The Declaration of Allulose and Calories From Allulose on Nutrition and Supplement Facts Labels; Availability, 66217-66219 [2020-22901]

Download as PDF Federal Register / Vol. 85, No. 202 / Monday, October 19, 2020 / Rules and Regulations To address this situation, the following text is added as a new paragraph d. at the end of Part III.2: d. What should a lender do if a borrower submits documentation of eligible costs that exceed a borrower’s PPP loan amount? The amount of loan forgiveness that a borrower may receive cannot exceed the principal amount of the PPP loan. Whether a borrower submits SBA Form 3508, 3508EZ, 3508S, or lender’s equivalent form, a lender should confirm receipt of the documentation the borrower is required to submit to aid in verifying payroll and nonpayroll costs, and, if applicable (for SBA Form 3508, 3508EZ, or lender’s equivalent form), confirm the borrower’s calculations on the borrower’s Loan Forgiveness Application, up to the amount required to reach the requested Forgiveness Amount. 3. Additional Information SBA may provide further guidance, if needed, through SBA notices that will be posted on SBA’s website at www.sba.gov. Questions on the Paycheck Protection Program may be directed to the Lender Relations Specialist in the local SBA Field Office. The local SBA Field Office may be found at https://www.sba.gov/tools/ local-assistance/districtoffices. Compliance With Executive Orders 12866, 12988, 13132, 13563, and 13771, the Paperwork Reduction Act (44 U.S.C. Ch. 35), and the Regulatory Flexibility Act (5 U.S.C. 601–612) Executive Orders 12866, 13563, and 13771 This interim final rule is economically significant for the purposes of Executive Orders 12866 and 13563, and is considered a major rule under the Congressional Review Act. SBA, however, is proceeding under the emergency provision at Executive Order 12866 Section 6(a)(3)(D) based on the need to move expeditiously to mitigate the current economic conditions arising from the COVID–19 emergency. This rule’s designation under Executive Order 13771 will be informed by public comment. jbell on DSKJLSW7X2PROD with RULES Executive Order 12988 SBA has drafted this rule, to the extent practicable, in accordance with the standards set forth in Section 3(a) and 3(b)(2) of Executive Order 12988, to minimize litigation, eliminate ambiguity, and reduce burden. The rule has no preemptive or retroactive effect. VerDate Sep<11>2014 16:28 Oct 16, 2020 Jkt 253001 Executive Order 13132 SBA and Treasury have determined that this rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various layers of government. Therefore, SBA has determined that this rule has no federalism implications warranting preparation of a federalism assessment. Paperwork Reduction Act, 44 U.S.C. Chapter 35 SBA and Treasury have determined that this rule modifies an existing information collection. This rule reduces the burden associated with lender review of borrower documentation of eligible costs for forgiveness. Additionally, SBA has developed a second streamlined Paycheck Protection Program—PPP Loan Forgiveness Application Form 3508S (SBA Form 3508S), which is available for borrowers meeting criteria described in the instructions accompanying the form. SBA has obtained Office of Management and Budget (OMB) approval of the modification to the existing information collection, which is currently approved as an emergency request under OMB Control Number 3245–0407 until October 31, 2020. Regulatory Flexibility Act (RFA) The Regulatory Flexibility Act (RFA) generally requires that when an agency issues a proposed rule, or a final rule pursuant to Section 553(b) of the APA or another law, the agency must prepare a regulatory flexibility analysis that meets the requirements of the RFA and publish such analysis in the Federal Register. 5 U.S.C. 603, 604. Specifically, the RFA normally requires agencies to describe the impact of a rulemaking on small entities by providing a regulatory impact analysis. Such analysis must address the consideration of regulatory options that would lessen the economic effect of the rule on small entities. The RFA defines a ‘‘small entity’’ as (1) a proprietary firm meeting the size standards of the Small Business Administration (SBA); (2) a nonprofit organization that is not dominant in its field; or (3) a small government jurisdiction with a population of less than 50,000. 5 U.S.C. 601(3)–(6). Except for small government jurisdictions with a population of less than 50,000, neither State nor local governments are ‘‘small entities.’’ The requirement to conduct a regulatory impact analysis does not PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 66217 apply if the head of the agency ‘‘certifies that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.’’ 5 U.S.C. 605(b). The agency must, however, publish the certification in the Federal Register at the time of publication of the rule, ‘‘along with a statement providing the factual basis for such certification.’’ If the agency head has not waived the requirements for a regulatory flexibility analysis in accordance with the RFA’s waiver provision, and no other RFA exception applies, the agency must prepare the regulatory flexibility analysis and publish it in the Federal Register at the time of promulgation or, if the rule is promulgated in response to an emergency that makes timely compliance impracticable, within 180 days of publication of the final rule. 5 U.S.C. 604(a), 608(b). Rules that are exempt from notice and comment are also exempt from the RFA requirements, including conducting a regulatory flexibility analysis, when among other things the agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest. SBA Office of Advocacy guide: How to Comply with the Regulatory Flexibility Act, Ch.1. p.9. Since this rule is exempt from notice and comment, SBA is not required to conduct a regulatory flexibility analysis. Jovita Carranza, Administrator Small Business Administration. Michael Faulkender, Assistant Secretary for Economic Policy Department of the Treasury. [FR Doc. 2020–23091 Filed 10–14–20; 4:15 pm] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA–2019–D–0725] The Declaration of Allulose and Calories From Allulose on Nutrition and Supplement Facts Labels; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ‘‘The SUMMARY: E:\FR\FM\19OCR1.SGM 19OCR1 66218 Federal Register / Vol. 85, No. 202 / Monday, October 19, 2020 / Rules and Regulations Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.’’ The guidance describes FDA’s views on the declaration of allulose on Nutrition Facts and Supplement Facts labels and the caloric content of allulose. The guidance also announces our intent to exercise enforcement discretion for the exclusion of allulose from the amount of Total Sugars and Added Sugars declared on the Nutrition Facts and Supplement Facts label and use of a general factor of 0.4 calories per gram (kcal/g) for allulose when calculating declarations on Nutrition and Supplement Facts labels. The announcement of the guidance is published in the Federal Register on October 19, 2020. ADDRESSES: You may submit either electronic or written comments on FDA guidances at any time 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’’). jbell on DSKJLSW7X2PROD with RULES 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 VerDate Sep<11>2014 16:28 Oct 16, 2020 Jkt 253001 information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–D–0725 for ‘‘The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.’’ 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, 240–402–7500. • 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. 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 guidance to the Office of Nutrition and Food Labeling, Center for PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 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 guidance. FOR FURTHER INFORMATION CONTACT: Blakeley 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 We are announcing the availability of a guidance for industry entitled ‘‘The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.’’ We are issuing this guidance consistent with our 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 alternate approach if it satisfies the requirements of the applicable statutes and regulations. In the Federal Register of April 18, 2019 (84 FR 16272), we published a notice announcing the availability of a draft guidance for industry entitled ‘‘The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.’’ The draft guidance: (1) Described our tentative views on the declaration of allulose on Nutrition Facts and Supplement Facts labels and on the caloric content of allulose; and (2) announced our tentative intent to exercise enforcement discretion for the exclusion of allulose from the amount of Total Sugars and Added Sugars declared on the label and use of a general factor of 0.4 kcal/g for allulose when calculating declarations on Nutrition and Supplement Facts labels pending review of the issues in a rulemaking. The draft guidance gave interested parties an opportunity to submit comments by June 17, 2019, for us to consider before beginning work on the final version of the guidance. We received approximately 30 comments from industry, health professionals, consumer advocacy groups, scientists, trade associations, and consumers. We are finalizing the positions in the draft guidance and have made technical corrections and editorial changes throughout the guidance to improve clarity. We also added language clarifying that allulose must still be declared in the ingredient statement E:\FR\FM\19OCR1.SGM 19OCR1 Federal Register / Vol. 85, No. 202 / Monday, October 19, 2020 / Rules and Regulations even if it is excluded from certain label declarations. Finally, we reorganized the section detailing our consideration of allulose as a sugar. The guidance announced in this notice finalizes the draft guidance with respect to: (1) Our views on the declaration of allulose on Nutrition Facts and Supplement Facts labels and on the caloric content of allulose; and (2) our intent to exercise enforcement discretion for the exclusion of allulose from the amount of Total Sugars and Added Sugars declared on the label and use of a general factor of 0.4 kcal/g for allulose when calculating declarations on Nutrition and Supplement Facts labels pending review of the issues in a rulemaking. II. Paperwork Reduction Act of 1995 This guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required. However, this guidance refers to previously approved FDA collections of information. These collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 101 have been approved under OMB control number 0910–0381. 