[Federal Register: August 7, 2008 (Volume 73, Number 153)]
[Notices]
[Page 46008-46020]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au08-67]
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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: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and docket number for this notice. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: For general information regarding
FDA's GGP policy contact: Lisa Helmanis, Office of Policy (HF-26), Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
827-3480.
For information regarding specific topics or guidances: Please see
contact persons listed in the table in the SUPPLEMENTARY INFORMATION
section.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 19, 2000 (65 FR 56468), FDA
issued its final rule on GGPs (21 CFR 10.115). GGPs are intended to
ensure involvement of the public in the development of guidance
documents and to enhance understanding of the availability, nature, and
legal effect of such guidance documents.
As part of FDA's effort to ensure meaningful interaction with the
public regarding guidance documents, the agency committed to publishing
an annual guidance document agenda of possible guidance topics or
documents for development or revision during the coming year. The
agency also committed to soliciting public input regarding these and
additional ideas for new topics or revisions to existing guidance
documents (65 FR 56468 at 56477; 21 CFR 10.115(f)(5)).
The agency is neither bound by this list of possible topics nor
required to issue every guidance document on this list or precluded
from issuing guidance documents not on the list set forth in this
document.
The following list of guidance topics or documents represents
possible new topics or revisions to existing guidance documents that
the agency is considering. The agency solicits comments on the topics
listed in this document and also seeks additional ideas from the
public.
The guidance documents are organized by the issuing Center or
Office within FDA, and are further grouped by topic categories. The
agency's contact persons for each specific area are listed in the
tables that follow.
II. Center for Biologics Evaluation and Research (CBER)
------------------------------------------------------------------------
Title/Topic of Guidance Contact
------------------------------------------------------------------------
CATEGORY--BLOOD AND BLOOD COMPONENTS Stephen Ripley,
Center for
Biologics
Evaluation and
Research (HFM-
17), Food and
Drug
Administration,
1401 Rockville
Pike, Rockville,
MD 20852-1448,
301-827-6210
------------------------------------------------------------------------
Pre-Storage Leukocyte Reduction of Whole Blood and Same as above (Do)
Blood Components Intended for Transfusion
------------------------------------------------------------------------
Assessment of Donors of Blood and Blood Components Do
for Transfusion Transmitted Malaria Risk
------------------------------------------------------------------------
Use of Serological of Tests on Samples from Donors Do
of Whole Blood and Blood Components for
Transfusion and Donors of Human Cells, Tissues,
and Cellular and Tissue-Based Products (HCT/Ps)
to Reduce the Risk of Transmission of Trypanosoma
cruzi Infection
------------------------------------------------------------------------
CATEGORY--VACCINES AND ALLERGENICS
------------------------------------------------------------------------
Considerations for the Development of Vaccines to Do
Protect Against Global Infectious Diseases
------------------------------------------------------------------------
[[Page 46009]]
Considerations for the Development of Products Do
that Contain Whole, Live Microorganisms with an
Intended Therapeutic or Preventive Effect in
Humans
------------------------------------------------------------------------
CATEGORY--CELLULAR, TISSUE, AND GENE THERAPY
------------------------------------------------------------------------
Potency Tests for Cell and Gene Therapy Products Do
------------------------------------------------------------------------
Characterization and Qualification of Cell Banks Do
Used in the Production of Cellular and Gene
Therapy Products
------------------------------------------------------------------------
Current Good Tissue Practice for Human Cell, Do
Tissue, and Cellular and Tissue-Based Product
Establishments
------------------------------------------------------------------------
Preparation of INDs for Certain Unlicensed Do
Minimally Manipulated, Unrelated Allogeneic
Placental/Umbilical Cord Blood Products (HPC-C)
------------------------------------------------------------------------
Clinical Study Design for Early Phase Studies of Do
Cellular and Gene Therapies
------------------------------------------------------------------------
Clinical Study Design Considerations for Cancer Do
Vaccine Development
------------------------------------------------------------------------
Somatic Cell Therapy for Cardiac Disease Do
------------------------------------------------------------------------
Determination of Homologous Use Designation Do
------------------------------------------------------------------------
Devices Involved in Manufacture, Storage and Do
Administration of Cellular Products and Tissues
------------------------------------------------------------------------
Preparation of Investigational Device Exemptions Do
and Investigational New Drugs for Tissue
Engineered and Regenerative Medicine Products
------------------------------------------------------------------------
III. Center for Drug Evaluation and Research (CDER)
------------------------------------------------------------------------
Title/Topic of Guidance Contact
------------------------------------------------------------------------
CATEGORY--ADVERTISING
------------------------------------------------------------------------
Amendment of the Brief Summary Emily T. Thakur,
Center for Drug
Evaluation and
Research (HFD-7),
Food and Drug
Administration,
10903 New
Hampshire Ave.,
Silver Spring, MD
20993, 301-796-
3601
------------------------------------------------------------------------
Presentation of Risk Information in Prescription Do
Drug and Medical Device Promotion
