[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)]
[Notices]
[Pages 10256-10257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04276]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Food and Drug Administration Tribal Consultation Policy; 
Availability; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of the draft FDA Tribal Consultation Policy. We are also 
announcing the establishment of a docket to receive comments on the 
draft FDA Tribal Consultation Policy. The purpose of the FDA Tribal 
Consultation Policy, when finalized, is to establish clear policies to 
further the government-to-government relationship between FDA and 
American Indian and Alaskan Native Tribes (hereafter, Indian Tribes) 
and facilitate tribal consultation with FDA. The draft FDA Tribal 
Consultation Policy provides background on FDA's mission and 
organizational structure and sets out principles and guidelines for the 
tribal consultation process.

DATES: Comments must be received on or before May 31, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0586 for ``Draft FDA Tribal Consultation Policy; 
Availability; Request for Comments.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more

[[Page 10257]]

information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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: Brian Kehoe, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-8913.

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 tribal officials 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 Department of Health 
and Human Services (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. To date, FDA has followed the 
HHS Tribal Consultation Policy (available at http://www.hhs.gov/about/agencies/iea/tribal-affairs/consultation/index.html). The draft FDA 
Tribal Consultation Policy is based on the HHS Tribal Consultation 
Policy and includes Agency-specific consultation guidelines that 
complement the Department-wide efforts.
    The purpose of the draft FDA Tribal Consultation Policy, when 
finalized, is to establish clear policies to further the government-to-
government relationship between FDA and Indian Tribes and facilitate 
tribal consultation with FDA. The draft policy provides background on 
FDA's mission and organizational structure and sets out principles and 
guidelines for the tribal consultation process. FDA intends for its 
Tribal Consultation Policy to serve as a platform for the Agency to 
create consistent and meaningful tribal consultation across FDA Centers 
and Offices.
    FDA is announcing the establishment of a docket to receive comments 
on the draft FDA Tribal Consultation Policy. We invite tribal 
officials, tribal organizations, individual tribal members and other 
interested persons to comment on the draft FDA Tribal Consultation 
Policy. We are interested in any general comments or concerns that 
would help us improve our policy as well as suggestions on how can we 
improve our communication and outreach with Indian Tribes. FDA also 
intends to consult with Indian Tribal officials on the draft FDA Tribal 
Consultation Policy and summaries of these consultations will be placed 
in the docket.

II. Electronic Access

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

    Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04276 Filed 2-26-16; 8:45 am]
BILLING CODE 4164-01-P