Ingredients Declared as Evaporated Cane Juice; Guidance for Industry; Availability, 33538-33540 [2016-12402]
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33538
Federal Register / Vol. 81, No. 102 / Thursday, May 26, 2016 / Notices
for identifying potential conflicts of
interests.
All currently listed compendia will be
required to comply with these
provisions, as of January 1, 2010, to
remain on the list of recognized
compendia. In addition, any
compendium that is the subject of a
future request for inclusion on the list
of recognized compendia will be
required to comply with these
provisions. No compendium can be on
the list if it does not fully meet the
standard described in section
1861(t)(2)(B) of the Act, as revised by
section 182(b) of the MIPPA. Form
Number: CMS–10302 (OMB control
number: 0938–1078); Frequency:
Annually; Affected Public: Business and
other for-profits and Not-for-profit
institutions; Number of Respondents:
845; Total Annual Responses: 900; Total
Annual Hours: 5,135. (For policy
questions regarding this collection
contact Brijet Coachman at 410–786–
7364.)
Dated: May 23, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–12476 Filed 5–25–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Number: 93.576]
Announcement of Award of an Urgent
Single-Source Grant to Gulf Coast
Jewish Family and Community
Services in Clearwater, FL
Office of Refugee Resettlement,
ACF, HHS.
AGENCY:
Notice of the award of an urgent
single-source grant to Gulf Coast Jewish
Family and Community Services to
provide mental health technical
assistance services for refugees.
ACTION:
The Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR) announces
the award of an urgent single-source
grant in the amount of $225,000 to Gulf
Coast Jewish Family and Community
Services (Gulf Coast) in Clearwater, FL
to train providers to effectively identify
and appropriately serve the mental
health needs of arriving refugee
populations.
sradovich on DSK3TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:47 May 25, 2016
Jkt 238001
The two-year project period for
the award is December 1, 2015 through
November 30, 2017.
DATES:
FOR FURTHER INFORMATION CONTACT:
Kenneth Tota, Deputy Director, Office of
Refugee Resettlement, 330 C. Street,
SW., Washington, DC 20201. Telephone:
202–401–4858. Email: kenneth.tota@
acf.hhs.gov
In the past
few years, ORR has seen an increasing
need for mental health services among
newly-arrived refugees, particularly
those who have suffered torture and
extreme trauma due to war and
genocide. ORR has received numerous
reports of refugees from Bhutan and
Burma completing suicide. Bhutanese
refugees, in particular, have
demonstrated a high incidence of
suicide upon arrival to the U.S. This
fiscal year the program is seeing a
significant increase in resettlement of
refugees from the Democratic Republic
of Congo and Syria.
Refugees face significant barriers to
accessing mental health resources since
they are unfamiliar with community
mental health systems, speak limited
English, and have few financial
resources. Health and mental health
providers are often overwhelmed by the
linguistic and cultural differences that
refugees present and respond by saying
they are unable to provide services.
Currently the provision of standardized
mental health screening and culturally
appropriate mental health services is
one the primary challenges facing the
US resettlement program. There is no
direct provision of much needed mental
health services to refugees in many
primary resettlement locations.
Gulf Coast has been a longstanding
refugee resettlement program and also
has been a grantee under the ORR
Survivors of Torture program for the
past 15 years. In addition, Gulf Coast
has provided technical assistance and
mental health services to a national
network of refugee service providers
and mainstream health and mental
health professionals for the past 9 years.
Gulf Coast is recognized as the primary
refugee mental health technical
assistance provider to states without a
survivor of torture program. As a result
of Gulf Coast’s training and technical
assistance 6 states applied for and
received ORR grants to provide direct
services to survivors. They are the only
technical assistance provider with
expertise in both refugee resettlement
and direct services to survivors of
torture. They are the only national
technical assistance provider with
expertise in both refugee resettlement
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
and direct services to survivors of
torture.
Gulf Coast’s National Partnership for
Community Training (NPCT) has
provided technical assistance and
training services to ORR grantees and
other refugee service providers since
2006.
It is expected that ORR will provide
awards to this grantee for a 2-year
project period with 12-month budget
periods. The grantee will be required to
submit applications for noncompetitive
awards in the subsequent year during
the project period. Future awards will
be based on the grantee’s performance,
the availability of funds, and the best
interest of the Federal Government.
