FDA/Office for Policy Response to the International Center for Technology Assessment - Partial Petition Approval/Denial

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FDA Office for Policy Response to the International Center for Technology Assessment Partial Petition Approval Denial

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Abstract: Andrew Kimbrell Partial Petition Approval/ Denial
 

List of References Related to FDAs Response to International Center for Technology Assessment ICTA et al Citizen Petition

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Reference 1 Alliance for Bio Integrity et al v Shalala 116 F Supp 2d 66 2000

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Reference 2 Australia National Industrial Chemicals Notification and Assessment Scheme NICNAS

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Publication Reference: Chemical Gazette, No. C. 10. 05. October 2010
 

Reference 3 Chaudhry et al Applications and Implications of Nanotechnologies for the Food Section

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Publication Reference: Food Additives & Contaminants: Part A, 25: 3, 241 - 258
 

Reference 4 Chen et al Food Protein Based Materials as Nutraceutical Delivery Systems

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Publication Reference: Trends in Food Science & Technology 17, 272 - 283 2006
 

Reference 5 European Commission Recommendations on the Definition of Nanomaterial October 18 2011

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Publication Reference: Official Journal of the European Union. 275.38. October 20, 2011
 

Reference 6 European Commission Draft Recommendations on the Definition of Nanomaterial October 2010

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Publication Reference: Official Journal of the European Union. June 2011
 

Reference 7 Environmental Protection Agency Proposed Policy Statement Pesticides Policies Concerning Products Containing Nanoscale...

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Publication Reference: 76 FR 35383 June 17 2011
 

Reference 8 Food and Drug Administration Notice of Public Meeting Request for Comments Regulated Products Containing...

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Reference 9 Food and Drug Administration Nanotechnology Task Force Nanotechnology Task Force Report July 23 2007

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Abstract: ...Nanotechnology A Report of the U.S. Food and Drug Administration Nanotechnology Task Force July 25 2007
Publication Reference: Nanotechnology Task Force Report July 23, 2007
 

Reference 10 Food and Drug Administration Guidance for Industry Preparation of Premarket Submission for Food Contact Substances...

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Publication Reference: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm081818.htm
 

Reference 11 Food and Drug Administration Notice of Public Meeting Request for Comments Consideration of FDA Regulated Products...

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Reference 12 Food and Drug Administration Guidance for Industry Recommendations for Submission of Chemical and Technological Data...

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Reference 13 Food and Drug Administration Guidance for Industry Color Additive Petitions FDA Recommendations for submission of...

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Publication Reference: http://www.fda.gov/ForIndustry/ColorAdditives/GuidanceComplianceRegulatoryInformation/ucm171631.htm
 

Reference 14 Food and Drug Administration Center for Drug Evaluation and Research Office of Pharmaceutical Science Nanotechnology...

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Reference 15 Food and Drug Administration Notice of Public Workshop Request for Comments Public Workshop on Medical Devices and...

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Reference 16 Food and Drug Administration Draft Guidance for Industry Considering Whether an FDA Regulated Product Involves the...

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Reference 17 Food and Drug Administration Draft Guidance for Industry Considering Whether an FDA Regulated Product Involves the...

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Abstract: ...re FDA–2010–D–0530
 

Reference 18 Food and Drug Administration Draft Guidance for Industry Dietary Supplements New Dietary Ingredient Notifications and...

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Reference 19 Food and Drug Administration Center for Devices and Radiological Health Draft Guidance for Industry 510k Device...

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Reference 20 Food and Drug Administration Center for Veterinary Medicine Review on ONADE Regulated Products that Contain...

