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[Federal Register: September 1, 2006 (Volume 71, Number 170)]
[Notices]
[Page 52125-52136]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01se06-52]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Annual Guidance Agenda
[Docket No. 2004N-0234]
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing its
annual guidance document agenda. This list is being published under
FDA's good guidance practices (GGPs) regulations. It is intended to
seek public comment on possible topics for future guidance document
development or revisions of existing ones.
DATES: Submit written or electronic comments on this list and on any
agency guidance documents at any time.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT:
For general information regarding FDA's GGP policy: Lisa Helmanis,
Office of Policy (HF-26), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-3480.
For information regarding specific topics or guidances: Please see
contact persons listed in the table in the SUPPLEMENTARY INFORMATION
section.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 19, 2000 (65 FR 56468), FDA's
issued its final rule on GGPs (21 CFR 10.115). GGPs are intended to
ensure involvement of the public in the development of guidance
documents and to enhance understanding of the availability, nature, and
legal effect of such guidance documents.
As part of FDA's effort to ensure meaningful interaction with the
public regarding guidance documents, the agency committed to publishing
an annual guidance document agenda of possible guidance topics or
documents for development or revision during the coming year. The
agency also committed to soliciting public input regarding these and
additional ideas for new topics or revisions to existing guidance
documents (65 FR 56477; 21 CFR 10.115(f)(5)).
The agency is neither bound by this list of possible topics nor
required to issue every guidance document on this list or precluded
from issuing guidance documents not on the list set forth in this
document.
The following list of guidance topics or documents represents
possible new topics or revisions to existing guidance documents that
the agency is considering. The agency solicits comments on the topics
listed in this document and also seeks additional ideas from the
public.
The guidance documents are organized by the issuing Center or
Office within FDA, and, in some cases, are further grouped by topic
categories. The agency's contact persons for each specific area are
listed in the tables that follow.
II. Center for Biologics Evaluation and Research (CBER)
------------------------------------------------------------------------
Title/Topic of Guidance Contact
------------------------------------------------------------------------
CATEGORY--COMPLIANCE AND INSPECTION Stephen M. Ripley, Center for
Biologics Evaluation and Research
(HFM-17), Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852-1448,
301-827-6210.
========================================================================
Design, Operation, and Validation Same as above (Do)
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
------------------------------------------------------------------------
CATEGORY--BLOOD AND BLOOD ...................................
COMPONENTS
========================================================================
Reentry Algorithm for Donors Who Do
Are Deferred Because of Reactive
Test Results for Antibody to
Hepatitis B Core Antigen (Anti-
HBc)
------------------------------------------------------------------------
[[Page 52126]]
Implementation of a Licensed West Do
Nile Virus Nucleic Acid Test (NAT)
for Whole Blood Donor Screening
------------------------------------------------------------------------
Revised Preventive Measures to Do
Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease (CJD) and Variant
Creutzfeldt-Jakob Disease (vCJD)
by Blood and Blood Products
------------------------------------------------------------------------
Recognition and Use of a Standard Do
for the Uniform Labeling of Blood
and Blood Components
------------------------------------------------------------------------
Use of Nucleic Acid Test (NAT) on Do
Source and Recovered Plasma for
Parvovirus B19
------------------------------------------------------------------------
CATEGORY--VACCINES AND ALLERGENICS ...................................
========================================================================
Characterization and Qualification Do
of Cell Substrates and Other
Biological Starting Materials for
the Production of Viral Vaccines
------------------------------------------------------------------------
CATEGORY--CELLULAR, TISSUE, AND ...................................
GENE THERAPY
========================================================================
Licensure of Minimally Manipulated, Do
Unrelated, Allogeneic Placental/
Umbilical Cord Blood Intended For
Hematopoietic Reconstitution in
Patients With Hematological
Malignancies
------------------------------------------------------------------------
Preparation of Investigational Do
Device Exemptions and
Investigational New Drugs for
Products Intended to Repair or
Replace Knee Articular Cartilage
------------------------------------------------------------------------
Initiation and Conduct of Clinical Do
Trials Using Cellular Therapies
for Cardiac Disease
------------------------------------------------------------------------
Potency Measurements for Cell and Do
Gene Therapy Products
------------------------------------------------------------------------
Considerations for Allogeneic Do
Pancreatic Islet Cell Products
------------------------------------------------------------------------
Current Good Tissue Practice for Do
Human Cell, Tissue, and Cellular
and Tissue-Based Product
Establishments
------------------------------------------------------------------------
Certain Distributed and Inventoried Do
Human Cells, Tissues, and Cellular
and Tissue-Based Products (HCT/Ps)
Recovered From Donors Who Were
Improperly Tested
------------------------------------------------------------------------
Clinical Study Design for Early Do
Phase Studies of Cellular and Gene
Therapies
------------------------------------------------------------------------
Devices Involved in Manufacture, Do
Storage and Administration of
Cellular Products and Tissues
------------------------------------------------------------------------
Validation of Rapid Microbiological Do
Methods for Assessing Sterility of
Cellular and Gene Therapy Products
------------------------------------------------------------------------
Submission of Information for the Do
National Xenotransplantation
Database
------------------------------------------------------------------------
Registration and Listing for Human Do
Cell, Tissue, and Cellular and
Tissue-Based Products
Establishments
------------------------------------------------------------------------
Preparation of Investigational Do
Device Exemptions and
Investigational New Drugs for
Tissue Engineered and Regenerative
Medicine Products
------------------------------------------------------------------------
Facilities and Controls for Do
Cellular and Gene Therapy Product
Manufacturing Operations Guidance
------------------------------------------------------------------------
CATEGORY--OTHER ...................................
