[Federal Register Volume 85, Number 98 (Wednesday, May 20, 2020)]
[Notices]
[Pages 30711-30713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10824]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1155]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food Labeling 
Regulations

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: Submit written comments (including recommendations) on the 
collection of information by June 19, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. All comments should be 
identified with the OMB control number 0910-0381. 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 Regulations

OMB Control Number 0910-0381--Revision

    This information collection supports our food labeling regulations 
and associated Agency guidance. Under the authority of sections 4, 5, 
and 6 of the Fair Packaging and Labeling Act (FPLA) (15 U.S.C. 1453, 
1454, and 1455) and sections 201, 301, 402, 403, 409, 411, 701, and 721 
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321, 
331, 342, 343, 348, 350, 371, and 379e), we have issued regulations 
regarding the labeling of food. The regulations are codified in parts 
101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105) and 
implement statutory provisions that a food product shall be deemed to 
be misbranded if, among other things, its label or labeling fails to 
bear certain required information concerning the food product, is false 
or misleading in any particular, or bears certain types of unauthorized 
claims. While part 101 sets forth general food labeling provisions, 
requirements pertaining to the common or usual name for nonstandardized 
foods; guidelines for nutritional quality to prescribe the minimum 
level or range of nutrient composition appropriate for a given class of 
food; and requirements for foods for special dietary use are found in 
parts 102, 104, and 105, respectively.
    The disclosure requirements, along with the reporting and 
recordkeeping provisions, are necessary to ensure the safety of food 
products produced or sold in the United States and enable consumers to 
be knowledgeable about the foods they purchase. Nutrition labeling 
provides information for use by consumers in selecting a nutritious 
diet. Other information enables consumers to comparison shop. 
Ingredient information also enables consumers to avoid substances to 
which they may be sensitive. Petitions or other requests submitted to 
us provide the basis for us to permit new labeling statements or to 
grant exemptions from certain labeling requirements. Recordkeeping 
requirements enable us to monitor the basis upon which certain label 
statements are made for food products and whether those statements are 
in compliance with the requirements of the FD&C Act or the FPLA.
    Specifically, the regulations set forth the general content and 
format requirements for food packaging, including nutrition and 
ingredient information. Additional regulations provide for nutrient 
content claims. To assist respondents in this regard, we developed the 
document entitled ``Guidance for Industry: Notification of a Health 
Claim or Nutrient Content Claim Based on an Authoritative Statement of 
a Scientific Body.'' The guidance is available from our website at: 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-notification-health-claim-or-nutrient-content-claim-based-authoritative-statement. The guidance communicates 
our recommendations regarding food labeling claims associated with 
regulations found in Sec. Sec.  101.13, 101.14, 101.54, 101.69, and 
101.70. It was developed to assist respondents in satisfying criteria 
found or discussed in these regulations regarding the submission of 
notifications for certain health claims and identifies information to 
include and information we will evaluate in determining compliance with 
statutory requirements (e.g., supporting literature; discussion of 
analytical methodology or methodologies used in support of a particular 
claim).
    The regulations also include provisions applicable to the labeling 
of dietary supplements. To assist respondents in this regard and in 
understanding provisions under the Dietary Supplement and 
Nonprescription Drug Consumer Protection Act (Pub. L. 109-462), we 
developed the guidance entitled ``Questions and Answers: Labeling of 
Dietary Supplements as Required by the Dietary Supplement and 
Nonprescription Drug Consumer Protection Act.'' The guidance is 
available from our website at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-labeling-dietary-supplements-required-dietary. 
The guidance communicates the following information: (1) What 
``domestic address'' means for purposes of the dietary supplement 
labeling requirements in section 403(y) of the FD&C Act; (2) FDA's 
recommendation for the use of an introductory statement

