Annual Guidance Agenda, 46008-46020 [E8-18126]
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46008
Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices
Dated: July 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–18128 Filed 8–6–08; 8:45 am]
BILLING CODE 4160–01–S
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: https://
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 email. 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 https://
www.regulations.gov, including any
personal information provided.
Docket: For access to the docket to
read background documents or
comments received, go to https://
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
Same as above (Do)
Assessment of Donors of Blood and Blood Components for Transfusion Transmitted Malaria Risk
Do
Use of Serological of Tests on Samples from Donors 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
sroberts on PROD1PC70 with NOTICES
Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion
Do
CATEGORY—VACCINES AND ALLERGENICS
Considerations for the Development of Vaccines to Protect Against Global Infectious Diseases
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Contact
Considerations for the Development of Products that Contain Whole, Live Microorganisms with an Intended Therapeutic or Preventive Effect in Humans
Do
CATEGORY—CELLULAR, TISSUE, AND GENE THERAPY
Potency Tests for Cell and Gene Therapy Products
Do
Characterization and Qualification of Cell Banks Used in the Production of Cellular and Gene Therapy
Products
Do
Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments
Do
Preparation of INDs for Certain Unlicensed Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Products (HPC-C)
Do
Clinical Study Design for Early Phase Studies of Cellular and Gene Therapies
Do
Clinical Study Design Considerations for Cancer Vaccine Development
Do
Somatic Cell Therapy for Cardiac Disease
Do
Determination of Homologous Use Designation
Do
Devices Involved in Manufacture, Storage and Administration of Cellular Products and Tissues
Do
Preparation of Investigational Device Exemptions and Investigational New Drugs for Tissue Engineered
and Regenerative Medicine Products
Do
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 Drug and Medical Device Promotion
Do
CATEGORY—CHEMISTRY
Assay Development for Immunogenicity Testing
Do
CMC Post-Approval Changes Reportable in an Annual Report
Do
Immunogenicity Assessment for Therapeutic Protein Products
Do
Incorporation of Physical-chemical Indentifiers (PCID) into Solid Oral Dosage Form Drug Products for
Anticounterfeiting
Do
Standards Recognition
Do
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug
Products Terminally Sterilized by Moist Heat Processes
Do
CATEGORY—CLINICAL/MEDICAL
Do
Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention
sroberts on PROD1PC70 with NOTICES
Adaptive Trial Designs
Do
Oncology Endpoints: Non-Small Cell Lunch Cancer
Do
Pain Management: Developing Drug and Biological Products
Do
Risk Management of Highly Suspect or Known Human Teratogens: Pregnancy Prevention Strategies
Do
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Title/Topic of Guidance
Contact
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 Policy Guide, Section 460.200
Do
Penicillins and Their Definition
Do
PET CGMPs
Do
Pre-Launch Activities Importation Request (PLAIR)
Do
Process Validation: General Principles and Practices
Do
CATEGORY—DRUG SAFETY INFORMATION
Contents of a Complete Submission Package for a Proposed Proprietary Drug or Biologic Name
Do
Dear Healthcare Professional Letters
Do
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During Pandemic Influenza
Do
CATEGORY—ELECTRONIC SUBMISSIONS
Providing Regulatory Submissions in Electronic Format—Analysis Datasets and Documentation
Do
CATEGORY—GENERICS
Submission of Summary Bioequivalence Data for ANDAs
Do
CATEGORY—IND
Consumer Product Safety Commission—Tamper Resistant Packaging for INDs
Do
Determining Whether Human Research Studies Can Be Conducted Without an IND
Do
CATEGORY—LABELING
Content and Format of the Clinical Pharmacology Section
Do
Drug Names and Dosage Forms
Do
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
Do
Labeling Dietary Supplements for Women Who are or Could be Pregnant
Do
Labeling Guidance for Inclusion and Placement of Safe Handling Statements in Package Inserts for
Human Pharmaceuticals
Do
CATEGORY—OTC
sroberts on PROD1PC70 with NOTICES
Label Comprehension Studies for OTC Drug Products
Do
Labeling of OTC Skin Protectant Drug Products
Do
CATEGORY—PHARMACOLOGY/TOXICOLOGY
Biotechnology-Derived Pharmaceuticals: Nonclinical Safety Evaluation
