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, 66539-66541 [2015-27588]
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Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices
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. This information
collection is the SBIR Application
Package. To comply with this
requirement, ACL/NIDILRR published a
notice of the proposed collection of
information set forth in this document,
inviting comment on: (1) Whether the
proposed collection of information is
necessary for the proper performance of
ACL/NIDILRR’s functions, including
whether the information will have
practical utility; (2) the accuracy of
ACL/NIDILRR’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. NIDILRR
received one comment asking for more
information on the method by which it
calculated burden. The Application
Package, including instructions and
forms, has been in continuous use with
minor modifications since it was first
approved by OMB in FY2012. This
request is for approval to extent the
current form and instructions, with
minor modifications to change the
sponsoring agency from Department of
Education to Department of Health and
Human Services (per requirement of the
Workforce Innovation Opportunity Act)
for three years, covering the FY 2015–
2017 reporting periods.
Dated: October 23, 2015.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2015–27512 Filed 10–28–15; 8:45 am]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0268]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Labeling of Certain
Beers Subject to the Labeling
Jurisdiction of the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
30, 2015.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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): Division of
Dockets Management (HFA–305), Food
VerDate Sep<11>2014
23:37 Oct 28, 2015
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66539
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2009–D–0268. Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to 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 Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
E:\FR\FM\29OCN1.SGM
29OCN1
66540
Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices
Submit comments on information
collection issues to the Office of
Management and Budget in the
following ways:
• Fax to the Office of Information and
Regulatory Affairs, OMB, Attn: FDA
Desk Officer, FAX: 202–395–7285, or
email to oira_submission@omb.eop.gov.
All comments should be identified with
the OMB control number 0910–0728.
Also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Labeling of Certain Beers Subject to the
Labeling Jurisdiction of the Food and
Drug Administration—OMB Control
Number 0910–0728—Extension
The definition of ‘‘food’’ under the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act), includes ‘‘articles used
for food or drink’’ and thus includes
alcoholic beverages. See 21 U.S.C.
321(f). As such, alcoholic beverages are
subject to the FD&C Act’s adulteration
and misbranding provisions, and
implementing regulations, related to
food. For example, manufacturers of
alcoholic beverages are responsible for
adhering to the registration of food
facilities requirements in 21 CFR part 1
and to the good manufacturing practice
regulations in 21 CFR part 110. There
are also certain requirements for
nutrition labeling on menus, menu
boards, and other written materials for
alcohol beverages served in restaurants
or similar retail food establishments in
21 CFR part 101 (79 FR 71156
(December 1, 2014)). However, as
reflected in a 1987 Memorandum of
Understanding (MOU) between FDA
and the Alcohol and Tobacco Tax and
Trade Bureau (TTB), TTB is responsible
for the dissemination and enforcement
of regulations with respect to the
labeling of distilled spirits, certain
wines, and malt beverages issued in the
Federal Alcohol Administration Act (the
VerDate Sep<11>2014
23:37 Oct 28, 2015
Jkt 238001
FAA Act). In TTB Ruling 2008–3, dated
July 7, 2008, TTB clarified that certain
beers, which are not made from both
malted barley and hops but are instead
made from substitutes for malted barley
(such as sorghum, rice, or wheat) or are
made without hops, do not meet the
definition of a ‘‘malt beverage’’ under
the FAA Act. Accordingly, TTB stated
in its Ruling that such products (other
than sake, which is classified as a wine
under the FAA Act), are not subject to
the labeling, advertising, or other
provisions of the TTB regulations issued
under the FAA Act.
In cases where an alcoholic beverage
is not covered by the labeling provisions
of the FAA Act, the product is subject
to ingredient and other labeling
requirements under the FD&C Act and
the implementing regulations that we
administer. In addition, as provided for
under the Fair Packaging and Labeling
Act (FPLA), alcoholic beverages that are
not covered by the labeling provisions
of the FAA Act are subject to the
provisions of the FPLA, which we
administer.