Statutory Authority: This program is
authorized by—
(A) Section 412 (c)(1)(A) of the
Immigration and Nationality Act (INA)(8
U.S.C. 1522(c)(1)(A)), as amended, which
authorizes the Director ‘‘to make grants to,
and enter into contracts with, public or
private nonprofit agencies for projects
specifically designed—[. . .](i) to assist
refugees in obtaining the skills that are
necessary for economic self-sufficiency,
including projects for job training,
employment services, day care, professional
refresher training, and other recertification
services; (ii) to provide training in English
where necessary (regardless of whether the
refugees are employed or receiving cash or
other assistance); and (iii) to provide where
specific needs have been shown and
recognized by the Director, health (including
mental health) services, social services,
education and other services.’’
(B) Refugee Assistance Extension Act of
1986, Pub.L. 99–605, Nov 6, 1986, 100 Stat.
3449.
Christopher Beach,
Senior Grants Policy Specialist, Division of
Grants Policy, Office of Administration.
[FR Doc. 2016–12462 Filed 5–25–16; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0430]
Ingredients Declared as Evaporated
Cane Juice; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a
guidance entitled ‘‘Ingredients Declared
as Evaporated Cane Juice.’’ The
document advises industry of FDA’s
view that sweeteners derived from sugar
SUMMARY:
E:\FR\FM\26MYN1.SGM
26MYN1
Federal Register / Vol. 81, No. 102 / Thursday, May 26, 2016 / Notices
cane, including those derived from
sugar cane syrup, should not be
declared on food labels as ‘‘evaporated
cane juice.’’ Instead, such ingredients
should be declared as ‘‘sugar,’’ preceded
by one or more truthful, non-misleading
descriptors if the manufacturer so
chooses.
Submit either electronic or
written comments on FDA guidances at
any time.
ADDRESSES: You may submit comments
as follows:
DATES:
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
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’’).
sradovich on DSK3TPTVN1PROD with NOTICES
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–
2009–D–0430 for ‘‘Ingredients Declared
as Evaporated Cane Juice.’’ Received
comments will be placed in the docket
and, except for those submitted as
VerDate Sep<11>2014
18:47 May 25, 2016
Jkt 238001
‘‘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
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
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
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 guidance to Food Labeling
and Standards Staff/Office of Nutrition
and Food Labeling, Center for Food
Safety and Applied Nutrition (HFS–
820), Food and Drug Administration,
5100 Paint Branch Pkwy., 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 guidance.
FOR FURTHER INFORMATION CONTACT:
Andrea Krause, Center for Food Safety
and Applied Nutrition (HFS–820), Food
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
33539
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–2371.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a guidance for industry entitled
‘‘Ingredients Declared as Evaporated
Cane Juice.’’ We are issuing this
guidance consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The guidance represents 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 alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
In the Federal Register of October 7,
2009 (74 FR 51610), we announced the
availability of a draft guidance for
industry entitled ‘‘Guidance for
Industry: Ingredients Declared as
Evaporated Cane Juice’’ and invited
comment by December 7, 2009. The
draft guidance, which was issued in
response to the use of the term
‘‘evaporated cane juice’’ on food labels,
stated FDA’s view that ‘‘evaporated cane
juice’’ is not the common or usual name
of any sweetener and that the ingredient
in question should instead be declared
as ‘‘dried cane syrup.’’ In the Federal
Register of March 5, 2014 (79 FR
12507), we reopened the comment
period until May 5, 2014, and requested
further comments, data, and information
about the basic nature and
characterizing properties of the
ingredient sometimes declared as
‘‘evaporated cane juice,’’ how this
ingredient is produced, and how it
compares with other sweeteners.
We received numerous comments on
the draft guidance, including many that
included information about the
processing and refining of ingredients
made from sugar cane. We have
modified the final guidance where
appropriate. In addition, we made
editorial changes to improve clarity.
Based on comments stating that the
ingredient sometimes declared as
evaporated cane juice is not made from
cane syrup as defined in 21 CFR
168.130, FDA is no longer
recommending that this ingredient be
labeled as ‘‘dried cane syrup.’’ Instead,
the guidance advises that ingredients
currently being declared as ‘‘evaporated
cane juice,’’ as well as other ingredients
that meet the description of ‘‘sucrose’’
in 21 CFR 184.1854, should be declared
using the term ‘‘sugar,’’ accompanied by
a truthful, non-misleading descriptor if
the manufacturer so desires. The
guidance announced in this notice
E:\FR\FM\26MYN1.SGM
26MYN1
33540
Federal Register / Vol. 81, No. 102 / Thursday, May 26, 2016 / Notices
finalizes the draft guidance dated
October 2009.
