Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration, 48322-48324 [2015-19741]
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48322
Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Skilled Nursing
Facility and Skilled Nursing Facility
Health Care Complex Cost Report Form;
Use: Providers of services participating
in the Medicare program are required
under sections 1815(a), 1833(e) and
1861(v)(1)(A) of the Social Security Act
(42 U.S.C. 1395g) to submit annual
information to achieve settlement of
costs for health care services rendered to
Medicare beneficiaries. In addition,
regulations at 42 CFR 413.20 and 413.24
require adequate cost data and cost
reports from providers on an annual
basis. The Form CMS–2540–10 cost
report is needed to determine a
provider’s reasonable cost incurred in
furnishing medical services to Medicare
beneficiaries and reimbursement due to
or from a provider. The revisions made
to the SNF cost report are in accordance
with the statutory requirement for
hospice payment reform in § 3132 of the
Patient Protection and Affordable Care
Act (ACA). Form Number: CMS–2540–
10 (OMB control number 0938–0463);
Frequency: Annually; Affected Public:
Private sector (Business or other forprofits and Not-for-profit institutions);
Number of Respondents: 14,398; Total
Annual Responses: 14,398; Total
Annual Hours: 2,908,396. (For policy
questions regarding this collection
contact Amelia Citerone at 410–786–
8008).
Dated: August 7, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–19837 Filed 8–11–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[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 or we) is
announcing an opportunity for public
SUMMARY:
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18:16 Aug 11, 2015
Jkt 235001
comment on our proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (the 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.
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 October 13, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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: 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, we are publishing notice of
the proposed collection of information
set forth in this document.
With respect to the following
collection of information, we invite
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of our functions, including whether the
information will have practical utility;
(2) the accuracy of our estimate of the
burden of the proposed collection of
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Sfmt 4703
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
section 201(f) of 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 (79 FR 71156,
December 1, 2014). 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
promulgation and enforcement of
regulations with respect to the labeling
of distilled spirits, certain wines, and
malt beverages pursuant to the Federal
Alcohol Administration Act (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 promulgated
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
E:\FR\FM\12AUN1.SGM
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Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices
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
48323
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:
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
Number of
disclosures
per
respondent
Number of
respondents
Citation
Total annual
disclosures
Average 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
12
2
2
2
2
2
2
1
24
24
24
24
24
24
12
0.5 (30 minutes) ...............................
1 .......................................................
0.25 (15 minutes) .............................
4 .......................................................
0.5 (30 minutes) ...............................
1 .......................................................
1 .......................................................
12
24
6
96
12
24
12
Total ...........................................
........................
........................
........................
...........................................................
186
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate of the number of
respondents in table 1 is based on the
number of regulatory submissions
submitted 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 number of respondents to
be 12 and the number of disclosures
annually to be 24. Thus, we adopt TTB’s
estimate of 12 respondents, and an
annual number of disclosures per
respondent of 2, in table 1 of this
document.
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Our estimates of the average burden
per disclosure for each regulation 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 101.105
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
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Sfmt 4703
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
E:\FR\FM\12AUN1.SGM
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48324
Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices
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
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, which was added by the
Food Allergen Labeling and Consumer
Protection Act of 2004, has been
approved under OMB control number
0910–0792.
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Sara
Rothman, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–3110.
SUPPLEMENTARY INFORMATION:
Dated: August 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
FDA is announcing the availability of
a final guidance for industry entitled
‘‘Guidance for Entities Considering
Whether to Register as Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.’’
On November 27, 2013, President
Obama signed the DQSA (Pub. L. 113–
54) into law. The DQSA added a new
section 503B to the FD&C Act that
created a category of entities called
‘‘outsourcing facilities.’’ Section
503B(d)(4) of the FD&C Act (21 U.S.C.
