[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30738-30740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14056]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection provisions of 
the recommended labeling of certain beers subject to our labeling 
jurisdiction.

DATES: Submit either electronic or written comments on the collection 
of information by August 28, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 28, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of August 28, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://www.regulations.gov.
    <bullet> 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:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, 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 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Labeling of Certain Beers Subject 
to the Labeling Jurisdiction of the Food and Drug Administration.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
    <bullet> 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
<a href="/cdn-cgi/l/email-protection#8fdfddcedcfbeee9e9cfe9ebeea1e7e7fca1e8e0f9"><span class="__cf_email__" data-cfemail="8cdcdecddff8edeaeacceae8eda2e4e4ffa2ebe3fa">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 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, including 
each proposed extension of an existing 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

[[Page 30739]]

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.

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) (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 (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 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 
information are manufacturers of beers that are subject to our 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
        21 CFR section; activity              Number of      disclosures per    Total annual         Average burden per disclosure         Total hours
                                             respondents       respondent        disclosures
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Sec.  Sec.   101.3 and 101.22...........                12                 2                24  0.5 (30 minutes)......................                12
Sec.   101.4............................                12                 2                24  1.....................................                24
Sec.   101.5............................                12                 2                24  0.25 (15 minutes).....................                 6
Sec.   101.9............................                12                 2                24  4.....................................                96
Sec.   101.105..........................                12                 2                24  0.5 (30 minutes)......................                12
Section 403(w)(1) of the FD&C Act.......                12                 2                24  1.....................................                24

[[Page 30740]]

 
Guidance document entitled ``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: June 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14056 Filed 6-28-18; 8:45 am]
 BILLING CODE 4164-01-P


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