[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Pages 66539-66541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27588]


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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 of availability.

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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 
November 30, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2009-D-0268. Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

[[Page 66540]]

    Submit comments on information collection issues to the Office of 
Management and Budget in the following ways:
     Fax to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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 (the FD&C Act), includes ``articles used for food or 
drink'' and thus includes alcoholic beverages. See 21 U.S.C. 321(f). 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 (MOU) 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 (the 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 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 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.
    In the Federal Register of August 12, 2015 (80 FR 48322), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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:

[[Page 66541]]



                           Table 1--Estimated Annual Third Party Disclosure Burden \1\
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                                                     Number of
            Reference                Number of      disclosures    Total annual     Avg. burden     Total hours
                                    respondents   per respondent    disclosures   per disclosure
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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
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.

    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. We adopt TTB's estimate of 12 annual respondents, 
and estimate an annual number of 2 disclosures per respondent, as 
reflected in table 1 above.
    Our estimate of the average burden per disclosure for each 
collection provision is based on our experience with food labeling 
under our 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 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 (21 U.S.C. 343(w)(1)), which was added by the Food Allergen 
Labeling and Consumer Protection Act of 2004 (FALCPA), has been 
approved under OMB control number 0910-0792.

    Dated: October 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27588 Filed 10-28-15; 8:45 am]
 BILLING CODE 4164-01-P