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Reference 21 Food and Drug Administration Nanotechnology Regulatory Science Research Plan

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Publication Reference: http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm273325.htm
 

Reference 22 Food and Drug Administration 2010 Meeting Materials Science Board to the Food and Drug Administration

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Publication Reference: http://www.fda.gov/advisorycommittees/committeesmeetingmaterials/scienceboardtothefoodanddrugadministration/ucm198503.htm
 

Reference 23 Food and Drug Administration 2011 Meeting Materials Science Board to the Food and Drug Administration

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Publication Reference: http://www.fda.gov/advisorycommittees/committeesmeetingmaterials/scienceboardtothefoodanddrugadministration/ucm241888.htm
 

Reference 24 Food and Drug Administration, Selected FDA Publications Related to Applications of Nanotechnology April 2012

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Reference 25 Health Canada Interim Policy Statement on Health Canadas Working Definition for Nanomaterials 2010

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Reference 26 Health Canada Policy Statement on Health Canadas Working Definition for Nanomaterials 2011

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Publication Reference: http://www.hc-sc.gc.ca/sr-sr/pubs/nano/pol-eng.php
 

Reference 27 International Organization for Standardization Technical Specification Nanotechnologies Vocabulary Part 1 Core Terms...

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Reference 28 Joint Research Centre Reference Reports Lovestam et al Consideration on a Definition of Nanomaterial for Regulatory...

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Publication Reference: Luxembourg Publications Office of the European Union; PUBSY: JRC58726 EUR 24403 EN; ISBN 978-92-79-16014-1 ISSN 1018-5593; doi 10.2788/98686
 

Reference 29 Kaittanis et al Emerging Nanotechnology Based Strategies for the Identification of Microbial Pathogenesis

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Publication Reference: Advanced Drug Delivery Reviews 62:408–423
 

Reference 30 Merisko Liversidge et al Drug Nanoparticles formulating Poorly Water Soluble Compounds

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Publication Reference: Toxicol Pathol 36:43
 

Reference 31 National Cancer Institute Alliance for Nanotechnology in Cancer Frequently Asked Questions Cancer Nanotechnology

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Publication Reference: http://nano.cancer.gov/learn/understanding/faq.asp August 2011 Accessed April 12, 2012
 

Reference 32 National Nanotechnology Initiative Nano What it is and How it Works

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Publication Reference: http://www.nano.gov/nanotech-101/what. Accessed April 12, 2012
 

Reference 33 Paciotti et al Colloidal Gold A Novel Nanoparticle Vector for Tumor Directed Drug Delivery

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Publication Reference: Drug Delivery, 11: 169–183
 

Reference 34 Pray et al Nanotechnology in Food Products Institute of Medicine Workshop Summary 2009

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Publication Reference: IOM Institute of Medicine 2009 Nanotechnology in Food Products Workshop Summary Washington DC The National Academies Press
 

Reference 35 Powers et al Research Strategies for Safety Evaluation of Nanomaterials Part VI Characterization of Nanoscale...

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Publication Reference: Toxicological Sciences 90(2) 296–303
 

Reference 36 Sadrieh et al Lack of Significant Dermal Penetration of Titanium Dioxide From Sunscreen Formulations Containing Nano...

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Publication Reference: Toxicological Sciences 115(1):156–166
 

Reference 37 Scientific Committee on Emerging and Newly Identified Health Risks SCHENIHR Scientific Basis for the Definition of...

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Publication Reference: European Union 2010
 

Reference 38 Scientific Committee on Emerging and Newly Identified Health Risks SCHENIHR Scientific Basis for the Definition of...

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Publication Reference: European Union 2010
 

Reference 39 United States Government Memorandum for the Heads of Executive Departments and Agencies Principles for Regulation and...

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Reference 40 United States Government Memorandum for the Heads of Executive Departments and Agencies Policy Principles for the US...

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Reference 41 Australia Therapeutic Goods Administration Report A Review of the Scientific Literature on the Safety of...

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Publication Reference: http://www.tga.gov.au/pdf/review-sunscreens-060220.pdf Accessed April 12, 2012
 

Reference 42 Bennat et al Skin Penetration and Stabilization of Formulations Containing Microfine Titanium Dioxide as a Physical...

