk Rd.,
                                      Beltsville, MD 20855, 301-827-8156
------------------------------------------------------------------------
Assessment of the Effects of         Haydee Fernandez, Center for
 Antimicrobial Drug Residues From     Veterinary Medicine (HFV-153),
 Food of Animal Origin on the Human   Food and Drug Administration, 7500
 Intestinal Flora                     Standish Pl., Rockville, MD 20855,
                                      301-827-6981
------------------------------------------------------------------------
Studies to Evaluate the Utility of   Henry Ekperigin, Center for
 Anti-Salmonella Chemical Food        Veterinary Medicine (HFV-222),
 Additives in Feed                    Food and Drug Administration, 7500
                                      Standish Pl., Rockville, MD 20855,
                                      301-827-0174
------------------------------------------------------------------------
CATEGORY--NEW ANIMAL DRUG            ...................................
 APPLICATIONS
------------------------------------------------------------------------

[[Page 16540]]

 
Development of Supplemental          Marilyn Martinez, Center for
 Applications for Approved New        Veterinary Medicine (HFV-130),
 Animal Drugs (Section 403(b) of      Food and Drug Administration, 7500
 the Food and Drug Administration     Standish Pl., Rockville, MD 20855,
 Modernization Act of 1997)           301-827-7577
------------------------------------------------------------------------
Administrative New Animal Drug       Gail Schmerfeld, Center for
 Application Process                  Veterinary Medicine (HFV-112),
                                      Food and Drug Administration, 7500
                                      Standish Pl., Rockville, MD 20855,
                                      301-827-0205
------------------------------------------------------------------------
CATEGORY--LABELING                   ...................................
------------------------------------------------------------------------
Manufacture and Labeling of Raw      William Burkholder, Center for
 Meat Diets for Consumption by        Veterinary Medicine (HFV-228),
 Dogs, Cats, and Captive Non-         Food and Drug Administration, 7500
 Companion Animal Carnivores and      Standish Pl., Rockville, MD 20855,
 Omnivores                            301-827-0179
------------------------------------------------------------------------
Labeling and Professional Flexible   Douglass Oeller, Center for
 Labeling                             Veterinary Medicine (HFV-112),
                                      Food and Drug Administration, 7500
                                      Standish Pl., Rockville, MD 20855,
                                      301-827-0131
------------------------------------------------------------------------
CATEGORY--TARGET ANIMAL SAFETY       ...................................
------------------------------------------------------------------------
New Drug Dosage or Dosage Range      Gail Schmerfeld, Center for
 Characterization                     Veterinary Medicine (HFV-112),
                                      Food and Drug Administration, 7500
                                      Standish Pl., Rockville, MD 20855,
                                      301-827-0205
------------------------------------------------------------------------
Use of Field Studies to Demonstrate  Steven Vaughn and Gail Schmerfeld,
 the Effectiveness of a New Animal    Center for Veterinary Medicine
 Drug                                 (HFV-130), Food and Drug
                                      Administration, 7500 Standish Pl.,
                                      Rockville, MD 20855, 301-827-7584
------------------------------------------------------------------------
CATEGORY--STATUTORY REQUIREMENTS     ...................................
------------------------------------------------------------------------
Dispute Resolution--Food and Drug    Marcia Larkins, Center for
 Administration Modernization Act     Veterinary Medicine (HFV-1), Food
 of 1997                              and Drug Administration, 7519
                                      Standish Pl., Rockville, MD 20855,
                                      301-827-4535
------------------------------------------------------------------------
CATEGORY--INTERNATIONAL              ...................................
 HARMONIZATION
------------------------------------------------------------------------
Guidance GL27 International          William Flynn, Center for
 Cooperation on Harmonization of      Veterinary Medicine (HFV-2), Food
 Technical Requirements for           and Drug Administration, 7519
 Registration of Veterinary           Standish Pl., Rockville, MD 20855,
 Medicinal Products                   301-827-4514
------------------------------------------------------------------------
VI. OFFICE OF THE COMMISSIONER, OFFICE FOR GOOD CLINICAL PRACTICE (OGCP)
------------------------------------------------------------------------
CATEGORY--GOOD CLINICAL PRACTICE;
 GUIDANCE FOR INSTITUTIONAL REVIEW
 BOARDS AND CLINICAL INVESTIGATORS
------------------------------------------------------------------------
Cooperative Arrangements for         Bonnie M. Lee, Office of the
 Institutional Review Board's         Commissioner, Office for Good
 Review of Research                   Clinical Practice (HF-34), Food
                                      and Drug Administration, 5600
                                      Fishers Lane, Rockville, MD 20857,
                                      301-827-3340
------------------------------------------------------------------------
Institutional Review Board's Review  Do
 of Research Conducted at Other
 Sites
------------------------------------------------------------------------
Continuing Review After Study        Do
 Approval
------------------------------------------------------------------------
Dates of Continuing Review           Do
------------------------------------------------------------------------
Interactions Among FDA, Sponsor,     Do
 Investigator, and Institutional
 Review Board
------------------------------------------------------------------------
Acceptance of Clinical Studies       Do
 Conducted Outside the United
 States
------------------------------------------------------------------------
Charging for Investigational         Do
 Products
------------------------------------------------------------------------
Recruiting Study Subjects            Do
------------------------------------------------------------------------
Payment to Research Subjects         Do
------------------------------------------------------------------------
Screening Tests Prior to Study       Do
 Enrollment
------------------------------------------------------------------------
A Guide to Informed Consent          Do
------------------------------------------------------------------------
Use of Investigational Products      Do
 When Subjects Enter a Second
 Institution
------------------------------------------------------------------------

