82_FR_1347 82 FR 1344 - Reference Amounts Customarily Consumed: List of Products for Each Product Category; Draft Guidance for Industry; Availability

82 FR 1344 - Reference Amounts Customarily Consumed: List of Products for Each Product Category; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 3 (January 5, 2017)

Page Range1344-1345
FR Document2016-32006

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Reference Amounts Customarily Consumed: List of Products for Each Product Category.'' The draft guidance, when finalized, will provide examples of products that belong to product categories included in the tables of Reference Amounts Customarily Consumed (RACCs)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 82 Issue 3 (Thursday, January 5, 2017) 
[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1344-1345]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-32006]


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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Product Category; Draft Guidance for Industry; Availability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availability of a draft guidance for industry entitled ``Reference 
Amounts Customarily Consumed: List of Products for Each Product 
Category.'' The draft guidance, when finalized, will provide examples 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: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on the draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
March 6, 2017.

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 Division of Dockets Management 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

[[Page 1345]]

with a heading or cover note that states ``THIS DOCUMENT CONTAINS 
CONFIDENTIAL INFORMATION.'' We 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 Division of 
Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft 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 draft 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 draft guidance for industry 
entitled ``Reference Amounts Customarily Consumed: List of Products for 
Each Product Category.'' We are issuing the draft guidance consistent 
with our good guidance practices regulation (21 CFR 10.115). The draft 
guidance, when finalized, will represent the current thinking of the 
FDA on which products belong to product categories included in the 
tables of RACCs per Eating Occasion established in Sec.  101.12(b) (21 
CFR 101.12(b)). This draft guidance 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.
    We intend for this draft guidance, when finalized, to help industry 
comply with the statutory requirement, under section 403(q)(1)(A)(i) of 
the Federal Food, Drug, and Cosmetic Act (the 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 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) to 
update or modify certain pre-existing RACCs, and to establish RACCs for 
new product categories.
    The draft guidance, when finalized, will help manufacturers 
identify the appropriate food category to which their product belongs, 
on which information manufacturers will be able to base the label 
serving size. The RACCs established in Sec.  101.12(b) are divided into 
two tables: One for infants and young children 1 through 3 years of 
age, and another for the general food supply (i.e., individuals four 
years and older). The draft guidance, when finalized, will provide 
examples of products that belong to product categories for which a RACC 
has been established in Sec.  101.12(b). The tables in the draft 
guidance are not meant to be an all-inclusive list of products that are 
available on the market for each product category.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: December 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-32006 Filed 1-4-17; 8:45 am]
 BILLING CODE 4164-01-P

