U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

TRIBAL CONSULTATION POLICY 

Table of Contents 

1. Background and Purpose 

2. Policy 

3. Tribal Consultation Process 

4. Tribal Consultation Roles and Responsibilities 

5. Health and Human Services Budget Formulation 

6. Tribal Consultation Evaluation, Performance, and Accountability 

7. Conflict Resolution 

8. Tribal Waiver 

9. Effective Date 

10. Definitions 

11. Acronyms 

1. Background and Purpose 

The Food and Drug Administration (FDA), an operating division within the U.S. Department 

of Health and Human Services (HHS), is responsible for protecting the public health by 

reducing the harm from regulated tobacco products and ensuring the safety, efficacy, and 

security ofhuman and veterinary drugs, biological products, medical devices, the nation's 

food supply, cosmetics, and products that emit radiation. (Further information about FDA's 

mission is provided in Appendix A). FDA adheres to the HHS Tribal Consultation Policy 

(HHS TCP), which serves as a guide for federally recognized Indian or Alaska Native Tribes 

(hereafter, Indian Tribes) to participate in policy development by HHS and its divisions to 

the greatest extent practicable and permitted by law. The purpose ofthe FDA Tribal 

Consultation Policy (FDA TCP) is to establish clear policies to further the government-togovernment relationship between FDA and Indian Tribes. Consistent with FDA's mission 

and authority, the FDA TCP seeks to advance the goal ofthe HHS TCP, which includes, but 

is not limited to, promoting and enhancing the public health oflndian Tribes. Nothing in the 

FDA TCP will be construed as diminishing or waiving the HHS TCP. 

As described in Section 2 of the HHS TCP, a unique government-to-government relationship 

exists between the Federal Government and Indian Tribes, which is grounded in the U.S. 

Constitution, numerous treaties, statutes, Federal case law, regulations and executive orders 

that establish and define a trust relationship with Indian Tribes. An integral element of this 

government-to -government relationship is that consultation occurs with Indian Tribes. 

Consultation is an enhanced form of communication which emphasizes trust, respect, and 

shared responsibility. True and effective consultation results in information exchange, 

mutual understanding, and informed decision making on behalf of the Tribal governments 

involved and the Federal Government. 

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The FDA TCP reaffirms Section 3 of the HHS TCP on Tribal Sovereignty, which discusses 

the right of Indian Tribes to self-government and self-determination and the significance of 

Tribal self-government, Tribal trust resources, Tribal treaties, and other rights. This policy 

does not waive any tribal governmental rights or authority, including treaty rights, sovereign 

immunities, or jurisdiction. Additionally, this policy does not diminish any rights or 

protections afforded other American Indians or Alaskan Natives or related entities under 

F ederallaw. 

2. Policy 

To the extent practicable and permitted by law, consultation with Indian Tribes will occur 

before any policy action is taken that has tribal implications and substantial direct effects on: 

• one or more Indian Tribe(s), or 

• the relationship between the Federal Government and the Indian Tribe(s), or 

• the distribution of power and responsibilities between the Federal Government and 

the Indian Tribe(s). 

A policy action includes actions such as the promulgation of a regulation and excludes 

actions related to compliance, enforcement, product applications, or other submissions which 

are not made public during FDA's review or are otherwise protected from public disclosure. 

Nothing in this policy waives the Federal Government's deliberative process privilege. 

Examples of the Federal Government's deliberative process privilege include: 

1. Reports, recommendations, or other assistance governed by Office of Management and 

Budget (OMB) Circular No. A-19: Legislative Coordination and Clearance. 

2. Specific requests by Members of Congress to the Department or FDA to respond to or 

report on proposed legislation. The development of such responses and of related 

policy is a part ofthe Executive Branch's deliberative process privilege and should 

remain confidential. 

3. FDA regulations prohibiting the Agency from providing a draft of a notice or 

proposed regulation or its preamble, or a portion of either, to an interested person 

outside the executive branch unless it is made available to all interested persons by a 

notice published in the Federal Register (21 CFR 1 0.80). Once it is determined that a 

notice or proposed regulation will be prepared, a representative of FDA may only 

discuss the general concepts. 