Therefore, the beers described in the
TTB’s Ruling as not being a ‘‘malt
beverage’’ are subject to the labeling
requirements under the FD&C Act and
FPLA, and our implementing
regulations. In general, we require that
food products under our jurisdiction be
truthfully and informatively labeled in
accordance with the FD&C Act, the
FPLA, and FDA’s regulations.
Furthermore, some TTB labeling
requirements, such as the Government
Health Warning Statement under the
Alcoholic Beverage Labeling Act and
certain marking requirements under the
Internal Revenue Code, continue to
apply to these products.
In the Federal Register of December
23, 2014 (79 FR 77013), we announced
the availability of a guidance entitled,
‘‘Labeling of Certain Beers Subject to the
Labeling Jurisdiction of the Food and
Drug Administration.’’ Persons with
access to the Internet may obtain the
guidance at 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
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Fmt 4703
Sfmt 4703
issued under the authority of sections 4,
5, and 6 of the FPLA (15 U.S.C. 1453,
1454, and 1455) and under sections 201,
301, 402, 403, 409, 411, 701, and 721 of
the FD&C Act (21 U.S.C. 321, 331, 342,
343, 348, 350, 371, and 379e). Most of
these regulations derive from section
403 of the FD&C Act, which provides
that a food product shall be deemed to
be misbranded if, among other things,
its label or labeling fails to bear certain
required information concerning the
food product, is false or misleading in
any particular, or bears certain types of
unauthorized claims. The disclosure
requirements and other collections of
information in the regulations in parts
101, 102, 104, and 105 are necessary to
ensure that food products produced or
sold in the United States are in
compliance with the labeling provisions
of the FD&C Act and the FPLA.
The primary user of the information
to be disclosed on the label or labeling
of food products is the consumer that
purchases the food product. Consumers
will use the information to assist them
in making choices concerning their
purchase of a food product, including
choices related to substances that the
consumer must avoid to prevent adverse
reactions. This information also enables
the consumer to determine the role of
the food product in a healthful diet.
Additionally, FDA intends to use the
information to determine whether a
manufacturer or other supplier of food
products is meeting its statutory and
regulatory obligations. Failure of a
manufacturer or other supplier of food
products to label its products in
compliance with section 403 of the FD&
C Act and parts 101, 102, 104, and 105
of FDA’s food labeling regulations may
result in a product being misbranded
under the FD&C Act, subjecting the firm
and product to regulatory action.
In the Federal Register of August 12,
2015 (80 FR 48322), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
Description of Respondents: The
respondents to this collection of
information are manufacturers of beers
that are subject to our labeling laws and
regulations.
We estimate the burden of this
collection of information as follows:
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66541
Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
Number of
respondents
Reference
Number of
disclosures
per
respondent
Total annual
disclosures
Avg. burden
per disclosure
Total hours
21 CFR 101.3 and 101.22 ...................................................
21 CFR 101.4 ......................................................................
21 CFR 101.5 ......................................................................
21 CFR 101.9 ......................................................................
21 CFR 101.105 ..................................................................
Section 403(w)(1) of the FD&C Act .....................................
Guidance document entitled ‘‘Labeling of Certain Beers
Subject to the Labeling Jurisdiction of the Food and
Drug Administration’’ ........................................................
12
12
12
12
12
12
2
2
2
2
2
2
24
24
24
24
24
24
0.5
1
0.25
4
0.5
1
12
24
6
96
12
24
12
1
12
1
12
Total ..............................................................................
........................
........................
........................
........................
186
asabaliauskas on DSK5VPTVN1PROD with NOTICES
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate of the number of
respondents is based on the number of
regulatory submissions to TTB for beers
that do not meet the definition of a
‘‘malt beverage’’ under the FAA Act.
Based on its records of submissions
received from manufacturers of such
products, TTB estimates the annual
number of respondents to be 12 and the
annual number of disclosures to be 24.
We adopt TTB’s estimate of 12 annual
respondents, and estimate an annual
number of 2 disclosures per respondent,
as reflected in table 1 above.
Our estimate of the average burden
per disclosure for each collection
provision is based on our experience
with food labeling under our
jurisdiction. The estimated average
burden per disclosure for §§ 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 § 101.4. Finally,
FDA estimates that a respondent will
spend 1 hour reading the guidance
document.
