82_FR_1351 82 FR 1348 - Food and Drug Administration Tribal Consultation Policy; Availability

82 FR 1348 - Food and Drug Administration Tribal Consultation Policy; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 3 (January 5, 2017)

Page Range1348-1349
FR Document2016-31951

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 Consultation Policy issued in February 2016.

Federal Register, Volume 82 Issue 3 (Thursday, January 5, 2017) 
[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1348-1349]
From the Federal Register Online  [www.thefederalregister.org]
[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

1348 Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices will not be disclosed except in how the nutrition information is 3520). The collections of information in accordance with 21 CFR 10.20 and other presented to consumers. The final rule 21 CFR part 101 have been approved applicable disclosure law. For more provided two compliance dates under OMB control number 0910–0813. information about FDA’s posting of distinguishing between manufacturers IV. Electronic Access comments to public dockets, see 80 FR with $10 million or more in annual food 56469, September 18, 2015, or access sales (July 26, 2018) and manufacturers Persons with access to the Internet the information at: http://www.fda.gov/ with less than $10 million in annual may obtain the draft guidance at either regulatoryinformation/dockets/ food sales (July 26, 2019). The final rule http://www.fda.gov/FoodGuidances or default.htm. also revised the Nutrition Facts label to https://www.regulations.gov. Use the Docket: For access to the docket to replace ‘‘sugars’’ with ‘‘total sugars’’ and FDA Web site listed in the previous read background documents or the to include the declaration of added sentence to find the most current electronic and written/paper comments sugars. The draft guidance is intended version of the guidance. received, go to https:// for conventional food and dietary V. Reference www.regulations.gov and insert the supplement manufacturers and will, docket number, found in brackets in the when finalized, provide questions and The following reference is on display heading of this document, into the answers on topics related to in the Division of Dockets Management ‘‘Search’’ box and follow the prompts compliance, labeling of added sugars, (see ADDRESSES) and is available for and/or go to the Division of Dockets declaration of quantitative amounts of viewing by interested persons between Management, 5630 Fishers Lane, Rm. vitamins and minerals, and format. 9 a.m. and 4 p.m., Monday through 1061, Rockville, MD 20852. Friday; it are also available II. Additional Issues for Consideration electronically at https:// Submit written requests for single copies of the draft guidance to the Office We invite interested persons to www.regulations.gov. FDA has verified of Nutrition and Food Labeling/ comment on topics related to the Web site address, as of the date this Nutrition Programs Staff, Center for compliance, labeling of added sugars, document publishes in the Federal Food Safety and Applied Nutrition, declaration of quantitative amounts of Register, but Web sites are subject to Food and Drug Administration, 5001 vitamins and minerals, and format. change over time. Campus Dr., College Park, MD 20740. However, we are particularly interested 1. U.S. Department of Health and Human Send two self-addressed adhesive labels in responses to the following questions: Services. 