========================================================================
Changes to an Approved Application: Do
Biological Products
------------------------------------------------------------------------
III. Center for Drug Evaluation and Research (CDER)
[[Page 52127]]
------------------------------------------------------------------------
Title/Topic of Guidance Contact
------------------------------------------------------------------------
CATEGORY--ADVERTISING ...................................
========================================================================
Presentation of Risk Information in Emily T. Thakur, Center for Drug
Prescription Drug and Medical Evaluation and Research (HFD-7),
Device Food and Drug Administration, 5515
Security Lane, Rockville, MD
20852, 301-594-2041.
------------------------------------------------------------------------
CATEGORY--CHEMISTRY ...................................
========================================================================
Immunogenicity Assessment for Do
Follow-on Protein Products
------------------------------------------------------------------------
Immunogenicity Assessment for Do
Therapeutic Protein Products
------------------------------------------------------------------------
Individual Product Bioequivalence Do
Recommendations
------------------------------------------------------------------------
Patient Specific Drug Products Do
------------------------------------------------------------------------
Quality by Design Do
------------------------------------------------------------------------
Recommendations for Determination Do
of Bioequivalence of Vaginal
Antifungal Products
------------------------------------------------------------------------
Submission of Documentation in Do
Applications for Parametric
Release of Human and Veterinary
Drug Products Terminally
Sterilized by Moist Heat Processes
------------------------------------------------------------------------
CATEGORY--CLINICAL/MEDICAL ...................................
========================================================================
Androgens in Aging Males Do
------------------------------------------------------------------------
Clinical Development of Drugs for Do
Irritable Bowel Syndrome
------------------------------------------------------------------------
Clinical Evaluation of Agents to Do
Lower the Risk of Developing
Sporadic Colorectal Adenomas
------------------------------------------------------------------------
Clinical Evaluation of Drugs for Do
Female Infertility
------------------------------------------------------------------------
Clinical Evaluation of Drug Do
Products for Inflammatory Bowel
Disease
------------------------------------------------------------------------
Clinical Trial Design for the Do
Treatment of Bacterial Blepharitis
------------------------------------------------------------------------
Clinical Trial Design for the Do
Treatment of Bacterial
Conjunctivitis
------------------------------------------------------------------------
Clinical Trial Design for the Do
Treatment of Bacterial Corneal
Ulcers
------------------------------------------------------------------------
Clinical Trial Design for the Do
Treatment of Dry Eye
------------------------------------------------------------------------
Clinical Trial Design for the Do
Treatment of Superficial Punctate
Keratitis (SPK)
------------------------------------------------------------------------
Conducting and Submitting Virology Do
Studies to the Division of
Antiviral Drug Products
------------------------------------------------------------------------
Co-packaged Sodium Nitrite and Do
Sodium Thiosulfate Drug Products--
Submitting a New Drug Application
------------------------------------------------------------------------
Developing Analgesic Products for Do
the Treatment of Pain
------------------------------------------------------------------------
Developing Drugs to Treat or Do
Prevent Smallpox (Variola)
Injection
------------------------------------------------------------------------
Development of Drugs for Chronic Do
Obstructive Pulmonary Disease
(COPD)
------------------------------------------------------------------------
Drug Development for the Treatment Do
of Malaria
------------------------------------------------------------------------
Evaluation of New Treatments for Do
Diabetes Mellitus
------------------------------------------------------------------------
Inhalational Anthrax (Symptomatic)-- Do
Developing Therapeutic Agents that
Target Anthrax Toxin
------------------------------------------------------------------------
Obesity and Weight Loss Do
------------------------------------------------------------------------
Oral Mucositis Do
------------------------------------------------------------------------
Patient Reported Outcomes (PRO) Do
Measures
------------------------------------------------------------------------
[[Page 52128]]
Periodontitis Do
------------------------------------------------------------------------
Peripheral Neuropathy Do
------------------------------------------------------------------------
Treatment of Congestive Heart Do
Failure
------------------------------------------------------------------------
CATEGORY--CLINICAL/PHARMACOLOGY ...................................
========================================================================
Immediate Release to Modified Do
Release Dosage Forms
------------------------------------------------------------------------
In Vitro Drug Metabolism/Drug Do
Interaction--Guidance for
Reviewers
------------------------------------------------------------------------
CATEGORY--COMBINATION PRODUCTS ...................................
========================================================================
Drug Diagnostic Co-Development Do
------------------------------------------------------------------------
CATEGORY--COMPLIANCE ...................................
========================================================================
Registration Requirements Under the Do
Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002
------------------------------------------------------------------------
Process Validation: General Do
Principles and Practices
------------------------------------------------------------------------
Penicillin as Defined in the CGMP Do
Regulation Under 21 CFR 211 and
Separation Requirements for
Manufacturing
------------------------------------------------------------------------
Non-Penicillin Beta-Lactam Do
Contamination
------------------------------------------------------------------------
Importation of Active Do
Pharmaceutical Ingredients
------------------------------------------------------------------------
CATEGORY--DRUG SAFETY INFORMATION ...................................