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 website listed in the previous sentence to find the most current version of the guidance. Dated: October 9, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–22901 Filed 10–16–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9918] jbell on DSKJLSW7X2PROD with RULES RIN 1545–BO87 Effect of Section 67(g) on Trusts and Estates Internal Revenue Service (IRS), Treasury. ACTION: Final regulations. AGENCY: VerDate Sep<11>2014 16:28 Oct 16, 2020 Jkt 253001 This document contains final regulations clarifying that the following deductions allowed to an estate or nongrantor trust are not miscellaneous itemized deductions: Costs paid or incurred in connection with the administration of an estate or nongrantor trust that would not have been incurred if the property were not held in the estate or trust, the personal exemption of an estate or non-grantor trust, the distribution deduction for trusts distributing current income, and the distribution deduction for estates and trusts accumulating income. Therefore, these deductions are not affected by the suspension of the deductibility of miscellaneous itemized deductions for taxable years beginning after December 31, 2017, and before January 1, 2026. The final regulations also provide guidance on determining the character, amount, and allocation of deductions in excess of gross income succeeded to by a beneficiary on the termination of an estate or non-grantor trust. The final regulations affect estates, non-grantor trusts (including the S portion of an electing small business trust), and their beneficiaries. DATES: Effective date: These regulations are effective on October 19, 2020. Applicability dates: For dates of applicability, see §§ 1.67–4(d), 1.642(h)–2(f) and 1.642(h)–5(c). FOR FURTHER INFORMATION CONTACT: Margaret Burow at (202) 317–5279 (not a toll-free number). SUPPLEMENTARY INFORMATION: SUMMARY: Background This document contains amendments to Income Tax Regulations (26 CFR part 1) under sections 67 and 642 of the Internal Revenue Code (Code). On May 11, 2020, the Department of Treasury (Treasury Department) and the IRS published a notice of proposed rulemaking (REG–113295–18) in the Federal Register (85 FR 27693) containing proposed regulations under sections 67 and 642(h) (proposed regulations). The Summary of Comments and Explanation of Revisions section of this preamble summarizes the provisions of sections 67 and 642(h) and the provisions of the proposed regulations, which are explained in greater detail in the preamble to the proposed regulations. On July 17, 2020, the Treasury Department and the IRS published in the Federal Register (85 FR 43512) a notice of public hearing on the proposed regulations scheduled for August 12, 2020. The Treasury Department and the IRS received no requests to speak at a PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 66219 hearing in response to that notice. On August 5, 2020, the Treasury Department and the IRS published in the Federal Register (85 FR 47323) a cancellation of the notice of public hearing. The Treasury Department and the IRS received written and electronic comments in response to the proposed regulations. All comments were considered and are available at www.regulations.gov or upon request. After full consideration of the comments received, this Treasury decision adopts the proposed regulations with modifications described in the Summary of Comments and Explanation of Revisions. Summary of Comments and Explanation of Revisions Most of the comments addressing the proposed regulations are summarized in this Summary of Comments and Explanation of Revisions. Comments merely summarizing or interpreting the proposed regulations or recommending statutory revisions are not discussed in this preamble. The Treasury Department and the IRS continue to study comments on issues related to sections 67 and 642(h) that are beyond the scope of these regulations, which may be discussed in future guidance if guidance on those issues is published. The scope of the proposed regulations and these regulations is limited to the effect of section 67(g) on the deductibility of certain expenses described in section 67(b) and (e) that are incurred by estates and non-grantor trusts and the treatment of excess deductions on termination of an estate or trust under section 642(h). This Summary of Comments and Explanation of Revisions also describes each of the final rules contained in this document. A. Section 67 Section 67(g) was added to the Code on December 22, 2017, by section 11045(a) of Public Law 115–97, 131 Stat. 2054, 2088 (2017), commonly referred to as the Tax Cuts and Jobs Act (TCJA). Section 67(g) prohibits individual taxpayers from claiming miscellaneous itemized deductions for any taxable year beginning after December 31, 2017, and before January 1, 2026. Prior to the TCJA, miscellaneous itemized deductions were allowable for any taxable year only to the extent that the sum of such deductions exceeded two percent of adjusted gross income. See section 67(a). Section 67(b) defines miscellaneous itemized deductions as itemized deductions other than those listed in section 67(b)(1) through (12). E:\FR\FM\19OCR1.SGM 19OCR1

