Document ID: FDA-2004-N-0056-0003
Agency: fda
Document Type: Notice
Title: Annual Guidance Agenda
Posted Date: 2008-08-07T04:00Z

[Federal Register: August 7, 2008 (Volume 73, Number 153)]
[Notices]               
[Page 46008-46020]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au08-67]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0056] (formerly Docket No. 2004N-0234)

 
Annual Guidance Agenda

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing its 
annual guidance document agenda. 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 comments on this list and on any agency guidance 
documents at any time.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2004-
N-0056, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously, in the ADDRESSES portion 
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and docket number for this notice. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: For general information regarding 
FDA's GGP policy contact: 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 
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 56468 at 56477; 21 CFR 10.115(f)(5)).
    The agency is neither bound by this list of possible topics nor 
required to issue every guidance document on this list or precluded 
from issuing guidance documents not on the list set forth in this 
document.
    The following list of guidance topics or documents represents 
possible new topics or revisions to existing guidance documents that 
the agency is considering. The agency solicits comments on the topics 
listed in this document and also seeks additional ideas from the 
public.
    The guidance documents are organized by the issuing Center or 
Office within FDA, and 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--BLOOD AND BLOOD COMPONENTS                  Stephen Ripley,
                                                       Center for
                                                       Biologics
                                                       Evaluation and
                                                       Research (HFM-
                                                       17), Food and
                                                       Drug
                                                       Administration,
                                                       1401 Rockville
                                                       Pike, Rockville,
                                                       MD 20852-1448,
                                                       301-827-6210
------------------------------------------------------------------------
  Pre-Storage Leukocyte Reduction of Whole Blood and  Same as above (Do)
   Blood Components Intended for Transfusion
------------------------------------------------------------------------
  Assessment of Donors of Blood and Blood Components  Do
   for Transfusion Transmitted Malaria Risk
------------------------------------------------------------------------
  Use of Serological of Tests on Samples from Donors  Do
   of Whole Blood and Blood Components for
   Transfusion and Donors of Human Cells, Tissues,
   and Cellular and Tissue-Based Products (HCT/Ps)
   to Reduce the Risk of Transmission of Trypanosoma
   cruzi Infection
------------------------------------------------------------------------
CATEGORY--VACCINES AND ALLERGENICS
------------------------------------------------------------------------
  Considerations for the Development of Vaccines to   Do
   Protect Against Global Infectious Diseases
------------------------------------------------------------------------

[[Page 46009]]

  Considerations for the Development of Products      Do
   that Contain Whole, Live Microorganisms with an
   Intended Therapeutic or Preventive Effect in
   Humans
------------------------------------------------------------------------
CATEGORY--CELLULAR, TISSUE, AND GENE THERAPY
------------------------------------------------------------------------
  Potency Tests for Cell and Gene Therapy Products    Do
------------------------------------------------------------------------
  Characterization and Qualification of Cell Banks    Do
   Used in the Production of Cellular and Gene
   Therapy Products
------------------------------------------------------------------------
  Current Good Tissue Practice for Human Cell,        Do
   Tissue, and Cellular and Tissue-Based Product
   Establishments
------------------------------------------------------------------------
  Preparation of INDs for Certain Unlicensed          Do
   Minimally Manipulated, Unrelated Allogeneic
   Placental/Umbilical Cord Blood Products (HPC-C)
------------------------------------------------------------------------
  Clinical Study Design for Early Phase Studies of    Do
   Cellular and Gene Therapies
------------------------------------------------------------------------
  Clinical Study Design Considerations for Cancer     Do
   Vaccine Development
------------------------------------------------------------------------
  Somatic Cell Therapy for Cardiac Disease            Do
------------------------------------------------------------------------
  Determination of Homologous Use Designation         Do
------------------------------------------------------------------------
  Devices Involved in Manufacture, Storage and        Do
   Administration of Cellular Products and Tissues
------------------------------------------------------------------------
  Preparation of Investigational Device Exemptions    Do
   and Investigational New Drugs for Tissue
   Engineered and Regenerative Medicine Products
------------------------------------------------------------------------

III. Center for Drug Evaluation and Research (CDER)

------------------------------------------------------------------------
               Title/Topic of Guidance                      Contact
------------------------------------------------------------------------
CATEGORY--ADVERTISING
------------------------------------------------------------------------
  Amendment of the Brief Summary                      Emily T. Thakur,
                                                       Center for Drug
                                                       Evaluation and
                                                       Research (HFD-7),
                                                       Food and Drug
                                                       Administration,
                                                       10903 New
                                                       Hampshire Ave.,
                                                       Silver Spring, MD
                                                       20993, 301-796-
                                                       3601
------------------------------------------------------------------------
  Presentation of Risk Information in Prescription    Do
   Drug and Medical Device Promotion
------------------------------------------------------------------------
CATEGORY--CHEMISTRY
------------------------------------------------------------------------
  Assay Development for Immunogenicity Testing        Do
------------------------------------------------------------------------
  CMC Post-Approval Changes Reportable in an Annual   Do
   Report
------------------------------------------------------------------------
  Immunogenicity Assessment for Therapeutic Protein   Do
   Products
------------------------------------------------------------------------
  Incorporation of Physical-chemical Indentifiers     Do
   (PCID) into Solid Oral Dosage Form Drug Products
   for Anticounterfeiting
------------------------------------------------------------------------
  Standards Recognition                               Do
------------------------------------------------------------------------
  Submission of Documentation in Applications for     Do
   Parametric Release of Human and Veterinary Drug
   Products Terminally Sterilized by Moist Heat
   Processes
------------------------------------------------------------------------
CATEGORY--CLINICAL/MEDICAL
------------------------------------------------------------------------
  Adaptive Trial Designs                              Do
------------------------------------------------------------------------
  Diabetes Mellitus: Developing Drugs and             Do
   Therapeutic Biologics for Treatment and
   Prevention
------------------------------------------------------------------------
  Oncology Endpoints: Non-Small Cell Lunch Cancer     Do
------------------------------------------------------------------------
  Pain Management: Developing Drug and Biological     Do
   Products
------------------------------------------------------------------------
  Risk Management of Highly Suspect or Known Human    Do
   Teratogens: Pregnancy Prevention Strategies
------------------------------------------------------------------------