========================================================================
Good Naming, Labeling and Packaging Do
(GNLP) Practices
------------------------------------------------------------------------
Premarketing Evaluation of Drug- Do
Induced Liver Injury
------------------------------------------------------------------------
Risk Management of Highly Suspect Do
or Known Human Teratogens:
Pregnancy Prevention Strategies
------------------------------------------------------------------------
Selecting and Submitting Do
Proprietary Names for Evaluation
------------------------------------------------------------------------
CATEGORY--ELECTRONIC SUBMISSIONS ...................................
========================================================================
Providing Regulatory Submissions in Do
Electronic Format--Analysis
Datasets and Documentation
------------------------------------------------------------------------
CATEGORY--GOOD REVIEW PRACTICES ...................................
========================================================================
Good Review Management Practices Do
for Investigational New Drugs
------------------------------------------------------------------------
CATEGORY--INVESTIGATIONAL NEW DRUGS ...................................
========================================================================
Consumer Product Safety Commission-- Do
Tamper Resistant Packaging for
Investigational New Drugs
------------------------------------------------------------------------
Guidance for Clinical Do
Investigators--Preparing and
Submitting an Investigational New
Drug Application
------------------------------------------------------------------------
CATEGORY--LABELING ...................................
========================================================================
Content and Format of the Clinical Do
Pharmacology Section
------------------------------------------------------------------------
Dosage and Administration Section Do
of Labeling for Human Prescription
Drug and Biological Products--
Content and Format
------------------------------------------------------------------------
Drug Names and Dosage Forms Do
------------------------------------------------------------------------
Indication and Usage Section of Do
Labeling for Human Prescription
Drugs and Biological Products--
Content and Format
------------------------------------------------------------------------
Labeling Dietary Supplements for Do
Women Who Are or Could Be Pregnant
------------------------------------------------------------------------
Labeling for Human Prescription Do
Drug and Biologic Products--
Pharmacologic Classification for
the Highlights Section of Labeling
------------------------------------------------------------------------
[[Page 52129]]
Labeling for Outcome Claims for Do
Drugs to Treat Hypertension
------------------------------------------------------------------------
Pregnancy Labeling Revisions Do
------------------------------------------------------------------------
Use of Pharmacologic/Therapeutic Do
Classification in Approved
Labeling
------------------------------------------------------------------------
CATEGORY--OVER-THE-COUNTER ...................................
========================================================================
Actual Use Trials Do
------------------------------------------------------------------------
Labeling Comprehension Studies for Do
Over-the-Counter Drug Products
------------------------------------------------------------------------
Labeling of Skin Protectants Do
------------------------------------------------------------------------
Topical Drug Products for Vaginal Do
Yeast Infections
------------------------------------------------------------------------
CATEGORY--PHARMACOLOGY/TOXICOLOGY ...................................
========================================================================
Nonclinical Safety Evaluation of Do
Reformulated Drug Products,
Including Administration by an
Alternate Route
------------------------------------------------------------------------
Nonclinical Studies for Anticancer Do
Drugs
------------------------------------------------------------------------
CATEGORY--PROCEDURAL ...................................
========================================================================
Assessment of Abuse Potential of Do
Drugs
------------------------------------------------------------------------
Clinical Source Data Do
------------------------------------------------------------------------
Determining Whether Human Research Do
With a Radioactive Drug Can be
Conducted Under a Radioactive Drug
Research Committee
------------------------------------------------------------------------
Good Meeting Management Guidance Do
------------------------------------------------------------------------
Nonclinical Evaluation of Late Do
Radiation Toxicity of Therapeutic
Radiopharmaceuticals
------------------------------------------------------------------------
Process for Contracts and Written Do
Requests Under the Best
Pharmaceutical for Children Act
------------------------------------------------------------------------
Qualifying for Pediatric Do
Exclusivity Under Section 505a of
the Federal Food, Drug, and
Cosmetic Act
------------------------------------------------------------------------
Target Product Profile--A Strategic Do
Development Process Tool
------------------------------------------------------------------------
IV. Center for Devices and Radiological Health (CDRH)
------------------------------------------------------------------------
Title/Topic of Guidance Contact
------------------------------------------------------------------------
Class II Special Control Guidance Robert A. Phillips, Center for
Document: Full Field Digital Devices and Radiological Health
Mammography (FFDM) (HFZ-470), Food and Drug
Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-
594-1212, ext. 130.
------------------------------------------------------------------------
Format Guidance (Table of Contents) Heather S. Rosecrans, Center for
for Special 510(k)s Devices and Radiological Health
(HFZ-404), Food and Drug
Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-
594-1190.
------------------------------------------------------------------------
Updated 510(k) Sterility Review Sheila A. Murphey, Center for
Guidance K90-1; Final Guidance for Devices and Radiological Health
Industry and FDA (HFZ-480), Food and Drug
Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-
443-8913.
------------------------------------------------------------------------
Antimicrobials; Draft Do
------------------------------------------------------------------------
510(k) Paradigm Guidance Heather S. Rosecrans, Center for
Devices and Radiological Health
(HFZ-404), Food and Drug
Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-
594-1190.
------------------------------------------------------------------------
Replacement Heart Valve Premarket Matthew Hillebrenner, Center for
Approval Applications Devices and Radiological Health
(HFZ-450), Food and Drug
Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-
443-8517.
------------------------------------------------------------------------
[[Page 52130]]
Breast Implant Guidance document Stephen P. Rhodes, Center for
Devices and Radiological Health
(HFZ-410), Food and Drug
Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-
594-3090.
