[Federal Register: August 7, 2008 (Volume 73, Number 153)]
[Notices]
[Page 46008-46020]
[DOCID:fr07au08-67]

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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:<PHONE_NUMBER>.
     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,
<PHONE_NUMBER>
------------------------------------------------------------------------
  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
------------------------------------------------------------------------

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

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

  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)
------------------------------------------------------------------------

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

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

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

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

  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,
<PHONE_NUMBER>,
                                                       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
<PHONE_NUMBER>,
                                                       robert.samuels@fd
                                                       a.hhs.gov
------------------------------------------------------------------------
Dietary Guidance Statements                           Kathy Ellwood,
                                                       CFSAN (HFS-830),
                                                       5100 Paint Branch
                                                       Pkwy., College
                                                       Park, MD 20740,
<PHONE_NUMBER>,
                                                       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,
<PHONE_NUMBER>,
                                                       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,
<PHONE_NUMBER>,
<EMAIL_ADDRESS>                                                       hs.gov
------------------------------------------------------------------------

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,
<PHONE_NUMBER>,
                                                       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,
<PHONE_NUMBER>,
                                                       vasilios.frankos@
                                                       fda.hhs.gov
------------------------------------------------------------------------
Pathogens in Diary Products Draft CPG                 Bob Childers,
                                                       CFSAN (HFS-316),
                                                       5100 Paint Branch
                                                       Pkwy., College
                                                       Park, MD 20740,
<PHONE_NUMBER>,
                                                       bob.childers@fda.
                                                       hhs.gov
------------------------------------------------------------------------
Prior Notice CPG                                      May Nelson, CFSAN
                                                       (HFS-024), 5100
                                                       Paint Branch
                                                       Pkwy., College
                                                       Park, MD 20740,
<PHONE_NUMBER>,
<EMAIL_ADDRESS>                                                       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
<EMAIL_ADDRESS>------------------------------------------------------------------------
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,
<EMAIL_ADDRESS>                                                       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
------------------------------------------------------------------------

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,
<EMAIL_ADDRESS>                                                       .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,
<EMAIL_ADDRESS>                                                       .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
------------------------------------------------------------------------

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

    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


[Federal Register Volume 76, Number 224 (Monday, November 21, 2011)]
[Notices]
[Pages 71987-71989]
[FR Doc No: 2011-29966]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2011-0854]

Collection of Information Under Review by Office of Management
and Budget

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding Information Collection Requests (ICRs),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting approval of a
revision to the following collections of information: 1625-0045,
Adequacy Certification for Reception Facilities and Advance Notice--33
CFR Part 158, 1625-0060, Vapor Control Systems for Facilities and Tank
Vessels, 1625-0081, Alternate Compliance Program, 1625-0083,
Operational Measures for Existing Tank Vessels Without Double Hulls and
l625-0113, Crewmember Identification Documents. Our ICRs describe the
information we seek to collect from the public. Review and comments by
OIRA ensure we only impose paperwork burdens commensurate with our
performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before
December 21, 2011.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2011-0854] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT) and/or to OIRA. To avoid
duplicate submissions, please use only one of the following means:
    (1) Online: (a) To Coast Guard docket at http://www.regulations.gov. (b) To OIRA by email via<EMAIL_ADDRESS>    (2) Mail: (a) DMF (M-30), DOT, West Building Ground Floor, Room
W12-140,

1200 New Jersey Avenue SE., Washington, DC 20590-0001. (b) To OIRA, 725
17th Street NW., Washington, DC 20503, attention Desk Officer for the
Coast Guard.
    (3) Hand Delivery: To DMF address above, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The telephone number is
(202) 366-9329.
    (4) Fax: (a) To DMF,<PHONE_NUMBER>. (b) To OIRA at<PHONE_NUMBER>.
To ensure your comments are received in a timely manner, mark the fax,
attention Desk Officer for the Coast Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    Copies of the ICRs are available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-611), Attn: Paperwork Reduction Act Manager, US Coast
Guard, 2100 2ND ST SW., STOP 7101, Washington DC 20593-7101.

