[Federal Register Volume 84, Number 76 (Friday, April 19, 2019)]
[Notices]
[Pages 16513-16516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07929]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1265]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Labeling: Nutrition Facts Label and Supplement 
Facts Label

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the collection of information for the 
nutrition facts label and supplement facts label, which the Agency 
believes will serve to promote and protect public health.

DATES: Submit either electronic or written comments on the collection 
of information by June 18, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 18, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 18, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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-N-1265 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food Labeling: Nutrition Facts 
Label and Supplement Facts Label.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed in the docket and, except 
for those submitted as ``Confidential

[[Page 16514]]

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.'' The Agency 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 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.gpo.gov/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.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Food Labeling: The Nutrition Facts Label and Supplement Facts Label--21 
CFR 101.9 OMB Control Number 0910-0813--Extension

    This information collection supports requirements for the Nutrition 
Facts and Supplemental Facts labels. Section 403(q) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(q)) specifies 
certain nutrients to be declared in nutrition labeling and authorizes 
the Secretary of Health and Human Services (Secretary) to require other 
nutrients to be declared if the Secretary determines that a nutrient 
will provide information regarding the nutritional value of such food 
that will assist consumers in maintaining healthy dietary practices. 
The Secretary also has discretion under section 403(q) of the FD&C Act 
to remove, by regulation and under certain circumstances, nutrient 
information that is otherwise explicitly required in food labeling 
under this section. Accordingly, we promulgated regulations in Sec.  
101.9 (21 CFR 101.9) setting forth how nutrition information is 
presented to consumers. The regulations also establish standards to 
define serving size and require that certain products provide 
additional information within the Nutrition Facts label that conveys 
that information to consumers.
    Specifically, Sec. Sec.  101.9 and 101.36 list nutrients that are 
required or permitted to be declared; provide Daily Reference Values 
and Reference Daily Intake values that are based on current dietary 
recommendations from consensus reports; provide requirements for foods 
represented or purported to be specifically for children under the age 
of 4 years and pregnant and lactating women and establish nutrient 
reference values specifically for these population subgroups; and 
provide the format and appearance of the Nutrition Facts label. Section 
101.12 (21 CFR 101.12) defines a single-serving container; requires 
dual-column labeling for certain containers; updates, modifies, and 
provides several reference amounts customarily consumed (RACCs); 
provides the label serving size for breath mints; and provides various 
aspects of the serving size regulations.
    The regulations also require that, under certain circumstances, 
manufacturers make and keep certain records to verify the amount of 
added sugars when a food product contains both naturally occurring 
sugars and added sugars, isolated or synthetic non-digestible 
carbohydrates that do not meet the definition of dietary fiber, 
different forms of vitamin E, and folate/folic acid declared on the 
Nutrition Facts or Supplement Facts label, which is the amount in the 
finished food product.
    Firms make and keep certain records necessary to verify the amount 
of the nutrients in the finished food product. This collection of 
information does not specify what records are to be used to verify the 
amounts of these nutrients but does specify the information that the 
records must contain. The collection requires manufacturers to provide 
FDA, upon request during an inspection, with the records that contain 
the required information for each of these nutrients to verify the 
amount of the nutrient declared on the label. These records may include 
analyses of nutrient databases, recipes or formulations, information 
from recipes or formulations, batch records, or any other records that 
contain the required information to verify the nutrient content in the 
final product.
    Description of Respondents: Respondents to this collection of 
information are manufacturers of food products sold in the United 
States. Respondents are from the private sector (for-profit 
businesses).
    We estimate the burden of this collection of information as 
follows:

[[Page 16515]]



                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                               Number of      Number of records     Total annual      Average burden
           Type of declaration; 21 CFR section               recordkeepers     per recordkeeper       records       per recordkeeping     Total hours
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Added Sugars; 101.9(c)(6)(iii) \2\.......................             31,283                  1             31,283                  1             31,283
Dietary Fiber; 101.9(c)(6)(i) \2\........................             31,283                  1             31,283                  1             31,283
Soluble Fiber; 101.9(c)(6)(i)(A) \2\.....................             31,283                  1             31,283                  1             31,283
Insoluble Fiber; 101.9(c)(6)(i)(B) \2\...................             31,283                  1             31,283                  1             31,283
Vitamin E; 101.9(c)(8) \3\...............................             31,283                  1             31,283                  1             31,283
Folate/Folic Acid; 101.9(c)(8) \3\.......................             31,283                  1             31,283                  1             31,283
New Products.............................................                216                  1                216                  1                216
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    Total................................................  .................  .................  .................  .................            187,914
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for added sugars, dietary fiber, and
  soluble and insoluble fiber. Manufacturers will only need to keep records for products with both added and naturally occurring sugars, added sugars
  that undergo fermentation in certain fermented foods, and products with non-digestible carbohydrates (soluble or insoluble) that do and do not meet
  the definition of dietary fiber.
\3\ These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for vitamin E and folate/folic acid. The
  declaration of vitamin E and folate/folic acid is not mandatory unless a health or nutrient content claim is being made or these nutrients are
  directly added to the food for enrichment purposes.

