[Federal Register Volume 74, Number 134 (Wednesday, July 15, 2009)]
[Notices]
[Pages 34353-34357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16869]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0296]


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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the 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 information collection 
provisions in FDA's food labeling regulations and on Form FDA 3570, 
``Model Small Business Nutrition Labeling Exemption Notice,'' which 
small businesses may use to claim the small business exemption from 
nutrition labeling.

DATES: Submit written or electronic comments on the collection of 
information by September 14, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

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,

[[Page 34354]]

when appropriate, and other forms of information technology.

Food Labeling Regulations--21 CFR Parts 101, 102, 104, and 105 (OMB 
Control Number 0910-0381)--Extension

    FDA regulations require food producers to disclose to consumers and 
others specific information about themselves or their products on the 
label or labeling of their products. Related regulations require that 
food producers retain records establishing the basis for the 
information contained in the label or labeling of their products and 
provide those records to regulatory officials. Finally, certain 
regulations provide for the submission of food labeling petitions to 
FDA. FDA's food labeling regulations under parts 101, 102, 104, and 105 
(21 CFR parts 101, 102, 104, and 105) were issued under the authority 
of sections 4, 5, and 6 of the Fair Packaging and Labeling Act (the 
FPLA) (15 U.S.C. 1453, 1454, and 1455) and under sections 201, 301, 
402, 403, 409, 411, 701, and 721 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, 
and 379e). Most of these regulations derive from section 403 of the 
act, which provides 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. The disclosure requirements and other collections of 
information in the regulations in parts 101, 102, 104, and 105 are 
necessary to ensure that food products produced or sold in the United 
States are in compliance with the labeling provisions of the act and 
the FPLA.
    Section 101.3 of FDA's food labeling regulations requires that the 
label of a food product in packaged form bear a statement of identity 
(i.e., the name of the product), including, as appropriate, the form of 
the food or the name of the food imitated. Section 101.4 prescribes 
requirements for the declaration of ingredients on the label or 
labeling of food products in packaged form. Section 101.5 requires that 
the label of a food product in packaged form specify 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. Section 101.9 requires that nutrition 
information be provided for all food products intended for human 
consumption and offered for sale, unless an exemption in Sec.  101.9(j) 
applies to the product. Section 101.9(g)(9) also provides for the 
submission to FDA of requests for alternative approaches to nutrition 
labeling. Finally, Sec.  101.9(j)(18) provides for the submission to 
FDA of notices from firms claiming the small business exemption from 
nutrition labeling. FDA has developed Form FDA 3570 to assist small 
businesses in claiming the small business exemption from nutrition 
labeling. The form contains all the elements required by Sec.  
101.9(j)(18).
    Section 101.10 requires that restaurants provide nutrition 
information, upon request, for any food or meal for which a nutrient 
content claim or health claim is made. Section 101.12(b) provides the 
reference amount that is used for determining the serving sizes for 
specific products, including baking powder, baking soda, and pectin. 
Section 101.12(e) provides that a manufacturer that adjusts the 
reference amount customarily consumed (RACC) of an aerated food for the 
difference in density of the aerated food relative to the density of 
the appropriate nonaerated reference food must be prepared to show FDA 
detailed protocols and records of all data that were used to determine 
the density-adjusted RACC. Section 101.12(g) requires that the label or 
labeling of a food product 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. Section 101.12(h) provides for the 
submission of petitions to FDA to request changes in the reference 
amounts defined by regulation.
    Section 101.13 requires that nutrition information be provided in 
accordance with Sec.  101.9 for any food product for which a nutrient 
content claim is made. Under some circumstances, Sec.  101.13 also 
requires the disclosure of other types of information as a condition 
for the use of a nutrient content claim. For example, under Sec.  
101.13(j), if the claim compares the level of a nutrient in the food 
with the level of the same nutrient in another ``reference'' food, the 
claim must also disclose the identity of the reference food, the amount 
of the nutrient in each food, and the percentage or fractional amount 
by which the amount of the nutrient in the labeled food differs from 
the amount of the nutrient in the reference food. It also requires that 
when this comparison is based on an average of food products, this 
information must be provided to consumers or regulatory officials upon 
request. Section 101.13(q)(5) requires that restaurants document and 
provide to appropriate regulatory officials, upon request, the basis 
for any nutrient content claims they have made for the foods they sell.
    Section 101.14(d)(2) and (d)(3) provides for the disclosure of 
nutrition information in accordance with Sec.  101.9 and, under some 
circumstances, certain other information as a condition for making a 
health claim for a food product. Section 101.15 provides that, if the 
label of a food product contains any representation in a foreign 
language, all words, statements, and other information required by or 
under authority of the act to appear on the label shall appear thereon 
in both the foreign language and in English. Section 101.22 contains 
labeling requirements for the disclosure of spices, flavorings, 
colorings, and chemical preservatives in food products. Section 
101.22(i)(4) sets forth reporting and recordkeeping requirements 
pertaining to certifications for flavors designated as containing no 
artificial flavor. Section 101.30 specifies the conditions under which 
a beverage that purports to contain any fruit or vegetable juice must 
declare the percentage of juice present in the beverage and the manner 
in which the declaration is to be made. Section 102.33 specifies the 
common or usual name for beverages that contain fruit or vegetable 
juice.
    Section 101.36 requires that nutrition information be provided for 
dietary supplements offered for sale, unless an exemption in Sec.  
101.36(h) applies. Section 101.36(f)(2) cross-references the provisions 
in Sec.  101.9(g)(9) for the submission to FDA of requests for 
alternative approaches to nutrition labeling. Also, Sec.  101.36(h)(2) 
cross-references the provisions in Sec.  101.9(j)(18) for the 
submission of small business exemption notices. As noted previously, 
FDA has developed Form FDA 3570 to assist small businesses in claiming 
the small business exemption from nutrition labeling. The form contains 
all the elements required by Sec.  101.36(h)(2).
    Section 101.36(e) permits the voluntary declaration of the 
quantitative amount and the percent of Daily Value of a dietary 
ingredient on a ``per day'' basis in addition to the required ``per 
serving'' basis, if a dietary supplement label recommends that the 
dietary supplement be consumed more than once per day.
    Section 101.42 requests that food retailers voluntarily provide 
nutrition information for raw fruits, vegetables, and fish at the point 
of purchase, and Sec.  101.45 contains guidelines for providing such 
information. Also, Sec.  101.45(c) provides for the submission of 
nutrient databases and proposed nutrition labeling values for raw 
fruit,

