[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Pages 48322-48324]
[FR Doc No: 2015-19741]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0268]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Labeling of Certain Beers Subject to the Labeling
Jurisdiction of the Food and Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on our 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. This notice
solicits comments on the information collection provisions of the
recommended labeling of certain beers subject to our labeling
jurisdiction.

DATES: Submit either electronic or written comments on the collection
of information by October 13, 2015.

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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
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, we are publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility; (2) the
accuracy of our 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.

Labeling of Certain Beers Subject to the Labeling Jurisdiction of the
Food and Drug Administration--(OMB Control Number 0910-0728)--Extension

    The definition of ``food'' under section 201(f) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) See 21 U.S.C. 321(f),
includes ``articles used for food or drink'' and thus includes
alcoholic beverages. As such, alcoholic beverages are subject to the
FD&C Act's adulteration and misbranding provisions, and implementing
regulations, related to food. For example, manufacturers of alcoholic
beverages are responsible for adhering to the registration of food
facilities requirements in 21 CFR part 1 and to the good manufacturing
practice regulations in 21 CFR part 110. There are also certain
requirements for nutrition labeling on menus, menu boards, and other
written materials for alcohol beverages served in restaurants or
similar retail food establishments in 21 CFR part 101 (79 FR 71156,
December 1, 2014). However, as reflected in a 1987 Memorandum of
Understanding between FDA and the Alcohol and Tobacco Tax and Trade
Bureau (TTB), TTB is responsible for the promulgation and enforcement
of regulations with respect to the labeling of distilled spirits,
certain wines, and malt beverages pursuant to the Federal Alcohol
Administration Act (FAA Act). In TTB Ruling 2008-3, dated July 7, 2008,
TTB clarified that certain beers, which are not made from both malted
barley and hops but are instead made from substitutes for malted barley
(such as sorghum, rice, or wheat) or are made without hops, do not meet
the definition of a ``malt beverage'' under the FAA Act. Accordingly,
TTB stated in its ruling that such products (other than sake, which is
classified as a wine under the FAA Act), are not subject to the
labeling, advertising, or other provisions of the TTB regulations
promulgated under the FAA Act.
    In cases where an alcoholic beverage is not covered by the labeling
provisions of the FAA Act, the product is subject to ingredient and
other labeling requirements under the FD&C Act and the implementing
regulations that we administer. In addition, as provided for

under the Fair Packaging and Labeling Act (FPLA), alcoholic beverages
that are not covered by the labeling provisions of the FAA Act are
subject to the provisions of the FPLA, which we administer.
    Therefore, the beers described in the TTB's Ruling as not being a
``malt beverage'' are subject to the labeling requirements under the
FD&C Act and FPLA, and our implementing regulations. In general, we
require that food products under our jurisdiction be truthfully and
informatively labeled in accordance with the FD&C Act, the FPLA, and
FDA's regulations. Furthermore, some TTB labeling requirements, such as
the Government Health Warning Statement under the Alcoholic Beverage
Labeling Act and certain marking requirements under the Internal
Revenue Code, continue to apply to these products.
    In the Federal Register of December 23, 2014 (79 FR 77013), we
announced the availability of a guidance entitled, ``Labeling of
Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug
Administration''. Persons with access to the Internet may obtain the
guidance at http://www.fda.gov/FoodGuidances. This guidance is intended
to assist manufacturers on how to label bottled or otherwise packaged
beers that are subject to our labeling laws and regulations.
    Our 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 FPLA (15 U.S.C. 1453, 1454, and 1455)
and under sections 201, 301, 402, 403, 409, 411, 701, and 721 of the
FD&C Act (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e). Most
of these regulations derive from section 403 of the FD&C 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 FD&C Act and the FPLA.
    The primary user of the information to be disclosed on the label or
labeling of food products is the consumer that purchases the food
product. Consumers will use the information to assist them in making
choices concerning their purchase of a food product, including choices
related to substances that the consumer must avoid to prevent adverse
reactions. This information also enables the consumer to determine the
role of the food product in a healthful diet. Additionally, FDA intends
to use the information to determine whether a manufacturer or other
supplier of food products is meeting its statutory and regulatory
obligations. Failure of a manufacturer or other supplier of food
products to label its products in compliance with section 403 of the
FD& C Act and parts 101, 102, 104, and 105 of FDA's food labeling
regulations may result in a product being misbranded under the FD&C
Act, subjecting the firm and product to regulatory action.
    Description of respondents: The respondents to this collection of
information are manufacturers of beers that are subject to our labeling
laws and regulations.
    We estimate the burden of this collection of information as
follows:

                           Table 1--Estimated Annual Third Party Disclosure Burden \1\
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                                                   Number of
                                   Number of      disclosures    Total annual    Average burden
           Citation               respondents         per         disclosures    per disclosure     Total hours
                                                  respondent
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21 CFR 101.3 and 101.22.......              12               2              24  0.5 (30 minutes)              12
21 CFR 101.4..................              12               2              24  1...............              24
21 CFR 101.5..................              12               2              24  0.25 (15                       6
                                                                                minutes).
21 CFR 101.9..................              12               2              24  4...............              96
21 CFR 101.105................              12               2              24  0.5 (30 minutes)              12
Section 403(w)(1) of the FD&C               12               2              24  1...............              24
 Act.
Guidance document entitled                  12               1              12  1...............              12
 ``Labeling of Certain Beers
 Subject to the Labeling
 Jurisdiction of the Food and
 Drug Administration''.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             186
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimate of the number of respondents in table 1 is based on
the number of regulatory submissions submitted to TTB for beers that do
not meet the definition of a ``malt beverage'' under the FAA Act. Based
on its records of submissions received from manufacturers of such
products, TTB estimates the number of respondents to be 12 and the
number of disclosures annually to be 24. Thus, we adopt TTB's estimate
of 12 respondents, and an annual number of disclosures per respondent
of 2, in table 1 of this document.
    Our estimates of the average burden per disclosure for each
regulation are based on our experience with food labeling under the
Agency's jurisdiction. The estimated average burden per disclosure for
Sec. Sec.  101.3, 101.4, 101.5, 101.9, 101.22, and 101.105 in table 1
are equal to, and based upon, the estimated average burden per
disclosure approved by OMB in OMB control number 0910-0381. We further
estimate that the labeling burden of section 403(w)(1) of the FD&C Act,
which specifies requirements for the declaration of food allergens,
will be 1 hour based upon the similarity of the requirements to that of
Sec.  101.4. Finally, FDA estimates that a respondent will spend 1 hour
reading the guidance document.
    Thus, we estimate that 12 respondents will each label 2 products
annually, for a total of 24 labels. We estimate that the manufacturers
will spend 7.25 hours (0.5 hours + 1 hour + 0.25 hour + 4 hours + 0.5
hour + 1 hour = 7.25 hours) on each label to comply with our labeling
regulations and the requirements of section 403(w)(1) of the FD&C Act,
for a total of 174 hours (24

labels x 7.25 hours = 174 hours). In addition, 12 respondents will each
spend 1 hour reading the guidance document, for a total of 12 hours.
Thus, we estimate the total hour burden of the proposed collection of
information to be 186 hours (174 hours + 12 hours = 186 hours).
    The guidance also refers to previously approved collections of
information found in our regulations. The collections of information in
Sec. Sec.  101.3, 101.4, 101.5, 101.9, 101.22, and 101.105 have been
approved under OMB control number 0910-0381. Allergen labeling of these
beers under section 403(w)(1) of the FD&C Act, which was added by the
Food Allergen Labeling and Consumer Protection Act of 2004, has been
approved under OMB control number 0910-0792.

    Dated: August 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19741 Filed 8-11-15; 8:45 am]
 BILLING CODE 4164-01-P