    Based on our experience with food labeling regulations, records 
that are required to be retained are records that a prudent and 
responsible manufacturer uses and retains as a normal part of doing 
business, e.g., analyses of nutrient databases, recipes or 
formulations, batch records, or other records. Thus, the recordkeeping 
burden of this collection of information consists of the time required 
to identify and assemble the records for copying and retention. Based 
on our previous experience with similar information collections, we 
estimate the recordkeeping burden to be 1 hour per product as estimated 
in table 1.
    The declarations for added sugars, dietary fiber, soluble fiber, 
and insoluble fiber are mandatory, and we conservatively estimate all 
of the roughly 31,283 food manufacturers would incur this recordkeeping 
burden and the required recordkeeping would be 1 hour per manufacturer. 
These calculations are reflected in table 1, rows 1 to 4. The 
declaration of vitamin E and folate/folic acid is not mandatory unless 
a health or nutrient content claim is being made or these nutrients are 
directly added to the food for enrichment purposes. However, we 
conservatively estimate that all 31,283 respondents would incur this 
recordkeeping burden and that the required recordkeeping would be 1 
hour per manufacturer. These calculations are reflected in table 1, 
rows 5 and 6.
    We estimate that the number of newly introduced products that are 
covered under this collection of information is 216. We assume the 
required recordkeeping is 1 hour per product, for an annual recurring 
recordkeeping burden of 216 hours, as reflected in table 1, row 7. 
Adding the burden from new products to the burden for existing products 
results in a total of 187,914 annual recordkeeping burden hours.

                                                     Table 2--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
   Filing of citizen petition regarding a particular isolated or        Number of      responses per     Total annual    Average burden    Total hours
               synthetic non-digestible carbohydrate                   respondents       respondent       responses       per response
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Dietary Fiber; 101.9(c)(6)(i)......................................              28                1               28                1               28
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Manufacturers of food products that contain an isolated or 
synthetic non-digestible carbohydrate that is not listed in the 
definition of dietary fiber have the option of submitting a citizen 
petition to FDA requesting us to amend the definition of ``dietary 
fiber'' to include the carbohydrate as a listed dietary fiber, by 
demonstrating the physiological benefits of the isolated or synthetic 
non-digestible carbohydrate to human health.
    We estimate that there are approximately 28 isolated or synthetic 
non-digestible carbohydrates that do not meet the definition of dietary 
fiber. Once a citizen petition filed by a manufacturer related to a 
particular isolated or synthetic non-digestible carbohydrate is granted 
or denied, or the carbohydrate is the subject of an authorized health 
claim, and the dietary fiber is listed in the definition of dietary 
fiber, the use of the dietary fiber as an ingredient in any food 
product must be included in the total amount of dietary fiber declared 
in nutrition labeling for such product.
    Thus, we estimate that 28 manufacturers would incur burden 
associated with filing a citizen petition to amend the listing of 
dietary fiber related to an isolated and synthetic non-digestible 
carbohydrate that is not currently listed in the definition of dietary 
fiber and that the required recordkeeping would be 1 hour per 
manufacturer. This calculation is shown in table 2.

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                                                 Table 3--Estimated Annual Third-Party Disclosure Burden
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                                                                                         Number of
                            21 CFR 101.9                                Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
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Nutritional labeling for new products..............................             500                1              500                2            1,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Under Sec. Sec.  101.9 and 101.12, some manufacturers of retail 
food products make labeling changes to modify the serving sizes and 
other nutrition information based on changes to what products may be or 
are required to be labeled as a single serving, or based on updated, 
modified, or established RACCs. We estimate that about 500 new products 
will be affected by these requirements each year and that the 
associated disclosure burden is 2 hours per product, for an annual 
burden of 1,000 hours.

    Dated: April 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07929 Filed 4-18-19; 8:45 am]
 BILLING CODE 4164-01-P