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Title/Topic of Guidance
Contact
Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches
Do
Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration
by an Alternate Route
Do
CATEGORY—PROCEDURAL
Assessment of Abuse Potential of Drugs
Do
Determining Whether Human Research With a Radioactive Drug Can Be Conducted Under a Radioactive Drug Research Committee (RDRC)
Do
Formal Meeting Between CDER/CBER Staff and Sponsors
Do
Integrated Summary of Effectiveness
Do
IV. Center for Devices and Radiological
Health (CDRH)
Title
Contact Person
Office of Compliance
Tim Ulatowski, Center for Devices
and Radiological Health (HFZ–
300), 2094 Gaither Rd., Rockville, MD 20850, 240–276–0100
Surveillance and Detention Without Physical Examination of Condoms
Do
Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination
Gloves
Do
Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)
Do
Manufacturing Site Change Supplements: Content and Inspectional Considerations
Do
Using the Global Harmonization Task Force (GHTF) Clinical Evaluation Guidance (SG5/N2R8:2007) for
Medical Devices
Do
Using the Global Harmonization Task Force (GHTF) Quality Management System—Process Validation
SG3/N99–10:2004 for Medical Devices
Do
Guidance on the Third Party Inspection Program for Medical Devices (FDAAA)
Do
Guidance on Submitting International Standards Organization (ISO) 13485 Audits to FDA for Medical
Devices Under the Food and Drug Administration Amendments Act of 2007 (FDAAA)
Do
30-Day Notices and 135-Day PMA Supplements (FDAAA)
Do
Regulatory Requirements for Foreign and Domestic Dental Laboratories
Do
Using the Global Harmonization Task Force (GHTF) SG1/N041:2005 Essential Principles of Safety &
Performance for Medical Devices
Do
Using the Global Harmonization Task Force (GHTF) SG1 PD/N0011 Summary Technical Documentation
(STED) for Demonstrating Conformity to the Essential Principles for Medical Devices
Do
Using the Global Harmonization Task Force (GHTF) SG3N17 (Proposed) Quality Management System
Medical Devices management of procured products, outsourced processes and their suppliers
Do
Using the Global Harmonization Task Force (GHTF) SG3 (Proposed) Criteria for Characterizing the Significance of Quality Management System Deficiencies for Medical Devices
sroberts on PROD1PC70 with NOTICES
Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007 (FDAAA)
Do
Using the Global Harmonization Task Force (GHTF) 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)
Do
Office of Communication, Education, and Radiation Programs (OCER)
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Title
Contact Person
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 Guidance
Joel Myklebust, 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 Submissions
William Midgette, 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 Premarket Applications
Alford Taylor, Jr. Center for Devices and Radiological Health,
10903 New Hampshire Ave., Silver Spring, MD 20933, 301–796–
2583
Premarket Clearance of Diagnostic Ultrasound Imaging Systems
Larry Grossman, 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 ultrasound therapy systems in lieu of older BRH mandatory standard
Do
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 Premarket Notification (510k) and Investigational Device Exemption Submissions
Joel Myklebust, Center for Devices
and Radiological Health, 10903
New Hampshire Ave., Silver
Spring, MD 20933, 301–796–
2491
Office of Surveillance and Biometrics
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
sroberts on PROD1PC70 with NOTICES
Bayesean Statistics
Howard Press, Center for Devices
and Radiological Health (HFZ–
530), 1350 Piccard Dr., Rockville,
MD 20850, 240–276–3457
CDRH Postmarket Problem Codes
Do
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Title
Contact Person
Global Harmonization Task Force (GHTF) Guidance on How to Handle Information Concerning Vigilance
Reporting Related to Medical Devices
Do
FDA’s Use of Global Harmonization Task Force (GHTF) Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form for Medical Devices
Do
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 Metapneumovirus (hMPV) Nucleic Acid Assays
Sally Hojvat, Center for Devices
and Radiological Health (HFZ–
440), 2098 Gaither Rd., Rockville
MD 20850, 240–276–0711
Class II Special Control Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay
Do
Class II Special Controls Guidance Document: Nucleic Acid Assay for Detection and Differentiation of Influenza A Virus Subtypes
Do
Special Controls Guidance Document: Bacillus spp. Serological Reagents; Guidance for Industry and
