[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Pages 76011-76015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30623]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0056] (formerly 2004N-0234)
Annual Guidance Agenda
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 either electronic or written comments on this list and on
any agency guidance document at any time.
ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: For general information regarding
FDA's GGP policy contact: Lisa Helmanis, Office of Policy, Food and
Drug Administration, 10903 New Hampshire Ave., WO32, rm. 3216, Silver
Spring, MD 20993-0002, 301-796-9135.
For information regarding specific topics or guidances, please see
contact persons or specific offices listed in the table in the
SUPPLEMENTARY INFORMATION section of this document.
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 in some cases are further grouped within the
issuing Center or Office by topic categories.
II. Center for Biologics Evaluation and Research (CBER)
[[Page 76012]]
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Title/topic of guidance Contact
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CATEGORY--BLOOD AND BLOOD COMPONENTS: Office of Communication,
Changes to an Approved Application: Outreach and Development,
Biological Products: Human Blood and Center for Biologics
Blood Components Intended for Evaluation and Research (HFM-
Transfusion or for Further Manufacture 40), Food and Drug
Implementation of an Acceptable Administration, 1401 Rockville
Abbreviated Donor History Pike, suite 200N, Rockville,
Questionnaire and Accompanying MD 20852-1448, 301-827-1800.
Materials for Use in Screening
Frequent Donors of Blood and Blood
Components
Implementation of Acceptable Full-
Length and Abbreviated Donor History
Questionnaire and Accompanying
Materials for Use in Screening Source
Plasma Donors
Use of Nucleic Acid Tests on Pooled and
Individual Samples From Donors of
Whole Blood and Blood Components
(Including Recovered Plasma, Source
Plasma and Source Leukocytes) to
Adequately and Appropriately Reduce
the Risk of Transmission of Hepatitis
B Virus.
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CATEGORY--CELLULAR, TISSUE, AND GENE Office of Communication,
THERAPY: Outreach and Development,
Preclinical Safety Assessment of Center for Biologics
Investigational Cellular, Gene Evaluation and Research (HFM-
Therapy, and Certain Related Products 40), Food and Drug
Characterization and Qualification of Administration, 1401 Rockville
Cell Banks Used in the Production of Pike, suite 200N, Rockville,
Cellular and Gene Therapy Products MD 20852-1448, 301-827-1800.
Clinical Study Design for Early Phase
Studies of Cellular and Gene
Therapies.
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CATEGORY--OTHER Office of Communication,
Early Clinical Trials With Live Outreach and Development,
Biotherapeutic Products: Chemistry, Center for Biologics
Manufacturing, and Control Information Evaluation and Research (HFM-
Bar Code Label Requirements--Question 40), Food and Drug
and Answer (Update for Vaccines). Administration, 1401 Rockville
Pike, suite 200N, Rockville,
MD 20852-1448, 301-827-1800.
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III. Center for Drug Evaluation and Research (CDER)
For information on the list of topics contact: Office of Training
and Communications, Division of Drug Information, 10903 New Hampshire
Ave., WO51, rm. 2201, Silver Spring, MD 20993, 301-796-3400, FAX: 301-
847-8714, e-mail: [email protected].