[[Page 46010]]

CATEGORY--CLINICAL/PHARMACOLOGY
------------------------------------------------------------------------
  End of Phase 2a Meeting                             Do
------------------------------------------------------------------------
CATEGORY--CLINICAL/STATISTICAL
------------------------------------------------------------------------
  Non-Inferiority Trials                              Do
------------------------------------------------------------------------
CATEGORY--COMBINATION PRODUCTS
------------------------------------------------------------------------
  Drug Diagnostic Co-Development                      Do
------------------------------------------------------------------------
CATEGORY--COMPLIANCE
------------------------------------------------------------------------
  Active Pharmaceutical Ingredient (API)              Do
------------------------------------------------------------------------
  Medical Gas                                         Do
------------------------------------------------------------------------
  Non-Penicillin Beta-Lactam Contamination            Do
------------------------------------------------------------------------
  Pharmacy Compounding of Human Drugs: Compliance     Do
   Policy Guide, Section 460.200
------------------------------------------------------------------------
  Penicillins and Their Definition                    Do
------------------------------------------------------------------------
  PET CGMPs                                           Do
------------------------------------------------------------------------
  Pre-Launch Activities Importation Request (PLAIR)   Do
------------------------------------------------------------------------
  Process Validation: General Principles and          Do
   Practices
------------------------------------------------------------------------
CATEGORY--DRUG SAFETY INFORMATION
------------------------------------------------------------------------
  Contents of a Complete Submission Package for a     Do
   Proposed Proprietary Drug or Biologic Name
------------------------------------------------------------------------
  Dear Healthcare Professional Letters                Do
------------------------------------------------------------------------
  Postmarketing Adverse Event Reporting for Medical   Do
   Products and Dietary Supplements During Pandemic
   Influenza
------------------------------------------------------------------------
CATEGORY--ELECTRONIC SUBMISSIONS
------------------------------------------------------------------------
  Providing Regulatory Submissions in Electronic      Do
   Format--Analysis Datasets and Documentation
------------------------------------------------------------------------
CATEGORY--GENERICS
------------------------------------------------------------------------
  Submission of Summary Bioequivalence Data for       Do
   ANDAs
------------------------------------------------------------------------
CATEGORY--IND
------------------------------------------------------------------------
  Consumer Product Safety Commission--Tamper          Do
   Resistant Packaging for INDs
------------------------------------------------------------------------
  Determining Whether Human Research Studies Can Be   Do
   Conducted Without an IND
------------------------------------------------------------------------
CATEGORY--LABELING
------------------------------------------------------------------------
  Content and Format of the Clinical Pharmacology     Do
   Section
------------------------------------------------------------------------
  Drug Names and Dosage Forms                         Do
------------------------------------------------------------------------
  Hypertension Indication: Drug Labeling for          Do
   Cardiovascular Outcome Claims
------------------------------------------------------------------------
  Labeling Dietary Supplements for Women Who are or   Do
   Could be Pregnant
------------------------------------------------------------------------
  Labeling Guidance for Inclusion and Placement of    Do
   Safe Handling Statements in Package Inserts for
   Human Pharmaceuticals
------------------------------------------------------------------------
CATEGORY--OTC
------------------------------------------------------------------------
  Label Comprehension Studies for OTC Drug Products   Do
------------------------------------------------------------------------
  Labeling of OTC Skin Protectant Drug Products       Do
------------------------------------------------------------------------
CATEGORY--PHARMACOLOGY/TOXICOLOGY
------------------------------------------------------------------------
  Biotechnology-Derived Pharmaceuticals: Nonclinical  Do
   Safety Evaluation
------------------------------------------------------------------------

[[Page 46011]]

  Genotoxic and Carcinogenic Impurities in Drug       Do
   Substances and Products: Recommended Approaches
------------------------------------------------------------------------
  Nonclinical Safety Evaluation of Reformulated Drug  Do
   Products and Products Intended for Administration
   by an Alternate Route
------------------------------------------------------------------------
CATEGORY--PROCEDURAL
------------------------------------------------------------------------
  Assessment of Abuse Potential of Drugs              Do
------------------------------------------------------------------------
  Determining Whether Human Research With a           Do
   Radioactive Drug Can Be Conducted Under a
   Radioactive Drug Research Committee (RDRC)
------------------------------------------------------------------------
  Formal Meeting Between CDER/CBER Staff and          Do
   Sponsors
------------------------------------------------------------------------
  Integrated Summary of Effectiveness                 Do
------------------------------------------------------------------------