[[Page 34355]]

vegetables, and fish to FDA for review and approval.
    Sections 101.54, 101.56, 101.60, 101.61, and 101.62 specify 
information that must be disclosed as a condition for making particular 
nutrient content claims. Section 101.67 provides for the use of 
nutrient content claims for butter, and cross-references requirements 
in other regulations for ingredient declaration (Sec.  101.4) and 
disclosure of information concerning performance characteristics (Sec.  
101.13(d)). Section 101.69 provides for the submission of a petition 
requesting that FDA authorize a particular nutrient content claim by 
regulation. Section 101.70 provides for the submission of a petition 
requesting that FDA authorize a particular health claim by regulation. 
Section 101.77(c)(2)(ii)(D) requires the disclosure of the amount of 
soluble fiber per serving in the nutrition labeling of a food bearing a 
health claim about the relationship between soluble fiber and a reduced 
risk of coronary heart disease. Section 101.79(c)(2)(iv) requires the 
disclosure of the amount of folate per serving in the nutrition 
labeling of a food bearing a health claim about the relationship 
between folate and a reduced risk of neural tube defects.
    Section 101.100(d) provides that any agreement that forms the basis 
for an exemption from the labeling requirements of section 403(c), (e), 
(g), (h), (i), (k), and (q) of the act be in writing and that a copy of 
the agreement be made available to FDA upon request. Section 101.100 
also contains reporting and disclosure requirements as conditions for 
claiming certain labeling exemptions (e.g., Sec.  101.100(h)).
    Section 101.105 specifies requirements for the declaration of the 
net quantity of contents on the label of a food in packaged form and 
prescribes conditions under which a food whose label does not 
accurately reflect the actual quantity of contents may be sold, with 
appropriate disclosures, to an institution operated by Federal, State, 
or local government. Section 101.108 provides for the submission to FDA 
of a written proposal requesting a temporary exemption from certain 
requirements of Sec. Sec.  101.9 and 105.66 for the purpose of 
conducting food labeling experiments with FDA's authorization.
    Regulations in part 102 define the information that must be 
included as part of the statement of identity for particular foods and 
prescribe related labeling requirements for some of these foods. For 
example, Sec.  102.22 requires that the name of a protein hydrolysate 
shall include the identity of the food source from which the protein 
was derived.
    Part 104, which pertains to nutritional quality guidelines for 
foods, cross-references several labeling provisions in part 101 but 
contains no separate information collection requirements.
    Part 105 contains special labeling requirements for hypoallergenic 
foods, infant foods, and certain foods represented as useful in 
reducing or maintaining body weight.
    The disclosure and other information collection requirements in the 
previously mentioned regulations are placed primarily upon 
manufacturers, packers, and distributors of food products. Because of 
the existence of exemptions and exceptions, not all of the requirements 
apply to all food producers or to all of their products. Some of the 
regulations affect food retailers, such as supermarkets and 
restaurants.
    The purpose of the food labeling requirements is to allow 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 a consumer to comparison shop. 
Ingredient information also enables consumers to avoid substances to 
which they may be sensitive. Petitions or other requests submitted to 
FDA provide the basis for the agency to permit new labeling statements 
or to grant exemptions from certain labeling requirements. 
Recordkeeping requirements enable FDA 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 act or the 
FPLA.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 1.--Total Estimated Annual Burden\1\
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                                                                 No. of        Annual Frequency     Total Annual        Hours per
             21 CFR Section and Part/Form No.                 Respondents        per Response        Responses           Response         Total Hours
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101.3, 101.22, 102 and 104                                            25,000               1.03             25,750                 .5             12,875
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101.4, 101.22, 101.100, 102,                                          25,000               1.03             25,750                  1             25,750
104 and 105
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101.5                                                                 25,000               1.03             25,750               0.25              6,438
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101.9, 101.13(n), 101.14(d)(3), 101.62, and 104                       25,000               1.03             25,750                  4            103,000
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101.9(g)(9) and 101.36(f)(2)                                              12                  1                 12                  4                 48
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101.9(j)(18) and 101.36(h)(2)/Form FDA 3570                           10,000                  1             10,000                  8             80,000
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101.10                                                               300,000                1.5            450,000               0.25            112,500
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101.12(b)                                                                 29                2.3                 67                  1                 67
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101.12(e)                                                                 25                  1                 25                  1                 25
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101.12(g)                                                              5,000                  1              5,000                  1              5,000
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101.12(h)                                                                  5                  1                  5                 80                400
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101.13(d)(1) and 101.67                                                  200                  1                200                  1                200
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[[Page 34356]]