Category--Advertising
Amendment of the Brief Summary
Comparative Claims in Prescription Drug Promotion
Direct to Consumer (DTC) Television Advertisements--Food and
Drug Administration Amendments Act of 2007 (FDAAA) DTC Television Pre-
Review Program
Promotion of Prescription Drug Products Using Social Media
Tools
Category--Chemistry
Chemistry, Manufacturing, and Controls (CMC)--Postmarketing
Plan
CMC Postapproval Changes Reportable in an Annual Report
Comparability Protocols for Approved Drugs: CMC Information
Standards Recognition
Residual Drug in Transdermal Drug Delivery Systems
Category--Clinical/Medical
Clinical Development of Drugs for Irritable Bowel Syndrome
Oncology Endpoints: Non-Small Cell Lung Cancer
Qualification Process for Drug Development Tools
Responsible Inclusion of Pregnant Women in Clinical Trials
Category--Clinical Pharmacology
Bioanalytical Methods Validation
Clinical Pharmacogenomics: Study Design and Premarketing
Evaluation
Clinical Pharmacology Consideration for Therapeutics Proteins
General Clinical Pharmacology Considerations for Pediatric
Studies for Drugs and Biological Products
Development of Extended Released Formulations
Category--Clinical/Statistical
Adaptive Trial Designs
Multiple Endpoints
Non-Inferiority Trials
Category--Combination Products
Drug Diagnostic Co-Development
Development of Drugs in Combination
Category--Current Good Manufacturing Practices (CGMPs)/Compliance
Contract Manufacturing
Control of Components
Control of Highly Potent Compounds
Expiration Dating of Unit-Dose Repackaged Drugs: Compliance
Policy Guide
Importation of Active Pharmaceutical Ingredients (API) for Use
in Human Drugs
Medical Gas, General CGMP
Non-Penicillin Beta-Lactam Contamination
Outsourcer Pharmacy Operations Compliance Policy Guide
Pharmaceutical Component Quality Control
Pharmaceutical Manufacturing Statistics
Pre-Launch Activities Importation Request (PLAIR)
Prevention and Control of Viral Contamination
Validation of Air Separation Processes for Medical Gas
Category--Drug Safety Information
Best Practices for Conducting Pharmacovigilance Studies Using
Electronic Healthcare Data
Dear Healthcare Professional Letters
Good Naming, Labeling, and Packaging Practices to Reduce
Medication Errors
Category--Electronic Submissions
Electronic Submission of Summary Level Clinical Site Data for
Data Integrity Review and Inspection Planning in New Drug Application
(NDA) and Biologics License Application (BLA) Submissions
Providing Regulatory Submissions in Electronic Format--
Analysis Datasets and Documentation
Category--Investigational New Drug Application (IND)
Adverse Events: Collection and Reporting for Secondary
Endpoints
[[Page 76013]]
Determining Whether Human Research Studies Can Be Conducted
Without an IND
IND Safety Reporting
Category--Labeling
Drug Names and Dosage Forms
Pediatric Information: Incorporating into Human Prescription
Drug and Biological Products Labeling
Category--Procedural
INDs prepared and submitted by Clinical Sponsor Investigators
IV. Center for Devices and Radiological Health (CDRH)
FDA has established a docket for CDRH, Docket No. FDA-2007-N-0270,
for comments on any or all of the proposed fiscal year 2010 guidance
documents. FDA invites interested persons to submit comments, draft
language on the proposed topics, and/or suggestions for new or
different guidance documents. FDA believes this docket is an important
tool for receiving information from interested parties and for making
information available to the public.
Guidance Related to FDAAA or General Premarket Issues
30-Day notices and 135-day Premarket Approval Application
(PMA)
Supplements
Actions on 510(k) Submissions
Annual Reports for PMAs
Protocol Review Guidance for In Vitro Diagnostics (IVDs)
Tracking Pediatric Device Approvals
Premarket Notification Submissions for Medical Devices That
Include Antimicrobial Agents
Guidance on Postmarket and Compliance Issues
Medical Device Reporting for Manufacturers
Postmarket Surveillance Under Section 522 of the Federal Food,
Drug, and
Cosmetic Act
Electronic Registration and Listing
Manufacturing Site Change Supplements: Content and
Inspectional
Considerations
Quality Systems for Laboratory Developed Tests
Device Specific Guidances
Bacillus spp. Serological Reagents
Clinical Performance Assessment: Considerations for Computer-
Assisted Detection Devices Applied to Radiology Images and Radiology
Device Data
Computer-Assisted Detection Devices Applied to Radiology
Images and
Radiology Device Data--Premarket Notification (510(k)) Submissions
Coronary Drug Eluting Stents
Dental Mouthguards
Helicobacter Pylori
Herpes Simplex Virus
Impact-Resistant Lenses
Invasive Portable Blood Glucose Monitoring Systems
Ovarian Adnexal Mass Surgery Referral Index
Percutaneous Transluminal Coronary Angioplasty Catheters
Suction Apparatus Device Intended for Negative Pressure Wound
Therapy
Tissue Adhesive With Adjunct Wound Closure Device
Topical Oxygen Chamber for Extremities
Transcranial Magnetic Stimulation Systems
Yersinia
Zonisamide and Lamotrigine Assays
Global Harmonization or Standards Related Guidances
Application of IEC 60601-1 Third Edition in Premarket
Applications
Global Harmonization Task Force: Quality Management System;
Process
Validation
Global Harmonization Task Force: Postmarket Surveillance;
National Competent Authority Report Exchange Criteria and Report Form
Crosscutting, Process, and Other Guidances
Radio-Frequency Wireless Technology in Medical Devices
Medical Device Appeals and Complaints: Guidance on Dispute
Resolution
Medical Devices Containing Materials From Animal Sources
(Except IVDs)
V. Center for Food Safety and Applied Nutrition (CFSAN)
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Title/topic of guidance Contact
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New Dietary Ingredient Notifications... Constance Hardy, CFSAN (HFS-
810), Food and Drug
Administration, 5100 Paint
Branch Pkwy., College Park, MD
20740, 301-436-2375,
[email protected].