Thus, we estimate that 12 respondents
will each label 2 products annually, for
a total of 24 labels. We estimate that the
manufacturers will spend 7.25 hours
(0.5 hours + 1 hour + 0.25 hour + 4
hours + 0.5 hour + 1 hour = 7.25 hours)
on each label to comply with our
labeling regulations and the
requirements of section 403(w)(1) of the
FD&C Act, for a total of 174 hours (24
labels × 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
VerDate Sep<11>2014
23:37 Oct 28, 2015
Jkt 238001
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
§§ 101.3, 101.4, 101.5, 101.9, 101.22,
and 101.105 have been approved under
OMB control number 0910–0381.
Allergen labeling of these beers under
section 403(w)(1) of the FD&C Act (21
U.S.C. 343(w)(1)), which was added by
the Food Allergen Labeling and
Consumer Protection Act of 2004
(FALCPA), has been approved under
OMB control number 0910–0792.
Dated: October 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–27588 Filed 10–28–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2033]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Survey on Occurrence of Foodborne
Illness Risk Factors in Selected
Institutional Foodservice and Retail
Food Stores Facility Types
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On June
25, 2015, the Agency submitted a
proposed collection of information
entitled ‘‘Survey on Occurrence of
Foodborne Illness Risk Factors in
Selected Institutional Foodservice and
Retail Food Stores Facility Types’’ to
OMB for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0799. The
approval expires on December 31, 2016.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: October 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–27556 Filed 10–28–15; 8:45 am]
BILLING CODE 4164–01–P
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Survey on Occurrence of Foodborne
Illness Risk Factors in Selected
Institutional Foodservice and Retail
Food Stores Facility Types’’ has been
approved by the Office of Management
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Pages 66539-66541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27588]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0268]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Labeling of Certain
Beers Subject to the Labeling Jurisdiction of the Food and Drug
Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 30, 2015.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2009-D-0268. Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to 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 Division of Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
[[Page 66540]]
Submit comments on information collection issues to the Office of
Management and Budget in the following ways:
Fax to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to
oira_submission@omb.eop.gov. All comments should be identified with the
OMB control number 0910-0728. Also include the FDA docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Labeling of Certain Beers Subject to the Labeling Jurisdiction of the
Food and Drug Administration--OMB Control Number 0910-0728--Extension
The definition of ``food'' under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), includes ``articles used for food or
drink'' and thus includes alcoholic beverages. See 21 U.S.C. 321(f). As
such, alcoholic beverages are subject to the FD&C Act's adulteration
and misbranding provisions, and implementing regulations, related to
food. For example, manufacturers of alcoholic beverages are responsible
for adhering to the registration of food facilities requirements in 21
CFR part 1 and to the good manufacturing practice regulations in 21 CFR
part 110. There are also certain requirements for nutrition labeling on
menus, menu boards, and other written materials for alcohol beverages
served in restaurants or similar retail food establishments in 21 CFR
part 101 (79 FR 71156 (December 1, 2014)). However, as reflected in a
1987 Memorandum of Understanding (MOU) between FDA and the Alcohol and
Tobacco Tax and Trade Bureau (TTB), TTB is responsible for the
dissemination and enforcement of regulations with respect to the
labeling of distilled spirits, certain wines, and malt beverages issued
in the Federal Alcohol Administration Act (the FAA Act). In TTB Ruling
2008-3, dated July 7, 2008, TTB clarified that certain beers, which are
not made from both malted barley and hops but are instead made from
substitutes for malted barley (such as sorghum, rice, or wheat) or are
made without hops, do not meet the definition of a ``malt beverage''
under the FAA Act. Accordingly, TTB stated in its Ruling that such
products (other than sake, which is classified as a wine under the FAA
Act), are not subject to the labeling, advertising, or other provisions
of the TTB regulations issued under the FAA Act.
In cases where an alcoholic beverage is not covered by the labeling
provisions of the FAA Act, the product is subject to ingredient and
other labeling requirements under the FD&C Act and the implementing
regulations that we administer. In addition, as provided for under the
Fair Packaging and Labeling Act (FPLA), alcoholic beverages that are
not covered by the labeling provisions of the FAA Act are subject to
the provisions of the FPLA, which we administer.
