83_FR_9042 83 FR 9000 - Reference Amounts Customarily Consumed: List of Products for Each Product Category; Guidance for Industry; Availability

83 FR 9000 - Reference Amounts Customarily Consumed: List of Products for Each Product Category; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 42 (March 2, 2018)

Page Range9000-9001
FR Document2018-04283

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Reference Amounts Customarily Consumed: List of Products for Each Product Category.'' The guidance provides examples of products that belong to product categories included in the tables of Reference Amounts Customarily Consumed (RACCs) per Eating Occasion established in our regulations.

Federal Register, Volume 83 Issue 42 (Friday, March 2, 2018) 
[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 9000-9001]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04283]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4098]


Reference Amounts Customarily Consumed: List of Products for Each 
Product Category; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``Reference Amounts 
Customarily Consumed: List of Products for Each Product Category.'' The 
guidance provides examples of products that belong to product 
categories included in the tables of Reference Amounts Customarily 
Consumed (RACCs) per Eating Occasion established in our regulations.

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 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-2016-D-4098 for ``Reference Amounts Customarily Consumed: List of 
Products for Each Product Category.'' 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 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: 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

    We are announcing the availability of a guidance for industry 
entitled ``Reference Amounts Customarily Consumed: List of Products for 
Each Product Category.'' 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 alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.
    This guidance is intended to help industry comply with the 
statutory requirement, under section 403(q)(1)(A)(i) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(q)(1)(A)(i)), 
that food that is intended for human consumption and offered for sale 
bear nutrition information that provides a serving size

[[Page 9001]]

that reflects the amount of food customarily consumed and is expressed 
in a common household measure that is appropriate to the food. To 
comply with this requirement, manufacturers must determine and label 
their food products with the appropriate label serving size based on 
the amount of the product customarily consumed.
    In the Federal Register of May 27, 2016, we issued a final rule 
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'' (81 
FR 34000). The final rule amends our regulations in Sec.  101.12(b) (21 
CFR 101.12(b)) to update or modify certain pre-existing RACCs, and to 
establish RACCs for new product categories.
    In the Federal Register of January 5, 2017 (82 FR 1344), we 
announced the availability of a draft guidance for industry entitled 
``Reference Amounts Customarily Consumed: List of Products for Each 
Product Category; Draft Guidance for Industry'' and gave interested 
parties an opportunity to submit comments by March 6, 2017, for us to 
consider before beginning work on the final version of the guidance. We 
received several comments on the draft guidance and have modified the 
content, where appropriate, for this final guidance. Changes to the 
guidance include the addition of flavored nut butter spreads (e.g., 
cocoa, cookie, and coffee flavored) as an example in the ``Nut and seed 
butters, pastes, or creams'' product category. In the Federal Register 
of November 2, 2016, we published a Request for Information and 
Comments requesting information and comments on the appropriate product 
category and RACC for flavored nut butter spreads (e.g., cocoa, cookie, 
and coffee flavored) (81 FR 76323). Based upon the information and 
comments received, and our own assessment, we have determined that 
flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored) 
are comparable to nut butters and belong in the ``Nut and seed butters, 
pastes, or creams'' product category with a RACC of two tablespoons. In 
addition to this and other clarifying substantive changes that we made 
to the guidance, we made editorial changes to improve clarity and to 
help ensure consistency with Sec.  101.12(b). The guidance announced in 
this notice finalizes the draft guidance dated January 2017.

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: February 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04283 Filed 3-1-18; 8:45 am]
 BILLING CODE 4164-01-P