The implementation of the FDA Tribal Consultation Policy will adhere to the following 

guidelines: 

A. FDA will follow the Tribal Consultation Process guidelines set forth in Section 3 of the 

FDA Tribal Consultation Policy to ensure meaningful and timely input by Indian Tribes 

in the development of policies that have tribal implications. 

FDA Tribal Consultation Policy Page2 
B. To the extent practicable and permitted by law, FDA will not promulgate any regulation 

that has tribal implications and that preempts tribal law or imposes substantial directcompliance costs on Indian Tribal governments, and that is not required by statute, 

unless: 

1. funds necessary to pay the direct costs incurred by the Indian Tribal government or 

the Indian Tribe(s) in complying with the regulation are provided by the Federal 

Government; or 

2. the FDA, prior to the formal promulgation of the regulation: 

a. consulted with Indian Tribes early and throughout the process of 

developing the regulation; 

b. provided, in a separately identified portion of the preamble to the 

regulation as it is to be issued in the Federal Register, a Tribal summary 

impact statement, which consists of a description of the extent of FDA's 

prior consultation with Tribal Officials, a summary of the nature of their 

concerns and the Agency's position supporting the need to issue the 

regulation, and a statement of the extent to which the concerns of Tribal 

Officials have been met; and 

c. made available to the Secretary of HHS any written communications 

regarding the proposed regulation submitted to FDA by Tribal Officials. 

C. On issues relating directly to tribal self-government, tribal trust resources, or Indian 

Tribal treaty and other rights, FDA will make all practicable attempts where appropriate 

to use consensual mechanisms for developing regulations, including negotiated 

rulemaking. 

3. Tribal Consultation Process 

A. Identification of a Critical Event: A critical event, which is defined as a planned or 

unplanned policy action that has or may have tribal implications and substantial direct 

effects on Indian Tribe(s), may be identified by FDA and/or an Indian Tribe(s). 

The following serve as guidelines to be utilized when FDA and/or an Indian Tribe(s) 

identifies a critical event: 

1. Identify the critical event, as well as the complexity, implications, time constraints, 

and issue(s) involved (e.g., policy, funding/budget development, programs, services, 

functions, or activities). 

2. Identify the affected/potentially-affected Indian Tribe(s). 

3. Identify the most useful and appropriate consultation mechanism(s). 

B. Consultation Mechanisms: Consultation mechanisms include, but are not limited to, 

one or more of the following: 

1. Written Communication 

2. Teleconferences 

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3. Meetings (face-to-face, via webinar, or video conference) at the local, regional, or 

national levels between FDA and Indian Tribes 

4. Roundtables 

5. Annual HHS Tribal Budget and Policy consultation sessions 

6. Consultation sessions held at tribal organization meetings where many Indian Tribes 

or tribal officials are likely to be represented 

7. Other regular or special HHS Division or program level consultation sessions. 

C. Communication Methods: FDA will communicate the determination of the critical 

event and the consultation mechanism to be used to affected/potentially-affected Indian 

Tribe(s) using appropriate methods and with as much advance notice as practicable. 

These methods include, but are not limited to, the following: 

1. Correspondence: FDA will issue written communications within 30 calendar days of 

an identified critical event. The communication should clearly provide 

affected/potentially-affected Indian Tribe(s) with details of the critical event and the 

manner and timeframe in which to provide comment. FDA may use a "Dear Tribal 

Leader" (DTL) letter format to notify individual Indian Tribes of consultation 

activities. Centers and Offices will work with the HHS Office of Intergovernmental 

Affairs and the FDA Intergovernmental Affairs staffiftechnical assistance is required 

for proper format, protocols, current mailing lists, and content. 

2. Official Notification: Upon the determination of a consultation mechanism other than 

written communication, FDA will give proper notice of the critical event and the 

consultation mechanism to be utilized to affected/potentially-affected Indian Tribe(s) 

within 30 calendar days, using appropriate methods, such as a DTL mailing, 

broadcast email, Federal Register notice, or other outlets. The Federal Register is the 

most formal form of notice used for consultation. 

3. Meeting(s): When FDA has determined the critical event to have substantial impact 

on Indian Tribes, FDA will convene a meeting, within 60 calendar days of official 

notification, with the affected/potentially-affected Indian Tribe(s) to discuss all 

pertinent issues in a national, regional, and/or local forum, as appropriate, to the 

extent practicable and permitted by law. 

