83 FR 30738 - Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 126 (June 29, 2018)

Page Range		30738-30740
FR Document		2018-14056

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.

Federal Register, Volume 83 Issue 126 (Friday, June 29, 2018)

[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30738-30740]
From the Federal Register Online [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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:
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.
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.thefederalregister.org/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,
PRAStaff@fda.hhs.gov.

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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

30740 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
Number of Total annual Average burden
21 CFR section; activity disclosures Total hours
respondents disclosures per disclosure
per respondent

Guidance document entitled ‘‘Labeling of 12 1 12 1 ................................ 12
Certain Beers Subject to the Labeling
Jurisdiction of the Food and Drug Ad-
ministration’’.

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 186 hours (174 hours + 12 hours = 186 OMB, Attn: FDA Desk Officer, Fax: 202–
collection since our last request for hours). 395–7285, or emailed to oira_
OMB approval, we have made no The guidance also refers to previously submission@omb.eop.gov. All
adjustments to our burden estimate. Our approved collections of information comments should be identified with the
estimate of the number of respondents found in our regulations. The OMB control number 0910–NEW and
is based on the number of regulatory collections of information in §§ 101.3, title ‘‘National Agriculture and Food
submissions to TTB for beers that do not 101.4, 101.5, 101.9, 101.22, and 101.105 Defense Strategy Survey.’’ Also include
meet the definition of a ‘‘malt beverage’’ have been approved under OMB control the FDA docket number found in
under the FAA Act. Based on its records number 0910–0381. Allergen labeling of brackets in the heading of this
of submissions received from these beers under section 403(w)(1) of document.
manufacturers of such products, TTB the FD&C Act, which was added by the
FOR FURTHER INFORMATION CONTACT: Ila
estimates the annual number of Food Allergen Labeling and Consumer
S. Mizrachi, Office of Operations, Food
respondents to be 12 and the annual Protection Act of 2004, has been
and Drug Administration, Three White
number of disclosures to be 24. Thus, approved under OMB control number
Flint North, 10A–12M, 11601
we adopt TTB’s estimate of 12 annual 0910–0792.
Landsdown St., North Bethesda, MD
respondents, and an annual number of Dated: June 22, 2018. 20852, 301–796–7726, PRAStaff@
disclosures per respondent of 2 in table Leslie Kux, fda.hhs.gov.
1. Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: In
Our estimates of the average burden [FR Doc. 2018–14056 Filed 6–28–18; 8:45 am] compliance with 44 U.S.C. 3507, FDA
per disclosure for each collection BILLING CODE 4164–01–P has submitted the following proposed
provision are based on our experience collection of information to OMB for
with food labeling under the Agency’s review and clearance.
jurisdiction. The estimated average DEPARTMENT OF HEALTH AND
burden per disclosure for §§ 101.3, HUMAN SERVICES National Agriculture and Food Defense
101.4, 101.5, 101.9, 101.22, and 101.105 Strategy Survey
in table 1 are equal to, and based upon, Food and Drug Administration
OMB Control Number—0910–NEW
the estimated average burden per [Docket No. FDA–2018–N–1129]
disclosure approved by OMB in OMB We are seeking OMB approval of the
control number 0910–0381. We further Agency Information Collection National Agriculture and Food Defense
Activities; Submission for Office of Strategy (NAFDS) under the FDA Food
estimate that the labeling burden of
Management and Budget Review; Safety Modernization Act (FSMA),
section 403(w)(1) of the FD&C Act,
Comment Request; National section 108. This is a voluntary survey
which specifies requirements for the
Agriculture and Food Defense Strategy of State governments intended to gauge
declaration of food allergens, will be 1
Survey government activities in food and
hour based upon the similarity of the
agriculture defense from intentional
requirements to that of § 101.4. Finally, AGENCY: Food and Drug Administration, contamination and emerging threats.
FDA estimates that a respondent will HHS. The collected information will be
spend 1 hour reading the guidance. ACTION: Notice. included in the mandatory 2019 NAFDS
Thus, we estimate that 12 respondents followup Report to Congress. The
will each label 2 products annually, for SUMMARY: The Food and Drug authority for FDA to collect the
a total of 24 labels. We estimate that the Administration (FDA) is announcing information derives from the
manufacturers will spend 7.25 hours that a proposed collection of Commissioner of Food and Drugs’
(0.5 hours + 1 hour + 0.25 hour + 4 information has been submitted to the authority provided in section
hours + 0.5 hour + 1 hour = 7.25 hours) Office of Management and Budget 1003(d)(2)(c) of the Federal Food, Drug,
on each label to comply with our (OMB) for review and clearance under and Cosmetic Act (21 U.S.C.
labeling regulations and the the Paperwork Reduction Act of 1995. 393(d)(2)(c)).
requirements of section 403(w)(1) of the DATES: Fax written comments on the Protecting the nation’s food and
sradovich on DSK3GMQ082PROD with NOTICES

FD&C Act, for a total of 174 hours (24 collection of information by July 30, agriculture supply against intentional
labels × 7.25 hours = 174 hours). In 2018. contamination and other emerging
addition, 12 respondents will each ADDRESSES: To ensure that comments on threats is an important responsibility
spend 1 hour reading the guidance the information collection are received, shared by Federal, State, local, tribal,
document, for a total of 12 hours. Thus, OMB recommends that written and territorial governments as well as
we estimate the total hour burden of the comments be faxed to the Office of private sector partners. On January 4,
proposed collection of information to be Information and Regulatory Affairs, 2011, the President signed FSMA.

VerDate Sep<11>2014 17:58 Jun 28, 2018 Jkt 244001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\29JNN1.SGM 29JNN1

Document Created: 2018-06-29 01:13:16
Document Modified: 2018-06-29 01:13:16

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by August 28, 2018.
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, [email protected]
FR Citation		83 FR 30738

83 FR 30738 - Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 126 (June 29, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration