83 FR 8953 - The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 42 (March 2, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 42 (March 2, 2018)
| Page Range | 8953-8955 | |
| FR Document | 2018-04281 |
[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)] [Proposed Rules] [Pages 8953-8955] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04281] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2018-D-0075] The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products: Guidance for Industry.'' The draft guidance, when finalized, will advise food manufacturers of our intent to exercise enforcement discretion related to the use in the Nutrition Facts label of a symbol ``[dagger]'' immediately after the added sugars percent Daily Value information on certain foods. The symbol would lead the reader to truthful and non-misleading statements outside the Nutrition Facts label to provide additional information regarding the added sugars present in particular foods. DATES: Submit either electronic or written comments by May 1, 2018 to ensure that we consider your comment before we take further action. ADDRESSES: You may submit comments on any guidance at any time 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. [[Page 8954]] 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2018-D-0075 for ``The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products: Guidance for Industry.'' 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 Dockets Management Staff 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.'' We will review this copy, including the claimed confidential information, in our 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 Dockets Management Staff. 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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: Claudine Kavanaugh, Office of Foods and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-1450. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a draft guidance for industry entitled ``The Declaration of Added Sugars on Honey, Maple Syrup and Certain Cranberry Products: Guidance for Industry.'' We are issuing the draft guidance consistent with FDA's 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. This guidance is not subject to Executive Order 12866. The draft guidance is intended to advise food manufacturers of our intent to exercise enforcement discretion related to the use in the Nutrition Facts label of a symbol ``[dagger]'' immediately after the added sugars percent Daily Value information on certain foods. The symbol would lead the reader to truthful and non-misleading statements outside the Nutrition Facts label to provide additional information regarding the added sugars present in particular foods. The draft guidance would explain that we intend to consider exercising our enforcement discretion for the use of this symbol on single ingredient packages and/or containers of pure honey or pure maple syrup, and certain dried cranberry and cranberry juice products that are sweetened with added sugars, and that contain total sugars at levels no greater than comparable products with endogenous (inherent) sugars, but no added sugars. II. 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 website listed in the previous sentence to find the most current version of the guidance. III. Other Issues for Consideration We invite interested persons to comment on topics related to the draft guidance. However, we are particularly interested in responses to the following questions: 1. The draft guidance is intended to advise food manufacturers of our intent to exercise enforcement discretion related to the use in the Nutrition Facts label of a symbol ``[dagger]'' immediately after the added sugars percent Daily Value information on certain foods. Should we use a different symbol? If so, what symbol should we use and what is the rationale for using an alternative? Also, should the placement or location of the symbol be elsewhere on the Nutrition Facts label? For example, should the symbol appear after ``Includes X g Added Sugars'' instead? Please explain where the symbol should appear and your reasons for placing the symbol elsewhere on the label. 2. We are considering giving an additional year to come into compliance with the changes required by the final rule for the labeling of packages or containers of pure honey and maple syrup, and for the dried cranberry and cranberry juice products described in this draft guidance. Consumers will likely become more acclimated and educated on having an added sugars declaration on the Nutrition Facts label during this time period, based in part on other products in the marketplace bearing the new Nutrition Facts label. Should FDA consider this period of enforcement discretion given that, in the Federal Register of October 2, 2017 (82 FR 45753), FDA has proposed to extend the Nutrition Facts label compliance date from July 26, 2018, to January 1, 2020, for manufacturers with $10 million or more in annual food sales and from July 26, 2019, to January 1, [[Page 8955]] 2021, for manufacturers with less than $10 million in annual food sales? Please explain your reasoning. Dated: February 27, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-04281 Filed 3-1-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Proposed Rules 8953
(b) Affected ADs of the local flight standards district office/ DEPARTMENT OF HEALTH AND
None. certificate holding district office. HUMAN SERVICES
(3) An AMOC that provides an acceptable
(c) Applicability level of safety may be used for any repair, Food and Drug Administration
This AD applies to The Boeing Company modification, or alteration required by this
Model 757–200, –200PF, –200CB, and –300 AD if it is approved by the Boeing 21 CFR Part 101
series airplanes, certificated in any category, Commercial Airplanes Organization
as identified in Boeing Alert Service Bulletin Designation Authorization (ODA) that has [Docket No. FDA–2018–D–0075]
757–53A0104, dated November 6, 2017. been authorized by the Manager, Los Angeles
The Declaration of Added Sugars on
(d) Subject ACO Branch, to make those findings. To be
Honey, Maple Syrup, and Certain
Air Transport Association (ATA) of approved, the repair method, modification
Cranberry Products; Draft Guidance
America Code 53, Fuselage. deviation, or alteration deviation must meet
for Industry; Availability
the certification basis of the airplane, and the
(e) Unsafe Condition approval must specifically refer to this AD. AGENCY: Food and Drug Administration,
This AD was prompted by an evaluation by (4) Except as required by paragraph (h)(2) HHS.
