Notice2021-25300
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 19, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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.
Full Text
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<title>Federal Register, Volume 86 Issue 221 (Friday, November 19, 2021)</title>
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[Federal Register Volume 86, Number 221 (Friday, November 19, 2021)]
[Notices]
[Pages 64941-64943]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-25300]
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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, Agency, or we) 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: Submit written comments (including recommendations) on the
collection of information by December 20, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0728. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
<a href="/cdn-cgi/l/email-protection#38686a796b4c595e5e785e5c591650504b165f574e"><span class="__cf_email__" data-cfemail="2e7e7c6f7d5a4f48486e484a4f0046465d00494158">[email protected]</span></a>.
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 (FD&C Act (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
[[Page 64942]]
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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-labeling-certain-beers-subject-labeling-jurisdiction-food-and-drug-administration">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-labeling-certain-beers-subject-labeling-jurisdiction-food-and-drug-administration</a>. 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.
In the Federal Register of May 21, 2021 (86 FR 27631), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received two comments pertaining to the
necessity and practical utility of the information being collected and
the accuracy of our burden estimate.
(Comment 1) One comment questioned the necessity and practical
utility of treating beer as a ``food'' making it subject to food
labeling regulations. A related comment questioned the need to label
beer at all.
(Response) As stated in the guidance as well in the above-
referenced 60-day notice, the definition of ``food'' under the FD&C Act
(see 21 U.S.C. 321(f)), includes ``articles used for food or drink''
and thus includes alcoholic beverages. 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 are administered by
FDA. In addition, as provided for under the FPLA, alcoholic beverages
that are not covered by the labeling provisions of the FAA Act are
subject to the provisions of the FPLA, which is administered by FDA.
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 FDA's implementing regulations. In general, FDA
requires that food products under its jurisdiction be truthfully and
informatively labeled in accordance with the FD&C Act, the FPLA, and
FDA's regulations.
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.
(Comment 2) One comment argued that the burden estimate
underestimated the number of respondents affected by this collection.
(Response) This collection of information applies to alcoholic
beverages not covered by the labeling provisions of the FAA Act. 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.
We estimate the burden of this collection of information as
follows:
[[Page 64943]]
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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101.3 and 101.22; statement of identity 12 2 24 0.5 (30 minutes)........................ 12
labeling requirements.
101.4; ingredient labeling requirements..... 12 2 24 1....................................... 24
101.5; requirement to specify the name and 12 2 24 0.25 (15 minutes)....................... 6
place of business of the manufacturer,
packer, or distributor.
101.9; labeling requirements for disclosure 12 2 24 4....................................... 96
of nutrition information.
101.7; declaration of net quantity of 12 2 24 0.5 (30 minutes)........................ 12
contents.
Section 403(w)(1) of the FD&C Act; 12 2 24 1....................................... 24
declaration of food allergens.
Guidance document entitled ``Labeling of 12 1 12 1....................................... 12
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.
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.
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 101.7
(21 CFR 101.3, 101.4, 101.5, 101.9, 101.22, and 101.7) are equal to,
and based upon, the estimated average burden per disclosure approved by
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, we estimate that a respondent will spend 1 hour reading the
guidance.
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 101.7 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: November 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25300 Filed 11-18-21; 8:45 am]
BILLING CODE 4164-01-P
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