Fish and Fishery Products Hazards and Thomas Latt, CFSAN (HFS-325),
Controls Guidance (Edition 4). Food and Drug Administration,
5100 Paint Branch Pkwy.,
College Park, MD 20740, 301-
436-1423,
[email protected].
Use of Dietary Guidance Statements..... Blakeley Denkinger, CFSAN (HFS-
830), Food and Drug
Administration, 5100 Paint
Branch Pkwy., College Park, MD
20740, (301-436-2176),
[email protected]
.
Questions and Answers Regarding Food Rhonda Kane, CFSAN (HFS-820),
Allergens, Including the Food Allergen Food and Drug Administration,
Labeling and Consumer Protection Act 5100 Paint Branch Pkwy.,
of 2004 (Edition 5). College Park, MD 20740, 301-
436-1803,
[email protected].
Processing of Acidified Foods.......... Michael Mignogna, CFSAN (HFS-
302), Food and Drug
Administration, 5100 Paint
Branch Pkwy, College Park, MD
20740, 301-436-1515,
[email protected].
Calorie Declaration.................... Vincent DeJesus, CFSAN (HFS-
830), Food and Drug
Administration, 5100 Paint
Branch Pkwy., College Park, MD
20740, 301-436-1774,
[email protected].
Compliance Policy Guide Sec. 527.300 Monica Metz, CFSAN (HFS-316),
Dairy Products-Microbial Contaminants Food and Drug Administration,
and Alkaline Phosphatase Activity 5100 Paint Branch Pkwy,
(Compliance Policy Guide 7106.08). College Park, MD 20740, 301-
436-2041,
[email protected].
Questions and Answers Regarding the Nancy Bufano, CFSAN (HFS-315),
Final Rule, Prevention of Salmonella Food and Drug Administration,
Enteritidis in Shell Eggs During 5100 Paint Branch Pkwy.,
Production, Storage, and College Park, MD 20740., 301-
Transportation. 436-1493,
[email protected].
Prevention of Salmonella Enteritidis in Nancy Bufano, CFSAN (HFS-315),
Shell Eggs During Production, Storage, Food and Drug Administration,
and Transportation. 5100 Paint Branch Pkwy.,
College Park, MD 20740, 301-
436-1493,
[email protected].
[[Page 76014]]
Positive Tests for Salmonella.......... Michael Kashtock, CFSAN (HFS-
317), Food and Drug
Administration, 5100 Paint
Branch Pkwy., College Park, MD
20740, 301-436-2022,
[email protected].
Compliance Policy Guide Sec. 550.050 Joyce Saltzman, CFSAN (HFS-
Canned Ackee, Frozen Ackee, and Ackee 317), Food and Drug
Products--Adulteration With Hypoglycin Administration, 5100 Paint
A. Branch Pkwy., College Park, MD
20740, 301-436-2041,
[email protected].
Assessing the Effects of Significant Annette McCarthy, CFSAN (HFS-
Manufacturing Process Changes, 205), Food and Drug
Including Emerging Technologies, on Administration, 5100 Paint
the Safety and Regulatory Status of Branch Pkwy., College Park, MD
Food Ingredients and Food Contact 20740, 301-436-1057,
Substances, Including Food Ingredients [email protected].
That are Color Additives.
Questions and Answers Regarding Felicia Billingslea, CFSAN (HFS-
Voluntary Registration by Authorized 820), Food and Drug
Officials of Retail Food Administration, 5100 Paint
Establishments and by Vending Machine Branch Pkwy., College Park, MD
Operators Electing to be Subject to 20740, 301-436-2371,
the Menu and Vending Machine Labeling [email protected]
Requirements Established by Section v.
4205 of the Patient Protection and
Affordable Care Act.
Questions and Answers Regarding the Felicia Billingslea, CFSAN (HFS-
Effect of Section 4205 of the Patient 820), Food and Drug
Protection and Affordable Care Act on Administration, 5100 Paint
State and Local Menu and Vending Branch Pkwy., College Park, MD
Machine Labeling Laws. 20740, 301-436-2371,
[email protected].