------------------------------------------------------------------------
Class II Special Control Guidance Ashley B. Boam, Center for Devices
Document: Percutaneous and Radiological Health (HFZ-450),
Transluminal Coronary Angioplasty Food and Drug Administration, 9200
(PTCA) Catheters Corporate Blvd., Rockville, MD
20850, 240-276-4222.
------------------------------------------------------------------------
Pulse Oximeter Premarket Ann A. Graham, Center for Devices
Notification [510(k)] Submissions and Radiological Health (HFZ-480),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD
20850, 301-827-4479.
------------------------------------------------------------------------
Keratome and Keratome Blade 510ks Everette T. Beers, Center for
Devices and Radiological Health
(HFZ-460), Food and Drug
Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-
594-2018, ext. 136.
------------------------------------------------------------------------
Coronary Drug Eluting Stents Ashley B. Boam, Center for Devices
Guidance Document and Radiological Health (HFZ-450),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD
20850, 240-276-4222.
------------------------------------------------------------------------
Metal Tracheal Stents Stephen P. Rhodes, Center for
Devices and Radiological Health
(HFZ-410), Food and Drug
Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-
594-3090.
------------------------------------------------------------------------
Class II Special Control Guidance Do
Document: Absorbable Hemostatic
Agent
------------------------------------------------------------------------
Preparation of Investigational Jonette Foy, Center for Devices and
Device Exemptions and Radiological Health (HFZ-450),
Investigational New Drugs for Food and Drug Administration, 9200
Products Intended to Repair or Corporate Blvd., Rockville, MD
Replace Articular Cartilage 20850, 301-443-8262.
------------------------------------------------------------------------
Premarket Approval Application Thinh X. Nguyen, Center for Devices
Modifications and Radiological Health (HFZ-402),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD
20850, 301-594-2186, ext. 152.
------------------------------------------------------------------------
Medical Device User Fee Ginette Y. Michaud, Center for
Modernization Act of 2002 Devices and Radiological Health
Validation Data in Premarket (HFZ-480), Food and Drug
Notification (510(k)) Submissions Administration, 9200 Corporate
for Reprocessed Single-Use Medical Blvd., Rockville, MD 20850, 301-
Devices 443-8879, ext. 143.
------------------------------------------------------------------------
Premarket Approval Application Thinh X. Nguyen, Center for Devices
Performance Goals and Review Clock and Radiological Health (HFZ-402),
Guidance Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD
20850, 301-594-2186, ext. 152.
------------------------------------------------------------------------
Humanitarian Device Exemption Q and Elisa D. Harvey, Center for Devices
A Guidance and Radiological Health (HFZ-403),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD
20850, 301-594-1190.
------------------------------------------------------------------------
Premarket Approval Application Thinh X. Nguyen, Center for Devices
Annual Reports and Radiological Health (HFZ-402),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD
20850, 301-594-2186, ext. 152.
------------------------------------------------------------------------
Class II Special Control Guidance Theodore R. Stevens, Center for
Document: Cutaneous Electrode Devices and Radiological Health
(HFZ-410), Food and Drug
Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-
594-1296.
------------------------------------------------------------------------
Class II Special Control Guidance Do
Document: Electroconductive Media
------------------------------------------------------------------------
Class II Special Control Guidance Do
Document: Powered Muscle
Stimulators for Muscle
Conditioning
------------------------------------------------------------------------
Class II Special Control Guidance Do
Document: Powered Muscle
Stimulators with Limited Output
for Muscle Conditioning
------------------------------------------------------------------------
Class II Special Control Guidance Do
Document: Powered Muscle
Stimulators for Rehabilitation
------------------------------------------------------------------------
Class II Special Control Guidance Do
Document: Powered Muscle
Stimulators With Limited Output
for Rehabilitation
------------------------------------------------------------------------
Class II Special Control Guidance Do
Document: Transcutaneous
Electrical Nerve Stimulators for
Pain Relief
------------------------------------------------------------------------
Class II Special Control Guidance Do
Document: Transcutaneous
Electrical Nerve Stimulators With
Limited Output for Pain Relief
------------------------------------------------------------------------
[[Page 52131]]
Class II Special Control Guidance Do
Document: Transcutaneous
Electrical Stimulators for
Aesthetic Purposed
------------------------------------------------------------------------
Class II Special Control Guidance Do
Document: Transcutaneous
Electrical Stimulators With
Limited Output for Aesthetic
Purposes
------------------------------------------------------------------------
Office of Science and Engineering ...................................
Laboratories
========================================================================
Application of IEC 60601 Third Jean M. Olson, Center for Devices
Edition in Premarket Applications; and Radiological Health (HFZ-84),
Draft Guidance for Industry and Food and Drug Administration, 9200
FDA Staff Corporate Blvd., Rockville, MD
20850, 301-827-0952.
------------------------------------------------------------------------
Establishing the Compatibility of Do
Medical Devices in Magnetic
Resonance Imaging Systems; Draft
Guidance for Industry and FDA
Staff
------------------------------------------------------------------------
Stereotactic Devices; Draft Do
Guidance for Industry and FDA
Staff
------------------------------------------------------------------------
Medical Device Electromagnetic Do
Compatibility Guidance
------------------------------------------------------------------------
Diagnostic Spectroscopy for Do
Detection of Cervical Disease
Guidance
------------------------------------------------------------------------
Criteria for Establishing Labeling Do
of Continuous Peripheral
Anesthesia Devices for Austere
Conditions
------------------------------------------------------------------------
Office of Compliance ...................................