IV. Center for Devices and Radiological Health (CDRH)

------------------------------------------------------------------------
                        Title                           Contact Person
------------------------------------------------------------------------
Office of Compliance
------------------------------------------------------------------------
  Implementation of Medical Device Establishment      Tim Ulatowski,
   Registration and Device Listing Requirements        Center for
   Established by the Food and Drug Administration     Devices and
   Amendments Act of 2007 (FDAAA)                      Radiological
                                                       Health (HFZ-300),
                                                       2094 Gaither Rd.,
                                                       Rockville, MD
                                                       20850, 240-276-
                                                       0100
------------------------------------------------------------------------
  Surveillance and Detention Without Physical         Do
   Examination of Condoms
------------------------------------------------------------------------
  Surveillance and Detention Without Physical         Do
   Examination of Surgeons' and/or Patient
   Examination Gloves
------------------------------------------------------------------------
  Medical Devices Containing Materials Derived from   Do
   Animal Sources (Except for In Vitro Diagnostic
   Devices)
------------------------------------------------------------------------
  Manufacturing Site Change Supplements: Content and  Do
   Inspectional Considerations
------------------------------------------------------------------------
  Using the Global Harmonization Task Force (GHTF)    Do
   Clinical Evaluation Guidance (SG5/N2R8:2007) for
   Medical Devices
------------------------------------------------------------------------
  Using the Global Harmonization Task Force (GHTF)    Do
   Quality Management System--Process Validation SG3/
   N99-10:2004 for Medical Devices
------------------------------------------------------------------------
  Guidance on the Third Party Inspection Program for  Do
   Medical Devices (FDAAA)
------------------------------------------------------------------------
  Guidance on Submitting International Standards      Do
   Organization (ISO) 13485 Audits to FDA for
   Medical Devices Under the Food and Drug
   Administration Amendments Act of 2007 (FDAAA)
------------------------------------------------------------------------
  30-Day Notices and 135-Day PMA Supplements (FDAAA)  Do
------------------------------------------------------------------------
  Regulatory Requirements for Foreign and Domestic    Do
   Dental Laboratories
------------------------------------------------------------------------
  Using the Global Harmonization Task Force (GHTF)    Do
   SG1/N041:2005 Essential Principles of Safety &
   Performance for Medical Devices
------------------------------------------------------------------------
  Using the Global Harmonization Task Force (GHTF)    Do
   SG1 PD/N0011 Summary Technical Documentation
   (STED) for Demonstrating Conformity to the
   Essential Principles for Medical Devices
------------------------------------------------------------------------
  Using the Global Harmonization Task Force (GHTF)    Do
   SG3N17 (Proposed) Quality Management System
   Medical Devices management of procured products,
   outsourced processes and their suppliers
------------------------------------------------------------------------
  Using the Global Harmonization Task Force (GHTF)    Do
   SG3 (Proposed) Criteria for Characterizing the
   Significance of Quality Management System
   Deficiencies for Medical Devices
------------------------------------------------------------------------
  Using the Global Harmonization Task Force (GHTF)    Do
   SG1 (Proposed) Multi-site Audits and Audits of
   Suppliers (Suppl 1. to Guidelines for Regulatory
   Auditing of Quality Management Systems of Medical
   Device Manufacturers--Part 2: Regulatory Auditing
   Strategy)
------------------------------------------------------------------------
Office of Communication, Education, and Radiation Programs (OCER)
------------------------------------------------------------------------

[[Page 46012]]