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Publication Reference: International J Cosmet Sci, 22(4): 271-283
 

Reference 43 Crosera et al Nanoparticle Dermal Absorption and Toxicity A Review of the Literature 2009

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Publication Reference: Int Arch Occup Environ Health, 82(9): 1043-1055
 

Reference 44 Cross et al Human Skin Penetration of Sunscreen Nanoparticles In-Vitro Assessment of a Novel Micronized Zinc Oxide...

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Publication Reference: Skin Pharmacology and Physiology, 20: 148-154
 

Reference 45 Department of Health and Human Services Regulatory Agenda Semiannual Regulatory Agenda 77 FR 7949 February 13 2012

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Reference 46 Durand et al In vitro Evaluation of the Cutaneous Penetration of Sprayable Sunscreen Emulsions With High...

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Publication Reference: International Journal of Cosmetic Science, 31: 279–292
 

Reference 47 Dussert et al Characterization of the Mineral Content of a Physical Sunscreen Emulsion and its Distribution Onto...

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Publication Reference: Int J Cosmet Sci, 19(3): 119-129
 

Reference 48 Filipe et al Stratum Corneum is an Effective Barrier to TiO2 and ZnO Nanoparticle Percutaneous Absorption 2009

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Publication Reference: Skin Pharmacology and Physiology, 22 266-275
 

Reference 49 Food and Drug Administration Compliance Policy Guide CPG Section 450 200 Drugs General Provisions and Administrative...

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Reference 50 Food and Drug Administration Labeling and Effectiveness Testing Sunscreen Drug Products for Over the Counter Human...

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Reference 51 Food and Drug Administration Guidance for Industry Enforcement Policy OTC Sunscreen Drug Products Marketed Without an...

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Reference 52 Food and Drug Administration Sunscreen Products for Over the Counter Human Use Proposed Amendment of Final Monograph...

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Reference 53 Food and Drug Administration Sunscreen Drug Products for Over the Counter Human Use Final Monograph Partial Stay...

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Reference 54 Food and Drug Administration Sunscreen Drug Products for Over the Counter Human Use Final Monograph Extension of...

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Reference 55 Food and Drug Administration Sunscreen Products for Over the Counter Human Use Final Monograph 64 FR 27666 May 21...

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Reference 56 Food and Drug Administration Sunscreen Drug Products for Over the Counter Human Use Amendment to the Tentative Final...

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Reference 57 Food and Drug Administration, Sunscreen Products for Over the Counter Human Use Tentative Final Monograph Proposed...

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Reference 58 Food and Drug Administration Sunscreen Products for Over the Counter Human Use Establishment of a Monograph Notice of...

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Reference 59 Food and Drug Administration Skin Protectant Drug Products for Over the Counter Human Use Establishment of a...

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Reference 60 Food and Drug Administration Over the Counter Topical Analgesic Including Antirheumatic Otic Burn Sunburn Treatment...

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Reference 61 Gamer et al The In Vitro Absorption of Microfine Zinc Oxide and titanium Dioxide Through Porcine Skin

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Publication Reference: Toxicology in Vitro, 20: 301-307
 

Reference 62 Gulson et al Small Amounts of Zinc From Zinc Oxide Particles in Sunscreens Applied Outdoors are Absorbed Through...

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Publication Reference: Toxicological Sciences, 118: 140-149
 

Reference 63 Jonaitis et al Concerns Regarding Nano Sized Titanium Dioxide Dermal Penetration and Toxicity Study

Abstract: ...Letter to the Editor re: Wu, et al.
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Publication Reference: Toxicology Letters, 192(2): 268
 

Reference 64 Kiss et al Investigation of Micronized Titanium Dioxide Penetration in Human Skin Xenografts and its Effect on...

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Publication Reference: Experimental Dermatology, 17: 659–667
 

Reference 65 Kuo et al Chemical Enhancer Induced Changes in the Mechanisms of Transdermal Delivery of Zinc Oxide Nanoparticles...

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Publication Reference: Biomaterials, 30: 3002–3008
 

Reference 66 Lademann et al Penetration of Titanium Dioxide Microparticles in a Sunscreen Formulation into the Horny Layer and the...