Therefore, the beers described in the TTB's Ruling as not being a
``malt beverage'' are subject to the labeling requirements under the
FD&C Act and FPLA, and our implementing regulations. In general, we
require that food products under our jurisdiction be truthfully and
informatively labeled in accordance with the FD&C Act, the FPLA, and
FDA's regulations. Furthermore, some TTB labeling requirements, such as
the Government Health Warning Statement under the Alcoholic Beverage
Labeling Act and certain marking requirements under the Internal
Revenue Code, continue to apply to these products.
In the Federal Register of December 23, 2014 (79 FR 77013), we
announced the availability of a guidance entitled, ``Labeling of
Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug
Administration.'' Persons with access to the Internet may obtain the
guidance at 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.
In the Federal Register of August 12, 2015 (80 FR 48322), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
Description of Respondents: The respondents to this collection of
information are manufacturers of beers that are subject to our labeling
laws and regulations.
We estimate the burden of this collection of information as
follows:
[[Page 66541]]
Table 1--Estimated Annual Third Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Reference Number of disclosures Total annual Avg. burden Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
21 CFR 101.3 and 101.22......... 12 2 24 0.5 12
21 CFR 101.4.................... 12 2 24 1 24
21 CFR 101.5.................... 12 2 24 0.25 6
21 CFR 101.9.................... 12 2 24 4 96
21 CFR 101.105.................. 12 2 24 0.5 12
Section 403(w)(1) of the FD&C 12 2 24 1 24
Act............................
Guidance document entitled 12 1 12 1 12
``Labeling of Certain Beers
Subject to the Labeling
Jurisdiction of the Food and
Drug Administration''..........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 186
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimate of the number of respondents is based on the number of
regulatory submissions to TTB for beers that do not meet the definition
of a ``malt beverage'' under the FAA Act. Based on its records of
submissions received from manufacturers of such products, TTB estimates
the annual number of respondents to be 12 and the annual number of
disclosures to be 24. We adopt TTB's estimate of 12 annual respondents,
and estimate an annual number of 2 disclosures per respondent, as
reflected in table 1 above.
Our estimate of the average burden per disclosure for each
collection provision is based on our experience with food labeling
under our jurisdiction. The estimated average burden per disclosure for
Sec. Sec. 101.3, 101.4, 101.5, 101.9, 101.22, and 101.105 in table 1
are equal to, and based upon, the estimated average burden per
disclosure approved by OMB in OMB control number 0910-0381. We further
estimate that the labeling burden of section 403(w)(1) of the FD&C Act,
which specifies requirements for the declaration of food allergens,
will be 1 hour based upon the similarity of the requirements to that of
Sec. 101.4. Finally, FDA estimates that a respondent will spend 1 hour
reading the guidance document.
Thus, we estimate that 12 respondents will each label 2 products
annually, for a total of 24 labels. We estimate that the manufacturers
will spend 7.25 hours (0.5 hours + 1 hour + 0.25 hour + 4 hours + 0.5
hour + 1 hour = 7.25 hours) on each label to comply with our labeling
regulations and the requirements of section 403(w)(1) of the FD&C Act,
for a total of 174 hours (24 labels x 7.25 hours = 174 hours). In
addition, 12 respondents will each spend 1 hour reading the guidance
document, for a total of 12 hours. Thus, we estimate the total hour
burden of the proposed collection of information to be 186 hours (174
hours + 12 hours = 186 hours). The guidance also refers to previously
approved collections of information found in our regulations. The
collections of information in Sec. Sec. 101.3, 101.4, 101.5, 101.9,
101.22, and 101.105 have been approved under OMB control number 0910-
0381. Allergen labeling of these beers under section 403(w)(1) of the
FD&C Act (21 U.S.C. 343(w)(1)), which was added by the Food Allergen
Labeling and Consumer Protection Act of 2004 (FALCPA), has been
approved under OMB control number 0910-0792.
Dated: October 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27588 Filed 10-28-15; 8:45 am]
BILLING CODE 4164-01-P
