83 FR 9003 - Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments-Small Entity Compliance Guide; 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 | 9003-9004 | |
| FR Document | 2018-04284 |
[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)] [Notices] [Pages 9003-9004] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04284] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-N-0258] Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments-- Small Entity Compliance Guide; 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 guidance for industry entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments--Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with a final rule we issued in the Federal Register of May 27, 2016, entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments.'' The final rule is designed to ensure that serving sizes are based on more recent consumption data and that consumers have serving size information on the Nutrition Facts label that will assist them in maintaining healthy dietary practices. DATES: The announcement of the guidance is published in the Federal Register on March 2, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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. 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 [[Page 9004]] 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-2004-N-0258 for ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments--Small Entity Compliance Guide.'' 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 SECG to the Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition (HFS-800), 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 SECG. FOR FURTHER INFORMATION CONTACT: Jillonne Kevala, 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 May 27, 2016 (81 FR 34000), we issued a final rule pertaining to serving sizes for food. The final rule amends the definition of a single-serving container; requires dual-column labeling for certain containers; updates, modifies, and establishes certain Reference Amounts Customarily Consumed (RACCs); amends the serving size for breath mints; and makes certain technical amendments to various aspects of preexisting serving size regulations. The final rule, which is codified at Sec. Sec. 101.9 and 101.12 (21 CFR 101.9 and 101.12), became effective July 26, 2016, and has a compliance date of July 26, 2018, for manufacturers with $10 million or more in annual food sales, and July 26, 2019, for manufacturers with less than $10 million in annual food sales. On October 2, 2017, FDA published a proposed rule to extend the compliance dates by approximately 1.5 years--to January 1, 2020, for manufacturers with $10 million or more in annual food sales and to January 1, 2021, for manufacturers with less than $10 million in annual food sales--and explained that, pending completion of the rulemaking with respect to the compliance dates, we intend to exercise enforcement discretion with respect to the compliance dates announced in the final rule (82 FR 45753). A final determination regarding the compliance dates is pending. We examined the economic implications of the final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined that the final rules on nutrition labeling, taken as a whole, will have a significant economic impact on a substantial number of small entities. In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, as amended by Pub. L. 110-28), we are making available the SECG to explain the actions that a small entity must take to comply with the rule. We are issuing the SECG consistent with our good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 The guidance refers to previously approved collections of information found in FDA regulations. The collections of information in Sec. Sec. 101.9 and 101.12 have been approved under OMB control number 0910-0381. III. Electronic Access Persons with access to the internet may obtain the SECG 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. Dated: February 27, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-04284 Filed 3-1-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices 9003
• E19 Optimization of Safety Data close of registration on April 3, 2018. If small entity compliance guide (SECG) is
Collection selected for presentation, any intended to help small entities comply
• E8(R1) Revision on General presentation materials must be emailed with a final rule we issued in the
Considerations for Clinical Trials to Amanda Roache (see FOR FURTHER Federal Register of May 27, 2016,
• E11A Pediatric Extrapolation INFORMATION CONTACT) no later than entitled ‘‘Food Labeling: Serving Sizes
• E14/S7B Discussion Group on April 3, 2018. No commercial or of Foods That Can Reasonably Be
Clinical and Nonclinical Evaluation of promotional material will be permitted Consumed at One Eating Occasion;
QT/QTc Interval Prolongation to be presented or distributed at the Dual-Column Labeling; Updating,
• M9 Biopharmaceutics Classification public meeting. Sign-up for making a Modifying, and Establishing Certain
System-Based Biowaivers public comment will also be available Reference Amounts Customarily
• M10 Bioanalytical Method Validation between 9 a.m. and 10 a.m. on the day Consumed; Serving Size for Breath
• S1(R1) Revision on Rodent of the meeting. Mints; and Technical Amendments.’’
Carcinogenicity Studies for Human Streaming Webcast of the Public The final rule is designed to ensure that
Pharmaceuticals Meeting: This public meeting will also serving sizes are based on more recent
• S5(R3) Revision on Detection of be webcast. To register to attend via consumption data and that consumers
Toxicity to Reproduction for Human webcast, please visit the following have serving size information on the
Pharmaceuticals website: https://ich_regional_ Nutrition Facts label that will assist
• Q3C(R7) Impurities: Guideline for consultation_2018.eventbrite.com. If them in maintaining healthy dietary
Residual Solvents you have never attended a Connect Pro practices.