Safety of Nanoscale Materials in Kapal Dewan, CFSAN (HFS-100),
Cosmetic Products. Food and Drug Administration,
5100 Paint Branch Pkwy.,
College Park, MD 20740, 301-
436-1130,
[email protected].
The Safety of Imported Traditional Michael Kashtock, CFSAN (HFS-
Pottery Intended for Use With Food and 317), Food and Drug
the Improper Use of the Terms ``Lead Administration, 5100 Paint
Free,'' and the Proper Identification Branch Pkwy., College Park, MD
of Ornamental and Decorative Ware. 20740, 301-436-2022,
[email protected].
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VI. Center for Tobacco Products (CTP)
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Title/topic of guidance Contact
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Enforcement Policy Concerning Office of Regulations, Center
Rotational Warning Plans for Smokeless for Tobacco Products, Food and
Tobacco Products. Drug Administration, 9200
Corporate Blvd., Rockville, MD
20850, 301-796-9250.
Compliance With Regulations Restricting ...............................
the Sale and Distribution of
Cigarettes and Smokeless Tobacco to
Protect Children and Adolescents.
Use of ``Light,'' ``Mild,'' ``Low,'' or ...............................
Similar Descriptors in the Label,
Labeling, or Advertising of Tobacco
Products.
``Harmful and Potentially Harmful ...............................
Constituents'' in Tobacco Products as
Used in Section 904(e) of the Federal
Food, Drug, and Cosmetic Act.
Tobacco Product Retailer Training ...............................
Program.
Civil Money Penalties for Tobacco ...............................
Retailers.
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VII. Center for Veterinary Medicine (CVM)
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Title of Guidance Contact
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Draft Guidance for Industry--Safe Phares Okelo, Center for
Animal Feeding. Veterinary Medicine (HFV-226),
Food and Drug Administration,
7519 Standish Pl., MPN-4, rm.
2661, Rockville, MD 20855, 240-
453-6862,
[email protected].
Draft Compliance Policy Guide-- Paul Bachman, Center for
Glucosamine/Chondroitin Animal Veterinary Medicine (HFV-230),
Products. Food and Drug Administration,
7519 Standish Pl., MPN-4, rm.
143, Rockville, MD 20855, 240-
276-9225,
[email protected].
Final Guidance for Industry-- Dennis Bensley, Center for
Comparability Protocols. Veterinary Medicine (HFV-140),
Food and Drug Administration,
7500 Standish Pl., MPN-2, rm.
E334, Rockville, MD 20855, 240-
276-8268,
[email protected].
Draft Guidance for Industry-- Michael Popek, Center for
Fermentation Derived Intermediates, Veterinary Medicine (HFV-144),
Drug Substances, and Related Drug Food and Drug Administration,
Products for Veterinary Medicinal Use-- 7500 Standish Pl., MPN-2, rm.
Chemistry, Manufacturing, and Controls E335, Rockville, MD 20855, 240-
Information. 276-8269,
[email protected].
Final Guidance for Industry--Drug Dennis Bensley, Center for
Substance Chemistry, Manufacturing, Veterinary Medicine (HFV-140),
and Controls Information. Food and Drug Administration,
7500 Standish Pl., MPN-2, rm.
E334, Rockville, MD 20855, 240-
276-8268,
[email protected].
Draft Guidance for Industry--Active Urvi Desai, Center for
Controls in Studies to Demonstrate Veterinary Medicine (HFV-110),
Effectiveness of a New Animal Drug for Food and Drug Administration,
Use in Companion Animals. 7520 Standish Pl., MPN-1, rm.
203, Rockville, MD 20855, 240-
276-8297,
[email protected].
Draft Guidance for Industry--Judicious William Flynn, Center for
Use of Antimicrobial Drugs in Food- Veterinary Medicine (HFV-1),
Producing Animals. Food and Drug Administration,
7519 Standish Pl. MPN-4, rm.
173, Rockville, MD 20855, 240-
276-9084,
[email protected].
[[Page 76015]]
Draft Guidance for Industry--Active Lisa Troutman, Center for
Controls in Studies to Demonstrate the Veterinary Medicine (HFV-116),
Effectiveness of a New Drug for Use in Food and Drug Administration,
Companion Animals. 7500 Standish Pl., MPN-2, rm.
N319, Rockville, MD 20855, 240-
276-8322,
[email protected].
