[Federal Register Volume 77, Number 142 (Tuesday, July 24, 2012)]
[Notices]
[Pages 43335-43337]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18028]


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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 (the PRA).

DATES: Fax written comments on the collection of information by August 
23, 2012.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-New and 
title ``Labeling of Certain Beers Subject to the Labeling Jurisdiction 
of the Food and Drug Administration.'' Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, domini.bean@fda.hhs.gov.

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-New)

I. Background

    In the Federal Register of August 17, 2009 (74 FR 41438) (the 
August 17, 2009, notice), FDA published a notice of availability of the 
draft guidance document entitled ``Labeling of Certain Beers Subject to 
the Labeling Jurisdiction of the Food and Drug Administration'' (the 
draft guidance). Persons with access to the Internet may obtain the 
draft guidance at http://www.fda.gov/FoodGuidances. This guidance, when 
finalized, will provide industry with information on how to label beers 
that are subject to FDA's labeling laws and regulations. This draft 
guidance was issued in light of the ruling by the Alcohol and Tobacco 
Tax and Trade Bureau (TTB) (formerly The Bureau of Alcohol, Tobacco, 
and Firearms (ATF)) clarifying that certain beers do not meet the 
definition of a ``malt beverage'' under the Federal Alcohol 
Administration Act (the FAA Act). Because these beers are not subject 
to the labeling provisions of the FAA Act, they are subject to the 
labeling provisions of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) and the Fair Packaging and Labeling Act (FPLA). FDA, in the 
draft guidance, also reminds manufacturers that the labeling of wine 
beverages containing less than 7 percent alcohol by volume, such as 
wine coolers, diluted wine beverages, dealcoholized or partially 
dealcoholized wine and ciders, is also subject to FDA labeling 
requirements.
    As reflected in the 1987 Memorandum of Understanding between FDA 
and TTB's predecessor Agency, the ATF (Ref. 1), TTB is responsible for 
the issuance and enforcement of regulations with respect

[[Page 43336]]

