
[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Pages 48322-48324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, PRAStaff@fda.hhs.gov.

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

[[Page 48323]]

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

[[Page 48324]]

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