 
101.13(j)(2), 101.13(k), 101.54, 101.56, 101.60, 101.61,               5,000                  1              5,000                  1              5,000
 and 101.62
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101.13(q)(5)                                                         300,000                1.5            450,000               0.75            337,500
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101.14(d)(2)                                                         300,000                1.5            450,000               0.75            337,500
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101.15                                                                   160                 10              1,600                  8             12,800
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101.22(i)(4)                                                              25                  1                 25                  1                 25
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101.30 and 102.33                                                      1,500                  5              7,500                  1              7,500
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101.36                                                                   300                 40             12,000                  4             48,000
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101.36(e)                                                                125                 13              1,625               0.25                406
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101.42 and 101.45                                                      1,000                  1              1,000                0.5                500
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101.45(c)                                                                  5                  4                 20                  4                 80
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101.69                                                                     3                  1                  3                 25                 75
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101.70                                                                     5                  1                  5                 80                400
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101.79(c)(2)(i)(D)                                                     1,000                  1              1,000               0.25                250
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101.79(c)(2)(iv)                                                         100                  1                100               0.25                 25
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101.100(d)                                                             1,000                  1              1,000                  1              1,000
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101.105 and 101.100(h)                                                25,000               1.03             25,750                0.5             12,875
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101.108                                                                    1                  1                  1                 40                 40
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Total                                                      .................  .................  .................  .................          1,110,279
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                       Table 2.--Total Estimated Annual Burden\1\
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                                                                 No. of        Annual Frequency  per      Total Annual     Hours per
                      21 CFR Section                         Recordkeepers         Recordkeeping            Records          Record       Total Hours
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101.12(e)                                                                 25                        1                 25            1                 25
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101.13(q)(5)                                                         300,000                      1.5            450,000         0.75            337,500
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101.14(d)(2)                                                         300,000                      1.5            450,000         0.75            337,500
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101.22(i)(4)                                                              25                        1                 25            1                 25
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101.100(d)(2)                                                          1,000                        1              1,000            1              1,000
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101.105(t)                                                               100                        1                100            1                100
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Total                                                      .................  .......................  .................  ...........            676,150
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated annual reporting and recordkeeping burdens are based 
on agency communications with industry and FDA's knowledge of and 
experience with food labeling and the submission of petitions and 
requests to the agency. Where an agency regulation implements an 
information collection requirement in the act or the FPLA, only any 
additional burden attributable to the regulation has been included in 
FDA's burden estimate.
    No burden has been estimated for those requirements where the 
information to be disclosed is information that has been supplied by 
FDA. Also, no burden has been estimated for information that is 
disclosed to third parties as a usual and customary part of a food 
producer's normal business activities. Under 5 CFR 1320.3(c)(2), the 
public disclosure of information originally supplied by the Federal 
Government to the recipient for the purpose of disclosure to the public 
is not a collection of information. Under 5 CFR 1320.3(b)(2), the time, 
effort, and

[[Page 34357]]

financial resources necessary to comply with a collection of 
information are excluded from the burden estimate if the reporting, 
recordkeeping, or disclosure activities needed to comply are usual and 
customary because they would occur in the normal course of activities.
    In this request for extension of OMB approval under the PRA, FDA is 
combining the burden hours associated with OMB control numbers 0910-
0395 (collection entitled ``Food Labeling: Nutrition Labeling of 
Dietary Supplements on a `Per Day' Basis'') and 0910-0515 (collection 
entitled ``Food Labeling: Trans Fatty Acids in Nutrition Labeling'') 
with the burden hours approved under OMB control number 0910-0381 
(collection entitled ``Food Labeling Regulations'').

    Dated: July 8, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16869 Filed 7-14-09; 8:45 am]
BILLING CODE 4160-01-S