[[Page 30712]]

before the domestic address or phone number that is required to appear 
on the product label under section 403(y); and (3) when FDA intends to 
begin enforcing the labeling requirements of section 403(y).
    The guidance entitled ``Substantiation for Dietary Supplement 
Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and 
Cosmetic Act'' has also been developed to assist respondents to the 
information collection. The guidance is available from our website at: 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiation-dietary-supplement-claims-made-under-section-403r-6-federal-food. The guidance discusses the 
requirement that a manufacturer of a dietary supplement making a 
nutritional deficiency, structure/function, or general well-being claim 
have substantiation that the claim is truthful and not misleading. The 
guidance is intended to describe the amount, type, and quality of 
evidence FDA recommends that a manufacturer have to substantiate a 
claim under section 403(r)(6) of the FD&C Act.
    Finally, we are revising the information collection by 
consolidating elements associated with revised Nutrition Facts and 
Supplement Facts labels regulations. Requirements included among the 
food labeling regulations found in part 101 govern both format and 
content of the Nutrition Facts (Sec.  101.9) and Supplement Facts 
(Sec.  101.36) labels. Currently, the information collection associated 
with food labeling under Sec. Sec.  101.9 (including petitions filed 
under 101.9(c)) and 101.36 (disclosures associated with serving size) 
is approved under OMB control number 0910-0813. These provisions were 
established by rulemaking (RIN 0910-AF22) and have now been 
incorporated into the regulations in part 101.
    Description of Respondents: Respondents to this information 
collection are manufacturers, packers, and distributors of food 
products, as well as certain food retailers, such as supermarkets and 
restaurants.
    In the Federal Register of February 5, 2020 (85 FR 6551), we 
published a notice inviting public comment on the proposed collection 
of information. One comment was received suggesting FDA consider 
including labeling requirements pertaining to folic acid, while a 
second comment was received that was not responsive to the information 
collection topics solicited. Neither comment suggested we revise our 
burden estimates, which are as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                               Number of
                                                  Number of    responses      Total       Average
            21 CFR section; activity             respondents      per         annual     burden per  Total hours
                                                               respondent   responses     response
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101.9(c)(6)(i); dietary fiber..................           28            1           28            1           28
101.9(j)(18) and 101.36(h)(2); procedure for          10,000            1       10,000            8       80,000
 small business nutrition labeling exemption
 notice using Form FDA 3570....................
101.12(h); petitions to establish or amend                 5            1            5           80          400
 referenced amounts customarily consumed (RACC)
101.69; petitions for nutrient content claims..            3            1            3           25           75
101.70; petitions for health claims............            5            1            5           80          400
101.108; written proposal for requesting                   1            1            1           40           40
 temporary exemptions from certain regulations
 for the purpose of conducting food labeling
 experiments...................................
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    Total......................................  ...........  ...........       10,042  ...........       80,943
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                  Number of      Total
    21 CFR section; activity       Number of     records per     annual       Average  burden per    Total hours
                                 recordkeepers  recordkeeper    records          recordkeeping
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101.9(c)(6)(iii) \2\; added            31,283              1       31,283  1.......................       31,283
 sugars.
101.9(c)(6)(i) \2\; dietary            31,283              1       31,283  1.......................       31,283
 fiber.
101.9(c)(6)(i)(A) \2\; soluble         31,283              1       31,283  1.......................       31,283
 fiber.
101.9(c)(6)(i)(B) \2\;                 31,283              1       31,283  1.......................       31,283
 insoluble fiber.
101.9(c)(8) \3\; vitamin E.....        31,283              1       31,283  1.......................       31,283
101.9(c)(8) \3\; folate/folic          31,283              1       31,283  1.......................       31,283
 acid.
New products...................           216              1          216  1.......................          216
101.12(e); recordkeeping to                25              1           25  1.......................           25
 document the basis for density-
 adjusted RACC.
101.13(q)(5); recordkeeping to        300,000            1.5      450,000  0.75 (45 minutes).......      337,500
 document the basis for
 nutrient content claims.
101.14(d)(2); recordkeeping to        300,000            1.5      450,000  0.75 (45 minutes).......      337,500
 document nutrition information
 related to health claims for
 food products.
101.22(i)(4); recordkeeping to             25              1           25  1.......................           25
 document supplier
 certifications for flavors
 designated as containing no
 artificial flavors.
101.100(d)(2); recordkeeping            1,000              1        1,000  1.......................        1,000
 pertaining to agreements that
 form the basis for an
 exemption from the labeling
 requirements of section
 403(c), (e), (g)-(i), (k), and
 (q) of the FD&C Act.
101.7(t); recordkeeping                   100              1          100  1.......................          100
 pertaining to disclosure
 requirements for food not
 accurately labeled for quality
 of contents.
                                --------------------------------------------------------------------------------
    Total......................  .............  ............    1,089,064  ........................      864,064
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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.