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Publication Reference: Skin Pharmacol Appl Skin Physiol, 12(5): 247-256
 

Reference 67 Lansdown et al Zinc and Titanium Oxides Oromising UV-Absorbers but What Influence do They Have on Intact Skin? 1997

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Publication Reference: International Journal of Cosmetic Science, 19: 167-172
 

Reference 68 Mavon et al In vitro Percutaneous Absorption and In Vivo Stratum Corneum Distribution of an Organic and a Mineral...

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Publication Reference: Skin Pharmacol Physiol, 20: 10-20
 

Reference 69 Menzel et al Investigations of Percutaneous Uptake of Ultrafine TiO2 Particles at the High Energy ion Nanoprobe...

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Publication Reference: Nucl. Instr. Meth. Phys. Res. B, 219-220: 82–86
 

Reference 70 Monteiro-Riviere et al Safety evaluation of Sunscreen Formulations Containing Titanium Dioxide and Zinc Oxide...

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Publication Reference: Toxicological Sciences, 123(1): 264-280.
 

Reference 71 Newman et al The safety of Nanosized Particles in Titanium Dioxide and Zinc Oxide Based Sunscreens 2009

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Publication Reference: J Am Acad Dermatol, 61(4): 685-692
 

Reference 72 Nohynek et al Nanotechnology, Cosmetics and the Skin Is There a Health Risk? 2008

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Publication Reference: Skin Pharmacol Physiol, 21(3):136-149
 

Reference 73 Pflucker et al The Human Stratum corneum Layer An Effective Barrier Against Dermal uptake of Different Forms of...

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Publication Reference: Skin Pharmacol Appl Skin Physiol,14 Suppl 1: 92-97
 

Reference 74 Pflucker et al The Outermost Stratum Corneum Layer is an Effective Barrier Against Dermal Uptake of Topically Applied...

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Publication Reference: Int J Cosmet Sci. 21(6): 399-411
 

Reference 75 Popov et al Effect of Size of TiO2 Nanoparticles Embedded Into Stratum Corneum on Ultraviolet A and Ultraviolet B Sun...

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Publication Reference: J Biomed Opt, 10(6): 064037-1–064037-9
 

Reference 76 Sadrieh et al Lack of Significant Dermal Penetration of Titanium Dioxide From Sunscreen Formulations Containing Nano...

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Publication Reference: Toxicological Sciences 115(1):156–166
 

Reference 77 Schulz et al Distribution of Sunscreens on Skin 2002

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Publication Reference: Advanced Drug delivery Reviews, 54 (Suppl): S157–S163
 

Reference 78 Senzui et al Study on Penetration of Titanium Dioxide TiO2 Nanoparticles Into Intact and Damaged Skin In Vitro 2010

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Publication Reference: The Journal of Toxicological Sciences, 35: 107-113
 

Reference 79 Tyner et al The State of Nano Sized Titanium Dioxide TiO2 May Affect Sunscreen Performance 2011

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Publication Reference: International Journal of Cosmetic Science, 33(3) 234-244
 

Reference 80 Butz et al University of Leipzig NANODERM Quality of Skin as a Barrier to Ultra Fine Particles Final Report

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Abstract: http://www.uni-leipzig.de/~nanoderm/ Downloads/Nanoderm_Final_Report.pdf
Publication Reference: http://www.uni-leipzig.de/~nanoderm/ Downloads/Nanoderm_Final_Report.pdf
 

Reference 81 Van Der Merwe et al Nanocrystalline Titanium Dioxide and Magnesium Oxide In Vitro Dermal Absorption in Human Skin...

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Publication Reference: Cutaneous and Ocular Toxicology, 28(2): 78–82
 

Reference 82 Wu et al Toxicity and Penetration of TiO2 Nanoparticles in Hairless Mice and Porcine Skin After Subchronic Dermal...

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Publication Reference: Toxicology Letters, 191: 1-8
 

 
 
Comment Period Closed
ID: FDA-2006-P-0213-0013

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Date Posted: Apr 20, 2012
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Country: United States
Category: Federal Government - G0007

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