------------------------------------------------------------------------
CATEGORY--CHEMISTRY
------------------------------------------------------------------------
Assay Development for Immunogenicity Testing Do
------------------------------------------------------------------------
CMC Post-Approval Changes Reportable in an Annual Do
Report
------------------------------------------------------------------------
Immunogenicity Assessment for Therapeutic Protein Do
Products
------------------------------------------------------------------------
Incorporation of Physical-chemical Indentifiers Do
(PCID) into Solid Oral Dosage Form Drug Products
for Anticounterfeiting
------------------------------------------------------------------------
Standards Recognition Do
------------------------------------------------------------------------
Submission of Documentation in Applications for Do
Parametric Release of Human and Veterinary Drug
Products Terminally Sterilized by Moist Heat
Processes
------------------------------------------------------------------------
CATEGORY--CLINICAL/MEDICAL
------------------------------------------------------------------------
Adaptive Trial Designs Do
------------------------------------------------------------------------
Diabetes Mellitus: Developing Drugs and Do
Therapeutic Biologics for Treatment and
Prevention
------------------------------------------------------------------------
Oncology Endpoints: Non-Small Cell Lunch Cancer Do
------------------------------------------------------------------------
Pain Management: Developing Drug and Biological Do
Products
------------------------------------------------------------------------
Risk Management of Highly Suspect or Known Human Do
Teratogens: Pregnancy Prevention Strategies
------------------------------------------------------------------------
[[Page 46010]]
CATEGORY--CLINICAL/PHARMACOLOGY
------------------------------------------------------------------------
End of Phase 2a Meeting Do
------------------------------------------------------------------------
CATEGORY--CLINICAL/STATISTICAL
------------------------------------------------------------------------
Non-Inferiority Trials Do
------------------------------------------------------------------------
CATEGORY--COMBINATION PRODUCTS
------------------------------------------------------------------------
Drug Diagnostic Co-Development Do
------------------------------------------------------------------------
CATEGORY--COMPLIANCE
------------------------------------------------------------------------
Active Pharmaceutical Ingredient (API) Do
------------------------------------------------------------------------
Medical Gas Do
------------------------------------------------------------------------
Non-Penicillin Beta-Lactam Contamination Do
------------------------------------------------------------------------
Pharmacy Compounding of Human Drugs: Compliance Do
Policy Guide, Section 460.200
------------------------------------------------------------------------
Penicillins and Their Definition Do
------------------------------------------------------------------------
PET CGMPs Do
------------------------------------------------------------------------
Pre-Launch Activities Importation Request (PLAIR) Do
------------------------------------------------------------------------
Process Validation: General Principles and Do
Practices
------------------------------------------------------------------------
CATEGORY--DRUG SAFETY INFORMATION
------------------------------------------------------------------------
Contents of a Complete Submission Package for a Do
Proposed Proprietary Drug or Biologic Name
------------------------------------------------------------------------
Dear Healthcare Professional Letters Do
------------------------------------------------------------------------
Postmarketing Adverse Event Reporting for Medical Do
Products and Dietary Supplements During Pandemic
Influenza
------------------------------------------------------------------------
CATEGORY--ELECTRONIC SUBMISSIONS
------------------------------------------------------------------------
Providing Regulatory Submissions in Electronic Do
Format--Analysis Datasets and Documentation
------------------------------------------------------------------------
CATEGORY--GENERICS
------------------------------------------------------------------------
Submission of Summary Bioequivalence Data for Do
ANDAs
------------------------------------------------------------------------
CATEGORY--IND
------------------------------------------------------------------------
Consumer Product Safety Commission--Tamper Do
Resistant Packaging for INDs
------------------------------------------------------------------------
Determining Whether Human Research Studies Can Be Do
Conducted Without an IND
------------------------------------------------------------------------
CATEGORY--LABELING
------------------------------------------------------------------------
Content and Format of the Clinical Pharmacology Do
Section
------------------------------------------------------------------------
Drug Names and Dosage Forms Do
------------------------------------------------------------------------
Hypertension Indication: Drug Labeling for Do
Cardiovascular Outcome Claims
------------------------------------------------------------------------
Labeling Dietary Supplements for Women Who are or Do
Could be Pregnant
------------------------------------------------------------------------
Labeling Guidance for Inclusion and Placement of Do
Safe Handling Statements in Package Inserts for
Human Pharmaceuticals
------------------------------------------------------------------------
CATEGORY--OTC
------------------------------------------------------------------------
Label Comprehension Studies for OTC Drug Products Do
------------------------------------------------------------------------
Labeling of OTC Skin Protectant Drug Products Do
------------------------------------------------------------------------
CATEGORY--PHARMACOLOGY/TOXICOLOGY
------------------------------------------------------------------------
Biotechnology-Derived Pharmaceuticals: Nonclinical Do
Safety Evaluation
