FR Doc E9-19640

[Federal Register: August 17, 2009 (Volume 74, Number 157)]
[Notices]
[Page 41438-41440]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au09-86]

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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Draft Guidance for Industry: Labeling of Certain Beers Subject to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availability of a draft guidance document entitled ``Guidance for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 This draft
guidance is being issued in light of the recent ruling by the Alcohol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 FDA, in this draft
guidance, also reminds manufacturers that the labeling of wine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DATES: Submit written or electronic comments on the draft guidance at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ADDRESSES: Submit written comments on this draft guidance, including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