Document ID: FDA-2004-N-0056-0012
Agency: fda
Document Type: Notice
Title: Annual Guidance Agenda - Notice
Posted Date: 2010-12-07T05:00Z

[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Pages 76011-76015]
From the Federal Register Online via the Government Printing 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]]

------------------------------------------------------------------------
        Title/topic of guidance                      Contact
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

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: druginfo@fda.hhs.gov.

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)

------------------------------------------------------------------------
        Title/topic of guidance                      Contact
------------------------------------------------------------------------
New Dietary Ingredient Notifications...  Constance Hardy, CFSAN (HFS-
                                          810), Food and Drug
                                          Administration, 5100 Paint
                                          Branch Pkwy., College Park, MD
                                          20740, 301-436-2375,
                                          Constance.Hardy@fda.hhs.gov.
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,
                                          Thomas.Latt@fda.hhs.gov.
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),
                                          Blakeley.Denkinger@fda.hhs.gov
                                          .
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,
                                          Rhonda.Kane@fda.hhs.gov.
Processing of Acidified Foods..........  Michael Mignogna, CFSAN (HFS-
                                          302), Food and Drug
                                          Administration, 5100 Paint
                                          Branch Pkwy, College Park, MD
                                          20740, 301-436-1515,
                                          Michael.Mignogna@fda.hhs.gov.
Calorie Declaration....................  Vincent DeJesus, CFSAN (HFS-
                                          830), Food and Drug
                                          Administration, 5100 Paint
                                          Branch Pkwy., College Park, MD
                                          20740, 301-436-1774,
                                          Vincent.Dejesus@fda.hhs.gov.
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,
                                          Monica.Metz@fda.hhs.gov.
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,
                                          Nancy.Bufano@fda.hhs.gov.
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,
                                          Nancy.Bufano@fda.hhs.gov.

[[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,
                                          Michael.Kashtock@fda.hhs.gov.
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,
                                          Joyce.Saltzman@fda.hhs.gov.
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   Annette.McCarthy@fda.hhs.gov.
 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    Felicia.Billingslea@fda.hhs.go
 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,
                                          Felicia.Billingslea@fda.hhs.gov.
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,
                                          Kapal.Dewan@fda.hhs.gov.
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,
                                          Michael.Kashtock@fda.hhs.gov.
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VI. Center for Tobacco Products (CTP)

------------------------------------------------------------------------
        Title/topic of guidance                      Contact
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

VII. Center for Veterinary Medicine (CVM)

------------------------------------------------------------------------
           Title of Guidance                         Contact
------------------------------------------------------------------------
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,
                                          phares.okelo@fda.hhs.gov.
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,
                                          paul.bachman@fda.hhs.gov.
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,
                                          dennis.bensley@fda.hhs.gov.
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,
                                          michael.popek@fda.hhs.gov.
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,
                                          dennis.bensley@fda.hhs.gov.
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,
                                          urvi.desai@fda.hhs.gov.
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,
                                          William.flynn@fda.hhs.gov.

[[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,
                                          lisa.troutman@fda.hhs.gov.
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,
                                          sudesh.kamath@fda.hhs.gov.
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,
                                          William.flynn@fda.hhs.gov.
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,
                                          dennis.bensley@fda.hhs.gov.
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,
                                          Mai.huynh@fda.hhs.gov.
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:
                                          emily.smith2@fda.hhs.gov.
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:
                                          angela.clarke@fda.hhs.gov.
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VIII. Office of the Commissioner

------------------------------------------------------------------------
             Guidance title/TOPIC                      OC Contact
------------------------------------------------------------------------
 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.
------------------------------------------------------------------------

    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