  Guidance Regarding Hand-Held X-Ray Equipment        Sean Boyd, Center
                                                       for Devices and
                                                       Radiological
                                                       Health (HFZ-240),
                                                       1350 Piccard Dr.,
                                                       Rockville, MD
                                                       20850, 240-276-
                                                       3287
------------------------------------------------------------------------
  Impact Resistant Lenses Q&A                         John Stigi, Center
                                                       for Devices and
                                                       Radiological
                                                       Health (HFZ-220),
                                                       1350 Piccard Dr.,
                                                       Rockville, MD
                                                       20850, 240-276-
                                                       3150
------------------------------------------------------------------------
Office of Science and Engineering Laboratories (OSEL)
------------------------------------------------------------------------
  Medical Device Electromagnetic Compatibility        Joel Myklebust,
   Guidance                                            Center for
                                                       Devices and
                                                       Radiological
                                                       Health, 10903 New
                                                       Hampshire Ave.,
                                                       Silver Spring, MD
                                                       20933, 301-796-
                                                       2491
------------------------------------------------------------------------
  Bone Sonometers                                     Keith Wear, Center
                                                       for Devices and
                                                       Radiological
                                                       Health, 10903 New
                                                       Hampshire Ave.,
                                                       Silver Spring, MD
                                                       20933, 240-796-
                                                       2538
------------------------------------------------------------------------
  Risk Management Information in Premarket            William Midgette,
   Submissions                                         Center for
                                                       Devices and
                                                       Radiological
                                                       Health, 10903 New
                                                       Hampshire Ave.,
                                                       Silver Spring, MD
                                                       20933, 301-796-
                                                       2583
------------------------------------------------------------------------
  Application of IEC 60601-1 Third Edition in         Alford Taylor, Jr.
   Premarket Applications                              Center for
                                                       Devices and
                                                       Radiological
                                                       Health, 10903 New
                                                       Hampshire Ave.,
                                                       Silver Spring, MD
                                                       20933, 301-796-
                                                       2583
------------------------------------------------------------------------
  Premarket Clearance of Diagnostic Ultrasound        Larry Grossman,
   Imaging Systems                                     Center for
                                                       Devices and
                                                       Radiological
                                                       Health, 10903 New
                                                       Hampshire Ave.,
                                                       Silver Spring, MD
                                                       20933, 301-796-
                                                       2502
------------------------------------------------------------------------
  Guidance on the use of the IEC standard(s) for      Do
   ultrasound therapy systems in lieu of older BRH
   mandatory standard
------------------------------------------------------------------------
  Stereotactic Devices                                Alford Taylor,
                                                       Jr., Center for
                                                       Devices and
                                                       Radiological
                                                       Health, 10903 New
                                                       Hampshire Ave.,
                                                       Silver Spring, MD
                                                       20933, 301-796-
                                                       2583
------------------------------------------------------------------------
  Electroconvulsive Therapy Device Class III          Joel Myklebust,
   Premarket Notification (510k) and Investigational   Center for
   Device Exemption Submissions                        Devices and
                                                       Radiological
                                                       Health, 10903 New
                                                       Hampshire Ave.,
                                                       Silver Spring, MD
                                                       20933, 301-796-
                                                       2491
------------------------------------------------------------------------
Office of Surveillance and Biometrics
------------------------------------------------------------------------
  Bayesean Statistics                                 Gerry Grey, Center
                                                       for Devices and
                                                       Radiological
                                                       Health (HFZ-530),
                                                       1350 Piccard Dr.,
                                                       Rockville, MD
                                                       20850, 240-276-
                                                       3451
------------------------------------------------------------------------
  Electronic Premarket Statistical Data Submission    Do
------------------------------------------------------------------------
  Electronic Medical Device Reporting                 Howard Press,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-530),
                                                       1350 Piccard Dr.,
                                                       Rockville, MD
                                                       20850, 240-276-
                                                       3457
------------------------------------------------------------------------
  CDRH Postmarket Problem Codes                       Do
------------------------------------------------------------------------

[[Page 46013]]

  Global Harmonization Task Force (GHTF) Guidance on  Do
   How to Handle Information Concerning Vigilance
   Reporting Related to Medical Devices
------------------------------------------------------------------------
  FDA's Use of Global Harmonization Task Force        Do
   (GHTF) Medical Devices: Post Market Surveillance:
   National Competent Authority Report Exchange
   Criteria and Report Form for Medical Devices
------------------------------------------------------------------------
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
------------------------------------------------------------------------
  Invasive Portable Blood Glucose Monitoring System   Pat Bernhardt,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-440),
                                                       2098 Gaither Rd.,
                                                       Rockville MD
                                                       20850, 240-276-
                                                       0397
------------------------------------------------------------------------
  Class II Special Control Guidance Document: Human   Sally Hojvat,
   Metapneumovirus (hMPV) Nucleic Acid Assays          Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-440),
                                                       2098 Gaither Rd.,
                                                       Rockville MD
                                                       20850, 240-276-
                                                       0711
------------------------------------------------------------------------
  Class II Special Control Guidance Document:         Do
   Respiratory Viral Panel Multiplex Nucleic Acid
   Assay
------------------------------------------------------------------------
  Class II Special Controls Guidance Document:        Do
   Nucleic Acid Assay for Detection and
   Differentiation of Influenza A Virus Subtypes
------------------------------------------------------------------------
  Special Controls Guidance Document: Bacillus spp.   Do
   Serological Reagents; Guidance for Industry and
   FDA
------------------------------------------------------------------------
  Adverse Event Reporting for IVD's (with appendix    Claudia Gaffey,
   on glucose meters)                                  Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-440),
                                                       2098 Gaither Rd.,
                                                       Rockville MD
                                                       20850, 240-276-
                                                       0718
------------------------------------------------------------------------
  Class II Special Control Guidance Document:         Uwe Scherf, Center
   Enterovirus Nucleic Acid Assays                     for Devices and
                                                       Radiological
                                                       Health (HFZ-440),
                                                       2098 Gaither Rd.,
                                                       Rockville MD
                                                       20850, 240-276-
                                                       0725
------------------------------------------------------------------------
  Therapeutic Drug Monitoring Assays: Zonisamide and  Avis Danishefsky,
   Lamotrigine                                         Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-440),
                                                       2098 Gaither Rd.,
                                                       Rockville MD
                                                       20850, 240-276-
                                                       0687
------------------------------------------------------------------------
  Assay Migration Studies for IVD's                   Sally Hojvat,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-440),
                                                       2098 Gaither Rd.,
                                                       Rockville MD
                                                       20850, 240-276-
                                                       0711
------------------------------------------------------------------------
  Administrative Procedures for CLIA Categorization   Carol Benson,
   Procedures                                          Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-440),
                                                       2098 Gaither Rd.,
                                                       Rockville MD
                                                       20850, 240-276-
                                                       0396
------------------------------------------------------------------------
  Class II Special Control Guidance Document:         Freddie Poole,
   Plasmodium Species Antigen Detection Assays         Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-440),
                                                       2098 Gaither Rd.,
                                                       Rockville MD
                                                       20850, 240-276-
                                                       0712
------------------------------------------------------------------------
  IVD Multivariate Index Assays                       Courtney Harper,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-440),
                                                       2098 Gaither Rd.,
                                                       Rockville MD
                                                       20850, 240-276-
                                                       0694
------------------------------------------------------------------------
Office of Device Evaluation (ODE)
------------------------------------------------------------------------
  Pediatric HDEs--Guidance for IRBs                   Stephen Rhodes,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-403),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       4036
------------------------------------------------------------------------