FDA
Do
Adverse Event Reporting for IVD’s (with appendix on glucose meters)
Claudia Gaffey, Center for Devices
and Radiological Health (HFZ–
440), 2098 Gaither Rd., Rockville
MD 20850, 240–276–0718
Class II Special Control Guidance Document: Enterovirus Nucleic Acid Assays
Uwe Scherf, Center for Devices
and Radiological Health (HFZ–
440), 2098 Gaither Rd., Rockville
MD 20850, 240–276–0725
Therapeutic Drug Monitoring Assays: Zonisamide and Lamotrigine
Avis Danishefsky, 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 Procedures
Carol Benson, Center for Devices
and Radiological Health (HFZ–
440), 2098 Gaither Rd., Rockville
MD 20850, 240–276–0396
Class II Special Control Guidance Document: Plasmodium Species Antigen Detection Assays
Freddie Poole, 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)
sroberts on PROD1PC70 with NOTICES
Pediatric HDEs—Guidance for IRBs
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Stephen Rhodes, Center for Devices and Radiological Health
(HFZ–403), 9200 Corporate
Blvd., Rockville, MD 20850, 240–
276–4036
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Title
Contact Person
Bram Zuckerman, 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 Notification Submissions
Chiu Lin, Center 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 Submissions
Samie Niver Allen, 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 Medical Device User Fees
Les Weinstein, 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 Notification Submissions
Heather Rosecrans, 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
sroberts on PROD1PC70 with NOTICES
Sex Differences in Clinical Evaluation of Cardiovascular Devices
Barbara Buch, Center for Devices
and Radiological Health (HFZ–
410), 9200 Corporate Blvd.,
Rockville, MD 20850, 240–276–
4000
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Title
Contact Person
Mark Melkerson, 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 Recommendations
Malvina Eydelman, 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 Indication
Chiu Lin, Center for Devices and
Radiological Health (HFZ–480),
9200 Corporate Blvd., Rockville,
MD 20850, 240–276–3742
Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities
Do
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 Skin
Do
FDA and Industry Actions on Premarket Approval Application
Samie Niver Allen, 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 Recommendations
Nancy Brogdon, Center for Devices
and Radiological Health (HFZ–
470), 9200 Corporate Blvd.,
Rockville, MD 20850, 240–276–
3650
Guidance on Dental Mouthguards
sroberts on PROD1PC70 with NOTICES
Trial Considerations for Hip Joint Replacement Systems
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
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Title
Contact Person
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 Guidances
Mark Melkerson, Center for Devices and Radiological Health
(HFZ–410), 9200 Corporate
Blvd., Rockville, MD 20850, 240–
276–3737
Sterile Devices in Premarket Notification (510(k)) Submissions
Chiu Lin, Center 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
Linda Pellicore, CFSAN (HFS–
810), 5100 Paint Branch Pkwy.,
College Park, MD 20740, 301–
436–1448,
linda.pellicore@fda.hhs.gov
Fish and Fishery Products Hazards and Control Guidance (Edition 4)
Robert Samuels, CFSAN (HFS–
325), 5100 Paint Branch Pkwy.,
College Park, MD 20740 301–
436–1418, robert.samuels@fda.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 Format—Food Additive Petitions, Color Additive Petitions,
Food Contact Notifications, Food Master Files, GRAS Notices, Biotechnology Consultations, and New
Protein Consultations
sroberts on PROD1PC70 with NOTICES
New Dietary Ingredient Notifications Guidance
Berhane Girmay, CFSAN (HFS–
205), 5100 Paint Branch Pkwy.,
College Park, MD 20740, 301–
436–1194,
berhane.girmay@fda.hhs.gov
Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer
Protection Act of 2004 (Edition 5)
Rhonda Kane, CFSAN (HFS–820),
5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–
1803, rhonda.Kane@fda.hhs.gov
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Title/Topic of Guidance
Contact
The Seafood List—FDA’s Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce
Spring Randolph, CFSAN (HFS–
325), 5100 Paint Branch Pkwy.,
College Park, MD 20740, 301–
436–1421,
spring.randolph@fda.hhs.gov
Small Entity Compliance Guide: ‘‘Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements’’
Vasilios Frankos, CFSAN (HFS–
810), 5100 Paint Branch 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.hhs.gov