Residual Solvents in Animal Drug Sudesh Kamath, Center for
Products; Questions and Answers. Veterinary Medicine (HFV-145),
Food and Drug Administration,
7500 Standish Pl., MPN-2, rm.
E365, Rockville, MD 20855, 240-
276-8260,
[email protected].
Draft Guidance for Industry--Updating William Flynn, Center for
Labeling of Certain Antimicrobial New Veterinary Medicine (HFV-1),
Animal Drug Products for Use in the Food and Drug Administration,
Feed or Water of Food-Producing 7519 Standish Pl., MPN-4, rm.
Animals. 173, Rockville, MD 20855, 240-
276-9084,
[email protected].
Final Guidance for Industry--Bracketing Dennis Bensley, Center for
and Matrixing Designs for Stability Veterinary Medicine (HFV-140),
Testing of New Veterinary Drug Food and Drug Administration,
Substances and Medicinal Products, 7500 Standish Pl., MPN-2, rm.
VICH GL-45. E334, Rockville, MD 20855, 240-
276-8268,
[email protected].
Revised Draft Guidance for Industry-- Mai, Huynh, Center for
Impurities: Residual Solvents In New Veterinary Medicine, (HFV-
Veterinary Medicinal Products, Active 142), Food and Drug
Substances and Excipients, VICH Administration, 7500 Standish
GL18(R). Pl., Rockville, MD 20855, 240-
276-8273,
[email protected].
Draft Guidance for Industry--Evaluating Emily R. Smith, (HFV-135),
the Effectiveness of Anticoccidial Center for Veterinary
Drugs in Food-Producing Animals. Medicine, Food and Drug
Administration, 7500 Standish
Pl., Rockville, MD 20855, 240-
276-8344, e-mail:
[email protected].
Draft Guidance for Industry--Protocol Angela Clarke, Center for
Submissions for the Division of Veterinary Medicine (HFV-105),
Therapeutic Drugs for Non-Food Animals Food and Drug Administration,
the Division of Production Drugs, and 7500 Standish Pl., Rockville,
the Division of Therapeutic Drugs for MD 20855, 240-276-8318; e-
Food Animals. mail:
[email protected].
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VIII. Office of the Commissioner
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Guidance title/TOPIC OC Contact
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Classification of products as John Weiner, Office of
biological products, devices, and drugs. Combination Products,
Food and Drug
Administration, 10903
New Hampshire Ave,
Silver Spring, MD 20993
301-796-8941.
Interpretation of the term Do.
``chemical action' in definition of device
under section 201(h) of the Federal Food,
Drug, and Cosmetic Act.
Types of submissions for Do.
postapproval changes to combination products.
Information Sheet Guidance for Bridget Foltz, Office of
Institutional Review Boards, Clinical Good Clinical Practices,
Investigators, and Sponsors--FDA Inspections Food and Drug
of Clinical Investigators Administration, 10903
Describes FDA's inspectional process when the New Hampshire Avenue,
agency inspects the site of an investigator Silver Spring, MD 20993,
who is conducting a clinical study regulated 301-796-8348.
by FDA.
Draft Information Sheet Guidance for Sara Goldkind (301-796-
Institutional Review Boards, Clinical 8342), Marsha Melvin
Investigators, and Sponsors--A Guide to (301-796-8345), Office
Informed Consent of Good Clinical
Describes in detail basic and additional Practices, Food and Drug
elements of informed consent and includes Administration, 10903
topics such as review of patient records, New Hampshire Ave.,
children as subjects, and subject Silver Spring, MD 20993.
participation in more than one study.
Guidance for Institutional Review Sara Goldkind, Office of
Boards, Clinical Investigators, and Good Clinical Practices,
Sponsors--Exception From Informed Consent Food and Drug
Requirements for Emergency Research Administration, 10903
This final guidance is intended to assist New Hampshire Ave.,
sponsors, clinical investigators, and IRBs Silver Spring, MD 20993,
in the development, conduct, and oversight 301-796-8348.
of research involving FDA-regulated products
(e.g., drugs, biological products, devices)
in emergency settings when an exception from
the informed consent requirements is
requested under 21 CFR 50.24. In particular,
the guidance clarifies FDA's expectations
related to planning and conducting community
consultation and public disclosure
activities, and the establishment of
informed consent procedures to be used when
feasible.
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Dated: December 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30623 Filed 12-6-10; 8:45 am]
BILLING CODE 4160-01-P