5. Receipt ofTribal Comment(s): FDA will use appropriate methods to communicate 

clear and explicit instructions on the means and time frames for Indian Tribe(s) to 

submit comments on the critical event. Where public comment is sought on a 

proposed rule, FDA will provide the docket number and deadline for comments to be 

received. All comments that are submitted to the docket during the comment period, 

including those submitted by Indian Tribes, will become part of the official 

rulemaking record. FDA will also submit to the related docket all transcripts and 

summaries of consultation sessions conducted in conjunction with a proposed rule. 

FDA will review the entire rulemaking record, including all comments, transcripts, 

and summaries submitted to the docket, when finalizing the rulemaking. 

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6. Reporting of Outcome: Consistent with Section 6 of the FDA Tribal Consultation 

Policy, FDA will report on the outcomes of the consultation within 90 calendar days 

of the final consultation. For ongoing issues identified during the consultation, FDA 

will provide status reports throughout the year to the HHS Office of 

Intergovernmental Affairs and the Indian Tribe(s). 

D. FDA Reply to Official Tribal Correspondence: Official correspondence from an 

Indian Tribe may come in various forms, but a resolution is the most formal declaration 

of an Indian Tribe's position for the purpose of tribal consultation. In some instances, 

Indian Tribes will submit official correspondence from the highest elected and/or 

appointed official(s) of the Indian Tribe. FDA will give equal consideration to these 

types of correspondence. Correspondence from a tribal staff person or tribal member 

who is not elected or appointed to speak on behalf of the Indian Tribe or a tribal leader 

will not be considered a request for consultation. 

When FDA receives an official Indian Tribe correspondence and/or resolution, the FDA 

Commissioner/Deputy Commissioner/ Associate Commissioner/Center Director and/or 

their designee will respond appropriately. The process for official FDA correspondence 

responding to an Indian Tribe is described below: 

1. Receipt of Correspondence: Correspondence submitted by Indian Tribes to FDA that 

does not identify a specific public docket will be entered into the FDA 

correspondence control tracking system and referred to the appropriate Office or 

Center. 

2. Acknowledgement of Correspondence: FDA will provide acknowledgement to Indian 

Tribes of letters entered into the FDA correspondence control tracking system within 

15 working days of receipt. 

3. Official Response to a Critical Event identified by an Indian Tribe: FDA will provide 

an official response to Indian Tribes that identifies the FDA Office or Center 

responsible for follow up, the process for resolution of the critical event, and a 

timeline for resolution. 

a. If an identified critical event is national in scope, the FDA will, to the extent 

practicable, respond to the request within 60 working days or less. 

b. If a critical event is specific to a single Indian Tribe, the FDA will, to the extent 

practicable, respond to the request within 45 working days or less. 

E. Policy Development through Tribal Consultation Process: The need to consult on the 

development or revision of a policy may be identified from within FDA or may be 

identified by Indian Tribes. This need may result from external forces such as executive, 

judicial, or legislative branch actions or otherwise. Once the need to consult on a policy 

action is identified, the consultation process will begin in accordance with the 

identification of the critical event and consultation mechanisms described above, as 

appropriate. 

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F. Schedule for Consultation: As needed, FDA will establish a formal schedule of 

meetings to consult with Indian Tribes and their representatives concerning the planning, 

conduct, and administration of applicable activities. 

4. Tribal Consultation Roles and Responsibilities 

A. Participant Roles and Responsibilities: 

1. Consultation Parties: Consultation occurs when the FDA Consultation Party (FDA 

Commissioner/Deputy Commissioner/ Associate Commissioner/Center Director), or a 

designee, meets in person or via teleconference or webinar or exchanges written 

correspondence with a Tribal Consultation Party (Tribal President/Chair/Governor/ 

Chief/Principal Chief and/or elected/appointed Indian Tribal Leader), or a designee, 

to discuss issues or concerns of either Party. Each party will identify its authorized 

representative(s) with delegated authority to act on its behalf. 

2. Indian Tribes: The government-to-government relationship between the United 

States and Federally recognized Indian Tribes dictates that the principal focus for 

FDA consultation is Indian Tribes, individually or collectively. 

