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                Tribal Affairs

Tribal Affairs

                        Dear Tribal Leader Letters
          Tribal Affairs- What's New Home
          For Federal, State, Local, Tribal, and Territorial Officials
          Tribal Affairs
          Dear Tribal Leader LettersTribal Affairs Dear Tribal Leader Letters
  
  	
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			Subject of Letter
			Responsible Center/OfficeJanuary 8, 2024
			FDA Tribal Listening Session: The U.S. Food and Drug Administration (FDA) invites federally recognized American Indian and Alaska Native Tribes to participate in an all tribes call with FDA to learn about FDA’s work related to front-of-package (FOP) nutrition labeling (FOP labels).
			Center for Food Safety and Applied NutritionDecember 7, 2023
			Center for Tobacco Products releases the “FDA Commercial Tobacco Retail Compliance Check Inspection Program" webinar as a resource for federally recognized AI/AN Tribes. The webinar may be viewed here.
			Center for Tobacco ProductsOctober 24, 2023
			Tribal Listening Session: The U.S. Food and Drug Administration (FDA) invites federally recognized American Indian and Alaska Native Tribes to participate in an all tribes call with the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) to learn about FDA’s nutrition initiatives.  Meeting recording.
			Center for Food Safety and Applied NutritionOctober 5, 2023
			Tribal Listening Session on Safe Disposal of Opioid Analgesics.  Meeting recording
			Center for Drug Evaluation and ResearchAugust 25, 2023
			Letter to Tribes regarding the release of draft guidance "Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products," issued by FDA's Oncology Center for Excellence. Please take this opportunity to review and provide comment.
			Oncology Center for ExcellenceMarch 10, 2023
			Invitation to Consultation on the proposed rules for Requirement for Tobacco Product Manufacturing Practice (TPMP).  Meeting recording.
			Center for Tobacco ProductsJanuary 18, 2023
			The U.S. Food and Drug Administration (FDA or the Agency) is pleased to share the Fall 2022 Unified Agenda of Regulatory and Deregulatory Actions (Unified Agenda) to ensure that federally recognized Tribal Nations are aware of FDA’s plans related to issuance of regulations and guidance documents.
			Office of Policy, Legislation, and International Affairs/International Accreditation Services, Inc.November 8, 2022
			Letter to Tribes regarding FDA’s authority to regulate non-tobacco nicotine products   Meeting Recording
			Center for Tobacco ProductsOctober 3, 2022
			**October 3, 2022 Comment Period Extended through December 28, 2022**: Invitation to Consultation on the proposed rules for Institutional Review Boards; Cooperative Research and Protection of Human Subjects and Institutional Review Boards. These proposed rules are intended to further FDA's harmonization with the Federal Policy for the Protection of Human.
			Office of the CommissionerMay 13, 2022
			Invitation to Consultation on the proposed rules for Tobacco Product Standards for Menthol in Cigarettes and Tobacco Product Standard for Characterizing Flavors in Cigars

			A recording of the FDA tribal consultation is available here.
			Center for Tobacco ProductsUpdated: January 27, 2022
			Invitation to Consultation on the proposed rule “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”

