[Federal Register Volume 71, Number 170 (Friday, September 1, 2006)]
[Notices]
[Pages 52125-52136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14549]


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

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://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:
                                      [email protected].
------------------------------------------------------------------------

[[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:
                                      [email protected].
------------------------------------------------------------------------
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:
                                      [email protected].
------------------------------------------------------------------------
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:
                                      [email protected].
------------------------------------------------------------------------
Analytical Methods Description for   Rebecca Owen, Center for Veterinary
 Type C Medicated Feeds (137)                               Administration, 7500 Standish Pl.,
                                      MPN-2, Rockville, MD 20855, 240-
                                      276-9842, e-mail:
                                      [email protected].
------------------------------------------------------------------------
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:
                                      [email protected].
------------------------------------------------------------------------
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:
                                      [email protected].
------------------------------------------------------------------------
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:
                                      [email protected].
------------------------------------------------------------------------
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:
                                      [email protected].
------------------------------------------------------------------------
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:
                                      [email protected].
------------------------------------------------------------------------
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:
                                      [email protected].
------------------------------------------------------------------------
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   [email protected].
 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:
                                      [email protected].
------------------------------------------------------------------------
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:       [email protected].
 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:
                                      [email protected].
------------------------------------------------------------------------
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:
                                      [email protected].
------------------------------------------------------------------------

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