the design approval holder indicating that of this AD: For service information that
the longitudinal lap splices of the fuselage ACTION: Notification of availability.
contains steps that are labeled as RC, the
skin are subject to widespread fatigue provisions of paragraphs (i)(4)(i) and (i)(4)(ii) SUMMARY: The Food and Drug
damage. We are issuing this AD to address of this AD apply.
fatigue cracking of the longitudinal lap Administration (FDA or we) is
(i) The steps labeled as RC, including announcing the availability of a draft
splices of the fuselage skin, which could
result in reduced structural integrity of the substeps under an RC step and any figures guidance for industry entitled ‘‘The
airplane. identified in an RC step, must be done to Declaration of Added Sugars on Honey,
comply with the AD. If a step or substep is Maple Syrup, and Certain Cranberry
(f) Compliance labeled ‘‘RC Exempt,’’ then the RC Products: Guidance for Industry.’’ The
Comply with this AD within the requirement is removed from that step or draft guidance, when finalized, will
compliance times specified, unless already substep. An AMOC is required for any advise food manufacturers of our intent
done. deviations to RC steps, including substeps to exercise enforcement discretion
(g) Required Actions and identified figures. related to the use in the Nutrition Facts
(ii) Steps not labeled as RC may be label of a symbol ‘‘†’’ immediately after
Except as required by paragraph (h) of this
AD: At the applicable times specified in deviated from using accepted methods in the added sugars percent Daily Value
paragraph 1.E., ‘‘Compliance,’’ of Boeing accordance with the operator’s maintenance
information on certain foods. The
Alert Service Bulletin 757–53A0104, dated or inspection program without obtaining
symbol would lead the reader to truthful
November 6, 2017, do all applicable actions approval of an AMOC, provided the RC steps,
and non-misleading statements outside
identified as ‘‘RC’’ (required for compliance) including substeps and identified figures, can
the Nutrition Facts label to provide
in, and in accordance with, the still be done as specified, and the airplane
Accomplishment Instructions of Boeing Alert additional information regarding the
can be put back in an airworthy condition.
Service Bulletin 757–53A0104, dated added sugars present in particular
November 6, 2017. (j) Related Information foods.
(h) Exceptions to Service Information (1) For more information about this AD, DATES: Submit either electronic or
Specifications contact David Truong, Aerospace Engineer, written comments by May 1, 2018 to
Airframe Section, Los Angeles ACO Branch, ensure that we consider your comment
(1) For purposes of determining
compliance with the requirements of this AD, FAA, 3960 Paramount Boulevard, Lakewood, before we take further action.
where Boeing Alert Service Bulletin 757– CA 90712–4137; phone: 562–627–5224; fax:
ADDRESSES: You may submit comments
53A0104, dated November 6, 2017, uses the 562–627–5210; email: david.truong@faa.gov.
on any guidance at any time as follows:
phrase ‘‘the original issue date of this service (2) For service information identified in
bulletin,’’ this AD requires using ‘‘the this AD, contact Boeing Commercial Electronic Submissions
effective date of this AD.’’ Airplanes, Attention: Contractual & Data
Submit electronic comments in the
(2) Where Boeing Alert Service Bulletin Services (C&DS), 2600 Westminster Blvd.,
757–53A0104, dated November 6, 2017, following way:
MC 110–SK57, Seal Beach, CA 90740–5600;
specifies contacting Boeing, and specifies • Federal eRulemaking Portal:
telephone 562–797–1717; internet https://
that action as RC: This AD requires using a https://www.regulations.gov. Follow the
www.myboeingfleet.com. You may view this
method approved in accordance with the instructions for submitting comments.
