[Federal Register Volume 85, Number 24 (Wednesday, February 5, 2020)]
[Notices]
[Pages 6551-6555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02253]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Labeling Regulations

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 information collection activity associated 
with our food labeling regulations.

DATES: Submit either electronic or written comments on the collection 
of information by April 6, 2020.

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 April 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 6, 2020. 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-2013-N-1155 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food Labeling Regulations.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential 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.govinfo.gov/content/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. 3501-3521), 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

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collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Food Labeling Regulations--21 CFR Parts 101, 102, 104, and 105

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 
guidance 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 document 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 
document 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 (21 CFR 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, 120 
Stat. 3469), we developed the guidance document entitled ``Questions 
and Answers: Labeling of Dietary Supplements as Required by the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act.'' The 
guidance document is available from our website at: www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-labeling-dietary-supplements-required-dietary. The guidance document 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 
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 document 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 document 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 document 
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 document 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 (21 CFR 101.9)) and 
Supplement Facts (Sec.  101.36 (21 CFR 101.36)) labels. Currently, the 
information collection provisions are approved under OMB control number 
0910-0813 and were established upon the implementation of associated 
rulemaking (RIN 0910-AF22). Now that the rulemaking is concluded, we 
are consolidating information collection associated with the specific 
regulations into this information collection.
    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.
    We estimate the burden of this collection of information as 
follows:

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                                  Table 1--Estimated Annual Reporting Burden 1
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                                                     Number of
    21 CFR section; activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per 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);            10,000               1          10,000               8          80,000
 procedure for small business
 nutrition labeling exemption
 notice using Form FDA 3570.....
101.12(h); petitions to                        5               1               5              80             400
 establish or amend referenced
 amounts customarily consumed
 (RACC).........................
101.69; petitions for nutrient                 3               1               3              25              75
 content claims.................
101.70; petitions for health                   5               1               5              80             400
 claims.........................
101.108; written proposal for                  1               1               1              40              40
 requesting 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                    Average burden
    21 CFR section; activity         Number of      records per    Total annual         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\ insoluble          31,283               1          31,283               1          31,283
 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         337,500
 document the basis for nutrient
 content claims.................
101.14(d)(2); recordkeeping to           300,000             1.5         450,000            0.75         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),
 (h), (i), (k), and (q) of the
 FD&C Act.......................
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101.7(t); recordkeeping                      100               1             100               1             100
 pertaining to disclosure
 requirements for food not
 accurately labeled for quality
 of contents....................
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    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.


                            Table 3--Estimated Annual Third-Party Disclosure Burden 1
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                                                     Number of
    21 CFR section; activity         Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
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101.3, 101.22, parts 102 and              25,000            1.03          25,750             0.5          12,875
 104; 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..........

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101.5; requirement to specify             25,000            1.03          25,750            0.25           6,438
 the 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         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                  25               1              25               1              25
 RACC 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         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         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             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             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              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), (h), (i), (k), and
 (q) of the FD&C Act............
101.7 and 101.100(h); disclosure          25,000            1.03          25,750             0.5          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.


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    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: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02253 Filed 2-4-20; 8:45 am]
 BILLING CODE 4164-01-P