========================================================================
Site Change Supplements and Express Christy Foreman Center for Devices
Premarket Approval Application and Radiological Health (HFZ-340),
Supplements Food and Drug Administration, 4
Oak Grove , Rockville, MD 20850,
240-276-0120.
------------------------------------------------------------------------
Consumer Directed Broadcast Deborah Wolf, Center for Devices
Advertising and Radiological Health (HFZ-302),
Food and Drug Administration, 4
Oak Grove, Rockville, MD 20850,
240-276-0100.
------------------------------------------------------------------------
Decorative, Non-corrective Contact Casper Uldriks, Center for Devices
Lenses and Radiological Health (HFZ-300),
Food and Drug Administration, 4
Oak Grove, Rockville, MD 20850,
240-276-0100.
------------------------------------------------------------------------
Good Manufacturing Practice Tim Ulatowski, Center for Devices
Inspectional Information (Medical and Radiological Health (HFZ-300),
Device User Fee Modernization Act Food and Drug Administration, 4
of 2002) Oak Grove, Rockville, MD 20850,
240-276-0100.
------------------------------------------------------------------------
Bioresearch Monitoring Program Matt Tarosky, Center for Devices
Inspectional Information (Medical and Radiological Health (HFZ-310),
Device User Fee Modernization Act Food and Drug Administration, 4
of 2002) Oak Grove, Rockville, MD 20850,
240-276-0243.
------------------------------------------------------------------------
Office of Surveillance and ...................................
Biometrics
========================================================================
Instructions for Completing FDA Howard A. Press, Center for Devices
Form 3500A With Coding Manual for and Radiological Health (HFZ-530),
Form 3500A Food and Drug Administration, 1350
Piccard Drive, Rockville, MD
20850, 240-276-3457.
------------------------------------------------------------------------
Electronic Medical Device Adverse Do
Event Reporting
------------------------------------------------------------------------
Office of Communication, Education, ...................................
and Radiation Programs
========================================================================
Medical Device Quality System John Stigi, Center for Devices and
Manual: A Small Entity Compliance Radiological Health (HFZ-220),
Guide Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850,
301-443-0806.
------------------------------------------------------------------------
Medical Device Reporting for Do
Manufacturers
------------------------------------------------------------------------
Revision to Compliance Program Sean Boyd, Center for Devices and
7386.001 Inspection of Radiological Health (HFZ-240),
Manufacturers of Laser Products Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850,
240-276-3287.
------------------------------------------------------------------------
Revision to Compliance Program Do
7386.002 Field Implementation of
the Sunlamp and Sunlamp Products
Performance Standard as Amended
------------------------------------------------------------------------
Revision to Compliance Program Do
7386.004 Field Compliance Testing
of Cabinet X-Ray Equipment
------------------------------------------------------------------------
[[Page 52132]]
Revision to Compliance Program Do
7386.006 Compliance Testing of
Electronic Products at Winchester
Engineering and Analytical Center
------------------------------------------------------------------------
Revision to Compliance Program Do
7386.007 Imported Electronic
Products
------------------------------------------------------------------------
Revision to Compliance Program Do
7386.007A Imported Non-certified
Radiation-Emitting Electronic
Products (Special Exemption for
Television Receivers, Microwave
Ovens, and Certain Class I Laser
Products) Amending or Revoking as
Appropriate Based on Guidance
Published in Fiscal Year 2006 on
Low Risk Product Reporting
Exemptions
------------------------------------------------------------------------
Revision to Compliance Program Do
7386.008 Medical Device and
Radiological Health Use Control
and Policy Implementation
------------------------------------------------------------------------
Guidance to Allow Alternate Means Do
of Labeling Certain Laser
Products: Granting Approval to
Include Labels for Small Laser
Products in Packaging or in
Product Literature, Rather Than on
Product Itself, to Eliminate
Burden on FDA and Industry
------------------------------------------------------------------------
Guidance to Exempt Laser Light Show Do
Manufacturers From Variance
Application Requirements Under
Certain Conditions: Granting Light
Show Variances by Guidance to
Reduce Burden on FDA and Industry
------------------------------------------------------------------------
Guidance Regarding Risk Messaging Margaret Tolbert, Center for
for Implantable Cardioverter Devices and Radiological Health
Defibrillator Dear Doctor Letters (HFZ-230), Food and Drug
to Include Flow, Order of Administration, 1350 Piccard Dr.,
Presentation, Required Elements of Rockville, MD 20850, 240-276-3240.
Content, and Language
------------------------------------------------------------------------
Device Use Safety: Incorporating Ron Kaye, Center for Devices and
Human Factors into Risk Management Radiological Health (HFZ-230),
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850,
240-276-3244.
------------------------------------------------------------------------
Office of In Vitro Diagnostic ...................................
Device Evaluation and Safety
========================================================================
Analyte Specific Reagents: Courtney Harper, Center for Devices
Frequently Asked Questions and Radiological Health (HFZ-440),
Food and Drug Administration, 8
Oak Grove , Rockville, MD 20850,
240-276-0443.
------------------------------------------------------------------------
Class II Special Controls Guidance Sally Hojvat, Center for Devices
Document: Herpes Simplex Virus and Radiological Health (HFZ-440),
Types 1 and 2 Serological Assays Food and Drug Administration, 8
Oak Grove, Rockville, MD 20850,
240-276-0496.