			A recording of the FDA tribal consultation is available here.
			Center for Food Safety and Applied Nutrition and Office of Food Policy and ResponseDecember 17, 2021
			Providing information to tribal leaders to share with tribal tobacco retailers on Tobacco 21 (T21).
			Center for Tobacco ProductsMay 17, 2021
			Publication of a fiscal year 2021 Request for Proposal (RFP) to contract with American Indian and Alaska Native (AI/AN) Tribes to conduct compliance check inspections of tobacco product retailers on tribal lands to help ensure retailer compliance with federal tobacco laws and regulations.
			Center for Tobacco ProductsOctober 21, 2020
			Invitation to Consultation on the proposed rule on Requirements for Additional Traceability Records for Certain Foods
			Center for Food Safety and Applied Nutrition and Office of Food Policy and ResponseJune 30, 2020
			Publication of a Request for Proposal (RFP) to contract with American Indian and Alaska Native (AI/AN) Tribes to conduct compliance check inspections of tobacco product retailers on tribal lands to help ensure retailer compliance with federal tobacco laws and regulations.
			Center for Tobacco ProductsApril 4, 2019
			Invitation to Consultation on the proposed rule on the content and format of substantial equivalence applications, and FDA actions on substantial equivalence reports
			Center for Tobacco ProductsAugust 15, 2019
			Invitation to Consultation on the proposed rule requiring new health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking
			Center for Tobacco ProductsApril 4, 2019
			Invitation to Consultation on the proposed rule on the content and format of substantial equivalence applications, and FDA actions on substantial equivalence reports
			Center for Tobacco ProductsMay 10, 2018
			Publication of a Request for Proposal to contract with American Indian and Alaska Native Tribes to conduct compliance check inspections of tobacco retailers on tribal lands to help ensure retailer compliance with federal tobacco laws and regulations
			Center for Tobacco ProductsAugust 18, 2017
			Publication of a Request for Proposal to contract with American Indian and Alaska Native Tribes to conduct compliance check inspections of tobacco retailers on tribal lands to help ensure retailer compliance with federal tobacco laws and regulations
			Center for Tobacco ProductsApril 7, 2017
			Invitation to Consultation on Tobacco Product Standard for N-nitrosonornicotine Level in Finished Smokeless Tobacco Products proposed rule
			Center for Tobacco ProductsDecember 22, 2016
			FDA Tribal Consultation Policy
			Office of Policy, Planning, Legislation, and AnalysisMay 26, 2016
			Mitigation Strategies to Protect Food Against Intentional Adulteration
			Office of Foods and Veterinary MedicineMay 10, 2016
			Deeming tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act, final rule:

			Clarifies FDA authority to regulate all tobacco products
				Restrictions on sales and requirements for health warningsSummary of the final rule
			Center for Tobacco ProductsApril 5, 2016
			Final FSMA Rule:

			Sanitary Transportation of Human and Animal Food
			Office of Foods and Veterinary MedicineFebruary 29, 2016
			Draft FDA Tribal Consultation Policy
			Office of Policy, Planning, Legislation, and AnalysisFebruary 12, 2016
			RFP on Tribal Training
			Office of Foods and Veterinary MedicineNovember 13, 2015
			Final FSMA Rules:

			Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human ConsumptionForeign Supplier Verification Programs for Importers of Food for Humans and AnimalsAccreditation of Third-Party AuditorsFinal Environmental Impact Statement for the Proposed Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
			Office of Foods and Veterinary MedicineSeptember 25, 2015
			Tribal Retailer Inspections
			Center for Tobacco ProductsSeptember 10, 2015
			Final FSMA Rules:

			Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human FoodCurrent Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls Food for Animals
			Office of Foods and Veterinary MedicineMarch 13, 2015
			Retail Inspections RFP
			Center for Tobacco ProductsDecember 31, 2014
			Draft Environmental Impact Statement for the Proposed Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule)
			Office of Foods and Veterinary MedicineMay 16, 2014
			Compliance and Enforcement collaboration, notification of webinars
			Center for Tobacco ProductsApril 25, 2014
			Invitation to Consultation on Deeming Tobacco Products
			Center for Tobacco ProductsMarch 27, 2014
			Invitation to Regional consultation at the Indian Pueblo Cultural Center, NM on FSMA proposed rules
			Office of Foods and Veterinary MedicineSeptember 12, 2013
			Invitation to FDA tribal consultation on FSMA proposed rules
			Office of Foods and Veterinary MedicineAugust 16, 2013
			Invitation to Consultation on Environmental Impact Statement for FSMA Produce Safety Rule
			Office of Foods and Veterinary MedicineApril 25, 2013
			Working Together
			Center for Tobacco Products



ResourcesForYou

For Federal, State, Local, Tribal, and Territorial Officials
	Engagement with American Indian and Alaska Native Tribal Governments (Center for Tobacco Products)

                                                                                  Content current as of:
      01/09/2024Tribal Affairs

          
                        Dear Tribal Leader Letters
          Tribal Affairs- What's New
 
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