353b(d)(4)) defines an outsourcing
facility, in part, as a facility that
complies with all of the requirements of
section 503B, including registering with
FDA as an outsourcing facility and
paying associated fees. If the conditions
outlined in section 503B(a) of the FD&C
Act are satisfied, a drug compounded by
or under the direct supervision of a
licensed pharmacist in an outsourcing
facility is exempt from certain sections
of the FD&C Act, including section
502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with
adequate directions for use) and section
505 (21 U.S.C. 355) (concerning the
approval of human drug products under
new drug applications (NDAs) or
abbreviated new drug applications
(ANDAs)). Drugs compounded in
outsourcing facilities are not exempt
from the requirements of section
501(a)(2)(B) of the FD&C Act (21 U.S.C.
351(a)(2)(B)) (concerning current good
manufacturing practice for drugs).
FDA has received questions about
whether entities engaged in various
types of activities (e.g., a facility that is
compounding only non-sterile drugs or
only repackaging biological products)
should register as an outsourcing
facility. Because entities that register as
outsourcing facilities must pay a
registration fee and FDA has determined
[FR Doc. 2015–19741 Filed 8–11–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1399]
Guidance for Entities Considering
Whether To Register as Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a final guidance entitled
‘‘Guidance for Entities Considering
Whether to Register as Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.’’
This guidance is intended to inform
entities that are considering registering
as outsourcing facilities under section
503B of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as added
by the Drug Quality and Security Act
(DQSA), of the regulatory implications
of registration as an outsourcing facility.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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I. Background
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that fees paid pursuant to sections 503B
and 744K of the FD&C Act will not be
refunded, FDA is issuing this guidance
to answer some of these questions and
to provide potential registrants
additional information about the
regulatory impact of registering as an
outsourcing facility.
In the Federal Register of February
19, 2015 (80 FR 8871), FDA issued a
notice announcing the availability of the
draft version of this guidance. The
comment period on the draft guidance
ended on May 20, 2015. FDA received
eleven comments on the draft guidance.
Some of the comments raised issues that
were not directly pertinent to the topics
addressed in this guidance. FDA intends
to consider those comments as they
relate to issues being addressed in other
policy documents being developed by
the Agency.
In response to received comments or
on its own initiative, FDA made the
following changes as it finalized this
guidance: (1) Removed the reference to
a separate guidance document that
explains how outsourcing facilities
should report the products they
compound to FDA because that
guidance is not directly related to the
issue of entities considering whether to
register as outsourcing facilities; (2)
noted that FDA has issued separate
guidance documents addressing some of
the conditions of section 503B and that
it intends to publish additional
guidance addressing other conditions;
(3) added a reference to FDA’s draft
guidance regarding compounding
animal drug products from bulk drug
substances, which addresses
outsourcing facilities engaging in this
activity; and (4) made grammatical and
other minor editorial changes for clarity.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on registering as an
outsourcing facility under section 503B
of the FD&C Act. It does not create any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
E:\FR\FM\12AUN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Pages 48322-48324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19741]
-----------------------------------------------------------------------
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 we) is announcing an
opportunity for public comment on our proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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. 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 October 13, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: 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, we are publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility; (2) the
accuracy of our 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 section 201(f) of 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 (79 FR 71156,
December 1, 2014). 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 promulgation and enforcement
of regulations with respect to the labeling of distilled spirits,
certain wines, and malt beverages pursuant to the Federal Alcohol
Administration Act (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
promulgated 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
[[Page 48323]]
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.
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:
Table 1--Estimated Annual Third Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average burden
Citation respondents per disclosures per disclosure Total hours
respondent
----------------------------------------------------------------------------------------------------------------
21 CFR 101.3 and 101.22....... 12 2 24 0.5 (30 minutes) 12
21 CFR 101.4.................. 12 2 24 1............... 24
21 CFR 101.5.................. 12 2 24 0.25 (15 6
minutes).
21 CFR 101.9.................. 12 2 24 4............... 96
21 CFR 101.105................ 12 2 24 0.5 (30 minutes) 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 in table 1 is based on
the number of regulatory submissions submitted 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 number of respondents to be 12 and the
number of disclosures annually to be 24. Thus, we adopt TTB's estimate
of 12 respondents, and an annual number of disclosures per respondent
of 2, in table 1 of this document.
Our estimates of the average burden per disclosure for each
regulation 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 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
[[Page 48324]]
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: August 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19741 Filed 8-11-15; 8:45 am]
BILLING CODE 4164-01-P