[[Page 46014]]

  Sex Differences in Clinical Evaluation of           Bram Zuckerman,
   Cardiovascular Devices                              Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-450),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       4038
------------------------------------------------------------------------
  Condom Labeling, Special Controls                   Nancy Brogdon,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-470),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3650
------------------------------------------------------------------------
  ECG Electrodes SCGD                                 Bram Zuckerman,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-450),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       4038
------------------------------------------------------------------------
  Dental Amalgam                                      Susan Runner,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-480),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3776
------------------------------------------------------------------------
  Antimicrobial Agent Devices; Premarket              Chiu Lin, Center
   Notification Submissions                            for Devices and
                                                       Radiological
                                                       Health (HFZ-480),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3742
------------------------------------------------------------------------
  Absorbable Hemostatic Devices                       Mark Melkerson,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-410),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3737
------------------------------------------------------------------------
  FDA and Industry Actions on Premarket Notification  Samie Niver Allen,
   Submissions                                         Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-402),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       4013
------------------------------------------------------------------------
  Annual Reports for PMAs                             Do
------------------------------------------------------------------------
  MDUFMA: Disputes Concerning Payment or Refund of    Les Weinstein,
   Medical Device User Fees                            Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-5),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3962
------------------------------------------------------------------------
  Topical Oxygen Chamber for Extremities              Mark Melkerson,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-410),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3737
------------------------------------------------------------------------
  MDUFMA: User Fees and Refunds for Premarket         Heather Rosecrans,
   Notification Submissions                            Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-404),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       4021
------------------------------------------------------------------------
  Pulse Oximeters; Submissions                        Chiu Lin, Center
                                                       for Devices and
                                                       Radiological
                                                       Health (HFZ-480),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3742
------------------------------------------------------------------------
  Tracking Pediatric Device Approvals Sec. 302 FDAAA  Barbara Buch,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-410),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       4000
------------------------------------------------------------------------

[[Page 46015]]

  Trial Considerations for Hip Joint Replacement      Mark Melkerson,
   Systems                                             Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-410),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3737
------------------------------------------------------------------------
  Replacement Heart Valves; IDE & PMA Applications    Bram Zuckerman,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-450),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       4038
------------------------------------------------------------------------
  Retina Prostheses; Preclinical & Clinical           Malvina Eydelman,
   Recommendations                                     Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-400),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3783
------------------------------------------------------------------------
  Bone Graft SCGD Adding Intra-Oral Barrier Membrane  Chiu Lin, Center
   Indication                                          for Devices and
                                                       Radiological
                                                       Health (HFZ-480),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3742
------------------------------------------------------------------------
  Labeling Reusable Medical Devices for Reprocessing  Do
   in Health Care Facilities
------------------------------------------------------------------------
  Pacing Leads Guidance                               Bram Zuckerman,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-450),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3783
------------------------------------------------------------------------
  Powered Wheelchairs                                 Mark Melkerson,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-410),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3737
------------------------------------------------------------------------
  Tissue Adhesive for the Topical Approximation of    Do
   Skin
------------------------------------------------------------------------
  FDA and Industry Actions on Premarket Approval      Samie Niver Allen,
   Application                                         Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-402),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       4013
------------------------------------------------------------------------
  Pacemaker Lead Adaptor 510(k) Submissions           Bram Zuckerman,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-450),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       4038
------------------------------------------------------------------------
  510(k) Paradigm                                     Heather Rosecrans,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-404),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       4021
------------------------------------------------------------------------
  Urinary Incontinence Devices; Clinical              Nancy Brogdon,
   Recommendations                                     Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-470),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3650
------------------------------------------------------------------------
  Guidance on Dental Mouthguards                      Chiu Lin, Center
                                                       for Devices and
                                                       Radiological
                                                       Health (HFZ-480),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3742
------------------------------------------------------------------------
  Tissue Expander                                     Mark Melkerson,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-410),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3737
------------------------------------------------------------------------

[[Page 46016]]

  PTCA Devices                                        Bram Zuckerman,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-450),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       4038
------------------------------------------------------------------------
  TENS, Muscle Stimulator, and Conductive Gel         Mark Melkerson,
   Guidances                                           Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-410),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3737
------------------------------------------------------------------------
  Sterile Devices in Premarket Notification (510(k))  Chiu Lin, Center
   Submissions                                         for Devices and
                                                       Radiological
                                                       Health (HFZ-480),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3742
------------------------------------------------------------------------
  Full Field Digital Mammography                      Nancy Brogdon,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-470),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       3650
------------------------------------------------------------------------
  Coronary Drug Eluting Stents Guidance Document      Ashley Boam,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-450),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       4222
------------------------------------------------------------------------
  Modifications to PMA Devices                        Samie Niver Allen,
                                                       Center for
                                                       Devices and
                                                       Radiological
                                                       Health (HFZ-402),
                                                       9200 Corporate
                                                       Blvd., Rockville,
                                                       MD 20850, 240-276-
                                                       4013
------------------------------------------------------------------------

V. Center for Safety and Applied Nutrition (CFSAN)

------------------------------------------------------------------------
               Title/Topic of Guidance                      Contact
------------------------------------------------------------------------
New Dietary Ingredient Notifications Guidance         Linda Pellicore,
                                                       CFSAN (HFS-810),
                                                       5100 Paint Branch
                                                       Pkwy., College
                                                       Park, MD 20740,
                                                       301-436-1448,
                                                       linda.pellicore@f
                                                       da.hhs.gov
------------------------------------------------------------------------
Fish and Fishery Products Hazards and Control         Robert Samuels,
 Guidance (Edition 4)                                  CFSAN (HFS-325),
                                                       5100 Paint Branch
                                                       Pkwy., College
                                                       Park, MD 20740
                                                       301-436-1418,
                                                       robert.samuels@fd
                                                       a.hhs.gov
------------------------------------------------------------------------
Dietary Guidance Statements                           Kathy Ellwood,
                                                       CFSAN (HFS-830),
                                                       5100 Paint Branch
                                                       Pkwy., College
                                                       Park, MD 20740,
                                                       301-436-1450,
                                                       kathy.ellwood@fda
                                                       .hhs.gov
------------------------------------------------------------------------
Providing Regulatory Submissions in Electronic        Berhane Girmay,
 Format--Food Additive Petitions, Color Additive       CFSAN (HFS-205),
 Petitions, Food Contact Notifications, Food Master    5100 Paint Branch
 Files, GRAS Notices, Biotechnology Consultations,     Pkwy., College
 and New Protein Consultations                         Park, MD 20740,
                                                       301-436-1194,
                                                       berhane.girmay@fd
                                                       a.hhs.gov
------------------------------------------------------------------------
Questions and Answers Regarding Food Allergens,       Rhonda Kane, CFSAN
 Including the Food Allergen Labeling and Consumer     (HFS-820), 5100
 Protection Act of 2004 (Edition 5)                    Paint Branch
                                                       Pkwy., College
                                                       Park, MD 20740,
                                                       301-436-1803,
                                                       rhonda.Kane@fda.h
                                                       hs.gov
------------------------------------------------------------------------

[[Page 46017]]

The Seafood List--FDA's Guide to Acceptable Market    Spring Randolph,
 Names for Seafood Sold in Interstate Commerce         CFSAN (HFS-325),
                                                       5100 Paint Branch
                                                       Pkwy., College
                                                       Park, MD 20740,
                                                       301-436-1421,
                                                       spring.randolph@f
                                                       da.hhs.gov
------------------------------------------------------------------------
Small Entity Compliance Guide: ``Current Good         Vasilios Frankos,
 Manufacturing Practice in Manufacturing, Packaging,   CFSAN (HFS-810),
 Labeling, or Holding Operations for Dietary           5100 Paint Branch
 Supplements''                                         Pkwy., College
                                                       Park, MD 20740,
                                                       301-436-1850,
                                                       vasilios.frankos@
                                                       fda.hhs.gov
------------------------------------------------------------------------
Pathogens in Diary Products Draft CPG                 Bob Childers,
                                                       CFSAN (HFS-316),
                                                       5100 Paint Branch
                                                       Pkwy., College
                                                       Park, MD 20740,
                                                       301-436-1494,
                                                       bob.childers@fda.
                                                       hhs.gov
------------------------------------------------------------------------
Prior Notice CPG                                      May Nelson, CFSAN
                                                       (HFS-024), 5100
                                                       Paint Branch
                                                       Pkwy., College
                                                       Park, MD 20740,
                                                       301-436-1722,
                                                       may.nelson@fda.hh
                                                       s.gov
------------------------------------------------------------------------

VI. Center for Veterinary Medicine

------------------------------------------------------------------------
                  Title of Guidance                         Contact
------------------------------------------------------------------------
Regulation of Genetically Engineered (GE) Animals     Larisa Rudenko,
 Containing Heritable nDNA Constructs                  Center for
                                                       Veterinary
                                                       Medicine (HFV-
                                                       100), Food and
                                                       Drug
                                                       Administration,
                                                       7500 Standish
                                                       Pl., Rockville,
                                                       MD 20855, 240-276-
                                                       8245, e-mail:
                                                       larisa.rudenko@fd
                                                       a.hhs.gov
------------------------------------------------------------------------
Labeling and Marketing of Nutritional Products for    William J.
 Dogs and Cats Intended to Diagnose, Cure, Mitigate,   Burkholder,
 Treat, or Prevent Diseases--Compliance Policy         Center for
 Guide--Final                                          Veterinary
                                                       Medicine (HFV-
                                                       228), Food and
                                                       Drug
                                                       Administration,
                                                       7519 Standish
                                                       Pl., MPN-4, rm.
                                                       2642, Rockville,
                                                       MD 20855,
                                                       william.burkholde
                                                       r@fda.hhs.gov
------------------------------------------------------------------------
Veterinary Drug Compounding Compliance Policy Guide   Neal Bataller,
                                                       Center for
                                                       Veterinary
                                                       Medicine (HFV-
                                                       230), Food and
                                                       Drug
                                                       Administration,
                                                       7519 Standish
                                                       Pl., MPN-4, rm.
                                                       143, Rockville,
                                                       MD 20855, 240-276-
                                                       9201,
                                                       neal.bataller@fda
                                                       .hhs.gov
------------------------------------------------------------------------
Voluntary Self Inspection of Medicated Feed           Paul Bachman,
 Manufacturing Facilities--Compliance Policy Guide     Center for
                                                       Veterinary
                                                       Medicine (HFV-
                                                       230), Food and
                                                       Drug
                                                       Administration,
                                                       7519 Standish
                                                       Pl., MPN-4, rm.
                                                       128, Rockville,
                                                       MD 20855, 240-276-
                                                       9225,
                                                       paul.bachman@fda.
                                                       hhs.gov
------------------------------------------------------------------------
Salmonella Contamination of Feeds Compliance Policy   Xin Li, Center for
 Guide                                                 Veterinary
                                                       Medicine (HFV-
                                                       222), Food and
                                                       Drug
                                                       Administration,
                                                       7519 Standish
                                                       Pl., MPN-4, rm.
                                                       221, Rockville,
                                                       MD 20855, 240-453-
                                                       6863,
                                                       Xin.Lin@fda.hhs.g
                                                       ov
------------------------------------------------------------------------
Criteria for Evaluating Tests for Detection of        Dragan Momcilovic,
 Animal Proteins Prohibited in Ruminant Feed           Center for
                                                       Veterinary
                                                       Medicine (HFV-
                                                       220), 7519
                                                       Standish Pl., MPN-
                                                       4, rm. 227,
                                                       Rockville, MD
                                                       20855, 240-453-
                                                       6856,
                                                       dragan.momcilovic
                                                       @fda.hhs.gov
------------------------------------------------------------------------