FDA encourages firms that market
sugar cane-derived sweeteners or
products that contain a sugar canederived sweetener to review the final
guidance and consider whether the
name under which the sweetener is
declared in food labeling accurately
describes its basic nature and
characterizing properties, as required by
the common or usual name regulation
(21 CFR 102.5). As explained in the
final guidance, our view is that products
currently labeled as containing
‘‘evaporated cane juice’’ should be
relabeled to use the name ‘‘sugar,’’
optionally accompanied by a truthful,
non-misleading descriptor to
distinguish the ingredient from other
cane-based sweeteners. FDA would not
object to the use of stickers to make this
change until the next regularly
scheduled label printing.
II. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/FoodGuidances or https://
www.regulations.gov. Use the FDA Web
sites listed previously to find the most
current version of the guidance.
Dated: May 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–12402 Filed 5–25–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on Combating AntibioticResistant Bacteria
Office of the Secretary, Office
of the Assistant Secretary for Health,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that a meeting is scheduled to be held
of the Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria
(Advisory Council). The meeting will be
open to the public; a public comment
session will be held during the meeting.
Pre-registration is required for members
of the public who wish to attend the
meeting and who wish to participate in
the public comment session. Individuals
who wish to attend the meeting and/or
send in their public comment via email
should send an email to CARB@hhs.gov.
sradovich on DSK3TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:47 May 25, 2016
Jkt 238001
Registration information is available on
the Web site https://www.hhs.gov/ash/
carb/ and must be completed by June
18, 2016; all in-person attendees must
pre-register by this date. Additional
information about registering for the
meeting and providing public comment
can be obtained at https://www.hhs.gov/
ash/carb/ on the Meetings page.
DATES: The meeting is scheduled to be
held on June 21, 2016, from 10:00 a.m.
to 5:00 p.m. ET, and June 22, 2016, from
9:00 a.m. to 4:00 p.m. ET (times are
tentative and subject to change). The
confirmed times and agenda items for
the meeting will be posted on the Web
site for the Advisory Council at https://
www.hhs.gov/ash/carb/ when this
information becomes available. Preregistration for attending the meeting in
person is required to be completed no
later than June 18, 2016; public
attendance at the meeting is limited to
the available space.
ADDRESSES: U.S. Department of Health
and Human Services, Hubert H.
Humphrey Building, Great Hall, 200
Independence Avenue SW.,
Washington, DC 20201.
The meeting also can be accessed
through a live webcast on the day of the
meeting. For more information, visit
https://www.hhs.gov/ash/carb/.
FOR FURTHER INFORMATION CONTACT:
Bruce Gellin, Designated Federal
Officer, Presidential Advisory Council
on Combating Antibiotic-Resistant
Bacteria, Office of the Assistant
Secretary for Health, U.S. Department of
Health and Human Services, Room
715H, Hubert H. Humphrey Building,
200 Independence Avenue SW.,
Washington, DC 20201. Phone: (202)
260–6638; email: CARB@hhs.gov.
SUPPLEMENTARY INFORMATION: Under
Executive Order 13676, dated
September 18, 2014, authority was given
to the Secretary of HHS to establish the
Advisory Council, in consultation with
the Secretaries of Defense and
Agriculture. Activities of the Advisory
Council are governed by the provisions
of Public Law 92–463, as amended (5
U.S.C. App.), which sets forth standards
for the formation and use of federal
advisory committees.
The Advisory Council will provide
advice, information, and
recommendations to the Secretary of
HHS regarding programs and policies
intended to support and evaluate the
implementation of Executive Order
13676, including the National Strategy
for Combating Antibiotic-Resistant
Bacteria and the National Action Plan
for Combating Antibiotic-Resistant
Bacteria. The Advisory Council shall
function solely for advisory purposes.
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
In carrying out its mission, the
Advisory Council will provide advice,
information, and recommendations to
the Secretary regarding programs and
policies intended to preserve the
effectiveness of antibiotics by
optimizing their use; advance research
to develop improved methods for
combating antibiotic resistance and
conducting antibiotic stewardship;
strengthen surveillance of antibioticresistant bacterial infections; prevent
the transmission of antibiotic-resistant
bacterial infections; advance the
development of rapid point-of-care and
agricultural diagnostics; further research
on new treatments for bacterial
infections; develop alternatives to
antibiotics for agricultural purposes;
maximize the dissemination of up-todate information on the appropriate and
proper use of antibiotics to the general
public and human and animal
healthcare providers; and improve
international coordination of efforts to
combat antibiotic resistance.
On June 21, the public meeting will
be dedicated to presentations from
federal and non-federal stakeholders
surrounding topic areas related to
incentives for the development of
vaccines, diagnostics, and therapeutics.