2015 Dietary Guidelines for to assist that office in processing your 1. What, if any, concerns are there for Americans. Accessed online at http:// manufacturers to use Brix values from www.health.gov/dietaryguidelines/dga2005/ request. See the SUPPLEMENTARY 21 CFR 101.30 when calculating the document/default.htm. INFORMATION section for electronic access to the draft guidance. added sugars content of products Dated: December 30, 2016. containing fruit juice concentrates? Leslie Kux, FOR FURTHER INFORMATION CONTACT: 2. For purposes of calculating the Associate Commissioner for Policy. Blakeley Fitzpatrick, Center for Food amount of added sugars, what, if any, Safety and Applied Nutrition, Food and concerns are there if we consider that all [FR Doc. 2016–32005 Filed 1–4–17; 8:45 am] Drug Administration (HFS–830), 5001 of the water in a formulation with fruit BILLING CODE 4164–01–P Campus Dr., College Park, MD 20740, or vegetable juice concentrate is used to 240–402–5429. reconstitute the fruit or vegetable juice? SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND To illustrate the issue, assume that fruit HUMAN SERVICES I. Background juice concentrate is added to a food and that the manufacturer also adds water to Food and Drug Administration We are announcing the availability of the food. We recognize that the water a draft guidance for industry entitled may reconstitute the fruit juice, but also [Docket No. FDA–2016–N–0586] ‘‘Questions and Answers on the recognize that some portion of the water Nutrition and Supplement Facts Labels Food and Drug Administration Tribal may have other purposes or affect Consultation Policy; Availability Related to the Compliance Date, Added ingredients other than the fruit juice Sugars, and Declaration of Quantitative concentrate. Nevertheless, to calculate AGENCY: Food and Drug Administration, Amounts of Vitamins and Minerals.’’ the amount of added sugars, we would HHS. We are issuing the draft guidance consider that all of the water goes ACTION: Notice of availability. consistent with our good guidance towards reconstituting the fruit juice. practices regulation (21 CFR 10.115). 3. What, if any, concerns are there if SUMMARY: The Food and Drug The draft guidance, when finalized, will we consider that all of the water that has Administration (FDA or we) is represent the current thinking of FDA been removed from a product during announcing the availability of the FDA on this topic. It does not establish any processing contributes towards the Tribal Consultation Policy. The purpose rights for any person and is not binding concentration of juice added as an of the FDA Tribal Consultation Policy is on FDA or the public. You can use an ingredient during the formulation of the to further the government-to- alternate approach if it satisfies the product? government relationship between FDA requirements of the applicable statutes When responding to these questions, and American Indian and Alaskan and regulations. please explain your reasoning. Native Tribes (Indian Tribes) and In the Federal Register of May 27, facilitate tribal consultation with FDA. 2016, we issued a final rule entitled III. Paperwork Reduction Act of 1995 The FDA Tribal Consultation Policy mstockstill on DSK3G9T082PROD with NOTICES ‘‘Food Labeling: Revision of the This guidance refers to previously provides background on FDA’s mission Nutrition and Supplement Facts Labels’’ approved collections of information and organizational structure and (81 FR 33742). The final rule amends found in FDA regulations. These elaborates on the principles and our regulations for the nutrition labeling collections of information are subject to guidelines in the U.S. Department of of conventional foods and dietary review by the Office of Management and Health and Human Services (HHS) supplements to provide updated Budget (OMB) under the Paperwork Tribal Consultation Policy. This policy nutrition information and to improve Reduction Act of 1995 (44 U.S.C. 3501– finalizes the draft FDA Tribal VerDate Sep<11>2014 21:06 Jan 04, 2017 Jkt 241001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1

Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices 1349 Consultation Policy issued in February II. Electronic Access comment will be made public, you are 2016. Persons with access to the Internet solely responsible for ensuring that your may obtain the document at either comment does not include any ADDRESSES: For access to the docket to confidential information that you or a read background documents or the http://www.fda.gov/tribal or https:// www.regulations.gov. Use the FDA Web third party may not wish to be posted, electronic and written/paper comments such as medical information, your or received, go to https:// site listed in the previous sentence to find the most current version of the anyone else’s Social Security number, or www.regulations.gov and insert the confidential business information, such docket number, found in brackets in the document. as a manufacturing process. Please note heading of this document, into the Dated: December 29, 2016. that if you include your name, contact ‘‘Search’’ box and follow the prompts Leslie Kux, information, or other information that and/or go to the Division of Dockets Associate Commissioner for Policy. identifies you in the body of your Management, 5630 Fishers Lane, Rm. [FR Doc. 2016–31951 Filed 1–4–17; 8:45 am] comments, that information will be 1061, Rockville, MD 20852. posted on https://www.regulations.gov. BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: • If you want to submit a comment Sarah Walinsky, Food and Drug with confidential information that you Administration, 10903 New Hampshire DEPARTMENT OF HEALTH AND do not wish to be made available to the Ave., Silver Spring, MD 20993, (240) HUMAN SERVICES public, submit the comment as a 402–4075. written/paper submission and in the Food and Drug Administration manner detailed (see ‘‘Written/Paper SUPPLEMENTARY INFORMATION: Submissions’’ and ‘‘Instructions’’). [Docket No. FDA–2010–N–0118] I. Background Written/Paper Submissions Agency Information Collection Under Executive Order 13175 of Activities; Proposed Collection; Submit written/paper submissions as November 6, 2000, executive Comment Request; Prior Notice of follows: departments and Agencies are charged • Mail/Hand delivery/Courier (for Imported Food Under the Public Health with engaging in regular and meaningful written/paper submissions): Division of Security and Bioterrorism consultation and collaboration with Dockets Management (HFA–305), Food Preparedness and Response Act of Indian tribal governments in the and Drug Administration, 5630 Fishers 2002 development of Federal policies that Lane, Rm. 1061, Rockville, MD 20852. AGENCY: Food and Drug Administration, • For written/paper comments have tribal implications and are HHS. submitted to the Division of Dockets responsible for strengthening the ACTION: Notice. Management, FDA will post your government-to-government relationship comment, as well as any attachments, between the United States and Indian SUMMARY: The Food and Drug except for information submitted, Tribes. The HHS Tribal Consultation Administration (FDA or the Agency) is marked and identified, as confidential, Policy, revised on December 14, 2010, announcing an opportunity for public if submitted as detailed in further clarifies that each HHS comment on the proposed collection of ‘‘Instructions.’’ Operating and Staff Division must have certain information by the Agency. Instructions: All submissions received an accountable consultation process to Under the Paperwork Reduction Act of must include the Docket No. FDA– ensure meaningful and timely input by 1995 (the PRA), Federal Agencies are 2010–N–0118 for ‘‘Agency Information tribal officials in the development of required to publish notice in the Collection Activities; Proposed policies that have tribal implications. Federal Register concerning each Collection; Comment Request; Prior The FDA Tribal Consultation Policy, proposed collection of information, Notice of Imported Food Under the which finalizes the draft FDA Tribal including each proposed extension of an Public Health Security and Bioterrorism Consultation Policy issued in February existing collection of information, and Preparedness and Response Act of 2016, is based on the HHS Tribal to allow 60 days for public comment in 2002.’’ Received comments will be Consultation Policy and includes response to the notice. This notice placed in the docket and, except for Agency-specific consultation guidelines solicits comments on the information those submitted as ‘‘Confidential that complement the Department-wide collection provisions of FDA regulations Submissions,’’ publicly viewable at efforts. requiring that the Agency receives prior https://www.regulations.gov or at the The purpose of the FDA Tribal notice before food is imported or offered Division of Dockets Management Consultation Policy is to further the for import into the United States. between 9 a.m. and 4 p.m., Monday government-to-government relationship DATES: Submit either electronic or through Friday. between FDA and Indian Tribes and written comments on the collection of • Confidential Submissions—To facilitate tribal consultation with FDA. information by March 6, 2017. submit a comment with confidential The policy provides background on ADDRESSES: You may submit comments information that you do not wish to be FDA’s mission and organizational as follows: made publicly available, submit your structure and elaborates on the comments only as a written/paper principles and guidelines in the HHS Electronic Submissions submission. You should submit two Tribal Consultation Policy. We Submit electronic comments in the copies total. One copy will include the consulted with Indian Tribes on the following way: information you claim to be confidential mstockstill on DSK3G9T082PROD with NOTICES FDA Tribal Consultation Policy, which • Federal eRulemaking Portal: with a heading or cover note that states is intended to serve as a platform for the https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS Agency to create consistent and instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The meaningful tribal consultation across Comments submitted electronically, Agency will review this copy, including FDA Centers and Offices. A copy of the including attachments, to https:// the claimed confidential information, in final policy has also been shared with www.regulations.gov will be posted to its consideration of comments. The Indian Tribes in a letter to tribal leaders. the docket unchanged. Because your second copy, which will have the VerDate Sep<11>2014 21:06 Jan 04, 2017 Jkt 241001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1


Document Created: 2018-02-01 14:50:45
Document Modified: 2018-02-01 14:50:45
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
ContactSarah Walinsky, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, (240) 402-4075.
FR Citation82 FR 1348 
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