83 FR 17961 - The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products: Draft Guidance for Industry; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 80 (April 25, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 80 (April 25, 2018)
| Page Range | 17961-17962 | |
| FR Document | 2018-08603 |
[Federal Register Volume 83, Number 80 (Wednesday, April 25, 2018)] [Proposed Rules] [Pages 17961-17962] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08603] ======================================================================= ----------------------------------------------------------------------- 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101 [Docket No. FDA-2018-D-0075] The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products: Draft Guidance for Industry; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is extending the comment period for the notification of availability of a draft guidance for industry entitled ``The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products: Guidance for Industry'' that appeared in the Federal Register of March 2, 2018. The draft guidance, when finalized, will advise food manufacturers of our intent to exercise enforcement discretion related to the use in the Nutrition Facts label of a symbol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. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: We are extending the comment period on the document that published in the Federal Register of March 2, 2018 (83 FR 8953). Submit either electronic or written comments by June 15, 2018. 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): 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.'' 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 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 [[Page 17962]] 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. FOR FURTHER INFORMATION CONTACT: Blakely Fitzpatrick, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1450. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of March 2, 2018 (83 FR 8953), we published a document 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 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 explains that we intend to consider exercising 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. We provided a 60-day comment period that was scheduled to close on May 1, 2018. We have received requests to extend the comment period for the draft guidance (Refs. 1 and 2). The requests conveyed concern that the current 60-day comment period does not allow sufficient time to develop meaningful or thoughtful comments to the draft guidance. We have considered the requests and are extending the comment period for the draft guidance for 45 additional days, until June 15, 2018. We believe that this extension allows adequate time for interested persons to submit comments without significantly delaying finalizing the guidance. II. References The following references are on display at the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. 1. Letter from Margaret Lombard, Chief Executive Officer, National Honey Board, to FDA Dockets Management Staff (April 3, 2018). 2. Letter from Ray Bonenberg, President, International Maple Syrup Institute, to Dr. Scott Gottlieb, Commissioner of Food and Drugs, FDA (April 4, 2018). Dated: April 19, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-08603 Filed 4-24-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 80 / Wednesday, April 25, 2018 / Proposed Rules 17961
Reducing Regulation and Controlling DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
Regulatory Costs, which requires HUMAN SERVICES confidential business information, such
agencies to repeal two regulations for as a manufacturing process. Please note
every new one issued and offset the Food and Drug Administration that if you include your name, contact
costs. Because, as AHAM has information, or other information that
demonstrated above, DOE’s cooktop test 21 CFR Part 101 identifies you in the body of your
procedure may be considered arbitrary [Docket No. FDA–2018–D–0075] comments, that information will be
and capricious because it is not posted on https://www.regulations.gov.
The Declaration of Added Sugars on • If you want to submit a comment
supported by sufficient data and likely
Honey, Maple Syrup, and Certain with confidential information that you
has a high degree of total variation, the
Cranberry Products: Draft Guidance do not wish to be made available to the
test procedure does not benefit public, submit the comment as a
consumers. It serves only to burden for Industry; Extension of Comment
Period written/paper submission and in the
manufacturers who must comply with a manner detailed (see ‘‘Written/Paper
test procedure that does not adequately AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’).
represent products and, due to HHS.
variation, will require manufacturers to ACTION: Notification of availability; Written/Paper Submissions
make conservative claims. extension of comment period. Submit written/paper submissions as
follows:
CONCLUSION SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for
Administration (FDA or we) is written/paper submissions): Dockets
Because AHAM’s testing shows that extending the comment period for the Management Staff (HFA–305), Food and
DOE did not sufficiently demonstrate notification of availability of a draft Drug Administration, 5630 Fishers
that the cooktop test procedure is guidance for industry entitled ‘‘The Lane, Rm. 1061, Rockville, MD 20852.
repeatable or reproducible for gas and Declaration of Added Sugars on Honey, • For written/paper comments
electric cooktops, because DOE has yet Maple Syrup, and Certain Cranberry submitted to the Dockets Management
to demonstrate—as EPCA requires it to Products: Guidance for Industry’’ that Staff, FDA will post your comment, as
do—that the final test procedure is appeared in the Federal Register of well as any attachments, except for
representative for gas cooktops, and March 2, 2018. The draft guidance, information submitted, marked and
because the test procedure is unduly when finalized, will advise food identified, as confidential, if submitted
burdensome to conduct, we respectfully manufacturers of our intent to exercise as detailed in ‘‘Instructions.’’