------------------------------------------------------------------------
Draft guidance--Class II Special Roxanne Shively, Center for Devices
Controls Guidance Document: and Radiological Health (HFZ-440),
Bacillus spp. Serological Reagents Food and Drug Administration, 8
Oak Grove , Rockville, MD 20850,
240-276-0496.
------------------------------------------------------------------------
Draft guidance--Tumor Marker Assays Maria Chan, Center for Devices and
Radiological Health (HFZ-440),
Food and Drug Administration, 8
Oak Grove , Rockville, MD 20850,
240-276-0493.
------------------------------------------------------------------------
Recommendations for Gene Expression Zivana Tezak, Center for Devices
and Radiological Health (HFZ-440),
Food and Drug Administration, 8
Oak Grove , Rockville, MD 20850,
240-276-0496.
------------------------------------------------------------------------
Guidance for Administrative Carol Benson, Center for Devices
Procedures for Clinical Laboratory and Radiological Health (HFZ-440),
Improvement Amendments of 1988 Food and Drug Administration, 8
Categorization Oak Grove , Rockville, MD 20850,
240-276-0496.
------------------------------------------------------------------------
Guidance for Over-the-Counter Veronica Calvin, Center for Devices
Ovulation Tests and Radiological Health (HFZ-440),
Food and Drug Administration, 8
Oak Grove , Rockville, MD 20850,
240-276-0496.
------------------------------------------------------------------------
In Vitro Diagnostic Product Devices Sally Hojvat, Center for Devices
Under Development: Frequently and Radiological Health (HFZ-440),
Asked Questions Food and Drug Administration, 8
Oak Grove , Rockville, MD 20850,
240-276-0496.
------------------------------------------------------------------------
Medical Device Reporting for Self- Claudia Gaffey, Center for Devices
Monitoring Blood Glucose Devices and Radiological Health (HFZ-440),
Food and Drug Administration, 8
Oak Grove , Rockville, MD 20850,
240-276-0496.
------------------------------------------------------------------------
[[Page 52133]]
Migration Studies for Assays With Sally Hojvat, Center for Devices
Multiple Instrumentation Systems and Radiological Health (HFZ-440),
Food and Drug Administration, 8
Oak Grove , Rockville, MD 20850,
240-276-0496.
------------------------------------------------------------------------
Nucleic Acid Based In Vitro Roxanne Shively, Center for Devices
Diagnostic Devices for Detection and Radiological Health (HFZ-440),
of Microbial Pathogens Food and Drug Administration, 8
Oak Grove , Rockville, MD 20850,
240-276-0496.
------------------------------------------------------------------------
Pharmacogenetic Tests and Genetic Kathleen Simon, Center for Devices
Tests for Heritable Markers and Radiological Health (HFZ-440),
Food and Drug Administration, 8
Oak Grove , Rockville, MD 20850,
240-276-0496.
------------------------------------------------------------------------
Points to Consider on Assayed and Carol Benson, Center for Devices
Unassayed Quality Control Material and Radiological Health (HFZ-440),
Food and Drug Administration, 8
Oak Grove , Rockville, MD 20850,
240-276-0496
------------------------------------------------------------------------
Recommendations for Therapeutic Avis Danishefsky, Center for
Drug Monitoring Assays Devices and Radiological Health
(HFZ-440), Food and Drug
Administration, 8 Oak Grove ,
Rockville, MD 20850, 240-276-0496.
------------------------------------------------------------------------
Recommendations for Clinical Carol Benson, Center for Devices
Laboratory Improvement Amendments and Radiological Health (HFZ-440),
of 1988 (CLIA) Waiver Applications Food and Drug Administration, 8
Oak Grove , Rockville, MD 20850,
240-276-0496.
------------------------------------------------------------------------
Serologic Assays for the Detection Sally Hojvat, Center for Devices
of Antibodies to Viral Agents and Radiological Health (HFZ-440),
Food and Drug Administration, 8
Oak Grove , Rockville, MD 20850,
240-276-0496.
------------------------------------------------------------------------
Total Product Life Cycle for Carol Benson, Center for Devices
Portable Invasive Blood Glucose and Radiological Health (HFZ-440),
Monitoring Systems Food and Drug Administration, 8
Oak Grove , Rockville, MD 20850,
240-276-0496.
------------------------------------------------------------------------
V. Center for Food Safety and Applied Nutrition (CFSAN)
------------------------------------------------------------------------
Title/Topic of Guidance Contact
------------------------------------------------------------------------
New Dietary Ingredient Linda Pellicore, Center for Food
Notifications Safety and Applied Nutrition (HFS-
810), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301-
436-1448.
------------------------------------------------------------------------
Evidence-Based Scientific Review Kathy Ellwood, Center for Food
System for Health Claims Safety and Applied Nutrition (HFS-
(Including Qualified Health 830), Food and Drug
Claims) Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301-
436-1450.
------------------------------------------------------------------------
Fish and Fishery Products Hazards Robert Samuels, Kathy Ellwood,
and Control Guidance Center for Food Safety and Applied
Nutrition (HFS-417), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301-
436-1418.
------------------------------------------------------------------------
Steps to Reduce Listeria Nega Beru, Kathy Ellwood, Center
Monocytogenes Contamination in for Food Safety and Applied
Ready-to-Eat Foods Nutrition (HFS-300), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301-
436-1700.
------------------------------------------------------------------------
Dietary Guidance Statements Kathy Ellwood, Center for Food
Safety and Applied Nutrition (HFS-
830), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301-
436-1450.