• Q3D(R1) Guideline on Elemental event before, test your connection at DATES: The announcement of the
Impurities https://collaboration.fda.gov/common/ guidance is published in the Federal
III. Participating in the Public Meeting help/en/support/meeting_test.htm. To Register on March 2, 2018.
Registration: Persons interested in get a quick overview of the Connect Pro ADDRESSES: You may submit either
attending this public meeting must program, visit https://www.adobe.com/ electronic or written comments on
register online by April 3, 2018. To go/connectpro_overview. FDA has Agency guidances at any time as
register for the public meeting, please verified the website addresses in this follows:
visit the following website: https://ich_ document, as of the date this document
publishes in the Federal Register, but Electronic Submissions
regional_consultation_
2018.eventbrite.com. Please provide websites are subject to change over time. Submit electronic comments in the
complete contact information for each Dated: February 26, 2018. following way:
• Federal eRulemaking Portal:
attendee, including name, title, Leslie Kux,
https://www.regulations.gov. Follow the
affiliation, address, email, and Associate Commissioner for Policy. instructions for submitting comments.
telephone. [FR Doc. 2018–04256 Filed 3–1–18; 8:45 am] Comments submitted electronically,
Registration is free and based on BILLING CODE 4164–01–P including attachments, to https://
space availability, with priority given to
www.regulations.gov will be posted to
early registrants. Persons interested in
the docket unchanged. Because your
attending this public meeting must DEPARTMENT OF HEALTH AND comment will be made public, you are
register by April 3, 2018, midnight HUMAN SERVICES solely responsible for ensuring that your
Eastern Time. Early registration is
comment does not include any
recommended because seating is Food and Drug Administration
confidential information that you or a
limited; therefore, FDA may limit the
[Docket No. FDA–2004–N–0258] third party may not wish to be posted,
number of participants from each such as medical information, your or
organization. If time and space permit, Food Labeling: Serving Sizes of Foods anyone else’s Social Security number, or
onsite registration on the day of the That Can Reasonably Be Consumed at confidential business information, such
public meeting will be provided One Eating Occasion; Dual-Column as a manufacturing process. Please note
beginning at 9:30 a.m. Labeling; Updating, Modifying, and that if you include your name, contact
The agenda for the public meeting Establishing Certain Reference information, or other information that
will be made available on the internet Amounts Customarily Consumed; identifies you in the body of your
at https://www.fda.gov/Drugs/ Serving Size for Breath Mints; and comments, that information will be
NewsEvents/ucm592065.htm Technical Amendments—Small Entity posted on https://www.regulations.gov.
approximately 2 weeks in advance of Compliance Guide; Availability • If you want to submit a comment
the meeting. with confidential information that you
If you need special accommodations AGENCY: Food and Drug Administration, do not wish to be made available to the
due to a disability, please contact HHS. public, submit the comment as a
Amanda Roache (see FOR FURTHER ACTION: Notification of availability. written/paper submission and in the
INFORMATION CONTACT) no later than manner detailed (see ‘‘Written/Paper
March 23, 2018. SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’).
Requests for Oral Presentations: If you Administration (FDA or we) is
wish to make a presentation during the announcing the availability of a Written/Paper Submissions
public comment session, please contact guidance for industry entitled ‘‘Food Submit written/paper submissions as
Amanda Roache (see FOR FURTHER Labeling: Serving Sizes of Foods That follows:
daltland on DSKBBV9HB2PROD with NOTICES
INFORMATION CONTACT) no later than Can Reasonably Be Consumed at One • Mail/Hand Delivery/Courier (for
March 23, 2018. Individuals and Eating Occasion; Dual-Column Labeling; written/paper submissions): Dockets
organizations with common interests are Updating, Modifying, and Establishing Management Staff (HFA–305), Food and
urged to consolidate or coordinate their Certain Reference Amounts Customarily Drug Administration, 5630 Fishers
presentations, and request time for a Consumed; Serving Size for Breath Lane, Rm. 1061, Rockville, MD 20852.
joint presentation. All requests to make Mints; and Technical Amendments— • For written/paper comments
presentations must be received by the Small Entity Compliance Guide.’’ The submitted to the Dockets Management
VerDate Sep<11>2014 18:10 Mar 01, 2018 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\02MRN1.SGM 02MRN1](https://thefederalregister.org/doc/83_FR_9045/page/1.svg)
![9004 Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices
Staff, FDA will post your comment, as Staff, 5630 Fishers Lane, rm. 1061, number of small entities. In compliance
well as any attachments, except for Rockville, MD 20852. with section 212 of the Small Business
information submitted, marked and You may submit comments on any Regulatory Enforcement Fairness Act
identified, as confidential, if submitted guidance at any time (see 21 CFR (Pub. L. 104–121, as amended by Pub.
as detailed in ‘‘Instructions.’’ 10.115(g)(5)). L. 110–28), we are making available the
Instructions: All submissions received Submit written requests for single SECG to explain the actions that a small
must include the Docket No. FDA– copies of the SECG to the Office of entity must take to comply with the
2004–N–0258 for ‘‘Food Labeling: Nutrition and Food Labeling, Center for rule.
Serving Sizes of Foods That Can Food Safety and Applied Nutrition We are issuing the SECG consistent
Reasonably Be Consumed at One Eating (HFS–800), Food and Drug with our good guidance practices
Occasion; Dual-Column Labeling; Administration, 5001 Campus Dr., regulation (21 CFR 10.115(c)(2)). The
Updating, Modifying, and Establishing College Park, MD 20740. Send two self- SECG represents the current thinking of
Certain Reference Amounts Customarily addressed adhesive labels to assist that FDA on this topic. It does not establish
Consumed; Serving Size for Breath office in processing your request. See any rights for any person and is not
Mints; and Technical Amendments— the SUPPLEMENTARY INFORMATION section binding on FDA or the public. You can
Small Entity Compliance Guide.’’ for electronic access to the SECG. use an alternative approach if it satisfies
Received comments will be placed in FOR FURTHER INFORMATION CONTACT: the requirements of the applicable
the docket and, except for those Jillonne Kevala, Center for Food Safety statutes and regulations. This guidance
submitted as ‘‘Confidential and Applied Nutrition, Food and Drug is not subject to Executive Order 12866.
