[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:
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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