------------------------------------------------------------------------
[[Page 46011]]
Genotoxic and Carcinogenic Impurities in Drug Do
Substances and Products: Recommended Approaches
------------------------------------------------------------------------
Nonclinical Safety Evaluation of Reformulated Drug Do
Products and Products Intended for Administration
by an Alternate Route
------------------------------------------------------------------------
CATEGORY--PROCEDURAL
------------------------------------------------------------------------
Assessment of Abuse Potential of Drugs Do
------------------------------------------------------------------------
Determining Whether Human Research With a Do
Radioactive Drug Can Be Conducted Under a
Radioactive Drug Research Committee (RDRC)
------------------------------------------------------------------------
Formal Meeting Between CDER/CBER Staff and Do
Sponsors
------------------------------------------------------------------------
Integrated Summary of Effectiveness Do
------------------------------------------------------------------------
IV. Center for Devices and Radiological Health (CDRH)
------------------------------------------------------------------------
Title Contact Person
------------------------------------------------------------------------
Office of Compliance
------------------------------------------------------------------------
Implementation of Medical Device Establishment Tim Ulatowski,
Registration and Device Listing Requirements Center for
Established by the Food and Drug Administration Devices and
Amendments Act of 2007 (FDAAA) Radiological
Health (HFZ-300),
2094 Gaither Rd.,
Rockville, MD
20850, 240-276-
0100
------------------------------------------------------------------------
Surveillance and Detention Without Physical Do
Examination of Condoms
------------------------------------------------------------------------
Surveillance and Detention Without Physical Do
Examination of Surgeons' and/or Patient
Examination Gloves
------------------------------------------------------------------------
Medical Devices Containing Materials Derived from Do
Animal Sources (Except for In Vitro Diagnostic
Devices)
------------------------------------------------------------------------
Manufacturing Site Change Supplements: Content and Do
Inspectional Considerations
------------------------------------------------------------------------
Using the Global Harmonization Task Force (GHTF) Do
Clinical Evaluation Guidance (SG5/N2R8:2007) for
Medical Devices
------------------------------------------------------------------------
Using the Global Harmonization Task Force (GHTF) Do
Quality Management System--Process Validation SG3/
N99-10:2004 for Medical Devices
------------------------------------------------------------------------
Guidance on the Third Party Inspection Program for Do
Medical Devices (FDAAA)
------------------------------------------------------------------------
Guidance on Submitting International Standards Do
Organization (ISO) 13485 Audits to FDA for
Medical Devices Under the Food and Drug
Administration Amendments Act of 2007 (FDAAA)
------------------------------------------------------------------------
30-Day Notices and 135-Day PMA Supplements (FDAAA) Do
------------------------------------------------------------------------
Regulatory Requirements for Foreign and Domestic Do
Dental Laboratories
------------------------------------------------------------------------
Using the Global Harmonization Task Force (GHTF) Do
SG1/N041:2005 Essential Principles of Safety &
Performance for Medical Devices
------------------------------------------------------------------------
Using the Global Harmonization Task Force (GHTF) Do
SG1 PD/N0011 Summary Technical Documentation
(STED) for Demonstrating Conformity to the
Essential Principles for Medical Devices
------------------------------------------------------------------------
Using the Global Harmonization Task Force (GHTF) Do
SG3N17 (Proposed) Quality Management System
Medical Devices management of procured products,
outsourced processes and their suppliers
------------------------------------------------------------------------
Using the Global Harmonization Task Force (GHTF) Do
SG3 (Proposed) Criteria for Characterizing the
Significance of Quality Management System
Deficiencies for Medical Devices
------------------------------------------------------------------------
Using the Global Harmonization Task Force (GHTF) Do
SG1 (Proposed) Multi-site Audits and Audits of
Suppliers (Suppl 1. to Guidelines for Regulatory
Auditing of Quality Management Systems of Medical
Device Manufacturers--Part 2: Regulatory Auditing
Strategy)
------------------------------------------------------------------------
Office of Communication, Education, and Radiation Programs (OCER)
------------------------------------------------------------------------
[[Page 46012]]
Guidance Regarding Hand-Held X-Ray Equipment Sean Boyd, Center
for Devices and
Radiological
Health (HFZ-240),
1350 Piccard Dr.,
Rockville, MD
20850, 240-276-
3287
------------------------------------------------------------------------
Impact Resistant Lenses Q&A John Stigi, Center
for Devices and
Radiological
Health (HFZ-220),
1350 Piccard Dr.,
Rockville, MD
20850, 240-276-
3150
------------------------------------------------------------------------
Office of Science and Engineering Laboratories (OSEL)
------------------------------------------------------------------------
Medical Device Electromagnetic Compatibility Joel Myklebust,
Guidance Center for
Devices and
Radiological
Health, 10903 New
Hampshire Ave.,
Silver Spring, MD
20933, 301-796-
2491
------------------------------------------------------------------------
Bone Sonometers Keith Wear, Center
for Devices and
Radiological
Health, 10903 New
Hampshire Ave.,
Silver Spring, MD
20933, 240-796-
2538
------------------------------------------------------------------------
Risk Management Information in Premarket William Midgette,
Submissions Center for
Devices and
Radiological
Health, 10903 New
Hampshire Ave.,
Silver Spring, MD
20933, 301-796-
2583
------------------------------------------------------------------------
Application of IEC 60601-1 Third Edition in Alford Taylor, Jr.
