[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1344-1345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Product Category; Draft Guidance for Industry; Availability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availability of a draft guidance for industry entitled ``Reference 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 The draft guidance, when finalized, will provide examples 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10.115(g)(5)), to ensure that we consider your comment on the draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 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