[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1348-1349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31951]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0586]


Food and Drug Administration Tribal Consultation Policy; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of the FDA Tribal Consultation Policy. The purpose of the 
FDA Tribal Consultation Policy is to further the government-to-
government relationship between FDA and American Indian and Alaskan 
Native Tribes (Indian Tribes) and facilitate tribal consultation with 
FDA. The FDA Tribal Consultation Policy provides background on FDA's 
mission and organizational structure and elaborates on the principles 
and guidelines in the U.S. Department of Health and Human Services 
(HHS) Tribal Consultation Policy. This policy finalizes the draft FDA 
Tribal

[[Page 1349]]

Consultation Policy issued in February 2016.

ADDRESSES: For access to the docket to read background documents or the 
electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sarah Walinsky, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 
(240) 402-4075.

SUPPLEMENTARY INFORMATION: 

I. Background

    Under Executive Order 13175 of November 6, 2000, executive 
departments and Agencies are charged with engaging in regular and 
meaningful consultation and collaboration with Indian tribal 
governments in the development of Federal policies that have tribal 
implications and are responsible for strengthening the government-to-
government relationship between the United States and Indian Tribes. 
The HHS Tribal Consultation Policy, revised on December 14, 2010, 
further clarifies that each HHS Operating and Staff Division must have 
an accountable consultation process to ensure meaningful and timely 
input by tribal officials in the development of policies that have 
tribal implications. The FDA Tribal Consultation Policy, which 
finalizes the draft FDA Tribal Consultation Policy issued in February 
2016, is based on the HHS Tribal Consultation Policy and includes 
Agency-specific consultation guidelines that complement the Department-
wide efforts.
    The purpose of the FDA Tribal Consultation Policy is to further the 
government-to-government relationship between FDA and Indian Tribes and 
facilitate tribal consultation with FDA. The policy provides background 
on FDA's mission and organizational structure and elaborates on the 
principles and guidelines in the HHS Tribal Consultation Policy. We 
consulted with Indian Tribes on the FDA Tribal Consultation Policy, 
which is intended to serve as a platform for the Agency to create 
consistent and meaningful tribal consultation across FDA Centers and 
Offices. A copy of the final policy has also been shared with Indian 
Tribes in a letter to tribal leaders.

II. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/tribal or https://www.regulations.gov. Use 
the FDA Web site listed in the previous sentence to find the most 
current version of the document.

    Dated: December 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31951 Filed 1-4-17; 8:45 am]
 BILLING CODE 4164-01-P