Agencies

[Federal Register Volume 85, Number 202 (Monday, October 19, 2020)]
[Rules and Regulations]
[Pages 66217-66219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22901]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2019-D-0725]


The Declaration of Allulose and Calories From Allulose on 
Nutrition and Supplement Facts Labels; 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 final guidance for industry entitled ``The

[[Page 66218]]

Declaration of Allulose and Calories from Allulose on Nutrition and 
Supplement Facts Labels.'' The guidance describes FDA's views on the 
declaration of allulose on Nutrition Facts and Supplement Facts labels 
and the caloric content of allulose. The guidance also announces our 
intent to exercise enforcement discretion for the exclusion of allulose 
from the amount of Total Sugars and Added Sugars declared on the 
Nutrition Facts and Supplement Facts label and use of a general factor 
of 0.4 calories per gram (kcal/g) for allulose when calculating 
declarations on Nutrition and Supplement Facts labels.

DATES: The announcement of the guidance is published in the Federal 
Register on October 19, 2020.

ADDRESSES: You may submit either electronic or written comments on FDA 
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 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-2019-D-0725 for ``The Declaration of Allulose and Calories from 
Allulose on Nutrition and Supplement Facts Labels.'' 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    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 guidance to the 
Office of Nutrition and Food Labeling, 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 guidance.

FOR FURTHER INFORMATION CONTACT: Blakeley 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

    We are announcing the availability of a guidance for industry 
entitled ``The Declaration of Allulose and Calories from Allulose on 
Nutrition and Supplement Facts Labels.'' We are issuing this guidance 
consistent with our 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 alternate approach if it satisfies the 
requirements of the applicable statutes and regulations.
    In the Federal Register of April 18, 2019 (84 FR 16272), we 
published a notice announcing the availability of a draft guidance for 
industry entitled ``The Declaration of Allulose and Calories from 
Allulose on Nutrition and Supplement Facts Labels.'' The draft 
guidance: (1) Described our tentative views on the declaration of 
allulose on Nutrition Facts and Supplement Facts labels and on the 
caloric content of allulose; and (2) announced our tentative intent to 
exercise enforcement discretion for the exclusion of allulose from the 
amount of Total Sugars and Added Sugars declared on the label and use 
of a general factor of 0.4 kcal/g for allulose when calculating 
declarations on Nutrition and Supplement Facts labels pending review of 
the issues in a rulemaking.
    The draft guidance gave interested parties an opportunity to submit 
comments by June 17, 2019, for us to consider before beginning work on 
the final version of the guidance. We received approximately 30 
comments from industry, health professionals, consumer advocacy groups, 
scientists, trade associations, and consumers. We are finalizing the 
positions in the draft guidance and have made technical corrections and 
editorial changes throughout the guidance to improve clarity. We also 
added language clarifying that allulose must still be declared in the 
ingredient statement

[[Page 66219]]

even if it is excluded from certain label declarations. Finally, we 
reorganized the section detailing our consideration of allulose as a 
sugar.
    The guidance announced in this notice finalizes the draft guidance 
with respect to: (1) Our views on the declaration of allulose on 
Nutrition Facts and Supplement Facts labels and on the caloric content 
of allulose; and (2) our intent to exercise enforcement discretion for 
the exclusion of allulose from the amount of Total Sugars and Added 
Sugars declared on the label and use of a general factor of 0.4 kcal/g 
for allulose when calculating declarations on Nutrition and Supplement 
Facts labels pending review of the issues in a rulemaking.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required.
    However, this guidance refers to previously approved FDA 
collections of information. These collections of information are 
subject to review by OMB under the PRA. The collections of information 
in 21 CFR part 101 have been approved under OMB control number 0910-
0381.

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 website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: October 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22901 Filed 10-16-20; 8:45 am]
BILLING CODE 4164-01-P
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