Submissions,’’ publicly viewable at Administration, 5001 Campus Dr.,
https://www.regulations.gov or at the II. Paperwork Reduction Act of 1995
College Park, MD 20740, 240–402–1450.
Dockets Management Staff between 9 The guidance refers to previously
SUPPLEMENTARY INFORMATION:
a.m. and 4 p.m., Monday through approved collections of information
Friday. I. Background found in FDA regulations. The
• Confidential Submissions—To collections of information in §§ 101.9
submit a comment with confidential In the Federal Register of May 27,
and 101.12 have been approved under
information that you do not wish to be 2016 (81 FR 34000), we issued a final
OMB control number 0910–0381.
made publicly available, submit your rule pertaining to serving sizes for food.
comments only as a written/paper The final rule amends the definition of III. Electronic Access
submission. You should submit two a single-serving container; requires Persons with access to the internet
copies total. One copy will include the dual-column labeling for certain may obtain the SECG at either https://
information you claim to be confidential containers; updates, modifies, and www.fda.gov/FoodGuidances or https://
with a heading or cover note that states establishes certain Reference Amounts www.regulations.gov. Use the FDA
‘‘THIS DOCUMENT CONTAINS Customarily Consumed (RACCs); website listed in the previous sentence
CONFIDENTIAL INFORMATION.’’ We amends the serving size for breath to find the most current version of the
will review this copy, including the mints; and makes certain technical guidance.
claimed confidential information, in our amendments to various aspects of
Dated: February 27, 2018.
consideration of comments. The second preexisting serving size regulations. The
final rule, which is codified at §§ 101.9 Leslie Kux,
copy, which will have the claimed
and 101.12 (21 CFR 101.9 and 101.12), Associate Commissioner for Policy.
confidential information redacted/
became effective July 26, 2016, and has [FR Doc. 2018–04284 Filed 3–1–18; 8:45 am]
blacked out, will be available for public
viewing and posted on https:// a compliance date of July 26, 2018, for BILLING CODE 4164–01–P
www.regulations.gov. Submit both manufacturers with $10 million or more
copies to the Dockets Management Staff. in annual food sales, and July 26, 2019,
for manufacturers with less than $10 DEPARTMENT OF HEALTH AND
If you do not wish your name and
million in annual food sales. On HUMAN SERVICES
contact information to be made publicly
available, you can provide this October 2, 2017, FDA published a
Food and Drug Administration
information on the cover sheet and not proposed rule to extend the compliance
in the body of your comments and you dates by approximately 1.5 years—to [Docket No. FDA–2018–D–0688]
must identify this information as January 1, 2020, for manufacturers with
‘‘confidential.’’ Any information marked $10 million or more in annual food sales Standardization of Data and
as ‘‘confidential’’ will not be disclosed and to January 1, 2021, for Documentation Practices for Product
except in accordance with 21 CFR 10.20 manufacturers with less than $10 Tracing; Draft Guidance for Industry;
and other applicable disclosure law. For million in annual food sales—and Availability
more information about FDA’s posting explained that, pending completion of AGENCY: Food and Drug Administration,
of comments to public dockets, see 80 the rulemaking with respect to the HHS.
FR 56469, September 18, 2015, or access compliance dates, we intend to exercise ACTION: Notice of availability.
the information at: https://www.gpo.gov/ enforcement discretion with respect to
fdsys/pkg/FR-2015-09-18/pdf/2015- the compliance dates announced in the SUMMARY: The Food and Drug
23389.pdf. final rule (82 FR 45753). A final Administration (FDA or Agency) is
Docket: For access to the docket to determination regarding the compliance announcing the availability of a draft
read background documents or the dates is pending. guidance for industry entitled
daltland on DSKBBV9HB2PROD with NOTICES
electronic and written/paper comments We examined the economic ‘‘Standardization of Data and
received, go to https:// implications of the final rule as required Documentation Practices for Product
www.regulations.gov and insert the by the Regulatory Flexibility Act (5 Tracing.’’ The draft guidance elaborates
docket number, found in brackets in the U.S.C. 601–612) and determined that on the standards for the interoperable
heading of this document, into the the final rules on nutrition labeling, exchange of transaction information,
‘‘Search’’ box and follow the prompts taken as a whole, will have a significant transaction history, and transaction
and/or go to the Dockets Management economic impact on a substantial statements (product tracing information)
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Document Created: 2018-03-01 23:57:05
Document Modified: 2018-03-01 23:57:05
| 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 | Notices | |
| Action | Notification of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on March 2, 2018. | |
| Contact | Jillonne Kevala, 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 9003 |
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