3. Indian Organizations: At times it is useful for the FDA to communicate with Indian 

organizations to solicit Indian Tribe(s) advice and recommendations. The Federal 

Government does not participate in government-to-government consultations with 

these entities; rather, these organizations represent the interest of Indian Tribes when 

authorized by those Tribes. These organizations by the sheer nature of their business 

serve and advocate for the issues and concerns of Indian Tribes that might be affected 

if these organizations were excluded from the process. 

4. FDA Intergovernmental Affairs: The FDA Intergovernmental Affairs (IGA) staff, 

within the Office ofthe Commissioner's Office ofPolicy, Planning, Legislation, and 

Analysis, is the FDA liaison to States and Indian Tribes and the staffs mission is to 

facilitate communication regarding FDA policy initiatives as they relate to Tribal, 

State, and local governments. In addition, some FDA Centers have staff that may 

work directly with Indian Tribes in coordination with the FDA IGA staff. The FDA 

IGA staff is available to assist Indian Tribes during interactions with the Agency. 

5. Health and Human Services Budget Formulation 

FDA will comply with Section 11 of the HHS Tribal Consultation Policy concerning Budget 

Formulation. 

6. Tribal Consultation Evaluation, Performance, and Accountability 

The consultation process and activities conducted according to this policy should result in 

meaningful outcomes for FDA and for the affected Indian Tribes. To effectively evaluate the 

results of consultation activity and FDA's ability to incorporate the input oflndian Tribes, 

FDA Tribal Consultation Policy Page 6 
FDA will comply with Section 12 of the HHS Tribal Consultation Policy concerning Tribal 

Consultation Performance and Accountability and Section 13 concerning Evaluation, 

Recording of Meetings, and Reporting. Included among these activities, FDA will maintain 

a record of all consultations and will contribute to the "HHS Annual Tribal Consultation 

Report," which describes consultation activity, including outcomes, as outlined in Section 13 

of the HHS Tribal Consultation Policy. 

7. Conflict Resolution 

The intent of this policy is to promote partnerships with Indian Tribes that enhance FDA's 

ability to address tribal issues, needs, and problems. However, Indian Tribes and FDA may 

not always agree and, inherent in the government-to-government relationship, Indian Tribes 

may elevate an issue of importance to a higher or separate decision making authority. FDA 

will comply with Section 14 of the HHS Tribal Consultation Policy concerning Conflict 

Resolution. 

Nothing in the FDA Tribal Consultation Policy creates a right of action against FDA or HHS 

for failure to comply with this Policy. 

8. Tribal Waiver 

FDA adheres to Section 15 of the HHS Tribal Consultation Policy concerning Tribal Waivers 

and will process all requests routinely received for waivers under existing program 

authorities within the statutorily set timeframes. 

9. Effective Date 

The FDA Tribal Consultation Policy is effective on the date of signature by the FDA 

Commissioner. 

10. Definitions 

Following is a list of definitions for this document: 

Agency: The Food and Drug Administration 

Communication: The exchange of ideas, messages, or information, by speech, signals, 

writing, or other means. 

Consultation: An enhanced form of communication, which emphasizes trust, respect, and 

shared responsibility. It is an open and free exchange of information and opinion among 

parties, which leads to mutual understanding and comprehension. Consultation is integral to a 

deliberative process, which results in effective collaboration and informed decision making 

with the ultimate goal of reaching consensus on issues. 

FDA Tribal Consultation Policy Page 7 
Critical Event: A planned or unplanned policy action that has or may have tribal 

implications and substantial direct effects on Indian Tribe(s). 

Deliberative Process Privilege: A governmental privilege exempting from disclosure 

agency materials containing opinions, recommendations, and other communications that are 

part of the agency's decision making process. 

Executive Order: An order issued by the President on the basis of authority specifically 

granted to the Executive Branch (as by the U.S. Constitution or a Congressional Act). 

Federally Recognized Indian Tribes: Indian Tribes with whom the Federal Government 

maintains an official government-to-government relationship; usually established by a 

Federal treaty, statute, executive order, court order, or a Federal Administrative Action. The 

Bureau oflndian Affairs (BIA) maintains and regularly publishes the list of federally 

recognized Indian Tribes. 