referenced service information at the FAA,
procedures specified in paragraph (i) of this Comments submitted electronically,
Transport Standards Branch, 2200 South
AD. including attachments, to https://
216th St., Des Moines, WA. For information
(i) Alternative Methods of Compliance on the availability of this material at the
www.regulations.gov will be posted to
(AMOCs) FAA, call 206–231–3195.
the docket unchanged. Because your
(1) The Manager, Los Angeles ACO Branch, comment will be made public, you are
Issued in Renton, Washington, on February solely responsible for ensuring that your
FAA, has the authority to approve AMOCs
22, 2018. comment does not include any
for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with Michael Kaszycki, confidential information that you or a
14 CFR 39.19, send your request to your Acting Director, System Oversight Division, third party may not wish to be posted,
principal inspector or local Flight Standards Aircraft Certification Service. such as medical information, your or
daltland on DSKBBV9HB2PROD with PROPOSALS
District Office, as appropriate. If sending [FR Doc. 2018–04229 Filed 3–1–18; 8:45 am] anyone else’s Social Security number, or
information directly to the manager of the confidential business information, such
certification office, send it to the attention of BILLING CODE 4910–13–P
as a manufacturing process. Please note
the person identified in paragraph (j)(1) of
this AD. Information may be emailed to: 9- that if you include your name, contact
ANM-LAACO-AMOC-Requests@faa.gov. information, or other information that
(2) Before using any approved AMOC, identifies you in the body of your
notify your appropriate principal inspector, comments, that information will be
or lacking a principal inspector, the manager posted on https://www.regulations.gov.
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![Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Proposed Rules 8955
2021, for manufacturers with less than DHS Department of Homeland Security and when so directed by that officer
$10 million in annual food sales? Please FR Federal Register would be operated at a minimum safe
explain your reasoning. NPRM Notice of Proposed Rulemaking navigation speed in a manner which
PATCOM Patrol Commander will not endanger participants in the
Dated: February 27, 2018. § Section
Leslie Kux, U.S.C. United States Code
regulated area or any other vessels. No
spectator vessel shall anchor, block,
Associate Commissioner for Policy.
II. Background, Purpose, and Legal loiter, or impede the through transit of
[FR Doc. 2018–04281 Filed 3–1–18; 8:45 am] Basis participants or official patrol vessels in
BILLING CODE 4164–01–P
On November 31, 2017, the marine the regulated area during the effective
event sponsor for the annual USA dates and times, unless cleared for entry
Triathlon Collegiate National by or through an official patrol vessel.
DEPARTMENT OF HOMELAND Any spectator vessel may anchor
Championships marine event submitted
SECURITY outside the regulated area, but may not
an application for a marine event
permit. The Captain of the Port Sector anchor in, block, or loiter in a navigable
Coast Guard channel. Spectator vessels may be
Mobile (COTP) has determined a special
moored to a waterfront facility within
33 CFR Part 100 local regulation is needed to protect the
the regulated area in such a way that
persons participating in and viewing the
[Docket Number USCG–2018–0014] they shall not interfere with the progress
USA Triathlon Collegiate National
of the event. Such mooring must be
RIN 1625–AA08 Championships marine event.
complete at least 30 minutes prior to the
The purpose of this proposed
Special Local Regulation; Black establishment of the regulated area and
rulemaking is to restrict transit into,
Warrior River, Tuscaloosa, AL remain moored through the duration of
through and within the regulated area
the event.
on the Black Warrior River extending
AGENCY: Coast Guard, DHS. The COTP or a designated
the entire width of the river from mile
ACTION: Notice of proposed rulemaking. representative may forbid and control
marker 338.5 to mile marker 339.5 in
the movement of all vessels in the
SUMMARY: The Coast Guard proposes to Tuscaloosa, AL during the USA
regulated area. When hailed or signaled
establish a temporary special local Triathlon Collegiate National
by an official patrol vessel, a vessel shall
regulation on the Black Warrior River Championships. The Coast Guard
come to an immediate stop and comply
extending the entire width of the river proposes this rulemaking under
with the directions given. Failure to do
from mile marker 338.5 to mile marker authority in 33 U.S.C. 1233.