------------------------------------------------------------------------
Microbiological Considerations for Paul DeLeo, Center for Food Safety
Antimicrobial Food Additive and Applied Nutrition (HFS-265),
Submissions Food and Drug Administration, 5100
Paint Branch Pkwy., College Park,
MD 20740, 301-436-1302.
------------------------------------------------------------------------
VI. Center for Veterinary Medicine (CVM)
------------------------------------------------------------------------
Title of Guidance Contact
------------------------------------------------------------------------
Key Elements in Labeling of Melanie Berson, Center for
Prescription Antimicrobial Drug Veterinary Medicine (HFV-110),
Products Food and Drug Administration, 7500
Standish Pl., MPN-2, Rockville, MD
20855, 301-827-7540, e-mail:
melanie.berson@fda.hhs.gov.
------------------------------------------------------------------------
[[Page 52134]]
Meetings With the Office of New Gail Schmerfeld, Center for
Animal Drug Evaluation (ONADE) Veterinary Medicine (HFV-100),
Food and Drug Administration, 7500
Standish Pl., MPN-2, Rockville, MD
20855, 301-827-1796, e-mail:
gail.schmerfeld@fda.hhs.gov.
------------------------------------------------------------------------
Blue Bird Medicated Feed Labels Dragan Momcilovic, Center for
Veterinary Medicine (HFV-220),
7519 Standish Pl., MPN-4,
Rockville, MD 20855, 240-453-6856,
e-mail:
dragan.momcilovic@fda.hhs.gov.
------------------------------------------------------------------------
Chemistry, Manufacturing, and Dennis Bensley, Center for
Control Changes to an Approved Veterinary Medicine (HFV-143),
NADA or ANADA (83) Food and Drug Administration, 7500
Standish Pl., MPN-2, Rockville, MD
20855, 301-827-6956, e-mail:
dennis.bensley@.fda.hhs.gov.
------------------------------------------------------------------------
Analytical Methods Description for Rebecca Owen, Center for Veterinary
Type C Medicated Feeds (< greek- Medicine (HFV- 141), Food and Drug
i>137) Administration, 7500 Standish Pl.,
MPN-2, Rockville, MD 20855, 240-
276-9842, e-mail:
rebecca.owen@fda.hhs.gov.
------------------------------------------------------------------------
Veterinary Drug Compounding Neal Bataller, Center for
Compliance Policy Guide Veterinary Medicine (HFV-235),
Food and Drug Administration, 7519
Standish Pl., MPN-4, Rockville, MD
20855, 240-276-9202, e-mail:
neal.bataller@fda.hhs.gov.
------------------------------------------------------------------------
Voluntary Self Inspection of Gloria Dunnavan, Center for
Medicated Feed Manufacturing Veterinary Medicine (HFV-230),
Facilities Compliance Policy Guide Food and Drug Administration, 7519
Standish Pl., MPN-4, Rockville, MD
20855, 240-276-9200, e-mail:
gloria.dunnavan@fda.hhs.gov.
------------------------------------------------------------------------
Recommended Study Design and Michelle L. Stull, Center for
Evaluation of Effectiveness Veterinary Medicine (HFV-133),
Studies for Swine Respiratory Food and Drug Administration, 7500
Disease Claims (178) Standish Pl., MPN-2, Rockville, MD
20855, 301-827-5058, e-mail:
michelle.stull@fda.hhs.gov.
------------------------------------------------------------------------
Extra-label Use of Drugs in Animals Gloria Dunnavan, Center for
Veterinary Medicine (HFV-230),
Food and Drug Administration, 7519
Standish Pl., MPN-4, Rockville, MD
20855, 240-276-9200, e-mail:
gloria.dunnavan@fda.hhs.gov.
------------------------------------------------------------------------
Salmonella Contamination of Feeds Henry Ekperigin, Center for
Compliance Policy Guide Veterinary Medicine (HFV-222),
Food and Drug Administration, 7500
Standish Pl., MPN-4, Rockville, MD
20855, 240-453-6868, e-mail:
henry.ekperigin@fda.hhs.gov.
------------------------------------------------------------------------
Criteria for Evaluating Tests for Dragan Momcilovic, Center for
Detection of Animal Proteins Veterinary Medicine (HFV-220),
Prohibited in Ruminant Feed 7519 Standish Pl., MPN-4,
Rockville, MD 20855, 240-453-6856,
e-mail:
dragan.momcilovic@fda.hhs.gov.
------------------------------------------------------------------------
International Cooperation on Dennis Bensley, Center for
Harmonisation of Technical Veterinary Medicine (HFV-143),
Requirements for Registration of Food and Drug Administration, 7500
Veterinary Medicinal Products Standish Pl., MPN-2, Rockville, MD
(VICH)GL-39 Specifications: Test 20855, 301-827-6956, e-mail:
Procedures and Acceptance Criteria dennis.bensley@fda.hhs.gov.
for New Veterinary Drug Substances
and New Medicinal Products:
Chemical Substances
------------------------------------------------------------------------
International Cooperation on Do
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products
(VICH) GL-40 Specifications: Test
Procedures and Acceptance Criteria
for New Biotechnological/
Biological Veterinary Medicinal
Products
------------------------------------------------------------------------
International Cooperation on Do
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products
(VICH); Draft Revised Guidance for
Industry on Impurities in New
Veterinary Drug Substances
(Revision) VICH GL10(R)
------------------------------------------------------------------------
International Cooperation on Do
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products
(VICH); Draft Revised Guidance for
Industry on Impurities in New
Veterinary Medicinal Products
(Revision) VICH GL11(R)
------------------------------------------------------------------------
Animal Drug User Fees: Fees Exceed Dave Newkirk, Center for Veterinary
Costs Waivers and Reductions Medicine (HFV-100) , Food and Drug
Administration, 7500 Standish Pl.,
MPN-2, Rockville, MD 20855, 301-
827-6967, e-mail:
David.Newkirk@fda.hhs.gov.