Premarket Applications Center for
Devices and
Radiological
Health, 10903 New
Hampshire Ave.,
Silver Spring, MD
20933, 301-796-
2583
------------------------------------------------------------------------
Premarket Clearance of Diagnostic Ultrasound Larry Grossman,
Imaging Systems Center for
Devices and
Radiological
Health, 10903 New
Hampshire Ave.,
Silver Spring, MD
20933, 301-796-
2502
------------------------------------------------------------------------
Guidance on the use of the IEC standard(s) for Do
ultrasound therapy systems in lieu of older BRH
mandatory standard
------------------------------------------------------------------------
Stereotactic Devices Alford Taylor,
Jr., Center for
Devices and
Radiological
Health, 10903 New
Hampshire Ave.,
Silver Spring, MD
20933, 301-796-
2583
------------------------------------------------------------------------
Electroconvulsive Therapy Device Class III Joel Myklebust,
Premarket Notification (510k) and Investigational Center for
Device Exemption Submissions Devices and
Radiological
Health, 10903 New
Hampshire Ave.,
Silver Spring, MD
20933, 301-796-
2491
------------------------------------------------------------------------
Office of Surveillance and Biometrics
------------------------------------------------------------------------
Bayesean Statistics Gerry Grey, Center
for Devices and
Radiological
Health (HFZ-530),
1350 Piccard Dr.,
Rockville, MD
20850, 240-276-
3451
------------------------------------------------------------------------
Electronic Premarket Statistical Data Submission Do
------------------------------------------------------------------------
Electronic Medical Device Reporting Howard Press,
Center for
Devices and
Radiological
Health (HFZ-530),
1350 Piccard Dr.,
Rockville, MD
20850, 240-276-
3457
------------------------------------------------------------------------
CDRH Postmarket Problem Codes Do
------------------------------------------------------------------------
[[Page 46013]]
Global Harmonization Task Force (GHTF) Guidance on Do
How to Handle Information Concerning Vigilance
Reporting Related to Medical Devices
------------------------------------------------------------------------
FDA's Use of Global Harmonization Task Force Do
(GHTF) Medical Devices: Post Market Surveillance:
National Competent Authority Report Exchange
Criteria and Report Form for Medical Devices
------------------------------------------------------------------------
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
------------------------------------------------------------------------
Invasive Portable Blood Glucose Monitoring System Pat Bernhardt,
Center for
Devices and
Radiological
Health (HFZ-440),
2098 Gaither Rd.,
Rockville MD
20850, 240-276-
0397
------------------------------------------------------------------------
Class II Special Control Guidance Document: Human Sally Hojvat,
Metapneumovirus (hMPV) Nucleic Acid Assays Center for
Devices and
Radiological
Health (HFZ-440),
2098 Gaither Rd.,
Rockville MD
20850, 240-276-
0711
------------------------------------------------------------------------
Class II Special Control Guidance Document: Do
Respiratory Viral Panel Multiplex Nucleic Acid
Assay
------------------------------------------------------------------------
Class II Special Controls Guidance Document: Do
Nucleic Acid Assay for Detection and
Differentiation of Influenza A Virus Subtypes
------------------------------------------------------------------------
Special Controls Guidance Document: Bacillus spp. Do
Serological Reagents; Guidance for Industry and
FDA
------------------------------------------------------------------------
Adverse Event Reporting for IVD's (with appendix Claudia Gaffey,
on glucose meters) Center for
Devices and
Radiological
Health (HFZ-440),
2098 Gaither Rd.,
Rockville MD
20850, 240-276-
0718
------------------------------------------------------------------------
Class II Special Control Guidance Document: Uwe Scherf, Center
Enterovirus Nucleic Acid Assays for Devices and
Radiological
Health (HFZ-440),
2098 Gaither Rd.,
Rockville MD
20850, 240-276-
0725
------------------------------------------------------------------------
Therapeutic Drug Monitoring Assays: Zonisamide and Avis Danishefsky,
Lamotrigine Center for
Devices and
Radiological
Health (HFZ-440),
2098 Gaither Rd.,
Rockville MD
20850, 240-276-
0687
------------------------------------------------------------------------
Assay Migration Studies for IVD's Sally Hojvat,
Center for
Devices and
Radiological
Health (HFZ-440),
2098 Gaither Rd.,
Rockville MD
20850, 240-276-
0711
------------------------------------------------------------------------
Administrative Procedures for CLIA Categorization Carol Benson,
Procedures Center for
Devices and
Radiological
Health (HFZ-440),
2098 Gaither Rd.,
Rockville MD
20850, 240-276-
0396
------------------------------------------------------------------------
Class II Special Control Guidance Document: Freddie Poole,
Plasmodium Species Antigen Detection Assays Center for
Devices and
Radiological
Health (HFZ-440),
2098 Gaither Rd.,
Rockville MD
20850, 240-276-
0712
------------------------------------------------------------------------
IVD Multivariate Index Assays Courtney Harper,
Center for
Devices and
Radiological
Health (HFZ-440),
2098 Gaither Rd.,
Rockville MD
20850, 240-276-
0694
------------------------------------------------------------------------
Office of Device Evaluation (ODE)
------------------------------------------------------------------------
Pediatric HDEs--Guidance for IRBs Stephen Rhodes,
Center for
Devices and