to the labeling of distilled spirits, wines, and malt beverages under 
the FAA Act.
    The TTB has 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. 
(See TTB Ruling 2008-3.) (Ref. 2). 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, and other provisions 
of the TTB regulations issued under the FAA Act. Therefore, these beers 
are subject to the labeling requirements under FDA's regulations. 
However, as explained in the TTB ruling, 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.
    The guidance is intended to assist manufacturers in labeling beers 
that are subject to FDA's labeling laws and regulations. In general, 
FDA requires that food products under its labeling jurisdiction be 
truthfully and informatively labeled in accordance with the FD&C Act 
and the FPLA, and FDA's implementing regulations. These FDA labeling 
requirements are explained in the guidance document.
    In the August 17, 2009, notice, FDA published a request for public 
comment on the proposed collection of information. FDA received one 
letter in response to the notice, containing multiple comments. Several 
comments in this letter were generally supportive of FDA's information 
collection provisions in the guidance. Additional comments were outside 
the scope of the four collection of information topics on which the 
notice solicits comments and will not be discussed in this document.
    (Comment 1) One comment stated that FDA should require alcohol 
content labeling for the beers discussed in the guidance, including the 
percent alcohol by volume (%ABV); the amount of alcohol (in fluid 
ounces (oz) or grams) per serving; the definition of a ``standard 
drink'' (i.e., 12 fluid oz of regular beer, 5 fluid oz of wine, or 1.5 
fluid oz of 80-proof distilled spirits); the number of standard drinks 
per container; and, the advice on moderate drinking, such as ``The 
Dietary Guidelines for Americans recommends no more than one drink per 
day for women, two drinks per day for men.'' The comment stated that 
when a consumer sees a beverage such as ``sorghum beer'' or ``wheat 
beer'' labeled the same way that all other FDA regulated beverages are 
labeled, the consumer may not know that it is an alcoholic beverage.
    (Response) FDA appreciates the concerns discussed in the comment. 
As explained in the guidance, certain TTB labeling requirements apply 
to these products. For example, these non-malt beers, like all alcohol 
beverages, are required to bear the health warning statement under the 
Alcoholic Beverage Labeling Act (27 U.S.C. 213-215). FDA's guidance 
documents do not establish legally enforceable requirements, and 
therefore cannot include mandatory language such as ``shall, must, 
required, or requirement'' unless specific regulatory or statutory 
requirements are cited. To the extent that the comment requests FDA to 
engage in rulemaking, the comment is outside the scope of the comment 
request on the four collection of information topics as they relate to 
the provisions of the draft guidance document.
    The guidance is intended to assist manufacturers in labeling beers 
that are subject to FDA's labeling laws and regulations. All labeling 
regulations discussed in this guidance have been previously approved by 
OMB in accordance with the PRA under OMB control number 0910-0381. The 
regulations approved under OMB control number 0910-0381 include 
Sec. Sec.  101.3, 101.4, 101.5, 101.9, 101.22, and 101.105 (21 CFR 
101.3, 101.4, 101.5, 101.9, 101.22, and 101.105). The proposed 
information collection seeks to add manufacturers of certain beers that 
do not meet the definition of a ``malt beverage'' under the FAA Act as 
new respondents to these labeling regulations. The proposed information 
collection also seeks OMB approval of allergen labeling of these beers 
under section 403(w)(1) of the FD&C Act (21 U.S.C. 343(w)(1)), which 
was added by the Food Allergen Labeling and Consumer Protection Act of 
2004 (FALCPA).
    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 the 
requirements for the declaration of ingredients on the label or 
labeling of food products in packaged form, including using the common 
or usual name of each ingredient. 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 101.22 contains labeling requirements 
for the disclosure of spices, flavorings, colorings, and chemical 
preservatives (Sec.  101.22(j)) in food products. Section 101.105 
specifies requirements for the declaration of the net quantity of 
contents on the label of a food in packaged form.
    Under the FD&C Act, as amended by the FALCPA, the food source name 
of any ``major food allergen'' present must be declared (section 
403(w)(1) of the FD&C Act). Section 201(qq) of the FD&C Act, (21 U.S.C. 
321(qq)), defines ``major food allergen'' as milk, egg, fish, 
Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well 
as any food ingredient that contains protein derived from one of them, 
with the exception of highly refined oils.
    Description of respondents: The respondents to this collection of 
information are manufacturers of beers that are subject to FDA's 
labeling laws and regulations.
    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   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               12
21 CFR 101.4....................              12               2              24            1                 24
21 CFR 101.5....................              12               2              24            0.25               6
21 CFR 101.9....................              12               2              24            4                 96

[[Page 43337]]

 
21 CFR 101.105..................              12               2              24            0.5               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''..........
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    Total.......................  ..............  ..............  ..............  ..............             186
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's 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, FDA adopts TTB's 
estimate of 12 respondents, and an annual number of disclosures per 
respondent of 2, in table 1 of this document.
    FDA's estimate of the average burden per disclosure for each 
regulation are based on FDA's 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. FDA further 
estimates 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, FDA estimates that 12 respondents will each label 2 products 
annually, for a total of 24 labels. FDA estimates 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 
FDA's 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, FDA estimates the 
total hour burden of the proposed collection of information to be 186 
hours (174 hours + 12 hours = 186 hours).
    The draft guidance also refers to previously approved collections 
of information found in FDA 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.

II. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but we are not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)
    1. Memorandum of Understanding 225-88-2000 between FDA and Bureau 
of Alcohol, Tobacco and Firearms, available at http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm116370.htm.
    2. TTB Ruling 2008-3 dated July 7, 2008, available at http://www.ttb.gov/rulings/2008-3.pdf.

    Dated: July 16, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18028 Filed 7-23-12; 8:45 am]
BILLING CODE 4160-01-P