Indian Organization: 1) Those federally recognized tribally constituted entities that have 

been designated by their governing body to facilitate communications and consultation 

activities with HHS; or 2) Any regional or national organizations whose board is comprised 

of federally recognized Indian Tribes and elected/appointed Tribal leaders. The Federal 

Government does not participate in government-to-government consultation with these 

entities; rather these organizations represent the interests of Tribes when authorized by those 

Tribes. 

Indian Tribe: An Indian or Alaska Native tribe, band, nation, pueblo, village, or community 

that the Secretary of the Interior acknowledges to exist as an Indian Tribe pursuant to the 

Federally Recognized Indian Tribe List Act of 1994, (25 U.S.C. 479a). 

Policy Action: Includes FDA actions such as the promulgation of a regulation and excludes 

actions related to compliance, enforcement, product applications, or other submissions which 

are not made public during FDA's review or are otherwise protected from public disclosure. 

Policies with Tribal Implications: Policy actions that have substantial direct effects on one 

or more Indian Tribes, on the relationship between the Federal Government and Indian 

Tribes, or on the distribution of power and responsibilities between the Federal Government 

and Indian Tribes. 

Self-Government: Government in which the people who are most directly affected by the 

decisions make the decisions. 

Sovereignty: The ultimate source of political power from which all specific political powers 

are derived. 

Substantial Direct Compliance Costs: Those costs incurred directly from implementation 

of changes necessary to meet the requirements of a Federal regulation. Because of the large 

variation in Tribes, "substantial costs" is also variable by Indian Tribe. Each Indian Tribe and 

FDA Tribal Consultation Policy Page 8 
the Secretary shall mutually detennine the level of costs that represent "substantial costs" in 

the context of the Indian Tribe's resource base. 

To the Extent Practicable and Permitted by Law: Refers to situations where the 

opportunity for consultation is limited because of constraints of time, budget, legal authority, 

etc. 

Treaty: A legally binding and written agreement that affirms the government-to-government 

relationship between two or more nations. 

Tribal Government: An American Indian or Alaska Native Tribe, band, nation, pueblo, 

village or community that the Secretary of the Interior acknowledges to exist as an Indian 

Tribe pursuant to the Federally Recognized Indian Tribe List Act of 1994, (25 U.S.C. 479a). 

Tribal Officials: Elected or duly appointed officials of Indian Tribes or authorized interTribal organizations. 

Tribal Organization: The recognized governing body of any Indian Tribe; any legally 

established organization of Indians which is controlled, sanctioned, or chartered by such 

governing body or which is democratically elected by the adult members of the Indian 

community to be served by such organization and which includes the maximum participation 

of Indians in all phases of its activities; provided, that in any case where a contract is let or 

grant made to an organization to perform services benefiting more than one Indian Tribe, the 

approval of each such Indian Tribe shall be a prerequisite to the letting or making of such 

contract or grant. 

Tribal Resolution: A formal expression of the opinion or will of an official Tribal governing 

body which is adopted by vote of the Tribal governing body. 

Tribal Self-Governance: The governmental actions of Indian Tribes exercising selfgovernment and self-determination. 

11. ACRONYMS 

BIA: 

CFR: 

FDA: 

HHS: 

OMB: 

U.S.: 

U.S.C.: 

Bureau of Indian Affairs 

Code of Federal Regulations 

Food and Drug Administration 

U.S. Department of Health and Human Services 

Office of Management and Budget 

United States 

United States Code 

FDA Tribal Consultation Policy Page 9 
Robert M. Califf, M.D. 

Commissioner of Food and Drugs 

FDA Tribal Consultation Policy 

Date 

Page 10 
Appendix A 

Background on the U.S. Food and Drug Administration 

More information is available at FDA.gov 

FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security 

of human and veterinary drugs, biological products, medical devices, the nation's food supply, 

cosmetics, and products that emit radiation. FDA also advances the public health by helping to 

speed innovations that make medicines more effective, safer, and more affordable, and by 

helping the public get the accurate, science-based infonnation they need to use medicines and 

foods to maintain and improve their health. Furthermore, FDA has responsibility for regulating 

the manufacture, marketing, and distribution of tobacco products to protect the public health and 

to reduce tobacco use by minors. Finally, FDA plays a significant role in the nation's 

counterterrorism capability by ensuring the security of the food supply and fostering 

development of medical products to respond to emerging public health threats. 

