[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Product Category; Draft Guidance for Industry; Availability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availability of a draft guidance for industry entitled ``Reference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 The draft guidance, when finalized, will provide examples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10.115(g)(5)), to ensure that we consider your comment on the draft
guidance before we begin work on the final version of the guidance,
submit either electronic or written comments on the draft guidance by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