Radiological
Health (HFZ-403),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
4036
------------------------------------------------------------------------
[[Page 46014]]
Sex Differences in Clinical Evaluation of Bram Zuckerman,
Cardiovascular Devices Center for
Devices and
Radiological
Health (HFZ-450),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
4038
------------------------------------------------------------------------
Condom Labeling, Special Controls Nancy Brogdon,
Center for
Devices and
Radiological
Health (HFZ-470),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3650
------------------------------------------------------------------------
ECG Electrodes SCGD Bram Zuckerman,
Center for
Devices and
Radiological
Health (HFZ-450),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
4038
------------------------------------------------------------------------
Dental Amalgam Susan Runner,
Center for
Devices and
Radiological
Health (HFZ-480),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3776
------------------------------------------------------------------------
Antimicrobial Agent Devices; Premarket Chiu Lin, Center
Notification Submissions for Devices and
Radiological
Health (HFZ-480),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3742
------------------------------------------------------------------------
Absorbable Hemostatic Devices Mark Melkerson,
Center for
Devices and
Radiological
Health (HFZ-410),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3737
------------------------------------------------------------------------
FDA and Industry Actions on Premarket Notification Samie Niver Allen,
Submissions Center for
Devices and
Radiological
Health (HFZ-402),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
4013
------------------------------------------------------------------------
Annual Reports for PMAs Do
------------------------------------------------------------------------
MDUFMA: Disputes Concerning Payment or Refund of Les Weinstein,
Medical Device User Fees Center for
Devices and
Radiological
Health (HFZ-5),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3962
------------------------------------------------------------------------
Topical Oxygen Chamber for Extremities Mark Melkerson,
Center for
Devices and
Radiological
Health (HFZ-410),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3737
------------------------------------------------------------------------
MDUFMA: User Fees and Refunds for Premarket Heather Rosecrans,
Notification Submissions Center for
Devices and
Radiological
Health (HFZ-404),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
4021
------------------------------------------------------------------------
Pulse Oximeters; Submissions Chiu Lin, Center
for Devices and
Radiological
Health (HFZ-480),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3742
------------------------------------------------------------------------
Tracking Pediatric Device Approvals Sec. 302 FDAAA Barbara Buch,
Center for
Devices and
Radiological
Health (HFZ-410),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
4000
------------------------------------------------------------------------
[[Page 46015]]
Trial Considerations for Hip Joint Replacement Mark Melkerson,
Systems Center for
Devices and
Radiological
Health (HFZ-410),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3737
------------------------------------------------------------------------
Replacement Heart Valves; IDE & PMA Applications Bram Zuckerman,
Center for
Devices and
Radiological
Health (HFZ-450),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
4038
------------------------------------------------------------------------
Retina Prostheses; Preclinical & Clinical Malvina Eydelman,
Recommendations Center for
Devices and
Radiological
Health (HFZ-400),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3783
------------------------------------------------------------------------
Bone Graft SCGD Adding Intra-Oral Barrier Membrane Chiu Lin, Center
Indication for Devices and
Radiological
Health (HFZ-480),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3742
------------------------------------------------------------------------
Labeling Reusable Medical Devices for Reprocessing Do
in Health Care Facilities
------------------------------------------------------------------------
Pacing Leads Guidance Bram Zuckerman,
Center for
Devices and
Radiological
Health (HFZ-450),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3783
------------------------------------------------------------------------
Powered Wheelchairs Mark Melkerson,
Center for
Devices and
Radiological
Health (HFZ-410),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3737
------------------------------------------------------------------------
Tissue Adhesive for the Topical Approximation of Do
Skin
------------------------------------------------------------------------
FDA and Industry Actions on Premarket Approval Samie Niver Allen,
Application Center for
Devices and
Radiological
Health (HFZ-402),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
4013
------------------------------------------------------------------------
Pacemaker Lead Adaptor 510(k) Submissions Bram Zuckerman,
Center for
Devices and
Radiological
Health (HFZ-450),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
4038
------------------------------------------------------------------------
510(k) Paradigm Heather Rosecrans,
Center for
Devices and
Radiological
Health (HFZ-404),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
4021