------------------------------------------------------------------------
International Cooperation on Lynn Post, Center for Veterinary
Harmonisation of Technical Medicine (HFV-210), Food and Drug
Requirements for Registration of Administration, 7519 Standish Pl.,
Veterinary Medicinal Products MPN-4, Rockville, MD 20855, 240-
(VICH) GL-24 Pharmacovigilance of 276-9062, e-mail:
Veterinary Medicinal Products: Lynn.Post@fda.hhs.gov.
Management of Adverse Event
Reports
------------------------------------------------------------------------
[[Page 52135]]
International Cooperation on Do
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products
(VICH) GL-42 Pharmacovigilance of
Veterinary Medicinal Products:
Data Elements for Submission of
Adverse Event Reports
------------------------------------------------------------------------
International Cooperation on Do
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products
(VICH) GL-29 Pharmacovigilance of
Veterinary Medicinal Products:
Management of Periodic Summary
Update Reports (PSUs)
------------------------------------------------------------------------
International Cooperation on Do
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products
(VICH) GL-30 Pharmacovigilance of
Veterinary Medicinal Products:
Controlled Lists of Terms
------------------------------------------------------------------------
International Cooperation on Do
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products
(VICH) GL-35 Pharmacovigilance of
Veterinary Medicinal Products:
Electronic Standards for Transfer
of Data
------------------------------------------------------------------------
Guidance for Industry, Submission Do
of Drug Experience Reports (DER)
to the Center for Veterinary
Medicine, Form Form FDA 2301
------------------------------------------------------------------------
Guidance for Industry, Submission Do
of Veterinary Adverse Drug Event
Reports to the Center for
Veterinary Medicine, Form FDA 1932
------------------------------------------------------------------------
Salmonellain Pet Turtles Compliance Joseph Paige, Center for Veterinary
Policy Guide Medicine (HFV-230), Food and Drug
Administration, 7519 Standish Pl.,
MPN-4, Rockville, MD 20855, 240-
276-9210, e-mail:
joseph.paige@fda.hhs.gov.
------------------------------------------------------------------------
Glucosamine/Chondroitin Animal Mark Hackman, Center for Veterinary
Products Compliance Policy Guide Medicine (HFV-232), Food and Drug
Administration, 7519 Standish Pl.,
MPN-4, Rockville, MD 20855, 240-
276-9215, e-mail:
mark.hackman@fda.hhs.gov.
------------------------------------------------------------------------
VII. Office of Regulatory Affairs (ORA)
------------------------------------------------------------------------
Title/Topic of Guidance Contact
------------------------------------------------------------------------
21 CFR Part 58: Closure of Director, Office of Regulatory
Nonclinical Laboratories Affairs (HFC-230), Food and Drug
Administration, 15800 Crabbs
Branch Way, Rockville, MD 20855,
240-632-6860.
------------------------------------------------------------------------
Disqualification of Clinical Do
Investigators
------------------------------------------------------------------------
Compliance Policy Guide, Section Jeffrey B. Governale, Office of
310.210, Blood Pressure Regulatory Affairs (HFC-230), Food
Measurement Devices and Drug Administration, 5600
(Sphygmomanometers)--Accuracy (CPG Fishers Lane, Rockville, MD 20857,
7124.23) 240-632-6851.
------------------------------------------------------------------------
Untrue Statements of Material Facts Director, Office of Regulatory
Affairs (HFC-230), Food and Drug
Administration, 15800 Crabbs
Branch Way, Rockville, MD 20855,
240-632-6860.
------------------------------------------------------------------------
Application Integrity Policy Do
------------------------------------------------------------------------
VIII. Office of the Commissioner (OC)
------------------------------------------------------------------------
Topic/Title of Guidance Contact
------------------------------------------------------------------------
Information Sheet Guidances for David Lepay, Office of the
Institutional Review Boards, Commissioner (HF-34), Food and
Clinical Investigators, and Drug Administration, 5600 Fishers
Sponsors Lane, Rockville, MD 20857, 301-827-
3340.
------------------------------------------------------------------------
Guidance for Industry Computerized Patricia M. Beers Block, Office of
Systems Used in Clinical Trials the Commissioner (HF-34), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-
6473.
------------------------------------------------------------------------
Guidance for FDA Staff Compliance Do
Program 7348.811, Inspection of
Clinical Investigators and Sponsor
Investigators
------------------------------------------------------------------------
[[Page 52136]]
Guidance for Institutional Review Carolyn Hommel, Office of the
Boards, Clinical Investigators, Commissioner (HF-34), Food and
and Sponsors, Exception from Drug Administration, 5600 Fishers
Informed Consent Requirements for Lane, Rockville, MD 20857, 301-827-
Emergency Research 9105.
------------------------------------------------------------------------
Dated: August 23, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14549 Filed 8-31-06; 8:45 am]
BILLING CODE 4160-01-S