[[Page 46018]]

Glucosamine/Chondroitin Animal Products Compliance    Paul Bachman,
 Policy Guide                                          Center for
                                                       Veterinary
                                                       Medicine (HFV-
                                                       230), Food and
                                                       Drug
                                                       Administration,
                                                       7519 Standish
                                                       Pl., MPN-4, rm.
                                                       128, Rockville,
                                                       MD 20855, 240-276-
                                                       9225,
                                                       paul.bachman@fda.
                                                       hhs.gov
------------------------------------------------------------------------
International Cooperation on Harmonisation of         Laura Hungerford,
 Technical Requirements for Registration of            Center for
 Veterinary Medicinal Products (VICH); Final           Veterinary
 Guidance for Industry on Target Animal Safety for     Medicine (HFV-
 Veterinary Pharmaceutical Products GL-43              143), Food and
                                                       Drug
                                                       Administration,
                                                       7500 Standish
                                                       Pl., MPN-2, rm.
                                                       E375, Rockville,
                                                       MD 20855, 240-276-
                                                       8232,
                                                       laura.hungerford@
                                                       fda.hhs.gov
------------------------------------------------------------------------
Guidance for Industry, Submission of Veterinary       Lynn Post, Center
 Adverse Drug Event Reports to the Center for          for Veterinary
 Veterinary Medicine, Form FDA 1932                    Medicine (HFV-
                                                       210), Food and
                                                       Drug
                                                       Administration,
                                                       7519 Standish
                                                       Pl., MPN-4, rm.
                                                       2612, Rockville,
                                                       MD 20855, 240-276-
                                                       9062,
                                                       lynn.post@fda.hhs
                                                       .gov
------------------------------------------------------------------------
Guidance for Industry, Submission of Drug Experience  Lynn Post, Center
 Reports (DER) to the Center for Veterinary            for Veterinary
 Medicine, Form FDA 2301                               Medicine (HFV-
                                                       210), Food and
                                                       Drug
                                                       Administration,
                                                       7519 Standish
                                                       Pl., MPN-4, rm.
                                                       2612, Rockville,
                                                       MD 20855, 240-276-
                                                       9062,
                                                       lynn.post@fda.hhs
                                                       .gov
------------------------------------------------------------------------
Draft Guidance for Industry--Documenting Statistical  Bob Abugov, Center
 Analyses                                              for Veterinary
                                                       Medicine (HFV-
                                                       105), Food and
                                                       Drug
                                                       Administration,
                                                       7500 Standish
                                                       Pl., MPN-2, rm.
                                                       N416, Rockville,
                                                       MD 20855, 240-276-
                                                       8168,
                                                       robert.abugov@fda
                                                       .hhs.gov
------------------------------------------------------------------------
Draft Guidance for Industry--Changes to Approved      Suzanne Sechen,
 NADAs--New NADA or Supplemental NADA                  Center for
                                                       Veterinary
                                                       Medicine (HFV-
                                                       126), Food and
                                                       Drug
                                                       Administration,
                                                       7500 Standish
                                                       Pl., MPN-2, rm.
                                                       N448, Rockville,
                                                       MD 20855, 240-276-
                                                       8108,
                                                       suzanne.sechen@fd
                                                       a.hhs.gov
------------------------------------------------------------------------
Draft Guidance for Industry--Anesthetics for          Germaine Connolly,
 Companion Animals                                     Center for
                                                       Veterinary
                                                       Medicine (HFV-
                                                       116), Food and
                                                       Drug
                                                       Administration,
                                                       7500 Standish
                                                       Pl., MPN-2, rm.
                                                       N331, Rockville,
                                                       MD 20855, 240-276-
                                                       8331,
                                                       germaine.connolly
                                                       @fda.hhs.gov
------------------------------------------------------------------------
Draft Guidance for Industry: Drug Residues Resulting  Deborah Cera,
 From the Extralabel Use of Approved New Animal        Center for
 Drugs 186                                    Veterinary
                                                       Medicine (HFV-
                                                       235), Food and
                                                       Drug
                                                       Administration,
                                                       7519 Standish
                                                       Pl., Rockville,
                                                       MD 20855, 240-276-
                                                       9209,
                                                       deborah.cera@fda.
                                                       hhs.gov
------------------------------------------------------------------------
Common or Usual Names for Animal Feed Ingredients     Sharon Benz,
 and Their Use in Animal Feed (CPG 7126.08); Draft     Center for
 Compliance Policy Guide                               Veterinary
                                                       Medicine (HFV-
                                                       220), Food and
                                                       Drug
                                                       Administration,
                                                       7519 Standish
                                                       Pl., rm. 2648,
                                                       Rockville, MD
                                                       20855, 240-453-
                                                       6864,
                                                       esharon.benz@fda.
                                                       hhs.gov
------------------------------------------------------------------------
Importation of New Animal Drugs by Licensed           Nadine Steinberg,
 Veterinarians; Draft Compliance Policy Guide          Center for
                                                       Veterinary
                                                       Medicine (HFV-
                                                       200), Food and
                                                       Drug
                                                       Administration,
                                                       MPN4, rm. 2658,
                                                       Rockville, MD
                                                       20855, 240-453-
                                                       6846
                                                       nadine.steinberg@
                                                       fda.hhs.gov
------------------------------------------------------------------------