------------------------------------------------------------------------
Urinary Incontinence Devices; Clinical Nancy Brogdon,
Recommendations Center for
Devices and
Radiological
Health (HFZ-470),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3650
------------------------------------------------------------------------
Guidance on Dental Mouthguards Chiu Lin, Center
for Devices and
Radiological
Health (HFZ-480),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3742
------------------------------------------------------------------------
Tissue Expander Mark Melkerson,
Center for
Devices and
Radiological
Health (HFZ-410),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3737
------------------------------------------------------------------------
[[Page 46016]]
PTCA Devices Bram Zuckerman,
Center for
Devices and
Radiological
Health (HFZ-450),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
4038
------------------------------------------------------------------------
TENS, Muscle Stimulator, and Conductive Gel Mark Melkerson,
Guidances Center for
Devices and
Radiological
Health (HFZ-410),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3737
------------------------------------------------------------------------
Sterile Devices in Premarket Notification (510(k)) Chiu Lin, Center
Submissions for Devices and
Radiological
Health (HFZ-480),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3742
------------------------------------------------------------------------
Full Field Digital Mammography Nancy Brogdon,
Center for
Devices and
Radiological
Health (HFZ-470),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
3650
------------------------------------------------------------------------
Coronary Drug Eluting Stents Guidance Document Ashley Boam,
Center for
Devices and
Radiological
Health (HFZ-450),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
4222
------------------------------------------------------------------------
Modifications to PMA Devices Samie Niver Allen,
Center for
Devices and
Radiological
Health (HFZ-402),
9200 Corporate
Blvd., Rockville,
MD 20850, 240-276-
4013
------------------------------------------------------------------------
V. Center for Safety and Applied Nutrition (CFSAN)
------------------------------------------------------------------------
Title/Topic of Guidance Contact
------------------------------------------------------------------------
New Dietary Ingredient Notifications Guidance Linda Pellicore,
CFSAN (HFS-810),
5100 Paint Branch
Pkwy., College
Park, MD 20740,
301-436-1448,
linda.pellicore@f
da.hhs.gov
------------------------------------------------------------------------
Fish and Fishery Products Hazards and Control Robert Samuels,
Guidance (Edition 4) CFSAN (HFS-325),
5100 Paint Branch
Pkwy., College
Park, MD 20740
301-436-1418,
robert.samuels@fd
a.hhs.gov
------------------------------------------------------------------------
Dietary Guidance Statements Kathy Ellwood,
CFSAN (HFS-830),
5100 Paint Branch
Pkwy., College
Park, MD 20740,
301-436-1450,
kathy.ellwood@fda
.hhs.gov
------------------------------------------------------------------------
Providing Regulatory Submissions in Electronic Berhane Girmay,
Format--Food Additive Petitions, Color Additive CFSAN (HFS-205),
Petitions, Food Contact Notifications, Food Master 5100 Paint Branch
Files, GRAS Notices, Biotechnology Consultations, Pkwy., College
and New Protein Consultations Park, MD 20740,
301-436-1194,
berhane.girmay@fd
a.hhs.gov
------------------------------------------------------------------------
Questions and Answers Regarding Food Allergens, Rhonda Kane, CFSAN
Including the Food Allergen Labeling and Consumer (HFS-820), 5100
Protection Act of 2004 (Edition 5) Paint Branch
Pkwy., College
Park, MD 20740,
301-436-1803,
rhonda.Kane@fda.h
hs.gov
------------------------------------------------------------------------
[[Page 46017]]
The Seafood List--FDA's Guide to Acceptable Market Spring Randolph,
Names for Seafood Sold in Interstate Commerce CFSAN (HFS-325),
5100 Paint Branch
Pkwy., College
Park, MD 20740,
301-436-1421,
spring.randolph@f
da.hhs.gov
------------------------------------------------------------------------
Small Entity Compliance Guide: ``Current Good Vasilios Frankos,
Manufacturing Practice in Manufacturing, Packaging, CFSAN (HFS-810),
Labeling, or Holding Operations for Dietary 5100 Paint Branch
Supplements'' Pkwy., College
Park, MD 20740,
301-436-1850,
vasilios.frankos@
fda.hhs.gov
------------------------------------------------------------------------
Pathogens in Diary Products Draft CPG Bob Childers,
CFSAN (HFS-316),
5100 Paint Branch
Pkwy., College
Park, MD 20740,
301-436-1494,
bob.childers@fda.
hhs.gov
------------------------------------------------------------------------
Prior Notice CPG May Nelson, CFSAN
(HFS-024), 5100
Paint Branch
Pkwy., College
Park, MD 20740,
301-436-1722,
may.nelson@fda.hh
s.gov
------------------------------------------------------------------------
VI. Center for Veterinary Medicine
------------------------------------------------------------------------
Title of Guidance Contact
------------------------------------------------------------------------
Regulation of Genetically Engineered (GE) Animals Larisa Rudenko,
Containing Heritable nDNA Constructs Center for
Veterinary
Medicine (HFV-
100), Food and
Drug
Administration,
7500 Standish
Pl., Rockville,
MD 20855, 240-276-
8245, e-mail:
larisa.rudenko@fd
a.hhs.gov
------------------------------------------------------------------------
Labeling and Marketing of Nutritional Products for William J.