request that DOE withdraw the final enforcement discretion related to the Instructions: All submissions received
cooktop test procedure while use in the Nutrition Facts label of a must include the Docket No. FDA–
maintaining the repeal of the oven test symbol ‘‘†’’ immediately after the added 2018–D–0075 for ‘‘The Declaration of
procedure that was part of this same sugars percent Daily Value information Added Sugars on Honey, Maple Syrup,
Final Rule. Even absent an energy on certain foods. The symbol would and Certain Cranberry Products:
conservation standard for cooktops that lead the reader to truthful and non- Guidance for Industry.’’ Received
requires use of the test procedure, misleading statements outside the comments will be placed in the docket
manufacturers are required to report Nutrition Facts label to provide and, except for those submitted as
energy use via a test procedure DOE has additional information regarding the ‘‘Confidential Submissions,’’ publicly
added sugars present in particular viewable at https://www.regulations.gov
not demonstrated is representative of
foods. We are taking this action in or at the Dockets Management Staff
consumer use for all product types and
response to requests for an extension to between 9 a.m. and 4 p.m., Monday
AHAM has demonstrated is not allow interested persons additional time through Friday.
reproducible. This means that reported to submit comments. • Confidential Submissions—To
energy values for some products could submit a comment with confidential
DATES: We are extending the comment
be inaccurate and, for all products, will period on the document that published information that you do not wish to be
not be directly comparable to each other in the Federal Register of March 2, 2018 made publicly available, submit your
across manufacturers. Thus, consumers (83 FR 8953). Submit either electronic comments only as a written/paper
could be misled when evaluating and or written comments by June 15, 2018. submission. You should submit two
comparing energy claims. Accordingly, ADDRESSES: You may submit comments copies total. One copy will include the
we also seek an immediate stay of the as follows: information you claim to be confidential
effectiveness of the cooktop test with a heading or cover note that states
procedure, including the requirement Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
that manufacturers use the final test Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
procedure to make energy related following way: Agency will review this copy, including
claims. • Federal eRulemaking Portal: the claimed confidential information, in
https://www.regulations.gov. Follow the its consideration of comments. The
Respectfully submitted,
instructions for submitting comments. second copy, which will have the
Association of Home Appliance Comments submitted electronically, claimed confidential information
Manufacturers By: including attachments, to https:// redacted/blacked out, will be available
daltland on DSKBBV9HB2PROD with PROPOSALS
Jennifer Cleary, www.regulations.gov will be posted to for public viewing and posted on
Senior Director, Regulatory Affairs, 1111 19th the docket unchanged. Because your https://www.regulations.gov. Submit
St. NW, Suite 402, Washington, DC 20036, comment will be made public, you are both copies to the Dockets Management
202-872-5955 x314. solely responsible for ensuring that your Staff. If you do not wish your name and
[FR Doc. 2018–08641 Filed 4–24–18; 8:45 am] comment does not include any contact information to be made publicly
BILLING CODE 6450–01–P
confidential information that you or a available, you can provide this
third party may not wish to be posted, information on the cover sheet and not
such as medical information, your or in the body of your comments and you
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![17962 Federal Register / Vol. 83, No. 80 / Wednesday, April 25, 2018 / Proposed Rules
must identify this information as day comment period does not allow ADDRESSES: You may submit comments
‘‘confidential.’’ Any information marked sufficient time to develop meaningful or identified by docket number USCG–
as ‘‘confidential’’ will not be disclosed thoughtful comments to the draft 2018–0078 using the Federal
except in accordance with 21 CFR 10.20 guidance. eRulemaking Portal at http://
and other applicable disclosure law. For We have considered the requests and www.regulations.gov. See the ‘‘Public
more information about FDA’s posting are extending the comment period for Participation and Request for
of comments to public dockets, see 80 the draft guidance for 45 additional Comments’’ portion of the
FR 56469, September 18, 2015, or access days, until June 15, 2018. We believe SUPPLEMENTARY INFORMATION section for
the information at: https://www.gpo.gov/ that this extension allows adequate time further instructions on submitting
fdsys/pkg/FR-2015-09-18/pdf/2015- for interested persons to submit comments.
23389.pdf. comments without significantly FOR FURTHER INFORMATION CONTACT: If
Docket: For access to the docket to delaying finalizing the guidance. you have questions about this proposed
read background documents or the II. References rulemaking, call or email LT Michael
electronic and written/paper comments Collet, Chief of Waterways Management,
received, go to https:// The following references are on
display at the Dockets Management Staff U.S. Coast Guard Sector Buffalo;
www.regulations.gov and insert the telephone 716–843–9322, email D09-
docket number, found in brackets in the (see ADDRESSES) and are available for
viewing by interested persons between SMB-SECBuffalo-WWM@uscg.mil.
