Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration, 27631-27633 [2021-10750]
Download as PDF
<![CDATA[
Federal Register / Vol. 86, No. 97 / Friday, May 21, 2021 / Notices
Topic
801, subpart B, and 830 ...........................
800, 801, and 809 ....................................
Unique Device Identification ........................................................................................
Medical Device Labeling Regulations ..........................................................................
[FR Doc. 2021–10752 Filed 5–20–21; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA, Agency, or we) 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 July 20, 2021.
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 July 20, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 20, 2021. 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.
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
OMB
control No.
21 CFR part
Dated: May 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
VerDate Sep<11>2014
17:15 May 20, 2021
Jkt 253001
Electronic Submissions
Submit electronic comments in the
following way:
• 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.
• 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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• 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
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
27631
0910–0720
0910–0485
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
E:\FR\FM\21MYN1.SGM
21MYN1
27632
Federal Register / Vol. 86, No. 97 / Friday, May 21, 2021 / Notices
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
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
jbell on DSKJLSW7X2PROD with NOTICES
OMB Control Number 0910–0728—
Extension
The definition of ‘‘food’’ under the
Federal Food, Drug, and Cosmetic Act
(the 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
VerDate Sep<11>2014
17:15 May 20, 2021
Jkt 253001
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
sake´, 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.
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
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.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\21MYN1.SGM
21MYN1
Federal Register / Vol. 86, No. 97 / Friday, May 21, 2021 / Notices
27633
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR part; activity
Total
annual
disclosures
Average
burden per
disclosure
Total hours
§§ 101.3 and 101.22; statement of identity labeling
requirements.
§ 101.4; ingredient labeling requirements ...................
§ 101.5; requirement to specify the name and place
of business of the manufacturer, packer, or distributor.
§ 101.9; labeling requirements for disclosure of nutrition information.
§ 101.7; declaration of net quantity of contents ..........
Section 403(w)(1) of the FD&C Act; declaration of
food allergens.
Guidance document entitled ‘‘Labeling of Certain
Beers Subject to the Labeling Jurisdiction of the
Food and Drug Administration’’.
12
2
24
0.5 (30 minutes) .....
12
12
12
2
2
24
24
1 .............................
0.25 (15 minutes) ...
24
6
12
2
24
4 .............................
96
12
12
2
2
24
24
0.5 (30 minutes) .....
1 .............................
12
24
12
1
12
1 .............................
12
Total ......................................................................
........................
........................
........................
................................
186
1 There
jbell on DSKJLSW7X2PROD with NOTICES
Number of
disclosures
per
respondent
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 §§ 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 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 § 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 §§ 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
VerDate Sep<11>2014
17:15 May 20, 2021
Jkt 253001
approved under OMB control number
0910–0792.
Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10750 Filed 5–20–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–3764]
Demonstrating Bioequivalence for
Soluble Powder Oral Dosage Form
Products and Type A Medicated
Articles Containing Active
Pharmaceutical Ingredients
Considered To Be Soluble in Aqueous
Media; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a final
guidance for industry (GFI) #171
entitled ‘‘Demonstrating Bioequivalence
for Soluble Powder Oral Dosage Form
Products and Type A Medicated
Articles Containing Active
Pharmaceutical Ingredients Considered
To Be Soluble in Aqueous Media.’’ This
guidance describes how the Agency
intends to evaluate requests for waiving
the requirement for performing in vivo
bioequivalence studies for animal drugs
administered orally as soluble powders
or as Type A medicated articles
SUMMARY:
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
manufactured from active
pharmaceutical ingredients considered
to be soluble in aqueous media.
The announcement of the
guidance is published in the Federal
Register on May 21, 2021.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• 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.
• 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’’).
E:\FR\FM\21MYN1.SGM
21MYN1
]]>Agencies
[Federal Register Volume 86, Number 97 (Friday, May 21, 2021)]
[Notices]
[Pages 27631-27633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10750]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 July 20, 2021.
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 July 20, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 20, 2021. 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:
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.
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
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,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of
[[Page 27632]]
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 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 (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.
We estimate the burden of this collection of information as
follows:
[[Page 27633]]
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part; activity Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. Sec. 101.3 and 101.22; statement of 12 2 24 0.5 (30 minutes)......................... 12
identity labeling requirements.
Sec. 101.4; ingredient labeling 12 2 24 1........................................ 24
requirements.
Sec. 101.5; requirement to specify the name 12 2 24 0.25 (15 minutes)........................ 6
and place of business of the manufacturer,
packer, or distributor.
Sec. 101.9; labeling requirements for 12 2 24 4........................................ 96
disclosure of nutrition information.
Sec. 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''.
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 186
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
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, 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: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10750 Filed 5-20-21; 8:45 am]
BILLING CODE 4164-01-P
