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Dear Tribal Leader Letters

Letter Date and Link

Subject of Letter

Responsible Center/Office

May 22, 2024 Dear Tribal Leader Letter inviting Tribes to participate in and All Tribes' Call on June 24, 2024. The call will discuss the published final rule "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water" issued by the Center for Food Safety and Applied Nutrition. Center for Food Safety and Applied Nutrition
January 31, 2024 Postponed until further notice. FDA Tribal Listening Session: The U.S. Food and Drug Administration invites the National Indian Health Board and Area Indian Health Boards to participate in a call with the FDA’s Stakeholder Engagement Staff and Intergovernmental Affairs (IGA) to discuss the FDA’s efforts to address misinformation and vaccine hesitancy. Office of the Commissioner, Office of External Affairs
January 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). The listening session may be viewed here. Center for Food Safety and Applied Nutrition
December 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 Products
October 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 Nutrition
October 5, 2023 Tribal Listening Session on Safe Disposal of Opioid Analgesics.  Meeting recording Center for Drug Evaluation and Research
August 25, 2023 Letter to Tribes regarding the release of draft guidance "Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products," issued by FDA's Oncology Center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 Excellence 
March 10, 2023 Invitation to Consultation on the proposed rules for Requirement for Tobacco Product Manufacturing Practice (TPMP).  Meeting recording. Center for Tobacco Products

January 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 Products
October 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 Commissioner
May 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 Products
Updated: 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 Response
December 17, 2021

Providing information to tribal leaders to share with tribal tobacco retailers on Tobacco 21 (T21).

Center for Tobacco Products
May 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 Products
October 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 Response
June 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 Products

April 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 Products

August 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 Products

April 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 Products

May 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 Products

August 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 Products

April 7, 2017

Invitation to Consultation on Tobacco Product Standard for N-nitrosonornicotine Level in Finished Smokeless Tobacco Products proposed rule

Center for Tobacco Products

December 22, 2016

FDA Tribal Consultation Policy

Office of Policy, Planning, Legislation, and Analysis

May 26, 2016

Mitigation Strategies to Protect Food Against Intentional Adulteration

Office of Foods and Veterinary Medicine

May 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 warnings

Summary of the final rule

Center for Tobacco Products

April 5, 2016

Final FSMA Rule:

  • Sanitary Transportation of Human and Animal Food

Office of Foods and Veterinary Medicine

February 29, 2016

Draft FDA Tribal Consultation Policy

Office of Policy, Planning, Legislation, and Analysis

February 12, 2016

RFP on Tribal Training

Office of Foods and Veterinary Medicine

November 13, 2015

Final FSMA Rules:

  • Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

  • Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

  • Accreditation of Third-Party Auditors

Final 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 Medicine

September 25, 2015

Tribal Retailer Inspections

Center for Tobacco Products

September 10, 2015

Final FSMA Rules:

  • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

  • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls Food for Animals

Office of Foods and Veterinary Medicine

March 13, 2015

Retail Inspections RFP

Center for Tobacco Products

December 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 Medicine

May 16, 2014

Compliance and Enforcement collaboration, notification of webinars

Center for Tobacco Products

April 25, 2014

Invitation to Consultation on Deeming Tobacco Products

Center for Tobacco Products

March 27, 2014

Invitation to Regional consultation at the Indian Pueblo Cultural Center, NM on FSMA proposed rules

Office of Foods and Veterinary Medicine

September 12, 2013

Invitation to FDA tribal consultation on FSMA proposed rules

Office of Foods and Veterinary Medicine

August 16, 2013

Invitation to Consultation on Environmental Impact Statement for FSMA Produce Safety Rule

Office of Foods and Veterinary Medicine

April 25, 2013

Working Together

Center for Tobacco Products

 
 
 

 

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