[[Page 46019]]

Marketed Unapproved New Animal Drugs; Draft           Nadine Steinberg,
 Compliance Policy Guide                               Center for
                                                       Veterinary
                                                       Medicine (HFV-
                                                       200), Food and
                                                       Drug
                                                       Administration,
                                                       MPN4, rm. 2658,
                                                       Rockville, MD
                                                       20855, 240-453-
                                                       6846
                                                       nadine.steinberg@
                                                       fda.hhs.gov
------------------------------------------------------------------------

VII. Office of the Commissioner

------------------------------------------------------------------------
               Title/Topic of Guidance                      Contact
------------------------------------------------------------------------
Guidance for Sponsors, Clinical Investigators, and    Patricia Beers
 IRBs; Frequently Asked Questions--Statement of        Block, Office of
 Investigator (Form FDA 1572)                          the Commissioner
                                                       (HF-34), Food and
                                                       Drug
                                                       Administration,
                                                       5600 Fishers
                                                       Lane, Rockville,
                                                       MD 20857, 301-827-
                                                       3340, FAX: 301-
                                                       827-1169
------------------------------------------------------------------------
Guidance for Sponsors, Clinical Investigators, and    Sara Goldkind,
 IRBs; Data Retention When Subjects Voluntarily        Office of the
 Withdraw from FDA-Regulated Clinical Trials           Commissioner (HF-
                                                       34), Food and
                                                       Drug
                                                       Administration,
                                                       5600 Fishers
                                                       Lane, Rockville,
                                                       MD 20857, 301-827-
                                                       3340, FAX: 301-
                                                       827-1169
------------------------------------------------------------------------
Guidance for Sponsors, Clinical Investigators, and    Marsha Melvin,
 IRBs; A Guide to Informed Consent                     Office of the
                                                       Commissioner (HF-
                                                       34), Food and
                                                       Drug
                                                       Administration,
                                                       5600 Fishers
                                                       Lane, Rockville,
                                                       MD 20857, 301-827-
                                                       3340, FAX: 301-
                                                       827-1169
------------------------------------------------------------------------
Guidance for Sponsors, Clinical Investigators, and    Carolyn Hommel,
 IRBs; IRBs Continuing Review After Study Approval     Office of the
                                                       Commissioner (HF-
                                                       34), Food and
                                                       Drug
                                                       Administration,
                                                       5600 Fishers
                                                       Lane, Rockville,
                                                       MD 20857, 301-827-
                                                       3340, FAX: 301-
                                                       827-1169
------------------------------------------------------------------------
Final Guidance for Sponsors, Industry, Researchers,   Jarilyn Dupont,
 Investigators, and FDA Staff: Certifications to       Office of Policy
 Accompany Drug, Biological Product, and Device        (HF-11), Food and
 Applications/Submissions: Compliance With Section     Drug
 402(j) of the Public Health Service Act, Added by     Administration,
 Title VII of the Food and Drug Administration         5600 Fishers
 Amendments Act of 2007                                Lane, Rockville,
                                                       MD 20857, 301-827-
                                                       3360
------------------------------------------------------------------------
Final Guidance on Good Reprint Practices              Do
------------------------------------------------------------------------
Guidance on Good Importer Practices                   Sharon Mayl,
                                                       Office of Policy
                                                       (HF-11), Food and
                                                       Drug
                                                       Administration,
                                                       5600 Fishers
                                                       Lane, Rockville,
                                                       MD 20857, 301-827-
                                                       3360
------------------------------------------------------------------------
Guidance on Private Labs                              Phil Chao, Office
                                                       of Policy (HF-
                                                       23), Food and
                                                       Drug
                                                       Administration,
                                                       5600 Fishers
                                                       Lane, Rockville,
                                                       MD 20857, 301-827-
                                                       3360
------------------------------------------------------------------------

[[Page 46020]]

    Dated: July 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18126 Filed 8-6-08; 8:45 am]

BILLING CODE 4160-01-S