[[Page 16541]]

 
Personal Importation of and Use of   Do
 Drug Products Not Approved in the
 United States
------------------------------------------------------------------------
Investigational Use of Marketed      Do
 Drugs, Biologics, and Medical
 Devices
------------------------------------------------------------------------
Emergency Use: Exceptions From the   Do
 Requirements for Institutional
 Review Board (IRB) Review and
 Informed Consent
------------------------------------------------------------------------
Emergency Use of an Investigational  Do
 Drug or Biologic Under 21 CFR Part
 312
------------------------------------------------------------------------
Expanded Access of Investigational   Do
 Drugs
------------------------------------------------------------------------
Waiver of Institutional Review       Do
 Board Requirements for Drug and
 Biologic Studies
------------------------------------------------------------------------
Drug Study Designs                   Do
------------------------------------------------------------------------
Evaluation of Gender Differences in  Do
 Clinical Investigations
------------------------------------------------------------------------
Medical Devices 21 CFR Part 812      Do
------------------------------------------------------------------------
Significant Risk and Nonsignificant  Do
 Risk Medical Device Studies
------------------------------------------------------------------------
Emergency Use of Unapproved Medical  Do
 Devices
------------------------------------------------------------------------
FDA Institutional Review Board       Do
 Inspections
------------------------------------------------------------------------
Clinical Investigator Regulatory     Do
 Sanctions
------------------------------------------------------------------------
Recordkeeping in Clinical            Do
 Investigations
------------------------------------------------------------------------
Significant Differences in FDA's     Do
 and the Department of Health and
 Human Services' Regulations
------------------------------------------------------------------------
A Self-Evaluation Checklist for      Do
 Institutional Review Boards
------------------------------------------------------------------------
                 VII. OFFICE OF REGULATORY AFFAIRS (ORA)
------------------------------------------------------------------------
INSPECTION GUIDES
------------------------------------------------------------------------
Techniques for Detecting False Data  Gerald Miller, Division of Field
 During Bioresearch Monitoring        Investigations (HFC-130), Food and
 Inspections                          Drug Administration, 5600 Fishers
                                      Lane, Rockville, MD 20857, 301-827-
                                      5655
------------------------------------------------------------------------
Guide to Inspections of Bulk         Do
 Pharmaceutical Chemicals
------------------------------------------------------------------------
Guide to International Inspections   Rebecca Hackett, Division of Field
 and Travel                           Investigations, (HFC-130), Food
                                      and Drug Administration, 5600
                                      Fishers Lane, Rockville, MD,
                                      20857, 301-827-3777
------------------------------------------------------------------------
Guide to Produce Farm                Ellen Morrison, Emergency
 Investigations                       Operations (HFC-160), Food and
                                      Drug Administration, 5600 Fishers
                                      Lane, Rockville, MD 20857, 301-827-
                                      5660
------------------------------------------------------------------------


    Dated: March 28, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-8262 Filed 4-3-03; 8:45 am]
BILLING CODE 4160-01-S