A. Major authorizing statutes for FDA include: 

• The Federal Food, Drug, and Cosmetic Act (P.L. 75-717), as amended (21 U.S.C. 301 

et seq.); 

• The Public Health Service Act (P.L. 78-140), as amended (42 U.S.C. 201 et seq.) 

The Office of the Commissioner: FDA is headed by the Commissioner ofFood and Drugs. 

The Office ofthe Commissioner includes the Office of Policy Planning, Legislation, and 

Analysis (which includes the Intergovernmental Affairs staff), the Office of Foods and 

Veterinary Medicine, the Office of Medical Products and Tobacco, the Office of Global 

Regulatory Operations and Policy, the Office of Minority Health, the Office ofWomen's Health, 

the Office of Special Medical Programs, and the Office of External Affairs. 

The Center for Biologics Evaluation and Research (CBER) regulates a wide range of 

biological products, such as vaccines, blood and blood components, allergenics, cells and tissues, 

gene therapy, and certain recombinant therapeutic proteins. Biological products are either 

isolated from a variety of natural sources -human, animal, or microorganism -or are produced 

by one of several different cutting edge technologies. 

The Center for Drug Evaluation and Research (CDER) regulates over-the-counter and 

prescription drugs, including biological therapeutics and generic drugs. CDER's principal 

functions are to review the evidence that prescription and over-the-counter human drugs (both 

brand name and generic) are safe and effective before allowing them to be marketed; monitor 

their use for unexpected health risks; ensure their continued high quality; and oversee the 

accuracy and completeness of drug information provided for health professionals and consumers. 

The Center for Devices and Radiological Health (CDRH) is responsible for assuring the 

safety, effectiveness, and quality of medical devices, and ensuring the safety of radiationemitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound 

equipment, and microwave ovens. CDRH is responsible for regulating firms that manufacture, 

repackage, relabel, and/or import medical devices sold in the United States. 

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The Center for Food Safety and Applied Nutrition (CFSAN) regulates human food to help 

ensure that the nation's food supply (everything we eat except for meat, poultry, and some egg 

products that are regulated by the U.S. Department of Agriculture) is safe, sanitary, wholesome, 

and honestly labeled and that cosmetics are safe and properly labeled. It also develops national 

retail food policy in the form of the FDA Food Code, a model code for adoption by state, local, 

tribal and territorial governmental bodies in the development of their own food safety 

regulations. 

The Center for Tobacco Products {CTP) regulates the manufacture, distribution, and 

marketing of tobacco products to protect public health. CTP's responsibilities include issuing 

and enforcing regulations that restrict youth access to tobacco products, educating the public 

about the harms of tobacco products, inspecting tobacco retailers across the United States, and 

reviewing and evaluating applications and claims before the products are allowed on the market. 

The Center for Veterinary Medicine (CVM) regulates and monitors animal food, animal 

drugs, and animal devices. The Center ensures a drug is safe and effective before approving the 

drug. These are drugs for companion animals such as dogs, cats, and horses, and food-producing 

animals such as cattle, chickens, and swine, and include prescription and over-the-counter drugs. 

In addition, if the drug is for a food-producing animal, the Center ensures food products derived 

from animals treated with the drug are safe for human consumption. The Center also regulates 

animal food-which includes animal feed, pet food, and pet treats-to help ensure it is safe, 

made under sanitary conditions, and properly labeled. 

The National Center for Toxicological Research (NCTR) is a research institute that conducts 

scientific research to develop a scientifically sound basis for regulatory decisions and reduce 

risks associated with FDA-regulated products. 

The Office of Regulatory Affairs (ORA) provides strategic leadership for all FDA field 

activities and policies involving imports, inspections, and enforcement. ORA supports the FDA 

product centers by inspecting regulated products and manufacturers, conducting sample analysis 

on regulated products, and reviewing imported products offered for entry into the United States. 

In pursuit of its mission, ORA also works with its state, local, tribal, territorial and foreign 

counterparts. 

The Office of International Programs (OIP) works with governments, industry and academia 

in foreign countries, as well as with multilateral organizations, to help assure that food and 

medical products exported to the United States meet U.S. standards. 

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