VI. Center for Veterinary Medicine
Title of Guidance
Contact
Larisa Rudenko, Center for Veterinary Medicine (HFV–100), Food
and Drug Administration, 7500
Standish Pl., Rockville, MD
20855, 240–276–8245, e-mail:
larisa.rudenko@fda.hhs.gov
Labeling and Marketing of Nutritional Products for Dogs and Cats Intended to Diagnose, Cure, Mitigate,
Treat, or Prevent Diseases—Compliance Policy Guide—Final
William J. Burkholder, Center for
Veterinary Medicine (HFV–228),
Food and Drug Administration,
7519 Standish Pl., MPN–4, rm.
2642, Rockville, MD 20855, william.burkholder@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 Manufacturing Facilities—Compliance Policy Guide
Paul Bachman, 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 Guide
Xin Li, Center for 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.gov
Criteria for Evaluating Tests for Detection of Animal Proteins Prohibited in Ruminant Feed
sroberts on PROD1PC70 with NOTICES
Regulation of Genetically Engineered (GE) Animals Containing Heritable nDNA Constructs
Dragan Momcilovic, Center for Veterinary Medicine (HFV–220),
7519 Standish Pl., MPN–4, rm.
227, Rockville, MD 20855, 240–
453–6856,
dragan.momcilovic@fda.hhs.gov
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Title of Guidance
Contact
Paul Bachman, 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 Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Final Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products GL–43
Laura Hungerford, Center for Veterinary Medicine (HFV–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 Adverse Drug Event Reports to the Center for Veterinary
Medicine, Form FDA 1932
Lynn Post, Center for Veterinary
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 Reports (DER) to the Center for Veterinary Medicine, Form FDA 2301
Lynn Post, Center for Veterinary
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 Analyses
Bob Abugov, Center 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 NADAs—New NADA or Supplemental NADA
Suzanne Sechen, 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@fda.hhs.gov
Draft Guidance for Industry—Anesthetics for Companion Animals
Germaine Connolly, 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 From the Extralabel Use of Approved New Animal
Drugs #186
Deborah Cera, Center for 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 and Their Use in Animal Feed (CPG 7126.08);
Draft Compliance Policy Guide
sroberts on PROD1PC70 with NOTICES
Glucosamine/Chondroitin Animal Products Compliance Policy Guide
Sharon Benz, Center for 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 Veterinarians; Draft Compliance Policy Guide
Nadine Steinberg, Center for Veterinary Medicine (HFV–200),
Food and Drug Administration,
MPN4, rm. 2658, Rockville, MD
20855, 240–453–6846 nadine.steinberg@fda.hhs.gov
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Title of Guidance
Contact
Marketed Unapproved New Animal Drugs; Draft Compliance Policy Guide
Nadine Steinberg, 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
Patricia Beers Block, 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 IRBs; Data Retention When Subjects Voluntarily Withdraw from FDA-Regulated Clinical Trials
Sara Goldkind, 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 IRBs; A Guide to Informed Consent
Marsha Melvin, 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 IRBs; IRBs Continuing Review After Study Approval
Carolyn Hommel, 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, Investigators, and FDA Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance With Section 402(j) of
the Public Health Service Act, Added by Title VII of the Food and Drug Administration Amendments Act
of 2007
Jarilyn Dupont, Office of Policy
(HF–11), Food and Drug Administration, 5600 Fishers 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
sroberts on PROD1PC70 with NOTICES
Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions—Statement of Investigator (Form FDA 1572)
Phil Chao, Office of Policy (HF–23),
Food and Drug Administration,
5600 Fishers Lane, Rockville,
MD 20857, 301–827–3360
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–M–0208]
Medical Devices Regulated by the
Center for Biologics Evaluation and
Research; Availability of Summaries of
Safety and Effectiveness Data for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved by the
Center for Biologics Evaluation and
Research (CBER). This list is intended to
inform the public of the availability
through the Internet and FDA’s Division
of Dockets Management of summaries of
safety and effectiveness data of
approved PMAs.
