[Federal Register: April 4, 2003 (Volume 68, Number 65)]
[Notices]
[Page 16523-16541]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap03-82]
-----------------------------------------------------------------------
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