Food and Drug Administration Tribal Consultation Policy; Availability, 1348-1349 [2016-31951]
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Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://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 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.
Submit written requests for single
copies of the draft guidance to the Office
of Nutrition and Food Labeling/
Nutrition Programs Staff, Center for
Food Safety and Applied Nutrition,
Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740.
Send two self-addressed adhesive labels
to assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
Blakeley Fitzpatrick, Center for Food
Safety and Applied Nutrition, Food and
Drug Administration (HFS–830), 5001
Campus Dr., College Park, MD 20740,
240–402–5429.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK3G9T082PROD with NOTICES
I. Background
We are announcing the availability of
a draft guidance for industry entitled
‘‘Questions and Answers on the
Nutrition and Supplement Facts Labels
Related to the Compliance Date, Added
Sugars, and Declaration of Quantitative
Amounts of Vitamins and Minerals.’’
We are issuing the draft guidance
consistent with our good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on this topic. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternate approach if it satisfies the
requirements of the applicable statutes
and regulations.
In the Federal Register of May 27,
2016, we issued a final rule entitled
‘‘Food Labeling: Revision of the
Nutrition and Supplement Facts Labels’’
(81 FR 33742). The final rule amends
our regulations for the nutrition labeling
of conventional foods and dietary
supplements to provide updated
nutrition information and to improve
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21:06 Jan 04, 2017
Jkt 241001
how the nutrition information is
presented to consumers. The final rule
provided two compliance dates
distinguishing between manufacturers
with $10 million or more in annual food
sales (July 26, 2018) and manufacturers
with less than $10 million in annual
food sales (July 26, 2019). The final rule
also revised the Nutrition Facts label to
replace ‘‘sugars’’ with ‘‘total sugars’’ and
to include the declaration of added
sugars. The draft guidance is intended
for conventional food and dietary
supplement manufacturers and will,
when finalized, provide questions and
answers on topics related to
compliance, labeling of added sugars,
declaration of quantitative amounts of
vitamins and minerals, and format.
II. Additional Issues for Consideration
We invite interested persons to
comment on topics related to
compliance, labeling of added sugars,
declaration of quantitative amounts of
vitamins and minerals, and format.
However, we are particularly interested
in responses to the following questions:
1. What, if any, concerns are there for
manufacturers to use Brix values from
21 CFR 101.30 when calculating the
added sugars content of products
containing fruit juice concentrates?
2. For purposes of calculating the
amount of added sugars, what, if any,
concerns are there if we consider that all
of the water in a formulation with fruit
or vegetable juice concentrate is used to
reconstitute the fruit or vegetable juice?
To illustrate the issue, assume that fruit
juice concentrate is added to a food and
that the manufacturer also adds water to
the food. We recognize that the water
may reconstitute the fruit juice, but also
recognize that some portion of the water
may have other purposes or affect
ingredients other than the fruit juice
concentrate. Nevertheless, to calculate
the amount of added sugars, we would
consider that all of the water goes
towards reconstituting the fruit juice.
3. What, if any, concerns are there if
we consider that all of the water that has
been removed from a product during
processing contributes towards the
concentration of juice added as an
ingredient during the formulation of the
product?
When responding to these questions,
please explain your reasoning.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
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3520). The collections of information in
21 CFR part 101 have been approved
under OMB control number 0910–0813.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA Web site listed in the previous
sentence to find the most current
version of the guidance.
V. Reference
The following reference is on display
in the Division of Dockets Management
(see ADDRESSES) and is available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; it are also available
electronically at https://
www.regulations.gov. FDA has verified
the Web site address, as of the date this
document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. U.S. Department of Health and Human
Services. 2015 Dietary Guidelines for
Americans. Accessed online at https://
www.health.gov/dietaryguidelines/dga2005/
document/default.htm.
Dated: December 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–32005 Filed 1–4–17; 8:45 am]
BILLING CODE 4164–01–P
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.
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-togovernment 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
SUMMARY:
E:\FR\FM\05JAN1.SGM
05JAN1
Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices
Consultation Policy issued in February
2016.
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.
ADDRESSES:
II. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://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
FOR FURTHER INFORMATION CONTACT:
Sarah Walinsky, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, (240)
402–4075.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK3G9T082PROD with NOTICES
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.
21:06 Jan 04, 2017
Jkt 241001
Food and Drug Administration
[Docket No. FDA–2010–N–0118]
I. Background
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prior Notice of
Imported Food Under the Public Health
Security and Bioterrorism
Preparedness and Response Act of
2002
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (the PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of FDA regulations
requiring that the Agency receives prior
notice before food is imported or offered
for import into the United States.
DATES: Submit either electronic or
written comments on the collection of
information by March 6, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
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1349
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 https://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–
2010–N–0118 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Prior
Notice of Imported Food Under the
Public Health Security and Bioterrorism
Preparedness and Response Act of
2002.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://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
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