ADDRESSES: Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Please include the appropriate docket
number as listed in table 1 of this
document when submitting a written
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the summaries of safety and
effectiveness data.
FOR FURTHER INFORMATION CONTACT:
Tiffany Brown, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, suite
200N, 1401 Rockville Pike, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
final rule that revised 21 CFR 814.44(d)
and 814.45(d) to discontinue individual
publication of PMA approvals and
denials in the Federal Register,
providing instead to post this
information on the Internet at https://
www.fda.gov. In addition, the
regulations provide that FDA publish a
quarterly list of available safety and
effectiveness summaries of PMA
approvals and denials that were
announced during the quarter. FDA
believes that this procedure expedites
public notification of these actions
because announcements can be placed
on the Internet more quickly than they
can be published in the Federal
Register, and FDA believes that the
Internet is accessible to more people
than the Federal Register.
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the act.
The 30-day period for requesting
administrative reconsideration of an
FDA action under § 10.33(b) (21 CFR
10.33(b)) for notices announcing
approval of a PMA begins on the day the
notice is placed on the Internet. Section
10.33(b) provides that FDA may, for
good cause, extend this 30-day period.
Reconsideration of a denial or
withdrawal of approval of a PMA may
be sought only by the applicant; in these
cases, the 30-day period will begin
when the applicant is notified by FDA
in writing of its decision.
The following is a list of PMAs
approved by CBER for which summaries
of safety and effectiveness data were
placed on the Internet from April 1,
2008, through June 30, 2008. There were
no denial actions during this period.
The list provides the manufacturer’s
name, the product’s generic name or the
trade name, and the approval date.
TABLE 1. LIST OF SUMMARIES OF SAFETY AND EFFECTIVENESS DATA FOR APPROVED PMAS MADE AVAILABLE APRIL 1,
2008, THROUGH JUNE 30, 2008
PMA No./Docket No.
BP050051/0/FDA–2008–M–0208
II.Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cber/products.htm.
Applicant
Trade Name
Approval Date
Ortho-Clinical Diagnostics,
Inc.
VITROS Immunodiagnostics Products AntiHIV 1+2 Calibrator, and VITROS
Immunodiagnostics Products Anti-HIV
1+2 Reagent Pack
March 27, 2008
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0413]
Dated: July 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–18125 Filed 8–6–08; 8:45 am]
Draft Guidance for Industry on
Residual Solvents in Drug Products
Marketed in the United States;
Availability
BILLING CODE 4160–01–S
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
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Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
DATES:
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Control of Residual
Solvents in Drug Products Marketed in
VerDate Aug<31>2005
the United States.’’ On July 1, 2008, the
United States Pharmacopeia (USP)
published a new test requirement for the
control of residual solvents, General
Chapter <467> ‘‘Residual Solvents,’’
which replaced USP General Chapter
<467> ‘‘Organic Volatile Impurities.’’
The change affects all compendial drug
products marketed in the United States.
This draft guidance reflects FDA’s
recommendations on how to comply
with those USP changes.
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]]>Agencies
[Federal Register Volume 73, Number 153 (Thursday, August 7, 2008)]
[Notices]
[Pages 46008-46020]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-18126]
-----------------------------------------------------------------------
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: https://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 https://www.regulations.gov, including any personal
information provided.
Docket: For access to the docket to read background documents or
comments received, go to https://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
Pa