heading of this document, into the SUPPLEMENTARY INFORMATION:
‘‘Search’’ box and follow the prompts 9 a.m. and 4 p.m., Monday through
and/or go to the Dockets Management Friday; they are also available I. Table of Abbreviations
Staff, 5630 Fishers Lane, Rm. 1061, electronically at https://
CFR Code of Federal Regulations
Rockville, MD 20852. www.regulations.gov. DHS Department of Homeland Security
FOR FURTHER INFORMATION CONTACT: 1. Letter from Margaret Lombard, Chief FR Federal Register
Blakely Fitzpatrick, Center for Food Executive Officer, National Honey Board, NPRM Notice of proposed rulemaking
Safety and Applied Nutrition, Food and to FDA Dockets Management Staff (April § Section
3, 2018). U.S.C. United States Code
Drug Administration, 5001 Campus Dr.,
2. Letter from Ray Bonenberg, President,
College Park, MD 20740, 240–402–1450. International Maple Syrup Institute, to II. Background, Purpose, and Legal
SUPPLEMENTARY INFORMATION: Dr. Scott Gottlieb, Commissioner of Food Basis
and Drugs, FDA (April 4, 2018). On December 27, 2017, the Buffalo
I. Background
Dated: April 19, 2018. Vintage Boat Racing Association and BR
In the Federal Register of March 2, Guest Inc., notified the Coast Guard that
Leslie Kux,
2018 (83 FR 8953), we published a it will be conducting a boat race from
document announcing the availability of Associate Commissioner for Policy.
[FR Doc. 2018–08603 Filed 4–24–18; 8:45 am]
10:00 a.m. to 4:00 p.m. on July 1, 2018,
a draft guidance for industry entitled on the Buffalo Outer Harbor. Hazards
‘‘The Declaration of Added Sugars on BILLING CODE 4164–01–P
from the boat regatta include high speed
Honey, Maple Syrup, and Certain vessels. The Captain of the Port Buffalo
Cranberry Products: Guidance for (COTP) has determined that potential
Industry.’’ The draft guidance is DEPARTMENT OF HOMELAND hazards associated with the Officer
intended to advise food manufacturers SECURITY Lehner Memorial Vintage Regatta would
of our intent to exercise enforcement be a safety concern for anyone within
discretion related to the use in the Coast Guard
the designated course encompassed by
Nutrition Facts label of a symbol ‘‘†’’ all waters inside of the Outer Harbor,
immediately after the added sugars 33 CFR Part 165
Buffalo, NY starting at position 42°
percent Daily Value information on [Docket Number USCG–2018–0078] 52′04″ N, 078° 53′03″ W then South to
certain foods. The symbol would lead 42° 51′07″ N, 078° 52′09″ W (NAD 83).
RIN 1625–AA00
the reader to truthful and non- The course will extend a minimum of
misleading statements outside the Safety Zone; Officer Lehner Memorial 100 yards from the shore and the
Nutrition Facts label to provide Vintage Regatta; Buffalo Outer Harbor, breakwall.
additional information regarding the Buffalo, NY The purpose of this rulemaking is to
added sugars present in particular ensure the safety of vessels and the
foods. The draft guidance explains that AGENCY: Coast Guard, DHS. navigable waters within the above stated
we intend to consider exercising ACTION: Notice of proposed rulemaking. points before, during, and after the
enforcement discretion for the use of scheduled event. The Coast Guard
this symbol on single ingredient SUMMARY: The Coast Guard proposes to
proposes this rulemaking under
packages and/or containers of pure establish a temporary safety zone for
authority in 33 U.S.C. 1231.
honey or pure maple syrup, and certain certain waters of the Buffalo Outer
dried cranberry and cranberry juice Harbor during the Officer Lehner III. Discussion of Proposed Rule
products that are sweetened with added Memorial Vintage Regatta. This The COTP proposes to establish a
sugars, and that contain total sugars at proposed rulemaking would prohibit temporary safety zone, enforced
levels no greater than comparable persons and vessels from being in the intermittently, from 9:45 a.m. to 4:15
daltland on DSKBBV9HB2PROD with PROPOSALS
products with endogenous (inherent) safety zone unless authorized by the p.m. on July 1, 2018. The safety zone
sugars, but no added sugars. We Captain of the Port Buffalo or a will encompass all waters inside of the
provided a 60-day comment period that designated representative. We invite Outer Harbor, Buffalo, NY starting at
was scheduled to close on May 1, 2018. your comments on this proposed position 42° 52′04″ N, 078° 53′03″ W
We have received requests to extend rulemaking. then South to 42° 51′07″ N, 078° 52′09″
the comment period for the draft DATES: Comments and related material W (NAD 83). The course will extend a
guidance (Refs. 1 and 2). The requests must be received by the Coast Guard on minimum of 100 yards from the shore
conveyed concern that the current 60- or before May 25, 2018. and the breakwall. The duration of the
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Document Created: 2018-11-02 08:17:07
Document Modified: 2018-11-02 08:17:07
| 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; extension of comment period. | |
| Dates | We are extending the comment period on the document that published in the Federal Register of March 2, 2018 (83 FR 8953). Submit either electronic or written comments by June 15, 2018. | |
| Contact | Blakely Fitzpatrick, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1450. | |
| FR Citation | 83 FR 17961 |
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