so may result in expulsion from the
339.5 in Tuscaloosa, AL. The proposed III. Discussion of Proposed Rule area, citation for failure to comply, or
rulemaking is needed to protect the both.
persons participating in the USA The Coast Guard proposes to establish
The COTP or a designated
Triathlon Collegiate National a temporary special local regulation on
representative may terminate the event
Championships marine event. This the Black Warrior River extending the
or the operation of any vessel at any
proposed rulemaking restricts transit entire width of the river from mile
time it is deemed necessary for the
into, through and within the regulated marker 338.5 to mile marker 339.5 in
protection of life or property. The COTP
area unless specifically authorized by Tuscaloosa, AL. The proposed
or a designated representative would
the Captain of the Port Sector Mobile rulemaking is needed to needed to
terminate enforcement of the special
(COTP) or a designated representative. protect the persons participating in the
local regulations at the conclusion of the
We invite your comments on this USA Triathlon Collegiate National
event.
proposed rulemaking. Championships marine event. This The regulatory text we are proposing
proposed rulemaking restricts transit appears at the end of this document.
DATES: Comments and related material
into, through and within the regulated
must be received by the Coast Guard on area unless specifically authorized by IV. Regulatory Analyses
or before April 2, 2018. the COTP. No vessel or person would be We developed this proposed rule after
ADDRESSES: You may submit comments permitted to enter the regulated area considering numerous statutes and
identified by docket number USCG– without obtaining permission from the Executive orders related to rulemaking.
2018–0014 using the Federal COTP or a designated representative. A Below we summarize our analyses
eRulemaking Portal at http:// designated representative may be a based on a number of these statutes and
www.regulations.gov. See the ‘‘Public Patrol Commander (PATCOM). The Executive orders and we discuss First
Participation and Request for PATCOM would be aboard either a Amendment rights of protestors.
Comments’’ portion of the Coast Guard or Coast Guard Auxiliary
SUPPLEMENTARY INFORMATION section for vessel. The Patrol Commander may be A. Regulatory Planning and Review
further instructions on submitting contacted on Channel 16 VHF–FM Executive Orders 12866 and 13563
comments. (156.8 MHz) by the call sign direct agencies to assess the costs and
FOR FURTHER INFORMATION CONTACT: If ‘‘PATCOM’’. All persons and vessels not benefits of available regulatory
you have questions about this proposed registered with the sponsor as alternatives and, if regulation is
rulemaking, call or email LT Kyle D. participants or official patrol vessels are necessary, to select regulatory
Berry, Sector Mobile, Waterways considered spectators. The ‘‘official approaches that maximize net benefits.
daltland on DSKBBV9HB2PROD with PROPOSALS
Management Division, U.S. Coast patrol vessels’’ consist of any Coast Executive Order 13771 directs agencies
Guard; telephone 251–441–5940, email Guard, state, or local law enforcement to control regulatory costs through a
kyle.d.berry@uscg.mil. and sponsor provided vessels assigned budgeting process. This NPRM has not
SUPPLEMENTARY INFORMATION: or approved by the COTP to patrol the been designated a ‘‘significant
regulated area. regulatory action,’’ under Executive
I. Table of Abbreviations Spectator vessels desiring to transit Order 12866. Accordingly, the NPRM
CFR Code of Federal Regulations the regulated area may do so only with has not been reviewed by the Office of
COTP Captain of the Port Sector Mobile prior approval of the Patrol Commander Management and Budget (OMB), and
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Document Created: 2018-03-01 23:56:39
Document Modified: 2018-03-01 23:56:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notification of availability. | |
| Dates | Submit either electronic or written comments by May 1, 2018 to ensure that we consider your comment before we take further action. | |
| Contact | Claudine Kavanaugh, Office of Foods and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-1450. | |
| FR Citation | 83 FR 8953 |
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