[[Page 30713]]


                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                 Number of
                                    Number of   disclosures     Total        Average  burden per
     21 CFR section; activity      respondents       per        annual            disclosure         Total hours
                                                 respondent  disclosures
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101.3, 101.22, parts 102 and 104;       25,000         1.03       25,750  0.5 (30 minutes).........       12,875
 statement of identity labeling
 requirements.
101.4, 101.22, 101.100, parts           25,000         1.03       25,750  1........................       25,750
 102, 104 and 105; ingredient
 labeling requirements.
101.5; requirement to specify the       25,000         1.03       25,750  0.25 (15 minutes)........        6,438
 name and place of business of
 the manufacturer, packer, or
 distributor and, if the food
 producer is not the manufacturer
 of the food product, its
 connection with the food product.
101.9, 101.13(n), 101.14(d)(3),         25,000         1.03       25,750  4........................      103,000
 101.62, and part 104; labeling
 requirements for disclosure of
 nutrition information.
101.9(g)(9) and 101.36(f)(2);               12            1           12  4........................           48
 alternative means of compliance
 permitted.
101.10; requirements for               300,000          1.5      450,000  0.25 (15 minutes)........      112,500
 nutrition labeling of restaurant
 foods.
101.12(b); RACC for baking                  29          2.3           67  1........................           67
 powder, baking soda, and pectin.
101.12(e); adjustment to the RACC           25            1           25  1........................           25
 of an aerated food permitted.
101.12(g); requirement to                5,000            1        5,000  1........................        5,000
 disclose the serving size that
 is the basis for a claim made
 for the product if the serving
 size on which the claim is based
 differs from the RACC.
101.13(d)(1) and 101.67;                   200            1          200  1........................          200
 requirements to disclose
 nutrition information for any
 food product for which a
 nutrient content claim is made.
101.13(j)(2) and (k), 101.54,            5,000            1        5,000  1........................        5,000
 101.56, 101.60, 101.61, and
 101.62; additional disclosure
 required if the nutrient content
 claim compares the level of a
 nutrient in one food with the
 level of the same nutrient in
 another food.
101.13(q)(5); requirement that         300,000          1.5      450,000  0.75 (45 minutes)........      337,500
 restaurants disclose the basis
 for nutrient content claims made
 for their food.
101.14(d)(2); general                  300,000          1.5      450,000  0.75 (45 minutes)........      337,500
 requirements for disclosure of
 nutrition information related to
 health claims for food products.
101.15; requirements pertaining            160           10        1,600  8........................       12,800
 to prominence of required
 statements and use of foreign
 language.
101.22(i)(4); supplier                      25            1           25  1........................           25
 certifications for flavors
 designated as containing no
 artificial flavors.
101.30 and 102.33; labeling              1,500            5        7,500  1........................        7,500
 requirements for fruit or
 vegetable juice beverages.
101.36; nutrition labeling of              300           40       12,000  4.025....................       48,300
 dietary supplements.
101.42 and 101.45; nutrition             1,000            1        1,000  0.5 (30 minutes).........          500
 labeling of raw fruits,
 vegetables, and fish.
101.45(c); databases of nutrient             5            4           20  4........................           80
 values for raw fruits,
 vegetables, and fish.
101.79(c)(2)(i)(D); disclosure           1,000            1        1,000  0.25 (15 minutes)........          250
 requirements for food labels
 that contain a folate/neural
 tube defect health claim.
101.79(c)(2)(iv); disclosure of            100            1          100  0.25 (15 minutes)........           25
 amount of folate for food labels
 that contain a folate/neural
 tube defect health claim.
101.100(d); disclosure of                1,000            1        1,000  1........................        1,000
 agreements that form the basis
 for exemption from the labeling
 requirements of section 403(c),
 (e), (g)-(i), (k), and (q) of
 the FD&C Act.
101.7 and 101.100(h); disclosure        25,000         1.03       25,750  0.5 (30 minutes).........       12,875
 requirements for food not
 accurately labeled for quantity
 of contents and for claiming
 certain labeling exemptions.
Nutritional labeling for new               500            1          500  2........................        1,000
 products.
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    Total........................  ...........  ...........    1,513,799  .........................    1,030,258
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Because of the consolidation of OMB control number 0910-0813, our 
estimate reflects an annual increase of 188,442 responses and 188,282 
hours. These estimates are based on our experience with food labeling, 
related submissions of petitions, and informal communications with 
industry.

    Dated: May 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10824 Filed 5-19-20; 8:45 am]
 BILLING CODE 4164-01-P