[Federal Register Volume 84, Number 140 (Monday, July 22, 2019)]
[Notices]
[Pages 35119-35121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15523]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
21, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0813. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

[[Page 35120]]

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 issued 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).
    In the Federal Register of April 19, 2019 (84 FR 16513), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One anonymous comment was received that made 
specific suggestions on how labeling might be improved, but that 
supported the overall goals of food labeling and making information 
available to consumers. The comment made no comments regarding our 
burden estimate.
    We estimate the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                      Average  burden
                Type of declaration; 21 CFR section                     Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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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

[[Page 35121]]

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.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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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. This information collection reflects adjustments 
resulting from regulations that have become effective since last OMB 
review (RIN 0910-AF22). Accordingly, we have lowered our third-party 
disclosure estimate to reflect that burden associated with changes in 
labeling resulting from the new requirements has since been realized by 
respondents. This results in a decrease of 1,149,158 annual disclosures 
and 2,299,816 burden hours attributable to those labeling changes.

    Dated: July 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15523 Filed 7-19-19; 8:45 am]
 BILLING CODE 4164-01-P