Dogs and Cats Intended to Diagnose, Cure, Mitigate, Burkholder,
Treat, or Prevent Diseases--Compliance Policy Center for
Guide--Final Veterinary
Medicine (HFV-
228), Food and
Drug
Administration,
7519 Standish
Pl., MPN-4, rm.
2642, Rockville,
MD 20855,
william.burkholde
r@fda.hhs.gov
------------------------------------------------------------------------
Veterinary Drug Compounding Compliance Policy Guide Neal Bataller,
Center for
Veterinary
Medicine (HFV-
230), Food and
Drug
Administration,
7519 Standish
Pl., MPN-4, rm.
143, Rockville,
MD 20855, 240-276-
9201,
neal.bataller@fda
.hhs.gov
------------------------------------------------------------------------
Voluntary Self Inspection of Medicated Feed Paul Bachman,
Manufacturing Facilities--Compliance Policy Guide Center for
Veterinary
Medicine (HFV-
230), Food and
Drug
Administration,
7519 Standish
Pl., MPN-4, rm.
128, Rockville,
MD 20855, 240-276-
9225,
paul.bachman@fda.
hhs.gov
------------------------------------------------------------------------
Salmonella Contamination of Feeds Compliance Policy Xin Li, Center for
Guide Veterinary
Medicine (HFV-
222), Food and
Drug
Administration,
7519 Standish
Pl., MPN-4, rm.
221, Rockville,
MD 20855, 240-453-
6863,
Xin.Lin@fda.hhs.g
ov
------------------------------------------------------------------------
Criteria for Evaluating Tests for Detection of Dragan Momcilovic,
Animal Proteins Prohibited in Ruminant Feed Center for
Veterinary
Medicine (HFV-
220), 7519
Standish Pl., MPN-
4, rm. 227,
Rockville, MD
20855, 240-453-
6856,
dragan.momcilovic
@fda.hhs.gov
------------------------------------------------------------------------
[[Page 46018]]
Glucosamine/Chondroitin Animal Products Compliance Paul Bachman,
Policy Guide Center for
Veterinary
Medicine (HFV-
230), Food and
Drug
Administration,
7519 Standish
Pl., MPN-4, rm.
128, Rockville,
MD 20855, 240-276-
9225,
paul.bachman@fda.
hhs.gov
------------------------------------------------------------------------
International Cooperation on Harmonisation of Laura Hungerford,
Technical Requirements for Registration of Center for
Veterinary Medicinal Products (VICH); Final Veterinary
Guidance for Industry on Target Animal Safety for Medicine (HFV-
Veterinary Pharmaceutical Products GL-43 143), Food and
Drug
Administration,
7500 Standish
Pl., MPN-2, rm.
E375, Rockville,
MD 20855, 240-276-
8232,
laura.hungerford@
fda.hhs.gov
------------------------------------------------------------------------
Guidance for Industry, Submission of Veterinary Lynn Post, Center
Adverse Drug Event Reports to the Center for for Veterinary
Veterinary Medicine, Form FDA 1932 Medicine (HFV-
210), Food and
Drug
Administration,
7519 Standish
Pl., MPN-4, rm.
2612, Rockville,
MD 20855, 240-276-
9062,
lynn.post@fda.hhs
.gov
------------------------------------------------------------------------
Guidance for Industry, Submission of Drug Experience Lynn Post, Center
Reports (DER) to the Center for Veterinary for Veterinary
Medicine, Form FDA 2301 Medicine (HFV-
210), Food and
Drug
Administration,
7519 Standish
Pl., MPN-4, rm.
2612, Rockville,
MD 20855, 240-276-
9062,
lynn.post@fda.hhs
.gov
------------------------------------------------------------------------
Draft Guidance for Industry--Documenting Statistical Bob Abugov, Center
Analyses for Veterinary
Medicine (HFV-
105), Food and
Drug
Administration,
7500 Standish
Pl., MPN-2, rm.
N416, Rockville,
MD 20855, 240-276-
8168,
robert.abugov@fda
.hhs.gov
------------------------------------------------------------------------
Draft Guidance for Industry--Changes to Approved Suzanne Sechen,
NADAs--New NADA or Supplemental NADA Center for
Veterinary
Medicine (HFV-
126), Food and
Drug
Administration,
7500 Standish
Pl., MPN-2, rm.