On June 22, the meeting will focus on
the topic of the environment and
antibiotic-resistance, in addition to a
presentation regarding the new
guidance from the Food and Drug
Administration for Industry #213, ‘‘New
Animal Drugs and New Animal Drug
Combination Products Administered in
or on Medicated Feed or Drinking Water
of Food-Producing Animals:
Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use
Conditions With Guidance for Industry
#209.’’ The meeting agenda will be
posted on the Advisory Council Web
site at https://www.hhs.gov/ash/carb/
when it has been finalized. All agenda
items are tentative and subject to
change.
Public attendance at the meeting is
limited to the available space.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Designated Federal Officer at
the address/telephone number listed
above at least one week prior to the
meeting. For those unable to attend in
person, a live webcast will be available.
More information on registration and
accessing the webcast can be found at
https://www.hhs.gov/ash/carb/.
Members of the public will have the
opportunity to provide comments prior
to the Advisory Council meeting by
emailing CARB@hhs.gov. Public
E:\FR\FM\26MYN1.SGM
26MYN1
Agencies
[Federal Register Volume 81, Number 102 (Thursday, May 26, 2016)]
[Notices]
[Pages 33538-33540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12402]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0430]
Ingredients Declared as Evaporated Cane Juice; Guidance for
Industry; 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 a guidance entitled ``Ingredients Declared as
Evaporated Cane Juice.'' The document advises industry of FDA's view
that sweeteners derived from sugar
[[Page 33539]]
cane, including those derived from sugar cane syrup, should not be
declared on food labels as ``evaporated cane juice.'' Instead, such
ingredients should be declared as ``sugar,'' preceded by one or more
truthful, non-misleading descriptors if the manufacturer so chooses.
DATES: Submit either electronic or written comments on FDA guidances at
any time.
ADDRESSES: You may submit comments as follows:
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 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-2009-D-0430 for ``Ingredients Declared as Evaporated Cane Juice.''
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
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://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 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 guidance to Food
Labeling and Standards Staff/Office of Nutrition and Food Labeling,
Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug
Administration, 5100 Paint Branch Pkwy., 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 guidance.
FOR FURTHER INFORMATION CONTACT: Andrea Krause, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-2371.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``Ingredients Declared as Evaporated Cane Juice.'' We are
issuing this guidance consistent with FDA's good guidance practices
regulation (21 CFR 10.115). The guidance represents 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
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
In the Federal Register of October 7, 2009 (74 FR 51610), we
announced the availability of a draft guidance for industry entitled
``Guidance for Industry: Ingredients Declared as Evaporated Cane
Juice'' and invited comment by December 7, 2009. The draft guidance,
which was issued in response to the use of the term ``evaporated cane
juice'' on food labels, stated FDA's view that ``evaporated cane
juice'' is not the common or usual name of any sweetener and that the
ingredient in question should instead be declared as ``dried cane
syrup.'' In the Federal Register of March 5, 2014 (79 FR 12507), we
reopened the comment period until May 5, 2014, and requested further
comments, data, and information about the basic nature and
characterizing properties of the ingredient sometimes declared as
``evaporated cane juice,'' how this ingredient is produced, and how it
compares with other sweeteners.
We received numerous comments on the draft guidance, including many
that included information about the processing and refining of
ingredients made from sugar cane. We have modified the final guidance
where appropriate. In addition, we made editorial changes to improve
clarity. Based on comments stating that the ingredient sometimes
declared as evaporated cane juice is not made from cane syrup as
defined in 21 CFR 168.130, FDA is no longer recommending that this
ingredient be labeled as ``dried cane syrup.'' Instead, the guidance
advises that ingredients currently being declared as ``evaporated cane
juice,'' as well as other ingredients that meet the description of
``sucrose'' in 21 CFR 184.1854, should be declared using the term
``sugar,'' accompanied by a truthful, non-misleading descriptor if the
manufacturer so desires. The guidance announced in this notice
[[Page 33540]]
finalizes the draft guidance dated October 2009.
FDA encourages firms that market sugar cane-derived sweeteners or
products that contain a sugar cane-derived sweetener to review the
final guidance and consider whether the name under which the sweetener
is declared in food labeling accurately describes its basic nature and
characterizing properties, as required by the common or usual name
regulation (21 CFR 102.5). As explained in the final guidance, our view
is that products currently labeled as containing ``evaporated cane
juice'' should be relabeled to use the name ``sugar,'' optionally
accompanied by a truthful, non-misleading descriptor to distinguish the
ingredient from other cane-based sweeteners. FDA would not object to
the use of stickers to make this change until the next regularly
scheduled label printing.
II. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov.
Use the FDA Web sites listed previously to find the most current
version of the guidance.
Dated: May 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12402 Filed 5-25-16; 8:45 am]
BILLING CODE 4164-01-P