[Federal Register Volume 74, Number 157 (Monday, August 17, 2009)]
[Notices]
[Pages 41438-41440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19640]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry: Labeling of Certain Beers Subject to 
the Labeling Jurisdiction of the Food and Drug Administration; 
Availability; Agency Information Collection Activities; Proposed 
Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance document entitled ``Guidance for 
Industry: Labeling of Certain Beers Subject to the Labeling 
Jurisdiction of the Food and Drug Administration.'' 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 This draft 
guidance is being issued in light of the recent ruling by the Alcohol 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 (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 (FD&C 
Act) and the Fair Packaging and Labeling Act (FPLA). FDA, in this draft 
guidance, also reminds manufacturers that the labeling of wine 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. FDA is also announcing an opportunity for public comment 
on the proposed collection of certain information by the agency.

DATES: Submit written or electronic comments on the draft guidance at 
any time. Submit written or electronic comments on the proposed 
collection of information by October 16, 2009.

ADDRESSES: Submit written comments on this draft guidance, including 
comments regarding the proposed collection of information, to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments on the draft guidance, including comments regarding the 
proposed collection of information, to http://www.regulations.gov. 
Submit written requests for single copies of the draft guidance to 
Office of Nutrition, Labeling and Dietary Supplements, Center for Food 
Safety and Applied Nutrition (HFS-800), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:
    With regard to the draft guidance: Loretta A. Carey, Center for 
Food Safety and Applied Nutrition (HFS-820), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2371.
    With regard to the proposed collection of information: Jonna 
Capezzuto, Office of Information Management (HFA-710), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3794.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of the draft guidance entitled 
``Guidance for Industry: Labeling of Certain Beers Subject to the 
Labeling Jurisdiction of the Food and Drug Administration.'' This 
guidance, when finalized, will provide industry with information on how 
to label beers that are subject to FDA's labeling laws and regulations. 
FDA, in this 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 (Ref. 1).
    As reflected in the 1987 Memorandum of Understanding between FDA 
and TTB's predecessor agency, the ATF (Ref. 2), TTB is responsible for 
the issuance and enforcement of regulations with respect to the 
labeling of distilled spirits, wines, and malt beverages under the FAA 
Act.
    TTB recently 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. 3). 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 laws and 
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.
    This draft 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 draft guidance document.

[[Page 41439]]

    FDA is issuing this draft guidance as a level 2 guidance consistent 
with FDA's good guidance practices regulation (21 CFR 10.115). This 
draft guidance represents the agency's current thinking on this topic. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of the applicable 
statues and regulations.

II. Paperwork Reduction Act of 1995

    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 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, when 
appropriate, and other forms of information technology.

Title: Labeling of Certain Beers Subject to the Labeling Jurisdiction 
of the Food and Drug Administration (OMB Control Number 0910-NEW)

    This draft 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 draft guidance have been 
previously approved by OMB in accordance with the PRA under OMB Control 
No. 0910-0381. The regulations approved under OMB Control No. 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, (21 U.S.C. 343(w)(1))). 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 Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
     Citation         Respondents        per Response        Responses           Response         Total Hours
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21 CFR 101.3 and                  12                  2                 24                 .5                 12
 101.22
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21 CFR 101.4                      12                  2                 24                  1                 24
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21 CFR 101.5                      12                  2                 24               0.25                  6
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21 CFR 101.9                      12                  2                 24                  4                 96
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21 CFR 101.105                    12                  2                 24                0.5                 12
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Section 403(w)(1)                 12                  2                 24                  1                 24
 of the Federal
 Food, Drug, and
 Cosmetic Act
----------------------------------------------------------------------------------------------------------------
Guidance                          12                  1                 12                  1                 12
 Document,
 ``Labeling of
 Certain Beers
 Subject to the
 Labeling
 Jurisdiction of
 the Food and
 Drug
 Administration''
----------------------------------------------------------------------------------------------------------------

[[Page 41440]]

 
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 submissions annually to be 25. Thus, FDA adopts TTB's 
estimate of 12 respondents, and an annual frequency per response of 2, 
in table 1 of this document.
    FDA's estimate of the hours per response for each regulation is 
based on FDA's experience with food labeling under the agency's 
jurisdiction. The estimated hours per response for Sec. Sec.  101.3, 
101.4, 101.5, 101.9, 101.22, and 101.105 in table 1 of this document 
are equal to, and based upon, the estimated hours per response approved 
by OMB in OMB Control No. 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, once finalized.
    Thus, FDA estimates that 12 respondents will each label two 
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), 
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).
    Before the proposed information collection provisions contained in 
this draft guidance become effective, FDA will publish a notice in the 
Federal Register announcing OMB's decision to approve, modify, or 
disapprove the information collection provisions. An agency may not 
conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB 
control number.
    This 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 No. 0910-0381.

III. Comments

    Interested persons may submit written or electronic comments 
regarding this draft guidance document, including comments regarding 
the proposed collection of information. Written comments should be 
submitted to the Division of Dockets Management (see ADDRESSES). 
Electronic comments should be submitted to http://www.regulations.gov. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at http://www.fda.gov/FoodGuidances.

V. References

    We have placed the following references on display in the Division 
of Dockets Management (see ADDRESSES). The references may be seen 
between 9 a.m. and 4 p.m., Monday through Friday. FDA has verified the 
Web site addresses, but it is not responsible for any subsequent 
changes to the Web site addresses after this document publishes in the 
Federal Register.
    1. FDA Compliance Policy Guide (CPG) 7101.04 (Dealcoholized Wine 
and Malt Beverages- Labeling), available at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074430.htm 
and CPG 7101.05 (Labeling --Diluted Wines and Cider with Less Than 
7% Alcohol), available at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074431.htm.
    2. 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.
    3. TTB Ruling 2008-3 dated July 7, 2008, available at http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm116370.htm.

    Dated: August 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19640 Filed 8-14-09; 8:45 am]
BILLING CODE 4160-01-S