FOR FURTHER INFORMATION CONTACT: Ms. Kenlinishia Tyler, Office of
Information Management, telephone<PHONE_NUMBER> or fax<PHONE_NUMBER>,
for questions on these documents. Contact Ms. Renee V. Wright, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the
docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collections. There is
one ICR for each Collection.
    The Coast Guard invites comments on whether these ICRs should be
granted based on the Collections being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collections; (2) the accuracy of the estimated burden of the
Collections; (3) ways to enhance the quality, utility, and clarity of
information subject to the Collections; and (4) ways to minimize the
burden of the Collections on respondents, including the use of
automated collection techniques or other forms of information
technology. These comments will help OIRA determine whether to approve
the ICRs referred to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG 2011-0854], and must be received by December 21,
2011. We will post all comments received, without change, to http://www.regulations.gov. They will include any personal information you
provide. We have an agreement with DOT to use their DMF. Please see the
``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number [USCG-
2011-0854], indicate the specific section of the document to which each
comment applies, providing a reason for each comment. If you submit a
comment online via www.regulations.gov, it will be considered received
by the Coast Guard when you successfully transmit the comment. If you
fax, hand deliver, or mail your comment, it will be considered as
having been received by the Coast Guard when it is received at the DMF.
We recommend you include your name, mailing address, an email address,
or other contact information in the body of your document so that we
can contact you if we have questions regarding your submission.
    You may submit comments and material by electronic means, mail,
fax, or delivery to the DMF at the address under ADDRESSES, but please
submit them by only one means. To submit your comment online, go to
http://www.regulations.gov, and type ``USCG-2011-0854'' in the
``Keyword'' box. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and will address them accordingly.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this Notice as
being available in the docket, go to http://www.regulations.gov, click
on the ``read comments'' box, which will then become highlighted in
blue. In the ``Keyword'' box insert ``USCG-2011-0854'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the DMF in Room W12-140 on the ground floor of the
DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Numbers: 1625-0045, 1625-0060, 1625-0081, 1625-0083 and 1625-
0113.

Privacy Act

    Anyone can search the electronic form of comments received in
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act statement
regarding Coast Guard public dockets in the January 17, 2008, issue of
the Federal Register (73 FR 3316).

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (76 FR 57749, September 16,
2011) required by 44 U.S.C. 3506(c)(2). That Notice elicited no
comments.

Information Collection Request

    1. Title: Adequacy Certification for Reception Facilities and
Advance Notice--33 CFR Part 158.
    OMB Control Number: 1625-0045.
    Type of Request: Revision of a currently approved collection.
    Respondents: Owners and operators of reception facilities, and
owners and operators of vessels.
    Abstract: This information helps ensure that waterfront facilities
are in compliance with reception facility standards. Advance notice
information from vessels ensures effective management of reception
facilities.
    Forms: CG-5401, CG-5401A, CG-5401B, CG-5401C.
    Burden Estimate: The estimated burden has decreased from 1,529
hours to 1,497 hours a year.

    2. Title: Vapor Control Systems for Facilities and Tank Vessels.
    OMB Control Number: 1625-0060.
    Type of Request: Revision of a currently approved collection.
    Respondents: Owners and operators of facilities and tank vessels,
and certifying entities.
    Abstract: The information is needed to ensure compliance with U.S.
regulations for the design of facility and tank vessel vapor control
systems (VCS). The information is also needed to determine the
qualifications of a certifying entity.
    Forms: None.
    Burden Estimate: The estimated burden has increased from 2,724
hours to 2,789 hours a year.
    3. Title: Alternate Compliance Program.
    OMB Control Number: 1625-0081.
    Type of Request: Revision of a currently approved collection.
    Respondents: Owners and operators of U.S.-flag inspected vessels.
    Abstract: This information is used by the Coast Guard to assess
vessels participating in the voluntary Alternate Compliance Program
(ACP) before issuance of a Certificate of Inspection.
    Forms: CG-3752 & CG-3752A.
    Burden Estimate: The estimated burden has decreased from 212 hours
to 176 hours a year.
    4. Title: Operational Measures for Existing Tank Vessels Without
Double Hulls.
    OMB Control Number: 1625-0083.
    Type of Request: Revision of a currently approved collection.
    Respondents: Owners, operators and masters of certain tank vessels.
    Abstract: The information is needed to ensure compliance with U.S.
regulations regarding operational measures for certain tank vessels
while operating in the U.S. waters.
    Forms: None.
    Burden Estimate: The estimated burden has decreased from 3,474
hours to 1,684 hours a year.
    5. Title: Crewmember Identification Documents.
    OMB Control Number: 1625-0113.
    Type of Request: Revision of a currently approved collection.
    Respondents: Crewmembers, and operators of certain vessels.
    Abstract: This information collection covers the requirement that
crewmembers on vessels calling at U.S. ports must carry and present on
demand an identification that allows the identity of crewmembers to be
authoritatively validated.
    Forms: None.
    Burden Estimate: The estimated burden has decreased from 34,553
hours to 30,275 hours a year.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: November 10, 2011.
R.E. Day,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. 2011-29966 Filed 11-18-11; 8:45 am]
BILLING CODE 9110-04-P