9000 Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices II. Electronic Access anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked Persons with access to the internet confidential business information, such as ‘‘confidential’’ will not be disclosed may obtain the draft guidance at either as a manufacturing process. Please note except in accordance with 21 CFR 10.20 https://www.fda.gov/Drugs/Guidance that if you include your name, contact and other applicable disclosure law. For ComplianceRegulatoryInformation/ information, or other information that more information about FDA’s posting Guidances/default.htm, https:// identifies you in the body of your of comments to public dockets, see 80 www.fda.gov/BiologicsBloodVaccines/ comments, that information will be FR 56469, September 18, 2015, or access GuidanceComplianceRegulatory posted on https://www.regulations.gov. the information at: https://www.gpo.gov/ • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015- Information/Guidances/default.htm, or with confidential information that you 23389.pdf. https://www.regulations.gov. do not wish to be made available to the Docket: For access to the docket to Dated: February 23, 2018. public, submit the comment as a read background documents or the Leslie Kux, written/paper submission and in the electronic and written/paper comments Associate Commissioner for Policy. manner detailed (see ‘‘Written/Paper received, go to https:// [FR Doc. 2018–04181 Filed 3–1–18; 8:45 am] Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the BILLING CODE 4164–01–P Written/Paper Submissions docket number, found in brackets in the heading of this document, into the Submit written/paper submissions as ‘‘Search’’ box and follow the prompts DEPARTMENT OF HEALTH AND follows: and/or go to the Dockets Management HUMAN SERVICES • Mail/Hand delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061, written/paper submissions): Dockets Rockville, MD 20852. Food and Drug Administration Management Staff (HFA–305), Food and You may submit comments on any Drug Administration, 5630 Fishers [Docket No. FDA–2016–D–4098] guidance at any time (see 21 CFR Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments 10.115(g)(5)). Reference Amounts Customarily Submit written requests for single Consumed: List of Products for Each submitted to the Dockets Management Staff, FDA will post your comment, as copies of the guidance to the Office of Product Category; Guidance for Nutrition and Food Labeling, Center for Industry; Availability well as any attachments, except for information submitted, marked and Food Safety and Applied Nutrition, AGENCY: Food and Drug Administration, identified, as confidential, if submitted Food and Drug Administration, 5001 HHS. as detailed in ‘‘Instructions.’’ Campus Dr., College Park, MD 20740. Instructions: All submissions received Send two self-addressed adhesive labels ACTION: Notification of availability. must include the Docket No. FDA– to assist that office in processing your SUMMARY: The Food and Drug 2016–D–4098 for ‘‘Reference Amounts request. See the SUPPLEMENTARY Administration (FDA or we) is Customarily Consumed: List of Products INFORMATION section for electronic announcing the availability of a for Each Product Category.’’ Received access to the guidance. guidance for industry entitled comments will be placed in the docket FOR FURTHER INFORMATION CONTACT: ‘‘Reference Amounts Customarily and, except for those submitted as Jillonne Kevala, Center for Food Safety Consumed: List of Products for Each ‘‘Confidential Submissions,’’ publicly and Applied Nutrition, Food and Drug Product Category.’’ The guidance viewable at https://www.regulations.gov Administration, 5001 Campus Dr., provides examples of products that or at the Dockets Management Staff College Park, MD 20740, 240–402–1450. belong to product categories included in between 9 a.m. and 4 p.m., Monday SUPPLEMENTARY INFORMATION: the tables of Reference Amounts through Friday. Customarily Consumed (RACCs) per • Confidential Submissions—To I. Background Eating Occasion established in our submit a comment with confidential We are announcing the availability of regulations. information that you do not wish to be a guidance for industry entitled DATES: The announcement of the made publicly available, submit your ‘‘Reference Amounts Customarily guidance is published in the Federal comments only as a written/paper Consumed: List of Products for Each Register on March 2, 2018. submission. You should submit two Product Category.’’ We are issuing this ADDRESSES: You may submit either copies total. One copy will include the guidance consistent with our good electronic or written comments on FDA information you claim to be confidential guidance practices regulation (21 CFR guidances at any time as follows: with a heading or cover note that states 10.115). The guidance represents the ‘‘THIS DOCUMENT CONTAINS current thinking of FDA on this topic. Electronic Submissions CONFIDENTIAL INFORMATION.’’ We It does not establish any rights for any Submit electronic comments in the will review this copy, including the person and is not binding on FDA or the following way: claimed confidential information, in our public. You can use an alternative • Federal eRulemaking Portal: consideration of comments. The second approach if it satisfies the requirements https://www.regulations.gov. Follow the copy, which will have the claimed of the applicable statutes and instructions for submitting comments. confidential information redacted/ regulations. This guidance is not subject Comments submitted electronically, blacked out, will be available for public to Executive Order 12866. including attachments, to https:// viewing and posted on https:// This guidance is intended to help www.regulations.gov will be posted to www.regulations.gov. Submit both industry comply with the statutory daltland on DSKBBV9HB2PROD with NOTICES the docket unchanged. Because your copies to the Dockets Management Staff. requirement, under section comment will be made public, you are If you do not wish your name and 403(q)(1)(A)(i) of the Federal Food, solely responsible for ensuring that your contact information to be made publicly Drug, and Cosmetic Act (FD&C Act) (21 comment does not include any available, you can provide this U.S.C. 343(q)(1)(A)(i)), that food that is confidential information that you or a information on the cover sheet and not intended for human consumption and third party may not wish to be posted, in the body of your comments and you offered for sale bear nutrition such as medical information, your or must identify this information as information that provides a serving size VerDate Sep<11>2014 18:10 Mar 01, 2018 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\02MRN1.SGM 02MRN1

Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices 9001 that reflects the amount of food II. Electronic Access Conference Center, Rm. 1503 (Great customarily consumed and is expressed Persons with access to the internet Room), Silver Spring, MD 20993–0002. in a common household measure that is may obtain the guidance at either The meeting will also be broadcast on appropriate to the food. To comply with https://www.fda.gov/FoodGuidances or the web, allowing participants to join in this requirement, manufacturers must https://www.regulations.gov. Use the person OR via the web. For those who determine and label their food products FDA website listed in the previous will attend in person, the entrance for with the appropriate label serving size sentence to find the most current the public meeting participants (non- based on the amount of the product version of the guidance. FDA employees) is through Building 1 customarily consumed. where routine security check Dated: February 27, 2018. In the Federal Register of May 27, procedures will be performed. For Leslie Kux, parking and security information, please 2016, we issued a final rule entitled Associate Commissioner for Policy. refer to https://www.fda.gov/AboutFDA/ ‘‘Food Labeling: Serving Sizes of Foods [FR Doc. 2018–04283 Filed 3–1–18; 8:45 am] WorkingatFDA/BuildingsandFacilities/ That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column BILLING CODE 4164–01–P WhiteOakCampusInformation/ Labeling; Updating, Modifying, and ucm241740.htm. For those who register Establishing Certain Reference Amounts to attend the public meeting remotely DEPARTMENT OF HEALTH AND via the webcast, a link to access the Customarily Consumed; Serving Size for HUMAN SERVICES webcast will be emailed 1 week in Breath Mints; and Technical Amendments’’ (81 FR 34000). The final Food and Drug Administration advance of the meeting. rule amends our regulations in You may submit comments as § 101.12(b) (21 CFR 101.12(b)) to update [Docket No. FDA–2016–N–1112] follows. Please note that late, untimely, or modify certain pre-existing RACCs, filed comments will not be considered. United States Food and Drug and to establish RACCs for new product Electronic comments must be submitted Administration and Health Canada categories. on or before April 30, 2018. The https:// Joint Regional Consultation on the In the Federal Register of January 5, International Council for www.regulations.gov electronic filing 2017 (82 FR 1344), we announced the Harmonisation of Technical system will accept comments until availability of a draft guidance for Requirements for Pharmaceuticals for midnight Eastern Time at the end of industry entitled ‘‘Reference Amounts Human Use; Public Meeting; Request April 30, 2018. Comments received by Customarily Consumed: List of Products for Comments mail/hand delivery/courier (for written/ for Each Product Category; Draft paper submissions) will be considered Guidance for Industry’’ and gave AGENCY: Food and Drug Administration, timely if they are postmarked or the interested parties an opportunity to HHS. delivery service acceptance receipt is on submit comments by March 6, 2017, for ACTION: Notice of public meeting; or before that date. us to consider before beginning work on request for comments. the final version of the guidance. We Electronic Submissions received several comments on the draft SUMMARY: The Food and Drug Administration (FDA or Agency) is Submit electronic comments in the guidance and have modified the following way: content, where appropriate, for this final announcing a regional public meeting guidance. Changes to the guidance entitled ‘‘U.S. Food and Drug • Federal eRulemaking Portal: include the addition of flavored nut Administration and Health Canada Joint https://www.regulations.gov. Follow the butter spreads (e.g., cocoa, cookie, and Regional Consultation on the instructions for submitting comments. coffee flavored) as an example in the International Council for Harmonisation Comments submitted electronically, ‘‘Nut and seed butters, pastes, or of Technical Requirements for including attachments, to https:// creams’’ product category. In the Pharmaceuticals for Human Use (ICH).’’ www.regulations.gov will be posted to The purpose of the public meeting is to the docket unchanged. Because your Federal Register of November 2, 2016, provide information and solicit public comment will be made public, you are we published a Request for Information input on the current activities of the solely responsible for ensuring that your and Comments requesting information ICH, as well as the upcoming ICH comment does not include any and comments on the appropriate Assembly Meeting and the Expert confidential information that you or a product category and RACC for flavored Working Group Meetings in Kobe, third party may not wish to be posted, nut butter spreads (e.g., cocoa, cookie, Japan, scheduled for June 4 through 7, such as medical information, your or and coffee flavored) (81 FR 76323). 2018. The topics to be addressed at the anyone else’s Social Security number, or Based upon the information and public meeting are the current ICH confidential business information, such comments received, and our own guideline topics under development as a manufacturing process. Please note assessment, we have determined that that will be discussed at the that if you include your name, contact flavored nut butter spreads (e.g., cocoa, forthcoming ICH Assembly Meeting in cookie, and coffee flavored) are information, or other information that Kobe. identifies you in the body of your comparable to nut butters and belong in the ‘‘Nut and seed butters, pastes, or DATES: The public meeting will be held comments, that information will be creams’’ product category with a RACC on Friday, April 6, 2018, from 10 a.m. posted on https://www.regulations.gov. of two tablespoons. In addition to this to 1 p.m. Submit either electronic or • If you want to submit a comment daltland on DSKBBV9HB2PROD with NOTICES and other clarifying substantive changes written comments on this public with confidential information that you that we made to the guidance, we made meeting by April 30, 2018. See the do not wish to be made available to the editorial changes to improve clarity and SUPPLEMENTARY INFORMATION section for public, submit the comment as a to help ensure consistency with registration date and information. written/paper submission and in the § 101.12(b). The guidance announced in ADDRESSES: The public meeting will be manner detailed in the sections below this notice finalizes the draft guidance held at FDA’s White Oak Campus, (see ‘‘Written/Paper Submissions’’ and dated January 2017. 10903 New Hampshire Ave., Bldg. 31 ‘‘Instructions’’). VerDate Sep<11>2014 18:10 Mar 01, 2018 Jkt 244001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\02MRN1.SGM 02MRN1


Document Created: 2018-03-01 23:56:31
Document Modified: 2018-03-01 23:56:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotification of availability.
DatesThe announcement of the guidance is published in the Federal Register on March 2, 2018.
ContactJillonne Kevala, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1450.
FR Citation83 FR 9000 
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