N448, Rockville,
MD 20855, 240-276-
8108,
suzanne.sechen@fd
a.hhs.gov
------------------------------------------------------------------------
Draft Guidance for Industry--Anesthetics for Germaine Connolly,
Companion Animals Center for
Veterinary
Medicine (HFV-
116), Food and
Drug
Administration,
7500 Standish
Pl., MPN-2, rm.
N331, Rockville,
MD 20855, 240-276-
8331,
germaine.connolly
@fda.hhs.gov
------------------------------------------------------------------------
Draft Guidance for Industry: Drug Residues Resulting Deborah Cera,
From the Extralabel Use of Approved New Animal Center for
Drugs 186 Veterinary
Medicine (HFV-
235), Food and
Drug
Administration,
7519 Standish
Pl., Rockville,
MD 20855, 240-276-
9209,
deborah.cera@fda.
hhs.gov
------------------------------------------------------------------------
Common or Usual Names for Animal Feed Ingredients Sharon Benz,
and Their Use in Animal Feed (CPG 7126.08); Draft Center for
Compliance Policy Guide Veterinary
Medicine (HFV-
220), Food and
Drug
Administration,
7519 Standish
Pl., rm. 2648,
Rockville, MD
20855, 240-453-
6864,
esharon.benz@fda.
hhs.gov
------------------------------------------------------------------------
Importation of New Animal Drugs by Licensed Nadine Steinberg,
Veterinarians; Draft Compliance Policy Guide Center for
Veterinary
Medicine (HFV-
200), Food and
Drug
Administration,
MPN4, rm. 2658,
Rockville, MD
20855, 240-453-
6846
nadine.steinberg@
fda.hhs.gov
------------------------------------------------------------------------
[[Page 46019]]
Marketed Unapproved New Animal Drugs; Draft Nadine Steinberg,
Compliance Policy Guide Center for
Veterinary
Medicine (HFV-
200), Food and
Drug
Administration,
MPN4, rm. 2658,
Rockville, MD
20855, 240-453-
6846
nadine.steinberg@
fda.hhs.gov
------------------------------------------------------------------------
VII. Office of the Commissioner
------------------------------------------------------------------------
Title/Topic of Guidance Contact
------------------------------------------------------------------------
Guidance for Sponsors, Clinical Investigators, and Patricia Beers
IRBs; Frequently Asked Questions--Statement of Block, Office of
Investigator (Form FDA 1572) the Commissioner
(HF-34), Food and
Drug
Administration,
5600 Fishers
Lane, Rockville,
MD 20857, 301-827-
3340, FAX: 301-
827-1169
------------------------------------------------------------------------
Guidance for Sponsors, Clinical Investigators, and Sara Goldkind,
IRBs; Data Retention When Subjects Voluntarily Office of the
Withdraw from FDA-Regulated Clinical Trials Commissioner (HF-
34), Food and
Drug
Administration,
5600 Fishers
Lane, Rockville,
MD 20857, 301-827-
3340, FAX: 301-
827-1169
------------------------------------------------------------------------
Guidance for Sponsors, Clinical Investigators, and Marsha Melvin,
IRBs; A Guide to Informed Consent Office of the
Commissioner (HF-
34), Food and
Drug
Administration,
5600 Fishers
Lane, Rockville,
MD 20857, 301-827-
3340, FAX: 301-
827-1169
------------------------------------------------------------------------
Guidance for Sponsors, Clinical Investigators, and Carolyn Hommel,
IRBs; IRBs Continuing Review After Study Approval Office of the
Commissioner (HF-
34), Food and
Drug
Administration,
5600 Fishers
Lane, Rockville,
MD 20857, 301-827-
3340, FAX: 301-
827-1169
------------------------------------------------------------------------
Final Guidance for Sponsors, Industry, Researchers, Jarilyn Dupont,
Investigators, and FDA Staff: Certifications to Office of Policy
Accompany Drug, Biological Product, and Device (HF-11), Food and
Applications/Submissions: Compliance With Section Drug
402(j) of the Public Health Service Act, Added by Administration,
Title VII of the Food and Drug Administration 5600 Fishers
Amendments Act of 2007 Lane, Rockville,
MD 20857, 301-827-
3360
------------------------------------------------------------------------
Final Guidance on Good Reprint Practices Do
------------------------------------------------------------------------
Guidance on Good Importer Practices Sharon Mayl,
Office of Policy
(HF-11), Food and
Drug
Administration,
5600 Fishers
Lane, Rockville,
MD 20857, 301-827-
3360
------------------------------------------------------------------------
Guidance on Private Labs Phil Chao, Office
of Policy (HF-
23), Food and
Drug
Administration,
5600 Fishers
Lane, Rockville,
MD 20857, 301-827-
3360
------------------------------------------------------------------------
[[Page 46020]]
Dated: July 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18126 Filed 8-6-08; 8:45 am]
BILLING CODE 4160-01-S