[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Notices]
[Pages 56856-56857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24786]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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: Fax written comments on the collection of information by 
December 14, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0728. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[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.

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 the Federal Food, Drug, and 
Cosmetic Act (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. 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 dissemination and enforcement of regulations 
with respect to the labeling of distilled spirits, certain wines, and 
malt beverages issued in 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 sak[eacute], which is classified 
as a wine under the FAA Act), are not subject to the labeling, 
advertising, or other provisions of TTB regulations issued 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 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.
    Persons with access to the internet may obtain the guidance 
entitled, ``Labeling of Certain Beers Subject to the Labeling 
Jurisdiction of the Food and Drug Administration,'' located at https://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

[[Page 56857]]

information are manufacturers of beers that are subject to our labeling 
laws and regulations.
    In the Federal Register of June 29, 2018 (83 FR 30738), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Two comments were received. One comment was 
unrelated to the Paperwork Reduction Act and is not addressed. The 
second comment was in favor of the practical utility and necessity of 
labeling the ingredients of beer for transparency to the consumer. We 
are appreciative of these comments. At this time, we do not plan on 
adjusting our current estimate.
    FDA estimates 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
          21 CFR section; activity             respondents         per         disclosures         Average  burden per  disclosure         Total  hours
                                                               respondent
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Sec.  Sec.   101.3 and 101.22; principal                 12               2              24  0.5 (30 minutes)...........................              12
 display and display panel.
Sec.   101.4; designation of ingredients...              12               2              24  1..........................................              24
Sec.   101.5; name of manufacturer; packer;              12               2              24  0.25 (15 minutes)..........................               6
 distributor.
Sec.   101.9; nutrition labeling...........              12               2              24  4..........................................              96
Sec.   101.7 (formerly 101.105); quantity                12               2              24  0.5 (30 minutes)...........................              12
 of contents.
Section 403(w)(1) of the FD&C Act..........              12               2              24  1..........................................              24
Review of Guidance Document: ``Labeling of               12               1              12  1..........................................              12
 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.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate. Our estimate of the number of respondents is based on the 
number of regulatory submissions 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 annual number of respondents to be 12 and the annual 
number of disclosures to be 24. Thus, we adopt TTB's estimate of 12 
annual respondents, and an annual number of disclosures per respondent 
of 2 in table 1.
    Our estimates of the average burden per disclosure for each 
collection provision 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.
    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: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24786 Filed 11-13-18; 8:45 am]
 BILLING CODE 4164-01-P