1344 Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices Center for Biologics Evaluation and Realtime Translation (CART)/captioning Electronic Submissions Research, Food and Drug should be made 2 weeks in advance of Submit electronic comments in the Administration, 10903 New Hampshire the event, no later than March 23, 2017. following way: Ave., Bldg. 71, Rm. 3128, Silver Spring, A request for either interpreting or • Federal eRulemaking Portal: MD 20993, CBERPublicEvents@ captioning is to be sent directly to the https://www.regulations.gov. Follow the fda.hhs.gov. For questions email: FDA Interpreting Services Staff email instructions for submitting comments. CBERPublicEvents@fda.hhs.gov (Subject account: interpreting.services@ Comments submitted electronically, line: Tick-Borne Diseases and Blood oc.fda.gov. including attachments, to https:// Safety Workshop). Transcripts: Please be advised that as www.regulations.gov will be posted to SUPPLEMENTARY INFORMATION: soon as a transcript of the public the docket unchanged. Because your workshop is available, it will be comment will be made public, you are I. Background accessible at https:// solely responsible for ensuring that your The purpose of the public workshop www.regulations.gov. It may be viewed comment does not include any is to discuss tick-borne pathogens that at the Division of Dockets Management confidential information that you or a continue to emerge as threats to blood (HFA–305) Food and Drug third party may not wish to be posted, safety, the effectiveness of current and Administration, 5630 Fishers Lane, Rm. potential mitigation strategies, and the such as medical information, your or 1061, Rockville, MD 20852. A link to anyone else’s Social Security number, or general approach to decision making on the transcript will also be available on blood safety interventions. confidential business information, such the Internet at http://www.fda.gov/ as a manufacturing process. Please note II. Topics for Discussion at the Public BiologicsBloodVaccines/NewsEvents/ that if you include your name, contact Workshop WorkshopsMeetingsConferences/ information, or other information that ucm525485.htm. identifies you in the body of your The workshop will include presentations and panel discussions on Dated: December 30, 2016. comments, that information will be the following topics: (1) Biology, Leslie Kux, posted on https://www.regulations.gov. epidemiology, and clinical burden of Associate Commissioner for Policy. • If you want to submit a comment Anaplasma phagocytophilum (the [FR Doc. 2016–32029 Filed 1–4–17; 8:45 am] with confidential information that you etiologic agent of human granulocytic BILLING CODE 4164–01–P do not wish to be made available to the anaplasmosis) and other emerging tick- public, submit the comment as a borne agents; (2) the performance written/paper submission and in the characteristics of currently available DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper diagnostic assays for agents of concern; HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). (3) known and potential risks of Written/Paper Submissions transfusion transmission posed by Food and Drug Administration emergent tick-borne agents; (4) current Submit written/paper submissions as and potential mitigation strategies; and [Docket No. FDA–2016–D–4098] follows: (5) considerations in decision making • Mail/Hand delivery/Courier (for for safety interventions. The day will Reference Amounts Customarily written/paper submissions): Division of conclude with a roundtable discussion. Consumed: List of Products for Each Dockets Management (HFA–305), Food Product Category; Draft Guidance for and Drug Administration, 5630 Fishers III. Participating in the Public Industry; Availability Lane, Rm. 1061, Rockville, MD 20852. Workshop • For written/paper comments AGENCY: Food and Drug Administration, submitted to the Division of Dockets Registration: To register for the public HHS. Management, FDA will post your workshop, please visit the following Web site at: https:// ACTION: Notification of availability. comment, as well as any attachments, www.eventbrite.com/e/emerging-tick- except for information submitted, SUMMARY: The Food and Drug marked and identified, as confidential, borne-diseases-and-blood-safety-public- Administration (FDA or we) is workshop-tickets-28654127266. Please if submitted as detailed in announcing the availability of a draft ‘‘Instructions.’’ provide complete contact information guidance for industry entitled for each attendee, including name, title, Instructions: All submissions received ‘‘Reference Amounts Customarily must include the Docket No. FDA– affiliation, address, email, and Consumed: List of Products for Each telephone. 2016–D–4098 for ‘‘Reference Amounts Product Category.’’ The draft guidance, Customarily Consumed: List of Products Registration is free and based on when finalized, will provide examples for Each Product Category.’’ Received space availability, with priority given to of products that belong to product comments will be placed in the docket early registrants. Persons interested in categories included in the tables of and, except for those submitted as attending this public workshop must Reference Amounts Customarily ‘‘Confidential Submissions,’’ publicly register by March 23, 2017. Early Consumed (RACCs) per Eating Occasion viewable at https://www.regulations.gov registration is recommended because established in our regulations. or at the Division of Dockets seating is limited. If time and space permit, onsite registration on the day of DATES: Although you can comment on Management between 9 a.m. and 4 p.m., the public workshop will be provided any guidance at any time (see 21 CFR Monday through Friday. beginning at 7:30 a.m. 10.115(g)(5)), to ensure that we consider • Confidential Submissions—To mstockstill on DSK3G9T082PROD with NOTICES If you need special accommodations your comment on the draft guidance submit a comment with confidential due to a disability, please contact before we begin work on the final information that you do not wish to be Kimberly Jones or Pauline Cottrell by version of the guidance, submit either made publicly available, submit your email sent to CBERPublicEvents@ electronic or written comments on the comments only as a written/paper fda.hhs.gov at least 7 days in advance. draft guidance by March 6, 2017. submission. You should submit two Requests for sign language ADDRESSES: You may submit comments copies total. One copy will include the interpretation or Computer Aided as follows: information you claim to be confidential VerDate Sep<11>2014 21:06 Jan 04, 2017 Jkt 241001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1

Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Notices 1345 with a heading or cover note that states thinking of the FDA on which products sentence to find the most current ‘‘THIS DOCUMENT CONTAINS belong to product categories included in version of the guidance. CONFIDENTIAL INFORMATION.’’ We the tables of RACCs per Eating Occasion Dated: December 30, 2016. will review this copy, including the established in § 101.12(b) (21 CFR Leslie Kux, claimed confidential information, in its 101.12(b)). This draft guidance does not Associate Commissioner for Policy. consideration of comments. The second establish any rights for any person and is not binding on FDA or the public. [FR Doc. 2016–32006 Filed 1–4–17; 8:45 am] copy, which will have the claimed confidential information redacted/ You can use an alternate approach if it BILLING CODE 4164–01–P blacked out, will be available for public satisfies the requirements of the viewing and posted on https:// applicable statutes and regulations. We intend for this draft guidance, DEPARTMENT OF HEALTH AND www.regulations.gov. Submit both when finalized, to help industry comply HUMAN SERVICES copies to the Division of Dockets Management. If you do not wish your with the statutory requirement, under Food and Drug Administration name and contact information to be section 403(q)(1)(A)(i) of the Federal made publicly available, you can Food, Drug, and Cosmetic Act (the [Docket No. FDA–2016–N–0567] provide this information on the cover FD&C Act) (21 U.S.C. 343(q)(1)(A)(i)), sheet and not in the body of your that food that is intended for human [Pediatric Advisory Committee; Notice comments and you must identify this consumption and offered for sale bear of Meeting; Establishment of a Public information as ‘‘confidential.’’ Any nutrition information that provides a Docket; Request for Comments information marked as ‘‘confidential’’ serving size that reflects the amount of AGENCY: Food and Drug Administration, will not be disclosed except in food customarily consumed and is HHS. accordance with 21 CFR 10.20 and other expressed in a common household measure that is appropriate to the food. ACTION: Notice of meeting; applicable disclosure law. For more establishment of a public docket; information about FDA’s posting of To comply with this requirement, manufacturers must determine and label request for comments. comments to public dockets, see 80 FR 56469, September 18, 2015, or access their food products with the appropriate SUMMARY: The Food and Drug the information at: http://www.fda.gov/ label serving size based on the amount Administration (FDA) announces a regulatoryinformation/dockets/ of the product customarily consumed. forthcoming public advisory committee default.htm. In the Federal Register of May 27, meeting of the Pediatric Advisory Docket: For access to the docket to 2016, we issued a final rule entitled Committee (PAC). The general function read background documents or the ‘‘Food Labeling: Serving Sizes of Foods of the committee is to provide advice electronic and written/paper comments That Can Reasonably Be Consumed At and recommendations to the Agency on received, go to https:// One Eating Occasion; Dual-Column FDA’s regulatory issues. The meeting www.regulations.gov and insert the Labeling; Updating, Modifying, and will be open to the public. FDA is Establishing Certain Reference Amounts establishing a docket for public docket number, found in brackets in the Customarily Consumed; Serving Size for comments. heading of this document, into the Breath Mints; and Technical ‘‘Search’’ box and follow the prompts DATES: The meeting will be held on Amendments’’ (81 FR 34000). The final and/or go to the Division of Dockets March 6, 2017, from 8:30 a.m. to 5:30 rule amends our regulations in Management, 5630 Fishers Lane, Rm. p.m. and March 7, 2017, from 8:30 a.m. § 101.12(b) to update or modify certain 1061, Rockville, MD 20852. to 12 p.m. The deadline for submitting pre-existing RACCs, and to establish Submit written requests for single comments to the public docket is RACCs for new product categories. copies of the draft guidance to the Office The draft guidance, when finalized, February 17, 2017. Comments received of Nutrition and Food Labeling, Center will help manufacturers identify the on or before February 17, 2017, will be for Food Safety and Applied Nutrition, appropriate food category to which their provided to the committee. Comments Food and Drug Administration, 5001 product belongs, on which information received after that date will be taken Campus Dr., College Park, MD 20740. manufacturers will be able to base the into consideration by the Agency. Send two self-addressed adhesive labels label serving size. The RACCs ADDRESSES: The meeting will be held at to assist that office in processing your established in § 101.12(b) are divided DoubleTree by Hilton Hotel Washington request. See the SUPPLEMENTARY into two tables: One for infants and DC—Silver Spring, 8727 Colesville Rd., INFORMATION section for electronic young children 1 through 3 years of age, Silver Spring, MD 20910. The hotel’s access to the draft guidance. and another for the general food supply telephone number is 301–589–5200. FOR FURTHER INFORMATION CONTACT: (i.e., individuals four years and older). Answers to commonly asked questions Jillonne Kevala, Center for Food Safety The draft guidance, when finalized, will including information regarding special and Applied Nutrition, Food and Drug provide examples of products that accommodations due to a disability, Administration, 5001 Campus Dr., belong to product categories for which visitor parking, and transportation may College Park, MD 20740, 240–402–1450. a RACC has been established in be accessed at http:// SUPPLEMENTARY INFORMATION: § 101.12(b). The tables in the draft doubletree3.hilton.com/en/hotels/ I. Background guidance are not meant to be an all- maryland/doubletree-by-hilton-hotel- inclusive list of products that are washington-dc-silver-spring-DCASSDT/ We are announcing the availability of available on the market for each product about/amenities.html. a draft guidance for industry entitled mstockstill on DSK3G9T082PROD with NOTICES category. You may submit comments as ‘‘Reference Amounts Customarily follows: Consumed: List of Products for Each II. Electronic Access Product Category.’’ We are issuing the Persons with access to the Internet Electronic Submissions draft guidance consistent with our good may obtain the draft guidance at either Submit electronic comments in the guidance practices regulation (21 CFR http://www.fda.gov/FoodGuidances or following way: 10.115). The draft guidance, when https://www.regulations.gov. Use the • Federal eRulemaking Portal: finalized, will represent the current FDA Web site listed in the previous https://www.regulations.gov. Follow the VerDate Sep<11>2014 21:06 Jan 04, 2017 Jkt 241001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\05JAN1.SGM 05JAN1


Document Created: 2018-02-01 14:50:50
Document Modified: 2018-02-01 14:50:50
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.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 6, 2017.
ContactJillonne Kevala, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1450.
FR Citation82 FR 1344 
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